Ethical Review of Biomedical Research in the CIS Countries

Transcription

Ethical Review of Biomedical Research
in the CIS Countries
(Social and Cultural Aspects)
Saint-Petersburg
2007
Contents
BBK 51.1
Performed with the financial support of the UNESCO Office in Moscow,
UNESCO Headquarters (Paris) and also the UNICEF/UNDP/World Bank/WHO Special
Programme for Research and Training in Tropical Diseases (TDR), Saint-Petersburg,
Fenix, 2007, 360 p.
isbn 978-5-98240-033-8
This book presents the first detailed review of the historical development, current situation and
further perspectives of national systems for the protection of human rights and dignity in biology
and medicine in CIS countries: Republic of Armenia, Republic of Azerbaijan, Republic of Belarus,
Georgia, Republic of Kazakhstan, Kyrgyz Republic, Republic of Moldova, Russian Federation,
Republic of Tajikistan, Ukraine and Republic of Uzbekistan. Separate chapters are given to the
discussion of social, historical, cultural, philosophical and legal issues of ethical review of biomedical
research. They also offer an analysis of specific problems with regard to national, state and regional
situation and outline ways of integrating CIS countries into the process of global discussion on
comprehending the humanitarian and scientific mission of the research. The book raises issues
concerning fundamental interests of states, governments and other authorized institutions of CIS,
interests of leading international structures and institutions in the relevant sphere and addressed to
broad sections of the public involved into the process of ethical review of biomedical research.
This book is the result of a collective work of the members of the Forum for Ethics Committees
in the Commonwealth of Independent States (FECCIS) functioning in the framework of the Project
“Strategic Initiative for Developing Capacity in Ethical Review” (SIDCER/TDR/WHO). The authors
of this edition are leading specialists in ethics, philosophy, medicine, biology, jurisprudence, social
and economical science recognized in their countries and at the international level.
The authors are responsible for the choice and the presentation of the facts contained in this
publication and for the opinions expressed therein, which are not necessarily those of UNESCO and
do not commit the Organization.
Editor-in-chief
and Project Director: Prof. Olga KUBAR
Editorial Board: Reviewer: Prof. Galina Mikirtichian
and Assistant Prof. Anastasiya Nikitina
Prof. Nadezda Golik, Saint-Petersburg State University
Editor: Translation: Nikolay Chaika, PhD
Olga Ochkur & Dr.Valery Zvonarev
Design: Page Print: Maria Krasnova
Oksana Achmitzanova
isbn 978-5-98240-033-8
© All rights are reserved by UNESCO
© Design. Phoenix, Ltd.
INTRODUCTION (O.I.Kubar, H. ten Have) ..............................................7
Chapter 1 - General tendencies of the social policy and human rights in
medicine in the CIS countries......................................................................9
1.1.
1.2.
Social and Demographic Factors (E.Yu.Vladimirova)....................9
Ethical and Legal Issues in the Field of Biology and Medicine
(O.I.Kubar, B.G.Yudin, A.E.Nikitina, E.Yu.Vladimirova).............27
Chapter 2 - Current Status and Perspective of the CIS’ Region
Participation in the International Biomedical Research ............................46
2.1.
2.2.
2.3.
Philosophical Aspects of the Biomedical Research
(P.D.Tishchenko, B.G.Yudin)........................................................46
Characteristic of the Biomedical Research in the Region
(O.I.Kubar, E.A.Malysheva)..........................................................63
Establishment of the Ethical Review System & Ethics Committees
in the Region (O.I.Kubar, A.G.Asatryan).......................................71
Chapter 3 - Ethical Review System for Biomedical Research in the CIS
Countries ....................................................................................................89
3.1.
3.1.1.
3.1.2.
3.1.3.
3.1.4.
3.1.5.
Republic of Armenia (G.D.Aslanyan, S.A.Davtyan)....................89
Historical and Cultural Background ..............................................89
Legal Regulations...........................................................................93
Education in Bioethics...................................................................95
The System of Ethical Review.....................................................100
Perspectives and Forms of International Cooperation.................103
3.2.
Republic of Azerbaijan (A.A.Namazova, Z.G.Guseinova,
T.G.Tagi-Zade).............................................................................104
3.2.1. Historical and Cultural Background ............................................104
3.2.2.
3.2.3.
3.2.4.
3.2.5.
Legal Regulations.........................................................................107
Education in Bioethics.................................................................108
3.3.
3.3.1.
3.3.2.
3.3.3.
3.3.4.
3.3.5.
Republic of Belarus (T.V.Mishatkina, Ya.S.Yaskevich)...............114
Historical and Cultural Background ...........................................114
Legal Regulations........................................................................119
3.4.
3.4.1.
3.4.2.
3.4.3.
3.4.4.
3.4.5.
Georgia (G.Kiknadze, G.Dgaviashvily, T.Kurtanidze) ...............149
3.5.
3.5.1.
3.5.2.
3.5.3.
3.5.4.
3.5.5.
Republic of Kazakhstan (A.B.Sadykova, B.E.Sarymsakova).....163
Historical and Cultural Background.............................................163
3.6.
Kyrgyz Republic (A.Z.Zurdinov, U.M.Tilekeeva,
B.A.Alisherov).............................................................................180
3.6.1.
3.6.2.
3.6.3.
3.6.4.
3.6.5.
3.7. 3.7.1.
3.7.2.
3.7.3.
3.7.4.
3.7.5.
3.8.
Republic of Moldova (V. I.Gikavyi, I.N.Pogonea,
T.N.Tirdea, V.I.Ojovanu)..............................................................196
Historical and Cultural Background ............................................196
Perspectives and Forms of International Cooperation ................219
3.8.1.
3.8.2.
3.8.3.
3.8.4.
3.8.5.
Russian Federation (G.L.Mikirtichian, A.F.Nikitina, A.S.Sozinov,
M.E.Guryleva, E.A.Malysheva) ..................................................223
3.9.
3.9.1.
3.9.2.
3.9.3.
3.9.4.
3.9.5.
Republic of Tajikistan (S.D.Achrorova) .....................................283
Historical and Cultural Background ............................................283
3.10. Ukraine (Yu.I.Kundiev, N.A.Chaschin,
A.N.Chaschin, S.V.Pustovit, P.N.Vitte) .......................................302
3.10.1.Historical and Cultural Background ............................................302
3.10.2.Legal Regulations.........................................................................305
3.10.3.Education in Bioethics.................................................................309
3.10.4.The System of Ethical Review.....................................................313
3.10.5.Perspectives and Forms of International Cooperation.................318
3.11. Republic of Uzbekistan (M.S.Abdullakhodjaeva).......................323
3.11.1. Historical and Cultural Background ............................................323
3.11.2. Legal Regulations........................................................................329
3.11.3. Education in Bioethics.................................................................340
3.11.4. The System of Ethical Review.....................................................344
3.11.5. Perspectives and Forms of International Cooperation.................349
Chapter 4 - The Perspectives for Global International Harmonization the
Ethical Review of Biomedical Research in CIS Countries (O.I.Kubar,
G.L.Mikirtichian) .....................................................................................353
INTRODUCTION
(Olga Kubar, Henk ten Have)
The current scientific and technological evolution in the field of
biomedicine is characterized by the growing importance of the role of
universal ethical values relating to the protection of human rights and
dignity. This tendency becomes particularly essential in the course of deep
social and cultural changes that have been happening during the last decades
in the post-Soviet space. The development and implementation of the new
countries’ national policies in the field of ethics and bioethics by bringing up
initiatives and consolidating activities in lawmaking, education, creation of
the system for the ethical review and international cooperation is presently
one of the topical issues. Thus the process of forming the Commonwealth
of Independent States (CIS), as a new concept of multilateral cooperation
that has united eleven member countries (Republic of Armenia, Republic of
Azerbaijan, Republic of Belarus, Georgia, Republic of Kazakhstan, Kyrgyz
Republic, Republic of Moldova, Russian Federation, Republic of Tajikistan,
Ukraine and Republic of Uzbekistan), gave rise to a unique experience of
a dynamic legislative, administrative and informational development in the
sphere of ethical regulation in biomedicine.
The actual necessity to analyze and systematize factors and conditions
influencing the development of ethical review in CIS countries with the
view of understanding perspectives and potentials of their interaction in the
global aspect of research ethics stimulated the Forum for Ethics Committees
in the CIS (FECCIS) to initiate the project of writing this book. The project
was presented within the framework of regional expert consultations on
the development of cooperation in the field of ethics and bioethics in CIS
and Baltic States organized by the UNESCO Moscow Office. The Division
of Science and Technology Ethics within the Social and Human Sciences
Sector at UNESCO Headquarters supported the project.
The structure of the book is intended to present a socio-demographic
characteristic of the CIS countries and their current situation, as well as the
perspectives of their involvement in the international system of biomedical
research as the basis of setting out ethical and legal tendencies in biomedicine.
Chapters presenting the analysis of the development of ethical review system
in CIS member countries describe all the variety of historical and cultural
tendencies and specific national experiences in this sphere.
Authors have used the results of the interaction between the CIS
countries in the framework of FECCIS and the Permanent Commission on
Social Policy and Human Rights of the Inter-Parliamentary Assembly of the
Commonwealth of Independent States (IPA CIS). Elements of UNESCO
and WHO programmes that outline general frames and set out fundamental
principles and conditions for international cooperation in working out and
implementation of national policies in bioethics formed the conceptual basis
of the book.
We do hope that the materials presented in this book make a
comprehensive and realistic picture of the current conditions and perspectives
of ethical review development in the CIS countries and will facilitate free
exchange of knowledge in this field for the mutual benefit. By providing
information on the CIS region potential for cooperation and education in
the sphere of bioethics and biomedical research ethics, the project makes an
important intellectual and informational contribution into UNESCO Global
Ethics Observatory.
Chapter 1. GENERAL TENDENCIES
OF THE SOCIAL POLICY AND HUMAN RIGTHS
IN MEDICINE IN THE CIS COUNTRIES
1.1 Social and Demographic Factors (E.Yu.Vladimirova)
To develop a system for the ethical review of biomedical research, we have
to consider the current social and economic situation in the Commonwealth
of Independent Countries. A state can ensure reproduction of population and
a high level of a living standard for its residents if it does not participate in
regulation of the current demographic situation and labour market.
The demographic situation in the CIS countries has both common
and specific features. Common features result from a long-term socioeconomic crisis of the 1990s, discrepancy between introduced reforms
and social policy, a dramatic decline in living standards at various social
levels, and aggravation of ecological conditions. Specific features in each
State are determined by different styles of life in the CIS countries due to
their historical, religious, cultural and ethnic development. All these factors
resulted in a general fertility rate decrease, mortality growth and a fall of
the health quality index. These processes affect negatively the demographic,
labour and migration potential of the CIS countries.
The last decade of the XX century was characterized by an essential
aggravation of the demographic situation that could be defined as a crisis.
High mortality rates had practically no precedents in the Eurasian peacetime
history. The “excess mortality” in the period since 1989 was much higher
than the mortality rate in the period of Great Depression in the North America
(1929-1933). Besides, recent changes of mortality rate, marriage ability and
fertility shifts have been no less sharp than those generally typical of the
wartime. The increase of the mortality rate due to cardiovascular diseases,
suicides, homicide, alcoholism et al. results from a drastic increase of the
social stress, the typical feature of which is a painful response to new and
unanticipated situations.
The main causes of stress are impoverishment, unemployment,
migration, divorces and family disruption, the death of relatives, the loss
of hope and security, the fear of the future, the growth of criminal offence
rate, conflicts at work and in the family. “The crisis of social adaptation” is
10
Labour Market in the countries of the Commonwealth of Independent States. М. 2005, p.11
Population census: Azerbaijan, Belarus, Kazakhstan and Kyrgyzstan; Tajikistan -- 2000; Armenia and Ukraine – 2001; Russia and
Georgia – 2002; Moldova – 2004. The census in Turkmenistan was conducted somewhat earlier – in 1995, as it was planned to carry
out a social and demographic analysis there; however, the question about the analysis is still undecided, as well as the question bout
the census in Uzbekistan
Resident population data in 2005-2006 are in accordance with the data of CIS Statistical Committee: “15 years of CIS”.
* here and henceforth Turkmenistan data are given to present most fully the migration of the population
in the region of Central Asia
Table 1
Resident Population*
(Beginning of the year, million people)
aggravated by the collapse of political, social and economic structures and
the change of moral values that had been guiding peoples’ life for decades.
Thus, the collapse of a customary life style led to social hardships in addition
to those relating to the difficult situation and socio-psychological stress.
These social complications include a rapid deterioration of the healthcare
system, degradation of the quality and narrowing of the range of public
services, vague administrative legislation, drastic increase in crime, and
social chaos. It is obvious that we should apply efforts to the reformation
of the “sick” economics and weak social sphere. However, to raise the
population’s quality of life and to maintain the level of labour resources for
generations participating in the economic life, we need to retain the major
achievements of the past in education, childcare, preventive and sanatoriumand-spa medicine.
At present, the demographic crisis in the majority of the CIS countries
still poses a threat to the social stability and to the whole process of
reformation; however, there is a certain stabilization of the situation.
Let us consider changes in resident population of the CIS countries and
Turkmenistan in the period from 1991 to 2006. (Table 1).
The presented data show the increase of population in Azerbaijan,
Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan
considering the change in the tendencies of population reproduction.
The population in the CIS member-countries is about 5% of world
population. The population density in the CIS countries varies from 69 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129
persons in Armenia and Moldova. Thus, the average population density in
the CIS countries is 13 persons per sq. km. For comparison: the population in
the European Union (EU) makes 7% of world population, while the average
density of population in the EU is 114 persons per sq. km. Over 66% of Belarus,
Armenia, Ukraine, and 73% of Russia population are city residents. In the
territory of the CIS there are 24 cities with the population over 1 million.
Since 1990, the fertility rate in all the CIS countries has been decreasing.
Moreover, in Ukraine (since 1991), in Russia (since 1992) and in Belarus
(since 1993) a natural decrease of population was registered. Thus in Russia
the number of deaths in 1993 exceeded the number of births by 800,000.
That was the lowest fertility rate (9.4 of births per 1000 of population)
among all the CIS countries.
11
We should note that 1993 was one of the most hard years in the
demography in the CIS countries, as the fertility rate decreased in all CIS
countries (except Tajikistan). In comparison with 1986, when the highest
fertility rate in the USSR for the last 50 years was registered, the fertility rate
in 1993 in the CIS countries decreased by 33% (and by 8% in comparison
with 1992, which is much enough in terms of annual oscillations) and
was 13.5 births per 1000 of population. The number of deaths in 1993 in
the CIS countries was 3.6 million, and increased, in comparison with 1992,
by 429,000. The general mortality rate increased by 14% and was 12.6
deaths per 1000 of population.
The growing share of elder people and a decreasing weight of children
in the total population are typical for the majority of the CIS countries. This
is connected with worldwide tendencies to population ageing and a drop in
birth rate, as well as with the crisis at the end of the 20th century. In six of the
CIS countries even the simple reproduction of population is not achieved,
i.e. the total fertility rate (see below) is equal to or less than 2.1. These
countries are Armenia, Belarus, Georgia, Moldova, Russia and Ukraine
Belarus, Georgia, Russia and Ukraine are noted for the ratio of persons
over 65 to the so called economically productive persons (at the age of
15-64), and Kyrgyz Republic, Tajikistan, Turkmenistan and Uzbekistan,
where the age-dependency ratio is 2-3 times higher than in Belarus, Russia
and Ukraine, stand out for that of children under 15.
The greatest reduction of the able-bodied population in comparison with
1989 is observed in Georgia (by 20% for males and by 18% for females)
and Ukraine (by 3,8% for males and by 4,9% for females). A significant
increase of the able-bodied citizens (by 26-47%) is registered in Azerbaijan,
Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
The increase in the number of young people has a favorable effect on the
increase of the total population, and the growing number of early marriages
implies a perspective of a sooner birth of the first children and the increase
of the total fertility rate.
During last four years in the majority of the CIS countries no decrease
of the fertility rate was registered. On the contrary, in 2003-2004 it has
slightly increased. This process can be related to some stabilization in
“Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional
Monitoring Report. Florence, 2005, p. 23.
12
social and economic situation in the CIS countries, as well as to the fact that
people, born in the middle of 1980-s when the birth rate in Soviet Union was
relatively high reached the fertility age.
At the beginning of 2005, the population size in the CIS countries was
279 million people (according to the Statistic Committee). In comparison
with the beginning of 1991, the population has reduced by 2.7 million
people or 1.0%.
By the type of demographic processes in the 90-s the CIS countries
were divided into two groups. In the first group including Ukraine, Belarus,
Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
been decreasing from year to year. The second group includes Azerbaijan
and Republics of Central Asia where the population and the demographic
potential kept on increasing. At the same time, as it was mentioned above,
depopulation processes in Belarus, Russia and Ukraine are increasing, which
means that the death rate exceeds the birth rate. This results in the increasing
polarization of the two groups of CIS countries by the demographic potential,
and hence creates, in prospect, additional preconditions for its redistribution
between countries through migration processes. (Table 2).
During last years in the majority of the CIS countries, the reduction
of the fertility rate was not registered. On the contrary, in 2003-2004 it has
somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed
in all age groups, in Belarus and Ukraine – at the age of 30 and older. At the
same time, the highest fertility rate is still registered in women at the age of
20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia,
Moldova, Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan
and Kyrgyzstan, 143 – in Kazakhstan).
Monitoring Report. Florence, 2005, p. 26.
In the previous decade – in the 1980s – the population in former Soviet Republics, except
for Baltic States, increased by 22.6 mln of people (8.7%).
13
CIS Statistic Committee. The data may be specified in connection with the population change in the period between population census.
Arbitrarily: at the age of 15-49. When calculating the coefficient for the age group under 20, the number of women at the age of
15-19 was used as denominator; when calculating the coefficient for the age group 15-49 years, all births, including those in mothers
under 15 and over 49, were taken into account in numerator.
3)
The cumulative fertility rate shows an average number of children a woman might give birth to throughout her life if the existing
fertility rate for each age remained the same. To ensure a simple reproduction, the value of this index should not be lower than 2,1.
Fertility in the CIS countries
1)
2)
Table 2
14
The increase of the age-specific rates results in the increase of the total
birth rate (the total birth rate is the sum of the age-specific fertility rates in
the age range of 15-49 years; it shows the average number of children born
by one women in her life if for every age the fertility rate remained the same
as it was in the year for which the age-specific rates were calculated). The
most significant increase of the fertility rate was in Kazakhstan where the total
fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent
data, the average value of this index in the CIS countries is 1,9 of births per
one woman. The half of the population of the CIS lives in the countries where
the simple reproduction of the population is not reached, i.e. this rate is below
2,1 (1,38 in Armenia (2004), 1,20 in Belarus (2004), 1,40 in Georgia (2003),
1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).
The problem of saving life and health of newborns is particularly
important especially considering the long period of fertility decrease. In
spite of a marked reduction of the infant mortality in all CIS countries in
recent years, its level remains very high. The infant mortality rate in the CIS
countries is much higher than that in the developed countries where its value
is 3-5 deaths during the first year per 1000 newborns. (Table 3).
About a half of dying infants falls to the share of the babies of the first
year of life, nearly 70% of which die in the first week. The prenatal mortality
rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
days and still-borns per every 1000 of births. The causes of these deaths are
respiratory states typical for the prenatal period, cases of the fetal asphyxia
and asphyxia at birth.
In many respects, a high death rate registered in the majority of the CIS
countries over a long period can be explained, by the population ageing and
by the decrease of the quality of life and health. At the same time, the number
of births per 1000 population in the countries of the European Union is less
(at the average 11,1) than in Azerbaijan (24,2), Kyrgyzstan (26,1), Tajikistan
and Turkmenistan (33,1). However, in spite of the high population ageing
rate, the number of deaths in the EU countries is lower (10,1) than in the CIS
countries (12,6), which in it’s turn, may be explained by the level of preventive
measures and healthcare in general, and by the social-economic situation in
the CIS countries.
Monitoring Report. Florence, 2005, p. 62“.
15
“Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence, 2005,
p. 74.
Infant mortality in the CIS countries
1) Mortality of the viable fetus in the period from the 28th week of pregnancy up to the beginning of the delivery, during the delivery
and infant mortality during the first week.
Table 3
16
The natural increase of the population is the main source for advanced
reproduction of labor resources at a certain territory. According to the data
shown above, in the CIS countries two types of reproduction prevail that
may by characterized as simple and reductive. If the simple population
reproduction requires the numeral equality of the parent and children
generation, the current level of survival rate (including the average life
expectancy) requires 250-260 births per each 100 families. The birth rate
corresponding to such a level is registered only in some CIS countries,
such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
and survival, as exogenous characteristics of the population reproduction,
form its endogenous characteristics, i.e. age structure of population and
also the measure of the population growth (net coefficient of population
reproduction) and, hence, the actual level of the natality. The Russian
Federation shows a tendency to a reductive reproduction of the population;
however, in some years the increase due to the migration has compensated
the natural decrease of the population, which is not so typical for Moldova,
Belarus and Ukraine. Therefore, the total population size has not reduced.
During the last five years the natural decrease of the population in the
Russian Federation has prevailed over the increase due to the migration,
which has decreased after 1994, and the total number of citizens began to
decrease steadily.
The population structure and the morbidity level characterize the
general social-demographic situation in the CIS countries.
Diseases of blood circulation system that are typical causes of death
in elder people, take the leading role among the main causes of death.
In 2003, the male mortality by this cause was 41% of deaths in Kyrgyzstan,
45% in Kazakhstan, 48-49% in Russia and Moldova, 50% and more in
Azerbaijan, Armenia, Belarus and Ukraine. Female mortality from these
diseases is somewhat higher – 55-61% of female deaths (in Ukraine – 72%).
(pic. 1 and 2).
17
female
– 7%).
(pic.more
andin).
49% in deaths
Russia(in
andUkraine
Moldova,
50% and
Azerbaijan, Armenia, Belarus and
Ukraine. Female mortality from these diseases is somewhat higher - 55-6% of
Diseases
of blood–circulation
female deaths
(in Ukraine
7%). (pic. system
and ).(per 100 000 of population)
6000
5000
Diseases of blood circulation system (per 100 000 of population)
6000
4000
5000
000
4000
000
000
000
Ukraine
Ukraine
Russia
Russia
Moldova
Moldova
Kyrgyzstan
Kyrgyzstan
Kazakhstan
Kazakhstan
Georgia
Georgia
Picture 1.
Belarus
Belarus
0
Armenia
Armenia
000
Azerbaijan
Azerbaijan
000
0
Picture 1. Diseases of blood circulation system (per 100 000 of
Picture
1.
population)
Mortality
from diseases of blood
circulation system (per 100 000 of
population)
Mortality from diseases of blood circulation system (per 100 000 of
population)
000
800
000
600
800
400
600
00
400
Picture 2.
Picture 2.
000.
Ukraine
Ukraine
Russia
Russia
Moldova
Moldova
Kyrgyzstan
Kyrgyzstan
Kazakhstan
Kazakhstan
000.
Georgia
Georgia
Belarus
Belarus
Armenia
Armenia
0
Azerbaijan
Azerbaijan
0
00
004 (Georgia – 00).
004 (Georgia – 00).
Picture 2. Mortality from diseases of blood circulation system
Malignant tumors (respiratory
organs
– in Kyrgyzstan) are in the
(per 100
000 ofdiseases
population)
Malignant
tumors
(respiratory
organs diseases – in Kyrgyzstan) are in the
second
place among
female
death causes.
second place among female death causes.
Malignant tumors (respiratory organs diseases – in Kyrgyzstan) are in
the second place among female death causes.
Malignant tumors as a death cause in men are in the second place in
Azerbaijan (88 deaths per 100000 of population in 2003) and Armenia
(160). The male mortality rate from suicides and other external causes
in other countries is higher than the mortality rate from cancer. In 2004
this index in Belarus was 281 deaths from external causes10 per 100000
of population, which is slightly higher than the mortality rate from the
malignant tumors (240); in Kazakhstan – 232 (142), in Kyrgyzstan – 110
(64), in Moldova – 162 (158), in Russia – 390 (236), in Ukraine – 258
(236). (Table 4).
In Belarus, Kazakhstan and Russia the mortality rate for males from
external causes is 4-5 times higher than that from diseases of respiratory
and digestion organs. Nearly 40% of deaths by these causes falls to the
share of working citizens.
On the average, in recent 15 years (in comparison to 1989) the male
mortality rate at the age of 15-64 has increased: in Belarus – by 41%,
in Kazakhstan – by 46%, in Russia – by 70%, in Ukraine – by 46%. In
Kyrgyzstan and Moldova the mortality rate of males at the age of 35-64
has been increased by 20% and 25% respectively.
The female mortality rate in women of working age is somewhat
lower than that for men, but the scale of its increase is the same. Thus
in the indicated period the mortality rate for females in the age 15-64
has increased in Kazakhstan by 32%, in Russia – by 62%, in Belarus and
Kyrgyzstan (for the age of 30-64) – by 30% and 14% respectively, and in
Ukraine (for the age of 20-64) – by 42%.
The most comprehensive index of the population health and of the
labor resources is the life expectancy. Since the beginning of the transition
period, it has decreased in the majority of the countries. (Table 5).
18
19
Mortality by main groups of death causes in 2004
1) 2003.
2) 2000.
3) From neoplasm.
4) 1995.
5) 2001.
20
Table 4
Table 5
Life expectancy in people of certain age1) in several CIS countries
1) Life expectancy is the average number of additional years a person could expect to live if
current mortality trends were to continue for the rest of that person’s life.
21
The significant increase of the total mortality rate and the decrease of the
life expectancy at birth, as shown above, affected different age and sex groups
with different intensity. First, the increase of mortality concerned males more
than females. This growing disparity resulted in the increase of the number
of incomplete families and widows, aggravation of the existing disbalance
(as will be shown below) in the sex structure, reduction of nuptiality and
population reproduction potential, and in a growing difference of the lifespan
between the sexes. In spite of substantiated expectations, the high mortality
rate in the period of transition at the early nineteenth did not affect seriously
those population groups that usually are considered as particularly vulnerable
due to biological or social causes, namely children and elder people. Perhaps
the most remarkable feature of this recent population health crisis became a
significant increase of the mortality rate for age groups of gainfully employed
population. The most drastic relative growth of the mortality rate for adult
males was registered in the group of “blooming age” i.e. at the age of 35-49,
which is most typical for Russia. As to females, the mortality changes had
unequal intensity, and the increase of mortality here was less marked, but it
affected exactly the “blooming” age group from 35 to 49 years.
As we know, the population reproduction depends mostly on two
factors: firstly – on the ratio of marriages and divorces; secondly – on the
ratio between males and females at the fertile age. As to the first factor,
in the conditions of the increasing youth unemployment, rapidly growing
prices housing costs and uncertain prospects, the nuptial ratio has decreased
in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation).
The decrease of the nuptial ratio for persons in the second marriage in all
countries was even sharper. An average decrease of this index was 28%; only
in Ukraine the increase of the nuptial ratio was registered, but in 1993 the
fertility in this country has decreased dramatically (by 20%), and hence the
hopes associated with the nuptial ratio were not justified. In contrast to the
number of marriages the number of the divorces was growing. The second
factor is also unfavorable. The female population exceeds male population,
and this ratio becomes worse with every new age group.
Thus, the marriage/divorce ratio, as well as male/female ratio determines
negative tendencies in demographic situation in the CIS countries. The
mentioned ratios have a negative impact on the generation renewal, and
retain conditions for a narrow reproduction.
22
When considering the situation we should note that the most dramatic
aggravation was observed in the areas of the income per person, poverty,
demography and social unity, which is essential for understanding socialeconomic conditions of the healthcare system development, and the
motivation of the CIS countries for integrating into the international system
of biomedical research both from a viewpoint of interested researchers and
potential participants.
In the period of transition to the market economics all the CIS countries
had to face such problems as considerable inequity in the income distribution,
stratification of the society by income and increasing poverty. In 2004, the
ratio of the total income of 10% of the most and 10% of the least well-todo population was 3-5 times in Azerbaijan, Belarus and Ukraine; 11 times
in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in
Armenia.
In recent years (2005-2007), in the majority of the CIS countries some
smoothing of the society stratification by income and the decrease of the
population quota with the income beyond the cost of living (poverty line)
was observed.
Some processes were observed in the CIS countries that were not typical
before. Thus, the number of the “poor” children usually was growing much
faster than the number of poor persons in every other age group because of
the rapid spread of the unemployment and increasing number of persons in
a low-paid job, alongside with a disproportional indexation of the family
allowances. The level of food consumption by children has considerably
decreased. Presently, the change in the nutrition structure is expressed by
transition to food products that are less expensive and richer in calories.
There is a lack of food products that are necessary for the normal growth
and development of the organism. Besides, a decrease in food consumption
and the worsening of the sanitary situation, hygiene and living conditions
have caused the increase of the number of diseases (tuberculosis, rachitis)
traditionally associated with poverty.
Specific features of the demographic situation and, indirectly, the
amount of labor resources depend also on the age groups prevailing in the
total population size, which, in its turn, implies special approaches to the
healthcare structure development in the CIS countries. The increase of
23
the elder population and the decrease of the share of children in the total
population are typical for the majority of the CIS countries.
In fact, during the period from 1989 to 2004 in all the CIS countries the
part of population under working age decreased. This especially concerns the
age group under four. The part of working population did not decrease due to
the generation born in the period from the late 70s to the mid-80s (time interval
characterized as a period of the highest fertility rate). At the same time, on the
average, the part of the population over working age has increased, which, as
shown above, alongside with the decrease of fertility and, consequently, the
decrease of the population under the working age, can lead to the population
ageing and the decrease of the population initiative and economic activity.
The number of children under 16 in the CIS countries is nearly 80
millions. Compared with 1989, the part of children under 16 in the total
population size of the CIS countries decreased by 11%. The youngest is the
population of Azerbaijan and Armenia where children make 35 and 29%
of the population. In the countries of Central Asia, due to a relatively high
fertility, children make on the average 39-45% of the total population. If we
consider the demographic situation in the Russian Federation, particularly
with regard to children, it should be noted that during the 90-s the number of
births was by 60 millions less than in the 80-s. In recent decade, the children’s
morbidity has increased dramatically. The most disturbing is the fact of the
mental health worsening, since in recent ten years the rate of mental diseases
in children doubled, that of moronity increased in 1.5 times and imbecility in
1.6 times. We have to recognize the growing number of disabled children; in
the CIS countries there are about 1.5 million disabled children. Undoubtedly,
this situation requires urgent measures aiming to provide preventive care to
future mothers and to ensure a compulsory free medical care. Unfortunately,
statistic data show the opposite. During the last five years, the CIS countries
have a tendency of reducing the number of hospital beds for children. This
is typical for the majority of the CIS countries, but the most complicated
situation is observed in Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan,
Uzbekistan and Ukraine. Besides, the number of doctors and other medical
professionals is decreasing. Non-involvement in any social associations and
the lack of meaningful occupation for children are also contributing to the
growth of teenagers belonging to a “risk-group”.
24
The spread of drug addiction, drug abuse and alcoholism among
children is becoming a serious problem. In recent 10 years the morbidity
level due to these causes has became 10, and in several regions even 14,
times higher. Consequently, there is a serious threat of HIV in teenagers. In
the CIS countries nearly 150 000 children are drug addicts. Every five years
the amount of drug addicts in the “youngest” group is increasing by 100%.
The children morbidity with venereal diseases is also connected with the
above-mentioned phenomena. According to the data provided by Russian
physicians, the syphilis morbidity rate in the group of 15-17 year females
exceeded the level of 1990 by a factor of 68.
To sum up, we may state that the beginning of the period of reforms,
accompanied by a drastic fertility decrease and a dramatic mortality increase,
civil wars and interregional armed conflicts was marked with a significant
fall of the population size in all CIS countries. Today, due to the strengthening
of the national state system in the independent states and stabilization of
their economic situation, the CIS countries may be divided into two main
groups. The first group includes countries in which the fertility rate indicates
the possibility for the simple reproduction of the population, and where in
the case of an essential improvement of the economic situation the extended
reproduction may be expected (Azerbaijan, Kazakhstan, Kyrgyzstan,
Tajikistan, Uzbekistan). In the countries of the second group the process of
the natural population loss takes place due to the various reasons (Armenia,
Belarus, Georgia, Moldova, Russia, Ukraine).
To summarize the analysis of the demographic situation, it is necessary
to note that with regard to self-preservation the following public processes
are crucial:
- depopulation of the nation through the decrease of the average
lifespan, increasing total mortality and mortality in able-bodied population,
“rejuvenation” of some diseases, spread of alcoholism and drug addiction;
- the change in consumption of genetically habitual food products,
decrease in food calorie content for the considerable part of the society;
- reduced access to social services in conditions of a large-scale
commercialization, which negatively affects the quality of human resources,
intellectual, scientific and physical potential of the country;
25
- the decreasing number of medical institutions; a level of the population
morbidity and mortality still remains high; the number of handicapped
people is increasing;
- stratification of the society by income, when 10% of the most wellto-do population have incomes more than 10 times higher than 10% of the
least successful people;
- increasing severity of indigence and poverty, both absolute and
relative. There is a formation of a stratum of the “nouveau paupers” among
economically active able-body population, which, in its turn, leads to a
noticeable decrease of the motivation for efficient work;
- situation with unemployment and physical survival of the unemployed
is getting more and more complicated, and the period of long-term
unemployment is increasing;
- low efficiency of target social assistance; (International Labour
Organisation – ILO, evaluates the efficiency of social assistance programs
by weight of amounts received by families beyond the poverty line in total
amounts of social support).
26
1.2 Ethical and Legal Issues
in the Field of Biology and Medicine
(O.I.Kubar, B.G.Yudin, A.E.Nikitina, E.Yu.Vladimirova)
Characterizing trends of legal and ethical control in the sphere of
practical health care and biomedical research in the CIS member states it is
necessary to emphasize a multilevel system of factors determining common
pattern of directions, characteristics, features and mechanisms of national
and international, retrospective and perspective influence. A rationale for
forming of the given community is geographical closeness, unity of political
history of the pre-Soviet and Soviet periods, contingency and interpenetration
of cultures and traditions, forming extreme ethnical, cultural and religious
multiplicity making countries in the region different.
By itself such multiplicity leads, in particular, to the following - the set
of actual ethical norms being a basis for medical care in the region countries
is a historical foundation and a clear reflection of tolerance concepts both
to cultural differences as they are and to their particular carriers. Moreover,
in this case we can talk not just about tolerance but also about respectful
relationship to differences of that kind.
One more factor, which should be taken into account when explaining
closeness of ethical and legal basis of health care, is that other countries in
the region inherited legal base that was established in the Soviet period of
their history. It should be noted that the legal system existing in the USSR
in the field of medicine and health care, first, was of declarative nature,
and, second, paid insufficient attention to issues of protection of rights and
dignity of both patients and participants of biomedical research.
Therefore, after the USSR breakup and appearance of new independent
states they faced tasks of development of new legal framework in the field of
practical and experimental biomedicine. All CIS countries in different forms
proclaimed such basic norms of state development as adherence to principles
of a social state, which policy is directed for creation of conditions providing
dignified life and free development of a man, acknowledgement of a person,
his rights and freedoms as top values, while compliance with and protection
of human and citizen rights and freedoms is a state obligation. In accordance
with these principles reflecting statements of both the Universal Declaration
27
of Human Rights adopted by UN in 1948 and other international documents
in this field, the legal framework of the CIS countries started to be formed.
Certainly, today far from all provisions and principles are actually
implemented into the practice of health care and biomedical research; the
same should be noted about more specific enactments being directly related
to the given sphere. They are more of being a kind of beacons that one
should focus on either developing legal and ethical norms and on their daily
implementation than as an actual measurement of achievements.
Thus, determining approaches to analysis of trends and tendencies in
building up a system for legal and ethical regulation in the sphere of practical
health care and biomedical researches in the CIS countries the following
most important factors shall be distinguished:
1. Historical community based on socio-cultural and economic
inheritance being present among the Commonwealth countries;
2. Global international interaction;
3. Realia of regional cooperation among the member states.
Among elements defining starting positions of new concept development
for ethical and legal regulation in the CIS countries as carriers of the
historical community, first of all, it is necessary to note a common health
care model and a common standard for an education system. Closeness
of these fundamental systems in many aspects is determined with various
conceptual and legal factors, which action is exhibited even under current
circumstances and that bear both positive and negative issues.
If one takes into account that in any society actually implemented (but
not only declared) medical ethics is a set of interrelated factors such as status
of medical and biological knowledge and its development rate, structure of
relationships between physicians and patients, physicians and patient relatives,
relationship pattern within a professional medical community, attitude of
medical workers to medical confidentiality and professional duties and so on,
it is necessary to emphasize both affinity of the CIS countries basing on these
parameters and their uniqueness comparing to other world regions.
Historically the leading ethical theory in the regions was ethics of
virtue within which framework the leading role is given to moral qualities
of a person – in medical context of personality of a physician who
developing relations with patients and patient relatives should possess
not only professional skills and knowledge but also such moral qualities
28
as sympathy, amicability, responsibility, ability to listen to, to understand
arguments, apprehensions and doubts of their patients. In its entirety these
qualities were commonly considered as medical (or physician) ethics which
development was the mostly intense in pre-revolution Russia at the edge of
the XIX-XX centuries.
However, soon after the October revolution of 1917 medical ethics
was apprehended by authorities including medical ones as something
incompliant with new social statements. Accusations of the existing
ethical concept were focused on two issues: first, the given ethics concept
as a phenomenon of existing social framework was bourgeois and, thus,
unacceptable in conditions of the new state. Secondly, traditional medical
ethics was criticized as corporate, thus, the one that protects interests of
only one medical corporation rather than all progressive classes. As a result,
there appeared the situation when for many years medical ethics existed
only at the level of those values and statements that were characteristic for
relationships of medical doctors educated before the revolution in 1917.
In regard to a new generation of physicians being taught after the October
revolution they were able to acquire ethical values and statements only as an
oral tradition due to daily contacts with their older colleagues.
Medical ethics revival in the Soviet period can be dated to 1944 when
outstanding surgeon Petrov N.N. published an article followed with a small
book related to deontology issues in surgery. According to his definition
“under the term of medical deontology we … should imply a teaching on
principles of behavior of medical personnel aimed not on reaching individual
wealth and general respectability for some doctors and their co-workers but
on maximal increase of social usefulness sum and maximal elimination of
harmful consequences of inferior medical practices.”
In about 20 years after these works by Petrov N.N. a subject matter of
medical deontology started to draw rather wide public attention that can be
perceived as revival of medical ethics in the USSR. Medical deontology was
One should note that the term “deontology” is used with two different meanings. First,
deontology is understood as a specific type of an ethical theory where a crucial definition is a
concept of obligation; thus, personal actions are analyzed and assessed from the point of view
to what extent they are fulfillment of a personal obligations by an individual. The most well
known representative of deontological ethics is the German philosopher, I.Kant. In medical
context this term is used with different, narrower meaning – deontology in this case implies a
teaching on professional duties of medical workers in regard to their patients.
29
included into curriculum of medical schools. At that, however, it was not
distinguished as a separate subject – it was to be taught by those professors
having classes on their medical fields. Therefore, within the study course
there was simply no time to highlight medical deontology issues.
A very important factor determining particularities and complexity of
relationship development during a research process was characteristic for
the entire medical community in the USSR paternalistic attitude among
doctors and patients, peculiar standoff of health care professions (no public
discussion on problems and errors, corporate spirit of medical workers) and
strict vertical pattern of administration resulting in dependence of actions
and making decisions.
The common features being found at appearance and development of
bioethics in the region are worth of specific attention. For a long time the
region countries were out of global international dialogue on bioethics issues,
therefore, they despite of their particular experience and specific approach
to ethical issues in health care were not represented in the international
bioethical society at a long run. Such isolation brought forth several
considerable consequences: relatively poor development of major bioethical
potential in the CIS countries and deficiency of capabilities for maintaining
direct contacts with members of international bioethical community, in
particular, due to limited knowledge of foreign languages for professional
use and insufficient acquaintance with basic foreign publications.
At the same time, within the community of the CIS countries there is a
unique opportunity for international communication since not only majority
of citizens but also specialists use a single instrument for communication,
the Russian language. Development of bioethics in the CIS countries started
about 20 years ago; one of the strongest impulses emerged after the first
contacts of Soviet philosophers and medical researchers with their foreign
colleagues at the end of the 1980’s. After the USSR break-up bioethics in
the region developed in different conditions but, at that, there were present
both stable cultural peculiarity and links among the region countries. The
most important instrument influencing rates and pattern of the bioethics
development is creation of special national facilities that having different
structure and functions in some cases are entitled to adopt and implement
mandatory decisions in the field of bioethics. Besides, all CIS countries
have more or less main and similar resources for dynamic development of
30
bioethics, and among them – teaching bioethics as a subject (mandatory
or optional) in medical colleges and universities as well as at departments
of philosophy in some of state universities; definite (though, in general,
far from being sufficient) interest to ethical issues from the side of those
working on legislation in the field of science and health care; development
of corporate ethics and national associations on ethics; stimulating
influence of research ethics; wider public interest to the bioethics issues
being discussed in mass media.
Besides factors of general social and economic development influencing
peculiarity and unity of the situation in this sphere, global impact was
provided by common cultural and educational environment based on
both advanced humanistic traditions of medicine and on capabilities for
interaction and mutual influence of different cultures in the given territorial
and historical space. Such specifics exist despite considerable cultural and
religious differences between populations of European and Central-Asian
countries of CIS. In particular, it is necessary to mention influence of
religious traditions in the Commonwealth countries on forming of bioethics
models currently acting there as well as models of research ethics. Likeness
in perception of moral and cultural values is built on the fact that among
population of the CIS countries (mostly it is related to the Russian population)
one can meet representatives of virtually all ethnical, religious and cultural
groups existing in the region in general. It means that multiplicity that can
be observed within the CIS countries to some extent repeats multiplicity of
population of separate countries that is especially characteristic for scientific
and medical creative environment formed during many years.
It is really hard to overestimate a role, which is played by the factor
of involvement of all Commonwealth countries in the process of global
international interaction, for creation of single approaches to collaboration
in ethical and legal sphere. It is related both to incorporation by the new
independent states into their legal systems of a set of international ethical
and legal acts which they joined to during existence of a single country, the
USSR, and to modern involvement of the CIS countries into international legal
and informational environment. It appears to be of tremendous importance
that officially each of the countries declared adherence to all major norms
and principles stipulated by such international and legal documents as the
Nuremberg Code of 1947, the Declaration of Helsinki of the World Medical
31
Association (WMA) of 1964 with amendments, International Ethical
Guidelines for Biomedical Research Involving Human Subjects developed
by CIOMS and WHO in 1982 and amended in 1993 and 2000, International
Guidelines for Ethical Review of Epidemiological Studies, CIOMS, 1991,
Guidelines for Good Clinical Practice (ICH GCP), 1996; Operational
Guidelines for Ethics Committees that Review Biomedical Research (WHO,
2000) with additional document of 2002, Convention for the Protection
of Human Rights and Dignity with Regard to the Application of Biology
and Medicine: Convention of Human Rights and Biomedicine (Council of
Europe, 1997) and adopted in addition thereof Additional Protocols including
the Protocol on Biomedical Research, Universal Declaration on Bioethics
and Human Rights (UNESCO, 2005), Universal Declaration on the Human
Genome and Human Rights (UNESCO, 1997), International Declaration on
Human Genetic Data (UNESCO, 2003) and a number of other documents
which current total list includes more than 150 publications. Regretfully,
among six CIS countries being current members of the Council of Europe
such basic document as the Convention on Human Rights and Biomedicine
are currently signed only by three – Georgia, Moldova, Ukraine; and it is
only Georgia that actually ratified it. At the same time, acknowledgement of
high authority of the Convention in this or that form is generally common
for virtually entire bioethical community in all CIS countries.
The international enactments mentioned above became a basis for
legal regulation of biomedical research and their ethical review in all CIS
countries (detailed analysis of legal participation of a particular country in
any of international documents – recommendation influence, ratification,
adaptation to national legislation, etc. – is presented in our book in
corresponding chapter for each specific state). A crucial issue emphasizing
profound importance of international documents regulating this sphere
is a fact of priority of international law approved by all Commonwealth
countries. International cooperation in the field of bioethics is implemented
also through formation of regional programs and Centres of bioethics
and research ethics with involvement of international organizations being
leaders in this field. A convincing example of such cooperation is a setup
of national committees of bioethics with UNESCO support in some of the
Commonwealth countries and planned scientific and educational activities
of the UNESCO office in Moscow and some other countries in the region
32
being held in context of national, social and cultural, historical and political
traditions and utilization of the world experience in the field of bioethics.
In 2001 an important bioethical resource, the Forum for Ethics Committees
in the CIS (FECCIS), was established in the region. The FECCIS is one of
five regional forums created within the framework of the WHO project, the
Strategic Initiative for Developing Capacity in Ethical Review (SIDCER).
Sharing main priorities of the WHO SIDCER project on protection of the
rights and dignity of research subjects in all countries in the world basing
on respect to cultural, religious and national differences the FECCIS seeks
the main task of facilitating development of bioethics in the region of the
CIS countries, paying specific attention to ethics of biomedical research
involving human subjects. During all its years of existence (2001–2007) the
Forum activities were directed on development of regulatory and methodical
basis on research ethics; development and implementation of education
programs for members of ethical committees; development of information
space and extensive dialogue with various parties involved in ethical review
of biomedical research that, certainly, facilitated harmonization of both
regional and global international approaches to establishment of ethical
standards in biology and medicine. Besides, notable value for adaptation and
improvement of universal ethical principles has the representation of some
of the CIS countries in several international entities, for instance, such highly
respected agency as the Council of Europe, in particular, in the structure of
the Steering Committee on Bioethics (CDBI) responsible for development
of multiple documents, mainly, the legal ones, on protection of rights and
dignity of human subjects in research and medical care. Consolidation
of efforts and mutually enriching knowledge exchange take place also at
the stage of regional or bilateral cooperation with international facilities
and leading world specialists in the field of ethics through trainings, joint
researches and discussions.
Another priority component with considerable contribution in forming
of ethical and legal unity in medical care is trends and mechanisms based on
realia of regional cooperation of the CIS member states.
Due to international and regional legal collaboration the constitutional
regulation of a legal status of a person in the Commonwealth countries
is adjusted to international standards creating legal opportunities for
implementing such important ethical principles of biomedical research as
33
respect to autonomy and individual dignity of a patient/subject as well as a
principle of justice.
Majority of constitutions of the CIS countries proclaim a person as a basic
value (Art. 4, Constitution of Armenia; Art. 13, Constitution of Azerbaijan;
Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free
development of a person is protected by law and independent court. Person
dignity is acknowledged as a special value to be protected by the state in
all Commonwealth countries. All constitutions of the CIS countries contain
prohibition for medical, scientific or other experiments involving human
subjects without their voluntary consent. Guarantees of respect for personal
autonomy are provided in the Commonwealth countries with constitutional
statements declaring the right for everyone on personal security (in some
countries physical and moral constituents of the security are indicated10), the
right on personal and family secrets, the right for everyone for confidentiality
of correspondence, phone communications, mail, telegraph messages and
information transmitted via other communication means (these rights can be
limited only as stipulated by law, usually, for prevention of crimes or finding
out truth during criminal investigations or as a punishment for committed
crimes). It is prohibited to collect, store, use and distribute information
about individual life without such person’s consent. Statements presented
in constitutions of all CIS countries guaranteeing equality of all persons
– independently of gender, race, nationality, language, origin, property
and position, place of residence, denomination, political and religious
beliefs, assignment to public unions as well as other circumstances – are of
tremendous value for acknowledgement and compliance with the principle
of justice in biomedical research. At that, the state becomes a guarantor for
protection of personal rights and freedoms. Other directions of the state
policy in social sphere are also extremely important for provision of human
rights in the area of health care and biomedical research.
The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of
the Constitution of Kyrgyz Republic). Since there is almost no special legal regulations within
the regions of the CIS countries for such sphere of biomedical research as psychological
studies this fact has a special value. Such constitutional statement can become a basis for
independent regulation of the given type of experiments.
10
Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova,
respectively.
34
The right for protection of health and its state support are legally fixed
in all Commonwealth countries (Art. 34 of the Constitution of the Republic
of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art.
45 of the Constitution of the Republic of Belarus, Art. 37 of the Constitution
of Georgia, Art. 29 of the Constitution of the Republic of Kazakhstan, Art.
34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution
of the Republic of Moldova, Art. 41 of the Constitution of the Russian
Federation, Art. 38 of the Constitution of the Republic of Tajikistan, Art. 49
of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution
of the Republic of Uzbekistan).
Majority of the CIS countries also declared in their constitutions the right
for medical care in different forms (excluding three republics – Armenia,
Azerbaijan and Uzbekistan: in these states guarantees of availability of
health care for people are set at the level of branch laws regulating public
relationships in the health care system). At the same time one should note
that the issue of underfunding in regard to required amount of medical care
today is still one of the most acute problems almost in all countries of the
Commonwealth.
States implement programs on population health protection, measures
for environmental protection and provision of free access to reliable
information on its status, living and working conditions, quality of food
products and household goods, facilitate development of physical culture
and sports, create opportunities for various forms of health insurance.
Financial support is guaranteed to pregnant women11, mothers with small
children and in case of children with disabilities – until they become older
– to families with many children, persons with various diseases and drug
abuse. The state provides special care for those who broke their health
protecting state and common interests. An important issue is inclusion into
the sphere of state policy and legal regulation of an issue of preservation of
national gene pool.
It is truly important that virtually all CIS countries adopted branch laws
related to issues of health care and patient rights – the Law of the Republic of
Armenia On Medical Care and on Services for Population (1996), the Law of
the Republic of Azerbaijan On Protection of Population Health (26.07.1997),
Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of
Moldova, respectively.
11
35
the Law of the Republic of Belarus On Health Care (1999), the Law of
Georgia On Health Care (1997), the Law of the Republic of Kazakhstan
On Protection of Population Health of the Republic of Kazakhstan (1991),
the Law of the Kyrgyz Republic On Protection of Population Health of
the Kyrgyz Republic (09.01.2005), the Law of the Republic of Moldova On
Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the
Russian Federation On Protection of Citizen Health (22.07.1993), the Law of
the Republic of Tajikistan On Protection of Population Health (15.05.1997),
Basics of the Law of the Ukraine On Health Care (1992), the Law of the
Republic of Uzbekistan On Protection of Citizen Health (29.08.1996).
Legislation specifically related to protection of especially vulnerable groups
of patients and subjects is of particular importance for regulation of biomedical
activities including valuation of biomedical research. Virtually all countries
adopted separate laws on psychiatric assistance to population, counteraction
to HIV infection, donorship, transplantation, protection of children rights.
These enactments reflect specificity of institutions of informed consent and
patient confidentiality in some situations of biomedical int rventions as well
as stipulate additional guarantees of rights of dependent groups of patients/
subjects. In many CIS countries laws and by-laws regulate various issues
in the area of auxiliary methods of reproduction and genetic assistance to
the population12. Two countries (the Russian Federation and the Ukraine)
For instance, in the Republic of Armenia – the Law of the Republic of Armenia On
Reproductive Health and Reproductive Rights of Person, 12 of September 2002, in the
Republic of Belarus – the Law of the Republic of Belarus On Safety of Gene Engineering
Activities, 9 of January 2006, in the Republic of Kazakhstan – the Law of the Republic of
Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees
of Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of
December 1999, On Reproductive Rights of Citizens, in the Russian Federation – the Order of
the Ministry of Health of the Russian Federation. 26 of February 2003, N 67 On Utilization of
Assisting Reproductive Technologies (ART) for Treatment of Female and Male Infertility, the
Federal Law, 5 of July 1996, N 86-FZ On State Regulation in the Field of Gene-Engineering
Activities, the Order of the Ministry of Health of the Russian Federation, 30 of December
1993, N 316 On Further Development of the Medical and Genetic Service of the Ministry of
Health of the Russian Federation, in the Republic of Tajikistan – the Law of the Republic
of Tajikistan, 2 of December 2002, No.72 On Reproductive Health and Reproductive Rights,
the Order of the Ministry of Health of the Republic of Tajikistan No.974, 1 of October 1985,
On Measures for Further Development of Medical and Genetic Assistance to the Population,
in the Ukraine – the Joint Order of the Ministry of Health Care and Academy of Medical
12
36
adopted laws prohibiting human cloning. At the same time, a range of actual
issues related to specifics of genetic studies, experiments on embryos and
utilization of embryo and fetal tissues for medical purposes, of psychological
and sociological studies still require legal solutions.
In general, one should note that among all other types of biomedical testing
at the CIS space only clinical studies of medicinal substances underwent
more consistent legal regulation13. All countries have special laws regulating
public relations appearing due to development, production, manufacture,
preclinical and clinical studies and other actions in the sphere of medicinal
agents. Besides, the Commonwealth countries usually have a whole set of
regulatory and legal acts including branch ones – at the level of ministries
of health care – establishing detailed order for conduct of preclinical and
clinical studies of medicinal agents. In some countries these documents are,
in fact, internationally acknowledged standards of Good Clinical Practice
adopted for a particular region. Along with establishing of ethical and legal
principles for the biomedical study conduct the national GCP requirements
create grounds for development and functioning of a system of ethical
committees in these countries. In some of the countries there are adopted
enactments regulating activities and status of such committees14. However,
in total at the CIS space there is no uniformity in regard to building up of
the ethics committee system that is related to both absence of basic solutions
for some issues in regard to legal nature of these facilities and to differences
in the system of administrative management in health care and scientific
activities. At the same time, some common features can be found. In each
of the Commonwealth states national committees on ethics/bioethics that,
Sciences of the Ukraine No.313/59, 1 of December 2000, On Further Development of
Medical Genetics and Bioethics in the Ukraine, etc.
13
In this case it is worth to mention positive experience of Georgia, which being the only
of the CIS countries that signed the Additional Protocol to the Convention of the Council
of Europe on protection of human rights and dignity with regard to application of biology
and medicine of 1997, On Biomedical Research (2005). The draft of the Law on Biomedical
Research Involving Human Subjects is currently pending in the Parliament of Georgia.
14
For instance, the Order of the Ministry of Health Care of the Republic of Moldova No.54r of 09.07.02 On Establishing of National Ethics Commission, the Order of the Ministry of
Health Care of the Republic of Moldova No.38 of 24.01.06, the Order of the Ministry of
Health Care and Social Development of the Russian Federation of 02.08.2004 No.57 On
Ethics Committee, the Statute On Committee on Medical Ethics approved by the Order of the
Ministry of Health Care of the Republic of Tajikistan No.118, 10 of March 2005, etc.
37
usually, perform ethical examination of research projects are created and
work subjected to central executive authorities (usually these are ministries
regulating activities in the sphere of health care, labor, social policy, etc.; in
some of the countries these are national academies of sciences). There are
also regional and local ethical committees at scientific medical Centres as
well as committees at professional medical societies. In some of the countries
the research ethics committees have a function of consulting higher state
authorities on issues for development of policies in health care as well as
resolving conflicts associated with routine medical practice. Participation of
all CIS countries in the process of moral and ethical professional resolution
of medical practical and research activities appears to be important. Many of
the Commonwealth countries have already adopted or are developing ethical
codes for medical and pharmaceutical workers, have approved national oaths
for medical school graduates, ethical codes for medical doctors15. These
codes and oaths provide higher vs. the legal enactments ethical standards
for behavior of representatives of medical profession and are related to both
relationships of doctors with their patients, with third party persons and to
intracorporate relations.
Analyzing trends in development of ethical and legal control of
biomedical activities in the Commonwealth countries one cannot but
mention influence of religious tradition on this process. For instance, in
some of the Central Middle Asia countries daily practice of medical workers
and researchers to a large extent is based on norms of the Koran, Shariat,
Hadises. An important role as a guideline for national policy formation in
the field of ethical examination development of biomedical studies as well
as for protection of the rights of patients and study subjects is played by the
Code of Islam medical ethics. Countries with prevailing Orthodox religious
tradition showed that a significant role for ethical consideration of medical
science and practices is dedicated to Basics of the Social Concept of the
Russian Orthodox Church (2000) containing official position on many of
the most arguable bioethical issues.
For instance, The Code of Medical Ethics of Armenia, The Ethical Code of Medical Doctor
of Georgia, The Ethical Code of Pharmacists of the Kyrgyz Republic, The Ethical Code of
Nurse of Russia, The Oath of Medical Doctor of Russia, The Medical Ethics Code of Russia.
In Uzbekistan the code on bioethics issues is under development, in Kazakhstan they started
to develop The Code on National Health and the Health Care System, in 2007 it is planned to
adopt The Ethical Code of Medical Doctor of the Republic of Kazakhstan.
15
38
Features mentioned above illustrating specific properties of legal and
ethical regulation are, mostly, in accord with general direction in legal
development of the Commonwealth countries as socially-oriented states.
Considering a social state as the most beneficial way for combination
of fundamentals of freedom and power for provision of personal well-being
and social wealth there is a real possibility for reaching social justice and
solidarity. Translating the given point at the language of conflicts of interests
that appear at the pace of scientific and technological progress in any sphere
of human activities (including biology and medicine), one can notice
crystallization of the main advantage of a social state being acknowledgement
of the role of ethics for resolution of conflicts and interpretation of ethical
principles as state control mechanisms.
However, it is worth stressing that in order to protect social rights of
citizens only legal mechanisms and procedures for prevention of breaching
of these rights are far from being sufficient. Along with aforementioned
versatile state activities aimed on development of conditions for execution of
these rights and freedoms as well as readiness of society for their conscious
perception and compliance are required.
This process takes prolonged gradual movement on development of
a complex mechanism for protection of human rights and constitutes of
legal, administrative, economic and humanitarian means. Such objective
is implemented in the most consistent fashion by the Inter-Parliamentary
Assembly of the Commonwealth of Independent States, which as one of the
main objectives takes development of mechanisms for interstate regulation
of respect for human rights in the region. IPA CIS as an agency for interparliamentary cooperation accumulates information on political, economic,
social and cultural, ecological, demographic and other constituents of life
of the Commonwealth countries that provides effectiveness, timeliness and
demand for produced recommendations on harmonization and convergence
of legislation of the CIS countries. Activity of IPA CIS in this respect is
versatile and includes a range of spheres and areas determined with specifics
and competence of permanent commissions such as commission on social
policy and human rights, on legal issues, on science and education, on
foreign policy issues, on defense and security, etc. In 1998 the Council
of IPA CIS as the higher leading authority of the Assembly approved the
declaration that emphasized solidarity of national parliaments with ideology
39
of the Universal Declaration of Human Rights and stressed that since the
moment of its proclamation the field of human rights exhibited considerable
progress in general and that efforts in the field of human rights undertaken
within CIS are also directed on provision of common respect for them,
facilitation of strengthening of atmosphere of friendship and trust, effective
implementation of multi-party agreements where a special place is given to
the CIS Convention on Human Rights and Fundamental Freedoms adopted
in Minsk in 1995.
Criminal, penal procedure and penal enforcement model codes adopted
by IPA CIS being a basis for development of similar codes in some of the
Commonwealth countries should be considered as norms of general type
establishing crucial requirements to an order of legal act execution in regard
to main freedoms and rights of citizens in the Commonwealth countries.
Statements of the given model codes were also reflected in initiation and
creation of many legislator enactments in the CIS countries in the field of
criminal law and criminal procedures. The model civil code adopted by IPA
CIS has special values for establishing of new conditions for administration
and management in all spheres of activities and its main statements were to
some extent practically embodied in civil legislation of all CIS countries.
Activity of the Permanent Commission on social policy and human
rights of IPA CIS has a special value from the point of harmonizing influence
on the health care field. After initiatives of the said commission model laws
determining main statements for a complex welfare system were adopted,
a list of international conventions recommended for immediate ratification
by the CIS countries was developed, a set of model laws on rights of human
beings related to category of vulnerable population groups was approved,
such as a law On Basic Children Rights and On Additional Guarantees to
Child-Orphans and Children without Parental Guardians, Guidelines On
Childhood Protection in Member Nations of CIS (1998) as well as The
Charter for Older People and other socially significant documents.
In accordance with basic statements on protection of human rights and
freedoms there are being prepared model laws related to both forming of
domestic policy in the Commonwealth countries in the field of health care and
developing of common approaches to international cooperation of the states
in this field. An important role for legislative regulation of special situations
in the area of medical practice and their potential application to cases of
40
biomedical studies and ethical review is assigned to the following model
laws: On Sanitary and Epidemic Well-being of the Population, On Prevention
of Spread of Diseases with Social Significance, the Concept on Formation
of Legal Basics and Mechanisms for Implementation of Social State in the
CIS Countries, the Charter of Social Rights and Guarantees for Citizens of
Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of
model acts included into perspective plan of model law development are also
important for formation of state policies of the CIS countries in the field of
health care and biomedicine such as the following: On Social Protection of
Handicapped, On Folk Medicine, Recommendations on National Legislations
Adjustment of the CIS Member States in the Sphere of Social Protection and
Medical Service for Liquidation Participants of the Disaster Consequences at
the Chernobyl NPS, On Counteracting HIV/AIDS in the CIS Member States,
Medical Code of the CIS Member States, On Preventing Distribution of
Forged and Low-quality Drugs, On Natural Medical Resources, Medicinalsanitary Areas and Resorts, and many others.
Activity of IPA CIS also facilitates development of regional legal
cooperation in the field of health care and social protection of the population
at the level of heads of states and governments. As per initiatives of this
authority the member states executed the following basic agreements:
- Agreement on Cooperation in the Field of Protection of Population
Health (Minsk, 26 of June 1992),
- Agreement on Medical Services for Military Personnel and Their
Family Members, Workers and Servants of Frontier Troops (Minsk, 26 of
June, 1992),
- Agreement on Provision for Population of Medicinal Drugs, Vaccines
and Other Immunobiological Agents, Goods for Medicinal Use and Medical
Equipment Manufactured at the Territory of the CIS Member States
(Ashkhabat, 24 of December 1993),
- Agreement on Social Security and Health Protection of Citizens
Exposed to Ionizing Radiation as a Result of Chernobyl and Other Radiation
Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of
September 1994),
- Agreement on Cooperation for Resolution of Issues of Disability and
Disabled (Moscow, 12 of April 1996),
41
- Agreement on Provision of Medical Care to Citizens of the CIS
Member States (Moscow, 27 of March 1997),
- Convention on Transfer of Persons with Mental Disorders for
Compulsory Treatment (Moscow, 28 of March 1997),
- Agreement on Cooperation for Resolution of Issues of HIV Infection
(Moscow, 25 of November 1998),
- Agreement on Prevention of Iodine-deficient Disorders among
Citizens of the CIS Member States (Minsk, 31 of May, 2001),
- Agreement on Cooperation of the CIS Member States in the Field of
Protection of Population Health (Yalta, 18 of September 2003),
- Decision on the Order of Medical Examination of a Donor of Blood
and Components Thereof (Cholpon-Ata, 2 of April 2004),
- Agreement on Order of Interaction for Hygienic Assessment of
Potentially Hazardous Products Imported to the CIS Countries (CholponAta, 16 of April, 2004),
- Agreement on Cooperation of the CIS Member States against
Trafficking of human beings, Human Organs and Tissues (Moscow, 25 of
November 2005)
- Concept for Development of Social and Medical Basics for Improvement
of Quality of Life and Prevention of Disability of War Veterans, Participants
of Local Conflicts, Peace-making Operations and Terrorism Victims in the
VIS Member States for 2006-2010 (Dushanbe, 25 of May 2006), etc.
From the point of view of international legislative practice adoption of
the Model Law on Protection of Human Rights and Dignity in Biomedical
Researches in the CIS by the General Assembly of IPA CIS at 18 November
2005, is fairly unique. Development of this document illustrates fruitful
cooperation of the CIS Forum for Ethics Committees in the CIS and the
Permanent Commission on social policy and human rights of IPA CIS.
Adoption of the given model law facilitates provision of protection of
dignity and respect, rights, security, health and interests of participants of
biomedical researches; reliability of the study results and development of
united legal space conducting biomedical research involving human subjects
in the region of the Commonwealth countries and within the framework
of international studies. The model law stipulates a conduct of ethical and
scientific review of biomedical studies as a basic instrument for protection
of each individual subject and community of people participating in the
42
study. Currently the member states work on implementation of the Model
Law into national legislation. In particular, the project of the Federal Law
on Biomedical Studies (Analytical Materials on the project Analysis of
Regulatory and Legal Framework in the Field of Human Rights in the Context
of Biomedical Research and Development of Guidelines for Improvement
Thereof; M., Publishing House of the Moscow State University, 2007, p.
329-342) was prepared in Russia with support from UNESCO. This project
specified many of statements of the model law.
Implementation of the model law statements by countries being the CIS
members or not being as such can assist in acknowledgement them from the
side of international community in the area of protection of fundamental
human rights and freedoms in the field of biology and medicine. It is
important to stress that states that conceptually adopted the given law made
themselves not only responsible for protection of dignity and individuality
of every person at the field of biomedicine but also for improvement of
internal legislation in order to make it to reflect statements of the present
model law and to be able to guarantee to everybody without exclusions
respect for personal integrity, fundamental rights and freedoms that every
person possesses.
The Forum for Ethics Committees in the CIS admitting its responsibility
for achieving the most rapid and rational utilization of the given law
statement confirmed readiness of the Forum members from various CIS
countries to facilitate the process of integration and operative application of
the model law in biomedicine as well as its further regulatory improvement
in accordance with local cultural, historical and social peculiarities and
the guarantee for retaining of the law spirit determined with commonly
acknowledged human rights and freedoms.
The implementation process assumes execution of the following
consequent actions: studying contingency of national legislation in the
given field with the model law statements; making legislative national
statements compliant with the model law ones; incorporation of the model
law statements into national legislation; further development of the model
law statements in accordance with national conditions and progress in
the field of biomedicine and ethics and development of mechanisms for
adherence and compliance with the given model law statements. Reaching
the said goals is possible only in conditions of authority and professional
43
integrity of cooperation of all stakeholders and it assumes wide and open
discussions involving various social layers and international entities. The
latter will facilitate formation of demand from the side of citizens of the
CIS countries and international community for the fastest inclusion of the
model law statements into professional, regulatory and general humanitarian
spheres of life in the region countries. Certainly, this process, beside
knowledge and confidence, will require signs of respect, acknowledgement,
tolerance and mutual understanding in order to bring forth comprehensive
dialogue with various social layers having final goal of reaching social and
individual ethical legal sense in the space of the CIS member states and their
full-grown inclusion in the global international regulatory framework on
adherence and preservation of human rights and freedoms. It is gratifying to
claim that value of the given model law for the international community was
time and again demonstrated at its development by representatives of such
international organizations as WHO, the Council of Europe, the European
Commission, the European Forum for Good Clinical Practice, UNESCO,
the World Medical Association, etc. Need for the model law implementation
into national legislation of the CIS countries and readiness of corresponding
structures for provision of enforcement of these statements was exhibited with
universal response of leading specialists in the field of medicine, biology,
ethics, legislation and sociology desiring to participate in promotion of the
given regulatory document in their countries and to facilitate to parliaments
and governments of their countries in reaching the said goal.
In regard to continuation of regulatory initiatives of the FECCIS with
IPA CIS there is work on-going on forming regulatory and ethical standards
for counteraction against HIV/AIDS at the CIS space as well as development
of the model guidelines On Ethical and Legal Regulation and Safety of
Medical Genetic Research in the CIS within the framework of cooperation
with the Permanent Commission of IPA CIS on Science and Education.
Summarizing statements in common trends in ethical and legal
regulation of public relationships on the field of medicine and biology in the
CIS countries one should note that the policy of the Commonwealth countries
including rational features of previous rich and versatile historical and
cultural experience is open to interaction with world bioethical community
and ready for rational collaboration in the region directed to development of
optimal conditions for reaching ethical comfort in medicine and in research
44
via building up of the society’s ethical self-consciousness, legal sense and
attaining of a new type of relationships among individuals, social groups
and states based on social partnership and dialogue in regard to the most
crucial issues of ethical content.
References to international documents mentioned in the text are
provided in the chapter for the member states. Texts of the model laws of
IPA CIS are available at the web site: www.iacis.ru/html, the text of the
model law of IPA CIS On Protection of Human Rights and Dignity in
Biomedical Researches in the CIS and the text of the model guidelines On
Ethical and Legal Regulation and Safety of Medical Genetic Research in
the CIS can be also found at the following web sites: www. feccis.net and
www.pasteur-nii.spb.ru
45
Chapter 2. Current Status and Perspective
of the CIS’ Region Participation
in the International Biomedical Research
2.1 Philosophical Aspects of the Biomedical Research
(P.D.Tishchenko, B.G.Yudin)
Philosophy of modern biomedical research (BMR) is a limitless topic
with multiplicity of versatile aspects. Here we would like to dwell on those
of them that are to some extent are related to issues of ethical examination
Specific Position of Science in the Modern Culture
Understanding of trends of development of the modern biomedical
research is impossible without taking into account on-going general
civilization transformations of our days. First of all, let’s take a look at the
most general context of the issue.
In this respect it is necessary to remind about a central role that science
have played and still plays in the modern culture. As to exact expression
by E. Husserl: “When at the beginning of the New Age religious belief
began to degenerate more and more into lifeless convention, intellectual
humanity stood in a new great faith – faith into autonomous philosophy
and science. Scientific judgments were to highlight and guide entire human
culture providing it with new autonomous form.” (Husserl E. Cartesian
Meditations, p.14). If to take into account that ideology of new European
education to a large extent is a gradual process of mastering the system of
scientific knowledge, then without exaggeration one can say that the modern
man (unlike a person in the Christian culture) is created “in the image and
likeness of a scientist”.
The leading position of science is retained and considerably strengthened
gaining qualitatively new forms. Along with that, in the modern cultural
situation science becomes more tolerant to other forms of cognition and
comprehending of the reality. Ideas, concepts and practices that several
decades ago were considered as superstitions are rehabilitated and gain
status of fully-developed modern doctrines. In the whole world one can
46
observe revival of archaic (shamanism, cabala and other esoteric practices)
and creation of new non-scientific (and often anti-scientific) ideologies.
Appear new bridges for cooperation between science and traditional religions
appear.
Another process is ongoing along with this paradoxical one. Science
is still a mainstream for resolution of human problems, protection of a man
against unfavorable natural impacts (for instance, diseases). But the mightier
is scientific control over the nature, the clearer hazards are – that is, risks,
related to development of science and scientifically-targeted technologies.
Along with realization of these risks there are two directions being formed
that influence in ideological sense establishment of procedures of ethical
examination for biomedical studies. We are talking about ecological
movement and bioethics. The ecological movement is concerned with
diagnostics and prevention of begotten by scientific and technical progress
risks related to biological survival of the humanity and biosphere as a
whole. Bioethics elaborates its own technologies for identification and
neutralization of those risks that the progress brings forth for the moral well
being of a human.
At that, it is paradoxical that in regard to the risks science has a triple
position – it is one of the main risk producers, virtually the only developer
of reliable methods for their assessment as well as it develops mechanisms
for prevention of undesirable consequences or handling them – when they
are present.
Sources for these shifts that radically change waypoints and setup for
the scientific search can be, at least, partially, found in events taking place
about 4 decades ago. Those days at the end of the 60’s, young people, mostly,
students in many Western countries initiated strong protesting movements
that resulted in serious social unrest. Targets for attacks of the “new left”
were key social institutions of bourgeois society and its culture; in this
context science was also strongly criticized.
Firstly, it was perceived as a power carrying the light of intellect and
closely bound to ideals of free critical thinking and, therefore, democracy.
One of bright mouthpieces of this position was the well-known sociologist
of science, R.Merton (Merton R. Sociology of science: theoretical and
empirical investigations. Chicago: Wiley, 1973). However, another point of
view also was fairly wide spread based on some neopositivism concepts
47
and accenting utilitarian and pragmatic sides of scientific activity; it was
expressed with neutral attitude to the social role of science. Now science
critics interpreted it as a power closely linked to establishment, positioned
too far from vital interests of common people and, moreover, even hostile to
them, facilitating not democratic but totalitarian trends, dehumanizing the
world, begetting and strengthening human alienation and enslavement.
In this case we are not interested in one or another point of view for
these counter-cultural and counter-scientific movements. But among many
consequences they caused it is worth to note rather basic and distressful
reappraisal of many values. It is characteristic that the criticism of science
by these new lefts was quite effective although as it often happens in the
history its further development took not the pace they dreamt of.
As a result initially in the USA and then in the countries of Western
Europe the range of expectations from the society considerably transformed
along with scientific and technical policies of a state. Now scientific
researches are required more and more that their results are to satisfy social
needs and personal requirements.
Science in the “Society of Knowledge”
One of the developers of the term “society of knowledge” is the American
sociologist, Piter Drucker, who in 1994 set a question on developing in
modern culture deep social transformations he determined as establishing
of new institutions of the “society of knowledge”. The society of knowledge
has altered nature of labor, higher education and ways of functioning for
the entire society as a complicated interrelated system (P. Drucker. The Age
of Social Transformation. The Atlantic Monthly, 274 – November 1994,
53-80). In our analysis we are going to use the Drucker’s ideas to some
extent adding them with useful, from our point of view, results from other
researchers.
P.Drucker proceeded from that transformation of scientific knowledge
into a main source of new technologies started as per historical measurements
quite recently. He stated that yet in the XVIII century “no one even tried
to talk over application of science for development of instruments of
production, technologies and goods, i.e. about use of scientific knowledge
in the field of techniques and technology. This idea matured only … in 1830
when the German chemist, Justus von Libikh (1803-1873), first invented
48
artificial manure and then a method for storing animal proteins (P. Drucker.
From Capitalism to Society of Knowledge. In: New Post-Industrial Wave
in the West, edited by Inozemtsev V.L., M., 1999). According to Drucker
that time the industrial revolution as a process of global transformation of
the society and civilization on the basis of technical development began. At
that, scientific knowledge took new, previously not characteristic role – as a
factor actively influencing life of a man and society and dynamicizing it.
In the context of technological application of science a research is
not only an investigation of the world as it is, the natural world, but as
transformation of this world, that is, as development of an artificial world
(being more precise, worlds). And in such respect the research is a prototype
of a technological method for learning and, moreover, vision of the world.
This fact is of special importance for understanding how exactly
biomedical technologies influence the very nature of a man. Now these
technologies can wider and more effectively control existence of a man from
stages prior to conception up to the death and even post-mortal existence
(taking futurological ideas of “cryonics” as an example).
Transfer from knowledge of reality to its artificial construction
is associated with overestimation of truth status, which is more often
substituted with ideas of “usefulness” and “effectiveness”. In technological
context issues of truth and quality of knowledge are falling into background.
One can say that in this context not research result by itself and not various
interpretations of effects of a research system are of interest but the effect
as it is – those transformations and conversions it provides. And while
technological capacities hidden in experimental device and, in a wider
meaning, in technological activities are being recognized, functions of
science are being changed dramatically.
At that, recognition of technological capacities of science is a mutual
process, which includes both those involved in scientific activities and
those of business and manufacture. As a result of the process people
become not only more perceptive in regard to various new technologies
but also, if one can say so, are “imbued” with technological mentality. Any
serious problem they face starts being recognized and thought over as a
significantly technological issue: initially it is distinguished as per canons
set by technology, and then technological problems for its resolution are
sought for and applied.
49
Nowadays the technological role of science became dominating and
many even think that the only function of science is development of new
technologies. At that, the way of practical implementation of scientific
knowledge and technologies based on it appears to be something like the
following. First, a theorist and/or a research laboratory discover something.
Then the result of this study during the process called as development (or
elaboration) is implemented in new technologies. The following stages of
a process are related to the fact that each such new technology is – with
more or less problems – implemented in practice of manufacture or any
other sphere of human activity. In other words, the traditional order of things
is characteristic with the following: first a technology is created, and then
markets to sell it are searched for. Talking about issues we mean particularly
the notorious one of “implementation”, which caused breaking lances in
the USSR times for many years and which does not have any satisfactory
solution so far.
Therefore, it makes sense to think over that the way the problem is
defined is likely to be incorrect. In our established views appearance of any
new technology looks like a move beyond the given and already mastered
order of things. This word, “implementation”, seems to be here rather
characteristic since it bears, beside other issues, a sense that there is some
influence from outside breaching the groove, something extraordinary.
Today, however, we can if to use the term by the German sociologist,
M.Weber, talk about routinization of this very process of technological
upgrades when new technologies do not break into manufacturing activities,
into lives of people, but are placed into preliminary prepared “cells”. In other
words, new technologies are “custom-made”. More often this sequence is
built in order directly opposite to the common way: development of a new
technology starts only when and because there is already a demand for it.
Phenomenon of “Technoscience”
Today in the beginning of the XXI century we have all grounds to
say about qualitatively novel stage in development not only of science but
its interaction with the society as well. One of the ways expressing it is
establishment of a new type of interaction between science and technology
that was called technoscience. For instance, the English sociologist Barry
Barnes wrote: “The term technoscience now is widely used in academic
50
sphere and is related to such activity within which framework science and
technology form a kind of a mixture or a hybrid… technoscience should be
perceived as specifically modern phenomenon” (B.Barnes. Elusive Memories
of Technoscience. – Perspectives on Science: Historical, Philosophical,
Social. Vol. 13, Issue 2 – Technoscientific Productivity, Summer 2005, pp.
142-165). The most evident sign of technoscience is considerably more
profound than before built-in pattern of scientific cognition into activities on
development and promotion of new technologies. According to the German
sociologist and political scientist, Wolf Schäfer: “Technoscience is a hybrid
of science-based technology and technology-based science. Global phone
communications and genetically modified products are para-scientific
things: their invasion into our world is due to complex interweaving of
particular human interests with modern understanding of electricity, on
one hand, and genetics, on the other.” (W.Schäfer. Global technoscience:
the dark matter of social theory.Univ. of Maryland conf. on globalizations,
April 2002. www.bsos.umd.edu/socy/conference). Here, as you can see, our
attention is drawn to the fact that technoscience is not only the tightest link
between science and technology, but also such symbiosis that includes also
human aspirations and interests.
However, relationships of science and technique in this symbiosis
are internally contradictive. On one hand, science is a generator of new
technologies and due to stable demand on these new technologies science
enjoys some, and sometimes quite generous support. On the other hand,
production of new technologies dictates demand on science of specific, if
you wish limited, single-sided type, therefore, many potentials of science
being used this way are still outstanding. Roughly speaking, science is
required neither to explain, nor to understand things – it is quite sufficient
that it makes possible to alter them effectively.
Besides, it assumes understanding of human cognitive activities
including the scientific one, as an activity being secondary to some extent,
subjected to practical transformation, changing of both the world around
and a man. Thus, reminding the said above, there is an opportunity for
rethinking, or, being more specific – reversion – of the balance of science and
technology established before. If traditionally this balance was perceived as
technological application, utilization by someone and at some time produced
scientific knowledge, now it turns out that the very activity for obtaining of
51
such knowledge is built in into processes of creation and development of
these or those technologies.
It is interesting not only how such transformations take place in reality
but also how they are comprehended. On the surface things seem to be the
same: it is proclaimed that science is a leading force of the technological
progress that, in turn, uses scientific achievements.
This is the background for realization that so-called applied science
deals with those problems that are determined with the very development
of technologies, and, along with that, such “servicing” science becomes
determinative both as to quantitative and financial or other supplies, and as
to social recognition. As we already noted a regulator for scientific activity
becomes not obtaining knowledge pretending to be the truth to some extent
but gaining an effect that can be implemented into a technology in demand.
One should say that also social expectations regarded to science today
shows clear domination of demands for new effective technologies but not
for explanation of the world. Such transformations of relationships among
science, technology and society, particularly, real move of science from
avant-garde to auxiliary roles are launched in the realm of natural sciences,
but then spread to social and humanitarian sciences.
Thus, both the society and the state including all authorities responsible
for formation of policies in regard to science are more inclined to perceive
both research activities and the very science as a machine capable of
generating new technologies.
Science on the Market
Commercialization of science is another very peculiar feature in
development of biomedical technologies. Emergence of the biotechnological
industry in the USA as a new institution for not only applied science, but also
for fundamental research at the 70’s of the XX century was provoked with
several factors including: a) considerably grown abilities to “recombine”,
“produce” and simply “manipulate” DNA and all other molecules; b)
transformation of the administrative environment which should encourage
rapid transition of research to applied problems such as changes in the patent
law that not just supported but forced to commercialize inventions in both
industrial and academic sectors; c) and in the limit case – fusion of statefunded scientific research with venture capital interested in investments
52
for development of extended base of molecular and biological studies”
(P.Rabinov. Making PCR: a story of biotechnology. Univ.of Chicago Press.
1996. p. 19). Commercialization made possible consolidation of resources
necessary for breakthrough in biotechnologies that occurred at the end of
XX – beginning of the XXI centuries. It has also resulted in reconstruction
of self-identity of science and scientists we observe these days changing
self-comprehension of science and creating new identity of “a businessman
scientist”.
Another important consequence of commercialization was changes of
patenting practices. In 1980 the US Supreme Court decided that creation of
new forms of life is subjected to the Federal Patent Law. It made possible,
after some time, to start patenting of not only artificially developed organisms
or laboratory animals, but also patenting of human genes, DNA sequences,
embryo stem cells, etc. Pragmatic interest for investment protection
has changed the world perception. In the form of a patent it provided
fundamental scientific knowledge with a form of merchandise. From the
point of view of philosophy it means radical fusion of cultural and natural
horizons, ideas of discovery and invention. Science commercialization in
the sphere of biotechnologies created a new market, a new type of goods,
new property rights, boosting synchronous similar processes in other
branches of biomedicine. And at that, not only living organisms or elements
of human body (genes and cells) become objects of commercial utilization
but genomes of entire nations. For instance, in 2000 in Iceland one private
biotechnological company, DeCode Genetics “purchased” an exclusive right
for commercial use of genome materials and data of the Iceland population
for 12 years.
Along with structural changes of scientific activities its main checkpoints
are altered as well.
Constructing a Human
One of the main vectors that can be used to characterize direction in
development of science and technologies in the last decade is its steady
approaching to a man, his needs, aspirations, desires. As a result we can
see, if one can say so, tighter “enveloping” of a man, his immersion into
the world projected and equipped for him by science and technologies.
Naturally, the case is not limited with only “servicing” for a man – science
53
and technologies approach him not only from outside, but, seemingly, from
inside, in a sense making him their creation, projecting not only for him
but also projecting himself. Literally speaking, it is done in some modern
genetic, embryologic and other biomedical research, for instance, related
to cloning16. As a result initially in the USA and then in the countries of
Western Europe the range of expectations from the society considerably
transformed along with scientific and technical policies of a state. Now
scientific researches are required more and more that their results are to
satisfy social needs and personal requirements.
Financial flows directed to support science and technologies are reoriented – more funds are allocated for researches in the field of environmental
protection and especially – for biomedical studies. There were stated such
ambitious objectives as overcoming cancer and cardiovascular diseases by
preliminary set time points. And though these disorders were not completely
eliminated successes achieved in this respect especially in regard to
cardiovascular diseases appeared to be highly impressive. And as people as
per their own knowledge of life felt those effects caused with these newest
technologies, their demands and desired addressed to science and technology
became more and more versatile and insistent. Thus, growing practical
effectiveness of science and technology in those fields that are the closest to
daily needs and interests of a common person started to act as a strong driver
orienting and boosting development of science and technologies.
Along with these changes in priorities of scientific and technological
policy similar re-orientation takes place also in business that gained
considerable success in re-targeting research interests on creation of what can
be attractive for mass consumer. And it is characteristic that those branches of
industry that had the closest links with medicine – pharmaceutical industry,
medical device manufacture, biotechnological manufacture – were among
the most successful. Thus, people become users of knowledge, technologies
See with this regard, e.g., Y.Habermas. Future of Human Nature. On the Way to Liberal
Eugenics. M., 2002; F.Fukuyama. Out Post-human Future: Consequences of Biotech
Revolution. M., 2004; Yudin B.G. About a Man, His Nature and Future. “Issues of
Philosophy” (Voprosi Filosofii), 2004, V.2; L. Kass. Non-ageing Bodies, Happy Souls…
“A Man” (Chelovek), 2003, V.6.
16
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and products developed due to biomedical researches and on corresponding
production facilities to a larger extent.
Here one terminological explanation is necessary. Generally speaking,
any innovation, being a part of not only manufacturing process but also
of our way of life and social practices, can be considered as a kind of
“object” (even in case of symbolic understanding of this term in regard to,
for instance, our social life). However, object-Centreed understanding quite
often turns to be too narrow since this novelty is not only a particular object,
but also particular practices of its use, operating, etc. Both from human and
social points of view this is the matter which is the most significant, since
consequences for a man and society usually beget not the object itself but the
ways how we interact with them, results of these interactions and, finally,
those changes in us that are caused with these interactions. In other words, in
real life we deal not with objects and things per se but technologies.
It is interesting to compare a pattern of development of biotechnologies
with what happened in the same years in the field of informatics and computer
technologies. In this respect, the crucial point was creation of a personal
computer that swiftly extruded bulky and hard to operate computers of the
past. And there we can again see the similar trend – modern technologies
approach a man closer and closer changing radically his lifestyle and how
and what he sees in the world and how he interacts with the world.
In this respect it is worth to turn your attention to the following. In the
beginning and middle of the previous century technical power of a man was
associated mostly with cyclopean size of his creations such as hydroelectric
power stations, nuclear ships, walking excavators, and gigantic electronic
calculating machines. Today, contrariwise, the most impressive are those
symbols of the technical progress that are proportional to a man. One can relate
to them growing versatility of information technologies that are implemented
within the scale of a personal computer, and biomedical technologies that, as
to their definition, are of the similar scale with a man and that today make
possible manipulations with human genes at the molecular level. Moreover,
in the nearest time more attention is started to be drawn to nanotechnologies
that allows influencing processes and events taking place at the level of
separate atoms. It is significant that one of the most important directions for
nanotechnology development becomes a search for possibilities of using
55
them in biomedicine; also it is peculiar that, first of all, in this very aspect of
their development appears within the sphere of ethical analysis.
Thus, scientific and technological progress is more and more oriented
on interests and needs of an individual who is a main consumer of what is
provided by the progress. New technologies turn to be such commodities
oriented on mass consumption; without this large-scale involvement it
would be impossible to provide effectiveness of a laboratory. In turn,
interests and needs of consumers become strong drivers determining, to
a large extent, directions and urging rates of the scientific and technical
progress. As a result, there is a two-way connection between the laboratory
producing new technologies and individuals being their consumers. The
laboratory and mass individual consumer, in other words, are included
into a single circuit.
However, such closing of science to needs of a man does not come on
its own – everything has the price. One of the most serious constituents of
this payment is more and more acute necessity to study specifically what
are actually human needs and requirements and how exactly to meet them.
And it means that a man becomes more and more an object for various
scientific researches. And to the extent, at which strength of scientific
cognition is focused on him, with which newer, finer and more effective
means of influencing on him are developed, elements of risk and hazard he
is exposed to are growing inevitably. Therefore, a task of protecting a man,
in whose direct interests science and technique is advancing, is actualized
from negative consequences of this very project.
The next constituent of the circuit described herein is business,
enterprise capital. It funds the laboratory, thus, providing opportunities for
development of new technologies. In turn, the mass consumer paying for
technological novelties allows business not only to reimburse for incurred
expenditures but also to gain profit, which often is again invested into the
laboratory and development of other new technologies. It is important to
stress stable type of connections among three discussed elements – business
is involved into this circuit not every once in a while but becomes an integral
part of permanently acting and steadily growing circuit. In society based on
knowledge investments into the laboratory are the most promising ones.
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Science and Mass Media
As a link for all said elements there is one more, this is mass media that
has a range of functions within this circuit.
First of all, they bring to potential customers information on appearance
of technological innovations at the market. But the mass media function
in this circuit is far from being limited with dispassionate informing. On
the contrary, quite often they form demand for these or those technological
products – in this respect it is sufficient to remind about how sophisticated,
obtrusive and even aggressive advertising can be. We can note here that
advertising of a hydro power station or, for instance, a walking excavator
would be senseless – advertising is appropriate only there and when it is
targeted on mass consumer. And mass media utilizing this function makes
possible to include it into the described circuit.
At that, the term “mass media” is used in actually wide and, possibly,
not very accurate sense. Mass media here is, actually, various technologies
of working with information, informational support for the circuit. Generally
speaking, this element – information and communication technologies
– is considered by many authors as crucial for the society of knowledge.
“Informational and communicational technologies – one of the supports for
so widely discussed society of knowledge and economics of knowledge;
other supports are growing importance of science, scientific knowledge as
well as knowledge originating from culture sources.” (J.Spanberger et al.
The knowledge-based society: measuring sustainability of the information
society. Futura, 2002). Or it could be said as follows: the term “mass media”
in this sense is related to all social and humanitarian technologies which are
substantially important, necessary for functioning of the circuit.
For instance, a special sphere of activity within the circuit is to bring to
a consumer not only information about a newly developed technology but
the technology itself. Let’s say, as per some estimation, when producing new
medicinal agent its development (i.e., the laboratory) takes about one tenth
of all financial expenditures, and all other costs are incurred for promotion of
a drug up to the stage of a marketed product. Naturally, an activity for new
technology promotion is also built upon technological basis, and at that at
these stages the main role is played by social and humanitarian technologies.
It indicates once again that development of some product – in this case, a
medicinal agent – within the framework of technoscience is nothing else but a
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part of technological process and, thus, technoscience deals, first of all, not with
objects as they are but with extensive circuits including, beside these objects,
also joint, coordinated activity of various people and social structures.
It does not matter how effective is advertising but one should not
demonize it and consider as omnipotent. A consumer, generally speaking,
is far from always being a puppet that is easy to manipulate. He has his
own and not only dictated externally needs and preferences. Effectiveness
of functioning of the technoscience circuit is, to a large extent, secured with
built in mechanisms of identification of consumer interests and expectations.
Due to use of social and humanitarian technologies these interests and
expectations, in their turn, are brought to notice of the business and laboratory
and become factors determining strategy of technology development.
Further, it is necessary to mention another network where information
circulates in the circuit. In this case we mean not mass but specialized
information about desire of a businessman to invest in development of
specific technologies, on one hand, and about technological possibilities and
perspectives of this or that laboratory, on the other. In many cases but not
always the laboratory is a constituent of a business company. If there are no
such tight connections, then information mediator is required.
Thus, in general, the technoscientific circuit includes four elements
related with one another with direct and reverse informational, financial
and commodity flows. It should be stressed that reverse connections within
this circuit are positive: a signal coming from one element to another does
not weaken as it happens in case of negative feedback but, contrariwise,
strengthens. Thus, it provides unprecedented dynamism for functioning of
the circuit.
In practice, it looks approximately like the following: the laboratory
purposefully works to meet demands of customers that it is aware of due
to work of mass media; customers are ready to bear expenses for products
meeting their demand; due to that a businessman gains profit which he, in
turn, invests into the laboratory, thus, launching a new cycle for technology
upgrade; mass media forms in mass consumers all new demands, making
them interested in continuous replacement of goods and technologies they
already have on new ones that become more effective, more useful and more
attractive.
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Now we can note that, as it is known from cybernetics and a theory of
system, circuits with negative feedback can be stable while circuits with
positive feedback are, contrariwise, characterized with extreme instability.
Any signal in such circuit, moving from an element to another, is enhanced,
thus, fairly fast a system with positive feedback, so to say, overspeeds and
either is destroyed or converts into qualitatively new state. Therefore, one
can say that the circuit of technoscience we described is unstable. But, alas,
neither cybernetics not the theory of systems can forecast future course of
events.
Industry of Biomedical Research
Thus, scientific research to larger and larger scale is focused on
cognition, on one hand, of various ways of influencing a man and, on the
other, capacities of a man. Multiple experiments, where a man participates
as a subject can be considered as the most characteristic expression of
both. Each such experiment, generally speaking, is designed to extend our
knowledge of properties of various agents, devices, methods of influencing
a man, etc. At that, necessity for its conduct can be determined with needs of
development of some particular section of biology, or medicine, or another
field of knowledge. If, however, one attempts to imagine integral totality of
such experiments (taken irrespective of subject specificity of each of them),
than it turns out that it provides us with some knowledge about a man. We
can claim: the more science pretends to serve interests and benefit of man,
the more significant role there should be played with experiments involving
human subjects.
Several decades ago H.Jonas discussing issues of experiments involving
a man, said perspicuously about a need to limit somehow “exorbitant
appetite of the industry of scientific research”. Also he turned attention to
the following - “now the scientific society will have to struggle with the
strongest temptation – to switch to regular, daily experimenting with the
most available human material: dependent ones due to various reasons,
ignorant and suggestible disabled” (H.Jonas. Philosophical reflections on
experiments with human subjects. In: Experimentation with human subjects,
ed. by P.Freund, George Braziller Inc., 1970, p. 529).
At the same time Jonas – and this was, generally, the commonly
accepted point of view – could claim that experiments with human subjects
59
“we consider as extraordinary but not normal ways to serve to public
good” (the same, p. 526). But those days no one disputed of the crucial
principles of the Nuremberg Code: each of such experiments due to risks it
is associated with can be justified only with paramount necessity. In other
words, it is acceptable only when there is not other way to gain knowledge
being extremely important for the society and science.
During the past decades an industry of scientific research or, being
more specific, biomedical research involving human subjects became fullscaled reality. At that, biomedical researches by themselves are more and
more often considered not only from the point of view of risks, but also
from the point of view of benefits that they can bring to a subject. Usually, a
therapeutic effect of a developed novel medicinal agent or a new method of
treatment is considered as such benefit.
And the issue on which of these two interpretations of biomedical
research is more acceptable is worth of specific discussion that we have
no possibility to talk over herein. It is important for us to stress that ethical
tracking for such researches became a commonly accepted principle. In other
words, in the modern scientific practice fairly well developed mechanisms
for ethical control over studies function.
Ethos of New Science
Transformation of cognition into production form creates a new kind
of an ethos of scientific society that is completely different from a classical
one as it was described in due time by R.Merton. In traditional academic
science an owner of knowledge was an individual scientist. Idea of his
personal responsibility corresponded to such state of affairs. In biotech
companies there appears corporate ownership of gained knowledge. Space
of personal responsibility shrinks dramatically. But at the same time there
emerges idea of collective (corporate) responsibility or accountability to the
society. From the point of view of ethics there appears a new type of a
moral subject (“businessman scientist”), for whom similarly doubled ethos
is characteristic. In English publications oppositions of these two ethos’s
features is sometimes fixed in terminological sense as a relation of personal
responsibility and corporate accountability for the society.
From the R.Merton’s point of view scientific society ethos includes the
following principles:
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1. “Communism (collectivism)” – knowledge as a result of scientific
activity is a public domain. Any scientific knowledge is built upon results
of previous studies. Therefore, a scientist should comprehend himself as
a member of scientific society who is able of implementing his destiny
only cooperating with other. His duty is to share unselfishly his scientific
results with other scientists and publish them in publications available to
the public.
2. “Universalism” – assessment of importance of scientific achievements
of a scientist should be based exclusively upon their objective assessments,
irrelevantly to his nationality, association with this or that scientific
institution, personal features, religious or political views.
3. “Disinterest” – scientific research shall be motivated only with
a desire to arrive at the truth. It is necessary to exclude all non-scientific
interests – economical, political, religious, and etc.
4. “Established skepticism” – researchers must be critical to results of
work not only of others but also of their own. Only basing on systematical
criticism scientific ideas can get rid of errors and come closer to the truth. A
duty of a scientist is to question constantly obtained results.
These aforementioned four Merton’s principles form scientific society
ethos. The word “ethos” underlines the fact that principles are, at the same
time, ethical standards for self-perfection of a scientist and methodological
rules providing arrival at the truth.
What is specificity of scientific ethos as a corporate activity at the
market of knowledge and technologies? In other words, what is specificity
of scientific society ethos where a hybrid of a scientist and a businessman
is a subject?
Ethos of this two-faced Janus is also similarly two-faced. Since science
does not terminate to be science, than self-consciousness of scientists retains
moral and methodological importance of principles formulated by Merton.
However, these principles in cases when “a scientist” starts to play a role of
a businessman are limited and appended with a system of other principles.
This system was for the first time described by the American sociologist
of science, Jan Mitroff, at the 70’s of the last century when a policy of
commercialization in various spheres of scientific studies was launched.
To some extent, these principles are directly opposite to the ones stated
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by Merton. In regard to reality of biotechnological science the Mitroff’s
principles can be stated as follows:
1. “Corporate egoism” (instead of communism) – knowledge as a
result of scientific activity is a corporate domain. They are patented and in
the form of patents can be sold to other members of scientific society.
2. “Particularism” (instead of universalism) – importance of
scientific achievements of a scientist shall be assessed not so much basing
on any objective grounds but on their practical usefulness for the given
corporation (given research institution). A corporation shall support a trend
to overrated assessment of own achievements and understated valuation of
the ones of others.
3. “Interest” (instead of disinterest) – scientific studies are motivated,
first of all, with corporate interest to maximize profits. Arrival at the truth is
a concomitant issue during gaining economical benefit.
4. “Established dogmatism” (instead of established skepticism) –
researchers must be critical to results of works of others. At the same time,
adhering to the spirit of “team game” researchers shall abstain from critical
discussion of results of activities of their own company. Negative results, i.e.
results questioning efficacy or usefulness of commodities and services sold
by the company (for instance, new vaccines or medicinal agents) practically
are never published and are a matter of corporate “trade secret”.
Contradiction between two types of scientific activity ethos is an essence
of a conflict of interests – a moral issue which individual scientists often
face at the sphere of development of biotechnologies. As a member of the
scientific society he is obliged to adhere to the Merton’s ethos principles but
as an employee of a biotech company he should follow principles described
by J.Mitroff. This conflict appears to be the most acute when assessing risks
associated with biotechnological activities. It is quite sufficient to point
out to the still unfinished discussion among biotech companies producing
genetically modified products and their opponents from a camp of ecological
movement activists.
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2.2 Characteristic of the Biomedical Research in the Region
(O.I.Kubar, E.A.Malysheva)
A biomedical study is a study involving human subjects held to
investigate new diagnostic, therapeutic and/or preventive means and
methods, gaining new knowledge on physiology and psychology of man in
conditions of norm, disease and extreme situations. The biomedical research
can stipulate both interests of a specific study participant and being held
without direct use for a persons taking part in the study.
Necessity of the biomedical research involving men as study subjects is
obvious in general scientific and historical sense as the only objective, real
and the most fruitful way for discovery of laws of physiology and pathology
of man and the most important condition for successful struggle for health
of every single individual and the humanity as a whole.
In the XXI century the words of one of the founders of bioethics, Claude
Bernand, he said at the end of the XIX century, sound quite fatefully: “a
doctor of future is a doctor-experimenter” that convincingly coincides with
novel capacities of modern medical science and practice not only to prevent
and treat diseases but also to control human life.
An issue of community of the biomedical research in the CIS region from
the point of view of philosophical consideration of community of knowledge
assumes, first of all, addressing characteristic of biomedical research on the
basis of integral scientific, social and value-vision phenomenon.
Since in the context herein there is no objective to describe structure and
order of conduct as it is that is resolved in many of special methodical and
regulatory documents we permit ourselves to utilize commonly accepted in
international practice definitions and concepts that, by itself, demonstrates
supranational scale in the CIS members states and makes possible to form
some perspective characteristics and prognoses.
However, both in any sphere of human activity and in the sphere of
biomedical research to forecast future in a correct way it is necessary to
have memory of the past and knowledge of the present. In this connection,
consideration of main stages of establishment of biomedical research in the
analyzed regional space at stages of its varying political and economical
development gains fundamental value being governed with historical frames
selected within the aspect of the given publication.
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To retain integrity of perception of materials herein as when defining
common elements of ethical and legal trends in the sphere of biology and
medicine there will be used similar parameters of chronological and logical
consideration due to priority of their influence.
Thus, from the point of view of historical community based on common
ideological and social and economic inheritance of the countries in the
region we should distinguish a set of important elements determining both
closeness of positions in the region in regard to international participation
in biomedical research and their specificity. First of all, one should note
that the USSR had a regulated state system of organizing, examination,
registration of medical use products that included regulatory and methodical
requirements and standards for study conduct. From administrative point of
view the system was purely “vertical” assuming a whole set for management,
approval and setup only at the All-Soviet level excluding possibility for
independent approving and executive structures to conduct biomedical
research in individual republics of the former Soviet Union. Regulations
determining this order were clearly determined and strictly controlled.
Studies could be conducted only at clinical sites of the Pharmacological
Committee being a central approving authority, and a list of the clinical sites
was centrally approved. The clinical site list included only research medical
facilities with corresponding staff and technical capacities. Representatives
of developing entities were prohibited from contacting directly with facilities
and performers of clinical studies. Representatives of sponsoring entities
including accredited foreign pharmaceutical companies had contacts only at
the level of central approving authorities.
From research methodical point of view the system for setup and conduct
of biomedical studies had clear pharmacological bias. Existing methodical
guidelines and regulations on biomedical research conduct were developed
for particular pharmacological groups of medicinal agents and took into
account all specifics of their biological and pharmacological action. Such
documents were produced with participation of only leading specialists in
the corresponding field of pharmacology, biology and medicine. Then these
documents were strictly examined at the level of specialized commissions
(also distinguished as per a principle of pharmacological orientation
of candidate agents) and later were to be discussed and approved at the
international level (within the system for international cooperation defined
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by borders of the former socialist camp). At this level specialized, specialized
profile approach for consideration and approval of documents was strictly
followed.
Such specialization could be tracked at all stages of biomedical
research from examination of application documents at the level of
specialized commissions to study conduct in specialized sites only. Even
the list of clinical sites mentioned above did not assume participation of
each of those facilities included in this list in biomedical research of any
specialization but it was clearly structured in regard to capabilities for
conduct of various studies. For instance, this list contained a system of
headings that included lists of facilities where it was permitted to perform
studies of immunobiological, antiviral, oncology, cardiovascular agents, etc.
Practically it meant that a particular facility had a technical complex able
of providing proper diagnostic degree and dynamic observation taking into
account registration of parameters significant for this pathology that was
stipulated with corresponding instructions as well as had specialists in this
particular field. The given specification was not limited with only medicinal
agents but also included medical devices and cosmetics. There was a system
of specialized, central expert institutions.
From the financial and economical point of view all studies (for
institutions and research personnel) did not assume any additional financial
investments and were based on the general budget of the institution. For
some cases there was a system of bonuses for participation in international
studies that was centrally defined.
Structure of the conducted biomedical research included also studies
involving volunteers in specifically established sites. There was an instruction
on the order for conduct of studies involving volunteers approved by the
Ministry of Health of the USSR with a list of facilities where such studies
could be conducted. And in the 60’s of the last century there were established
hospitals for testing vaccine strain candidates and for space-related studies.
The order of participation of volunteers in these studies assumed their
informed written consent and reimbursement for their participation.
From the point of view of international status the USSR participated in
all significant international conventions in this field, was a partner with WHO
and some other international organizations, conventions of narcotics (1961),
psychotropic agents (1971) were signed. In regard to patent protection the
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country was a member of the Paris Convention (1965), protection of patent
rights covered invention, utility models and industrial designs and it lasted
for 20 years for the whole world. At the beginning of the 90’s first (approved
by authorized agencies) contract research organizations appeared.
The entire set of these elements in combination with peculiarities of
the system of health care and medical education determined unique features
inherited from the former USSR providing motivation for pharmaceutical
companies to conduct biomedical research in the CIS countries. All analytical
reviews from all representatives of world pharmaceutical industry interested
in conduct of studies made in the beginning of the 90’s of the XX century
noted their interest for conduct of biomedical research in this region, first of
all, due to the following reasons:
- existence of centralized specialized Centres capable of inclusion large
number of patients into a study within short term;
- epidemiology of infectious and non-infectious diseases in conditions
of absence of treatment standards approved for foreign practices (“naïve
patients”);
- high scientific and medical potential of researchers and research
Centres;
- knowledge of foreign languages by leading specialists, high quality
of documenting;
- interest of all stakeholders involved into a research process (state
authorities, researchers and research Centres, high degree of trust of patients
to medical personnel);
- perspectives of future pharmaceutical market and low competitive
strength of local pharmaceutical industry.
Naturally, these capacities were not evenly distributed in all CIS countries
but general trends were explicitly present and determined attractiveness of
this region.
However, it is necessary to introduce significant correction in the
course of events presented above that coincided in time with deep social and
economic depression of the initial stage of independence of the CIS countries
making them “vulnerable” countries in regard to conduct of biomedical
research. This “vulnerability” was characterized with high dependence of
all parties indicated above involved into a research process (state agencies,
researchers and research sites as well as patients) as to facts of considerable
66
conflicts of interests, direct and indirect pressure due to absence of tangible
assets, medicines, work, etc.
The mostly civilized response on present situation was transition
explicitly marked in all CIS countries to the level of global international
interaction in the sphere of biomedical researches (described in details
herein in chapters regarded to the CIS member states). Currently the basis
of legal regulation of biomedical research in all CIS countries is formed by
a set of international legal and recommendation documents among which,
first of all, one can emphasize previously mentioned (1.2) Guidelines for
Good Clinical Practice (ICH GCP) of 1996. This document along with
a set of documents regulating the order of ethical examination to a large
extent determined domestic regulation in the sphere of biomedical research
in the CIS member states and added to the aforementioned parameters of
attractiveness of the region in regard to the biomedical research setup the
following features:
- compliance with international research standards;
- predictability and openness of approval systems;
- availability for monitoring, audit and inspection.
Activities of IPA CIS and the CIS Council on Cooperation in the Field
of Health Care contributed a lot into this process and its unification within
CIS identifying unity of views on a range of factors determining modern
realia of development of the CIS countries.
First of all, one should note that strengthening of health of the
population as one of the main priorities for formation of a social state is
included into a concept of legal basics and mechanisms for the social state
implementation in the Commonwealth countries. Mechanism of state social
and technical standard as norms and regulations providing implementation of
constitution-guaranteed social rights of citizens and being, at the same time,
checkpoints for implementation of social and economical policy of a social
state is determined as the most important element of social policy. Value of
this statement for the state regulation in any sphere of human activities is
extremely high, and in regard to biomedical studies at the state legislative
level it introduced an order for regulation on the basis of state standards,
which established as highly important the standards for good preclinical,
clinical and manufacture practices identical to international standards of
GLP, GCP and GMP.
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Returning to statements of the aforementioned (1.2) model Law of IPA
CIS On Protection of Human Rights and Dignity in Biomedical Researches
in the CIS, it is necessary to indicate that even the text preamble of the
law states that “the present law introduces state guarantees for protection of
human rights, dignity, autonomy and integrity when conducting biomedical
studies” and it is based on statements of the Constitution and a set of universal
principles proclaimed by fundamental international documents.
The sphere of action of the present law is spread on state citizens
participating in biomedical research and is applied in regard to all facilities
and persons being related to conduct of biomedical research at the territory
of the state as well as it stipulates that foreign citizens and persons with
absent nationality being present at the territory of the state in case of
participation in a biomedical study can enjoy all rights established with the
given law equally to citizens of this state. Such statement is quite significant
in regard to situation in the CIS region due to openness of borders and
notable migration processes.
In regard to harmonization both within CIS and at the international
level it is important that the law unifies terminology in compliance with
GCP-approved definitions creating attitude for mutual understanding and
development of a united information field of biomedical research. Some
articles of the law stipulate the state policy standard and rights of participants
of biomedical studies. Separate chapters are dedicated to study safety and
an ethical review system, a format of an informed consent and compliance
with confidentiality requirements, therefore, corresponding to the core of
all international enactments in the sphere of biomedical research. There is
a separate chapter on special situations of the biomedical study conduct
including articles regarding biomedical research involving vulnerable
persons, research in emergency clinical situations, epidemiological and
social studies. In general, force of the law covers all types of biomedical
research involving human subjects including the ones with embryos in vivo,
but excluding research on embryos in vitro. Liability for breaching the law
is also stipulated.
Beside regulatory model regulation there is a functioning union for
executive authorities of the Commonwealth countries as the Council on
Cooperation in the Field of Health Care mentioned above which has the
interstate commission on standardization, registration and control of quality
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of medicinal agents, products for medical use and medical equipment in the
CIS member states.
By the order of the Council on Cooperation in the Field of Health Care
the CIS Executive Committee prepared and submitted final information of
regulatory and legal documents in the field of sanitary and epidemiological
regulations and provision of sanitary and epidemiological well-being of
population in the CIS member states as well as concerning agreements and
decisions on provision of coordinated actions of the CIS member states in
the field of standardization, registration and quality control of medicinal
agents, products for medical use and medical equipment.
Acknowledging logic of closeness of conditions and problems of
biomedical study conduct in the CIS region the coordinated harmonized
actions include not only authorized state agencies but also public entities
(for instance, the FECCIS) and professional associations of manufacturers
of medicinal agents and pharmaceutical companies working at the market
of the CIS member states. Within the framework of activity of the interstate
commission on standardization, registration and quality control of medicinal
agents, products of medical use and medical equipment along with the CIS
Executive Committee there are being prepared documents for harmonization
of requirements at all levels of medicinal agent promotion within the region
space and globally through collaboration with corresponding international
structures.
These actions and documents are determinative for strategy of
development of mutual cooperation. The world society for a long time
acknowledged as one of the most important conditions for success in
cooperation development of regulatory and legislative framework and
system providing “free movement of ideas, goods and people”. Activity
for acknowledging of advisability of biomedical studies with similar level
of requirements, standards for setup and ethical standards is aimed for this
purpose that is provided with creation of special international structures
working on both generation of such documents and their promotion and
implementation.
Summarizing the aforesaid, serious potentials of full-fledged inclusion
of the CIS region into the global system of international biomedical studies
are rather evident. Analyzing modern market of biomedical studies one can
note considerable contribution of the CIS countries into the biomedical
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research industry and its progressive development. Number of international
studies conducted in separate CIS countries grows dynamically each year and
simultaneously a scale of these studies is being extended that is represented
in chapters on individual CIS countries herein.
Certainly, different CIS countries have different possibilities for
implementation of these potentialities due to varying population size,
development degree of health care system, research potential levels,
morbidity structure, general infrastructure state required to guarantee quality
of biomedical research including service lines, customs rules, etc. It is
important that universality and community of regulation and implementation
of biomedical research in total provides universality and community of
biomedical knowledge and enables common use of results of science and
progress in medicine and biology.
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2.3 Establishment of the Ethical Review System
& Ethics Committees in the Region
(O.I.Kubar, A.G.Asatryan)
Throughout its history medical activity has been guided by two forms
of social regulation: moral (ethics) and law. Issues relating to the observance
of ethical and normative principles in biomedical research involving human
subjects are most topical nowadays. The development and implementation
of protective legislation aiming to safeguard human rights and freedoms, i.e.
those ethical values that are acknowledged as the most essential ones in all
lawful states, is a distinctive feature of the social state the building of which
is the strategic goal of all the CIS countries.
To illustrate the significance of understanding the evolution of ethical
aspects relating to biomedical research, we may trace the dialectics of
advances in biology and medicine represented by the following stages of
goals and motivations:
• The utmost goal of medical science is to provide knowledge.
• The utmost goal of medical practice is to satisfy needs and interests
of an individual and the society with regard to protection and maintenance
of human health basing on knowledge obtained by science.
• The utmost goal of bioethics is to resolve conflicts of individual and
social interests that might arise in the course of science development and in
medical practice.
Thus, it is obvious that ethics is the measure and criterion of resolving
conflicts of interests resulting from the advance of biomedical science, and
ethical review, alongside with the scientific consistency, becomes an integral
part of the research. In this context, the universal significance of the ethical
component of the scientific research and its global effect on the development
of ethical ideas and on the ways of their implementation at the general
level of civilization in the history of humankind is quite obvious. From the
theoretical viewpoint, it is impossible to speak about the history of medical
ethics without considering interdependent processes of the development
of various ethical concepts and an essential role of main landmarks in the
history of world ethical practice that have determined a harmonious and
comprehensive understanding of general ethical principles of the research.
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From the practical point of view, the history of biomedical research
ethics is inseparable from understanding the essence and process of the
biomedical research as such.
According to the main research subject, the biomedical research may be
divided into the following categories:
• Research that physicians carry out on themselves
(autoexperiments);
• Research involving healthy people;
• Research involving patients.
In historical context, the concept of informed and voluntary consent of
a research subject requires subdividing into separate groups within these
categories
Besides, both in healthy (e.g. prisoners and military men) and ill (e.g.
persons with mental disorders or ill minors) research subjects, groups of
vulnerable contingents should be distinguished, i.e. groups of persons who
for social, legal, age-specific, intellectual, mental or other reasons have
a limited capacity or do not have the capacity to make an independent,
informed and voluntary decision to participate in a clinical research.
It is also essential to distinguish different types of biomedical research
depending on the character of the connection between the research goal and
its actual clinical motivation.
Research of the first type, defined in international documents as
“therapeutic” (or clinical) biomedical research, implies the application of
new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
research conducted in the interests of a particular research subject.
Research of the second type, defined as “non-therapeutic” (or nonclinical) biomedical research, does not imply actions in the interests of ill
or healthy subjects. Biomedical research is carried out with the purpose of
obtaining some scientific knowledge or studying how the human organism
would respond to one or another condition or factor (pharmokinetic studies,
studies in the field of normal physiology, in cosmonautics and sport, etc.).
Each of the mentioned types of biomedical research forms and
determines special ethical and legal relations. In historical context, the
influence of ethical dialectics of each type of biomedical research on the
current concept of bioethics is most essential.
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Thus, high moral principles of physicians (investigators) who conducted
experiments on themselves gave rise to a symbol of heroic dedication - a
“burning candle”, which personified the motto of medical profession “Aliis
lucens uror”. The history of medicine knows many examples of heroic
dedication to science, self-sacrifice and modesty. Often those experiments
ended tragically and entered the chronicle of “tragic medicine” in the
world history. Among devotees there are many physicians (investigators)
representing peoples of the CIS countries, which is reflected in chapters
describing the cultural and historical background of ethics development
in each country. On the whole, the scientific feat of those people is of a
supranational character, and arouses feelings of a deep respect and admiration.
Their work served the purpose of scientific knowledge, saving people’s life
and making achievements for the welfare of the humankind.
Inhuman experiments on concentration camp prisoners carried out on
an appallingly large scale and sanctioned by the state law of the Nazi regime
arouse opposite emotions, and the very word “experiment” with regard to a
human being has a dismal echo.
However, the development of biomedical research is based not only on
those polar, in terms of ethics, examples.
International standards of implementation into the medical practice of
new therapeutic, diagnostic and preventive pharmaceuticals and methods, as
well as their scientific and moral resonance are reflected in historical stages
of setting out legal concepts of bioethics.
Currently, the list of international recommendations, declarations, codes,
resolutions and other documents relating to bioethics is very extensive, and
in the last decades it has a tendency to increase.
One of the most important events in the history of bioethics in the XX
century was the Nuremberg Code adopted by the International Military
Tribunal in 1947. When commenting on this historical document, the world
press emphasized that the accusatory sentence of the Nuremberg Trial
“speaks on behalf of insulted human conscience”. The Nuremberg Code
was the first document based on the “judgment of the victorious truth”,
which declared the cardinal ethical principles with regard to an individual
and stimulated the growth of public awareness and peoples’ responsibility.
Among international documents in which the ethical principles in
medicine and their actual application were further developed, the Declaration
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of Helsinki is certainly the most important. It was adopted by World Medical
Association in 1964, and has been continuously revised and updated.
Recognizing the key role of the Nuremberg Code and the Helsinki
Declaration with regard to ethical regulation of biomedical research, we
should mention also some important documents that set up a kind of a
base for those, and a number of documents facilitating the development
and interpretation of the general principles set out in the Declaration of
Helsinki and its actualization in connection with new conditions caused by
the progress in biology and biomedicine in the last decades of the XX and in
the beginning of the XXI century.
The current concept of ethical regulation of biomedical research,
asserting that an individual, and the society as a whole, has the right to
benefit from scientific achievements and must be safeguarded against any
risk or damage, developed only by the middle of the XX century. However,
international community has also recognized some documents written in
the end of the XIX and in the beginning of the XX century. Among the
XIXcentury documents there Ethical Codes by Thomas Percival (Great
Britain, 1803); William Beaumont (USA, 1833) и Claude Bernand (France,
1865).
Dr. S. Fluss, the Scientific Councilor at the Council for International
Organizations of Medical Sciences (CIOMS), in his historical analysis of
materials relating to the ethics of medical research involving human subjects
developed in the XX century, before the Declaration of Helsinki, mentions
about 15 documents adopted in Germany (1900, 1931), USSR (1936, 1949),
Netherlands (1955), Great Britain (1962-63) and Sweden (1963).
Among significant international documents adopted in the period before
the Declaration of Helsinki, we should mention the International Code of
Medical Ethics (WMA, London, 1949). It states: “the physician shall act
in the patient’s best interest when providing medical care that is to improve
the patient’s physical and mental health”. Declaration of Geneva Adopted
by the 2nd General Assembly of the World Medical Association (Geneva,
Switzerland, September 1948) defined the physician’s duty: “The health of
my patient will be my first consideration”.
These canons of the physician’s behaviour entered the Preamble of the
Declaration of Helsinki, which proves the significance of the abovementioned
documents.
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Below is the chronology list of main documents aiming at developing
ethical principles of biomedical research:
• International Covenant on Civil and Political Rights adopted by the
General Assembly of United Nations (UN, 1996) to enforce the “Universal
Declaration of Human Rights” (General Assembly of United Nations,
1948);
• International Ethical Guidelines for Biomedical research Involving
Human Subjects (CIOMS in collaboration with WHO, Geneva, 1982);
• International Guidelines for Ethical Review of Epidemiological
Studies, СIOMS (Geneva, 1991);
• Declaration on the Human Genome Project. Adopted by the 44th
World Medical Assembly (Marbella, Spain, September 1992);
• International Ethical Guidelines for Biomedical research Involving
Human Subjects (СIОМS, Geneva, 1993 – an updated version of Guidelines
adopted in 1982);
• Declaration on the Promotion of Patients’ Rights in Europe (World
Health Organization, WHO Regional Office for Europe, Amsterdam,
1994);
• Convention for the Protection of Human Rights and Dignity with
Regard to the Application of Biology and Medicine: Convention of Human
Rights and Biomedicine (Council of Europe, Strasbourg, 1996 and its
Additional Protocols);
• Guidelines for Good Clinical Practice (GCP) developed by the
International Conference on Harmonization of Technical Requirements
for the Registration of Pharmaceuticals for Human Use (ICH) (Brussels,
Washington, Tokyo, 1996);
• Guidelines and Recommendations for European Ethics Committees
(European Forum for Good Clinical Practice (EF GCP), Brussels, 1997);
• The Universal Declaration on the Human Genome and Human
Rights (UNESCO, 1997);
• Operational Guidelines for Ethics Committees that Review
Biomedical Research (WHO, 2000)
• Universal Declaration on Bioethics and Human Rights (UNESCO,
2005)
• and a number of other documents.
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Alongside with the key role of international documents and the
significance of joint efforts of the world community aiming to work out
a uniform standard for biomedical ethics, we have to mention the impact
of cultural and legal aspects on the development of a current concept of
bioethics. Therefore, it is essential to trace the evolution of ethical and
legal aspects with regard to biomedical research in the history of the CIS
countries during last century and evaluate interrelating tendencies in the
development of bioethics in the world, regional and national space. The
moral basis of the medical profession since early times has been reflected in
national traditions and worldview, which revealed itself in humanistic ideals
of physicians-enlighteners of the past. (See Chapter 3 “Ethical Review
System for Biomedical Research in the CIS Countries”). National cultures
and ethical views relating to medicine alongside with penetration into and
acceptance of world experience formed the foundation for medical activity
in the CIS countries.
However, we should mention that in the common historical canvas there
are particular written evidences of moral and legal regulation with regard to
biomedical research dating back to the first half of the XX century.
Chronologically, the first case of legal regulation of medical activity that
is available for our analysis is the case of Dr. Modlinsky (Sudebnye Dramy
(Dramas in the Court) Journal, 1902, No. 2). On 15 of November 1901, the
Moscow regional court, basing its judgement on Article 1468 of the Statute
on punishment in Russia, with respect to “causing death by an obviously
careless, but not legally prohibited, deed”, judged Modlinsky to be guilty of
having performed surgery without obtaining the patient’s consent. Although
there was no requirement for patient consent for medical interventions under
the relevant medical code at that time, on 19 of November 1902 the Criminal
Court of Appeal of the Senate of Russia endorsed the findings of the lower
court, stating that “not obtaining the patient’s consent for surgery deprives
medicine of its legal character and is the sign of overt neglect, giving the
doctor’s deed the status of a criminally culpable act”. Already at that time, it
had been accepted that a patient’s consent to a medical intervention should
be sought (Tregubov “Ugolovnaia otvetstvennost vracha za vrachevanie bez
soglasia bolnogo” (Physicians’ Criminal Liability for Treating the Patient
without His Consent) St.-Petersburg, 1904, No. 12), and that the patient may
make a conscious decision. According to the famous professor of criminal
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law, Tagantzev, “the patient’s consent is not always sufficient to prove that
any particular case of medical practice is not indictable” (Pravo (Law)
Journal, 1902, No. 12).
An understanding of the ethical and legal issues with regard to organ
transplantation and the necessity to obtain a written and documented consent
from the donor and the recipient, as in a case described by the Dr B.V.Dmitriev
in the beginning of the XX century (Medicinskoe Obozrenie (Medical
Review) 1917, vol. LXXXVII, No. 13-14-15-16,), to a large extent reflects
the modem view of the basic moral principles of biomedical research. Dr.
Dmitriev sets out some other ethical norms of such surgical operation. The
donor and recipient should be informed about potential consequences of the
surgical intervention; there are requirements concerning the donor’s mental
and physical health; the physician should guarantee that the harm done to
the donor would be mild and transient. Dr. Dmitriev’s article contains a
unique text, an early example of a carefully designed a patient’s informed
consent form that is still valid today. It deserves to be quoted in full.
“I, the undersigned E.R, by myself, without any external influences,
offered a piece of my thyroid gland for transplantation. The piece would be
of the size required for successful transplantation (approximately up to one
eighth of the gland’s volume). I have had all the details explained to me and
I am aware of all the risks I am subject to, i.e.:
1) as a result of an unsuccessful operation life-threatening bleeding can
occur,
2) suppuration of neck and even blood contamination can follow which
can result even in death.
I was told that the effect of the operation on the human health is not yet
known, because this operation is very rarely performed, and that in the books
where it is described it is not stated how the people from whom pieces of
thyroid gland were taken felt themselves, but experiments on animals prove
that one can remove up to two-thirds of the thyroid gland without doing any
harm to the animal, and that because with respect to the thyroid animals and
human beings are similar, these conclusions are probably applicable to humans
as well; and indeed, when the tumors of thyroids are removed, it can be enough
to preserve a very small portion of it so that the person can continue living
without experiencing troubles related to the absence of the thyroid gland. I am
also aware how a shortage of thyroid gland affects the human.
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Then I was told that although I will have analgesic medicine injected
under the skin for pain relief, I will possibly feel some pain during the
surgery and afterwards. And finally, it was explained to me, that in the case
of successful operation or especially if the wound suppurates I will have
a scar for life on my neck about 7.5-10 cm long. And, despite all the facts
mentioned above, I agree to the surgery, and whatever happens, I will never
have any claims either against the doctors who will perform the surgery, or
the patient who will receive my thyroid gland. I am signing this paper in the
presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the
nurse E.V.Shevchenko (signature); we witnessed the reading and signing of
this paper and hereby certify that E.P. is an adult and mentally capacitated
person (signatures of doctors and nurse)”.
This document dated 1917, contains all elements of current ethical
concept relating to biomedical research: confidentiality, respect for a
person’s autonomy, information about all risks associated with the research,
freedom of a voluntary choice, verification of the research subject’s
social and mental maturity. All statements in Dmitriev’s article base on a
legal concept of a famous lawyer A.F.Kony who testified to the absence
of criminal deed in the case of the sale of organs for treatment purposes
in accordance with the contract between the donor (seller) and recipient
(buyer). At the same time he noted that “under these circumstances the only
ethical issue that might arise concerned the permissibility of such a deal
in a situation where the “seller” was a minor, imbecile, or a person in a
state of artificial excitation, and where the “buyer” was a person who acted
through psychological compulsion, deception, seduction, promise of profit
or suggestion by authority.
On the whole, the analysis of legal and ethical principles referring to
biomedical research existing in the tsarist Russia in the beginning of the XX
century shows that humanistic concepts of a voluntary and conscious choice
made by the research subject and confidentiality have been combined with
a responsible and merciful attitude on the part of a physician-investigator,
and reinforced with accepted moral and ethical norms and legislative acts
in force.
Turning to a more recent period in national history, the following stages of
Soviet law development illustrate how the issues in ethical and legal regulation
of medical and biological research were interpreted in the USSR.
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In the law of the Russian Soviet Federal Socialistic Republic (RSFSR)
on 1 of December 1924 “On the Professional Activity and Rights of Health
Professionals” the need to obtain the patient’s consent, in particular when
surgery is being planned, was declared. It was also stated that “with respect to
those under 16 years of age or mentally disabled, the consent of their parents
or care-givers”, i.e., their legal representatives, was necessary. Similar laws
were adopted in the other Republics of the USSR. One should specifically
underline that neither the law on 1 of December 1924, nor the decrees of the
Soviet Ministries of Health until 1936, clarified how the patient’s consent
was to be documented, and how it was necessary to regulate the conditions
of medical research involving human subjects.
In 1936 the legal regulation of the scientific and ethical aspects of the
medical experiment was addressed in the Statutes “On the conduct of study
of new medicines and medical methods associated with the risk for life and
health of patients” adopted by the Scientific Medical Council of the People’s
Commissariat of Health Care of the RSFSR (Resolution of the Bureau of
the Scientific Medical Council, 23 of April 1936. In: Book of Resolutions
- Peoples Commissariat of Health Care of the RSFSR. Scientific Medical
Council. No 1-4, pp. 37-38).
The events that encouraged the authorities to develop this document
were described in detail in an article by professor I.Ya. Bychkov, where
the author emphasized that in medicine “in order to assess the value of
invention it is always necessary to study it in humans; and considering the
fact that the medicine or device is new, it is always associated with some
risk, can cause health problems or even endanger the life of the person who
is the subject of the trial of a new method or a new medicine”(Bychkov
I.Ya. On the question of legal regulation of medical experiments on human
subjects. Soviet Medical Journal (1939) 1, 61-68). At the same time it was
stated that “medicine cannot develop without such experiments. These
experiments are conducted, and they are inevitable; if we stop conducting
them we will risk staying at the “freezing point”, but we have to ensure
maximum guarantees for patients. The appropriate regulation of the use
of new diagnostic and treatment methods and medicines in human beings
will to a large extent protect the inventors from censure and unfavourable
criticism of them”. By way of illustration, the author describes several cases
of medical “experimentation” conducted by private doctors, which caused
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adverse effects in patients. Under these circumstances the work of “legal
and investigatory institutions was complicated by the absence of official
rules regulating the conditions of medical experimentation”. In order to
eliminate this legal vacuum, in 1936 the Scientific Medical Council of the
People’s Commissariat of Health Care of the RSFSR established a special
commission responsible for development of rules concerning trials of new
medical methods and medicines in humans.
It is especially interesting to compare the principles declared in the
statute “On the conditions of conducting the research of new medicines and
medical methods which can endanger the health and life of patients” with the
principles stated by modem international instruments regulating the conduct
of medical research. According to the Statute, trials of new medicines in
human beings are permissible when the following conditions are observed:
“when it is conducted by a physician working in the medical institution,
upon notification and under responsibility of the medical person-in-charge
of the institution, with the purpose of alleviating the patient’s suffering,
and when the research subject has given his consent to participate (in a
case where the patient, due to her condition, is unable to give her consent,
or her consent will not have legal force, the physician must ask the legal
representative’s consent prior to enrollment of the patient)” - this term of the
Statute corresponds to the ethical principles formulated in articles 15, 20, 22
and 24 of the Declaration of Helsinki;
“when it is conducted after preliminary animal experimentation which
is necessary and possible based on modern scientific data” - this term
corresponds with article 11 of the Declaration of Helsinki;
“any use of new medicines and methods defined in the present Statute
should be documented in detail by the physician. The doctors in-charge of
the institutions where the research is being conducted must report the results
of the research”.
As a whole, the Statute of 1936 was the first legal act of the Soviet
health care system, which regulated the rules and conditions of the conduct
of biomedical research, and defined the responsibility for observation of
such regulations. As to its contents, the Statute illustrates a number of
cardinal principles regulating the modem practice of biomedical research.
However, the Statute did not declare the need to establish ethics committees,
nor emphasize the need for independent ethical review, and the decisions on
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both professional and ethical aspects of the review were still the responsibility
of the institutional organizations.
On the whole, the significance of all these documents (considering
their content and the time when they had been adopted) consists in
the fact that the requirements concerning scientific justification and
preliminary experiments on animals, research participants’ informed and
conscious consent, high qualification of a physician-investigator and his
responsibility in relation to research subjects fully coincide with modern
norms of research ethics. The other important and positive aspect with
regard to the analyzed documents is that the motivation to create those and
their content has a protective legal character.
At the same time, it should be noted that the Soviet legislation had
a legal mechanism for the attribution of criminal liability for committing
“crimes against Humankind”. (Decree of Presidium of the Supreme Council
of the USSR on 19 of April 1943. Art. 1). There is an important historical
document that reflected moral and legal understanding of experiments on
live human beings – the protocols of a legal action conducted by the Military
Tribunal of the USSR in Khabarovsk in 1949. It concerned the case of former
Japanese military men accused of the development and use of biological
weapons (“Indictment on the case of the former Japanese military men”; a
supplement to Novoe Vremia (New Time) Journal, No 1, 1 of January 1950).
The importance of the Conclusion adopted by the Tribunal in Khabarovsk
is comparable with the importance of the Nuremberg Trials and the Code
adopted there. In both cases the moral aspects of decisions concerned not
only the individuals guilсссty of the crimes, but also the governmental
policy and ideology which made these crimes possible.
In the context of this Chapter the above documents are mentioned for
the following purposes:
• to eliminate informational vacuum existing in relation to the ethics
of biomedical research in the former Soviet Union;
• to clarify the reason of including the abovementioned documents
into the international list on important documents of “pre-Helsinki” era to
the CIOMS list;
• to illustrate mutually enriching and complementary values of
studying fundamentals of moral and cultural heritage;
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• to define the basis for a timely and harmonious assimilation of
international universal norms of biomedical research ethics by the CIS
countries.
Summarizing the data on the ethical component of biomedical research
at the time of the Soviet Union disintegration and formation of new
independent states in the end of the nineteenths of the last century, we have to
state that there existed efficient moral and ethical norms of medical practice
and the governmental system regulating biomedical research. Although
there were separate cases of establishing ethics committees at medical
centres taking part in international studies, those were but of a “decorative”
or “declarative” character, as they were established to meet the requirements
of foreign pharmaceutical companies and did not have a legal status.
The actual process of entering into the international system of ethical
review began for the CIS countries also in the nineteenths of the last century.
The rhythm and procedure for different CIS countries depended on their
involvement in international biomedical research. As to the documents
and international regulations that formed the basis for the development of
national legislation, they were quite comparable. Materials presented for
this book by the CIS country show all the details (See Chapter 3).
To analyze common and specific features in the CIS region with regard to
the topic, we have chosen key elements of the ethical concept of biomedical
research. According to the interpretation of a number of international
(adopted in the CIS countries) and national documents that have been
usually developed on the basis of existing national legislation, the ethical
review of biomedical research is performed by independent bodies – ethical
committees (ECs). The ECs activity aims at protecting research subjects’
rights, well-being and health, as well as at providing additional guarantees
of this protection through the review of research protocols, amendments to
research protocols and the procedure of obtaining and documenting research
subjects’ informed consent. The review is concluded with the EC decision
relating to the proposed research project. The subject of the ethical review
is the research compliance with ethical and legal requirements regulating
biomedical research and set out in documents of various status and application
sphere. Statements relating to a potential research subject’s voluntary
consent to participate in the research, to providing adequate information on
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all aspects of the research and to confidentiality of all patient’s data obtained
in the course of the research are of crucial importance.
Here is seems reasonable to review main characteristics of these two
elements of biomedical research ethics in the CIS countries and to determine
perspectives for their development.
When analyzing the situation in the CIS countries with regard to ECs
activity and its compliance with standards of ethical review of biomedical
research the following main problems should be mentioned:
• usually there is no accurate distinction as to ECs functions, which
creates potential conditions for the redoubling of the review and decisions;
• ethical review conducted only at the level of the national EC (in some
CIS countries) hampers the analysis of a specific character of a particular
research centre and limits opportunities of a dynamic monitoring of ongoing
research;
• we cannot exclude cases of administrative and economic dependence
of local EC on interests of research centres as they are highly motivated to
conduct a research;
• usually there is no legal system of appeal with regard to the EC
decisions;
• the lack of detailed regulations concerning EC financing;
• the lack of state inspection of the EC activity;
• the lack of demand for ethical review on the part of research
subjects;
• the lack of a regular state system for training EC members.
The mentioned problems determine the leading trends in the development
of the system of the EC performance and structure in the CIS countries:
• to develop legislation ensuring the EC independent performance;
• to separate power (responsibilities and rights) in the performance of
EC on different levels (national, regional, local);
• to create the system of EC interaction inside the country and on the
international level;
• to develop the demand for ethical review in all research subjects;
• to eliminate informational vacuum with regard to issues of the
protection of human rights and dignity in biomedical research;
• to create an educational and informational programme on bioethics
for medical professionals and other persons associated with the research;
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• to develop a special system for training EC members;
• to introduce the practice of the state inspection and independent
audit of EC performance;
• to develop legal regulations for the EC economic activity.
The analysis of the current state from the viewpoint of the principle
of obtaining research subjects’ informed consent shows that a principal
achievement of the CIS countries is a legal regulation of this procedure.
Among issues requiring a further development we should mention first the
need to work out guidelines and norms for interpreting separate statements
in legislative acts, terms of their application and their harmonization with
norms of international law in the field of bioethics. There is a particularly
urgent need to create bioethics information field with potentials for a
differential education of various population groups aiming at raising the
level of public knowledge about human rights and moral responsibility in
biomedical research.
In the history of establishing a system of ethical review and ethics
committees in the region the performance of the mentioned Forum for
Ethics Committees in the Commonwealth of Independent States takes
a special place as a public movement aiming at fulfilling this task in the
region via creating a possibility for the access to the world experience in the
development of ethical concept of biomedical research considering national
cultural and moral values.
The FECCIS was established on 21 of March 2001 according to the
Resolution of the Conference for representatives of ethics committees and
others authorized bodies from the CIS countries held in Saint-Petersburg,
Russia. The FECCIS is one of the five regional forums, established in the
framework of the WHO/SIDCER project.
Sharing the basic priorities of the SIDCER project referring to the
protection of human rights and dignity in biomedical research all over the
world with respect to cultural, historical, religious and social differences, the
FECCIS has defined as its the main objective to support the development
of bioethics in the region with an emphasis on ethics of biomedical research
involving human subjects.
Over the period 2001-2006, the FECCIS activity has been directed
to developing legislative and normative system in the field of research
ethics, working out and implementing educational programmes for the EC
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members, developing informational space and a dialogue with all interested
parties participating in the review of biomedical research.
With regard to the legislative initiative, FECCIS, as mentioned above,
has been concentrating its efforts on working out a legislative basis for
protecting human rights in biomedical research through collaboration with
the Permanent Commission on Social Policy and Human Rights of the Inter–
Parliamentary Assembly of the Confederation of the Independent States.
This collaboration resulted in the development of the IPA CIS model Law
‘On the Protection of Human Rights and Dignity in Biomedical Research
in the CIS’ adopted in 2005 (see Chapters 1.2 and 2.2). In collaboration
with the Permanent Commission on Science and Education of the IPA CIS
the FECCIS worked out Model recommendations “ On Ethical and Legal
Regulation and Safety of Medical Genetic Research in the CIS “.
An important direction of the FECCIS activity is the development of
mechanisms, fundamentals and conditions for an internal monitoring and
independent surveying, and evaluating the EC performance, to ensure a due
quality of ethical review.
This direction of the FECCIS activity includes working out the
Collection of model Standard Operational Procedures. Independent and
competent representatives of the CIS countries and experts from all over
the world took part in this work. Consultations, discussions and analysis
of the main statements on the establishment, structure and operation of EC
and advanced methods of ethical review in international practice laid the
foundation for a dynamic development of standards and criteria for EC
activity that are described in this book.
The integrity of the model SOPs is achieved through the use of universal
terminology, commonly accepted norms of bioethics reflected in documents
that have been used and a consistent description of the EC operation at
different stages and in different situations of ethical review of biomedical
research.
The Collection of model SOPs prepared at the FECCIS Secretariat
is to become an available practical manual on working out SOPs as a
universal instrument for achieving professionalism, openness, pluralism and
independence of the EC practices and for ensuring a common methodological
space for the CIS countries and the world community, which will facilitate
the protection of rights and dignity of individuals and communities in
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biomedical research. The process of SOP implementation was accompanied
with a thorough consideration for specific features and the potential of
their practical applications. The Collection of model SOPs was presented
and discussed at the FECCIS Workshops in St.-Petersburg, Russia (2003);
Kiev, Ukraine (2004, 2006); Minsk, Republic Belarus (2005). Two editions
of the Collection of model SOPs were published in 2004 and 2005. The
development and publication of the Collection of model SOPs stimulates
writing national manuals and methodical standards for ECs functioning on
different levels. Publication of methodical guidelines in Ukraine (2006, in
Ukrainian) is one of the examples.
The other priority in the FECCIS activity is the design and development
of educational programmes for training EC members that could be integrated
into national programmes of professional education of cardinal problems of
bioethics. The programmes can also be helpful in formation of a database on
practical teaching materials referring to biomedical research ethics.
To form the database, national programmes on bioethics adopted in the
CIS countries have been displayed in the FECCIS website. New programmes
have been developed by a FECCIS working group headed by professor
B.G. Yudin in the framework of the Fogarty grant. Representatives of five
CIS countries have attended the course “E-Education in Research Ethics:
Central and Eastern Europe” organized by Albany Medical College (USA)
in partnership with the Department of Medical History and Ethics of Vilnius
University (Lithuania) and sponsored by the Fogarty International Centre.
A special attention has been paid to a direct participation in organizing
and conducting training seminars for the EC members in the framework of
the SIDCER “Recognition Programme”. The Project objective is to promote
the highest ethical and scientific standards of conducting ethical review of
biomedical research. The Project includes the procedure of the EC selfevaluation, preparation for a follow-up survey and the survey that results in
granting the “Recognition” status if the EC meets the standards of ethical
review. The EC members are trained according programmes including
lectures and seminars in working groups. Programmes offer the following
Modules: “Human Subject Protection”, “Standard Operational Procedures”
and “Inspection and Survey of the Ethics Committee”. This Project is
actually the first stage of implementing the system of the EC accreditation,
certification and survey in the CIS countries.
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Organization of 17 international seminars and conferences in 8 of 11
CIS countries has been very important with regard to the formation of the
common informational field. Conference and seminars have been held in
cooperation with different national and international structures. Conference
materials have been published in Russian, English and national languages
of the CIS countries.
The conferences and seminars aimed at exchanging information and
discussing topical issues of the development of regulation and educational
standards relating to the protection of research participants’ rights, to the
development of national systems of ethical review and to the creation of a
harmonized legislation and methodology referring to biomedical research
ethics both in the CIS region and in the global international space.
Due to the development of these main initiatives, the following has
been achieved and accomplished:
• information exchange in the field of bioethics in the CIS region;
• the analysis of issues relating to bioethical education in the region;
• an open access to and discussion of international documents
and guidelines on bioethics and research ethics (translation into national
languages);
• implementation of SOPs into the process of ethical review;
• stimulation of efforts directed towards the development of national
systems of ethical review in compliance with the GCP standards and
international guidelines;
• assistance in the organization of the EC members education and
training in the region;
• the EC preparation for the survey and evaluation of their
performance;
• raising the EC authority and their role in the development of
international standards concerning the protection of research subjects’
rights;
• assistance in the development of national Forums for Ethics
Committees in the CIS countries;
• the evaluation of the current legislation referring to the protection of
human rights in biomedical research and medical practice in the region;
• the performance as a regional centre for cooperation in the field of
ethical review development;
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• assistance in the practical application of the SOPs for ethical
review in the region in compliance with Operational Guidelines for Ethics
Committees That Review Biomedical Research (WHO, 2002);
• coordination of the CIS countries in the sphere of bioethical issues
and ethical review of biomedical research in the region.
Summarizing the above said we should recognize that the history of the
development of the system for ethical review of biomedical research in the
CIS countries is a dialectic process of ethical and legal development of the
national consciousness and legislation directed towards protecting rights,
dignity and autonomy of an individual as a biomedical research subject, and
providing moral and ethical guarantees to the society that biomedical research
is conducted in a strict conformity with universal ethical standards.
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Chapter 3. Ethical Review System
for Biomedical Research
in the CIS Countries
3.1 Republic of Armenia
(G.D.Aslanyan, S.A.Davtyan)
3.1.1 Historical and Cultural Background
Like any new field of knowledge related to the rise or appearance in the
foreground of some new realities in the life of our society, bioethics needs to be
considered first of all from the historical, cultural and religious perspective.
Republic of Armenia is rich in objects of unsurpassed art. There are
over 4000 monuments of architecture at the territory of today’s Armenia.
“Armenian history, – wrote Valery Briusov, a Russian poet, – is as noteworthy
as the history of the most famous peoples of the world, including Egyptians
and peoples of today’s Europe, who made their unique contributions into the
world culture”.
“If asked in what place of the world one is likely to find the greatest
number of wonders, I would name Armenia first of all.... Here, in this tiny
corner of the world, you can see monuments and meet people which can
become treasure and pride for the world” (Rockwell Kent).
Although much of cultural and artistic wealth of Medieval Armenia,
including manuscripts, had been destroyed over ages by different invaders,
around 24 thousands of manuscripts have survived to our time, and about half
of them is currently kept at the Matenadaran Institute of Ancient Manuscripts
named after Mesrop Mashtots in Yerevan. According to historian Ghazar
Parbetsi (V c.) that was the most ancient collection formed already in the Vc.
in Echmiadzin Patriarchy. One third of the survived manuscript collection
is illuminated manuscripts. Among those, many concern problems of ethics,
morals and law.
Armenian culture roots back to the great antiquity, which is proved by
numerous petroglyphs in Armenian Plateau, stone and bronze statuettes,
skillfully decorated wooden carts, ornamented arm, ceramic and glass
ware. In the beginning of the IX century B.C. these cultural strata related to
the rise of Urartu art with its remarkable monuments of architecture, wall
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painting, sculpture and domestic ware. One of the art Centres was the town
of Yeribuni (Yerevan) founded 3000 years ago.
A powerful development and expansion of Armenian State in the
Hellenic period, direct contacts with the Hellenic world and Roman Empire
determined a rapid development of Armenian Hellenic culture, and many
masterpieces survived up to now. Among those there are majestic colossal
sculptures erected by the Yervadian dynasty on the Nemrut mountain, a cast
bronze head of the goddess Anahit (nowadays in the British Museum), coins
with portraits of Armenian tsars and rulers (starting from IV century B.C.),
ornaments of a heathen temple and mosaic floor of a bath-house in Garni.
Adoption of Christianity (III century) imparted new content and new
trends to Armenian art. Antique steles were transformed into an entirely new
sculpture style: “khachkary” (cross stones). These marvelous stone plates
with tracery all over the surface surrounding carved crosses were erected as
headstones or in honor of outstanding people or events.
In medieval Armenian painting, alongside with frescoes, book illustrations
(miniatures) are of great value. We find them in thousands of manuscripts
starting from the VI century. Highly developed and widely spread art of
Armenian miniature had its Centres (Van, Cilicia, Gladzor et al.). There were
original schools representing different trends of one national style. Among
miniaturists Toros Roslin (the XIII century) was particularly famous, in whose
miniatures one may see many features of the Renaissance art.
Armenian classical medicine that emerged in the great antiquity based on
the experience of folk medicine during its centuries-old history had come a
long way from empiricism to scientific knowledge. Being closely connected
at the dawn of its development with the experience of traditional systems of
the East (Mesopotamia, Egypt and India), later, in the period of establishing
scientific basics of medicine, Armenian classical medicine had a beneficial
impact from antique science. The influence of antique philosophers and
physicians (Plato, Aristotle, Empedocles, Hippocrates and Galen) on the
development of Armenian classical medicine was particularly strong. Due
to the active translation from Greek language, during the period of the VVII centuries texts of antique scientists had been translated into Armenian.
Those texts inspired medieval Armenian physicians and naturalists, e.g.
Grigor Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi
(XV c.) et al.
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It is noteworthy that great Armenian philosophers (David the Invincible,
Anania Shirakatsi et al.) placed high emphasis on the problems of good
and evil, suffering and compassion, life and death. They considered those
issues in light of Christian morals. Today Armenian Apostolic Church is
continuing this tradition. Suffice it to say, that the Ararat Eparchy with its
rich experience in propagating ideas of bioethics is planning to establish a
Church Public Council for Medical Ethics. Armenian Apostolic Church takes
a rather strict position on some problems of bioethics: it prohibits human
cloning and cloning of human organs, euthanasia, artificial fertilization and
abortion, which is considered as infringement of human life.
In this context the views of David Anhaght (the Invincible) formulated in
his works (“Definition of Philosophy”, “Commentary on Aristotle’s Analytics”
and “Commentary on Porphyry’s Introduction”) are of much interest.
David Anhaght took problems of medical ethics very much to heart. His
ideas on the value of human life are of particular importance. In his book
“Definition of Medicine” he mentioned views of the Stoics who tended to
justify suicide under certain conditions: starvation, loss of close relatives,
natural cataclysms, violation of human dignity, terminal illness and senile
marasmus. Two last cases are directly related to medicine. The Stoics wrote:
“A man who kills himself to rid himself of pain in his ill and wretched body,
commits the righteous act. Thus, a philosopher who was half-paralyzed
appealed to the emperor Julian: Half of my body is dead; the other half is
still alive. Have pity on the half-alive philosopher and order either to heal
or to kill me. Likewise, it would be right for a man who had reached old
age to kill himself when he is delirious, confused and utters meaningless
phrases”.
David Anhaght did not share Stoic views on permissibility of suicides
under conditions mentioned: “In this regard we say that no one should
kill oneself – neither those who have the right to do this, nor those who
don’t… Trials, whenever or wherever they happen, come to us not in order
that we should kill ourselves, but so that we tried our soul. Like a good
helmsman is tested not in still water, but in the stormy sea, the lofty soul
goes to meet a trial”.
Thus David Anhaght (the Invincible), in line with Nerses the Great, a
prominent philosopher (V c.), gave a negative answer to the question “Does
the physician have a moral right to hasten his patient’s death?”.
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Similar views we find in works of Armenian thinkers Mkhitar Hosha
and Smbat Hundstabl (XIII c.). In “The Book of Laws” we read: “The
physician who deliberately or through ignorance does harm to the patient’s
health or, what is more, hastens the patient’s death, as well as the physician
who educates a disciple, but does not give him proper knowledge deserves
a severe punishment, up to death penalty”.
This discussion started many ages ago is still topical nowadays.
Neither lawsuits against physicians who support euthanasia thus violating
one of the fundamental principles in The Hippocratic Oath (“To please no
one will I prescribe a deadly drug nor give advice which may cause his
death”), nor protests of public at large advocating traditional views do not
guarantee that those who stick to more radical opinions will not triumph
in the near future (alas!).
Philosophical moral principles of the Hellenistic world had a great
influence on the moral code of medieval Armenian medicine along with
the highest values of the Christian ethics. The physician who violated The
Hippocratic Oath and gave his patient “a deadly drug” was not merely
reproached for that but treated as a criminal guilty of an innocent person’s
death with all the corresponding consequences, as stated in the chapter “On
Physicians Prescribing Deadly Drugs” in “The Book of Chrii”.
In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an
outstanding Armenian physician (XV c.) writes: “The physician should be
reasonable and have the sense of duty; he should be tolerant and ready to give
advice. In no circumstance should he be a drunkard nor should he be greedy
and mercenary-minded. He should love the poor and be merciful, faithful
and god-fearing. If he does not understand the essence of the disease he
should prescribe no drug in order not to stain his reputation. If the physician
is ignorant it would be better not to call him to see a patient, and, in general,
he should not be regarded as a physician.” These words showing an ideal
image of the physician-humanist and his moral code are still essential for
modern medicine that synthesized imperishable moral values set forth in
medical systems of the East and the West.
Today, each of the presented problems gives rise to many new questions.
At the present stage of bioethics development we are more able to formulate
the questions than to offer a comprehensive solution, and therefore most of
them remain open.
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References
1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9
(in Armenian).
2. Arevshatyan S.S. Early Armenian Translations and Their Cultural
and Historical Significance. // Journal of History and Philology of Academy
of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
3. Vardanyan S.A. Medical and Biological Views of David the
Invincible. / Philosophy of David the Invincible. Moscow, 1984, pp. 83-93
(in Russian).
4. David Anhaght. Works. Moscow, 1980, pp. 84, 77, 71, 49, 72, 44, 75,
61, 63, 65 (in Russian).
5. Oganesyan L.A. The History of Armenian Medicine. Yerevan, 1946,
Vol. 1, pp. 85-127, 141-143 (in Russian).
6. Vardanyan Stella. History de la medicine en Armenia. Paris, 1999.
pp. 43-52.
7. Vardanyan S. Medicine and Philosophy in Early and Medieval
Armenia. In: Collection of Scientific Works. Yerevan, 2005, pp. 644-647
(in Russian).
8. Informed Consent. UNESCO Chair in Bioethics, Editor: Prof. Amnon
Carmi. – Israel, 2003.
9. Davtyan S.A. The Problem of Implementing New Approaches in the
Process of Teaching Traditional Ethics and Bioethics. In: The Process of
Implementing New Teaching and Scientific Technologies. Yerevan, 2003,
pp. 40-42 (in Armenian).
10. Davtyan S. The traditions, customs, culture, and mentality of the
nation and problem of Eutanasia in Armenia. Eilat, Israel, 2002, p. 10.
3.1.2 Legal Regulations
Biomedical research and, particularly, a clinical trial is a complicated
process requiring not only heavy financial and intellectual costs, but also a
competent approach to research planning in order to obtain eventually a safe
and effective pharmaceutical product or method.
The development and study of new pharmaceutical products is
impossible without research involving human subjects, and here we face
two main problems. On the one hand, we have to obtain reliable data on
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the efficiency and safety of any new drug or method, while; on the other
hand we must not expose human subjects participating in the research to an
excessive risk.
Modern rules of conducting clinical drug trials are very strict both in
relation to the protection of human rights of research participants and in
relation to reliability of research results. The history of biomedical research
knows many examples proving the importance of such an approach.
In connection with the broadening of international contacts and the
increasing exchange of drugs, it is necessary to have uniform requirements
of conducting experiments on animals, laboratory studies and clinical trials.
Today principles and procedures of biomedical research involving human
subjects, particularly of clinical trials, are most thoroughly elaborated, as
biomedical research is an inevitable part of scientific activity aiming at
developing a new drug or method or extending the list of indications for
the application of a drug already known. Today the role of clinical trials
has increased in connection with implementation of principles of evidencebased medicine into healthcare practice.
The primary principle implies that individual clinical decisions on
treatment of a certain patient should be based on strong evidenced scientific
data which may be obtained in the course of a thoroughly planned and
controlled clinical trials rather than on expert’s personal experience
or views.
Nowadays in conducting biomedical research the world community
follows the rules stated in Guidelines on Good Clinical Practice. This
document presents a set of regulations ensuring an unbiased evaluation
and reliability of research outcomes, as well as protection of research
participants. The protection of human rights is guaranteed by independent
ethics committees that review documents relating to the clinical trial in view
of evaluation of risks for patients and protection of their rights.
As we know from the history of clinical trials, initially the organization
and performance of those was lacking for an ordered and systematic
approach, and there were problems regarding implementation of GCP
guidelines in different countries. At the same time, it is clear that safe and
reliable research outcomes may be obtained only if the rules are observed.
To protect rights and health of human subjects involved into clinical
trials of new drugs, treatment methods and medical technologies,
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Ethics Committee at the Ministry of Health of Republic of Armenia was
established in 1996 on the initiative of the Agency for Drugs and Medical
Technologies.
With regard to legal regulation in the sphere of human rights protection,
members of Ethics Committee are guided in their ethical review practice by
the following documents:
• Constitution of Republic of Armenia (Article 34)
• Law on Healthcare in Armenia
• Law on Drugs
• Law on Social Protection of the Disabled
• Law on the Rights of the Child
• Law on the Prevention of HIV Infection
• Law on Transplantation of Human Organs and/or Tissues
• Law on Reproductive Health
• Law on Providing Psychiatric Care
As to international legal documents, Republic of Armenia ratified
Convention on the Rights of the Child. The practice of ethical review is
regulated by principles set in the relevant WHO and WMA documents as
well as in other international legal and ethical documents.
3.1.3. Education in Bioethics
At Yerevan State University named after M.Heratsi ethics and aesthetics
have been traditionally taught over many decades. In 2000 bioethics was
introduced into the programme of the Department of Social Sciences as a
compulsory discipline.
In the post-Soviet space, including Armenia, a different – “home” – model
of bioethics has been developed, in which bioethics is an interdisciplinary,
orientated on biology, modern field of knowledge analyzing moral problems
of human existence and human attitude to life and to individual living
organisms. This model covers the range from the development of ethical
norms and principles regulating human practical activity in the process of
studying nature and human beings to the study of the role and place of the
human being in the context of biological reality and the estimate of the status
of life and death categories.
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In the beginning bioethics was taught only to students who were
citizens of Armenia, but since 2003 also to foreign students. The most
important stimulus for introducing basics of bioethics into the syllabus was
an essential need to harmonize our education programmes with international
standards of education. Republic of Armenia enters the Council of Europe,
and, accordingly, takes an active part in the work of its social and legal,
healthcare, economical and culturological structures.
At Yerevan State University lectures on bioethics are read in the first
year at all faculties. Unfortunately, during last two years the time assigned
for bioethics was reduced from 36 to 17 hours. Besides, now bioethics is an
elective course for citizens of Armenia, while it is a compulsory discipline
for foreign students (Russian- and English-speaking students from 18
countries). Thus, since the academic year 2006-2007 bioethics is included
into the list of elective courses, and hence a number of students get their
medical diplomas without training in bioethics.
During the last two years the Chair of Social Sciences did its best in
providing students with necessary teaching materials. Most of them were
received from the Russian Federation, Belarus and Israel. However, as the
new generation of students does not know either Russian or English language
well enough, there is an urgent need for teaching materials on bioethics in
Armenian language. The Department of Social Sciences has developed a
brief course on bioethics in Armenian language. The course aims at:
- providing students with some fundamental knowledge on the essence
and principal problems of bioethics so that they would be capable to
comprehend problems of life and death, health and life;
- acquainting future physicians with moral aspects of topical problems
of modern medicine and biomedical research associated with the application
of modern technologies.
The Manual has the following distinctive features:
1. It contains views and ideas of medieval Armenian thinkers,
philosophers and physicians relating to the problems of life and death, good
and evil, etc. In particular, it presents views of David Anhaght whose 1500th
anniversary was celebrated by UNESCO in 1980 in Saloniki (Greece) and
Yerevan.
2. It should be noted that the Manual presents results of sociological
research on some issues conducted among the University students and
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teaching staff. The research was initiated by the Centre for the Study of
Public Opinion on Bioethics Problems at the Chair of Social Sciences. It
allowed the authors to enrich the theoretical material with the results of
sociological studies.
3. The Supplement includes main legislative acts adopted not only by
the international community but also by the National Assembly of Republic
of Armenia.
4. The Supplement also contains different tests and questionnaires for
the self-analysis, so that students could test to what extent they are morally
and physiologically ready to follow rules and requirements of modern
bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
A. Karmy from Israel kindly sent these Case Studies to us.
In spite of all difficulties in teaching bioethics, we have a noteworthy
experience of student’s work. Within the framework of international
student conferences, the Medical University organized round table
discussions. In 2001 and 2003 two international student conferences on
the fundamental principles and norms of bioethics were held. The majority
of both foreign and Armenian students for the first time began to learn
elements of bioethics. For a more comprehensive study of such topics
as patient—physician relationship, the culture of physician’s speech and
professional communication, compulsory hospitalization, etc., we give
several lectures in Yerevan theatres instead of University lecture halls.
These theatres show specially and only for our students, such plays as
“Psychosis” and “The Street-Car Named Desire” (Sandukian Academic
Theatre), “The Dentist from the East” (Akop Paronian Theatre of Musical
Comedy) and “Physiology of Family” (Malian Theatre). Each performance
is followed by a vivid discussion with actors and directors, and after that
students write their essays on a suggested topic. In addition to theatre
performances, students are invited to watch relevant films (documentaries
and feature films).
Together with the Institute of Philosophy, Sociology and Law of the
Academy of Science of Republic of Armenia our Chair is writing a brochure
“Albert Schweizer: A Great Humanist”. We also prepare for publication the
glossary on bioethics in Armenian language. We give a special attention to
practical aspects of teaching bioethics. Thus we began to design special training
programmes on bioethics for students of medical institutes in Armenia.
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TV programmes on cloning, euthanasia and other problems with
participation of associate professor S.Davtyan evoked a wide public
response. If we manage to resolve the problem of sponsorship in the nearest
future, we shall be able to give a series of TV programmes on topical issues
of bioethics. This would facilitate a more active propagation of bioethical
knowledge in various strata of Armenian society. UNESCO Office in
Yerevan may participate in financing of the projects.
Despite all this work a considerable part of Armenian medical
community are skeptical about bioethics. Some physicians and University
professors believe that teaching bioethics is something needless, to put it
mildly. Apart from implicit forms of discrediting teaching of bioethics, there
are cases when lecturers openly tell students that there is no need to study
bioethics, which, actually, creates the atmosphere of dislike and distrust for
the discipline, and puts a psychological barrier between students and the
teaching staff.
Another problem is a shortage of young teachers who might lecture
in English, Russian and Armenian and the absence of a system for training
specialists on bioethics.
In the period from September 2004 until February 2005 the Society for
Bioethics Development of Republic of Armenia implemented the project
aiming at acquainting medical community of Armenia with the principles
and norms of bioethics. The Democracy Committee of the USA Embassy
in Armenia sponsored the project. Within the framework of the project, the
Committee published brochures in Armenian language distributed in the
medical community and made a 30-minute publicistic film demonstrated
on two national TV channels. At the same time specialists from Society
for Bioethics Development held seminars where explained norms and
principles of bioethics, discussed specific bioethical problems and focused
the attention of the medical community on different bioethical issues. It is
necessary to underline that this programme was developed according to
recommendations of this fund. The main idea of the project was to develop
foundations of democratic society and to raise the level of legal competence
in the medical community and in public at large.
Results of the research in the medical community (1600 participants
from all regional municipal clinics in Armenia and Yerevan) revealed the
scarcity of information on bioethics and the fact that the interest to bioethical
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problems rose sharply after the seminars. However, it is necessary to
mention that literature on bioethics is available, if any, only in Russian and
in English, which essentially hampers the access to information on bioethics
for the medical community.
Unfortunately, our experience shows that with regard to financing of
different programs (international grants) Armenia is currently outside the
zone of interests of donor organizations, while funds functioning in Armenia
have mandates that do not correspond to our goals and tasks. Personal
initiatives are also unrealizable for technical or financial reasons (e.g.
implementation of a programme, attending international training seminars
and conferences, etc.).
It would be reasonable that The Division of Science and Technology
Ethics within the Social and Human Sciences Sector at UNESCO did not
confine its activity to providing information for national ethics and bioethics
committees, but also furnished a financial support for our organization and
for implementation of training courses as well as for publication of teaching
materials on bioethics in Armenian language.
It is clear that the development of teaching programmes on bioethics
and research ethics in Armenia should be adapted to its national, social and
spiritual traditions and its healthcare system. At the same time, it should
correlate with actual models of modern bioethics, and therefore we make
steps towards integrating Yerevan Medical University named after M.
Heratsi into the system of UNESCO International Committee for Medical
Schools.
University administration does its best for international acknowledgement
of our University as a member of UNESCO International Committee for
medical Schools by introducing new disciplines, including bioethics, into the
syllabus. It would be expedient that out lecturers and professors could have
a financial support to participate in the work of international conferences
and seminars on bioethics.
We would like to emphasize that here we mentioned only some of the
most acute problems of teaching bioethics in Armenian medical institutes.
However, this is enough to conclude that bioethics needs more attention
from Health Ministry and Ministry of Education of Republic of Armenia,
and from the Armenian Institute of Protection of Human Rights.
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3.1.4 The System of Ethical Review
In its activity Ethics Committee of Health Ministry of Armenia is guider
by “The Order of Conducting Clinical Trials of New Drugs in Republic
Armenia” approved by the Decree of Armenian Government (No 63, 24 of
January 2002). This document regulates the practice of clinical trials in our
country. According to the set order, clinical trials can be conducted only when
approved by Ethics Committee. The entire responsibility for the accuracy and
reliability of data obtained in the trial rests on the investigator.
Presently, Ethics Committee of Armenian Health Ministry has
12 members who are independent experts and represent different social
communities: physicians of different specialties, clinical pharmacologists,
lawyers, nurses, representatives of culture, etc.
Ethics Committee of Health Ministry of Republic of Armenia has the
following responsibilities:
- ethical review of clinical trials;
- control of the trial process through a regular monitoring;
- review of research protocol amendments;
- protection of confidentiality.
For a thorough and complete ethical review of clinical trials in Armenia
the following documents are required:
- research protocol,
- informed consent form signed by the trial participant,
- investigator’s brochure,
- written information and promotion materials for potential trial
participants
- documents confirming investigator’s qualification.
When reviewing the protocol of the clinical trial the following should
be considered:
- scientific justification of the trial goals and objectives;
- data of pre-clinical studies;
- results of previous clinical trials;
- risk/benefit balance of the suggested treatment;
- the justification of the treatment plan (dosages, duration of the
treatment);
- ethics of control choice (placebo, reference drug, no treatment);
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- criteria of recruitment of the trial participants (inclusion/exclusion
criteria);
- procedures of informing trial participants;
- materials presented to the trial participant;
- procedures of obtaining written informed consent to participate in
the trial.
In its activity Ethics Committee follows three main principles: scientific
justification, risk/benefit balance, informed consent.
Scientific justification. No scientific research can be considered ethical
unless it has a comprehensive scientific justification. A poor justification
may, at best, result in the loss of participants’ time, and, at worst, it may
bring about an unwarranted risk. Ethics Committee has the right to reject the
planned research if it repeats a similar research, and yields no new results.
Risk/benefit balance. The main ethical requirement for clinical trials
of new drugs is to gain benefit with the minimum risk for the patient. It is
necessary to monitor clinical trials, and register all complications, not only
physical but such as discomfort, invasion of participant’s privacy, etc. In many
cases risks are unavoidable, but it must be minimum and under control.
Informed consent. The main method of protecting the individual
involved in the clinical trial is his/her informed consent and its approval by
Ethics Committee.
The procedure of obtaining informed consent is evaluated with regard
to the following requirements:
- the potential clinical trial participant must be provided with
comprehensive information on the goals, methods, nature of the clinical
trial and its expected results, as well as on recommended and alternative
treatment and patients’ rights and measures for their protection; information
should be given in a clear and understandable language;
- the potential participant must not be coerced to participate in the
clinical trial;
- the potential participant must know that he/she may refuse to participate
or voluntarily withdraw at any time without any harmful repercussions;
- the clinical trial participant should receive all information that appears
during the course of the trial.
The clinical trial participant should be also informed about verification
of reliability of his/her personal data by official persons or sponsors, and
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his/her consent should be sought (the right for confidentiality of personal
information).
If the clinical trial participant is unable to give his/her personal consent
Ethics committee agrees to the following procedure: the consent form should
be signed be the participant’s legal representative.
In addition to that, Ethics Committee of Health Ministry of Republic of
Armenia is obliged to review all amendments to the Protocol and to consider all
cases of unfavorable events and changes of ethical aspects of the clinical trial.
Ethics Committee of Health Ministry of Republic of Armenia has the
right to invite independent consultants without granting them the right to
vote.
The procedure of decision-making in Armenia has several stages. At the
first stage the documents relating to the clinical trial undergo a multistage
review at the Centre for Expertise of Drugs and Medical Technologies. In
case of positive results documents are forwarded to Ethics Committee of
Armenian Health Ministry. Ethics Committee should present its decision to
the Centre for Expertise of Drugs and Medical Technologies within 30 days.
At the last stage, on the basis of a final decision made by the Centre for
Expertise Health Ministry of Armenia either permits or forbids conducting
the clinical trial in Armenia.
Only within last 5 years Ethics Committee of Health Ministry of Republic
Armenia reviewed over 30 protocols of clinical trials, including protocols
of bioequivalence studies involving healthy subjects. Our experience shows
that externally sponsored clinical trials conducted in Armenia necessarily
follow the official procedure and seek approval from Ethics Committee. This
is the customer’s requirement, as in developed countries scientific results
are of no value if the organization of the clinical trial does not meet GCP
requirements. Unfortunately, the procedure of clinical trials conducted for
receiving an academic degree does not always corresponds to present-day
international scientific requirements. In this connection we cooperate with
Supreme Certifying Commission in our work on introducing requirements
for the ethical review of clinical trials conducted within the framework of a
dissertation into the Bulletin of Supreme Certifying Commission.
Within last years local ethics committees have been established at
medical institutions. Ethics Committee is functioning at the Yerevan State
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University. Since 2006 Ethics Committee perform ethical review of projects
and works conducted at the University chairs and clinics.
3.1.5 Perspectives and Forms
of International Cooperation
With regard to international cooperation, Armenia as a member
of FECCIS has all possibilities for a wide interaction and international
cooperation on research ethics and bioethics offered by this organization.
In 2005 FECCIS International Conference “Cooperation between
Ethics Committees and Authorities, Investigators, Sponsors and Patients in
Biomedical Research in CIS (the share of ethical problems related to genetic
research)” was held in Yerevan. The Conference was organized with a wide
international support (WHO, European Commission, UNESCO, European
Forum for Good Clinical Practice, World Medical Association, Department
of Health & Human Service (DHHS), USA, and also representatives of
Ethics Committees from Italy, Latvia, Lithuania and Estonia). Within the
framework of the conference a join meeting of FECCIS and Permanent
Commission on Science and Education of the Inter-Parliamentary Assembly
of the Commonwealth of Independent States took place. At the conference the
question about the development of model guidelines On Ethical and Legal
Regulation and Safety of Medical Genetic Research in the CIS was raised for
the first time, which later found its reflection in joint activities of FECCIS and
Permanent Commission on Science and Education of the Inter-Parliamentary
Assembly of the Commonwealth of Independent States. The Conference in
Armenia was also the start ground for including CIS countries in SIDCER
Project “Recognition”. Thus, for the first time, Module 1 of the programme
“Human Subject Protection” for members of the National Ethics Committee
of Republic Armenia and Armenian medical community was launched in
October 2005 due to efforts of FECCIS and international experts.
As to education in bioethics, the representatives from Republic of
Armenia participated in the International Course on Research Ethics for
Countries of Central and Eastern Europe at Albany Medical College (USA)
and Vilnius University (Lithuania). The course received support from Fogarty
Foundation. There are perspectives for participation of other representatives
from Armenia in this Course.
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3.2. Republic of Azerbaijan
(А.А.Namazova, Z.G.Guseinova, T.G.Tagi-Zade)
Rich historical and cultural heritage reflected in works by progressive
thinkers of the past and contemporary scientists, multinational and
multiconfessional population of the republic are the factors contributing to
the development of bioethics in Azerbaijan. Tolerance and respect for other
national cultures and human dignity, esteem for elderly people, principles
of mercy, concern and care for dying people, i.e. traditions that have been
forming over centuries-long history, play a significant part in this process.
Azerbaijan people, as many other peoples of Eastern countries find
evidence of physicians’ search and reflection on philosophy and ethics
in ancient medical manuscripts. The ancient world knew the name of a
legendary physician Logman. In Azerbaijan secrets of medical knowledge and
prescriptions for treatment and prevention of different diseases were passed
across the generations in the name of Logman. Not long ago two Logman’s
precepts were found. The first precept is about the noble mission of the
physician: “Everything in the Earth is the fruit of human kindness/ And where
the doctor is, there is always air of kindness”. The second one warns against
excessive eating and drinking alcohol, i.e. advocates the culture of hygiene:
“Do not thou fill thyself with vine/ Be moderate in eating pilaw and bread/ Or
otherwise the world in which we live/ Will turn into a cattle-shed”.
Fundamental principles of the physician’s ethical behaviour were set
forth in an ancient monument of Azerbaijan literature – a folk epic poem
“Dede Korkud”. There we find many pieces of useful advice on how to stay
healthy and about significance of moral purity and health.
Prominent thinkers, poets and scientists of ancient land of Azerbaijan,
such as Bahmanyar Ibn Mirzaban, Nizami Gyandjavi, Hatib Tabrizi, Mahmud
Shabustari, Omar Osmanogli, Seid Yahya Bakuvi, Nahchivani, Hagani,
Fizuli, Vagif, and many others described in their works a hard unselfish and
dedicated work of ancient physicians and fruitful results of their job [6]. They
all contributed into the development of medical ethics in Azerbaijan.
In the XI century the first madrasah schools were established in
Azerbaijan where theology and medicine were taught. Those schools
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trained mullahs, imams and physicians. In the XII century a specialized
medical school was founded in Azerbaijan. There under the direction of
Omar Osmanogli, future physicians were provided medical education.
Omar Osmanogli with his profound knowledge followed moral principles
proclaimed by Logman, and he always taught his disciples that in his work
the physician should be guided by love to the human being. His demands
even went contrary to deep-rooted customs: “Do not thou turn you back
on the enemy. Cure him.” Omar Osmanogli educated his pupils in the
spirit of moral purity and patriotism. ”Be useful to your people even if it is
contrary to your own interest”, “Do not be selfish”, “Work not just in order
to make your way to paradise, and do not be afraid of hell” -- such were
his mottos.
In line with Omar Osman’s traditions, the famous poet Khagani wrote:
“If you want your heart to be clear like a mirror, rid it of ten qualities: avarice,
hypocrisy, envy, slander, anger, haughtiness, breach of the laws, duplicity,
hostility and lie”. Nizami, a great poet and writer of Azerbaijan, who was
one of the most educated men of his period, thought highly of medicine and
medical profession. In his works he set forth a number of scientific ideas
and conclusions characterizing some ways and means used in Azerbaijan
folk medicine. He also wrote on nutrition hygiene, and his ideas did not lose
their importance to present day.
Not many know that in the XIII century there was a “Dar-Ash-Shafa”
University (the House of Cure) in Azerbaijan, in which 5-7 thousands of
students were educated. Many scientists from Iran, India, China, Syria,
Egypt and from Central Asia were happy to visit this University. The ancient
Azerbaijan capital attracted foreign scientists not only with its wealth and
luxury but also with the possibility for scientific research and education.
In many works of eminent Azerbaijan thinkers, such as Mirza Fatali
Akhundov (1812-1814), Gasanbek Zardabi, Nariman Narimanov, Jalil
Mamedguluzadeh known under the name of Molla Nasreddin (1866-1932)
et al., we can find progressive views on medicine.
Mirza Fatali Akhundov [3] is the author of immortal works on politics,
natural sciences, medicine, ethics and aesthetics. When describing historical
events, traditions and ways of life Mirza Fatali Akhundov always mentioned
those national customs that negatively affected human health and moral
qualities [5].
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Gasanbek Melikov Zardabi (1842-1907) followed Akhundov on the
thorny path of asserting the best moral qualities. In his book “Hygiene”, he
wrote that physicians should be warm-hearted and honest; they should keep
to the rules of personal hygiene, and watch over the hygiene of their patients
and their homes.
N.Narimanov (1870-1925) in his numerous works wrote about the
social role of physicians: “Physicians should strictly criticize all medical
institutions and their own actions, so as to extirpate everything that is not
meeting patients’ interests, and, especially, what might hurt them. Patients’
interests should always be a priority, and all intellectual efforts should be
devoted to meeting their needs” [1].
Making good use of their rich heritage in the field of ethics medical
professionals of Azerbaijan followed the traditions in later years. Today we
may speak of a new historical situation in the development of medical ethics
as an area of medical knowledge aimed at education of medical personnel.
We know that the social environment plays an essential part in the
development of medical ethics. Moral qualities of medical professionals are
not innate but acquired. They reveal themselves in the social milieu in which
a person grew up, studied and worked.
Academician Zarifa Alieva (1923-1985), a well-known scientist, in
her excellent work “The Noble Mission” emphasized the fundamental
importance of ethics in the physician’s professional activity: “Medicine
is progressing day by day, it cannot stay unchanged, and only one thing
remains constant – high moral, ethical and professional standards demanded
from the physician”.
After the disintegration of the Soviet Union and declaration of Azerbaijan
independence, the reformation of the healthcare system began. Professional
education, creation of a new pharmaceutical market, etc, and, naturally, the
main principles of medical ethics (the physician’s duty and responsibility,
relationships with patients, colleagues and society) underwent a strong
correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et
al. made a great contribution into the development of bioethics.
An important milestone in the history of Azerbaijan was the year of 1999,
when, on the initiative of UNESCO, the Presidium of National Academy of
Sciences established the Committee on Bioethics and Technology Ethics
(Decree 9/1).
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3.2.2. Legal Regulations
Health is one of a few subjective human values without which many
other comforts and values lose their significance. Today every democratic
country acknowledges the importance of human rights protection in all
spheres of social life. Within last years, the National Assembly of Azerbaijan
adopted legislative acts setting forth political, economic, social, cultural,
scientific and medical measures for maintaining and strengthening physical
and mental health of every person and providing medical care in case of loss
of health. When drawing up the documents the experience of other countries
was used, and the following legal norms based on international legal norms
were adopted:
- UN Convention on Children’s Rights (Decree of the National Assembly
of Azerbaijan Republic. No 236; 21 of July 1992)
- Law on Sanitary-and-epidemiologic Well-being of Population
(10.11.1992)
- Law on Preventing the Spread of the Disease Caused by HIV in
Azerbaijan (16.04.1996)
- Law on Pharmaceutical Activity (05.11.1996)
- Law on Health Protection (26.07.1997)
- Law on Medical Insurance (1997)
- Law on Radiation Safety (30.12.1997)
- Law on Children’s Rights (19.05.1998)
- Law on Transplantation of Human Organs and Tissues (28.10.1999)
- Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
- Law on Tuberculosis Control in Azerbaijan (05.02.2000)
- Law on Psychiatric Care (12.06.2001)
- Law on Narcological Service and Control (29.06.2001)
- Law on Nutrition of Newborns and Infants (17.06.2003)
- Law on the State Care for Patients with Diabetes (23.12.2003)
- Law on Iodination of Sodium Chloride for the Mass Prevention of
Iodine Deficiency.
- Law on Donorship of Blood, Blood Components and Blood Donor
Service (03.05.2005)
- Law on State Care for Patients with Hereditary Diseases Such as
Hemophilia and Thalassemia (03.05.2005).
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When considering problems of education we precede from the fact
that bioethics, in relation to medicine, is nowadays a developing academic
discipline with its inherent strict standards. We should start teaching
bioethics in the period when students pass on from theoretical subjects to
practical activity.
In accordance with recommendations of the World Health Organization
to introduce courses on medical ethics into the syllabus of medical schools
everywhere in the world, an educational programme on bioethics was
developed in Azerbaijan in the 1990s. The programme emphasizes the
universal character of principles and rules of bioethics and covers all basic
problems of bioethics with due consideration for the international experience
and national traditions. The method of teaching aims at enabling medical
professionals to acquire ethical skills in physician-patient relationships,
professional decision-making and conducting scientific research.
Education in bioethics at Azerbaijan Medical University (8,000
students) began in 2000. Considering an interdisciplinary character of the
programme, issues of biomedical ethics are normally introduced into the
teaching process of all faculties, especially, clinical ones.
In 2000 an international conference “Methods of Teaching Medical
Ethics” was held in Baku. On that occasion numerous methodical materials
were prepared: methodical plans, textbooks, brochures and glossaries of
bioethical terminology. The materials have been very helpful in training
specialists with an experience in research and applied ethics who have
received appropriate certificates.
To improve the quality of teaching bioethics and to increase educational
level of medical students, the initiative group of Azerbaijan Medical
University including the academician of the Russian Academy of Medical
Sciences and the National Academy of Sciences professor A.A.Namazova,
professor G.A.Aliev, assistant professor Z.G.Guseinova, candidate of
medical sciences T.G.Tagi-Zade developed a teaching and methodical
programme “Introduction of Teaching Materials on Biomedical Ethics Into
the Syllabus of Higher Educational Institutes”. For that purpose the group
has made up the following materials: the first Azerbaijan manual on medical
ethics «Tiabaiat etikasy», a number of methodical recommendations and
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such texts as “Ethical Principles in Medicine”, “Euthanasia: Bioethical
Aspects”, “Deontology in Medicine” et al.
Alongside with the abovementioned, sociological surveys in medical
community and public at large were conducted in Azerbaijan with the aim to
assess the level of awareness and knowledge about legal aspects of bioethical
issues. The surveys are helpful in outlining ways of further activity in the
field of education and scientific research.
With the assistance of Azerbaijan Ministry of Health and international
organizations, especially the Forum for Ethics Committees in the
Commonwealth of Independent States, the initiative group develops standard
operational procedures and protocols for ethics committees and proposals on
adaptation and implementation of international standards for biomedicine in
Azerbaijan.
References
1. Ethical Problems in Azerbaijan. In: Materials of Regional Swiss
Conference on Medical Ethics. Tbilisi, Georgia, 1999 (in Russian).
2. Implementation of Teaching Materials on Medical Ethics into the
Syllabus of the Medical University. In: Materials of the International Seminar
“Methods of Teaching Medical Ethics”. Baku, Republic of Azerbaijan, 2000
(in Russian).
3. The Role of Bioethics in Training Future Physicians. In: Materials
of the First National Congress on Bioethics. Kiev, Ukraine, 2001, pp. 41-44
(in Russian).
4. The State of Ethical Review of Biomedical Research in Azerbaijan.
In: Ethics Committees in Russia and other CIS Countries. International
Seminar. St.-Petersburg, Russia, 2001, pp. 41-44 (in Russian).
5. Ethics’ in Pediatric Clinics. First International Conference «Clinical
Trails in Russia». Moscow, Russia, 2001 (in Russian).
6. Medical Ethics and Deontology. - Medical Journal “Vita”, 2001,
pp. 3-4.
7. Bioethical Aspects of Education in Medical Institutes. In: Good
Ethical Practice in Biomedical Research. International Conference of the
CIS Countries. Almaty, Republic of Kazakhstan, 2002, p. 87 (in Russian).
8. Ethical Principles in Medicine. Part 1. Methodical Manual. Baku,
Republic of Azerbaijan, 2002, p. 32 (in Russian).
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9. Euthanasia. Medical Journal «Vita», 2002, pp. 3-4.
10. Ethical Principles in Medicine. Part 2. Bioethical Aspects of
Euthanasia. Methodical Manual. Baku, Republic of Azerbaijan, 2002, 32 p.
(in Russian).
11. Ethical Standard Operational Procedures in Azerbaijan. “Ethics
Committees in Russia and Other CIS Countries. International Seminar. St.Petersburg, Russia, 2003, p. 15 (in Russian).
12. Medical Ethics. Baku, Republic of Azerbaijan, 2004, 100 p. (in
Russian).
13. The Role and Meaning of Ethical Education of Medical University
Graduates in the Protection of Patients’ Rights in Biomedical Research.
International Conference of CIS Countries. Kiev, Ukraine, 2004, pp. 23-25
(in Russian).
14. Ethical Education and Protection of Human Rights in Biomedical
Research. Baku, Republic of Azerbaijan, 2004, pp. 65-67 (in Russian).
15. Moral and ethical aspects of healing. Azerbaijan Medical Journal,
2005, 1, p. 34.
16. Dictionary of Biomedical Ethics. Baku, Republic of Azerbaijan,
2007, 96 p. (in Russian).
3.2.4. The System of Ethical Review
During the last years the issues of arranging conditions for the
development of ethical review which is to safeguard rights and safety of
patients and other persons involved into clinical trials are widely discussed.
State regulation and control of drug quality is one of the principal ways
to ensure protection of rights of individuals participating in trials.
With that purpose, a Pharmaceutical Committee based on GCP principles
was established at the Ministry of Health of Azerbaijan. Good clinical
trials guarantee observance of ethical and other fundamental principles and
requirements for organizing the research. Legal aspects are set forth in the
“Law on Pharmaceutical Products”.
In line with GCP principles, Azerbaijan Pharmacological Committee
developed and endorsed a number of recommendations on the review of
documents submitted for drug registration, on pre-clinical drug trials, on
clinical drug trials, etc.
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Basic medical institutions with an adequate technical equipment and
staff potential for conducting biomedical research were determined and
appointed.
The system of monitoring was developed. Basic medical institutions
receive drugs through the Pharmacological Committee that approves the
Research Protocol and then receives a report on results of trials. The drug
is registered only after the survey of the review quality. This system is
compulsory for every drug designed in Azerbaijan. There is also an effective
system of licensing and accreditation. The Pharmacological Committee is
planning a further development of normative documents and improvement
of the existing system.
Currently, comprehensive measures are taken to develop and
implement international standards for ethical review – standard operational
procedures.
On UNESCO initiative, the International Committee on Bioethics was
established in 1997, and national committees began to form.
The Presidium of the National Academy of Sciences acknowledged
the expedience of joining world scientific community in observing rules of
bioethics when conducting biomedical and medical research and made the
decision to constitute the Committee for Bioethics and Technology Ethics at
the Presidium of the National Academy of Sciences.
In 1999, following The Universal Declaration on the Human Genome
and Human Rights adopted at UNESCO’s 29th General Conference, the
Presidium of the National Academy of Sciences established the National
Committee for Bioethics and Technology Ethics (Order No 9/1, 24.03.99).
The Committee has the following structure:
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In 2003 the Committee developed guidelines regulating the work of
ethics committees, their structure and management principles as well as
rights and responsibilities of the committee members.
Currently, the Committee works intensively at propagating ethical norms
and principles and protecting fundamental human rights in Azerbaijan.
Alongside with this, the Azerbaijan Medical Association made an
essential contribution into development of bioethics in Azerbaijan.
The main role of the Association consists in
• integrating ethics committees,
• studying international experience and achievements of different
countries,
• consolidating efforts by the establishing partnership between nongovernmental organizations and government structures.
3.2.5 Perspectives and Forms of International Cooperation
Since 1999, the National Committee for Bioethics and Technology
Ethics, as well as its sections, and particularly, the Committee for Bioethics
at the Medical University and Ethics Committee at the Azerbaijan Medical
Association, make mutual efforts for establishing different forms and
methods of international relations and extending cooperation with leading
organizations, committees and associations in different countries having
experience in the study of biomedical ethics.
In 2001 the Republic of Azerbaijan entered the Forum for Ethics
Committees in the Commonwealth of Independent States, and thus got a
wider opportunity to exchange achievements in the field of bioethics and
law with leading world specialists. This continuous interaction is fulfilled
through:
- corresponding by means of electronic technologies;
- studying and implementing international legal documents and acts on
biomedical ethics;
- visiting meetings and conferences on topical issues of bioethics;
- consultations and exchange of experience with leading international
specialists;
- seminars and training courses on principles of organizing good ethical
review;
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- providing FECCIS members with necessary literature.
The “working group” at Azerbaijan Medical University and Azerbaijan
Medical Association was rendered a special support and assistance.
In October 2004 the international conference “Health Legislation in
Human Rights Protection and Access to Medicines in Health Research
in the CIS” was held in Baku. It was organized with the assistance of
FECCIS, Permanent Commission on Social Policy and Human Rights of
the Inter-Parliamentary Assembly of CIS, and a number of international
organizations (WHO, European Forum for Good Clinical Practice, World
Medical Association, and DHHS, USA).
In the framework of this conference, the open session of Permanent
Commission on Social Policy and Human Rights of the Inter-Parliamentary
Assembly of CIS together with scientists and specialists in bioethics from
Baltic States and international organizations was held. At the Session, the
draft project of the model law “On the Protection of Human Rights and
Dignity in Biomedical Research in the CIS” was discussed in detail.
Due to acquired experience, the initiative group succeeded in working
out teaching and methodical materials. Perspective plans imply an extension
of the network of bioethics committees and further broadening of relations
and cooperation with FECCIS and other international organizations keeping
to the strategy of World Health Organization.
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3.3 Republic of Belarus
(T.V. Mishatkina, Ya.S. Yaskevich)
A specific social and cultural development of Belarus had been
predetermined by its geographical position and geopolitical features. Belarus
Republic stands at the juncture of the Western and Eastern civilizations, and
therefore its leading representatives of ethical and philosophical thought
inherited the most essential tendencies in the development of European
ethical theories, while the applied moral was, to a certain extent, influenced
by Eastern traditions.
Ethical ideology in Belarus roots back to the IX-XI centuries, and
initially it was based on primitive magic, shamanism, pagan worship.
Ethical ideas as such began to form only in the XI-XII centuries after the
adoption of Christianity. Such thinkers as Evfrosinia Polotskaya and Kirill
Turovsky, who were instilling Christian ideas in Byelorussia and polemized
with heresy and paganism, were widely known for their enlightening
activity. They were preaching the Bible commandments of love, kindness
and unity. In the XIII-XVI centuries, when the territory of Belarus became a
part of the Grand Duchy of Lithuania that later united with the Kingdom of
Poland and formed the Polish-Lithuanian Commonwealth, works of Belarus
philosophers Francis Scorina, Symon Budny and Vasily Tiapinsky reflected
topical ideas of West-European culture, particularly, the idea of humanism.
In the period of counter-Reformation (XVI-XVII c) Jesuit colleges and
catholic universities actively used the rationalistic heritage of medieval
scholastic ethics, and ethical teachings of Aristotle and Thomas of Aquinas
were very popular among the educated part of Belarus population. The idea
of the Unia (union) of Orthodoxy and Catholicism under the aegis of the
Pope carried in itself ethical and philosophical values of religious tolerance.
In the XVI-XVII centuries Orthodox communities also did extensive
teaching popularizing the most important achievements of West-European
countries among Orthodox believers in Belarus. Simeon Polotsky, one of
the most outstanding figures in Belarus culture of that period, compiled a
collection of poems that formulated, in a poetic form, basic ethical and moral
principles of the Orthodoxy. The end of the XVIII and the beginning of the
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XIX century was marked by naturalistic ethical concepts that resulted from
the development of exact and natural sciences and considered ethics in the
spirit of theories of “natural law”, “social contract” and “rational egoism”
asserting the necessity of universal secular education.
After the October revolution and the collapse of the Russian Empire
Belarus became Belarusian People’s Republic. The second decade of the
XX century was characterized by a rapid growth of national self-awareness.
Specific ethical traditions of the Belarusian ethnos and moral aspects of the
revival of the Belarusian culture, as well as closeness to nature and healthy
moral relations, were widely discussed and reflected in works by such
thinkers and poets as F.Bogushevich, A.Pashkevich, Y.Kupala, Y.Kolas.
However later, during the Soviet period, ethical thought in Belarusian SSR
had been in conformity with the general authoritarian trend.
In the last decade of the XX century the developments of Belarus
ethics was marked with pluralism and attempts to pass from authoritarian to
humanistic ethics. National features of moral self-awareness were analyzed;
attempts were made to revise the fundamental moral values. It was the time,
when new systems of substantiation of ethical ideas came into being, and
trends of applied ethics began to develop. In the 1900s preconditions for the
development of theoretical concepts of bioethics and biomedical ethics were
formed (T.V.Mishatkina, Ya.S.Yaskevich, S.D.Denisov). First publications
and presentations at scientific conferences on different levels appeared;
ideas of bioethics find their reflection in the system of medical education
[2-6]. Since that time, the ethical thought in Belarus steadily began to
approach leading world tendencies in scientific bioethics.
Important factors in this process have been specific features of national
world-perception and spiritual culture of Belarus people, which revealed
itself in such moral qualities as the tendency to self-determination, inherent
feeling of self-respect in combination with tolerance and good-nature, as
well as hospitality and openness, etc.
Moral qualities of Belarus people are in a direct relation to specific
features of Slavic national character. Nikolai Lossky, a Russian philosopher,
proved this by associating those with such factors as vast expanses of
East-European Plain and its climate (short summer), forming “the habit
of excessive short-term strain of efforts” and “the ‘non-habit’ of a regular,
continuous labour” [7]. Lossky’s comments on the Russian national character
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may be fully attributed to Belarus people: “Obeying the call of duty, Russian
people develop in themselves an ability to fulfill a compulsory job accurately
and honestly. However, if the job is not strictly compulsory, then they may
be careless and inaccurate… Hence, there is often a loss of interest in the
work begun and aversion for continuing it; the initial intention, idea and the
general outline is often quite valuable, but inevitable imperfections would
dim the enthusiasm, and people would be lazy to proceed with a thorough
and detailed work.” Nevertheless, some effect of European Protestant ethics
resulted in a more developed diligence and thoroughness in Belarus people.
Nikolai Lossky mentioned also some other contradictory qualities of the
Slavic soul: humaneness, mildness, kindness and, on the other hand, cruelty
and tendency towards violence (e.g.: attitude to the death penalty in Belarus
society); acute self-perception and impersonal collectivism; the feeling
of belonging to the humankind and national self-boasting; humility and
inclination to a revolt; love of freedom and a need for the authoritarian State
system. These features show themselves distinctly in social life, business
relations and scientific activity. Besides, Orthodoxy has always supported
orientation towards a strong power, as the Orthodox Church believed
that only a strong State system could struggle against evil. At the same
time, Lossky noted that in their character the Slavs are more disposed to
democracy, which shows itself, for example, in the protest against all sorts
of conventionalities.
Currently the Orthodox Church still has a strong effect on the
development of bioethics in Belarus, which has both positive and negative
aspects. The programme of interaction between the Orthodox Church of the
country and the Belarus Health Ministry of is being realized. The programme
helps to introduce moral constants into the medical community, facilitates
moral and spiritual growth of the worldview of students (future specialists in
medicine, biology and biotechnology) and the general growth of bioethical
competence in the society. A rich experience in promoting ideas of bioethics
has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus
Exarchate. Charity Centre has been organized at the Parish of the Church of
All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
Centre provides spiritual and medico-psychological care for terminally ill
children. However we should not ignore the conservatism of the Orthodox
Church and, in particular, with regard to topical bioethical problems. In
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relation to a number of bioethical problems, the Orthodox Church adheres
to a very strict position: it prohibits human cloning and cloning of human
organs (especially heart cloning) and euthanasia; expresses censure on
artificial fertilization, abortion, sexual education of young people. They also
hold to uncompromising position regarding some issues of transplantation
of certain organs, which showed itself in the discussion of amendments to
the “Law on Transplantation of the Republic of Belarus”.
Since 1995 bioethics in Republic Belarus has been developing in
parallel, along two main lines — theoretical and practice-organizing ones,
and initially the connection between these lines was rather weak.
Theoretical trend implied the analysis of bioethics as an interdisciplinary
scientific knowledge showing, most fully, the tendencies of science
development in the XX century. On the other hand, bioethics was analyzed as
a special field of applied ethics with its distinctive features and modifications,
and, at the same time, allegiant to fundamental ethical principles and general
human values [8, part II, 9,10,13]. In choosing priorities we are guided, first
of all, by general tendencies in the evolution of scientific knowledge as a
whole, and ethics in particular, as well as by historical and cultural grounds
for the development of bioethics.
Organizational and practical trend of bioethics development in Republic
of Belarus focuses on searching and working out mechanisms of institutional
regulation of biomedical research.
Today the society demands a socially responsible behaviour from
investigators and obliges them to accept framework principles, standards
and norms for the functioning of relevant structures. And here comes the
organization ethics with its main task to understand how to make correct
ethical decisions. All these principles, standards and norms are addressed
not to an individual but to institutions as organized groups with their tasks,
specific features and cultural traditions. Therefore ethics committees and
ethical competence take on special significance.
The Western model of bioethics is an institutionally organized social
technology with a system of standardized liberal values ensuring the
protection of human rights and freedoms in biomedicine. The protection of
human rights from negative consequences resulting from the application of
modern biomedical technologies is performed through ethic codes, laws,
extending the sphere of responsibility of medical professionals and biologists
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and their social obligations not only fixed on their personal moral level but
also stated by law. Mechanisms controlling ethical aspects in the activity of
physicians and scientists are supplemented with a developed system of legal
regulation, a special system of bioethics committees and education.
In the post-Soviet space, including Belarus, a different – “home” – model
of bioethics has been created, in which bioethics is an interdisciplinary,
orientated on biology, field of theoretical knowledge analyzing moral
problems of human existence and human attitude to life and to different
living organisms. This model covers the range from the development of
ethical norms and principles regulating human practical activity in the
process of studying nature and human beings to the study of the role and
place of the human being in the context of biological reality and the estimate
of the status of life and death categories.
At the same time, for Belarus with its post-Chernobyl crisis level of the
balance in the “nature--society” system, when the data of biomedical studies
prove a direct and evident threat to the public health and to the safety of gene
pool because of the complex radiochemical pollution, practical measures are
extremely important. Besides, the majority of physicians in Belarus still stick
to the conventional paternalistic model of patient—physician relationships,
which goes with a widespread legal and ethical nihilism in the medical
community. Therefore the modern model of bioethics, as well as programmes
of biomedical research, should be adapted to the national healthcare system,
its scientific, socio-cultural, legal and spiritual traditions.
At present, we have objective and subjective conditions for the
development of bioethics in the form that is accepted in the West. We are
developing ethical and legal norms regulating biomedical research and aiming
to create adequate models of education. In compliance with the Order of the
Health Ministry of Belarus “On Establishing Rules for Conducting Clinical
Trials of Pharmaceutical Products”, a Republican Unitary Institution “The
Centre of Expertise and Trials in Healthcare” was founded in 1999. A serious
work has been carried out on organizing institutional activity of local ethics
committees. Scientists, governing structures and public organizations put
their efforts in creating the basis for establishing in Belarus the National
Committee for Bioethics similar to those existing in many countries. The
Committee can rightly represent Belarus on the international level and take
initiatives in the protection of human rights in biomedicine, coordinate
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activity of local ECs and develop main concepts of professional and public
education. The National Committee for Bioethics (NCBE) at the Health
Ministry of Belarus was established in 2005 with the support of the National
Commission of Belarus for UNESCO.
At the same time there are still organizational and legislative problems in
the development of bioethics in Belarus. This concerns an under-developed
system of legal regulation of bioethics, a low level of ethical knowledge
and legal culture in the medical community and in the population, and a
high level of bureaucracy and conservatism in institutions that are to make
decisions. Thus during a year, due to delays and impediments of the law,
the question of the legal status of NCBE established on the instructions of
Council of Ministers (26.07.2005) could not be decided, which certainly
hampered NCBE activity.
Like in the healthcare as a whole, in establishing local ECs and the NCBE
Belarus follows international legal and ethical documents. These documents are:
The Nuremberg Code (1947); Declaration of Helsinki (1964, with subsequent
amendments); ICH GCP (1996); WHO Operational Guidelines for Ethics
Committees That Review Medical Research (2002); UNESCO documents
“The Declaration on the Principles of Tolerance” (1995); “The Universal
Declaration on the Human Genome and Human Rights” (1997); UNESCO
Guide No 1 “Establishing Bioethics Committees” (2005); UNESCO Guide
No 2 “Bioethics Committees at Work: Procedures and Policies” (2005).
The National Strategy of Steady Development and the Concept of
Healthcare Development in Belarus (1995) are the basis for adopting legal acts
and national programmes and determine particular measures and resources
for ethical and legal control of biomedical research. Laws of Belarus “On
Healthcare” (1999 with subsequent amendments), “On the Safety of Genetic
Engineering” (2005), the Draft Law “On transplantation of Human Organs
and Tissues”, orders and instructions of the Belarus Health Ministry of are in
compliance with the main principles of bioethics set out by WHO.
The central law determining the State policy in the sphere of citizens’
health protection, legal, economical and ethical principles of conducting
biomedical and genetic research involving human subjects, as well as
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patients’ rights and responsibilities is the Law of Belarus on Healthcare.
According to the Article 31 of the Law, clinical and biomedical research
involving human subjects may be conducted for therapeutic purposes at
national institutions of healthcare provided that the research is scientifically
justified, and a written voluntary consent from a potential research subject
informed about the goals, duration, expected results and an effect on his/
her health has been obtained. It is not permitted to carry out clinical trials
and biomedical research involving pregnant women and children unless the
research is conducted for diagnostics or treatment of these particular classes.
Research involving children may only be carried out after a written consent
from a parent has been received. It is not permitted to conduct clinical
trials and biomedical research involving children without parents, members
of armed forces, prisoners and persons under arrest, persons with mental
disorders or those who receive compulsory (involuntary) medical treatment.
Thus, the Law is the legal implementation of the modern principle of respect
for the patient’s autonomy based on the rule of informed consent.
The Code of Medical Ethics (CME) adopted at the First Congress
of Physicians of Republic of Belarus (1998) and approved by the Health
Ministry of Belarus (1999) also includes rules of medical ethics and
deontology reflecting fundamental principles of biomedical activity and
patient-physician relationships.
The Chapter “Physician-Patient Relationship” of the Code implies the
following:
• Equal rights of patients and physicians to respect for their human
dignity (Art. 14);
• Mutual trust and mutual responsibility of the patient and the physician,
patient is an active participant of the treatment process (Art. 16);
• Compulsory consent from the patient for a medical intervention,
except for cases provided by law (Art. 21);
• Compulsory written consent from a patient, his/her close relatives
or legal representatives for removal organs or tissues for diagnostic or
therapeutic purposes; removal of organs and tissues for other purposes may
not be carried out (Art. 23);
• Confidentiality of patients’ personal data obtained in the patient—
physician relationship; it is not permitted to disclose the patient’s personal
information even after the patient’s death (Art. 24).
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An analysis and classification of fundamental statements of the Law of
Republic Belarus on Healthcare and the Code of Medical Ethics show how
the documents reflect topical principles and problems of biomedical ethics.
The principle of human life sanctity (value) directs the physician’s
activity towards all possible care for patients and implies that euthanasia is
unacceptable:
- “The physician should relieve sufferings of a dying patient by every
available and legal means. Euthanasia as an act of an intentional taking of
one’s life is not permissible at the patient’s or his/her relative’s request”
(Art. 25 CME).
- “Medical or pharmaceutical professionals are not permitted to
perform euthanasia. A person who consciously induces the patient to
euthanasia and/or performs euthanasia shall bear criminal responsibility
according to legislation of Republic of Belarus” (Art. 38 of the Law on
Healthcare).
Priority of a person’s interests implies that interests and well-being of
an individual should prevail over scientific and public interests:
- “In his/her scientific and research activity the physician should
be guided by the priority of the patient’s benefit over scientific interests;
clinical trials and research may only be carried out in compliance with the
rules established by law and with the patient’s consent” (Art. 36 CME).
Principle of tolerance implies that all citizens, with no exception, are
guaranteed that the individual’s integrity, principal rights and freedoms shall
be respected:
- “The main goal of physician’s professional activity is to save an
individual’s life and health… regardless of the patient’s sex, age, nationality,
social and financial status, political convictions and religion” (Art. 2, CME);
- “Physician shall in every possible way contribute into protection
of population health and to struggle against any forms of cruelty and
disparagement” (Art. 5 CME).
Equal rights and cooperation in physician-patient relationship as a
cardinal principle of modern deontology implies the following:
- “Physician and patient have equal rights to respect for their human
dignity and may protect it according to current legislation” (Art. 14 CME).
Principle of physician’s and patient’s autonomy following from the above
statement reveals itself in recognizing the autonomy of the physician:
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- “Physician shall bear responsibility for all his/her professional
decisions and has the right to reject any attempts of pressure from colleagues,
patients and other persons if their requests contradict ethical principles,
professional duty and law.” (Art. 11 CME).
Secondly, the principle of autonomy implies the patient’s autonomy:
- “Patient is an active participant of the treatment process” (Art. 16
CME).
- “Patient has the right to choose the physician. In case of a
disagreement with the physician the patient may apply to the head of the
institution, to the commission on medical ethics and to other governing
institutions or public associations involved in protection of patients’ rights”
(Art. 17 CME).
- “Organ and tissue removal for diagnostic or therapeutic purposes
from a patient may only be carried out with a written consent from a patient
obtained in an order established by law, or, in conditions provided for under
legislative acts of Belarus, with the consent from the patient’s close relatives
or his/her legal representatives. Organ and tissue removal for any other
purposes is not permitted” (Art. 23 CME).
- “Autopsy examination may only be carried out with the consent
from the relatives of the deceased person with the exception of the events
provided for under legislation of Belarus” (Art. 27 CME).
“Exceptionally, in the patient’s interests, it is permitted to use a
scientifically justified method or a medicinal product designed for a disease
prevention, diagnostics, treatment, rehabilitation or prosthesis that has not yet
been authorized in accordance with established procedure. Written informed
consent should be obtained from the patient.” (Law on Healthcare, Art. 26).
“Voluntary informed consent should be obtained from the patient before
a medical intervention.
Complicated medical interventions (surgical operation, blood
transfusion, complicated methods of diagnostics) may only be carried out
with the voluntary consent obtained from the patient informed about the
goal and possible results of the intervention.
The patient may withdraw his/her consent to a medical intervention at
any time except for cases when physicians have already begun the medical
intervention and its termination or return to the initial state is either impossible
or hazardous for the patient’s life or health.” (Law on Healthcare, Art. 27).
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Principle of patient’s and physician’s informed consent has also bilateral
nature, which is formulated in the following way:
- “Patient should tell a person providing medical care what he/
she knows about his/her health condition including contraindications to
pharmaceutical products, previous and hereditary diseases.” (Law on
Healthcare, Art. 29).
- “Patient has the right to comprehensive information about his/her
health condition, suggested methods of assessment and treatment and the
risk level.” (Art. 17 CME).
- “Any medical intervention may only be carried out after the patient’s
consent has been obtained except for events when because of severe physical
or mental condition the patient cannot make a conscious decision or in other
cases as provided for under the law.” (Art. 21 CME).
Several special articles in Belarusian Law on Healthcare also gives a
detailed information about inform consent process.
“The physician in charge, the head of the department, other officials
inform the patient in a clear and understandable form about his/her health
including information about examination results, the disease, diagnose and
prognosis, methods of examination and treatment and associated risks,
possible variants of medical interventions and their consequences and also
about treatment results and possible complications. Information should be
provided in a form corresponding to requirements of medical ethics and
deontology.”(Law on Healthcare, Art.30).
Principle of collective decision-making is outlined in the following
clause:
“In case of professional difficulties the physician should consult
competent specialists. Whenever an examination or treatment is beyond the
physician’s capacity, he/she should consult with or refer to another physician
who has the necessary ability.” (Art. 20 CME)
Principle of confidentiality protecting citizens’ rights to inviolability of
their private life and confidentiality of personal information is stated in the
following documents:
- “The physician should safeguard a patient’s right to confidentiality
and may not disclose confidential information even after the patient’s death;
the physician should also prevent the disclosure of confidential information
by other persons.
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The physician may disclose information on the patient’s health to the
patient’s close relatives when it is necessary for the patient’s treatment or
care and the patient consents to it. The physician may disclose confidential
information to healthcare and law institutions as provided for under current
legislation of Belarus.” (Art. 24 CME)
- “Information about applying for medical help, the patient’s health
condition, diagnosis, results of diagnostic examination and treatment, and
other information including that of personal character obtained during the
patient’s assessment, treatment or, in the event of death, during post-mortem
examination are confidential”.
The use of confidential information obtained in the course of physician—
patient relationship for a study process or in scientific literature is only
permitted if a patient consents to it.
Alongside with medical and pharmaceutical professionals, other
persons to whom the information was disclosed in accordance with current
legislation should also safeguard the confidentiality of information.
“Healthcare organizations ensure archiving and storing medical
documents in compliance with the confidentiality requirements.
Medical and pharmaceutical professionals bear the responsibility for
a breach of confidentiality in accordance with the current legislation of
Belarus.” (Law on Healthcare, Art. 60)
Besides basic principles of biomedical ethics, legislative acts of Belarus
state that any intervention into a human body for research purposes should
be performed in compliance with existing requirements and professional
standards. Thus, Law on Healthcare states that:
- “The permission to carry out clinical trials and biomedical research
involving human subjects is granted by Health Ministry of Belarus.”
(Art. 31).
- “The procedure and conditions of anatomical donation are
determined by the Health Ministry of Belarus” (Art. 39).
- “The procedure of post-mortem examination and a list of cases
for a compulsory post-mortem examination are determined by the Health
Ministry of Belarus” (Art. 52).
-“Regulations for an independent ethical review are approved by the
Council of Ministers of Belarus” (Art. 53).
Like the procedures of treatment and care provided to patients, clinical
trials and biomedical research are also regulated by the above-mentioned
documents.
Alongside with establishing local ECs, improving legislation referring
to biomedical research and carrying out a theoretical analysis, we have been
developing education in bioethics. Here is the chronology of establishing a
system of education in bioethics in Belarus*:
• In October 1997, on the initiative of the Minsk State Medical
Institute and with the support from the Health Ministry of Belarus, the
European Parliament, The Embassy of United Kingdom in Belarus,
and World Association for the Protection of Animals, the international
symposium “Ethical Problems of Using Animals in Teaching and Scientific
Research” was held in Belarus. The Symposium stimulated the study of the
problems of humanizing medical education. Members of the teaching staff
and students from Belarus, Russia, United Kingdom and Sweden took part
in the Symposium [14,16,18,19].
• In 1999 recommendations “Teaching Basics of Medical Ethics and
Deontology in the Course on Human Anatomy” (Denisov S.D., Yaroshevich
S.P.) were published, as well as other works relating to ethical norms of
handling anatomic preparations [3,15,17].
• In 2000 Minsk hosted the international scientific-and-practical
conference “Biomedical Ethics: Problems and Perspectives”; a volume of
conference proceedings was published [9].
• In 2000 one of the first text-books in CIS countries “Biomedical
Ethics” (220 p.) for students studying medicine and biology approved by the
Ministry of Education of Belarus was published [12]. The text-book includes
a supplement in which leading scientists and physicians of Belarus of different
age and specialties give their professional opinion on ethical problems.
• In 2001 the International State Ecological University named after
A.D.Sakharov introduced a course “Basics of Biomedical Ethics” (20 h)
into the syllabus for students studying medicine and biology. Since 2003
* Data by N.E. Luigas and C.D. Denisov
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the course in biomedical ethics (36 h) is taught at the Belarus State Medical
University (BSMU) and other institutes of higher medical education.
Teaching programmes “Basics of Biomedical Ethics” for undergraduate
students and “Topical Problems of Biomedical Ethics” for medical postgraduates have been designed.
• A programme in biomedical ethics has been developed for the system
of raising the professional level of medical practitioners and teaching staff
of medical institutes (18—36 h). Academy for Post-Graduate Education of
Republic Belarus offers a course “Biomedical Ethics in Psychiatry” (for
teaching professionals, clinical psychiatrists and investigators – 24 h).
• In the framework of Russia—Belarus scientific-and-practical
conferences on the problem of developing professional knowledge in
bioethics (Kirov, 2003; Minsk, 2004) problems of teaching bioethics to
medical students were discussed [17].
In 2003 a second revised and amended edition of the text-book
“Biomedical Ethics” is published [8]. The text-book supplement contains
international guidelines, methodical recommendations for teachers, tests
and case-studies.
• In January (Moscow) and March (Minsk) 2005 in the framework of
regional consultations for professionals in the field of education in ethics and
bioethics held under the aegis of UNESCO experts from Belarus presented
their relevant teaching programmes.
• Since February 2005 BSMU offers a 64-hour course “Problems of
Biomedical Ethics in Modern Theory and Practice” for BSMU teaching
staff.
• In May 2005 the republican student conference “Bioethics: Theory,
Practice and Perspectives” was held and a volume of student papers was
published.
• In autumn 2005 BSMU held the student conference “AIDS:
Information Practice. Formation of Positive Moral Values in Youth”.
• In September 2005 BSMU organized a round table with Dr. Henry
Williams (Head of the Tennessee Hospital, USA) and Dr. Joy Raily (Director
of the Centre for Bioethics and Cell Technologies).
• In May 2006 the Republican Scientific-and-Practical Conference
“Medicine and Christianity” was held with a Section where bioethical
problems were discussed in the context of the Orthodox worldview.
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• In November 2006 young scientists from the Institute for PostGraduate Education of Belarus in cooperation with NCBE organized the
scientific-and-practical conference “Humanization in the Education of
Specialists in Medicine and Biology”; proceedings of conference were
published [21].
• The republican scientific-and-practical student conference “Culture
and Medicine: interaction Paradigm” was held in May 2007.
Thus, today we have relevant methodical materials including manuals,
and national manuals.
Besides, there are following teaching programmes for the system of
high (undergraduate) medical education [11]:
a. “General Ethics” (with sections “Bioethics” and “Ecological Ethics”)
– for students of all specialties (Mishatkina T.V., Belyaeva E.V.) – 36 h;
b. “Basics of Biomedical Ethics” – for medical undergraduate students
(Mishatkina T.V., Denisov S.D., Kevra V.K., Lugais N.E.) – 36 h;
c. “Humanitarian Aspects of Modern Science (with Elements of
Bioethics)” - for students of humanitarian specialties (Yaskevich Ya. S.) 18 h;
d. “The Conception of Modern Natural Sciences” – for students
studying natural sciences (Yaskevich Ya.S., Viazovkin V.S.) – 18 h;
e. “Human Rights” – for students of all specialties (Yaskevich Ya.S.,
Gusev A.D., Gafarova Yu.Yu.) – 18 h;
f. “Basics of Ecological Ethics” – for students in specialties “Ecology”,
“Agricultural Science”, “Veterinary Science” (Mishatkina T.V., Boronnikova
V.T., Silich T.V.) – 18 h.
Today there are four institutes of higher medical education (in
Minsk, Grodno, Gomel and Vitebsk) and the Faculty of Biomedicine at
the International State Ecological University named after A.D. Sakharov.
“Bioethics” as a subject is not included into the State Standard for Education,
and, hence, there is no State system of education in bioethics.
Therefore, bioethics is mostly taught within the Ethics Course (course
duration depends on the decision of the Institute Council). At the BSMU
bioethics is taught in the 1st and 2nd years (36 h). For senior students issues
on biomedical ethics and deontology are included into courses on medical
disciplines.
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With regard to bioethical education, we believe that it is essential
to develop the ability to reflect on problems of human life and death, to
form an understanding of the necessity to follow principles and rules of
biomedical ethics in professional activity, to combine reason and feelings,
intuition and logic, emotions and intellectual efforts. To achieve this goal,
we have to define the problems we choose for bioethical education. From
a variety of topics arising due to the development of biology, medicine
and practical healthcare we chose most essential problems consistent
with the principles of a system and holistic approach. Besides, to analyze
ethical situations, we need to select from the whole volume of special
knowledge sections that are most ethics-orientated and provide ethical and
humanitarian comments by ethicists.
At the same time, we are searching for interdisciplinary approaches to
bring moral and ethical norms in conformity with the current medical and
biological reality.
An important achievement of the BSMU is that already at the stage of preclinical training medical students participate in resolving ethical problems
relating to using dead human bodies in the teaching process and experiments
on animals [14, 20]. In the course on human anatomy students are informed
about legal, ethical and religious aspects of using a dead body of separate
organs for an educational or scientific purpose. Learning ethical norms of
handling anatomic preparations facilitates the development of the most
essential humanistic quality – respect for a human being. Humane attitude
to animals involved in experiments is very important for the development
of compassion and empathy. Implementation of teaching aids alternative
to experiments (computer programmes of experiments on virtual animals,
video-films, CDs, three-dimensional models, etc.) allowed to exclude or
minimize experiments on animals. As the result, students see that ethical
principles are not merely postulated but implemented in practice.
Medical students acquire bioethical knowledge out of class as well.
Students of BSMU participate actively in the hospice movement. During
several years they have been taking part in the BACCUP Programme at
the Cardiff Medical University working as volunteers together with British
medical students in summer holidays.
Problems of bioethics, medical deontology and clinical ethics in medical
practice can be successfully resolved only if medical professionals know the
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current legislation referring to healthcare. Therefore it is necessary, firstly, to
regulate norms of medical activity according to new conditions in practical
healthcare, and, secondly, to provide legal knowledge to medical specialists.
Sociological surveys carried out in Belarus showed that, unfortunately,
medical students, as a rule, do not have systematic knowledge in either
deontology or medical ethics, or in medical and common law.
A low level of education in ethics is typical of other categories: medical
specialists and investigators, members of ECs, representatives of governing
and legal institutions adopting laws and making decisions in healthcare and
biomedicine, general public. This is a problem not only in Belarus or all
regions of the post-Soviet space but in many other countries. Even when the
level of education in bioethics may seem quite satisfactory, there is much
of traditional paternalism. Thus, we still cannot get used to the idea that
an individual’s right to life and death is his/her right and not the right of a
physician, investigator or a legislator. Paternalism, in its turn, roots back
to the authoritarian ethics in which interests of the society, State, science
prevail over interests of an individual. Therefore we face the necessity
to form new humanistic ethical way of thinking, which may be achieved
through bioethical education.
Today there are three levels of bioethical education in Belarus.
The first level is teaching bioethics to medical undergraduates. The
course “Basics of Biomedical Ethics” aims at forming a consciously ethical
attitude to the alive and a devout attitude to human life. After completing the
course, students have to:
- know key conceptual models of bioethics and biomedical ethics,
the history of their development and current state; understand their main
concepts and categories;
- be able to characterize the essence and basic problems of bioethics
and biomedical ethics, their principles and values, moral aspects of topical
problems of modern medicine and biomedical research;
- be able to analyze specific character of bioethical knowledge and its
role in resolving professional problems;
- be able to analyze actual ethical situations in the context of the highest
moral values and use normative and applied aspects of ethical knowledge in
professional communication;
- be able to make their own moral choice and bear the responsibility.
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It is desirable that during the Course medical students would acquire
skill of ethical discussion and dialogue; would be able to prevent and resolve
conflicts, develop an adequate self-evaluation, tolerance in evaluating their
colleagues and an appropriate style of professional and personal behavior.
Education at the second level aims at providing bioethical knowledge
for medical practitioners through the system of raising their professional
knowledge and post-graduate education. Here the situation is more
complicated as the system is yet to be developed, though there are some
achievements. At the Academy for Post-Graduate Education of Belarus at
least four aspects of education in biomedical ethics are considered, though
time given to these issues is insufficient (2-4 h). The four aspects are:
– raising professional level of specialists with higher and secondary
special education in medicine and pharmacy through education in bioethics
– introducing courses on bioethics into syllabi and teaching programmes
for retraining specialists with higher and secondary special education in
medicine and pharmacy;
- teaching bioethics within a programme for training teaching staff of
high qualification (postgraduates, doctoral students);
– raising professional level of professionals who organize and carry out
clinical trials so that they could be admitted to this activity.
However, we do not have a separate course on bioethics at the graduate
and post-graduate levels. We also lack a State system of teaching GCP and
a systematic training for EC members. Training courses in ethical review of
clinical drug trials are held at the Republican Centre of Expertise and Trials
in Healthcare. The course is very short (2-4 hours). There are no dissertation
boards, and no dissertation on bioethics has been defended, as the Higher
Certifying Commission does not have this discipline on the list of specialties.
The first dissertation on bioethics as a basis of the physician’s professional
culture is planned in the section of “Culturology”. Therefore, currently the
question of introducing differentiated specialized courses on bioethics for
different categories of postgraduate audience is under consideration.
We also use some other opportunities to raise graduates’ and
postgraduates’ professional level in bioethics, particularly, international
grants received on one’s personal initiative. Thus V.K.Kevra participated in
an Educational Project at the Lithuanian National Committee on Bioethics;
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O.P.Aizberg attended the Seminar on Bioethical Problems in Narcology
organized by the “AWEF—AIDS: East-West” Foundation (Kiev, 2006).
The third level – providing bioethical knowledge for the population
– is the most “deserted” field of work. A low level of public awareness
affecting the public opinion and decision making with regard to vitally
important issues – from informed consent to adoption of laws – requires
taking immediate measures to change the situation.
Here we have high hopes for the Project “Education in Bioethics and
Promotion of Bioethical Knowledge in Belarus” approved and supported
by the Division of the Social Sciences and Humanities of the UNESCO
Moscow Office. Within the next few years, the Project will help us to resolve
the mentioned problems.
The Project includes:
• the development of teaching programmes in bioethics for ECs
members considering their qualification and the content of EC work;
• the development of guidelines for the system of raising the expertise
level for EC members, organization of seminars on international documents
relating to bioethics (UNESCO, WHO, Council of Europe, etc.);
• the development of methodological basis and a long-term programme
for raising the level of public awareness in bioethics.
We hope that due to the use of necessary facilities, resources and ways
of implementing the Project we shall be able to create a harmonious, logical
and comprehensive theoretical model of biomedical ethics and a system
programme of continuing education.
Today in Belarus a number of highly qualified specialists are involved
in theoretical work and in teaching bioethics. In the framework of the
UNESCO Project, a list of experts in bioethics and bioethical education from
Belarus has been compiled (49 experts). Among them, there are such leading
specialists as Vismont F.I., Dr. of Medical Sciences, professor, corresponding
member of the National Academy of Sciences, vice-chairman of the
NCBE; Aizberg O.P., Candidate of Medical Sciences; Godovalnikov G.V.,
Candidate of Pharmaceutical Science, the director of the Republican Centre
of Expertise and Trials in Healthcare; Denisov S.D., professor, prorector of
BSMU; Lugais N.E., Candidate of Historical Science, the secretary of NCBE;
Mishatkina T.V., Ph.B., assistant professor, NCBE member; Morozkina T.S.,
professor, the State Prize laureate; Mosse I.B., Dr. of Biological Science,
131
132
In Belarus a gradual implementation of the procedure for a compulsory
Commission on immunobiological
products
Pharmacopeia
Committee
Pharmacological
Committee
Experts
Republican Analytical
Laboratory
Republican Clinical and
Pharmacological Laboratory
Office for Medical
Equipment
Vice-Director for Medical
Equipment
First Vice-Director for Hygienic
Registration
Office for Hygienic Regulation
and Registration
Office for Pharmaceutical
Products
* This section has been written with the assistance of G.G. Voronov and G.V. Godovalnikov
(Republican Centre of Expertise and Trials in Healthcare)
Vice-Director for
Pharmaceutical Products
Ethical review of clinical trials in Belarus is performed by Ethics
Committees (local committees) at healthcare institutions authorized to carry
out clinical trials, and at some institutions of the system of higher medical
education (e.g.: BSMU and Medical Academy for Postgraduate Education
of Belarus). National Committee on Bioethics (NCBE) established in
April 2006 ensures public control with regard to the observance of ethical
regulations in conducting clinical trials involving human subjects and
experiments on animals.
The process of establishing local ECs at healthcare institutions (hospital,
out-patient clinic, scientific-and-research institute, scientific-an-practical
centre) goes in parallel with the accreditation allowing to conduct clinical
trials and in compliance with the Law on Healthcare (1993; amended in
2001); the Law on Pharmaceutical Products (2006); the Order No 254 of the
Health Ministry of Belarus “On Approval of Guidelines for Clinical Trials
of Pharmaceutical Products” (1999); Methodical Recommendations on
Establishing ECs and their Operation (2000); Guidelines on Accreditation
of Healthcare Institutions and Certification of Specialists Conducting
Clinical Trials of Pharmaceutical Products, Medical Equipment and other
Medical Goods (2004). The control of the process rests with the Republican
Centre of Expertise and Trials in Healthcare authorized hereto by the Health
Ministry of Belarus.
Director
3.3.4. The System of Ethical Review*.
The Structure of the Republican Centre of Expertise
andCenter
Trials in
The Structure of the Republican
of Healthcare
Expertise and Trials in Healthcare
The process of establishing local ECs at healthcare institutions (hospital,
out-patient clinic, scientific-and-research institute, scientific-an-practical centre)
goes in parallel with the accreditation allowing to conduct clinical trials and in
compliance with the Law on Healthcare (99; amended in 00); the Law on
Pharmaceutical Products (006); the Order No 54 of the Health Ministry of
Belarus "On Approval of Guidelines for Clinical Trials of Pharmaceutical
Products" (999); Methodical Recommendations on Establishing ECs and Their
Operation (000); Guidelines on Accreditation of Healthcare Institutions and
Certification of Specialists Conducting Clinical Trials of Pharmaceutical Products,
Medical Equipment and other Medical Goods (004). The control of the process
rests with the Republican Centre of Expertise and Trials in Healthcare authorized
hereto by the Health Ministry of Belarus.
professor; Okeanov A.E., Dr. of Biological Science, professor; Silich T.V.,
senior staff scientist of the Central Scientific-and-Research Laboratory at the
Medical Academy for Postgraduate Education of Belarus; Sliadneva N.E.,
the chief editor of newspapers “Animal World” and “Ecologist and Myself”;
Yaskevich Ya.S., Ph.D., professor, vice-chairman of NCBE. Information
about some of them is in the UNESCO site [22].
133
In Belarus a gradual implementation of the procedure for a compulsory
ethical review of clinical trials performed by ECs began in 1999 when the
Order No 254 of the Health Ministry of Belarus was issued. The Order No
161 on 14 of May 1999 stimulated the process of accrediting healthcare
institutions and certifying specialists conducting clinical trials. According to
this Order, to gain the right to conduct clinical trials, an Ethics Committee
should be established at accredited institutions in compliance with Methodical
Recommendations. There also should be specialists with the knowledge in
good clinical practice.
Since 2000 the Republican Centre of Expertise and Trials has been
organizing educational seminars on international regulations for carrying
out clinical trials in compliance with GCP. During 7 years over 700
physicians and pharmacists, conducting clinical trials and participating
in the EC activity, attended the seminar. This helped to create optimum
conditions for the development
of the network of local ECs,
which formed the basis for
implementing ethical review
procedures into the practice of
biomedical research.
Due to the mentioned
measures, currently, apart from the
NCBE, 51 local ECs at healthcare
institutions accredited to conduct
clinical trials are functioning in
Belarus. Among those there are,
in particular, 11 regional and
20 city hospitals, 3 out-patient
clinics, 9 Republican science-andpractical Centres; 3 scientific-and-research institutes. In 1998 the National
Coordinating Safety Centre was established at the Institute of Genetics and
Cytology of the National Academy of Sciences; in 2000 BSMU established
an EC, and the International State Ecological University named after A.D.
Sakharov established an EC in 2003. ECs at healthcare institutions work on
implementing ethical review into the design of dissertation research that would
precede the approval of the dissertation theme by the Scientific Council.
While one of the main NCBE tasks is to facilitate public control ensuring
the observance of ethical norms and regulations in pre-clinical and clinical
trials, local ECs at healthcare institutions are implementing in practice the
system of administrative and State control ensuring the protection trial
subjects’ rights and interests.
bioequivalence
studies)
post-registration
(Phase
clinical
Presently,
local and
ECs carry
out ethical review,
whichIV)
includes
the trials
reviewmedicine
of documents(cardiology,
(research protocols,
forms of individual
registration
fields of
oncology,
gastroenterology,
al
cards, informed consent forms, etc.) relating to pre-registration (Phase I, II
endocrinology, traumatology) including international multicenter trials.
and III trials, generic bioequivalence studies) and post-registration (Phase
IV) clinical trials in various fields of medicine (cardiology, oncology,
Multicentre
clinical trials
of pharmaceutical
in Belarus
gastroenterology,
allergology,
endocrinology, products
traumatology)
including (1998
international multicentre trials.
11
12
10
10
8
6
5
4
4
2
2
1
1
1
0
1998
1999
2000
2001
2002
2003
2004
2005
Multicentre clinical trials of pharmaceutical products in Belarus
(1998-2005)
When conducting ethical review ECs give a special attentio
protection of
rights
and interests
of ECs
healthy
involved
When
conducting
ethical review
give avolunteers
special attention
to the in th
clinical protection
trials and
in and
theinterests
clinical
stagevolunteers
of bioequivalence
studies.
of rights
of healthy
involved in the Phase
I clinicalistrials
in theto
clinical
stage ofinvolving
bioequivalence
studies. A special
consideration
alsoand
given
research
vulnerable
groups (chil
consideration is also given to research involving vulnerable groups (children,
people, armed
forces personnel, etc.).
aged people, armed forces personnel, etc.).
Bioequivalence Studies of Pharmaceutical Products
135
134
9
8
eople, armed forces personnel, etc.).
8. The statement that the investigator should promptly report to the EC
deviations from the protocol to reduce the risk, changes increasing risks for
8
patients and unexpected and/or serious adverse effects;
7
7
9. Appeal procedure referring to the EC’s decision;
6
6
10. Terms of payment for the EC members and the procedure of the
6
5
5
financial activities (if stipulated);
5
11. The procedure of archiving documentation of the EC.
4
In its activity, ECs follow the following fundamental principles:
• Principle on independence requires that to maintain the EC
3
2
independence, specialists making the decision should not depend of the
2
administration of a trial centre or be one of the investigators;
• Principle of competence implying that the investigator(s) should
1
have
an appropriate medical qualification and experience for the propped
0
conduct
of the trial;
1999
2000
2001
2002
2003
2004
2005
• Principle of openness implying transparency and availability of all
documents referring to the clinical trial;
• Principle of objectivity requiring that an investigator or a member of
The reviewofof documents
documents referring
to clinical
including
the trial
The review
referring
to trials,
clinical
trials,
including the trial
his/her team who is a member of EC conducting ethical review of documents
protocol, is performed by local ECs within 5-7 days. Without the approval
referring to an clinical trial which she/he is planning to undertake should not
rotocol,from
is performed
local of
ECs
5-7 days.
Without
the approval from
local ECs theby
Chairman
the within
Pharmacological
Committee
of the
take part in voting;
ocal ECs
the Ministry
Chairman
of themay
Pharmacological
Committee
oftrial
the Health Ministry
Health
of Belarus
not approve the documents,
and the
• Principle of confidentiality according to which materials of the clinical
maymay
not be
started.
In the the
casedocuments,
of disagreementand
withthe
the trial
EC decision,
the be started. In the
f Belarus
not
approve
may not
trial should be documented and stored in compliance with GCP rules;
applicant (sponsor) may appeal against the decision to the NCBE.
• Principle of collective decision-making implying that decisions
The activity of local ECs is regulated by respective normative and legal
should only be made by a majority considering opinions of all EC
acts, the EC Statute and Standard Operational Procedures. These documents
members;
0
define the following:
• Principle of inadmissibility of unjustified prohibitions implying
1. Composition of the EC and membership requirements
that any EC decision should be well-justified, all EC members should have
(qualification, etc.);
an opportunity to give their opinions, especially in the case of a negative
2. Operating schedule, contact telephones of the EC members,
decision, and to appeal against the decision.
notification procedure;
3. A list of documents to be submitted to the EC for ethical review;
Local ECs of Belarus act in compliance with the rules regulating ethical
4. The procedure for ethical review of submitted documents;
review of clinical trials:
5. Standard forms of the EC decisions;
1. Estimation and minimization of risks concerning physical
6. The statement that all amendments to the protocol (programme) of a
and psychological harm to a patient, invasion of privacy breach of
clinical trial come into force only after approval by the EC;
confidentiality;
7. The statement that no subject may be involved in a clinical trial
without the EC approval;
9
136
8
137
2. Estimation of expected benefit: both the direct benefit for the patient
and gaining new knowledge about diseases and methods of
3. Analysis of risk/benefit ratio;
4. Review of informed consent and the procedure of obtaining it, selection
of subjects and stimulation of subjects to participate in the clinical trial.
Before starting the clinical trials Ethics Committee review the
following documents: the trial protocol (programme); informed consent of
the prospective subject to participate in the clinical trial; case report form
of the prospective research subject; the investigator’s brochure; advertising
materials; information for the clinical trial subjects; information on the
investigational pharmaceutical product, medical equipment and/or medical
goods; information on payments or compensation to subjects (if stipulated);
the permission by the regulatory institution (Health Ministry of Republic of
Belarus) to conduct the clinical trial.
In the course of the clinical trial EC reviews amendments to the protocol
(programme); amendments to the subject’s IRC; amendments to the text of
the subject’s IC; amendments to the investigator’s brochure; information on
safety (serious undesirable events); interim trial reports (especially in the
case of long-term trials).
When the ethical review is completed, the EC may make the following
decisions: a positive decision (approval of the clinical trial); conditional
decision (with clear suggestions for amendments); a negative decision (with
clearly stated reasons);
The Centre of Expertise and Clinical Trials in Healthcare surveys and
evaluates ECs practices via inspections at the site of the trial. In the period
from September 2004 to February 2006, the Centre carried out 76 inspections
to survey EC practices in Minsk and all regional Centres.
Thus, Republic Belarus has created quite an efficient system for ethical
review of the CT documents that forms a part of a system for public and
State control, which ensures the protection of human rights and interests
in the Republic. Today we have different types of committees for bioethics
(ethical committees, commissions on ethics, associations, etc.) functioning
at different regulatory levels (national, regional, local). Committees
belonging to each of these types have their goals and functions and find
a common ground in solving ethical dilemmas arising in different fields
of research and healthcare. The creation of the National Committee for
138
Bioethics (NCBE) and its efficient functioning in compliance with the
Project Proposal “Establishing the National Committee for Bioethics and
Providing Bioethical Education to Specialists in Republic of Belarus”
(in the framework of the Programme of Social Sciences and Humanities,
UNESCO Moscow Office) aims to provide a competent ethical review of
scientific research in healthcare, to organize forums for discussing problems
of bioethics on a national level, and to have an impact on the development
of legislation policy in the field of bioethics.
The NCBE has been established as an advisory body to exercise public
control of compliance with ethical norms and regulations in experiments on
animals and research involving human subjects in order to safeguard human
rights and freedoms when applying to them modern scientific achievements,
and in educational, treatment-and-preventive and other activities. The
Statement on the National Committee for Bioethics has been approved by
the Order of the Health Ministry of Republic Belarus. The Statement sets
out a wide range of the NCBE functions with regard to:
- providing healthcare, monitoring clinical trials and registration of new
pharmaceutical products and medical technologies;
- disease treatment and prevention and scientific-research activity;
- providing bioethical education to professionals and public at large;
- legislative initiatives concerning healthcare and biomedical
research;
- resolving social and legal problems in nature-conservative
activities [20].
The NCBE is independent in its appraisals, opinions and decisions.
It has the status of an advisory body, and does not make legal decisions
but actively cooperates with legislative and executive bodies and with
public organizations. In autumn 2006 the NCBE members T.V. Mishatkina
and Ya.S. Yaskevich took part in the meeting of the Round Table at the
National Assembly of Republic Belarus, where the Law Project “On the
Transplantation of Human Organs and Tissues” was discussed [25,26]. The
Law was adopted in March 2007.
Thus, the NCBE should facilitate:
- the development of a democratic mechanism for the discussion
and analysis of difficult moral problems relating to the achievements in
biomedical science and technology;
139
- public control ensuring the protection of human rights according to
criteria of biomedical ethics;
- the development of proposals relating to the legal regulation in
biomedicine;
- EC establishing, regulation and coordination of their activity at
different levels; education of the EC members;
- raising the level of a continuing bioethical education in professional
medical community (from undergraduate to postgraduate education);
- creating the opportunity for international cooperation in bioethics;
- promoting a healthy life-style and informing the population about
achievements and current problems in bioethics.
3.3.5. Perspectives and Forms of International Cooperation
Republic of Belarus has developed an effective partnership with the
leading international organizations such as UNESCO and Forum for Ethics
Committees in the Commonwealth of Independent States, as well as bilateral
cooperation with The Institute of Philosophy of the Russian Academy of
Sciences, the Ukraine State Medical University named after Bogomolets,
the Ukrainian Association on Bioethics, Higher Medical School of Hanover,
the Committee for Ethics in Science of the Warsaw University, the National
Committee for Bioethics of Lithuania, the Lithuanian Association of
Psychiatrists, the Fogarty International Centre and National Institute of
Health (USA), etc. Results of scientific and teaching-and-methodical work
are presented at international conferences. In particular, professionals
from Belarus participated in the International Scientific Conference on
Humanities in the Contemporary World (Saint-Petersburg, 2002) [10] in the
International Scientific and Practical Seminar on Bioethics in the framework
of the programme of Fogarty International Centre (Bulgaria, 2003) and in
regular international seminars and symposia held in Kiev Materials prepared
by Belarusian scientists in the framework of international cooperation are
published in Russian and Ukrainian scientific journals and in volumes of
conference proceedings [27-29].
Participation of Belarus professionals in the FECCIS and, particularly,
in meetings and symposia of the FECCIS in St.-Petersburg, Baku, Yerevan
and Kiev is very essential for the development of bioethical thought and
140
bioethics in Belarus. Seminars organized in the framework of the FECCIS
and reports by leading specialists and experts of the international level are
certainly very helpful for a more profound understanding of bioethical
problems and dilemmas and facilitate education of persons concerned.
During the last years, specialists in bioethics from Belarus have been
taking part in activities undertaken by UNESCO, particularly, in meetings of
regional experts in bioethics (January 2005, Moscow; March 2005, Minsk;
September 2005, Vilnius). On the request of UNESCO, T.V.Mishatkina,
an expert in ethics from Belarus, designed and submitted to the UNESCO
Headquarters 11 educational programmes on the fundamentals of education
in ethics and bioethics.
Today the international cooperation in implementing bioethical
principles and developing ethical review of biomedical research goes along
three directions supported by UNESCO:
– theoretical development of a conceptual model of bioethics;
– practical work on the organization of the National Committee and on
the development of local ECs activity;
– providing bioethical education to professionals and general public
in accordance with the Project Proposal within the Programme for Social
Sciences and Humanities(UNESCO Moscow Office) “Bioethics Education
in Republic of Belarus”.
Cooperation in developing the theory of the ethics of biomedical
research. A joint project “Social, Philosophical and Ethical Problems of
Genomic Research and Clinical Medicine” is carried out in cooperation
with the Institute of Philosophy of the Russian Academy of Sciences. The
theme of the Project has been approved by the Belarusian Republican Fund
of Fundamental Research at the National Academy of Science of Belarus
and Russian Foundation for the Humanities (Project Directors: B.G. Yudin
and T.V. Mishatkina; the term of the Project – two years).
Project objectives:
1. on the basis of the interdisciplinary approach to make an inventory,
description and analysis of social, philosophical and ethical problems in
genomics, modern biotechnologies and clinical medicine;
2. to trace global and national tendencies of principles of bioethical
regulation in research and medical practices;
141
3. to work out recommendations on methodology and procedures of
humanitarian review in the above-mentioned fields;
4. to specify the conceptual model of biomedical ethics.
To achieve the goals, we have to solve the following tasks:
- theoretical and methodological analysis of interdisciplinary
approaches and finding mechanisms for interaction between humanities and
natural sciences;
- definition of the methodological status of fundamental ethical
problems referring to achievements in genomics, development of new
biotechnologies and situations in modern biomedicine;
- content structure determination, inventory, classification and
interpretation of main elements of bioethical knowledge; investigation
of its structure, functions, principles and specific nature of moral values;
development of a conceptual model of bioethical ethics;
- development of operational standards for a complex humanitarian
expertise and control in the field of genomics, biotechnologies and clinical;
- theoretical and methodological substantiation of the activity of the
National Committee on Bioethics of Republic Belarus, the development of
its Statute and recommendations for stimulating the activity of regional and
local bioethics committees.
Project Outcomes: the inventory and analysis of social, philosophical
and ethical problems caused by the development of genomics, modern
biotechnologies and clinical medicine as a methodological basis for the
development of a conceptual model of biomedical ethics, and for working
out recommendations for a complex humanitarian expertise and ethical
regulations guiding the practice of biomedical research.
The practical application of the Project results is possible in the
following directions:
а) in establishing and regulating practices of bioethical committees
to conduct a complex humanitarian expertise and to monitor biomedical
research and pharmacological trials involving human subjects, the process
of implementing results of new biotechnologies and the compliance with
ethical regulations in clinical practice;
б) in developing the strategy and tactics of bioethical education and
the system of a continual education to raise the professional level of
specialists in medicine and biology; in designing manuals and methodical
142
recommendations for teaching fundamentals of biomedical ethics to
undergraduate medical students;
в) in raising the level of bioethical culture and competence in the
population.
Results of this cooperation will be presented at an international scientific
conference in 2007; the work on a collective monograph is under way.
In the framework of international cooperation, we continue the analysis
of bioethical consequences of genetic research. In October 2006 Minsk
hosted the International Conference “The Evaluation of Risks from a
Combined Effect of Anthropogenic Factors: Prognosis for the Future”. CoDirectors of the Conference were prof. C.Mazersill (McMaster University,
Hamilton, Canada) and prof. I.B.Mosse (Minsk, National Academy of
Science, Republic Belarus). Leading specialists from 16 countries (USA,
Canada, England, Norway, Italy, Portugal, Ireland, Russia, Belarus and other
countries of East Europe, Asia and Africa) attended the Conference. Fortyfive presentations made at the Conference reflected the current situation with
regard to the environment pollution with radiation and chemical products.
The speakers suggested possible ways of preventing negative consequences
caused by anthropogenic factors. Reported data are of a great interest for
the Belarusian science. They also are helpful in outlining ways for the use
of achievements of modern science taking into account bioethical problems.
Joint scientific projects aiming at the elimination of consequences from a
combined effect of anthropogenic factors were designed in the framework
of international scientific-and-technical programmes. Full texts of the
Conference reports (about 1000 pages) will be published in a monograph.
The co-editor of the monograph from Belarus is prof. I.B. Mosse.
Cooperation in the field of bioethical education is focused on the
development of teaching programmes and on the exchange of methods,
materials and experience in bioethical education with countries which are
most developed in this respect. In the post-Soviet space, our partners are
Russia, Lithuania (Lithuanian Bioethical Committee, Medical Faculty of
the Vilnius University, Kaunas Medical University), Ukraine (Ukrainian
Association on Bioethics, the Medical Academy of Post-Graduate Education
of Ukraine); Moldova and Armenia are our prospective partners.
Cooperation in this field aims at enhancing the access to existing
information resources and widening contacts between experts in bioethics.
143
Another objective is to develop and introduce into practice teaching
programmes, methods and approaches ensuring the acknowledgement and
understanding of principal bioethical problems in medical community and
in public at large.
Main ways of cooperation here are the design and subsequent use of
modules of teaching programmes on biomedical ethics for a differentiated
ethical education in different social communities.
One of the last events demonstrating the cooperation in bioethical
education was a Scientific-and-Practical Seminar “Humanization in the
Education of Specialists in Medicine and Biology” held by young scientists
of the Belarus Academy of Post-Graduate Education. The Seminar was
supported by the Health Ministry of Republic Belarus, the National Committee
on Bioethics and the Belarusian Republican Fund of Fundamental Research
at the National Academy of Science of Belarus. Experts from UNESCO,
InterNICHE (United Kingdom) and Centre for Protection Animals’ Rights
“Vita” (Russia) participated in the Seminar. The main objectives of the
seminar were the discussions relating to the observance of principles of
bioethics in scientific and educational activity, and, in particular, the use
of laboratory animals in science and education and the application of new
alternative technologies in education and in scientific experiments [39-42].
International cooperation on establishing the National Committee
on Bioethics in Belarus. The starting point in establishing the National
Committee on Bioethics in Belarus was an International Seminar “The
National Committee on Bioethics of Belarus Republic and the Activity
of Local (Regional) Committees on Bioethics: the Experience of the East
and Central Europe”. The seminar aimed at providing knowledge on ECs
operation and the procedure of ethical review of biomedical research in
the context of European experience. The Seminar was supported by the
UNESCO Moscow Office and the Belarusian Commission for UNESCO.
Other partners in organization and holding the Seminar were the FECCIS,
GCP Alliance – Europe, the Health Ministry of Republic of Belarus, the
Centre for Expertise and Trials in Healthcare, Belarus State Medical
University, the State Economical University of Belarus (Institute of
Education in Social Sciences and Humanities), the Belarus Academy of
Post-Graduate Education, International State Ecological University named
after A.D. Sakharov.
144
International experts in bioethics and research ethics, prof. O.I. Kubar
– the Chairperson of the FECCIS, prof. B.G.Yudin and representatives
from Latvia, Lithuania, Moldova, Poland, Russia and Ukraine attended the
Seminar. Members of Belarus local and regional ECs also took part in the
Seminar. Participants discussed issues relating to the creation and functioning
of National Committees on Bioethics in the light of Universal Declaration
on Bioethics and Human Rights adopted by UNESCO in 2005. Other issues
discussed at the Seminar were the perspectives of establishing the NCBE of
Belarus; its main objectives, tasks and functions; coordinating its activity
with the Centre of Expertise and Clinical Trials of Republic Belarus and
local ECs in the context of the relevant experience in countries of East and
Central Europe. There was much discussion on the NCBE functions, rights
and responsibilities, its possible impact on the activity of local ECs and
providing assistance and support to them. Independence of financing of the
NCBE and problems of raising the public awareness in bioethics were also
topics of an active discussion. The experience of countries of the Central
and East Europe in the development of bioethics and in the ECs practices
was discussed at one of the Seminar sessions. In the course of the Seminar
FECCIS presented the SIDCER “Recognition Programme “ and organized a
training course for members of Belarus local and regional ECs and all other
participants. After the course, the participants received course certificates. At
the closing session perspectives and tasks of Belarus bioethics committees
were discussed. The Seminar adopted Recommendations and the Resulting
Document on prospective directions of the NCBE and local ECs activities.
One of the Seminar’s results was a volume of papers “National and Local
Committees on Bioethics: the Experience of Central and East Europe”
(Minsk, 2006). It comprised not only texts of presentations, but also Russian
translation of papers describing the experience of ECs in the countries of
Central and East Europe and the text of the UNESCO Universal Declaration
on Bioethics and Human Rights. The volume included documents relating
to establishing the NCBE of Republic Belarus and the Resulting Document
adopted at the seminar [37].
In our society, bioethics, as a social and cultural phenomenon, determines,
largely, mutual enrichment of legal and ethical awareness and sets guiding
lines for biology, medical practice and administrative decision-making.
Bioethics ensures the moral climate in scientific and medical communities
145
and adequate choices made by physicians, biologists and biotechnologists
by determining the measure of their intervention into the sphere of the live,
and the measure of their responsibility for the results of their scientific and
practical activity before the society.
References
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3rd edition. Minsk, 2002. (in Russian)
2. Boyko Yu.G., Silyaeva N.F. The problem of physicians’ mistakes in
medical deonthology. Medical News, 1999, No. 9. (in Russian)
3. Denisov S.D., Yaroshevich S.P. Teaching of medical ethics and
deontology bases in the course of human anatomy. Guidelines. Minsk, 1999.
(in Russian)
4. Makshanov I.Ya. Physician’s deothology. Teaching manual for
medical institutes. Minsk, 1998.
5. Medical ethics and deonthology. Teaching manual for students and
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Russian)
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8. Biomedical ethics. Teaching manual. (Ministry of education of
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2003, 320 p. (in Russian)
9. Biomedical ethics: problems and perspectives. Proceedings of
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S.D.Denisov, Ya.S.Yaskevich. Minsk, 2000. (in Russian)
10.Mishatkina Т.V. Biomedical ethics: status and the round of problems.
Ibid.
11.Mishatkina Т.V. Bases of biomedical ethics: the programme of
training course. Ibid., 23rd issue, pp. 355-360.
12.Biomedical ethics. Teaching manual. Ed. by T.V.Mishatkina,
S.D.Denisov. Minsk, MSMU publications, 2001. 256 pp. (in Russian)
13.Yaskevich Ya.S., Kuznetsova L.F., Barkovskaya А.V. Contemporary
science: value orientation. Teaching manual. Minsk, 2003. (in Russian)
146
14.Denisov S.D. Humanistic attitude to animals – one of main goals
in humanization of higher medical education. Abstracts of Belarus-Britain
symposium “Ethical aspects of animal use in training process and in
research” (October 1997, Minsk, MSMI). Ed. by S.D.Denisov. Minsk, 1998.
(in Russian)
15.Denisov S.D. Medical students should not kill. Proceedings of the
international symposium “Bioethics on the eve of XXI century”. Kharkov,
October 2000. (in Russian)
16.Denisov S.D. Requirements to scientific experiment with animals.
Public Health, 2001, N 4. (in Russian)
17.Morozkina T.S. Deontological aspects of animal use in teaching
process. Higher School, 1996, N 1, p. 30-35. (in Russian)
18.Morozkina T.S., Denisov S.D. Implementation of the principles of
the three RS in Belarus: reality and perspective. Abstracts of the 3th World
Congress on Alternatives and Animal Use in the Life Sciences. Bologna,
Italy, 1999, p. 397.
19.National and local bioethics committees: the experience of Central
and Eastern Europe. Materials of international conferences on bioethics.
Minsk, 2006. (in English)
20.Bioethics: theory, practice, perspectives. Proceedings of the
Republican student conference. Ed. by S.D.Denisov. Minsk, BSMU, 2005.
(in Russian)
21.Mishatkina Т.V. Ethical and humanistic bases of contemporary
biomedical education. Humanization of teaching of medical and biological
specialists (in Russian)
22.Ethical training in Belarus (Programmes of bioethics courses).
UNESCO web-site www.bioethics.ru (in Russian)
23.Mishatkina Т.V. Three circles of ethics. “Chelovek”, 2006, N 5, p.
89-98. (in Russian)
24.Mishatkina Т.V., Yaskevich Ya.S. Collaboration of ethics committees
with patients during biomedical research in Belarus. Proceedings of the
international conference of FEC CIS. Erevan, 2005. (in Russian)
25.Yaskevich Ya.S. Moral, ethical, legislative and organizational bases
of organ and tissue transplantation. Materials of round-table of the Belarus
National Assembly for discussion of the druft of Belarussian Law “On
147
transplantation of human organs and tissues”. Minsk, 2006, p. 27-31. (in
Russian)
26.Mishatkina Т.V. Biomedical ethics as a science and as teaching
discipline. Values of the world: ethics and bioethics. Scientific Forum. Kiev,
2005. (in Russian)
27.Mishatkina Т.V. Existencial meaning of suffering and compassion
in biomedical ethics. Proceedings of the Russian scientific conference with
international participation “Anthropological bases for bioethics”. Tomsk,
2006, p.125-127. (in Russian)
28.Yaskevich Ya.S. Anthropological, social and cultural bases for
bioethics. Ibid, p. 232-237. (in Russian)
29.Mosse I.B. Modification of radiation-induced bystander effect with
melanin. Abstracts of the 52th annual meeting of the Radiation research
society (Denver, Colorado, USA, – November 16-19, 2005). (in English).
3.4. Georgia
(G.Kiknadze, G.Dgaviashvily, T.Kurtanidze)
Like many other developing countries, Georgia experiences considerable
difficulties. One may suggest that it is not time to speak about research ethics
when you hear everyday, that fundamental rights of citizens, including right
to life, are violated (e.g. in terms of regional conflicts). However, it is never
too early or too late to speak about the rights and freedoms of individuals,
particularly in the field of health and biomedical research as far as various
biomedical researches are being carried out currently in those countries. So,
we have to do something to ensure the safety of people in this sphere.
Georgia has made considerable step forward in establishing legal
framework for human rights protection in the field of health care and
biomedicine, including specific legislation on protection of research subjects.
Georgia has signed and ratified all major documents of the Council of Europe
in this sphere and endorsed various international texts. Moreover, national
legislation has been brought in harmony with internationally accepted
standards of human rights protection. These steps have been followed by
educational activities to raise awareness of the society.
However, there is a lot of work to be done to effectively implement
aforementioned legislation, particularly in the field of biomedical research.
The most topical issue for Georgia now is the development of effective
system of ethical review of research projects. Although, certain type of
system is operating, it needs improvement in terms of accessibility and
quality.
Georgia is situated on the border of Europe and Asia. It occupies the
Central and Western parts of the Caucasus. The Western part of the country
is washed by the Black Sea. The Northern boundaries of Georgia run along
the Great Caucasian Range. Citizens of Georgian nationality comprise about
70% of the whole population. Other nationalities are Russians, Osetians,
Abkhazians, Azerbaijanis, Armenians, Greeks.
Georgia is a newly independent Republic (It restored its independence
in April 1991). At the same time it has a long history of Statehood.
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149
Georgian slave-owning kingdoms Kolkheti and Iberia emerged in the 6th4th centuries BC. The unification of Georgia in the form of the united
kingdom started in XI century. In 1801 Georgia lost its independence as a
result of the expansive policy of Russian Empire. In 1918 independence of
Georgia was re-announced (Republic of Georgia), which lasted only up to
1921, when intervention of Russia resulted in incorporation of Georgia in
the Soviet Union.
Georgia has little experience in building the civil society. However,
it has definitively moves towards the integration with the Western World
and harmonisation with the western law. The legislative basis apparently
is one of the most important points in the process of establishing common
anthropocentric values and viewpoint of the civil, open society.
The history of the Georgian state and law dates back to ancient times.
Due to the historical misfortunes Georgia never participated in the process
of great codifications. In this connection legislative activity of the King
Vakhtang VI (XVII-XVIII cc) deserves major attention. Chronologically
this period coincides with the epoch of creation of the basis for the modern
law and state in Western Europe. Drafting of King Vakhtang’s Law Book
can be considered to be an attempt to get closer to the cultural world, at
which Georgia aspired during its whole history. In some regions of Georgia
the code of Vakhtang’s Laws was in force up to the second half of the XIX
century.
An attempt to build a modern independent state in 1918-1921 was not
successful due to the expansion of Russia. As a result Georgia became the
part of the communistic space for the next 70 years. Thus, formation of
the civil society in Georgia started within the borders of another country
(Soviet Union), making Georgia unable to develop its own legislation
independently.
During aforementioned 70 years legislative activity in Georgia was
restricted to the slight alteration or, at best, adaptation of the frame laws,
provided by the central authorities (Moscow). As well as in other republics
of the Soviet Union there was no tradition of training the legal professionals
for the health care system in Georgia. Before re-establishment of Georgia’s
sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government,
was in force. This document showed significant negligence of individual
rights of patients. Almost none of the basic principles of ensuring patients’
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autonomy and self-determination (except the right to keep personal data
confidentially) were even declared.
The creation of national legislation is an essential condition for building
the national and democratic state and a civil society. Adoption of Georgian
Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997)
is definitely significant step toward establishment of national state.
Legislation of Georgia related to health, biomedicine and human
rights comprise laws which regulate various aspects of medicine/health
care: rights of patients and research subjects (including vulnerable groups;
such as minors, persons with mental disorders, patients with HIV/AIDS
etc.), duties and responsibilities of health care professionals, human organ
transplantation, assisted reproductive technologies etc.
From the above-mentioned laws the Law of Georgia on Health Care
(adopted by the Parliament of Georgia in 1997) is considered to be the
framework law, which determines the priorities and sets out fundamental
principles of the health care legislation of Georgia. It covers full range of
problems related to health, including issues related to protection of research
subjects.
In general, there are three major documents serving the legal basis for
biomedical research involving human subjects. These legal texts are:
• Convention on Human Rights and Biomedicine (Signed by Georgia
in May 2000; Ratified by the Parliament in September 2002; Entered into
force on 1 of March 2001);
• Law of Georgia on Health Care (Adopted by the Parliament of
Georgia in December, 1997);
• Law of Georgia on Drug and Pharmaceutical Activity (Adopted by
the Parliament of Georgia in 1995; Updated in 2001).
The draft of specific law on biomedical research –“Law on Biomedical
Research Involving Human Subjects” will be the fourth and the most
comprehensive document regulating research on human subject. Draft
“Law on Biomedical Research Involving Human Subjects” (originally
drafted in 1999) has been reviewed by the expert appointed by the Council
of Europe in 2000 and updated according to the comments provided.
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It was submitted to the Government in 2000 and to the parliament of
Georgia by the President in 2002. However, in 2005 it was taken back by
the Government for further consideration against the background of the
latest developments of the Council of Europe. In 2006 the draft law was
reviewed by the working group based on the comments of the experts,
including experts appointed by the Council of Europe. The draft law was
the subject of debates during the international conference “The Council
of Europe and Promotion of Research Ethics in East European States”
organized by the Council of Europe and the Government of Georgia in
Tbilisi in October 2006.
Since the Convention on Human Rights and Biomedicine entered
into force in Georgia it becomes the integral part of Georgian legislation,
taking precedence over other laws and coming after the Constitution in the
hierarchy of law. So, provisions of the Convention related to the research
on human subjects is applicable to all relevant research projects being
carried within jurisdiction of Georgia. However, more specific impact
on biomedical research and its ethical evaluation will have its Additional
Protocol on Biomedical Research, which has been signed by Georgia but is
not yet ratified.
The law of Georgia on Health Care includes separate chapter – Chapter
XIX “Biomedical Research”, in which basic principles regulating biomedical
research are set out. Particularly according to the above-mentioned law:
• aims, objectives, methods and possible outcomes of the research
should be specified in the research protocol; research should be carried out
only within the frames of the research protocol;
• research protocol should be reviewed by independent body and
ethics committee;
• risks and benefits of the research should be assessed; risk associated
with the research should not be disproportional to the expected benefits;
• research subject should be fully informed about the details of the
research (objectives, methods, potential benefits, risks, alternatives etc.);
• research should not be started without informed consent of the
research subject;
• research subject has the right to refuse to participate in the research
or withdraw from the research at any time despite already given written
informed consent.
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The law also outlines general principles for the protection of incapable
persons and minorities in the context of biomedical research.
The law on Drug and Pharmaceutical Activity sets out the rules for
organizing drug trials including trials in clinical phase when human beings
are involved in the research programme. It requires that ethics committee to
be created at the institution where the trial is to be carried out. Interestingly,
this law specifically mentions recommendations set out in WMA Declaration
of Helsinki to be the basis for conducting clinical trials on human beings.
As already mentioned the most specific law on the protection of the
research subjects will be the Law on Biomedical Research involving Human
Subjects, which is being submitted to the Government this year. The aim of
the draft law is protection of the rights, health and life of a research subject
of biomedical research and provision of safety and respect for dignity during
the research. The draft law concerns any type of research aiming at obtaining
information and broadening knowledge in the sphere of biomedicine, which
serves the interests of human health protection and implies:
• Physical intervention on human being;
• Research on biological materials which initially were taken and
stored with other purpose;
• Intervention which doesn’t imply physical intervention on human
being but can pose danger to mental health or psychological condition of
human being;
• Research on foetus and/or embryo in vivo (The Law does not apply
to research on embryos in vitro.
The draft Law on Biomedical Research involving Human Subjects is
based on the following core principles:
• Primacy of the human being;
• Autonomy of research subjects: information, informed consent,
confidentiality and privacy;
• Scientific quality;
• Minimizing risks and keeping adequate risk-benefit ratio;
• Safety;
• Protection of vulnerable groups;
• Multidisciplinary review of ethical acceptability of research protocol
and its approval by an ethics committee.
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Side by side with legislation certain impact on the ethical conduct of
health care providers as researchers has ethical regulations, which could be
considered as soft legal instruments. In April 2003 the Congress of Georgian
Physicians endorsed the Ethics Code of Physician of Georgia. The code was
developed by Georgian Health Law and Bioethics Society (GHLBS) and
the Health Legislation and Bioethics Department of the National Institute
of Health. The first version of the Code was discussed by the participants
of the Congress and was submitted to further considerations to the National
Council on Bioethics. The letter considered the document during its three
different sittings and finally published the final text of the Code, which was
adopted at the last session of the First Congress of Physicians of Georgia.
The Ethics Code of Physician of Georgia is the first national code of
ethics in the sphere of biomedicine. It includes specific provisions aiming at
protecting research subjects. Particularly it says the following:
“Patient’s interests are supreme in scientific research on human being.
The research goals and its possible outcomes never interfere with the main
mission of a physician – to serve for patient’s health and life.”
Although much has been done in building of the legal protection of
the research subjects, many problems are remained to be addressed. Just
to mention, no sanctions are yet introduced against violation of the rights
of research subjects and infringement of the principles reflected in existing
legislation on biomedical research. Also, existing ethics committees need
be improved and the new system of research ethics committees is to be
implemented. The draft regulation for the new system of research ethics
committees has been already prepared. Its legitimisation will become
possible after ratification of the Law on Biomedical Research Involving
Human Subjects.
3.4.3 Education in Bioethics
Education in the field of Bioethics in Georgia has developed chiefly
in two domains: on one hand, high medical education system at Tbilisi
State Medical University; on the other hand, in the shape implementation
of legislation related to human rights, health and biomedicine developed
by Health legislation and bioethics group at National Institute of Health
(former National Health Management Centre) and Georgian Health Law
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and Bioethics Society. Since its establishment GHLBS has been actively
involved in educational programmes in the field of Bioethics and has been
incessantly organizing various training courses aiming at rising awareness
of, on one hand, patients and general public, and on another, medical
society.
Currently, Tbilisi states medical university offers courses in Bioethics
at different levels: on undergraduate level – for medical students, and on
postgraduate level – for residents. Both courses are obligatory and constitute
integral part of study curriculum.
Individuals who successfully enter residency-training program after
graduation of high medical school are expected to take one-week obligatory
program in bioethics during their residency training. The course focuses
on raising awareness of residents about modern principles of bioethics/
medical ethics and of relevant legislation of Georgia and assisting them
in developing skills for coping with various ethical problems/dilemmas
which may arise during their professional medical activity. During the
course the audience is introduces with the issues related to various ethical
problems associated with development of new technologies in the field of
health care/biomedicine: the role of ethics and law in health care; individual
rights of patients, Georgian legislation on individual rights of patients;
informed consent; competency and decision making capacity; specific
groups of patients; genetics, ethics and law; ethics, law and biomedical
research involving human subjects, etc.
Healthcare professionals have an opportunity to take short CME
courses with credit hours. The course has been developed and submitted for
accreditation by GHLBS. It offers the audience the variety of topical issues
related to ethics inherent in doctor-patient relationship: basic principles
of modern medical ethics; the rights of patients with the principles of
modern medical ethics; active legislation of Georgia on patient’s rights;
ethical basis of informed consent, regulations about informed consent in
Georgian legislation; necessity of obtaining a written informed consent and
protection of dignity of a patient, protect confidentiality and privacy in the
process of teaching students and residents, role of Ethics committees, etc.
There is one more programme specifically developed for doctoral
students. This one day programme is focused on research ethics and covers
all aspects of ethical and legal regulation of biomedical research.
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3.4.4 The System of Ethical Review
Below is given unofficial data collected about the drug trials being
conducted in Georgia.
In 1998-2002 12 internationally sponsored drug trials have been
conducted in Georgia. About 15 medical centres participated in it and
it included about two thousand people. As to the local trials, their total
number is about 55, but number of participants is not so large.
On the other hand several hundred biomedical researches are being
conducted unnoticed. They are not related to drug experiments (which
usually attract more public interest), however many of these researches
include human subjects. Just to give idea about their number - in only
one academic institution 50 research plans are approved annually. Most
of experiments conducted or to be conducted in the framework of these
research plans, involve human subjects, but yet only scientific merit of
these studies are assessed without evaluating its ethical acceptability.
It is expected that the number of international multi-centre biomedical
research (mostly drug trials) will dramatically increase in this region and
many thousand of people will participate in it. Therefore, the issue becomes
very important and appropriate mechanisms should put on place to ensure
that biomedical research involving human subjects is conducted in ethical
manner and the rights and safety of research subjects are protected. The
most effective and widely tested approach is mandatory ethical review of
any research project that considers interventions on human beings. The first
mention of ethics committee in legislation was appears in 1997 (the Law
on Health Care). However, the first ethics committees were established
in 2000.
Ethics Committees in Georgia
Three types of ethics committees exist currently in Georgia: National
Council on Bioethics, research and clinical (medical) ethics committees.
The table below schematically outlines all these ethics committees and the
legal basis for their establishment and functioning.
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157
National Council on Bioethics
National Council on Bioethics17, which is advisory body to the Minister of
Labour, Health and Social Affairs, prepared several recommendations during
the last two years. However, it could not avoid discussion of certain specific
cases upon request of the minister or other officials within the Ministry. On of
the most interesting text of the Council is recommendation prepared for the
government on the possible position of Georgia on international banning of
cloning human beings. Based on this recommendation Government of Georgia
took its position that all types of human cloning should be prohibited.
Clinical Ethics Committees
Although there are considerable legal developments related to the
establishment and development of Clinical Ethics Committees (CECs) in
Georgia18, very few committees have been established. According to the
survey (in total 22 HC institutions completed the questionnaire) carried
out by the National Council on Bioethics and Georgian Health Law and
Bioethics Society, only 9 health care institutions run medical ethics
committees (CECs). Only 3 of the above 9 committees would have their
own bylaw/regulation developed on the bases of the Charter. The number of
members varies from 5 to 13. Most of the committees are established in 2003
soon after the National Council on Bioethics issued recommendation about
establishment and development of CECs based on the Charter (approved by
the order of the Minister of Labour, Health and Social Affairs).
At present intensity of the CECs work is quite law (each committee
would hold 1-4 meetings since their establishment) and the competence
(training, experience) of many members of the above committees is still
under the question. For some members of the above-mentioned committees
the cycle of workshops have been designed and carried out. However, it is
not definitely enough and more intense training programs should be made
available for the members of medical ethics committees.
At the moment it is not clear what the views of health care professionals
and administrations of health care institutions (basically hospitals) are about
17
Charter for National Council on Bioethics was approved with the Order of the Minister of
Labour, Health and Social Affairs (Order # 157/0, 5 of July 2000).
18
Law on Health Care, Law on Patient’s Rights, Charter for Clinical Ethics Committees
endorsed by the Order # 128/n of the Minister of Labour, Health and Social Affairs (2 of
October 2000).
158
the value of CECs. Several projects are on their way of implementation
aiming at intensifying clinical/medical ethics committee movement in
Georgia.
First Research Ethics Committees
The first research ethics committees in Georgia were introduced about
5-6 years ago. The idea of their establishment at the first stage was related to
the fact that well-known foreign medical journals do not publish the articles
representing results of biomedical research, without prior approval of the
research protocols by ethics committee. Therefore, only narrow circle of
citizens (few scientists interested in publishing results of their research in
foreign journals) was informed about the existence of the above-mentioned
committees in the “western world”.
The legal basis for the establishment of ethics committees, which would
be in charge of reviewing protocols of drug-trials, was the Law on Drug and
Pharmaceutical Activity enforced in 1996.
In 1995-97 the law regulating generally almost all fields of healthcare,
was drafted. This document – The Law of Georgia on Health Care - was
thought to be the framework law for ongoing healthcare reforming process
in Georgia. The Law was enacted in 1997. It lays down the legal basis for
the establishment of the research ethics committees, which shall carry out
ethical review of all research protocols (not only research protocols related
to drug testing). So, currently “a scientific research plan shall be considered
and reviewed …by the ethics committee” (article 107; the Law of Georgia
on Health Care).
At the first stage due to the lack of appropriately trained professionals it
was considered wise to establish ethics committees bearing the functions of
hospital ethics committees as well as research ethics committees. So the first
version of the draft regulation for the so-called Medical Ethics Committees
(prepared according to the Presidents Decree #15 on 12 of January 1998)
was prepared.
In 1999 two separate documents were drafted – the first one lays down
principles of establishment and operation of Medical (Hospital) Ethics
Committees (already adopted by the Order of the Minister of Labour, Health
and Social Affairs) and the second one will regulate the activity of Research
Ethics Committees. According to latter document the two-tiered network
of committees on the regional level will be created in Georgia. The central
159
research ethics committee shall coordinate the activity of regional research
ethics committees.
Unfortunately the statute for the Research Ethics Committees has not
been yet approved, because of the comments of the Ministry of Justice
stating that establishment of the separate committees for research ethics is
not required by existing legislation (law in force or the Presidents Order).
Therefore, it is suggested to amend the draft law on “Biomedical Research
Involving Human Subjects” (which is now before Parliament) by introducing
in it basic statements from the above-mentioned draft statute.
About 15 research ethics committees were established during the last
5-6 years, from which about 6 would function at the moment. They have
been created at the institutions that used to participate in the multi-centre
trans-national drug trials. Without having such committees they would not
have been able to participate in such trials. Only few of them would have
their own regulation/bylaw. The number of the members would vary from
5 to 11 (mostly their number is 5 as it is defined in the Law on Drug and
Pharmaceutical Activity).
Finally, the National Council on Bioethics would exceptionally review
some research protocols that reflect international multi-central biomedical
research, because still there is no central research ethics committee in
Georgia that would be in charge of carrying out ethical review of multicentral studies.
Below is given brief schematic summary of what have has done and
what is to be done in Georgia for the protection of research subjects in the
sphere of biomedicine.
Has been done:
• General legal framework outlining basic principles for conducting
biomedical research involving human subjects is created (law on health care;
adopted in 1997) and requirements for organizing drug trials are specified
(law on drug and pharmaceutical activity; adopted in 1995),
• Convention on Human Rights and Biomedicine is signed and ratified
(entered into force in Georgia on 1.03.01); also, its additional protocol on
Biomedical Research has been signed;
• First research (institutional) ethics committees for drug trials are
established;
160
• Specific law on biomedical research involving human subjects has
been drafted and submitted to the Government;
• Concept on the establishment of the two-tired network of research
ethics committees on the regional level has been drafted (central research
ethics committee and regional research ethics committees);
• National council on bioethics stresses the importance of strengthening
the system of ethical review of research protocols and advocates for the
speeding up of the process of adoption of the specific law on biomedical
research;
• Teaching programmes in bioethics, including research ethics
have been introduced on undergraduate as well as postgraduate level
(programmes for residents and doctoral students as well as continuing
medical education programmes for practicing physicians) of medial
education/training.
Is to be done:
• Stimulation and speeding up the process of ratification of the law on
biomedical research involving human subjects;
• Introduction of sanctions in administrative and criminal code of
Georgia for the infringement of the principles set out in the legislation
related to the protection of research subjects;
• Enforcement of the above mentioned concept on ethics committees
(order of the minister of health or inclusion of the main statements of the
concept in the draft law on biomedical research during the discussions at the
parliament);
• Education: undergraduate, postgraduate education; education of
potential members of research ethics committees;
• Establishment of central and regional ethics committees;
• Setting up quality assurance system for research ethics
committees.
Finally, step-by-step we have to strengthen mechanisms, which will
ensure that the rights and dignity of human research subjects are duly
protected. This will be one more brick in the wall in the process of building
democratic society, which doesn’t allows injustice to take place among
people.
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3.4.5 Perspectives and Forms of International Cooperation
Georgia is the member of all international cooperation in the field
of protection human rights in biology and medicine. Collaboration
develops through the representatives of Georgia in international bodies
and organisations, by following the international regulations, involving
in educational and training programmes on bioethics and research ethics
and by participation in scientific and practical conferences and workshops
organized on global and regional levels. Scientific publication and common
international projects help to share the experience and to build the harmonized
relations in the bioethics in the frame of international informational, legal
and research space.
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3.5. Republic of Kazakhstan
(А.B.Sadykova, B.Е.Sarymsakova)
3.5.1. Historical and Cultural Background
Kazakhstan is a country with very rich historical and cultural past time.
Being geographically located in the Centre of Eurasia Kazakhstan was on
the crossroad of ancient world civilizations, on the cross of transportation
arteries, social and economic, cultural and ideological relations between
East and West, South and North, between Europe and Asia, between the
largest states of Eurasian continent. At different phases of the history states
with original cultural history were organized and developed at the territory
of Kazakhstan; the modern Kazakhstan is the inheritor of this cultural
history. In the middle of XV century Kazakhs united in the unique khanate
but after the death of khan Tauke and invasions of Djungars the country
disintegrated and was divided into 3 “zhuzes” (sub-countries) each of which
was practically independent of others. The khan of Jounger Zhuz applied
to Russia for protection – so since that time the incorporation of Kazakh
territories started.
In 1866 all Kazakh territories were under the political power of Russia
but some part of Older Zhuz and Middle Zhuz was incorporated into the
Czinn Empire.
In 1917 «Alash-Ordy» declared its autonomy.
In 1920 Kirgyz Autonomic Republic was organized as a part of the
Russian Federation.
In 1925 the republic received the name of Kazakh Autonomic Republic
with the capital in Almaty and in 1936 it was transformed into Kazakhskaya
Soviet Socialist Republic.
In 1956 some part of republican territory was adjoined to Omskaya
province and Altaysky krai.
On 16th of December 1991 Kazakhstan became independent republic.
The official name of the country is the “Republic of Kazakhstan” (RK).
Astana is the capital of the country, Almaty – the biggest city of the country.
The territory of Kazakhstan is equal to 2,717,300 sq. km.
The population size of the country (data of 2006) is equal to 15.3 million
citizens. Around 53% of the population is urban citizens. There are over
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120 nationalities in Kazakhstan, among them Kazakhs – 58.9%, Russians
– 25.9%, Ukranians - 15,2%, and Uzbeks, Germans, Tatars, Uygurs and
representatives of other nationalities.
Medicine as a part of population culture is the result of practical and
scientific selection of methods for the treatment of different diseases. It is
well known that even ancient healers used infusions, decoctions, bloodlettings and other traditional methods of treatment (1).
Multiple archeological findings on the territory of Kazakhstan proves
the existence of drug therapy, surgery, neurosurgery. For example, the scull
with marks of trepanation was found in Karagandinskaya province and the
origin of this scull was dated by V-IV centuries B.C. Mortars for preparation
of medical drugs from the same epoch were found not far away from
Shymkent. Due to achievements of Arabic and Greek medicine, Kazakh
healers’ medicine in middle ages was characterized with deep knowledge
in the area of disease prognosis, prevention and timely treatment. There are
definite data that healers of that era used already laparathomy, abdomen
punctures, and surgery for hernias and cataract surgery.
The great scientist and healer Oteyboidak Tleukabyl uly (1397-1492)
underlined the importance of combination use of traditional treatment
with innovation methods and considered that such approach improved the
diagnostics of diseases and increased the efficacy of treatment.
In the middle of XVIII century when Kazakh territories began tom
unite with Russia the first professional health care workers appeared on
the territory of Kazakhstan and together with them the first health care
institutions were created – such as hospitals and military medical units of
the Siberian Cossack army.
In 1827 and in 1831 several epidemics of smallpox spread in Kazakhs
steps. To take urgent measures, khan Zhangir had sent Sarlybay Zhanibekov
for medical studies to Orenburg and in 1828 Sarlybay returned to Kazakhstan
as professional smallpox vaccinator and surgeon’s assistant. Since that time
mass immunization of local population against smallpox started.
In 1920 special anti-plague laboratories were organized to control social
diseases in the country. In 1922 the Scientific Medical Council was created
under the Commissariat of Public Health.
On 10 of October 1925 the first scientific institution was founded in
Kzyl-Orda – The Regional Institute of Sanitation and Bacteriology. In meant
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the organization of the national medical science of Kazakhstan. Konstantin
Ivanovich Skryabin gave very valuable help in the process of medical science
development; due to his initiative anti-helminthic unit was organized in the
city of Kzyl-Orda, special laboratory in the city of Dzhambul, parasitological
laboratory at the Institute of Zoology of the Academy of Sciences of the
Kazakhstan Soviet Socialist Republic. Special scientific journal “Public
Health of Kazakhstan” was founded in for dissemination of scientific
knowledge and best practice; this journal played the distinguished role in
the development of Kazakhstan’s science.
In 1930s several research institutions were organized actively;
these Centres began to develop scientifically based recommendations on
prevention, early diagnostics and treatment of diseases.
During the first years of the Great Patriotic War 112 military hospitals
were organized at the territory of Kazakhstan. During the war in spite of
very complicated situation medical scientists of Kazakhstan continued
their research activity and enriched the practice with very important
discoveries and patents that did not loose their actuality even after the war.
Academician N.F.Gamaleya – the founder of the Russian microbiology
– after experiments on himself developed the drug for the treatment of
tuberculosis. Professor A.P.Polosukhin developed an effective drug for
shock treatment; Dr. A. N. Syzganov proposed and scientifically based the
use of salicylic acid and acidophilic cream for the treatment of infected
wounds and frostbites; Dr. V.V.Zikeev used formalized bone transplants for
the treatment of pseudo-arthroses.
During the war research institutions of Kazakhstan did not interrupt
their activity; immediately after the war several medical research institutions
were organized under the Academy of Sciences of Kazakhstan Republic: the
Institute of Regional Pathology, the Institute of Clinical and Experimental
Surgery, the Institute of Physiology.
World-known academician Nikolai Dmitrievich Beklemishev – doctor
of medical sciences, professor, honored scientist of Kazakhstan Republic
and the winner of the State Prize – made a great input in the study and
control of brucellosis. His monograph “Chronic brucellosis” was included
as big section in the manual «Die brucellose des Menschen» that was edited
and published in Berlin by J.Parms and in recommendations published by
the World Health Organization.
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When Kazakhstan became independent country the public health
sector in the country changed dramatically. The president of the state
N.A.Nazarbaev declared the health of the population as the most important
value in the country and formulated the specific goals of the policy – the
improvement of the population health, support to the public health system
and advocacy for the healthy lifestyle.
Taking into consideration more strict demands and requirements for
the quality of medical aid to population several social programmes were
developed and approved in the country including the State Programme “The
Health of Population”, “The program for the Control of Illegal Drug Use and
Drugs Traffic”, the conception “On the development of Medical Sciences
in Kazakhstan Republic”, the complex programme “The healthy lifestyle”,
the State Programme “On reforms of Public Health System and its future
development in 2005-2010” and other programmes.
During the last several years new methods for treatment of patients
were developed successfully in the Republic as well as new directions in
medical sciences were created. Research studies were conducted on clinical
efficacy of transplantations of pancreatic B-cells and embryonic liver cells.
The National Genetic Register was organized. Public health authorities
spend great efforts to implement the best results and discoveries of medical
science into everyday practice of health care institutions. At the same time
medical professionals like the Association of Physicians and Pharmacists
of Kazakhstan (APPK) started very serious dialogue with the Government
and society on such complicated issues as protection of human rights of
participants of research studies and experiments. At all international
conferences members of this Association stressed that the research activity
should not harm the health and life of human beings. The importance of this
problem found very positive response in the Government of the country. As
a result in September 2005 the Commission on Bioethics was organized in
frames of the National Coordination Council for Health Protection under
Kazakhstan Government.
During the last decade several very important social laws were approved
in Kazakhstan. In 1991 special law “On Health Protection of Citizens of
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the Republic of Kazakhstan” was adopted, in 1994 – “On Prevention of
AIDS”, in 1997 – “On Psychiatric Aid and Guarantees of Patient Rights
during Treatment”, in 1998 – “On Radioactive Safety of Population”, in
1999 – “On Physical Culture and Sports”, in 2002 – “On Medical and Social
Rehabilitation of Persons with Drug Addiction” and “On Prevention and
Control of Tobacco Use” and “On Sanitary and Epidemiological Protection
of Population”. Several laws – such as “On Health Protection of Citizens”,
“On the System of Public Health”, “On Medical Drugs” that were adopted
in 2004-2005 – have the greatest importance in area of bioethics (2).
Ethical problems of biomedical research in Kazakhstan were discussed
actively since 2001 when according to initiative of the Association of
Physicians and Pharmacists of Kazakhstan (APPK) and with the support
from FECCIS and WHO the republican conference was organized and later
– international conferences (in 2002 and 2005) under the common title –
“High quality ethical practice for biomedical research in the Republic of
Kazakhstan”.
At present time there are definite trends for increase of attention to
bioethical issues in the Republic of Kazakhstan not only from the state
but from the general population too. These trends are reflected by the
improvement of legal regulations in Kazakhstan.
The article 29 of the “Constitution of the Republic of Kazakhstan” says
that all Kazakhstan citizens have the right for health protection. The article
29 of the Constitution says that administrative persons that keep the secret
on the facts and circumstances that are dangerous for population health and
life can be prosecuted according to the Law (3).
In July 2006 new version of the Law of Kazakhstan Republic “On
Health Protection of Citizens” was approved. Requirements to preclinical
studies and medical and biological experiments as well as to clinical trials or
implementation of new methods and means of disease prevention, diagnostics,
treatment and medical rehabilitation are described in the article 31 (4):
- Preclinical studies and medical and biological experiments should be
done in animals only.
- Clinical trials in human beings can be done only with written informed
consent or according to a special agreement between the person and health
care institution after getting positive results of preclinical studies and medical
and biological experiments in animals.
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- Clinical trials should be interrupted immediately according to the will
of a person participating in such trials as well as in the situation that can be
dangerous for the health or life of a patient.
- The use of new methods and means of disease prevention, diagnostics,
treatment and medical rehabilitation is possible only after positive results of
clinical trials were obtained.
According to the article 9 of the same law (“The competence of responsible
institution”) the Ministry of Health of Kazakhstan has the right to:
- determine the requirements for the use of new methods and means of
disease prevention, diagnostics, treatment and medical rehabilitation;
- determine the requirements for implementation of preclinical studies
and medical and biological experiments as well as to clinical trials;
- develop and approve the order and conditions of collection,
conservation and transplantation of tissues and (or) organs (fragments of
organs) from human to human, from the dead body to human and from
animals to humans.
According to the article 14 of this law every person has the right to
receive the information on possible methods of treatment and consequences
of clinical trials from public health institutions.
According to the article 15 any person has a right to apply to independent
experts for assessment of the quality of medical procedures that were offered
to this person.
The law “On Medical Drugs” approved on 13th of January 2004
contains articles 18, 19 and 20 that describe the order of development of
biologically active substances and their preclinical studies or clinical trials
of medical drugs. These articles were developed in the line with international
experience (5):
- the participation of the patient in clinical trials and (or) in testing
of pharmaceutical substance or medical drug should be voluntary and is
possible with his/her written informed consent only;
- before clinical trials and (or) testing all information on the substance/
drug, on the contents of trials or tests, on safety and risks for patients health,
on actions in the case of unforeseen effects of pharmaceutical substance or
medical drug for the patient’s health as well as on patient’s health and life
insurance should be provided to the patient;
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- the patient has a right to interrupt his/her participation in trials and
(or) tests of pharmaceutical substance or medical drug at any phase of such
trials or tests;
- it is strictly prohibited to perform clinical trials and (or) tests of
pharmaceutical substances or medical drugs with participation of: children
and adolescents; pregnant women; military persons; imprisoned or
incarcerated persons; non-competent persons.
At the web-site www.medik.kz the Association of Physicians and
Pharmacists of Kazakhstan has the page, where all legislative and regulatory
documents in public health area. At present time specialists began to develop
the Code of Republic of Kazakhstan “On Population Health and Public
Health System” that will take into consideration all international legislative
experience including legislative acts in area of biological and medical
studies. For example, on 22nd of January 2007 the Frame Convention on
Tobacco Control was officially ratified by the Republic of Kazakhstan; it is
planned to bring laws of Kazakhstan in line with international documents
that can ensure good clinical practice and improvement of activity of ethical
committees [6].
In 1995 according to initiative of the Association of Physicians and
Pharmacists of Kazakhstan drafts of “The Ethical Code of Physician of the
Republic of Kazakhstan” and “The Oath of Physician of the Republic of
Kazakhstan” were developed. In 2002 the Second Congress of Physicians
and Pharmacists approved the text of “The Oath of Physician of the Republic
of Kazakhstan” that was reflected in special Decree of the Government of
the Republic of Kazakhstan No/ 1189 published on 27th of November 2003
and in the article 50 of the Law of the Republic of Kazakhstan “On the
System of Public Health” [7, 8].
The Third Congress of Physicians and Pharmacists should be organized
in 2007; the participants will discuss “The Ethical Code of Physician of the
Republic of Kazakhstan”.
In 2006 according the law “On changes and additions to some legislative
documents on public health of the Republic of Kazakhstan” the article 20
was supplemented with the following paragraphs:
«it is prohibited to perform clinical trials and(or) testing of pharmaceutical
substances or medical drugs with participation of:
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- persons before coming to age with the exception of cases when the
medical drug under trial is specifically aimed to treatment of children diseases
or when the goal of clinical trial is to collect data on the optimal dosage of
this medical drug supposed for usage in children and adolescents. In the last
case clinical studies of any medical drug in adults should precede clinical
studies in persons before coming to age. When clinical trials of medical
drugs are performed in children or adolescents the written permission from
their parents is absolutely necessary;
- it is prohibited to perform clinical trials of medical drugs in children
and adolescents without parents;
- pregnant women with the exception of cases when the medical drug
under trial is specifically aimed to treat pregnant women and when necessary
information can be collected only during clinical trials in pregnant women
and when any risk of harmful consequences for pregnant woman or her
child is excluded;
- military personnel;
- persons in prisons or detention Centres;
- persons that are non-competent with the exception of cases when the
medical drug under trial is specifically aimed to treat psychiatric disorders
and persons that were considered non-competent according to official
legislative procedure of the Republic of Kazakhstan (9).
The article 43 of the Law of the Republic of Kazakhstan “On the
System of Public Health” published on 4th June 2003 contains the juridical
definition of scientific medical expertise; in this article it is indicated that
objects of scientific medical expertise are as follows:
- drafts of programmes of basic and applied scientific research;
- republican targeted scientific medical programmes;
- results of completed scientific medical programmes and projects;
- scientific research that were nominated for the state awards of the
Republic of Kazakhstan;
- results of scientific medical programmes that are supposed to be
implemented into public health practice.
The order of scientific medical expertise is determined by the national
authority in public health area.
The article 42 “Expertise of medical drug” of the same Law says that
the expertise of medical drug represents a study or a trial of medical drug
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for its safety, efficacy and quality and that physical, chemical and biological
tests as well as clinical trials should be used for this process; besides all
documentation for this medical drug should be assessed thoroughly; the order
of all these tests and trials is determined by the national authority in public
health area. Paragraphs 2 and 3 of the article 42 clarify that “assessment of
safety, efficacy and quality of medical drugs should be performed by expert
commissions via expertise of medical drug according to specification and
other documents in the order determined by the national authority in public
health area”. The expertise should be performed by institutions and persons
that did not participate in the process of development and production of this
specific medical drug.
In 2005 two official documents were approved by the orders of the
Ministry of Health №3493 and №3494 on 15th of March 2005: “On approval
of instructions on clinical trials and studies and (or) tests of pharmaceutical
substances and medical drugs in Kazakhstan” and №3489 on 14th of March
“On approval of instructions on monitoring of adverse reactions produced
by medical drugs”. These instructions were developed in accordance to
international standards GLP and GCP.
Mentioned legislative and regulatory documents formulated the unified
requirements to planning, implementation, documentation and control of
clinical trials in the Republic of Kazakhstan. They ensure the protection
of rights, safety and health of persons participating in trials as well as
reliability and good quality of data collected during such trials. The right
for supervision of clinical trials was delegated to the National Centre for
expertise of medical drugs, medical devices and medical equipment of the
Ministry of Public Health of Kazakhstan.
The important rule that was introduced in obligatory conditions for clinical
trials was the necessity to obtain the inform consent of each participant of
studies/experiments; this consent should be provided in the written form.
The rule on the control of biological and medical studies was implemented
for the first time in Kazakhstan. Special commission on ethics is responsible
for these functions. The commission consists of specialists in public health
and researches, representatives of non-governmental organizations who
should protect the rights, safety and welfare of all participants and researches
of trials or studies. The commission is responsible for ethical, moral and
juridical assessment of all materials of clinical trials.
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The order regulates the development of standard operational procedures
that should be prepared in the form of detailed written instructions.
The serious progress in the field of protection of human rights of persons
participating in clinical trials was the description by this Order of norms that
allow the ethical commission to formulate the conclusion on possibility of
clinical trials or on refusal. At the same time there is some controversy in
this document, namely the delegation of monopolistic/exclusive right for
conclusion on approval or disapproval of clinical trial to such institution as
National Centre.
For protection of rights of persons participating in studies or trials the
article 35 clarifies that the person “can be included in the trial only after
receiving of information”:
1) on medical drug and on the principles of its clinical trial;
2) on safety and efficacy of medical drug as well as on the potential
risks for the health of the participant;
3) on actions to be taken in case of unforeseen effects of medical drug
on the health of trials participant;
4) on terms of medical insurance of participant’s health”.
The Order contains several annexes, including the standard form of
informed consent; using this form the potential participant can refuse to
participate or to continue the clinical trials of pharmaceutical substance
or medical drug during any phase of the trial. This Order is comparatively
big document because it contains detailed descriptions of application form
and process, protocol of the study, the form of conclusion, the structure and
contents of researcher brochure and so on.
In this Order the special attention is given to the “Instructions on activity
of ethical commission and on performance of ethical assessment of clinical
trials”. This instructions clarifies the basic requirements to assessment of
ethical, moral and legislative aspects of materials of clinical trials that can
be done in patients. The principal goals and targets of the commission are
described as follows:
1) protection of rights and interests of participants involved in clinical
trials;
2) protection of rights and interests of researches;
3) assessment of importance and reliability of clinical trials goals;
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4) ensuring the ethical, moral and legislative assessment of materials of
clinical trials.
The main principles of commission activity include independence,
competence, pluralism, openness, high professional standards, internal
believes “for good only and never to harm people”, interests of participant
prevails over interests of any scientific research, positive effects are much
greater in comparison with potential risks.
It is anticipated that commissions to be organized under the responsible
institution will have responsibility of the Republican Ethical Commission.
Regional commissions will be organized under local authorities of the state
system of public health, and local commissions will be organized in separate
public health and medical institutions.
The main functions of the Republican Ethical Commission are as
described below:
1) assessment of the activity of regional and local commissions
responsible for ethical review of clinical trials as well as their membership
and development of standard operational procedures;
2) arbitration of complex aspects on ethical assessment performed by
regional and local commissions;
3) counseling and training of members of regional and local commissions
on different aspects of ethics;
4) development and implementation of measures for improvement of
the process of ethical assessment.
The main functions of regional commissions are as follows:
1) assessment and coordination of the activity of local commissions
responsible for ethical reviews of clinical trials;
2) arbitration of complex aspects on ethical assessment performed by
local commissions;
3) registration of clinical trials that are performed in the province or in
the city;
4) counseling of members of local commissions.
The main functions of local commissions responsible for ethical reviews
are as follows:
1) performance of ethical assessment of all documentation on clinical
trials;
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2) performance of ethical assessment of all changes and additions to
documentation on clinical trials;
3) conclusions on agreement or refusal for the beginning or continuation
of clinical trials;
4) assessment of following ethical, moral and juridical norms in the
process of clinical trials and after their end.
The commission should include sufficient number of members that
would have the necessary experience and qualification to be able to assess all
ethical, moral and juridical aspects of planned research; besides commission
members should be independent of researches and sponsors and should
not participate in the planned clinical research. The commission should
include at least 5 members, namely specialists that are competent in the
area of clinical trials as well as persons who are not researches themselves,
specialist in legislation, representatives of religious community and of nongovernmental organizations; the commission should include males and
females of different age groups.
During the last decades due to new approaches to moral and ethical
problems in medicine and science, development of bioethics as a
interdisciplinary field, it was necessary to revise the respective educational
programmes at all levels.
The science “Bioethics” as a separate science was not included in the
State standard of university medical education in the Republic of Kazakhstan,
but many aspects related to bioethics were included in other programmes
(specialties). For example, at the Semipalatinsk State Medical Academy
problems of biomedical ethics were included in the programme of discipline
“Communicative skills” at the department of internal diseases. At the
moment special training programme is under the process of development. At
the Kazakhstan State Medical Academy (in Astana) problems of biomedical
ethics were included in the training programme at the department of public
health. Similar situation took place in other medical universities of the
country. In December 2006 the Scientific Council of the Almaty Institute
for Postgraduate Training has decided to organize the Department of health
legislation and bioethics in 2007. It will allow to introduce widely into
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the practice main principles of human rights protection of persons who
participate in studies or experiments.
At present time different aspects of scientific research ethics are often
included in programmes of postgraduate training. For example, since
2001 the Higher School of Public Health (HSPH) began to realize training
programmes for researches of the public health system. Starting since 2002
the Higher School of Public Health became the participant of the international
programme “Intensive training on bioethics”. Together with Bangladesh
Council on Medical Research with financial and technical support from the
International Educational Reward in Bioethics and Carrier Development
of the Fogarty International Centre (FIC) and National Institutes of Health
(NIH), USA, several workshops were conducted in Almaty for physicians
of Kazakhstan.
The programme of these workshops had the following main goals:
1. The development of complete training plan/programme for the
workshop on bioethics;
2. Training of young researches of different scientific specialties in the
area of bioethics of scientific research.
Many important topics were discussed during these workshops
including: historical perspectives of ethics of scientific research in public
health area; international declarations and manuals on scientific research
with participation of human beings; informed consent; confidentiality;
motivation; ethics of clinical studies; ethics of population and demographic
studies; ethical aspects of scientific research in the area of health of children
and reproductive health; functions of ethical committees; manuals on ethical
review; organization of scientific research in developing countries; religion
and culture in ethics and other topics.
Around 20 specialists from different research institutions of the country
participated in the development of programmes for workshops that were
organized at the Higher School of Public Health. In future the Consultative
Committee will be responsible for the general management of the programme,
its monitoring and assessment. The programme was translated into English
and sent for revision to international consultants.
Recently programmes on bioethics were developed at the department
of pharmaceutical management of the Higher School of Public Health for
public health managers (18 training hours) and for public health masters (45
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training hours). At the same time it is necessary to mention that programmes
that were developed not fulfill completely the growing demands of education
in bioethics area.
The level of knowledge and education on legislation among general
public seeking health care improved recently; the network of ethical
committees in research institutions of the country enlarged significantly, the
role of Kazakhstan’s scientists in international research increased including
multi-centre clinical trials of medical drugs. That is why educational
programmes in the area of bioethics should be revised and improved for
medical students and graduate physicians, researches, nurses, members of
ethical committees and other specialists.
According to recent legislative acts to ensure ethical control of
biomedical research in the Republic of Kazakhstan the Ministry of Public
Health started intensive activity to organize ethical commissions at research
institutes and in the most significant clinical institutions. Simultaneously
according to initiative of the Association of Physicians and Pharmacists of
Kazakhstan at the Almaty Institute for Postgraduate Training The National
Public Committee on Bioethics was organized; this committee is responsible
for ethical control not only in the system of the Ministry of Health but also
in institutions of other ministries where studies and trials with participation
of human beings are conducted. Recently this initiative became more active
through the National Coordinating Council for Health Protection, the
Government of Kazakhstan, the Parliament of the Republic of Kazakhstan,
non-governmental organizations and international organizations.
To create favorable conditions for the development of similar structures
in other ministries and agencies the Commission on Bioethics determined
principal targets for the near time:
- coordination of the activity of ethical committees in the country;
- development of unified approaches to requirements and mechanisms
of ethical review process;
- counseling help to other ethical structures and implementation of
different models;
- help in training of experts;
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- realization of inter-agency and international cooperation.
The working group should be organized to ensure the regular and
planned activity of this commission. Great work should be done to develop
and implement working principles of independent ethics committees, their
collaboration with the state commissions on bioethics as well as with juridical
institutions. In spite of the great amount of the work that was already done, it
is necessary to do many things in national legislation for implementation of
bioethics principles in our country. The definite disadvantage of the modern
legislation is the absence of regulations on the process of clinical trials
when developing new methods of treatment, surgery procedures, study of
diagnostic equipment and manipulations, implementation of new methods
of medical rehabilitation.
It is necessary to determine the status of bioethics expert and accreditation
principles of bioethics commissions, to develop and approve mechanisms of
interaction with independent non-governmental commissions on bioethics
and with other ministerial and international organizations that participate
in the control on ethics of biomedical research, to introduce new bioethics
discipline in curriculums of medical universities etc.
The goal of this activity is the legislative confirmation of norms that
will ensure the human rights protection of researches and participants of any
biomedical studies. Solving of all these problems and questions will help to
realize principles of bioethics and to protect the right for life and health of
all citizens of the Republic of Kazakhstan.
Two international conferences were organized in Kazakhstan in frames
of collaboration with the Forum for Ethics Committees in the CIS: “Good
Ethical Practice in Biomedical Research” (Almaty, 2002) and “Physicians
of XXI Сentury and Bioethics (Almaty, 2005). The documents “Inspection
and assessment of ethical expertise” that were developed by WHO in 2002
with participation of FECCIS chair-person were introduced for the first time
at the FECCIS conference in Kazakhstan. The translation of this document
into Russian was performed by the FECCIS secretariat.
Unique possibilities were offered to Kazakhstan due to collaboration
between TDR/WHO and Western Committee on Research Bioethics
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(WIRB, Olympia, USA). As FECCIS representative the participant from
Kazakhstan took part in the 6 months training course on the programme
of research ethics in 2004–2005. In July 2006 еhe representative from
Kazakhstan participated in the inspection of ethics committees in
Taiwan. This mission that is very good example of collaboration was
organized and supported by FECCIS, and it is very perspective in terms of
organization and implementation of inspections of ethics committee in our
country. Members of National and local ethics committees participated
in workshops that were organized according to SIDCER programme
«Recognition» - module 1 «Human Subject Protection» and module
2 «Standard Operational Procedures»; these workshops took place in
Tashkent in November 2006. In June 2007 such workshop was organized
in the Republic of Kazakhstan with the support from FECCIS, WHO and
EFGCP. The international collaboration on different aspects of ethics and
bioethics is also realized with UNESCO, WMA and other international
organizations and agencies.
References
1. «Densaulyk. Public Health of Kazakhstan». Almaty: «ТаuKajnar»,
2001, 432 pp.
2. Legislative documents of the Republic of Kazakhstan «On Health
Protection of Citizens of the Republic of Kazakhstan» №111 of 19 May 1997;
«On Psychiatric Care and Guaranties for Human Rights Protection during
Psychiatric Care» N96 of 16 April 1997, the last revision date: 20.12.2004;
«On Sanitary-Epidemiological Protection of Population Health» N361 of 4
December 2002, the last revision date: 07.07.2006, No 13705 in the State List
(Inventory); «On Medical and Social Rehabilitation of Patients with Drug
Addiction» N325 of 27 May 2002, the last revision date: 20.12.2004, No
12306 in the State List (Inventory); «On Prevention and Control of Tobacco
Use» от 10 июля 2002 года N340 N340 of 10 July 2002, the last revision
date: 11.12.2006, No 12697 in the State List (Inventory); «On the System of
Public Health» N430 of 4 June 2003, the last revision date: 29.12.2006, №
15742 in the State List (Inventory); «On Physical Culture and Sports» N490
of 2 December 1999, the last revision date: 05.07.2006, No 4761 in the State
List (Inventory).
178
3. «The Constitution of the Republic of Kazakhstan», adopted during
the republican referendum on 30 August 1995, the last revision date:
07.10.1998, No 1 in the State List (Inventory).
4. «On Health Protection of Population». The Law of the Republic of
Kazakhstan N170 of 7 July 2006, the last revision date: 07.07.2006, No
28793 in the State List (Inventory).
5. «On Medical Drugs». The Law of the Republic of Kazakhstan N522
of 13 January 2004, the last revision date: 29.12.2006 No 18187 in the State
List (Inventory).
6. «On Prevention and Control of Tobacco Use». The Law of the Republic
of Kazakhstan N340 of 10 July 2002, the last revision date: 11.12.2006, No
7. Law PK «The Oath of Physician of the Republic of Kazakhstan».
The Resolution of the Government of the Republic of Kazakhstan №1189
of 27.11.2003.
8. «On the System of Public Health». The Law of the Republic of
Kazakhstan N430 of 4 June 2003, the last revision date: 29.12.2006, №
9. «On Changes and Additions to Several Laws of the Republic of
Kazakhstan on Public Health». The Law of the Republic of Kazakhstan
N171 of 7 July 2006, the last revision date: 07.07.2006, № 28850 in the
State List (Inventory).
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3.6. Kyrgyz Republic
(A.Z.Zurdinov, U.M.Tilekeeva, B.A.Alisherov)
Kyrgyz Republic is a country in the middle part of Central Asia;
most of it is located in the Tenir-Too mountainous region. The territory of
Kyrgyzstan is equal to 198.5 thousands sq. km; nearly 90% of the territory
is 1500 m above the sea level. According to 1999 census, the population
is 4.8 million people including 3.1 million of ethnic Kyrgyz. About one
third of Kyrgyzstan population (35%) lives in urban areas and 65% are rural
population (1999).
Kyrgyzstan is a multinational unitary state. The country is divided into
seven administrative regions: Batken, Zhalal-Abad, Naryn, Osh, Talass,
Chuisk, Issyk-Kul. The capital of Kyrgyz Republic is Bishkek, the form of
government – republic.
The land of Kyrgyzstan, like all Central Asia, is one of the most ancient
places of human civilization. Archeological studies show that primitive men
settled there in the time of the Stone Age. Kyrgyz ethnos that was known in
Central Asia since the first millennium BC retained its self-name to our time.
First politically organized communities in the territory of the presentday Kyrgyzstan appeared in the II century BC when southern agricultural
regions joined the State of Parkan. During the IV and III centuries BC
early Kyrgyz formed part of powerful unions of nomadic tribes that were
a serious problem for China. It was the time when the Great Wall of China
began to be built. During the II and I centuries BC a part of Kyrgyz tribes
got away from the power of Hunnu State and moved to Enisei (the Kyrzys
meaning of “Ene-sai” is the Mother-River) and Baikal (Rich Lake) regions.
There they founded their first state Kyrgyz Kaganat that became the centre
of the Kyrgyz consolidation and the centre of their culture where their
written language developed. Runic inscriptions still can be seen on stone
monuments. Invaders destroyed the state but they could not destroy people’s
memory, although the written language was lost.
During the V century the transition from nomadic to settled lifestyle
began in the North of Kyrgyzstan. First written sources mentioning Kyrgyz
tribes inhabiting Tian Shan date back to the X century.
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Petroglyphs of Saimaly Tash, one of the oldest and biggest collections
of rock pictures, demonstrate a high level of Kyrgyz civilization. The Burana
Tower and Uzgen architecture complex are examples of an amazing mastery
of architects and builders.
From the middle of the IX century to the beginning of the X century AD
the Great Kyrgyz Khanate extended to the South Siberia, Mongolia, Baikal,
the Upper Irtysh, Issyk Kul and Talas. This period was not only the time of
conquests but also time of an active trade with China, Tibet and peoples of
South Siberia and Central Asia. It was the period when after defeating the
Uighur Kaganat the Kyrgyz for the first time entered the Tian Shan territory.
In the X century, however, the Kyrgyz domination had shrunk to South
Siberia, Altai and South-West of Mongolia and in the XI and XIIcenturies to
Altai and Sayan Mountains. Nevertheless, parts of Kyrgyz tribes scattered
over a large territory participated actively in numerous historical events
in Central Asia. They managed to keep their ethnic independence and
became the centre of attraction for other ethnic groups. The final stage of
ethnogenesis related Kyrgyz people to Oirot (Kalmats), Naiman and other
peoples of Central Asia.
Starting from the XIII century Kyrgyz people had to fight wars of
independence from different invaders. In the second half of the XV century
Kyrgyz tribes joined in an independent khanate that embraced a major part
of Kyrgyz people. The Great Silk Road was very important for Kyrgyzstan.
The town of Osh – the main city in the south of the present-day Kyrgyzstan
– due to its favorable geographic location was a transit town in the Fergana
line of the Great Silk Road.
In 1863 the North Kyrgyzstan and in 1876 the South Kyrgyzstan were
incorporated into the Russian Empire. After the Great October Revolution
Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet
Republic
In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet
Socialist Republic. In 1924 the Kara-Kyrgyz Autonomous Region within the
Russian SFSR was established. In 1926 it was transformed into the Kyrgyz
Autonomous Republic, and in 1936 – into the Kyrgyz Republic. On 31 of
August 1999, Kyrgyzstan declared its independence.
We know that myths and legends form the base of every culture.
Nomadic life-style and the loss of written language of early Kyrgyz people
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stimulated the rise of a special philosophy that revealed itself in poetic
folklore. It has accumulated the basic problems of human existence, mental
and philosophic activity and spirituality.
To reconstruct spiritual life of the Kyrgyz ancestors, we should mention
an epic poem “Manas” that depicted historical events and ethnographic
details, different aspects of the Kyrgyz life, worldview and national outlook
from the III century BC (the Hunnu period) and to the beginning of the XX
century. As a concentrated representation of folk philosophy, “Manas” is
both the result of creative thinking across generations and the evidence of
ancient Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads
and still a source of morals and humanism, as it describes customs and
moral traditions, philosophical and aesthetic views, moral principles and
norms of behaviour. With regard to its moral significance, “Manas” may
be compared to Confucian Pentateuch. Like Confucian ethics, “Manas”
depicts a model of putting the world into good order. Much attention is
given to the struggle against chaos, which is expressed through regulation
of human relationships, i.e. by establishing norms of behaviour, the system
of prohibitions and social stratification.
“Manas” is called a “cultural encyclopedia” of Kyrgyz people. It
ranks among outstanding monuments of world culture, such as “Iliad” and
“Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda”
and many others. The Turkic epic poem “Manas” differs from west European,
Slavonic and other epic poems not just in its volume. It covers a long
historical period and gives a detailed genealogy and a distinct biographical
line of athlete Manas – the central hero of the epic poem – from the moment
of his birth to his death including the description of main events of his life.
Poems, songs and legends passed across the generations served as a
teaching material in folk pedagogics. The unique nature of oral folklore
allows people to pass their moral knowledge to future generations within
a family and within a clan thus ensuring continuity of spiritual life and
connection between epochs. Another equally efficient method of education
was joining to folk customs and traditions. Epic poems embraced all sides
of people’s life. Over many ages, people’s ideals have been associated
with “Manas”; ethical norms and concepts of the good and the evil were
exemplified by the acts and deeds of “Manas” characters.
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Ethical views of the early Kyrgyz make up a system of values, norms
and rules based on aspiration for happiness. Therefore, ethics of the ancient
Kyrgyz may be defined as the ethics of positive eudemonism19, and their
overall worldview as world- and life-asserting.
Although the epic poem does not contain distinctly formulated precepts,
moral lessons learned from centuries-long history formed a traditional
system of moral values that has survived to our days:
1. unity and solidarity of the nation,
2. international accord,
3. national honour,
4. movement towards prosperity and well-being through a continuous
labour and knowledge,
5. humanism, generosity, tolerance,
6. harmony with nature,
7. strengthening and protection of Kyrgyzstan state system.
Ethical norms in “Manas” are based on four cardinal virtues (wisdom,
patience, conscience and generosity) that are personified in images. They
are opposed by four vices: laziness, wickedness, greed and arrogance. It is
said that a clever person is always able by using one’s mind which is “the
best of all treasures” to oppose positive qualities to negative ones and defeat
the evil by kindness, wickedness by patience, greed by generosity. Hence,
the person has to make every effort to improve his or her moral nature, to
overcome evil elements and to change the surrounding world.
Among human qualities most valued in Kyrgyz culture are health and
longevity, diligence and valour, sense of duty and honour, modesty, selfcontrol and wisdom. These virtues ensure a harmonious life of the individual
[5]. Openness, love for children, hospitality, generosity, humanism, patience,
firmness, goodwill, respect for old age and other qualities inherent in Kyrgyz
people form the basis of moral and ethical principles of their life [1].
Historical conditions dictated to Kyrgyz people the necessity to stand up
for their freedom and integrity in the fight with stronger neighboring states.
Severe war conditions required from men who were admitted to military
The word eudemonism comes from the Greek word for happiness or flourishing
(eudaimonia), and refers to any conception of ethics that puts human happiness and the
complete life of the individual at the Centre of ethical concern.
19
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service not only physical strength, but also moral maturity. Wars depicted
in “Manas” and episodes associated with those exemplify heroic traditions
implying the observance of the rule of military necessity and an innate
aversion to violence, as well as a wish to live in peace. Kyrgyz warriors
regarded their sacred duty not to harm peaceful population of conquered
peoples. It was forbidden to plunder or humiliate them. Thus an epic sage
Bakai addresses his warriors:
“Do not thou slaughter their cattle more that thou need for food,
A foe today may be kinsman tomorrow,
Do not thou harm them”.
The early Kyrgyzstan was located on the crossroad of the Great Silk
Road routs, which made it “a bastion of religious syncretism” where
representatives of different confessions could coexist. This is, perhaps,
the reason for a remarkable tolerance in the Kyrgyz in relation to other
confessions and cultures of people inhabiting Kyrgyzstan.
“The Beneficial Knowledge” by Jusup Balasagyn (XI c.) is another
treasure of the Kyrgyz. The treatise was so perfect that in China it was titled
“The Code of Decent Men”, in Iran – “The Book of Shahs” and in Turania
– “The Book of Precepts for Rulers”. For Turkic peoples “The Beneficial
Knowledge” “was as much important as “Lay of Igor’s Warfare” for Slavic
peoples” (Naum Grebnev).
“The Beneficial Knowledge” covers problems of sociology, ethics,
aesthetics, theology and social psychology. It presents a sum of knowledge
in different fields of science and culture of that time. The treatise presents a
comprehensive system setting forth and analyzing philosophical problems
relating to sense and meaning of human life. It defines human duties and
norms of behaviour in the community and reflects “moral and ethical ideals
with regard to life-style, culture and ideology of settled Turkic peoples still
retaining the memories about their nomadic civilization” [13].
According to “The Beneficial Knowledge” just and fair laws are the
cardinal mechanism ensuring stability in the society, and everyone, be it a
ruler or a subject should follow the laws.
Law rules the world – we shan’t forget this,
It is a sign of humanity inherent in people.
In its character, “The Beneficial Knowledge” is an ethical and didactic
poem written with the purpose to show the way towards learning the wisdom
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of government, every-day life and relationships between people on different
occasions. Jusup Balasagyn describes qualities necessary for viziers,
military commanders, secretaries, ambassadors, penmen and copyists,
treasurers, cooks, cup-bearers, scientists, physicians, dream interpreters,
magi, astrologers, merchants, cattle-breeders, craftsmen and others. He also
writes how people should behave, reflects on human responsibilities and
duties, virtues and vices. For Balasagyn sees “dissolution of morals and
depreciation of spiritual values as one of the worst vices of his time” [8].
A peculiar feature of “The Beneficial Knowledge” is that the author
allows the reader to himself to gain an understanding of sense of life, of
virtues and vices. Jusup Balasagyn argues that everyone should know and
observe moral norms and rules of behaviour. “The Beneficial Knowledge”
is a peculiar moral code of its time. Over a long time Kyrgyz ethnos had
been existing in form of clans. Relationships within the community had
been forming during a long historical period. Changes, if any, occurred due
to the influence of external environment forming the worldview: the sense
of sharing needs and interests of other people, feelings of mutual aid and
collectivism. Kyrgyz people survived in crisis situations only due to spiritual
and genetic health of their ancestors. People retained and developed clan
traditions, upbringing practices, code of ancestral honour. Clan honour for
Kyrgyz people is one of the most essential concepts. Every Kyrgyz had
his ancestors, his land and his clan. Each clan had its hierarchy at the head
of which was the most respected clan member. Collectivism, mutual aid,
empathy, respect for other people – those were the qualities inherent in
Kyrgyz mentality.
Cultural and historical sources reveal respect to women in nomadic
tribes, however there were conflicting traditions with regard to this issue. It
is noteworthy that women had a high social status in Kyrgyz society [6].
Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz
people reflected in philosophical and poetic art of akyns20 is characterized
by the search for perfection. Problems of upbringing and education, of
humanism and love for people have a significant place in philosophical
poetry of Kyrgyz thinkers, and therefore there is every reason to consider
Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played
and important role in terms of expressing people’s thoughts and feelings, exposing social
vices, and glorifying heroes.
20
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it as a code of moral and ethical norms on human behaviour in Kyrgyz
culture. Some scientists associate this special attention to moral issues with
an access to Chinese sources known for their interest in ethics. The history
of development of ethical and philosophical ideas in Kyrgyz culture may
be divided into three stages. The first stage is associated with names of late
medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and SanchSynchi (XIII c) [3]. Kyrgyz people justly call them legendary thinkers,
folk sages (akylmanam). We know about these Kyrgyz thinkers from folk
legends. Only fragments of their sayings survived to our time.
The epoch of late Middle Ages with its patriarchal and feudal system
sets a number of moral tasks. Undoubtedly, moral in a class society was at
all times an instrument for ruling people, however, in akyns’ philosophical
poetry one may find an unbiased opinion on moral and ethical issues. They
reflected on the eternal question about struggle with the evil and dreamt
about “universal well-being”. Due to reconstruction of Asan Kaigy’s ethical
ideas, we may see that empathy, compassion, sympathy for others are the
main principles of his moral.
Considering the time when the sage lived and worked, it would be
appropriate to note that the call for compassion and love for all living beings
related mostly to the oppressed people, disunited by internecine feud,
and the compassion might be interpreted as a protest against the existing
system of inequality. Therefore Asan Kaigy saw his task in cultivating love
and compassion not only for human beings but also for everything alive.
Actually, Asan Kaigy proclaimed a categorical imperative “treat others as
you would like to be treated, if you were them” and gave everyone the right
to be understood. Only if a person follows this rule, he will rid his soul of
evil and find harmony. Asan Kaigy was telling people that they should love
and respect others and thus to contribute to their happiness [4].
Tolubai Synchi also focused his attention on analyzing relationships
between people and cultivating magnanimity that, in his view, was a
combination of such virtues as nobleness, generosity, justice in compassion,
love and respect for people. For him greed is the worst vice: “A generous
man is a good man; a greedy man is a good-for-nothing man” [12]. Like
Asan Kaigy, Tolubai-Synchi was also searching after ways to happiness. His
maxims based on opposing the good and the evil, kind and wicked acts have
the form of edifications. Like Asan Kaigy he tried to avoid blaming actively
the existing state system.
Another humanist-philosopher was Sanchi-Synchi. Unlike Asan-Kaigy
and Tolubai-Synchi, he mostly valued the active elements of human nature:
strong will, strength of mind, persistency in the struggle against the evil.
Sanchi-Synchi called people for an active struggle for the sake of Justice.
In his songs he developed the idea of righteous retribution and blamed the
oppressors.
The heritage of legendary thinkers allows us to return to forgotten
spiritual values of Kyrgyz people based on love, compassion, empathy,
clear conscience, peaceable disposition and feeling that they are a part of
the universe. They felt aversion to violence and rudeness. Throughout the
course of ethics development, starting from legendary thinkers to akynsdemocrats, the care for widows and orphans was the responsibility of all
clan members.
The next stage of development of ethics philosophy is represented by
akyn-zamanists21 Kalygul Bai Uulu (1785-1855), Arstanbek Bailashuulu
(1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the
time of global changes resulting from the decay of patriarchal feudalism
and the rise of capitalistic relations. Besides in 1876 the territory inhabited
by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
those processes were reflected in akyns’ poetry. In their poems “Time of
Downfall”, “Time of Poverty” and “Time of Sorrow” akyn-zamanists called
their epoch the time of degradation and decay. Moldo Kylych, being a son
of a learned man, received a good education. He was acquainted with works
by eastern classics Firdousi, Navoi, Jami, Yasavi and others. He wrote about
his time: “Morals and manners show the loss of people’s well-being”. In
his poem “Time of Sorrow” he noted that moral bankruptcy, degradation
of moral principles, moral apathy were frightening features of the time. In
their attitudes zamanists were close to French philosophers of the Age of
Enlightenment (J.-J. Russo, Voltaire et al.).
At the same time akyn-zamanists’ poetry contained some optimism and
faith in moral potential of Kyrgyz people that would help them to overcome
all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
21
186
Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
187
leader expressing expectations of Kyrgyz people through his poetry inspires
their hopes.
Problems of justice are very essential for Kalygul. Being a judge, he
proclaims a kind of ethical code comprising universal values and norms of
human behaviour: honesty, unselfishness, justice, mutual respect.
Criticizing the state system of their time as a form of social inequality
akyns offered a moral characteristic of behaviour in different social strata.
Akyn-democrats tended to give a realistic picture of the world. Thus
Toktogul Saltyganov presents his ethical views through opposing the good
to the evil. Jenijok taught that every man should strive for self-perfection
from his young days [7].
Akyn-zamanists were spiritual elite of Kyrgyz society and true patriots.
Their laments were neither the echo of feudalism nor an attempt to stop the
development of the society. Those were the thoughts about the traditional
culture that in their time was at a deadlock and could not find way out of it;
thoughts about the future of Kyrgyz people. They understood well a close
connection between the destiny of their people and the integrity of ethnocultural space. Today we may rightly say that zamanism is a special king of
creative work of poetry initially establishing in set verbal formulae a system
of moral and ethical priorities of nomadic peoples. Zamanists lived in the
epoch of disintegration of traditional Kyrgyz community, and therefore
efforts were required to form an integrated Kyrgyz nation. They realized the
hardship of that mission and used for that purpose moral norms and rules of
behaviour that did not lose their significance to our days.
The next stage in ethics development is associated with names of akyndemocrats Toktogul Satylganov (1864-1993), Togolok Moldo (1860-1942),
Jenijok (1860-1918), Varna Alykulov (1884-1949). In contrast to their
predecessors, they actively expressed ethical views of oppressed sections of
Kyrgyz population.
References
1. Abramzon S.M. Kyrgyz People and their Ethno-Genetic, Historical
and Cultural Contacts. Leningrad, 1971, p. 152 (in Russian)
2. Akmoldoeva Sh. B. Spiritual World of the Early Kyrgyz (Analyzing
Epos). “Manas” and Concepts of Geneva Conventions. Bishkek, 1999, p.
211 (in Russian)
188
3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze,
1863 (in Russian).
4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in
Kyrgyz)
5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972
(in Russian)
6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in
Russian)
7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p.
339 (in Russian)
9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999
(in Kyrgyz)
10.Moldo Kylych. Time of Sorrow. Manuscript No 56, Library of the
Kyrgyz Academy of Sciences (in Kyrgyz)
11.Moldo Kylych Shamyrkan Uulu. Time of Sorrow. In: Anthology of
Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
12.Tolubai-Synchi. Ibid.
13.http://www.peoples.ru/art/literatur...age/balasaguny.
In Kyrgyz Republic biomedical research and protection of human rights
in this sphere is regulated by a number of national legal acts, and first of all
by Constitution.
According to the principal Law, residents of the Kyrgyz republic have
the right to health protection, free health care provision by a network of
state healthcare institutions. The Constitution guarantees rights to healthy
environment and to indemnification for harm caused to health or property
due to actions in the sphere of nature management.
Article 18 of the Constitution states that no medical, biological, and
psychological experiments on human subjects shall be permitted unless there
is a voluntary consent of the potential research subject, properly expressed
and duly authenticated.
The legal basis for the protection of human subjects in biomedical
research are the Constitution provisions ensuring every individual’s right
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to life, physical and moral inviolability; the right to freedom and safety, the
right to a free development of one’s personality; right to dignity and freedom
of private life, confidentiality of personal and family information et al.
The Law “On Health Protection of Citizens of Kyrgyz Republic”
(adopted in November 2004) sets essential rules relating to medical
research. Article 27 of the said Law states patients’ right to participate in
scientific and medical research on the condition of their written consent and
in accordance with the procedure established by authorized healthcare state
institutions of Kyrgyz Republic. This Article also stipulates that patients
have the right to refuse the participation of medical students in the process
of their diagnostics and treatment.
According to Article 74 of the Law, no medical intervention, including
medical research, may be carried out unless a voluntary person’s consent
is obtained. According to law, where a minor or an adult does not have the
capacity to consent to an intervention the intervention may only be carried
out with the authorization of his or her legal representative.
The mentioned Law states rights of different categories of vulnerable
individuals – pregnant women, mothers of minors, elderly persons, disabled
persons, persons who had suffered from an emergency situation and residents
of ecologically unfavorable regions (Art. 67, 68, 69, 70, 71).
The Law on Pharmaceutical Products (March 2003) regulates clinical
trials of pharmaceutical products.
According to this Law, no clinical trials of pharmaceutical products
in Kyrgyz Republic may be carried out without the permission granted by
the authorized healthcare state institution of Kyrgyz Republic. Those guilty
of violating rules of clinical trials, falsifying clinical results obtained in
clinical trials of pharmaceutical products or conducting the trials without the
permission granted by an authorized healthcare state institutions of Kyrgyz
Republic bear the responsibility according to the relevant legislation.
Article 27 of the Law on Pharmaceutical Products if particularly
important as it sets a list of documents necessary for an authorized healthcare
state institutions of Kyrgyz Republic to make a decision about a clinical trial
of a pharmaceutical product. The list includes an approval by the ethics
committee of an authorized healthcare state institution of Kyrgyz Republic.
Article 27 states that the ethics committee of an authorized healthcare state
190
institution of Kyrgyz Republic participates in the design of a clinical trial
programme.
According to this Article, clinical trial results are referred only to the
authorized healthcare state institution of Kyrgyz Republic. It is forbidden
to provide any information about the process and results of a clinical trial
of a pharmaceutical to a research sponsor without the permission from an
authorized healthcare state institution of Kyrgyz Republic.
Article 28 of the Law states the procedure of establishing ethics
board: “Ethics Boards are composed of medical professionals, lawyers and
persons representing public organizations. The Statute of the Ethics Board
and membership requirements are adopted by an authorized healthcare
state institution of Kyrgyz Republic in compliance with the principles of
Declaration of Helsinki”. According to the Law, ethics board at an authorized
healthcare state institutions of Kyrgyz Republic and at healthcare institutions
carry out an expert evaluation with regard to ethical criteria, consider moral
and ethical problems arising in the course of clinical trials of pharmaceutical
products and ensure the protection of patient’s rights.
This Law contains important provisions concerning human rights
in clinical trials of pharmaceutical products. In particular, it says that a
patient gives his or her written consent to participate in a clinical trial of a
pharmaceutical product and has the right to withdraw his or her consent at
any stage of the research. Before obtaining the informed consent, patients
should be informed about
- the pharmaceutical product used in the clinical trial and the essence of
clinical trials of pharmaceutical products;
- the expected efficiency of the pharmaceutical product and the degree
of risk to the patient;
- patient’s actions in case of unforeseeable effects of the pharmaceutical
product on the patient’s health;
- terms of the patient’s health insurance.
The Law on Pharmaceutical Products states that no clinical trials of
pharmaceutical products may be carried out in such vulnerable patients as
children without parents; military personnel; prisoners and persons under
investigation in detention Centres; pregnant women (except for cases when
clinical trials are designed specially for pregnant women and when the
191
necessary information can only be obtained in a clinical trial provided that
the trail is not hazardous to a woman or to a fetus).
Besides, the Law sets certain restrictions relating to clinical trials
involving children. Thus the trials are only permitted if the investigational
pharmaceutical product is specially indicated for use in children or to obtain
knowledge relevant to the health needs of children (e.g. to determine the
best dosages for treating diseases of childhood).
The Law on Pharmaceutical Products permits clinical trials of
pharmaceutical products designed for the therapy of mental disorders and
involving subjects who by reason of mental disorders are not capable of
giving adequately informed consent. Clinical trials involving subjects with
mental disorders should be carried out in compliance with the Law of Kyrgyz
Republic “On Providing Psychiatric Care and Safeguarding Human Rights”.
Clinical trials of pharmaceutical products involving subjects with mental
disorders may only be carried out after obtaining a written informed consent
from a legally authorized representative in accordance with applicable law.
Protection of patients’ rights in biomedical research and other
interventions in Kyrgyz Republic are also regulated by the following laws:
- “On Narcotic and Psychoactive Drugs and Precursors” (No 66,
22 May 1998);
- “On Donorship of Blood and Blood Components in Kyrgyz
Republic” (No 951-XII, 3 July 1992);
- “On Tuberculosis Prevention in Kyrgyz Republic” (No 56, 18
May 1998);
- “On Prevention of Diseases Caused by Iodine Deficit” (No 40,
8 February 2000);
- “On Citizens’ Medical Insurance in Kyrgyz Republic” (No 208,
28 December 2006);
- “On HIV/AIDS Prevention in Kyrgyz Republic” (No 149, 13
August 2005);
- “On Citizens’ Reproductive Rights” (No 5, 13 January 2000).
Statements of civil, administrative and criminal codes set the
responsibility in case of violating patients’ rights in medical interventions
and in case of violating the legally established order of practice in healthcare
and biomedicine.
192
Today Kyrgyz Republic has several institutions for a higher medical
education: the Kyrgyz State Medical Academy, Medical Faculty of the
Kyrgyz-Russian (Slavic) University, Medical Faculty at the International
University of Kyrgyzstan and Medical Faculty at the Osh State University.
The State Standard of Education in Kyrgyz Republic does not include
bioethics as a separate subject. Nevertheless, bioethics has been introduced
into the syllabus of the Kyrgyz State Medical Academy and is taught to
undergraduate students. The course in bioethics consists of lectures (36
h) and practical seminars (18 h). One of the course topics is “Ethical and
Legal Control of Biomedical Research”. Bioethics is also taught at Chairs
of Clinical Medicine and Pediatrics of the Medical Faculty at the KyrgyzRussian (Slavic) University (lectures – 19 h and seminars – 19 h). Bioethics
is not taught at the postgraduate level.
Presently, there is no state system of teaching GCP to members of ethics
committees. However courses on basic and clinical pharmacology provide
information on clinical trials and GCP principles to students at all faculties
of the Kyrgyz State Medical Academy.
Two staff-members from the Department of Basic and Clinical
Pharmacology of the Kyrgyz State Medical Academy (one of them is the
Chairman of Independent Ethics Committee and the other one the Chairman
of the Pharmacological Committee) and three professionals from the
Department for Providing Pharmaceutical Products and Medical Facilities
have attended training courses in GCP conducted by WHO.
Two members of the Independent Ethics Committee for Biomedical
Research and the Chairman of the Pharmacological Committee have attended
Module 1 and Module 2 Training Courses in the framework of FECCIS
Worcshop on SIDCER «Recognition programme» (Tashkent, 2006).
No dissertations in bioethics were defended. In the list of specialties
there is no specialty “Bioethics”. Scientific and research works in bioethics
as an allied subject are planned.
Today we do not have manuals on bioethics by national authors.
Monographs and guidelines on bioethics we use have been published in
Russia and Ukraine.
193
In Kyrgyz Republic the Ministry of Health is responsible for establishing
ethics committees at all levels. At present we lack a developed system of
ethical review. Therefore functions and authorities of ethics committees
on different levels have not been outlined, and activities relating to ethical
review are performed on the national level.
The National Ethics Committee responsible for decisions concerning
ethical review of both national and international biomedical research was
established in 1998 at the Ministry of Health of Kyrgyz Republic to implement
state policy in providing pharmaceutical products. The Committee was
established as a separate and independent body registered at the Ministry
of Justice of Kyrgyz Republic. The Committee consists of 13 members and
includes medical professionals representing practical healthcare, medical
research institutions and medical laboratory service, as well as a lawyer,
leading specialists from the Health Ministry, representatives of the Medical
Association and Trade-Union Federation.
The procedure of ethical review is regulated by legal and normative
documents of Kyrgyz Republic. Thus, the rules regulating tasks and activity
of ethics committees are set out in the Law “On Pharmaceutical Products”
adopted in 1997 and revised and amended in 2003 in compliance with general
provisions, tasks and operations of the Ethics Committee at the Health
Ministry of Kyrgyz Republic. Chapter 7 of the Law “On Pharmaceutical
Products” entitled “Design, Pre-Clinical and Clinical Trials of Pharmaceutical
Products” includes 5 Articles, 3 of which directly concern clinical trials.
Article 28 emphasizes rights of the patients involved into clinical trials of
pharmaceutical products stating that boards at authorized healthcare state
institutions of Kyrgyz Republic “are guarantees for the patients’ rights”.
Besides a set of documents has been designed in compliance with GCP
international standards.
All documents relating to pharmaceutical products submitted to
the Pharmacological Committee (the institution responsible for ethical
review of research protocols) are simultaneously submitted to the Ethics
Committee for ethical review. There is a certain algorithm of conducting
ethical review using standard operational procedures; however we lack a
complete and comprehensive SOP system. According to the Statute of the
194
Ethics Committee, a decision is made within 30 days after submitting the
complete set of documents.
Currently Kyrgyz Republic does not have systems of certifying ethics
committees and surveying ethical review practices; neither has it a procedure
for appealing against decisions. During last eight years The Ethics Committee
has carried out ethical review of 23 clinical trial protocols, mostly phase 3
and 4 trials. Phase 1 clinical trials do not involve volunteers.
Education and training for members of ethics committees is essential for
their efficient work. Meanwhile there is no regular system of education for
members of ethics committees; however, in the framework of cooperation in
FECCIS members of the Ethics Committee of Kyrgyz Republic participated
in WHO training programmes on the protection of patients’ rights and the
meaning of SOPs in EC practice.
Thus, at the present stage of sovereign Kyrgyzstan development basic
legislation has been developed and the order of the Ethics Committee practice
in compliance with international standards has been established. Now there is
a theoretical and practical basis for a successful integration of Kyrgyz republic
into the international process of ethical review development.
The independent Ethics Committee of the Kyrgyz Republic is a
member of FECCIS, which gives an opportunity for cooperation in research
ethics. The activity of EC of the Kyrgyz Republic has been presented at
international conferences, which facilitates the exchange of information and
working experience.
In addition to participation of EC members in training courses organized
by FECCIS, there is an opportunity to take part in training seminars on
GCP conducted by WHO. Staff-members from the Chairs of Basic and
Clinical Pharmacology of the Kyrgyz State Medical Academy and from the
Department for Providing Pharmaceutical Products and Medical Facilities of
the Health Ministry, members of the Independent EC for biomedical research
and of the Pharmacological Committee participated in those programmes.
Last year the Ethics Committee of Kyrgyzstan entered the Regional
Association of Ethics Committees in Central Asia Countries, which opens
up opportunities for extending international cooperation.
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3.7. Republic of Moldova
(V. I.Gikavyi, I.N.Pogonea, T.N.Tirdea, V.I.Ojovanu)
The Republic of Moldova is located in southeastern Europe, bordered
by Romania on the west and by Ukraine on the east. The country spreads
from the north to the south to 350 km, from the east to the west to 150 km.
Territory of the Republic of Moldova is 33.8 thousand square km.
Population is 4,320 thousand inhabitants including Moldavans – 64.5%,
Ukrainians – 13.8%, Russians – 13%, Gagauzians – 3,5%, Bulgarians – 2%.
Correlation of urban/rural population is 45/55. Settlement network of the
country is represented by 4 municipalities, 61 cities, 1,611 villages united
into 925 communes. Kishinev (Chişinău) is the capital of Moldova with 1.1
mln inhabitants. The largest cities of the country are Tiraspol, Beltsy (Bălţi),
Bendery.
Getae (Dacians) and Romans are considered to be ancestors of local
ethnos. Thracians were ancestors of Dacians. They inhabited a wide-spreading
territory from the Aegean Sea to upstream of the Dniester River, from the
Bug to the Tisza. Thracian tribes of the north Danube were called Dacians;
Romans called them Dacians and Greeks – Getaes. We draw information on
cultural life of Dacians from multiple archaeological sources and evidences
of outstanding persons of the ancient world (Herodotus, Strabo, Thucydides,
Plato, Joseph Flavius, Dio Cassius, Jordanes etc.). Farming was a prime
activity of the Dacians. 72 fortresses were discovered.
The Dacians had medical concept according to which at treating it was
necessary to take into consideration the state of a body in general, including
mental state. Their medical knowledge for that period was excellent.
4 large Dacian communities existed in the first part of the 2nd century
B.C. Each community had the army and institution of money. The union
and strengthening of Dacia happened in the time of king Burebista (+80
- 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was
conquered by the Romans and turned to be a province. That was the last
province of the Roman Empire. It was followed by Roman epoch (106271) with the Romanization of Dacian population, the Latinization of the
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language and evangelization. There was the ethnogenesis of Romanians
(from “Romans”) later.
Development of feudal relationship was attested in the X century. Three
principalities were formed in the one-time Dacian territory: Transylvania,
which felt under the reign of Hungarians (Hungarians are Finno-Ugric transUral tribes settled here by the end of the IX century) in the beginning of
the X century, Ţara Românească (or Walachia, Muntenia); Ţara Moldovei.
The first written diplomas mentioning political and military strength of
Ţara Românească and Moldova are referred to the years 1330 and 1359,
respectively.
During the Middle Age Moldova kept suffering from raids of the Tatars,
the Turks, the Hungarians and the Poles. Historical Moldova covered the
territory between Eastern Carpathians, woody Carpathians, the Dniester,
the Black Sea and the Danube under Roman 1 of Moldavia (1392-1394).
Geographic location of the territory was favorable as to the nature and
life resources and at the same time unfavorable as to geopolitical strategic
aspect. The country was located in the strategic pass connecting Eastern and
Western Europe, being situated between the Carpathians and the Black Sea.
The Silk Road, i.e. the longest commercial route connecting the Far East
with the western European countries was there in the Middle Age. Since the
first centuries AD and until now great states, trying to preserve the influence
here had strategic interests in common. Our people have never been involved
in wars of aggression but only defensive ones. Such state of affairs left a
deep track in the spiritual life of the country. Spirituality of the inhabitants,
philosophic thoughts are of the patriotic and the humanist nature. The ideas
of the Italian Renaissance were taken here caught on with some works of
some local cultural figures.
Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504)
ruled Moldova during the most difficult times. He provided a long-term
unity of the state, its economical growth and prosperity of cultural life.
Protecting his land from invasion he stopped the advance of the invaders to
the Western Europe. The Patriarch of Rome for that time deemed him verus
christianae fidei athleta (true Champion of Christian Faith) for his services.
Soon after the king’s death in 1513 Moldova had to resign to regime of the
Ottoman suzerainty.
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In 1600 Mihai Viteazul (Michael the Brave) (1595-1601) united for
the first time and for a short period Moldavia, Wallachia and Transylvania.
Several territorial breaking-ups happened after that. During the RussianTurkish War of 1768–1774 Austria took the north of Moldova including the
ancient capital of Suceava. However the painful and drastic re-allotment
of Moldova happened in 1812 when as a result of the other RussianTurkish War the Russian Empire took the territory between the Prut, the
Dniester, the Danube and the north-eastern part of Bucovina, having called
it Bessarabia.
In 1859 the rest of Moldova was united with Muntenia (Wallachia)
forming a new state - Romania.
In 1917 Sfatul Ţării was formed as a representative body of Bessarabia,
which during World War I and revolution in Russia declared Bessarabia’s
independence as the Moldavian People’s Republic. In 1918 Sfatul Ţării
declared consolidation with Romania. Transylvania joined Romania being
under the Austro-Hungarian Empire the same year.
Clause 3 of the secret Annex to the Molotov-Ribbentrop Pact signed
on 23 of August, 1939, was devoted to the south-east of Europe and
Bessarabia in particular: as a result Soviet government required Romania
to cede Bessarabia and the demand was satisfied. On 2 of August 1940, a
Moldavian Soviet Socialist Republic was established. On 23 of May 1991,
it was renamed to the Republic of Moldova.
Pursuant to the decision of the Great National Meeting on 27 of
August 1991, the Parliament adopted the Declaration of Independence of
the Republic of Moldova. On 2 of March 1992 the Republic of Moldova
became a full member of the U.N.
It is possible to find ethic attitude to life, living beings, covering some
aspects of medical treatment or medicine in works or actions to some extent
of a number of persons. Such as:
Neagoe Basarab (ruled - 1512-1521), Dimitrie Cantemir (1673-1723),
Constantin Virnav (1806-1877), Zamfir Ralli Arbore (1848-1933), Toma
Chorbe (1864-1936), Anatolie Kotovski (1864-1937), Nicoale Testemitanu
(1927-1986).
Neagoe Basarab was one of the rulers of the XVI century whose works
influenced various issues of the ethics of life. It is necessary to mention his
fundamental work called Advice of Neagoe Basarab to his Son Theodosius.
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Dimitrie Cantemir was a talented ruler of Moldova of the 18th century
and at the same time an outstanding scientist and man of culture. It is
necessary to state that he was a member of two Academies – Berlin and SaintPetersburg, spoke 12 languages. He is considered to be the first national
philosopher, first theorist and historian of medicine. Cantemir is known as
the author of philosophic and physiological works. The works of Cantemir
include The Divan or The Wise Man’s Parley with the World; Metaphysics;
General Brief Logics; Research of the Nature of Monarchies; The History of
the Growth and Decay of the Ottoman Empire; Geographical, Ethnographical
and Economic Description of Moldavia; The Life of Constantine Cantemir;
Events from the Life of the Cantacusins and the Brunkovyans; The System
or the State of Muhammad Religion; The Hieroglyphic History. Works of
Cantemir on the history of the Ottoman Empire were considered classic
research and were translated into English, German, and French. Voltaire
called this work his reference book on the East. His works are of high value
until today.
Constantin Virnav is one of the scientists-medics of the XIX century,
whose activity as the doctor and civilian had a great significance for
development of the public health care and medical ideas in the area. He
is the first doctor of medicine in Moldova (he defended his dissertation in
1836 in the city of Buda, Hungary). He is the author of numerous scientific
researches. His ethical ideas, application in treatment practice are especially
valuable.
Zamfir Ralli Arbore was a doctor, the Encyclopaedist, writer and public
figure, graduate of the Saint Petersburg Medical and Surgery Academy, a
person of encyclopedic learning. During his student years he jointed the
narodnik movement and was jailed in St. Peter and Paul Fortress. He went
back to Bessarabia. Later, being afraid of new prosecution of the tsar’s
secret political police he settled in Romania. He is the author of numerous
scientific researches. His encyclopedias are highly valuable. He was an
excellent humanist and moralist. He supported active propaganda of high
moral values on different levels.
Anatolie Kotovski – leading doctor, reformer of the mental health service
in Bessarabia, scientist, public figure who made plenty for the development
of the social medicine of Moldavia. Many of rules considered bioethical
today were applied to his activity.
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Toma Chorbe is considered as one of the great doctors-humanists,
founder of sanitary and epidemiologic service in the area. He won the name
of the unmercenary doctor rightfully. He advocated strongly spreading and
efficient introduction of ethic norms and values in medicine.
Nicoale Testemitanu is an outstanding scientist, public figure and
manager of modern medicine, Doctor of Medicine, professor. He served
as: Chief of the Traumatic Surgery Department of the Republican Territory
Hospital, the Minister of Public Health, President of the Chisinau State
Medical Institute, Chief of the Department of Public Health and Social
Medicine Department. He is the most prominent organizer of national
medicine of the second part of the XX century. His works on organization of
public health care examining medical ethics and deontology are especially
valuable. He strongly supported introduction to the practice of moral medical
principles. In this respect his everyday activity was a bright example.
Any event in nature and especially in the society is known to have strictly
defined grounds, knowledge of which allow researchers analyzing them deeply
and widely, determine their (fundamentals) role in formation and development
of this phenomenon, to evaluate significance of the latter in formation of social
conscience at the level of country, region and even mankind in general. Such
fact as biomedical researches is not an exception in this sense.
Cultural and historical grounds of biomedical researches in the Republic
of Moldova may be examined from several aspects.
Firstly, cultural traditions of our country initially suppose existence
of stable moral system, reality of which allows rather accurate control of
different actions including science. Public mentality is strived to carry
out true moral appraisal. Such situation dominates both in public social
consciousness and in traditions, folk and literary works.
Social and cultural life of Moldova is defined to a large extent by
demographic situation. Density of population equal to 127 people per
1 square km is high comparing to other regions of the southeastern Europe.
In addition the distance between settlements is small. Hence there appears
singularity of information process.
Moldova to strengthen its economy and independence besides critical
times kept original scientific traditions practically in all fields of knowledge.
Medicine, pharmacy, biology, ecology, philosophy and science of culture
exhibited considerable development.
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Efficient ways for establishing of bioethics were found in Moldova. As a
result, significant progress as to this field was made in a short period of time.
First bioethical ideas entered our Republic in the end of the 80’s of the
last century, as the ex-USSR though. However, they found true response
in the scientific circles in the beginning of the 90’s. Comparing to western
countries establishment of bioethics in the Republic of Moldova happened
rather late - in the first part of the last decade of the XX century. This is the
first stage of bioethics development in the local, national territory. Bioethical
problems of this stage were however at the background due to large-scale
social shock happened during that time: collapse of the USSR, declaration of
the Republic’s independency, Transdniestria conflict, etc. Notwithstanding
abovementioned small group of scientists examined consistently possibilities
for bioethics development in our country.
The second stage includes the period from 1995 trough 1999. It is
necessary to stress that in such a contingency the Department Philosophy
(since 1999 – Department of Philosophy and Bioethics) of the State University
of Medicine and Pharmacy named after Testemitsanu N.F. became the core
or the Centre for establishment and development of bioethics in the Republic
of Moldova. Academician Theodor Tsidrya, chief of the Department of
Philosophy, was the initiator for distribution of bioethics ideas in Moldova.
He created efficient grounds for introduction of bioethics into different fields
of operation especially in scientific and educational spheres, first alone, then
together with the staff of the Department. Lectures of the famous Italian
expert in philosophy - Pietro Cavasin – in the past director of one of the
Italian bioethics institutes - became a stimulus. Taking into consideration his
activity in promotion of bioethical knowledge in the Republic of Moldova in
2001, the University conferred him with Doctor Honoris Causa title.
Professor and teacher’s group of the Department became a prime
scientific, teaching and methodological and practical Centre of bioethics
development in the Republic of Moldova. We need to stress great support of
the National Commission for UNESCO Affairs in organization of the National
Bioethics Centre in the Republic of Moldova on 10 of November 2004, and
holding of different events. Mission of the Centre includes first of all the
following: 1) harmonization and coordination of joint actions in this field
between the Department, Bioethics Association and National Commission
for UNESCO Affairs in the Republic of Moldova and the Ministry of Health
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Care and Social Security; 2) consolidation of all competent bodies at the
national level to organize different events and implementations; 3) effectual
promotion of bioethical knowledge; 4) facilitation of implementation of
research results into different activities’ areas; 5) coordination of various
activities in the bioethics at the national level.
Since 2005 expansion of different activities connected with further
establishing of bioethical ideas in our country is noticed: increase of academic
hours in subject block for bioethics for students, doctoral candidates,
applicants and residents, introduction of bioethical training for medical and
nursery medical personnel of medical institutions of the Republic; publication
of text-books and set of training materials; expansion of scientific research
themes; holding of topical workshops; regular organization of round-tables
with invitation of experts in gynecology, transplantology, resuscitation
science, intensive care, biology, genetics, forensic medicine, psychiatry etc.;
increase of student’s interest to bioethical issues through participation in
student philosophic study groups, extending of international relations.
Other advances were rather marked as well. However, the main
achievement of this stage was foundation of true scientific bioethical school
in our country.
Prime bioethics development trends in the Republic of Moldova:
1) organization of training process in bioethics; 2) organizational and
practical events; 3) scientific activity.
Organizational and practical events include the whole set of activities:
holding of different workshops and lectures in medical institutions,
organization of programs on the Republic’s television and radio channels;
presentation of books, information exchange with foreign organizations
involved in bioethical issues; permanent advisory service for executives of
medical institutions, drug stores, laboratories, sanitary and epidemiological
stations on issues of documentation creation and set-up of bioethics
committees; development and improvement of regulations, provisions,
participation in adoption of laws; sample by-laws for bioethics committees
under hospitals of our country were worked out.
Main tasks of scientific activity: elaboration of comprehensive
bioethical researches; intensification of researches on theoretical bioethics;
examination of bioethical issues of clinical medicine (i.e. practical bioethics);
identification set of issues of related subjects, where bioethics development
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is a catalyst of their demonstration; creation of practical teaching aids for
bioethics intended for doctors majoring in other fields.
It is possible to conclude that significant work was performed in the
Republic of Moldova during rather short period of time as to development
and introduction of bioethical knowledge as well as to research and solving
of different issues in the sphere. That was the solid base for introduction and
functioning of ethical review of biomedical research system.
Regulations for clinical researches have been introduced in Moldova
since the middle of the 90’s. Prime legal documents of the Republic of
Moldova as to biomedical researches are as follows:
1. The Law of the Republic of Moldova On Pharmaceutical Products
No. 1409 of 17.12.1997.
2. Law On the Rights and Responsibility of a Patient No. 263 of
27.10.2005
Legal and ethical issues at clinical research are addressed in the Law of
the Republic of Moldova On Pharmaceutical Products elaborated taking into
consideration a series of international documents. So, Article 11 “Clinical
Researches” particularly states:
1) Clinical researches of pharmaceuticals shall be performed in
accordance with the Rules on Good Clinical Practice approved by the
Ministry of Health Care.
2) Application on performance of clinical research of medicament
shall be filed to the Ministry of Health Care or to an authorized institution.
The application shall be filed with materials containing general information
on a medicinal agent, agent samples, and results of pre-clinical studies, draft
design of clinical researches.
3) Permit for clinical research shall be given in case of:
a) positive conclusion of review on efficacy and safety of a medicinal
agent held basing on materials of pre-clinical research;
b) availability of accurate data on the fact that the risk of adverse
events of the medicinal agent will be less than expected benefit.
4) Procedure for clinical research materials review shall be established
by the Ministry of Health Care or by the authorized body.
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5) Clinical research must be performed by skilled specialists in the
relevant sphere.
6) Clinical research of the medicinal agent may be permitted only
after receipt of positive conclusion on ethical and moral and legal issues
of research program issued by ethics commissions created and operating at
patient treatment and prevention facilities having held clinical researches.
7) Ethics Commissions shall be formed in each medical institution
empowered by the Ministry of Health Care to perform clinical researches.
Ethics Commission includes therapists, pharmacists, pharmacologists,
layers, and representatives of professional and public organizations.
8) A sponsor of clinical research shall have the right to obtain
information on pharmaceuticals research process, results of review and
demand substitution of medical institution carrying out the research;
9) Inspection of clinical research shall be carried out by the Ministry of
Health Care or by the authorized body.
Article 12 of the Law “On Pharmaceutical Products” is fully devoted to
protection of patient (volunteer) rights:
1) Clinical researches shall be performed on volunteers (healthy
people) and on patients during their disease treatment;
2) Clinical research shall be performed only with written consent of
the patient or volunteer, and in case of non-adult or disabled person – with
written consent of their legal representative;
3) Patient, volunteer or their legal representatives shall be entitled to
obtain information on research content, medical agent properties, expected
effect of application and possible adverse events, risk level affecting the
person in the research;
4) The sponsor of a clinical study shall be obliged before the research
to execute life and health insurance contract with respect to the patient or
volunteer as provided in the applicable laws;
5) In case of danger to health or life of the patient or the volunteer, as
well as its own desire, the head of the clinical research shall have the right
to interrupt the research;
6) The Ministry of Health Care or authorized body shall cancel the
clinical research in case of:
a) danger to health and life of the patient or the volunteer;
b) violation of ethical regulations at conduct of clinical research;
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c) absence or insufficient expected effect.
So, the Law “On Pharmaceutical Products” from one side details above
requirements and principles for biomedical researches, and from the other
side established some regulations for pharmaceuticals research and patient
care methods.
The Law states that the pre-clinical researches of medicaments must be
performed prior to clinical researches pursuant to the Regulations on Good
Laboratory Practice approved by the Ministry of Health Care and Social
Security. The Law stipulates that a positive conclusion of the National
Ethics Committee under the Ministry of Health Care and Social Security
shall be a condition for issuance of permit on clinical research made by the
Commission on Pharmaceutical Products of the Ministry of Health Care
and Social Security. The Law “On Pharmaceutical Products’ also contains
regulations devoted to operation of the ethical committees. It is specifically
prescribed that such committees must operate under institutions of public
health (local and territorial) in accordance with model regulations approved
by the Ministry of Health Care and duties and responsibilities of the
committees must include participation in development of clinical research
protocol. Local commissions and ethics committees set under Academy of
Science of Moldova and public health institutions (republic’s, municipal and
district ones) being a structure with extended functions are set by relevant
enactments and operate.
The Law On the Rights and Responsibility of a Patient sets general
requirements to performance of biomedical research.
First it is necessary to stress that pursuant to said law the patient is a
person in need for medical service, using such services or applied for the
latter notwithstanding the state of his health, or voluntary participating as
a subject in biomedical researches. That means all set rights of the patient
relate to subjects of the medical research as well.
To ensure the rights of the patient during biomedical research connected
with use of new diagnostic, treatment, prevention, rehabilitation methods,
medicaments and other similar means the said law sets the following
provisions:
Any biomedical research may be performed only after obtaining of
written consent from the patient;
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a) persons incapable to express their will except for researches in
the interest of patient and consent of the legal representative shall not be
involved in the clinical research;
b) At receipt of patient’s consent on participation in the biomedical
research, the latter should be provided with comprehensive information on
objectives, methods, adverse events, possible risk, benefits and expected
results of the study;
c) the patient may refuse from participation in the biomedical research
at any stage of such research;
d) during biomedical research life and health of the person participating
in the trial shall be insured at the expense of an institution performing this
research in one of insurance agencies operating in the Republic of Moldova
in accordance with the laws;
e) to perform biomedical research the permit of the body on ethics for
biomedical researches must be obtained;
f) Performance of the biomedical research shall be permitted only
in organizations of the state system of public health and shall be based
on preliminary laboratory research. Performance of the research must be
recorded in the research protocol in accordance with a sample elaborated
and approved by the Ministry of Health Care and Social Security;
g) new diagnostics, prevention and rehabilitation methods may be used
for patient care only after written consent of the patient, and for treatment of
a person with limited capability at direct danger to his life and with written
consent of its legal representative;
h) Promotion and advertising including mass media of diagnostic,
treatment, prevention, rehabilitation methods, medicaments and other similar
means without test examination according with the laws is prohibited.
Pursuant to the Law On Pharmaceutical Products the set of documents
related to clinical researches was elaborated and approved by the Order of
the Ministry of Health Care and Social Security No. 10, 14 of January, 2002
On Performance of Clinical Research of Pharmaceutical Products in the
Republic of Moldova:
1. The ICH Guidelines for Good Clinical Practice was adopted;
2. Reference by-laws of the National Ethics Committee:
3. List of clinical sites certified for clinical research of
pharmaceuticals;
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4. By-laws of the clinical site for clinical research of
pharmaceuticals;
5. Protocol of the clinical research etc.
The National Ethics Commission, currently the National Ethics
Committee on Clinical Research and Pharmaceuticals and New Methods of
Treatment (Order of the Ministry of Health Care and Social Security No.38
of 24.01.06) started its work the same year in accordance with the Law On
Pharmaceutical Products and the Order of the Ministry of Health Care (No.
54-r par.12 of 09.07.2002 On Creation of National Ethics Commission).
International pharmaceutical companies performing CT and interested in
creation of GCP-compliant conditions were initiators of its creation as well.
Operation of the said Committee, in fact, is a part of control and permission
system of the Ministry of Health Care and Social Security. To obtain permit
of the Ministry of Health Care for CT it is necessary to receive an approval
of this Committee.
An attribute of this Committee is availability of detailed standards
for its work – “standard operation procedures”. Meeting requirements of
international laws, these procedures at the same time take into account
statements of Moldova laws and peculiarities of conduct of clinical
researches in our country.
So, the network of ethics committees targeted on ethical review of
CT is currently developing smoothly. There is a necessary background
for their development: necessity in their functioning from the side of
researches willing to perform qualified clinical researches in accordance
with international regulations and legal base. Experience of ethical review
subject to future interpretation is being accumulated.
There is no doubts that training and education in bioethics for population
and firstly for youth has become a necessity, a requirement of the time
and not a fashion or somebody’s ambition. This imperative is caused by
anthropoecological and anthropogenic crisis sweeping today the Earth
as a result of natural and even unrestrained activities of a man and world
community in general to provide human existence. In this connection it
is necessary concentrate human powers firstly intellectual ones for safety
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development of modern civilization. This is the time to elaborate new
approaches to human survival strategy, which would provide opportunities
of more efficient handling of global anthropoecological crisis, exclude
planetary omnicide that closely follows tracks of the modern world.
Bioethics as it is well known is an efficient mechanism in securing
safety development of the society. That means that well-established training
and education of population in this practical philosophy would facilitate
solutions for many issues related to survival of mankind. The Republic of
Moldova performs a lot as to the issue:
Firstly, for purposeful coordination of this work the Bioethics
Association of the Republic of Moldova was created in the country in
2001 (31 of May), and the National Bioethics Centre was founded (10 of
November 2004) uniting experts in this science and practical philosophy
of all country higher educational institutions, other scientific institutions,
for effectual organization and implementation of different decisions and
advises in this field with the help of UNESCO together with the Department
of Philosophy and Bioethics project called Extension of Development and
Promotion of Knowledge in Bioethics in the Republic of Moldova.
Secondly, for purposeful teaching of bioethics in students circles
and primary at the biomedical, agronomical, veterinarian and similar
departments, traditional Department of Philosophy has been reorganized
into the Department of Philosophy and Bioethics in 1999 under the Order
of the President of State University of Medicine and Pharmacy named after
Testemitianu N.A., which undertook solving of all issues related to teaching
of this discipline to students. They include: working out of text-books and
teaching aids, dictionaries, elaboration of thematic plans, curriculums and
workshop projects, tests, staff training, method teaching and methodological
training of teachers of higher education institutions, colleges and lyceums of
the Republic including in bioethics.
64-hour training course for students of our institution and 32-hour course
for other universities has been worked out by the Department. Several textbooks and teaching aids on this discipline were published in Romanian and
Russian, we will point of the following:
- Philosophy and Bioethics: History, personalities, paradigms.),
Chisinau, 2000, 256 p.
- Philosophy (with Bioethics course). Chisinau, 2002, 552 p.
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- Philosophy and Bioethics Dictionary. Chisinau, 2004, 441 p.
- Elements of Bioethics. Chisinau, 2005, 176 p.
- Bioethics: origin, dilemma, trends. Chisinau, 2005, 234 p.
These and other training and methodological and scientific works of the
Department staff allowed organization and holding of training not only for
students but for a certain number of professors of universities and colleges
of the country in accordance with detailed program on Bioethics through
the National Bioethics Centre and Bioethics Association of the Republic
of Moldova. More than 50 persons who would be able to give lectures on
bioethics in the higher and secondary specialized educational institutions of
our country as well as in lyceums underwent advanced training in science
and method training related to this field at these national workshops.
Thirdly, the Department of Philosophy and Bioethics of State University
of Medicine and Pharmacy named after Testemitianu N.A., the National
Bioethics Centre carries out permanent research work in bioethical knowledge
considering bioethics in the widest definition of this term (as per V.P. Rotter).
Since 1995 until 2006 the Department has organized and held eleven
international scientific workshops on topic Bioethics, Philosophy and Medicine
in Human Survival Strategy. Scientists and practitioners from many world
countries (the Ukraine, the Russian Federation, Bulgaria, Romania, Canada,
the USA, the Republic of Moldova, etc.) and other specialties (philosophers,
medics, biologists, ecologists, engineers, economists, agronomists etc.)
participate in such workshops contributing to bioethical development in close
connection with biomedicine, philosophy, ecology, economy, technique, other
fields of knowledge. This promoted development of researches in ethics of life
not only in the Department of Philosophy and Bioethics of State University
of Medicine and Pharmacy named after Testemitianu N.A. but in other higher
educational institutions of the country.
Since 2002 the Department offers post-gradual studies (daily and distant
training), doctor of science (distant) and master (daily) training in bioethical
sphere where graduates of philosophic, medical, theological, agricultural and
other department study. After graduation and successful defense of works
they are conferred the degree of doctor or doctor habilitate of philosophic
science (majoring in bioethics) and master on bioethics, respectively.
If we are to continue to develop our ideas related to organization of
training process in bioethical knowledge in our country it is necessary
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to especially stress the work of the Department, Association and the
National Bioethics Centre in popularization of this phenomenon among the
population of the Republic and primarily among the youth. Introduction
into Bioethics program is of special popularity among the radio and
television auditoria. Over last 3 years the personnel of the Centre and the
Department organized and held about 20 talks (radio and television) of 15
to 45 minutes each on basic themes of this type of practical philosophy.
Such programs as Bioethics – The Science of Survival, Euthanasia from the
Point of View of Bioethics, Cloning in the Contest of Bioethics, Bioethical
Aspects of Artificial Human Reproduction, Experiments in Humans and
Animals in Biomedical Sphere: Bioethical Aspects, Religion and Bioethics
and other with participation of bioethics specialists, biologists, medics
and religious theologists can be marked among them, as well as From
Anthropocentrism to Biospherocentrism, Backgrounds of Bioethics, From
Ethics to Biological Ethics, Abortion and Bioethics, Bioethical Education
of Society – Requirement of the Human Survival Strategy, Transplantology
and Bioethics, Human Genome and Bioethics, Biomedical and Spiritual
World: Comparative Analysis, Principles and Imperatives of Bioethics,
Paternalism and Antipaternalism in Human Activity, Informative Consent
and Interpretation in Medical Practice and others.. Here we started to check
the interest in some ideas from social bioethics, such as Senility and Bioethics,
Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism
in the Contest of Bioethics, Suicide and Bioethics, Homeless in the Light of
Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light
of Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism
in the Contest of Bioethics etc. All that promotes propaganda of bioethical
knowledge among the population both of the cities and rural settlements,
formation of skill to care about living and biosphere in general.
Periodicals with regular publication of interviews, articles and, for
example, such newspapers as Komsomolskaya Pravda, Argumenty i
Fakty, Nezavisimaya Moldova, Făclia, Moldova Suverană, Literatura şi
arta are used to the same extent, i.e. for propaganda and promotion of
knowledge in bioethics. We will underline several of them: Philosophy
(With Bioethics Course), the Svetoch newspaper, No. 14 of 5 April 2003,
p.6 (in Romanian); Homo Sapiens, be a Human!, the Argumenty i Fakty
newspaper, No. 21, May 2005, p.3 (in Russian); Bioethics, Philosophy,
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Economics and Medicine in the Strategy of Humane Safety Ensuring, the
Literatura i Iskusstvo weekly, No. 11, 17 of March 2005, p.2; Philosophy
and Bioethics, the Literatura i Iskusstvo weekly, No. 35, 1 of September
2005, p.7; And Philosophers May Safe the Mankind, the Svetoch newspaper
on 19 of February 2000, p.6, etc.
Traditions of extensive participation of the community in formation of
moral principles of social life are rather strong in our country as in other
CIS countries. As it was said before, the first public officially registered
organization in 2001 undertaking responsibility to promote ideas of
bioethics in the Republic was Bioethics Association, united philosophers,
medics, lawyers, theologists, biologists, scientists, students and other
public representatives. All bioethics commissions created in local hospitals,
scientific institutions and others are the result of the activity of the Association
and the National Bioethics Centre. Today, bioethics commissions operate
in practically all patient care and preventive and scientific and biomedical
institutions, elaborating procedures for operation and standard operation
procedures based on model regulation.
It is necessary to underline the role of bioethics committees in
organization and holding of training and educational process starting with
the National Ethics Committee under the Ministry of Health Care and Social
Security and to basic levels of this system. First of all, we set up trainings for
members of the committees at workshops, and then they perform the same
work in their teams, i.e. promote bioethical knowledge.
So, successful set up of bioethical training is important for the Republic
of Moldova from various points of view, and, first of all at the point of
integration of our country into European and world community. From one
side use of experience of other countries in this process is the condition
for formation of moral mechanisms embodiment for ensuring of secure
development strategy for our region, further democratization of social life.
From the other side, the experience of the Bioethics Association of the
Republic of Moldova, the National Bioethics Centre on bioethics and the
Department of Philosophy and Bioethics of the State University of Medicine
and Pharmacy named after Testemitianu N.A. on set up of trainings and
education of inhabitants in bioethical interconnections and interactions
among humans, society and biosphere, i.e. in implementation of one of the
significant principles of bioethics – the co-evolutional one.
211
And finally, wide spread of the experience and practice of the state and
public formations in training and educational process of bioethical knowledge
will favor integration in social life of new ethical and legal approaches,
principles and values, the help of which may not only reasonably use
achievements of current scientific and technological progress but promote
implementation of modern strategy of the world community meaning
survival of the mankind through steady and safe development.
These are summary results of our works during the last 10-12 years in
organization of training, education and promotion of bioethical knowledge
among people of our country, and, first of all, among the youth. The work
we have performed undoubtedly will be a serious base for further extension
and strengthening of the developed system especially in carrying on of
bioethical education of young students, future specialists of all types.
References
1. Bioethics: principles, rules, issues. Edited by Yudin B.G. М., 1998,
472 p. (in Russian)
2. Vekovshinina S.V., Kulinichenko V.L. Bioethics: onset and rationale
(philosophy and methodological analysis). Kiev, 2002, 152 p. (in Russian)
3. Second National Congress on Bioethics. 29.09 – 2.10 2004. Kiev,
2004, 305 p. (in Russian)
4. Testemitsanu N.A., Popushoy Ye.P., Ioksa V.A. Famous Doctors of
Moldavia. Chisinau, 1985, 231 p. (in Russian)
5. Tsirdya T.N., Berlinsky P.V. Philosophy (with course on bioethics).
Chisinau, 2002, 553 p. (in Russian)
6. Development of Bioethics Ideas in the European Context. Mater.
of the IV International symposium on bioethics. Kiev, 2006, 160 p.
(in Ukrainian)
7. Dicţionar de Filosofie şi Bioetică. T.Ţîrdea, P.Berlinschi, A.Eşanu
et al. Chişinău, 2004, 441 p. (in Rumanian)
8. D’Onofrio F., Giunta R. La Bioetica nel futuro dell’uomo. Napoli,
1999, 224 p.
9. Istoria medicinei româneşti. Red. V.Bologa et al. Bucuresti, 1972,
565 p.
10.Istoria şi Filosofia culturii. Coord. Gr. Socolov. Chişinău, 1998,
398 p. (in Rumanian)
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11. Nistor Ion. Istoria Basarabiei. Chişinău, 1991. 295 p.
(in Rumanian)
12. Ţîrdea T. Filosofie şi bioetică: istorie, personalităţi, paradigme.
Chişinău, 2000, 215 p. (in Rumanian)
13.Ţîrdea T. Bioetică: origini, dileme, tendinţe. Chişinău, 2005, 234 p
(in Rumanian)
14.Tirdea T. Elemente de bioetică. Chisinau, 2005, 176 p (in
Rumanian)
So called independent ethical committees are created to ensure the
rights and safety of subjects of clinical research.
Pursuant to the definition applied in Europe (Good Clinical Practice
for Trials on Medicinal Products in European Community, III/3976/88/EN, July 1991), ethical committees are independent bodies consisting of
professional medics or persons of non-medical specialties being responsible
for ensuring of rights and health protection of people participating in the
research and guaranteeing such protection for the society in general, i.e.
public associations exclusively involved in issues of clinical researches
involving human subjects.
The ethics committees are currently entities, where scientific interests,
medical facts and moral norms and legal regulations are appear interrelated.
Ethics committees carry out functions of review, advising, recommendations,
motivation, valuation, handling of CT moral and legal issues. They work
to ensure all possible protection measures and safety regulations in the
scientific researches.
The system of ethical committees in the Republic of Moldova is created
under the following principle:
a) National Ethics Committee founded under the Ministry of Health
Care and Social Security;
b) regional with jurisdiction applying to a certain territory;
c) local, created under patient care institutions and universities.
Ethics committee set-up process has started in Moldova since 2002.
In 2002 the first was the National Ethics Commission at the Ministry of
Health Care and Social Security of Moldova, which in 2006 was reregistered
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as a Committee (National Ethics Committee– NEC). Then the Bioethics
Committee under the Presidium of the Academy of Science of Moldova
was established. During this period bioethics commissions started to appear
everywhere in the Republic, municipal and territorial patient care institutions,
and firstly in those being sites for clinical research of pharmaceuticals and
new treatment methods involving human subjects.
The NEC created at the Ministry of Health Care of Moldova functions
now in Moldova. The Committee considers materials of all clinical
researches held in Moldova. The National Ethics Committee is not involved
in consideration of other issues (such as relationship between a doctor and
patient, medical ethics, review of regulations). These issues in the system of
the state health car are the responsibility of other public unions – associations,
leagues and other committees and commissions.
Main task of the NEC is to perform high quality ethical review of planned
clinical researches. The NEC is governed by the general international principles
for the conducting clinical trials, as well as applicable laws and regulations of
the Republic of Moldova. Prime principles of operation of the NEC at conduct
of the CT ethical review are: independence, competence, openness, plurality
as well as objectivity, confidentiality and collective nature.
Independence of the ethics committee means independence of decisions
from researches, sponsors or other excessive influences. The committee is
independent from bodies making decision on performance of CT including
governmental authorities, as governmental and departmental interests may
as well be in conflict with interests of personality involved in CT.
Competence of the Ethics Committee is expressed by high qualification
of each member of the committee in its professional field or competence in the
field of operation ensuring interdisciplinary approach at discussion of CT, in
understanding of the CT principles and knowledge of the GCP guidelines.
Openness of the activity of the ethics committee is ensured by
transparence of operation principles, regulation etc. Standard operation
procedures are open for all willing to get acquainted with them. Any decision
of the committee has bona fide explanation.
Plurality of the ethics committee is guaranteed by variety of professions,
age, sex, confessions of its members. This principle requires participation
in discussion as far as possible for all members of the committee to reflect
different views on this or that topics.
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Principle of objectivity at consideration of the CT materials is
implemented through exclusion of a “conflict of interests”. Besides, the
rights of all participants of the research, particularly, not only patients but
doctors as well, are taken into consideration at review.
Adherence to confidentiality is required in respect to the CT materials,
persons involved in the research.
Collective nature is usually expressed in consensus manner of discussion
and decision making.
One more significant principle of the NEC activities, if possible to say so,
an ideological principle of ethical review is inadmissibility of prohibitions.
None of the international document devoted to the ethics committees
include the word ‘permitted’ or ‘prohibited’. Prohibition limits the freedom
of personality that is impossible to recognize as ethical. That is why the
ethics committee makes its conclusion leaving to a researcher or sponsor
to take into consideration or not (however, pursuant to the GCP regulations
absence of the ethics committee permit is a ground for prohibition actions of
controlling and regulatory bodies).
General aspects of the operation of the ethics committee are as
follows:
a) independence of the parties participating in the research;
b) non-pursuing commercial or any other tangible interests;
c) being a public body with certain authorities provided by the law,
such as:
• to review documents related to conduct of clinical researches and,
when necessary, to require amending or altering the documents;
• to make decision on possibility to perform or to continue clinical
research;
• to control how CT is performed.
For its work the NEC elaborated and observes strictly its standard
operation procedures governed by international and national laws for
clinical researches. SOP are fixed on paper, create principles and regulations
for committee activities. That is why researches and study sponsors pay to
them more attention. Published collections of SOP allow improvement of
the ethics review process by means of methodological and legal integrity of
structure and functions of the Ethics Committee.
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Ethical standard for operation of the NEC in the country is worked
out based on mutual respect to cultural, religious, national differences and
acknowledgement of universal values. Elaborated national collection of SOP
is a logical stage of the further introduction of Operational Guidelines for
Ethics Committees that review of biomedical researches (WHO, 2000) into
daily practice of the NEC that provides methodological uniformity of these
documents and their grounding on fundamental international principles of
ethical review.
The NEC consists of people with experience and qualification for
valuation of scientific, medical and ethical aspects of CT, well acquainted with
cultural and ethnical traditions of the country population, which supposedly
would be involved in research. To solve special issues an ethical committee
attracts when necessary experts – not members of the committee.
Clinical research materials are presented to a committee by researchers
responsible for scientific and ethical aspects of the research or by the
client representatives (qualified specialist capable to explain all aspects of
the research). An applicant shall provide all documentation necessary for
complete and detailed valuation by the Committee. Pursuant to the GCP
requirements the following documents are filed to the ethics committee:
- application for review of clinical research materials;
- clinical research protocol with all annexes and supplements
- brief description of the protocol;
- investigator’s brochure;
- information on researches including curriculum vitae and other
necessary data;
- description of methods for attraction of potential subjects of the
research;
- content of research information provided to the patient;
- patient written consent form for participation in the study;
- information on payment and remuneration to the research subjects;
- information on insurance of the subjects and possible
indemnification;
- individual registration form, any dairies and questionnaires filled-in
by patients;
- documents, confirming decisions made on this research by an
authorized body;
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- documents confirming all decisions (including negative ones)
previously made by the ethics committees (local or otherwise) in respect to
this research;
- documents confirming absence of interest of the research group
members in the result of the research.
During discussion of the clinical research materials the following issues
shall be considered:
1. Concordance of the provided protocol to the goals and objectives of
the research, possibility to obtain well based result at lowest risk level for
the study subjects, appropriateness of possible risk and inconvenience for
the subjects or other persons.
2. Aptitude of a researcher as to conduct of suggested clinical research,
such as:
- high professional qualification;
- sufficient work experience in the relevant field of medicine;
- sufficient scientific experience confirmed by documents and
publications;
- correspondence to high ethical standards;
- availability of sufficient time for performance of the clinical research
under the protocol;
- availability of necessary means and facilities for performance of
planned research.
3. Concordance of a study research site to the study goals and
objectives:
- ability to enroll subject cohorts within scheduled study time;
- provision of clinic with necessary personnel: diagnostic and patient
care equipment, communication facilities, computer equipment;
- ability to provide emergency medical care in case of adverse events
and side effects.
4. Procedure for attraction of possible study subjects (advertising,
announcements, etc.), evaluation of correspondence of provided information
to ethical norms.
5. Patient insurance procedure and payment of remuneration.
6. Content of research information provided to the patient.
7. Procedure for obtaining of the patient written consent for participation
in the research;
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Only members of the ethics committee independent from sponsor
and researcher take part in decision-making process as to certain clinical
research.
Decision of the ethics committee is given in accordance with one of the
following variants:
a) Permission to perform of a clinical research (approved opinion);
b) Amendments are required to produce a positive decision;
c) Negative decision;
d) Cancellation of any previously made decision.
During a clinical research an investigator must inform the Ethics
Committee on necessity to introduce certain amendments and alterations to
the clinical study protocol and to the information provided to study subjects,
as well on occurrence of severe and/or unexpected adverse events and side
effects and on any new data on possible impact of the tested article on humans.
Based on results of review of materials provided by the investigator, the
Ethics Committee makes decision on possible introduction of these or those
alterations and amendments, continuation of clinical research or its separate
stages, on measures which must be taken to ensure safety and protection of
study subject rights.
The Ministry of Health Care and Social Security and authorized agencies
pay great attention to settlement of such complicated and diverse ethical and
legal issues arising during clinical researches. We are trying to observe the
following main principles in operation of the committee involved in ethical
issues of the CT:
- unified methodological approach based on GCP guidelines;
- striving to independence of decisions to promote protection of study
subject rights.
- special attention is paid to patient informed consent
- assistance to educational programs for members of the ethics
committees, for doctors- researchers, patients.
- inclusion all researches (pharmaceutical products as well as
biological active substances, technologies, materials, devices and items for
medical use involving human subjects as a study object) into the sphere of
activities of the ethics committee
- maintenance of ethical environment using medical publications issuing
only results of researches that passed ethical review by ethics committees.
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New documents devoted to ethical and legal aspects of clinical researches
are elaborated annually, changes are made to existing documents. General
provisions of international laws, in particular, ICH GCP are reflected in
guidelines produced by the Agency for Pharmaceutical Products of the
Ministry of Health Care and Social Security of Moldova. There is a process
of regular and consistent introduction of GCP principles into the practice of
organization and performance of clinical researches of medical agents. Upto-date task is creation of local ethics committees in Moldova. Creation of
such independent committees authorized with relevant powers will promote
active participation of Moldova clinics in multi-Centreed international
researches, allow controlling observance of the rights and safety of study
subjects not only at the stage of setting up but also during the study course.
There are no doubts that successful education in bioethics, improvement
of ethical review system for biomedical researches mainly depend on
involvement of the country, its governmental bodies, public entities, scientific
communities in different international events connected with provision of
safe development of society, cooperation with other states, international
organizations for improvement of research work in bioethics (to a large extent),
in promotion and popularization of bioethical knowledge, in performance of
biomedical researches involving human and animal subjects, etc.
Certain experience in international cooperation related to this field
is gained by the Republic of Moldova. First, we would like to remind
about organization and holding of scientific workshops with international
participation of many European countries on bioethical topics in our country
and abroad, first of all, about a role of bioethization of the society to ensure
safety of the modern world. During the last 11 years the same number of
scientific conferences was held and eleven books were published with
materials of speakers at these scientific forums (organizers: Department of
Philosophy and Bioethics of State University of Medicine and Pharmacy
named after Testemitianu N.A., the National Bioethics Centre of the
Republic of Moldova).
Since 2000 the National Ethics Committee is a member of the FEC
CIS. Moldova collaborates with ethics committees of the CIS countries
219
through this Forum. As to international cooperation and as a member of the
Forum, representatives of our committee were participants of the majority
of conducted conferences and workshops of the FECCIS: Saint-Petersburg,
Russia, 2001; Kiev, Ukraine, 2001; Almaty, the Republic of Kazakhstan,
2002; , Kiev, Ukraine, 2004; Saint-Petersburg, Russia, 2003; Baku, the
Republic of Azerbaijan, 2004; Saint-Petersburg, Russia, 2004; Minsk,
Belarus, 2005; Almaty, the Republic of Kazakhstan, 2005; Tashkent, the
Republic of Uzbekistan, 2005; Yerevan, the Republic of Armenia, 2005.
In 2006 the workshop on “Human Rights Protection &. Standard
Operation Procedures” with participation the representatives from FECCIS
(Russia, Ukraine, Moldova) and SIDCER (WHO) and EFGCP (Belgium)
was held in Chicinau. Chairman of the National Ethics Committee of the
Republic of Moldova, Professor Gikavy V.I. took part in the workshop of the
Commission of the Council of Europe on Ethical Issues (Ljubljana, 2004).
Professor M. Gavrilyuk, Deputy-director of the Neurology and Neurosurgery
Institute of the Ministry of Health Care and Social Security is a permanent
representative of the Republic in the Commission of the Council of Europe
on ethics of biomedical researches since 2005.
Secondly, the staff of the State University of Medicine and Pharmacy
named after Testemitianu N.A., the State University of Moldova, the State
Agricultural University and other, members of the National Bioethics
Centre of the Republic of Moldova take part on a regular basis in scientific
conferences organized in other countries, exchange with their experience,
mainly, on scientific and educational publications, activity of bioethical
committees, etc. Four workers of the Department of the Philosophy and
Bioethics just for the last 3-4 years took part and made presentations at
the 2nd National Bioethics Congress (Kiev, 2004), the same number of
presentations was made at the 4th Bioethics Symposium (Kiev, 2006),
four presentations were made at the International Conference on bioethical
education (Romania, Keya, 2006 and Romania, Bucharest, 2006), with
presentations at the International seminar on issues of ethical review in
biomedical researches (Ukraine, Kiev, 2006), with presentations on issues
of students bioethics education (Croatia, Split, 2006), etc.
Thirdly, professors of philosophy, philosophy and bioethics departments
of many of higher educational institutions of Chisinau published lately
materials on bioethics in different scientific journals, other foreign
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publications, for example in Kursk (Russian Federation) – 5 articles, in
Yassy (Romania) – 2 articles, in Arad (Romania) – 2 articles, in Galatia
(Romania) – 2 articles, in Lvov (Ukraine) – 1 article, etc. Our colleagues
from these scientific Centres publish their works in scientific publications of
Chisinau (journals, university research works, conference materials, etc.).
During the last years the Department of Philosophy and Bioethics of the
State University of Medicine and Pharmacy named after Testemitianu N.A.
is trying to enter different international projects related to training programs
on bioethics, performance of ethical review of biomedical researches,
staff training, etc. To this extent we are looking for forms of international
scientific and pedagogical cooperation in bioethics with the CIS countries,
and especially with those states where large educational experience for this
subject was already gained, where large-scale research work is carried out.
To improve training programs in bioethics and its lecturing in the State
University of Medicine and Pharmacy named after Testemitianu N.A., a
famous Italian specialist in these spheres of practical philosophy, Pietro
Cavasin, give lectures to students and doctor candidates for 5 years in the
State University of Moldova. There was constant exchange of both scientific
and educational literature here.
Since 2004 we expanded relationship with foreign colleagues as to
training of high-qualified specialists, i.e. through post-graduate and master
studies in bioethics. Anna Marin, post-graduate of the Department prepares
dissertation in bioethics under guidance of two specialists now: Doctor of
Philosophy Raymond Massé – Laval University (Canada) and professors
of our Department. Two professors of the Department gained master
degree majoring in bioethics in French in Bucharest, and one more staff
member got training in the University of Angers (France). All expenses
on implementation of these projects were covered by the French-speaking
Agency for the Republic of Moldova.
We consider for the future (as a suggestion) as useful and, more important,
as necessary development and publication of a text-book for the University
students under the title The Fundamentals of Bioethics by scientists of the
CIS countries. It could be started now without any long-term delay, let’s say,
from January 2007 under general scientific and methodological guidance of
heads of departments where this subject is a part of a curriculum of a higher
educational facility, where it is taught, where teaching aids were published, and
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some experience in this sphere was gained. At least, our Department as well
as plenty of other groups from other countries are ready to participate in such
project. It would be rational and useful to organize regular educational and
methodical workshops for professors lecturing bioethics in scientific Centres
of different CIS countries (Kiev, Moscow, Chisinau, Baku, Yerevan, etc.)
We also consider as useful the initiative of Moscow colleagues with
participation of other CIS countries on development of a training course in
bioethics for highest qualification specialists with duration of 320 academic
hours (it is possible to reduce the time if to consider that information sciences
and foreign languages were already taught to young university professors of
higher educational facilities). This is the beginning of the large work and we
hope to see it finished in the nearest future as a good example of cooperation
among the CIS countries.
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3.8 Russian Federation
(G.L.Mikirtichian, A.F.Nikitina, A.S.Sozinov,
M.E.Guryleva, E.A.Malysheva)
During the period of its existence Russian medicine has accumulated the
great volume of ethic knowledge both in theoretical research and in practice.
Founding and development of medical ethics as predecessor of bioethics in
Russia was determined by social and economical factors, historical, cultural
and national features, religious and moral traditions of the peoples living
over the country.
Chapter 5 From the beginning Russia was multinational state with
multinational neighbors. This multinationality influenced the foundation of
Russian culture. Geographical position of the state at the junction of Europe
and Asia resulted in ambivalence of people nature and state organization as
European as Asian and gave birth to a philosophical concept of eurasianism,
that was founded by one of the most universal Russian thinkers abroad
N.S.Trubetskoy (1890-1938). D.L.Lihachev believed that universality and
belonging to East and West were the most characteristic features of the
Russian culture (14). Junction of East and West civilizations, crossing of
two pole streams of culture, which pushed off each other and could not be
joined but co-existed, have determined such features of Russian soul, as its
polarity, apocalyptic character and nihilism, which “do not admit a middle
kingdom of the culture” (1).
Habitat, the geographical position, nature and climate where people
were settled in the result of historical processes of moving and settling,
determined the formation of Russian national character. Famous historian
V.O.Kluchevskiy believed that external nature always and everywhere
determines the mankind in different way. The different determination
specified features of people, first of all everyday and mental, which form
the national character; in this case they are the humanitarian foundations
characterizing Russians (9).
Russian ethnos originated and evaluated on great Russian plains that
determined particular life style and view on external world, so-called
“Russian soul breadth”. Social surroundings, relationships and labor system
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had the great influence on formation of the Russian national character.
Humanity, placability and openness of our ancestors soul were formed
under the influence of their main activities such as arable farming, cattle
breeding and workmanship, and of community social order, which had been
lasting longer then at other peoples. Among values of community it should
be mentioned justice, power of “world”, thrifty housekeeping, knowing of
folk wisdom, bogatyr (a Russian hero) strength, etc. Having given voluntary
his destiny over to the community, man condemned himself to be tolerant
and obedient. The community, by means of which the Russian people were
able to keep their ethnos independent in spite of numerous invasions, had
also the high value. For the sake of the community a Russian was ready
to suffer, tolerate and sacrifice almost everything. Nevertheless, historical
facts demonstrated examples of “Slavic freedom” from Cossacks, drinkingbouts, revelries, disorder, “fantastically fast life” to rebel and revolutions.
The Russian culture is well known to exist inasmuch as Russian
(and Old Russian) words meaning cultural contents exist. Contemporary
analysis of the word “personality” (autonomy of “personality” is one of
the principles of bioethics) in Russian and European languages showed
that word “personality” is rather young for the Russian language, it was
absent in the Old Russian language and in the modern Russian it handed
its meaning to word “person” (15). As regards the notion “individuality” it
has been adopted slowly and hardly in modern word usage. This fact differs
Russia from Western Europe where individuality became the main value of
the Modern time. The idea of person, personality itself began to form here
in XIII century. And today in Western Europe the notion of personality is
central, important as daily bread, and it is not high but everyday, though in
Russia the word “personality” is in one row with the high notions and its
meanings are not everyday.
Speaking about language as means of communication one should
note one more feature which is important for doctor-patient relations. The
Russian language in contrast with the Romance and German languages is
synthetic, not analytical, i.e. it may be axiomatizated hardly but is able to
express emotions and feelings (22,27).
Folk proverbs are very important feature of ethnos awareness and
national mentality. They accumulate important conclusions and observations
about nature and society laws. Many of them assert group priority over
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personality, collective things priority over individual, necessity to obey any
group law. Man strength is in his group membership, whilst his personnel
responsibility is vogue (25).
Russians were characterized to have many interethnic contacts with
people of different origin, cultural traditions and language that influenced
undoubtedly the general Slavic culture foundation. Connections with
Byzantine, a godmother and keeper of ancient civilization where Orthodoxy
became a state religion, were the most fruitful for the Old Russian culture.
Together with adoption of Christianity a Byzantine philosophy related to
the Plato’s Hellenism, which gave it anthropological and historiosophy
orientation, had penetrated to Russia. Anthropocentrism of Russian
philosophical researches became one of characteristic principles of Russian
philosophy. From Nil Sorskiy to A.N.Radischev, from Radischev to Soloviev
and Berdiaev a Russian thought has been always attracted by cognition of
mystery of person, his death and immortality (3). The Russian philosophy
created “philosophy of life” long before birth of western European
existentialism and pragmatism. Peculiarity of the Russian philosophy is in the
fact that the Russian thought has always been (and will be forever) connected
with its religion element and grounding and inspiration of freedom valued at
any time by Russian minds had never died inside of church awareness. First
of all everywhere dominance of morality evidences that. We can see it in
works of nearly all Russian thinkers even those who had no works devoted
to moral problems.
Adoption of Christianity determined evaluation of Russian spirituality
in subsequent periods. Founding on traditions of eastern orthodoxy, ideas
of spirituality, shame and conscience, love to neighbor were brought in Old
Russia, a spiritual foundation of charity as everyday piety was formed. Alms
as early form of personnel charity was spread among all social classes, it
was not only simple execution of commandment of love to a neighbor, but a
true need. It was personnel charity that created the foundation necessary for
helping the poor at the following times. It was forming morality, the most
important social and philological category of national self-awareness (16).
Establishment of monasteries on the north territories of Russia became
considerable event for keeping the original Russian culture. Their foundation
was connected with the names of outstanding well educated people with
universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
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Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of
Greek and Byzantium manuscripts were collected there. In Middle Age
Russia monasteries were not only religious institutions but presented a form
of people social life organization on the basis of common views (19).
Under church influence and with its participation care for people in
need for medical and social help was brought to life and principles of
mercy, charity, sympathy, concern were actively embodied. Together with
monasteries, monastery and church hospitals and hospices were founded,
monastery medicine appeared. Monasteries accumulated reserves of food,
which were used in case of national disasters, wars, epidemics and bad
harvest years. During that period they also defended people and served as
refuge for mentally persecuted, hungry people, for all people being needy,
mentally sick persons received help here, special wards were settled for
wounded soldiers.
Certainly, our ancestors could not be regarded absolutely irreproachable
in their moral live. The soul of Russians was so broad that there were
evidenced many vices and heave sins along with feat of great holiness.
F.M.Dostoevskiy had reason to say that there were two abysses in the soul
of a Russian man. Moral state of a Russian can raise him up to the heavens
or drop him down to depth of hell.
Following form of charity in Old Russia was zemsko-parish, which
based on church parish that was an administrative, tax and territory unit.
Self-organized financially independent parishes could keep and support
thousands of disabled, old people and orphans. In the 50’s of XVI century
they attempted to place a part of care for people health, social support
for sick and weak people on the state. Stoglav, a great council of Russian
bishops held in 1551, together with tsar and boyar Duma ordered to found
everywhere hospices for “leprous, aged, lying in boxes on the streets,
carrying carts and sledges and having no place to sleep”. “Desyatina”, the
tenth part of funds from sale of bread, cattle and from rent, was brought in
to keep churches, monasteries, hospitals, hospices and receive odd and poor
people. At the same time representatives of different social classes donated
money for church and charity needs.
Breakup between secular and church ideologies that began in the second
half of the XVII century became wider in the XVIII century. Peter I activity
is characterized with two mutually exclusive tendencies: strengthening
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of absolutism and europeisation of Russia. Implementing reforms for
strengthening of role of the state in all spheres Peter I included the Orthodox
church in government structure and strengthen state control on it and
consequently on church charity. On Peter’s initiative social charity became
state one. At Peter I times they took measures against beggary, parish as selforganized church and social unit was abolished.
At the same time in the XVIII century higher medical education was
formed in Russia. Hospital schools, medical department of the Moscow
University, surgery academies were founded. In these circumstances the
following feature of Russian nature revealed: to study and to alter forms and
methods of organization appeared in other countries. For example, based
on medical education system in Western Europe, in Holland particularly, in
Russia it certainly had disadvantages but it had no breakup between interns
and sergeants, between theoretical and clinical educations, students were
trained “at patient bed”.
Students of religious schools were studying medicine because of
specific features of the Russian society of the XVIII century. They were
raznochinets, Russian intellectuals not of gentle birth, they knew Greek and
Latin. This fact explains such features of Russian doctors and scientists as
democracy and patriotism, self-denying service to people. Activity of such
scientists as C.G.Zabelin, D.S.Samoilovich, N.M.Maximovich-Ambodic,
M.G.Shein, A.S.Shumlyanskiy exemplify it. Physicians of the XIX century
such as M.Y.Muromov, E.O.Mukhin. N.I.Pirogov, A.M.Filomafitskiy,
S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their
professional activity and civil position were based on moral ideals. They
wrote works where they discuss qualities characterizing a doctor, ethical
aspects of relations with society, patients and colleagues. In everyday activity
they pointed and solved problems, which were beginnings of bioethics
principles and rules. They used method of experiment, observing disease
activity and experimented on animals. At that time ethical approaches to
experiments were formed. So, A.M.Filomafitckiy (11807-1849), the first
Russian scientist, who made vivisection and surgery method as the base of
physiology, said: “... Experiment made by inexperienced hand and aimlessly
should be severely punished, especially if sufferings of an animal after
blood operation are lengthened without any need, but experiments made by
hands of a skillful and loyal observer are necessary for science and saving
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of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian
epidemiology, self-tested plague infection and its course. There were
negative examples. In the middle of the XIX century in Moscow foundling
hospital they were searching for substitute of breast milk for children, and
among others Libihovskiy beef broth was studied. As a result many children
fell ill and so it was concluded to be harmful (8).
One of the first who began to defend rights of prisoners on health and
medical help was F.P.Gaaz (1780-1853). In his everyday practice he defended
and implemented the slogan “hurry up to make good”, displaying humane
attitude to most miserable people such as exiles, convicts, he supported them
morally and gave medical and social help, took care about their children. He
both worked with selfless devotion and attracted unselfish assistants being
of different classes and generations.
Moral position of N.I.Pirogov (1810-1881) displays principle of honesty
in Russia. He paid special attention to medical mistakes. In contrast with
existing in medical society opinion he believed that every honest man should
be able to admit and proclaim his mistakes to warn against them not wellinformed people (24). Many Russian physicians became his followers and
were able to admit and analyze their mistakes. They were A.Y.Krasovskiy,
C.P.Kolomina, F.I.Sinitsin and others.
An issue of patient consent for surgery was discussed by physicians in
the past. N.I.Pirogov remembered in the Old Doctor Dairy, that an inspector
of medical institutions I.Rule required from doctors in the hospital not to do
any surgery without patient agreement.
The time since the end of the XVIII century till beginning of the
XIX century one can state as a birth of public medicine. First medical
papers, medical societies, public hospitals and chemist’s shops, charity
organizations were founded in Russia. One of the forms of public movement
was movement of narodniks, which in the 60-70’s of the XIX century became
mass ideology of intelligence not of gentle birth trying to be spokesman of
peasants. At the call of members of organization Narodnaya Volya (People’s
Will) Russian teachers and doctors went willingly “close to the people” and
went to work in the depth of Russia (13).
Conditions existing in Russia after abolition of serfdom such as
quick development of capitalism and industrial and urban growth changed
medicine very much. In the second half of the XIX century medicine became
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scientific and based on experimental methods. Medicine was differenced
and integrated. Owing to scientific and technical progress many discoveries
were made in biology and medicine, they changed conceptions of etiology
and pathogenesis of diseases, diagnostics and treatments methods were
improved. At this time many outstanding scientists, who gave us lessons
of morality, lived, and scientific medical schools were established. They
could not exist without succession between generations of researchers of
traditions of handling not only knowledge and ideas but skills of research
and truth comprehension, way of thinking and work, peculiar cooperation
and creative work.
The Pirogov’s medical association became a Centre of public medical
thinking in Russia in the beginning of the 80’s. It grew from narrow
professional community of physicians into a specific forum of Russian
intelligence discussing social, political and moral problems. Its founders
and leaders were famous physicians N.V. Sklifosovskiy, S,S, Korsakov,
A.Y. Krasovskiy, F.F. Arisman, E.A. Osipov, G,E. Rain and others. The
association held Pirogov’s congresses where the most urgent problems of
medicine health protection such as fight against epidemics, management
of medical care, medical organization at the front and home front and
others were discussed. Congresses sent to the government decisions and
applications and though most of them were not answered some of them
were followed by orders. They were: decision on foundation of the Women
Medical Institute (1902), manifest of corporal punishment abolition for all
peasants in Russia and some others. Many times the Pirogov association
discussed ethic issues such as status of physicians in Russia, problems of
private practice and treatment payment, physicians’ mutual aid, physician
right to treat without patient and his relatives’ consent and others (12).
One more considerable page of Russian public medicine history has
moral accent and is connected with struggle of progressive public persons for
women rights and their political emancipation, the right for higher medical
education and independent practice. Progressive university professors,
scientists and writers supported these demands. Supporters of equal rights
for women were S.P. Botkin, I.M. Sechenov, A.L. Krasovskiy, P.F. Lesgaft,
V.L. Gruber, etc. They opened the door of their classes for first women and
give them equal opportunities with men. Progressive media magazines and
newspapers such as Medicine bulletin, Modern medicine, Saint-Petersburg
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Bulletin wrote about a need for the country to have women-doctors, about
their role in propagation of hygiene, necessity of treatment of women whose
shame often “results in great evil in medical practice”. Foundation of the
Higher Women Medical Courses (1872, 1876) was the beginning of higher
women medical education in our country, thus, Russia left behind almost all
European states, besides Switzerland and the USA (the College of 1864).
Courses could exist only on private donations. Means were collected in
favor of the Courses. Zemskiy doctors sent part of their salary in favor of the
courses. Association of mutual aid of women-doctors founded in 1890 was
very useful. In 1897 efforts of progressive society resulted in foundation
of the first Russian Women Medical Institute, which was opened in SaintPetersburg (now the Saint-Petersburg Medical University named after I.P.
Pavlov).
Events in medicine and health protection happened in period from 2nd
half of the XIX — beginning of the XX century stimulated development of
medical ethical ideas. Many old problems became more acute and new ones
appeared, relations of doctor and society, doctor and patient, intercolleagueal
relations in medicine were changed. Russian physicians were characteristic
of not only speeches and declarations, talks about duty and morality but of
deeds, behavior, example, and demonstration – quite often during dozens of
years or even during their whole life - of what a doctor should be.
Open discussion of “complicated” medical issues not only inside
of medical society can be considered as a root of such bioethics feature
as openness, transparency, necessity in public monitoring of biological
researches.
Development of a method of chronic experiment in animals is linked
to the name of I.P.Pavlov (1849-1936). In 1876 at the Botkin’s clinic of the
Medical Military Academy in Saint-Petersburg an experimental laboratory
was founded. In 1878-1889 I.P.Pavlov made his researches here. Approval
of experiments with animals as a basis of medicine resulted in usage of
many animals and their death. It caused reproaches to experimentalists in
cruelty, their accusation in misuse of vivisection. In reply to the letter of
the Russian association of animal patronage “On vivisection as shocking
and useless misused in the sake of science” of January 17, 1904, the
commission consisting of professors P.M. Albitskiy, I.P. Pavlov and N.P.
Kravkov was founded in the Medical Military Academy. This commission
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presented its conclusions on this letter. Conclusions showed disagreements
with accusations, the statements of the letter were named anti-scientific and
sanctimonious. Nevertheless this case forced to think about humanity of
experiments in animals and improvements of conditions of their keeping.
At the same time legitimacy of trials with human subjects is under
discussion in the society. In connection with achievements in microbiology
doctors by way of self-experimenting researched contagiousness of infectious
diseases even the highly harmful ones. Self-experimentations carried out by
physicians have never been disapproved of; they were rather perceived as
acts of heroism and admired. There were a great number of such examples.
In 70-s of the XIX century O.O. Motchutkovskiy, a physician from Odessa,
several times made self injections with blood samples from patients infected
with epidemic typhus and got severely diseased. After injecting themselves
with blood samples from patients infected with relapsing fever, G. N. Mikh
and N.I. Mechnikov also suffered through severe illnesses. N.F. Gamaleja,
N.I. Metchnikov, D.K. Zabolotnyi, M. Pettnkofer took pure culture of
cholera vibrio. Such examples can be continued.
In relation to experiments with other human subjects many researchers
were guided by the respectful opinion of S.P. Botkin (1832-1889): “It is
evident that trials with human subjects are permitted only in extraordinary
cases when we can be sure of their harmlessness otherwise we resort to
experiments with animals, conditions for our observations being significantly
simplified”.
In early XX century a book by V.V. Veresaev “Doctor’s notes”
produced great social aftersound. It can be regarded as social and cultural
assessment of many problems in medical ethics which are of concern even
today in the rise of the XXI century. It contained sharp criticism towards a
common practice of that time to neglect patients’ rights and needs including
subjects of biomedical research. V.V. Veresaev (1867-1945) provides
ample evidence of cruel experiments with human subjects and puts under
question the researchers’ reports that these trials were performed with those
people’s consent. V.V. Veresaev was courageous to disclose and put under
public scrutiny the secrets of medical community. Thoroughly, providing
great number of examples he showed the destitute position of an average
practicing doctor, his vulnerability. And at the same time he stressed the
high requirements that the community imposed over a physician (5, 6).
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V.A. Manassein (1841-1901), a noted general practitioner, editor of
“The Doctor” magazine, a person who won a name of a ‘knight of medical
ethics’, ‘conscience of medical community’ stressed the necessity for a
doctor to comply with medical confidentiality even at the expense of his
own benefits. A contrary position was expressed by a denoted lawyer A.F.
Kony (1844-1927), who considered that in situations of grave threat needs
of the society should prevail over the ban to disclose patients’ secrets. At the
same time he advocated the idea of sticking to medical confidentiality after
a patient’s death. A.F. Kony also stipulated the conditions which allowed
active euthanasia both legally and ethically.
In he beginning of the XX century it was acknowledged that relationship
of physicians with the community require dramatic revision especially when it
comes to correlation of a doctor’s right to perform medical assistance essential
for a patient and consent of the latter to have it in terms of observing or violating
the principle of physical integrity (“Court newspaper”, 1901, №№ 51, 52) and
also about the legal grounds and limits of criminal responsibility for the harm
caused to patients health (‘Law”, 1902, №51). The issue to what extent the
patient’s consent for medical treatment should be based upon his conscious
understanding of the nature of this treatment especially if it is performed not
only for the benefit of a patient but out of experimental needs. Prominent law
experts A.F. Kony, N.G. Tagantsev, I.G. Sceglovitov, S.N. Tregubov and others
come to join this discussion. According to Professor of Criminal Law N.G.
Tagantsev “patients consent is incapable of setting impunity to all medical
cases”. The fundamental principles of biomedical research in connection with
thyroid gland transplantation were described from both legal and ethical sides
in 1917 in an article by B.V. Dmitriev, a physician who worked for a machine
factory in Kolomna and whose expertise was based on the consultation
that the author obtained from A.F. Kony (12). Considering legal aspect of
a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked:
“Whether a physician is granted any right to cause even minute and fleeting
harm to a healthy person for the sake of another human being? Whether he is
competent to decide in every particular situation if the benefit for one patient
compensates for the harm done to the other, having the widest sense of the
words benefit and harm in mind, that means not only in relation to physical
health of these individuals but taking into account a complex of spiritual and
physical strength of both?”.
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In response to these concerns Doctor Dmitriev stated the main
provisions of implementing a medical research, the most essential of which
are providing information and obtaining a conscious consent (of a donor in
this case) which fully complies with the modern requirements. The same
article provides a text of the first Russian full-scale minutely formulated
patient’s informed consent form which retains its actual continuity up to
contemporary time.
Achievements of academic medicine did not significantly influence
public health factors and demographic processes. Mortality and morbidity
rates among population were high, infant mortality was common, there
were many physically retarded children. Russia was shaken by epidemics
of epidemic typhus, cholera, smallpox, malaria, and diphtheria and other.
Medical facilities were scattered between different authorities and were
mainly financed through beneficent funds.
The number of physicians and hospitals was inadequate to provide
citizens with medical service. In late XIX – early XX centuries there were 10
hospital beds and 1.8 physicians for every 10000 people in Russia. Medical
service was mainly available in large cities. Out of 257 sanitation physicians
135 worked in Moscow and Saint-Petersburg. According to the data of 1913
allocations in health care accounted for 91 kopeks, for sanitation – 1.25
kopeks per year per capita. The major, rural, part of Russian population
was almost completely deprived of medical service. In these conditions the
position of F.F Erisman and V.V. Veresaev is a notable one, they called for not
staying indifferent to the reasons inducing such situation, not to “powerlessly
grumble about the unfair destiny”, but to consider it a moral duty to “take all
possible steps to prevent such undue events from happening”
Development of country medicine was a great event, the establishing of
which was tightly connected with the community mode of life characteristic
of Russian people and with the so-called country self-administration
introduced in the 60-s of the XIX century. Subsequently, country medicine
widely implemented in 34 provinces in European part of Russia (in 1911 6
more were added) appeared at that time most reasonable form of medical
service for rural population and was unique to our country.
The most important achievement of country medicine, which was far
ahead of its time, was a declared and practically implemented combination
of medical and sanitary activities. In the frameworks of country medicine
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the approach of providing local service for rural population was introduced,
the approach that made its way successfully through time and up to now is
applied in health care systems of many countries. It was the country doctors
who came up with the idea of sanitary and preventive activities as priority
in health care. Up to the present day in rural health care the stage-by-stage
approach is applied in medical service provision. Great impact was made
in the development of medical statistics and expanding medical geography.
Moreover, country doctors strived for introduction of free medical service
not only out of general humanistic ideas but also because of understanding
that even a smallest charge for medical advice, medication, and in-hospital
treatment decreased seeking for medical help. And this deprived country
physicians, in particular, of an opportunity to detect contagious cases in due
time and efficiently combat epidemics, which meant undermining social and
sanitary significance of country medicine as such.
The key features of country medicine were determined by country
physicians who were greatly influenced by ideas of democracy, had deep
community links with peasants, and considered it to be their duty to protect
the peasants’ interests. That is why one can say that the period went a long
way with reinforcement of pattern like approach in Russian medicine.
Many of the practicing country doctors were active both medically
and socially and grew into eminent representatives of public medicine
(E.A Osipov, I.I. Molleson, P.I. Kurkin, F.F. Erisman and others). The main
treasure of country medicine were medical doctors, whose itinerant activities
were described by such remarkable Russian writers and physicians, who
themselves received first-hand experience of country medicine, as A.P.
Tchekhov, V.V. Veresaev, M.A. Bulgakov.
“Country medicine with its relative freedom and opportunity to
study, educate, and serve people attracted good number of conscientious,
ideologically aware colleagues, - noted country doctor S. Igumnov during
the 11th Pirogov conference - neglecting personal comfort, abandoning
attractive and profitable careers, went into country medicine, moved to
remote rural areas, dark and cold shanties; some doctors hired themselves as
medical assistants, worked for salaries of medical assistants; some shared one
job and salary; sometimes refused part of the salary for the sake of building a
hospital or organizing a new health locality; perceived country medicine not
as employment but rather as a moral duty”. However, Igumnov mentioned:
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“I am far from idealizing that time and certainly far from thinking that all
physicians of those times were ideologically aware and inspired by ideas of
populism. Those were a minority and even a tiny minority, but it was that
minority that coined country medicine”.
Russian physicians more than once informed the international community
about achievements of country medicine and it obtained due reputation and
recognition overseas. Thus in 1934 the League of Nations Committee for
Hygiene advised other nations to adopt the practice of country medicine in
order to provide rural population with due medical service. It was confirmed
in 1952 in the World Health Organization Assembly guidelines on country
medicine development. Importance of organizing medical service by health
localities, the approach introduced alongside with country medicine, was
well demonstrated at the WHO conference on primary medical and sanitary
care issues in Alma-Ata in 1978.
It is important stress the role of country medicine in public health care
system setup after October 1917. Almost all of its main trends – such as
free service and accessibility, preventive trend, involving the community,
the citizens themselves into health care, integrity of academic and practical
medicine – became determining aspects of the Soviet health care.
After the revolution of 1917 medical ethics in the USSR underwent it
way of development and was influenced by a range of factors.
Medicine started to be perceived from a position of class, individualistic
bourgeois medicine being matched against collectivist and proletarian,
which led to neglecting a personal value of a human being and it absolute
humility to social use. In terms of ethics and morality key significance also
belonged to class approach. It was promoted that medical ethics represented
corporate and class ideology alien to the working class needs. In contrast to
medical ethics common ethical norms of communist morality were pushed
forward. These conditions altered social perception of a medical doctor. In
the early years of the Soviet regime a physician was seen as representing
hostile bourgeois class and should have been tolerated as a specialist
but was allowed to practice only under rigid supervision of the working
class. Subsequently, physicians suffered political and ideological pressure.
Unfortunately, repressions against medical professionals were started time
and again and they were accused of poisoning and killing both common
citizens and party and state leaders. Priority trends in medicine and health
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care were determined not by logical development of science and essential
needs but were rather dictated by economic policy, ideology and conformist
ideas.
Repressive measures taken against genetics, pedology; campaigns
restricting research in physiology, psychology and other areas that impeded
and even set back many promising academic and applied directions of
science can serve us a good example.
There was a target to stipulate ideology for a physician of a new type.
The contrast in moral portrait of doctors in capitalist and socialist societies
is rendered in the lines by first People’s Commissar for health care N.A.
Semashko: “Certainly among foreign physicians there are doctors who
perceive there duties the way their humane profession suggests them. But is
it a rule and what is an exception? This would depend on the ground where
these phenomena bud. Capitalistic ground is rocky and not suited to growing
humanistic ideas. If in a capitalistic society “dog eats dogs”, how can we
speak of any humanistic feelings? All this finds its way into a physician’s
behavior… It is clear that the problems of the so called medical ethics are
solved completely differently in our country and in the capitalist world.
Ethics for a soviet physician means the ethics of our socialist Motherland,
the ethics appropriate for a creator of communism; it is communist morality
which is above class distinctions. That is why we see the concept of medical
ethics and high ethical standards of a Soviet Union citizen as integral”.
Many achievements of ideas in medical ethics were declared left-overs
of capitalistic approach to medicine and should have been dumped to a
landfill of history. In this respect a bringing under discussion an issue of
medical confidentiality is natural and N. A. Semashko claimed “firm course
towards eradicating medical secrecy”, although in the years to follow he
came back to classical understanding of this problem.
Ambiguous attitude of governmental bodies to medical ethics brought
to life medical deontology (28). A prominent surgeon in oncology N.N.
Petrov in 1944 came to publish his work “Issues of Surgical Deontology”
which was reedited several times. It saw into many problems of doctor
patient relationship like providing information and obtaining an informed
consent form, which are first and foremost principles today. Deontology
provided an opportunity to sustain public attention to staple points of
humanism in medical practice.
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In the 60-70’s the interest towards medical deontology grew. Five AllSoviet Union conferences were devoted to the issues of medical deontology,
first of which took place in Moscow on January, 28-29 in 1969. One could
then observe a singular outburst of publications on aspects of deontology
in different fields. A two volume manual “Deontology in Medicine”,
published in 1988 and edited by academician B.V. Petrovskiy exercised
great influence.
Management and funding in medicine and health care in the Soviet years
were of centralized character and were characterized by well developed
intrabranch links, which were mainly supported by administrative and
bureaucratic type of management and planning gaining a narrow corporate
nature and becoming almost unavailable to public control. A medical doctor
became a civil servant, whose activities were regulated by great number
of departmental guidelines and to a large scale were limited to drawing
reports.
Nevertheless, within relatively short time period based on virtually
efficient grounds and principles of public health care system a coherent
framework of medical, preventive treatment and epidemiological services
was organized. Assessment of health care system developments was done
primarily quantitatively, but qualitative data within this field showed
impressive success. Many infectious fevers were eradicated, infant mortality
drastically dropped, average life expectancy increased. Effectiveness of
primary medical was distinguished by the medical community in 1978
during the WHO and UNICEF international conference in Alma-Ata
(Kazakhstan).
Many achievements in medicine and health care were made due to
enthusiasm and responsible attitude of medical professionals, retaining ideas
of self-denying and generosity in medical community, pursuit of classical
ideas of medical ethics.
Gradually in the 70-80’s in the society there started to occur
shortcomings underpinned by lack of attention that the government paid to
social spheres including health care, insufficient budget allocation that led
to decline in provision of up-to-date technical equipment and medications,
failure to comply with capital construction projects and health care facilities
reconstruction plans, low and leveling salaries for medical staff, lack of
opportunities to immediately apply recent developments of medical science,
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low availability of quality medical service and other. There were indicated
adverse trends in public health, in medical and demographic values: drop
in birth rate, growth in mortality rate, decrease of mean life expectancy.
Retaining an essential principle of free medical care health care system
found itself unable to meet the citizens’ needs in provision of high quality of
service. Various forms of financing medical service started to be implemented.
Apart from that the declared idea of free service brought up consumptive
attitude to medicine among citizens, lowered public responsibility for their
health issues, deteriorated medical activity of citizens. There was indicated
a multilevel approach in medical service provision for different groups of
patients. With the growing differentiation and narrow fields of medical
activity and no relevant integration processes there occurred “fragmentation”
of medical responsibility, weakening of the inner moral control mechanisms,
perception of a patient as one whole was lost. In these conditions the
controversy between the declared moral principles of medical service and
the way they were put into practice became outstanding. Staples of medical
ethics alongside with legal standards became increasingly irrelevant to
real life social practices. In medicine moral strain became ever increasing;
such vital principles as humane and respectful attitude to a patient, medical
confidentiality were violated. Increasing intensity of flaws in the field of
ethics resulted in decline in medical doctors’ prestige and influence in
society, aroused disaffection with their work among doctors, affected the
moral climate in the society in general (10).
All these issues developed alongside with lack of regulatory framework
in the environment of legal and ethical unpreparedness of the citizens to
work in new economic situation on the one hand and the growing application
of new medical technology on the other.
Political, economic and social reforms in the XX century 90’s badly
affected all areas of social and spiritual life of people. Unfortunately they
were not scientifically proved and never underwent ethical evaluation.
The following years demonstrated that immoral economy does not prove
effective. But above all – drastic large scale changes in the country
significantly influenced the state of mind and mentality of the general
public suffering through the pressure of social changes. Because of being
psychologically unprepared for the current events, for the suddenly acquired
freedom both individuals and certain social groups showed deadaptation
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which was demonstrated through manifested sense of social destitution and
injustice, extraneity to novel social norms, culture and values, awareness
of helplessness and alienation (2). The results of the social surveys
demonstrated “collapse’ of such traits, traditionally characteristic of the
Russians, as friendliness, warm heartedness, sincerity, self-forgetfulness”
alongside with the evidently growing manifests of aggressiveness and
cynicism (23). All this drastically affected medicine and health care,
the medical community and the eventual patients. Availability of not
only technology intensive methods of diagnostics and treatment but also
common routine manipulations, vitally essential medications dramatically
dropped. A far more important role in the market economy environment
now belonged to private commercial firms, companies and foundations,
which implemented research of new medications and promoted them in
the pharmaceutical market as part of their business activity, often being
driven by the idea of profit and seeing pragmatic solution to problems at
the expense of ethics and morality as priority.
Changes in the social and political life of Russia, setback from principles
of socialism made creating health care model in the new environment
a burning issue. And the most complicated task was to work out new
approaches at the same time retaining the entire positive that with no doubt
the previous experience of health care development in Russia contained.
In this respect the most critical issues are those related to fair distribution
of limited resources in health care, determining priorities of allocation,
organizing supervision of these processes.
It became evident in early 90’s that without ethical framework integrating
into the world community would not be possible. Publications on issues of
bioethics started to occur (I. Frolov, B. Judin, P. Tistchenko, I. Silujanova,
N. Sedova, E. Mikhailovska-Karlova, V. Orlov, V. Vlasov, A. Ivanjushkin,
A. Zilber, R. Korotkikh, M. Jarovinskiy and others) Great impact was made
by the Human magazine (editor in chief B. Judin).
The 90’s in Russia saw the set up of infrastructure in bioethics, 5
Central Committees on Bioethics were organized. First in 1993 there
was established the Russian Academy of Science National Committee
on Bioethics. It was followed by the Committee of Presidium of Russian
Academy of Medical Science, Committee of Russian Medical Association
(RMA), Committee of Medical Doctors’ Association, and Committee of the
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Russian Federation Public Health Ministry. After the RF Act On Medical
Agents and in compliance with article 37 of this act there was established
the Ethical Committee of Federal Agency for Control over Medical Agents
(prior to that ethical evaluation of clinical research protocols was carried
out by the Special Board of RMA National Committee). In the same
2000 year a spearhead of health care professionals set up the Independent
Multidisciplinary Committee on Ethical Evaluation of Clinical Research
which was aimed at answering various requests and appeals on voluntary
basis. Local and regional ethical committees are set up with lower activity
but their number gradually grows (22).
The current stage is characterized by booming information and
communication technology, rapid development of market economy, drastic
changes in demography, persistent urbanization process, and trends towards
development of open society. Signs of two controversial tendencies:
globalization on the one hand and on the other – increased attention of
people to their national and cultural traditions.
After seventy years of atheism as state ideology and withdrawal from
those ideas and values that the society was governed by, the caused moral
vacuum in Russia failed to be compensated with a more or less integral
framework of secular ideas and values clear and conventional to people and
capable of appealing to people and give them hope. A distinguishing feature
of the Russian society is that conventional factors invariably play significant
role in many walks of social life, adherence to traditional ideological and
social values which saw little influence of the changing social and economic
systems, political regimes as well as fresh social and ideological paradigms for
development declared in the recent decades of the XX century. Under any state
system – monarchical or collective type, totalitarian or liberal – an impact of a
number of constants which determine a civilization portrait of Russia is feasibly
evident. Among them a crucial role belongs to religion, first and foremost the
Orthodox Christian Church which by masses of population is perceived not
only as an institution with the main function of not just disseminating the
ideas of Christianity but mostly as preserver of the Russian national values
and traditions (by different social studies three fourths of believers who are
almost half of the population in Russia are Orthodox Christians). The same can
be said about the Islam – second confession in Russia in terms of adherents’
number and influence (about 19% among believers) (20).
240
Today religious organizations prove active in most different fields:
religion itself, education, health care, culture, charity and mercy, business
and economic. Changes occurring in the society and the Church demanded
for a comprehensive philosophy that would reflect general attitude of the
Church to issues of state and the Church relations and concerns of the
modern society on the whole.
At the Anniversary Episcopal Assembly in 2000 the Basic Social
Conception of Russian Orthodox Church was adopted. The conception falls
into 16 sections covering most various issues related to life of a Christian
believer in secular world. In section 11 – “Public and Individual Health” – the
attitude of Orthodox Church to disease and health is rendered, importance of
church activities in health care is stressed, necessity of society and church
cooperation in public health care issues is emphasized. It covers such vital
from religious viewpoint principles as doctor and patient relationship which
should be based with respect to integrity, free choice and “personal dignity”.
In particular it stresses: “We should by all means encourage a dialogue
between a doctor and a patient that is characteristic of current medical
approach. This approach is undoubtedly engrained in the Christian tradition,
although there is a temptation to relegate it to a level of merely agreement
relationship. At the same time one should admit that a more conventional
“pattern like” model of physician and patient relationship which is fairly
criticized for numerous attempts to justify medical power abuse may as well
represent a truly fatherly attitude to patient that depend on doctor’s morality.
Not giving preference to any of the health care organization models the
Church considers that this service should work efficiently at its maximum
and must be available to all members of society disregarding their financial
and social status even with limited medical resources distributed. For such
distribution to be fair the aspect of “vital requirements” should prevail over
the aspect of “market relations”. The doctor should not see the degree of
their responsibility for medical service in relation with financial reward and
its amount only by this turning his profession into pure profit making. At the
same time decent payment for medical professionals is seen as an essential
task for the society and the state (26).
Section 12 “Bioethical Issues” shows the official position of RCOC
on a range of aspects which currently are concerning in the society and are
brought about by blooming development of biomedical technology in late the
241
XX century. These completely new challenges are once again comprehended
and reinterpreted in the context of ideas of human life and personal dignity
which are entrenched in the “Divine afflation”. It shows attitude of the
Church to abortion, new reproductive methods, medical genetic methods
of diagnostics, tissue and organ transplantation, reanimation and help to
the parting, sexual issues. Moreover some sections of the social conception
are devoted to the questions of marriage and family, psychological health,
problems of drug and alcohol addiction, health care and the ecological
environment (7).
The current trend is towards younger age among religious groups of
society. A study by VCIOM showed that 58% of young Russian citizens
under the age of 25 refer to themselves as Orthodox Christians, a similar
trend can be observed among adherents of the Islam.
It should be particularly stressed that among young believers patriotic,
pro-governmental ideas, believe that there is a necessity to restore the decent
position of Russia in the world community, strive for order, strong power,
collective like, collegial philosophies, support of the current government
and antagonism to liberal western ideas prevail. A common trend among
all young interviewees, disregarding distinctions in their philosophic and
religious ideas, towards moral and spiritual values is demonstrated, for
instance, the way they reacted to the concept of ‘morality’ (positive 87.9%
among believers and 81.8% among non-believers, negative 12.1% and
18.2% respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular
part of young believers and non-believers advocates the idea of paternal
mode of relations, sticks to the idea of conventional patriarchal views in
family pattern, supporting filial piety within the family, male dominance in
family relations (believers 28%, non-believers 21.9%).
For the Russian medicine and health care a paternal model of doctor
and patient relations is a typical one. Genesis of these relations can not be
seen apart either from economic and cultural development of Russia on the
whole or from the ethical staples of medical activity in Russia. Orthodox
theological ideas and Russian religious philosophy to a significant extent
reinforced the paternal model of doctor and patient relations, promoting
ideas of humbling, non-resistance, and respect to universal hierarchy.
242
Developments in medical science and biotechnology increased the
power and responsibility of a medical doctor in terms of understanding what
life and death and use harm mean. A simultaneous turn of mind in social
ideas and mentality of people brought about by a wide spread liberal ideas
gave a great impetus to new attitudes based on ideas of personal rights and
freedom. All this entailed a necessity to seek for such grounds in doctor
and patient communication as recognizing patients’ autonomy, their right
for identity and decision making. Process of shifting towards non-paternal
model in our country is not a smooth one.
One can judge about the steadiness of paternal model by numerous
interviews among doctors and patients carried out in recent years. The results
of medical and social study in the St-Petersburg Pediatric Academy in 20022004, viewpoints of doctors and citizens on the staple issues of medical
ethics (bioethics) depending on their status revealed that currently only
few doctors as well as their patients are prepared to apply an antipaternal
relationship model in practice (17, 18). Big number of doctors sticks to
paternal positions in communication with patients. This situation is also
seen as psychologically favorable by many patients who lack desire to take
decisions for their own health issues either partly or completely, they are
happy to shift this responsibility to doctors.
The study reveals that attitude of many doctors and patients to current
biotechnology is not yet coined; there is no solid ethical basis. Opinions
of church-going interviewees differs drastically from that of non-believers’
and to greater extent meets the provisions of religious and medical ethics.
At the same time among church-going doctors great number of interviewees
proved not prepared to solving current ethical tasks and either refused to
answer questions of the interview or found them too challenging.
Russia has not yet determined the answer to the question of referring
itself to a civilization – Western or Eastern. In the early 1990’s the strategy
was linked to the opportunity for Russia to be integrated into the Western
community, and it was first of all seen through attitude to values and interests.
Integrity of values in Russia and in the West is retained today in recognition of
such values as freedom, justice, material well-being and other. However, our
country yet has not seen them implemented fully. Establishing value system in
the field of medicine which represent perhaps the most conventional block in
the general system of values is still under way. In the mentality of citizens of
243
Russia the principles of identity typical of the West are still underdeveloped.
The basis of human rights theory is yet being established. Majority of Russian
citizens as social studies show, reject the imposed ‘alien’ communication
schemes, for instance, the Western view over various issues of personal and
social life not out of reasonable arguments or some ideological efforts but out
of their inconsistency with customary ideas and values.
This gives grounds for discussion and implementation of the bioethical
staple principles and provisions in countries with various ethnic, culture
and religious traditions, creates challenges because of peculiarities and
inconsistencies between the Russian and western ethical systems in health
care and medicine. In this respect it is reasonable to draw guidelines and
interpret specific regulations and acts and their provisions taking into
account two main aspects: culture and ethnical traditions of given states and
their compliance with the common norms of international laws in the field
of bioethics.
References
1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov:
EKSMO Press Folio, 1998, 736 p. (herein and hereinafter in Russian)
2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
Citizens. Human, 2002, №6, p. 21-31.
3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
early XX cc. StP., 1994.
4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p. II, p. b.
5. Ivanjushkin A.J. Medical ethics in Russia (XIX - early XX cc.). In
bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
6. Ivanjushkin A.J. History of medical ethics and biomedical
experiments in human and animal parties. In bk.: Introduction to bioethics.
М., 1998, p. 95-133.
7. Cirill, metropolite. On «Basic social conception of Russian Orthodox
Church». Anniversary Episcopal Assembly RCOC. StPb, 2000, p. 133-149.
8. Klementovskiy А.I. On application of Libikhov meat extract (broth)
for a child at the breast. Moscow medical newspaper, 1859, №34, p. 269272; №35, p. 278-280; №36, p. 285-287.
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10.Korotkikh R.V. Legal and ethical issues of health care in Russia
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11.Koshtojantz Kh.S. Study on history of physiology in Russia.
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Russia. StP, 1907, p. 4.
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on problems of information and obtaining informed consent form. In bk.:
Actual problems of diagnostics, treatment and disease prevention, issue. 3.
StP, 2004, p. 291-302.
18. Mikirtitchan G.L., Filimonov S.V. Results of social study attitudes
among doctors and patients to some genetic methods. International
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p. 52-56.
19. Mirskiy М.B. Medicine in Russia XVI - XIX cc. М., 1996, p.
301- 309.
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27.Judin B.G. National specific of establishing bioethics in Russia. In
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528 p.
The ethical review of biomedical research involving human subjects is
the important component in rights, interests and dignity of human subjects
and in the same time is the necessary condition for further development of
medical science and technology.
The basis for legal regulation of biomedical research and its ethical
evaluation is laid by a complex of international acts both of legal and ethical
character.
First of all we could mention Nuremberg Code (1947), the Declaration
of Helsinki (1964, with all further revisions) – the documents which in
many points determined the Russian policy on regulation of biomedicine
and healthcare sphere22.
The serious stimulus for Russian domestic legislative activity and for
biomedical practice is also produced by other documents of recommending
character, which are devoted to general and specific questions of biomedical
research. Here are some examples of such documents: International Ethical
Guidelines for Biomedical Research Involving Human Subjects (1982,
1993, 2002), International Guidelines for Ethical Review of Epidemiological
Studies (CIOMS, 1991), ICH GCP (1996), Operational Guidelines for Ethics
Committees that Review Biomedical Research (2000) and others23.
“Nurnberg code” (The sentence of Nurnberg Tribunal)//Medical doctor.1993. N7, Helsinki
Declaration (WMA) 1964//Collection of official documents of Association of medical
doctors of Russia: medical associations, medical ethics and general medical problems/Ed.
V.Uranov. M.:PAIMS.1995.
23
International Ethical Guidelines for Biomedical Research Involving Human Subjects
(1982, 1993, 2002)//World Health Organization, Geneva, 1993, International Guidelines for
Ethical Review of Epidemiological Studies (CIOMS, 1991)///CIOMS- Geneva. – 1993, ICH
Harmonized Tripartite Guideline for GCP //http://www.ich.org/LOB/media/MEDIA482.pdf,
Operational guidelines for ethics committees that review biomedical research http://www.
who.int/tdr/publications/publications/ethics.htm.
22
246
The intention to accede to Convention for the Protection of Human
Rights and Dignity with regard to the Application of Biology and Medicine
(Council of Europe (1997)24 which is the fundamental document for
biomedical research and which imposes legal obligations for countries-parties
was expressed by the Russian Federation in 1998 in the Order of Ministry
of Health of the Russian Federation N 248 “On organizing of biomedical
ethics committee of Ministry of Health of the Russian Federation” of 30
December 199825. However, this intention is still not realized. That is why
the Convention, as well as the Additional Protocols to this Convention,
particularly the Additional Protocol concerning Biomedical Research are
still the only recommendations for the Russian Federation, although the
recommendations of great importance26.
Many other international acts of universal and regional character
concerning special situations in the sphere of biomedical investigations;
medical practice and its ethical expertise play a guiding role in biomedical
study legal regulation in Russia27.
Evaluating the system of Russian legal documents in the sphere of
biomedical research we may conclude that only clinical trials of medicines
became the object of comprehensive legal regulation. The special situations
of biomedical investigations involving human subjects, for instance, in the
sphere of medical genetics and human genetics, in the sphere of reproduction,
Convention on Human Rights and Biomedicine, concerning Biomedical Research//
Biomedical ethics. Collection of articles. Ed V. Pokrovsky and Y. Lopuhin. M., 1-st
publication, 1997.
25
The Order of Ministry of Health of the RF N 248 “On organizing of biomedical ethics
committee of Ministry of Health of the RF”, 30 of December 1998.// http://www.recipe.ru/
docs/nd/print.php?id=50.
26
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning
Biomedical Research http://conventions.coe.int/Treaty/EN/Treaties/Html/195.htm
27
For example – in the sphere of genetic research - UNESCO Declaration on Human Genome
and Human Rights (1997), UNESCO International Declaration on Human Genetic Data (2003),
Economical and Social Council Resolution (2004/9), in the sphere of transplantation and xenotransplantation - Declaration on human organ donation and transplantation (52 WMA, 2000,
2006, Edinburgh, Scotland), Statement on persisting vegetative state (41 WMA, 1989; HongKong), Statement on live organ trade (37 WMA, 1985; Brussels, Belgium), Resolution on
Physicians’ Conduct Concerning Human Organ Transplantation (46 WMA, 1994; Stockholm,
Sweden), Additional Protocol to the Convention on Human Rights and Biomedicine (Strasbourg,
24.I.2002), on Transplantation of Organs and Tissues of Human Origin, Recommendation Rec
(2003) 10 on xeno-transplantation and documents in other spheres.
24
247
psychology and psychiatry, as well as some other fields are only partially
regulated. The development of legal policy referring to various aspects of
protection of the subjects’ rights in the studies mentioned, as well as to the
procedure of ethical review of these studies is only on the agenda.
Fundamental ethical and legal requirements concerning biomedical
research are set out in the Article 21 of the Constitution of the Russian
Federation (1993): “No one may be subjected to medical, scientific or other
experiments without his or her free consent”28. Besides, the Constitution
declares that the dignity of person shall be protected by the state, and no
circumstance may be used as a pretext for belittling it. According to the
Article 2 of the Constitution, the rights and interests of the individual are
recognized as the highest value.
Among general norms in the discussed field we should mention the
Article 43 of Fundamental Principles of Legislation of the Russian Federation
on Healthcare on 22 of July 1993 (henceforth – the Fundamental Principles
of Legislation) formulating the key requirements for the application of
new methods of disease prevention, diagnostics and treatment, as well as
application of new pharmaceutical products, immunobiological products,
disinfectants, and conducting biomedical research29. The Article states that
biomedical research may only be conducted at the institutions of public
or municipal system of healthcare and should be preceded by preliminary
laboratory studies. Besides, it is indicated that methods of disease
prevention, diagnostics and treatment, as well as pharmaceutical products
are not officially permitted but are under consideration according to the
established procedure can be applied in the interests of a patient. Hence,
we may conclude that Fundamentals of Legislation relate only to clinical
(therapeutic) research. The mentioned Act also demands as an obligatory
condition for biomedical research the written voluntary consent of a subject
for participating in the study and guaranties his right to withdraw the consent
at any moment of the study. Before the obtaining of consent for biomedical
research the patient should be informed about goals, methods, side effects,
possible risk, duration and expected results of the investigation.
The given Article sets rather strict limitations on research involving
minors (under 15 – in general cases, and under 16 in the case of drug
addicts). In this case, the methods of disease prevention, diagnostics and
treatment, as well as pharmaceuticals that are not officially permitted but
are under consideration may only be applied for the treatment of minors
if there is a direct threat to their life and with a written consent of their
legal representatives. Here we should mention the Act “On Applying
Pharmaceutical Products according to the Necessities of life” adopted by
the Order of Ministry of Health and Social Development (09.08.2005, No.
494).30 This Act regulates issues relating to the individual case of application,
according to the necessities of life, of a pharmaceutical product that is not
registered in Russian Federation. This is a matter of non-interventional
research. The decision about the use of a pharmaceutical product in this
case is made via the Federal specialized medical commission; the protocol is
documented and signed by the medical director of the director of the Federal
specialized medical commission. This document emphasizes again the need
to seek the patient’s voluntary written consent (in cases provided by law the
consent from the patient’s legal representatives) to apply an unregistered
pharmaceutical product. The physician should inform the patient about the
pharmaceutical product, its expected benefit, safety and the degree of risk.
The physician should also explain measures that will be taken in the case of
unexpected effect of the pharmaceutical product on the patient’s health.
The Article 29 of the Fundamental principles of Legislation also imposes
the ban on biomedical trials involving persons under any form of detention
or imprisonment.
The strict character of legal norms relating to biomedical trials involving
two categories of vulnerable subjects – minors and persons under detention
or imprisonment – from the one hand is the sign of the law-maker’s intention
to prevent the possibility of abuse of depending persons, from the other hand
- it actually means the limitation of rights of mentioned persons to access to
new medicines, diagnostic and prophylactic methods.
At the same time it is to be taken into account that the Federal aw of
the Russian Federation ”On Pharmaceutical Products” on 22 of June 1998
Constitution of the Russian Federation, St-Pb, 1995.
Fundamental principals of Legislation of Russian Federation Concerning Public Healthcare?
on 22 of July 1993// Rossiyskaya Gaseta, August 18, 1993. № 158.
Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted
by the Order of Ministry of Health and Social Development (09.08.2005, No. 494) //Bulletin
of normative acts of Federal Executive Authorities. No 36, 05.09.2005.
28
29
248
30
249
N86-FZ fixes another approach towards some vulnerable contingents31.
This document takes the central place in legal regulation of preclinical and
clinical study of pharmaceutical products.
The issues concerning rights of patients participating in clinical trials
are touched on by the Article 40 of the mentioned law. The general rules
of obtaining the informed consent for participating in research constituted
by this article correspond in a whole with the discussed provisions of the
Fundamental principles of Legislation. The noteworthy point is the more
detailed description of information which should be given to subject,
namely: 1) information on pharmaceutical products and nature of clinical
trials of this drugs; 2) information on anticipated efficiency, the drug safety,
and the degree of risks for the patient; 3) information on measures in the
case of unforeseeable effects of pharmaceutical product on his health;
4) information on the terms of patient’s health insurance.
The provision of the Law concerning the necessity of health insurance
as well as insurance of civil liability of persons who carry out the study
(items 3, 9 of the article 40, items 2 of the article 38) ensures an important
additional guarantee of protection of subjects’ interests.
At the same time, we cannot but mention an excessively “soft” approach
to the question of terminating a clinical trial in the case of events that may be
hazardous to the patient’s health. The Law states only that clinical trials may
be terminated, while it should state that clinical trials must be terminated.
Aiming at safeguarding the rights and interests of vulnerable
contingents the Law forbids or limits their participation in clinical trials
of medicines. Particularly clinical trials involving minors who don’t have
parents, soldiers, persons under any form of detention or imprisonment is
absolutely forbidden. The Law also sets up the limitation for the cases of
clinical studies involving minors who have parents – such studies may be
conducted only if pharmaceutical product is proposed for treatment of child
diseases or if the aim of clinical trial is the getting the information about the
best dosing of drug for therapy of minors. In latter situation the clinical trial
may only be carried out after clinical investigation on adults.
Pregnant women represent another category of vulnerable contingents
who can participate in clinical studies of drugs in clearly named cases.
Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta,
N 118, 25.06.1998
31
250
The general rule which prohibits recruiting this contingent to participate in
clinical trials has one exclusion under three following conditions: the drug
which is studied is proposed for pregnant women; the necessary data can
be only obtained in the clinical trials on pregnant women; the risk of harm
to pregnant woman and to a fetus is completely excluded. Although the last
situation looks improbable nevertheless this provision allows us to assume
the indirect legislative protection of fetuses “in uterus”.
Notable feature of the Law is that it covers the issue of clinical studies
involving patients with mental diseases and recognized as legally incapable
persons. The Law addresses us to another Federal law of the Russian
Federation “On Psychiatric Assistance and Related Guarantees of Citizens”
and also remarks that such trials may be carried out only after obtaining the
written consent of legal guardians of these persons32.
The latter Law states that all persons with mental disorders have to right
for the preliminary consent or to refusal at any time to be used as a subject
of trials of drugs and medical methods, scientific investigations or study
process, video or photo or film shooting (item 2 of the article 2).
Besides the Article 11 of this Law clarifies that the clinical trials
involving persons under compulsory medical treatment or involuntarily
hospitalized persons are absolutely prohibited.
Such a key element of the ethical review as confidentiality of the
information about patient and received from the patient throughout
biomedical research is guarantied by means of the institute of medical secrecy
stipulated by the Fundamental principles of Legislation and by the institute
of personal and family secrecy (privacy) provided by the Constitution of the
Russian Federation (the Article 23). It is also necessary to take into account
the general norms guarantying the protection of personal data which are
fixed by the Federal Law of the Russian Federation “On information,
information technologies and protection of information” of 27 July 2006
and by the Federal Law of the Russian Federation “On personal data” of 27
July 200633.
32
Federal Law of Russian Federation “On psychiatric assistance and related guarantees of
citizens” N 3185-1 of July 2, 1992 // Vedomosty of CND and VS RF, 20 of August 1992.
№ 33, article 1913.
33
Federal Law of Russian Federation “On information, information technologies and
protection of information” of July, 27 2006, Federal Law of Russian Federation “On personal
data” on 27 of July 2006// Rossiyskaya Gaseta, N 165, 29.07.2006
251
The legal rules on specifics of the institutes of informed consent and
medical secrecy in some particular situations as well as norms concerning
guaranties of the other rights of patients/subjects were also reflected in the
following acts: the Federal Law of the Russian Federation “On transplantation
of human organ and tissues” on 22 of December 1992, N 4180-1, the Federal
Law of the Russian Federation “On blood donation” on 9 of June 1993,
N 5142-1, the Federal Law of the Russian Federation “On prevention of
dissemination of the disease caused by HIV” on 30 of March 1995, N 38FZ, the Federal Law of the Russian Federation “On immune prophylactics
of infection diseases” on 17 of September 1998, N 157- FZ34.
The norms related to some organizational, administrative and financial
aspects of biomedical research have also the crucial importance for the
effectiveness of ethical evaluation.
In particular, the issues of planning and conducting studies involving
human, standards of the recording and presenting of findings, are ruled by
the mentioned Federal law of the Russian Federation “ On Pharmaceutical
Products”, as well as by-laws: The Rules of Clinical Practice in the
Russian Federation”, adopted by the order of Ministry of Public Health of
the Russian Federation on 19 of June 2003, N 266, the national standard
“Good Clinical Practice. GOST- R 52379-2005 “ on 27 of September
2005, N 232- st., adopted by the order of the Federal agency for technical
regulation and metrology, The Instruction “On the Organization and
Conducting of Expertise, Clinical Trials and Registering of Foreign
Medicines and Substances” on 15 of May 1996, adopted by the order
of the Ministry of Public Health and medical industries of the Russian
Federation, the Operating Instruction “Conducting qualitative studies
of bioequivalence “ on 10 August 2004, adopted by Ministry of Public
Health of the Russian Federation, the Instruction “On Expertise and Trials
of Medical Immunobiological Products with the Purpose of Registration “
Federal Law of Russian Federation “On transplantation of human organ and tissues”
on 22 of December 1992, N 4180-1// Vedomosty of CND and VS RF, 1993. № 2, article
62, Federal Law of Russian Federation “On blood donation”, 9 of June 1993, N 5142-1//
Vedomosty of CND and VS RF, 1993. № 28, article 1064, Federal Law of Russian Federation
“On prevention of dissemination of the disease caused by HIV” on 30 of March 1995, N
38-FZ//Sobranie zakonodatelstva, 03/04/1995, N 14, article 1212, Federal Law of Russian
Federation “On immune prophylactics of infection diseases” on 17 of September 1998, N
157- FZ// Sobranie zakonodatelstva, 21.09.1998, N 38, article 4736.
34
252
on 15 April 1999, N 129, adopted by the order of Ministry of Public Health
of the Russian Federation, the Branch Standard “ Clinical and economic
research. General provisions” (OST 91500.14.0001-2002) on 27 of May
2002, N 163, adopted by the order of Ministry of Public Health of the
Russian Federation and other documents35.
The provisions of these legal acts set out requirements to the scientific
validity of biomedical research, the risk and benefit ratio, safety of the
investigational products or medical methods, the follow-up procedure to
monitor the reliability of the research findings, and a number of other
requirements that should be met when conducting biomedical research in
Russia.
With regard to regulation of ethical review of biomedical research it
should be marked the importance of the positions of chapter IX of the Federal
Law of the Russian Federation “On Pharmaceutical Products”, namely item
2 of the article 37 and item 1 of the article 39. These norms mention two
forms of ethics committees, which participate in taking the decision on the
forthcoming research.
First, this is ethics committee at an institution that conducts the clinical
trials. In particular, it is stipulated that this committee takes part in working
out the program of the clinical research.
35
The Rules of Clinical Practice in the Russian Federation”, adopted by the order of Ministry
of Public Health of Russian Federation on 19 of June 2003, N 266//Bulletin of normative acts
of the federal bodies of the executive power, N42, 27.10.2003, the national standard “Good
Clinical Practice. GOST- R 52379-2005 “ on 27 of September 2005, N 232- st., adopted by the
order of the Federal agency for technical regulation and metrology//M., “Standardinform”,
2005, The Instruction “On the organization and conducting of expertise, clinical trials and
registering of foreign medicines and substances” on 15 of May 1996, adopted by the order
of the Ministry of Public Health and medical industries of the Russian Federation//the legal
e-database “Consultant Plus” , the Operating instruction “Conducting qualitative studies of
bioequivalence “ on 10 of August 2004, adopted by Ministry of Public Health of Russian
Federation// the legal e-database “Consultant Plus”, the Instruction “On expertise and trials
of medical immunobiological products with the purpose of registration “ on 15 of April
1999, N 129, adopted by the order of Ministry of Public Health of Russian Federation//”The
normative documents” (Healthcare committee), N 7, 2000, the Branch Standard “Clinical
and economic research. General provisions” (OST 91500.14.0001-2002) on 27 of May 2002
N 163, adopted by the order of Ministry of Public Health of Russian Federation// the legal edatabase “Consultant Plus”.
253
Besides, the law describes the ethics committee at the federal body
of executive power36, the competence of which includes the realization of
state control and supervision in the sphere of use of medicines. The positive
verdict of this ethical committee is the essential condition for a resolution
on conducting of biomedical research, taken by the authorized body of
executive power.
Thus, the ethical assessment and approval constitutes the condition of
lawfulness and legality of conducting research, and the ethical requirements
acquire the juridical force. Default on this condition leads to legal liability
in accordance with the legislation of the Russian Federation.
The legalistic basis of the activity of ethics committee at the federal
body of executive power is determined by the order of the Ministry of Public
Health and social development of the Russian Federation on 2 of August
2004, N 57 “On Ethics Committee”, which approved the Regulations for
this committee and its structure37.
In accordance with the Regulations, the ethics committee is created as
an independent body for the purpose of the efficient participation of society
in the protection of clinical research subjects’ rights and health.
In its work the committee is guided by the basic international principles
of conducting the clinical trials and by the current legislation of the Russian
Federation.
The basic tasks of committee are the following:
- carrying out the qualitative ethical and legal review of the materials
of clinical research for the purpose of subjects protection from the possible
negative consequences resulting from the application of medicines.
- adjustment of scientific validity of clinical research, expected
effectiveness and safety of the tested medicines.
- preparation of resolutions on the expediency of conducting the clinical
research.
The structure of the committee is formed on the interdisciplinary basis
by the Federal Service for supervision in the sphere of public health and
At present moment this body is represented by the Federal Service for supervision in the
sphere of public health and social development of the Ministry of Public Health and social
development of Russian Federation.
37
The order of the Ministry of Public Health and social development of Russian Federation
on 2 of August 2004, N 57 “On ethics committee”//Healthcare. N1, 2005.
36
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social development and is approved by the Ministry of Public Health and
social development of the Russian Federation.
The committee may include persons who are not directly dependent on
the researchers and sponsor. The members of the committee should have the
proper qualification and experience of ethics review of scientific, medical
and ethical aspects of different studies. The committee may include the
representatives of the public (lawyers, journalists, priests, etc.).
Among documents which are important for development of the system
of ethical review in Russia we should also point out the mentioned “Rules
of Clinical Practice in the Russian Federation” (Rules of Clinical Practice)
and the national standard “Good Clinical Practice. GOST- R 52379-2005 “
(National standard).
Today the Rules of Clinical Practice have limited application caused
by essential reorganization of the system of control and assessment of
effectiveness and safety of products, processes and services, including those
in medical sphere.
The National standard that entered into force in April, 2006 is more
meaningful document in this sphere.
This act is the element of the system of technical regulation and develops
the provisions of the Federal Law “On Technical Regulation”, which
establishes the requirements for products, manufacturing, exploitation,
storage, transportation, realization and utilization, service delivery, etc.
The national standard is the Russian version of ICH GCP and by its status
is recommending document. It establishes the ethical and scientific standard
of the quality of planning and conducting research involving human subjects
as well as the standard of recording and registering the study results.
These standards may be applied not only to the studies of medicines,
but also to “other clinical experiments, which can affect the safety and wellbeing of a subject”.
The observation of the rules of the national standard is the guarantee of
the validity of research results, safety of subjects and protection of their rights
and health in accordance with the basic principles of Helsinki Declaration.
Ignoring this standard actually means that the results of clinical research
cannot be accepted as the evidence of drug effectiveness and safety. This
fact serves as the stimulus of an effective compliance with the requirements
of the present document.
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While analyzing the national standard, which in general is identical to
ICH GCP, we should note two basic moments, which make it extremely
important for development and functioning of the system of biomedical
research ethical review in Russia.
First, this document contains the definitions of all internationally
accepted terms in sphere of clinical practice, including the definition of
ethics committee.
In accordance with item 1.29 of the national standard, the expert council
of the organization/independent ethics committee is the independent body,
which consists of medical professionals and persons, who are not engaged
in medical sphere. This body provides protection of research subjects’ rights,
safety and well-being and serves as guarantee of this protection, in particular
via examination, approving of the study protocol, candidacy of researchers,
research Centres, as well as materials and methods, which are used for
obtaining and documentation of the informed consent of research subject.
The document also emphasizes that the ethics committee can act at the
level of organization, on regional, national or international levels. Thus, this
standard establishes the four-level system of ethics committees in Russia.
Secondly, it is necessary to draw attention to the Chapter 2 of the
national standard that fixes the system of principles of clinical practice. This
point has the essential importance for the lawful regulation of biomedical
studies in the Russian Federation.
The given principles are not new for Russian biomedical branch; they
were followed earlier by researchers as the universally recognized standards
of medical practice. However, up to now they were only partly reflected in
the separate normative acts of the national legislation.
In addition to legal acts of the federal level the functioning of local
ethics committees at research institutions, is also regulated by legal acts of
the local level – Regulations on certain ethics committees, approved by the
heads of institutions and Standard Operating Procedures, adopted by each
committee.
The latter documents determine the order of work, the list of documents
to be submitted, terms and procedure for the review of the documents, the
procedure of making decisions, condition of their revocation and appeal,
follow-up procedure, achieving and storage of documentation and other
compulsory procedures.
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Biomedical studies, conducted within the framework of dissertation
work, present another sphere where it is necessary to ensure the protection
of subjects’ rights, interests and dignity.
According to the Letter of the Supreme Certifying Commission “On the
Procedure of Biomedical Research Involving Human Subjects”38:
- “when considering the dissertation works relating to application of
both registered and new medicines, methods of diagnostics and treatment
the chairpersons of dissertation councils should review the compliance of
such works with international and Russian legal acts on biomedical research
involving human subjects”.
- “when planning scientific clinical research involving human
subjects within the framework of a dissertation work investigators should
follow regulating documents of the Ministry of the Russian Federation and
must obtain a written informed consent from research subjects or their legal
guardians. The research project should be approved by the independent local
ethics committee”. Dissertation councils may only accept dissertation works
for review if they meet the abovementioned requirements.
It should also be noted that the ethical review of biomedical research
takes place at the level of the publication of their results.
Unfortunately, nowadays there is no domestic legal document in Russia,
which stipulates the ensuring of compliance of wide recognized ethical
standards by investigator as the binding condition for the publication of data
in the scientific journal, such as obtaining the informed consent from each
research participant, approval of a study by ethics committee.
However, in practice many Russian scientific journals require the
observance of Vancouver “Uniform requirements for manuscripts submitted
to biomedical journals” (ed. of 1997)39.
The positive moment is the awareness of the necessity of the biomedical
branch ethical regulation at the legislative level. The Federal law of the
Russian Federation “On temporary ban on human cloning” enacted in 2002
is the result of the ethical review at the national scale.
The Letter of the Supreme Certifying Commission “On the Procedure of Biomedical
Research Involving Human Subjects”//Bulletin of the Supreme Certifying Commission
No 3, 2002.
39
“Uniform requirements for manuscripts submitted to biomedical journals”//Ann Intern
Med – 1997 – Vol. 126 – P. 36 - 47.
38
257
Being guided by the principles of respect for human, the ensuring of
the value of person, protection of rights and freedoms of individual and
taking into account the insufficiency of studying of biological and social
consequences of human cloning the above-mentioned law put temporary
ban on the biomedical trial on human cloning.
The attention of legislators to the ethical side of biomedicine is also
demonstrated by the Draft Technical Regulations “On requirements for the
safety of medicines, the processes of their development, manufacturing,
production, testing, storage, transportation, realization, application and
utilization”.
In contrast to current federal laws, this bill proposes the more detailed
regulation of process of the clinical drug research ethical review. It also
constitutes research subjects’ rights and guarantees of these rights in
accordance with the most progressive international standards in this field.
Legislation initiatives in the sphere of protection of patients’ rights40,
activity directed to adaptation of international guidelines, as well as
transformation of the positions of international declarations and conventions
in the sphere of biomedicine into the domestic legal acts, give us the reason
to expect the strengthening and development of the institute of ethical review
in our country.
Issues on education of medical ethics and deontology in medical
schools and colleges of the USSR were started to discuss in the 60’s of
the XX century after the 1st All-Union Conference on issues of medical
deontology in 1969 being a kind of triggering point for revival of talks on
them. The final resolution, in particular, said: “The Conference would like to
draw attention of the Chief Agency on Educational Facilities of the Ministry
of Health of the USSR on necessity to implement medical deontology into
education process”.
For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive
rights of citizens”, “On additions to Criminal Code of the Russian Federation regarding
to criminal liability for conducting medical trials involving human subjects without their
voluntary consent” and others.
40
258
Many medical schools developed medical oaths based on the Hippocratic
Oath. In 1971 the Presidium of the Supreme Soviet of the USSR approved
an official text of the Oath of Medical Doctor of the Soviet Union.
In 1976 the Ministry of Health of the USSR approved interdepartmental
curriculum on medical ethics (deontology) for higher medical and
pharmaceutical educational facilities. The curriculum distributed the course
along the entire educational process basing on that “concepts of morals and
morality, development of higher feelings and medical ethics is an integral
part of the entire educational process and should be implemented in various
aspects during all years of training at all departments“.
The curriculum stipulated one lecture for the 1 year students:
“Medical ethics and medical deontology, their role for formation of a
medical doctor and pharmacist” (Introduction for the subject); 5 lectures
for the 2 year students: “Soviet health care as qualitatively new system“
(Department of Social Hygiene and Health Care Management), “Main
peculiarities of deontology development at different stages of health care
formation” (Department of History of Medicine), “Categories of medical
ethics” (Department of Marx and Lenin Philosophy), “Modern concepts on
medical and psychological aspects of an individuality” (Course on medical
psychology), “Deontological issues in disease diagnostics” (Department
of Preliminary Studies of Internal Diseases); 1 lecture for 3 year students:
“Deontological issues of treatment” (Department of Faculty Therapy);
2 lectures for 5 year students: “Deontological issues for work of district
physician” (Department of Hospital Therapy) and “Legal principles of
medical services for working population in the USSR” (Department of
Forensics Medicine). The curriculum was widely discussed in mass media
and majority of comments were that it was inefficient, did not cover many
important issues, which are of tremendous value for medical practice, for
instance, no definition of patient rights was given, it did not dwell on issues
of brain death, refusal of extraordinary treatment for dying patients, it never
mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
In 1977 and 1982 two other All-Union conferences on medical
deontology were held. There were published multiple books on issues of
medical ethics and deontology for various medical fields. It indicated that
in 70-80’s the system of Soviet higher medical education had professors
who not only fully understood a role of medical deontology for education
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and training of undergraduate doctors but also contributed considerably for
development of the content of this subject (Evlashko Y.P., Kosarev I. I.,
Leschinsky L.A., Orlov A.N., Suvorova R.V., Rokitsky M.R., Shamov I. A.,
Jarovinsky M.Ya., etc.). In 1988 two volume manual Deontology on
Medicine was published edited by Petrovsky B.V.
In the 80’s the educational curriculum of medical nurse colleges had
some academic hours assigned to medical deontology – the course was
called as Basics of medical psychology, ethics and deontology. In 1992 the
Pledge of Medical Doctor of Russia came into force.
In 1993 the Vrach (Doctor) magazine published an appeal to scientific
community and heads of the Russian science from members of the Russian
national committee on bioethics (“Bioethics in Russia: Beginning of the
way”). The Appeal stated: “Modern medicine requires modern moral
consciousness. In the whole world principles of bioethics for a long time
are an integral part of professional life of medical workers ... Absence in
our country of the said mechanisms of ethical control results in a range of
negative consequences, hinders improvement of moral environment within
our scientific community; it is one of the main reasons for distrust of the
society to science (that, by the way, impacts the society readiness provide
science with tangible support); it is a direct violation of international
acts enforced in this field...” In this document the most well-known
medical scientists of the country wrote with anxiety about those harmful
consequences indicating absence of proper ethical control on scientific
experiments. Neglect of elementary medical and ethical norms in practical
health care being widely spread in our days looks similarly dangerous. It
was noted by many speakers at the XVIII All-Russia Pirogov’s Conference
of Medical Doctors held in Moscow in 1997. The Conference approved a
new text for the Oath of Russian Medical Doctor and the Code of Medical
Ethics presented by the National Ethics Committee – Russian Medical
Association.
In October 1994 in Geneva the 4th WHO Conference on issues of
medical ethics education was held where participant unanimously stated
that education to ethics (bioethics) issues should be mandatory rather than
optional. The Conference participants agreed that medical ethics should
become an integral part of medical education and that its coaching should
be obligatory and continuous during the entire pre-graduate educational
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process and for post-graduate education, therefore, all medical schools were
to have a department on medical ethics and appropriate number of trained
professors.
In 1997 under the aegis of the Ministry of Health of the Russian
Federation the meeting on issues of medical ethics education was held where
necessity of introduction of bioethics learning was acknowledged. It is
necessary to note that the Russian Orthodox Church supported introduction
of the biomedical ethics education into the medical education system of
Russia. It is indicated with the appeal to the ministries of health care and
vocational education of the Russian Federation approved during the VI
International Christmas educational lectures of 1998 held by the Moscow
Patriarch of the Russian Orthodox Church.
Some of higher educational facilities of medical as well as philosophy,
law and other fields as per initiative of those enthusiasts-professors the
bioethics education process was launched as well. Since the beginning
of the 90’s the separate course on biomedical ethics was provided in the
Moscow State University named after Lomonosov M.V. at the Departments
of philosophy and psychology, and since 1994 it was also introduced at the
medical department.
The most capacious course in regard to number of academic hours
assigned was provided at the nurse department for the 1st year students of
the Moscow Medical Academy named after Sechenov I.M. - 56 hrs (30 hrs
of lectures and 26 hrs of seminars). Actually, this subject was given at the
Department of history of medicine since 1994, and as a separate course – since
1995. Another issue is even more important: at this department biomedical
ethics was included into the state educational standard, i.e. it is obligatory
for all 22 departments of the higher nurse education in Russia. Making this
subject as mandatory from the point of view of educational minimum for this
category of medical workers, naturally, required generation of appropriate
curriculum (author – Professor Yarovinsky M.Ya.).
In the Russian State Medical University since 1996 the Department of
philosophy and culture sciences was called as the Department of philosophy
and culture sciences with a course on bioethics, and there the biomedical
education course (22 academic hours: 18 hours of lectures and 4 hours of
seminars) is provided since 1996 for all 4 year students of physician and
pediatric departments.
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Also since 1996 the course on bioethics was provided in the StPetersburg Pediatric Medical Academy at the Department of humanitarian
subjects and bioethics and in the Kazan Medical University. The Department
of philosophy of the Moscow Medical Dentistry Institute since 1997 was
called the Department of philosophy and biomedical ethics, the course of
biomedical ethics there (40 academic hours) is provided at the dentistry
department for 1-year students, and at the physician department — for 3year students. At the evening education department for 1-year students this
subject was assigned with 20 academic hours. As an option biomedical
ethics was suggested for students since 1993. In the Krasnoyarsk Medical
Academy the course on professional medical ethics was provided for pregraduate students (48 academic hours), and at the higher nurse education
department (40 academic hours).
The next step for establishing of this subject education was the AllRussian Educational and Methodical Conference Biomedical Ethics in
Higher Medical Education Facilities held by the Ministry of Health of the
Russian Federation in 1999; since 2000 bioethics became an obligatory
subject in medical schools. Introduction of biomedical ethics into a set of
humanitarian subjects of medical education is one of the evidences of real
renewal of humanitarian training of medical students in Russia.
Currently educational system in the Russian Federation has curriculums
for general (beginning, secondary) and professional (secondary, higher,
additional) education. Their content is determined by state educational
standards. Standards for “secondary” and nurse vocational training
do not contain bioethical issues. At the stage of higher vocational
training bioethics become an integral part of curriculums of medical or
pharmaceutical fields (a course of humanitarian and social and economic
subjects), for such majors as Law, International Relations, Social Work
(natural sciences part in the course Concepts of modern natural sciences),
Biology and Bioecology (a part of general vocational subjects). As a
negative sign it should be noted that bioethics education is not stipulated
for such major as Philosophy. Existence of national and regional (schoolrelated) component in state standards and the right to some extent to alter
curriculum content allows for many of educational facilities in Russia to
include bioethics into education of future agriculture workers, veterinaries,
teachers, philosophers and other trades.
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At the same time there is no trade of bioethics in the All-Russian
Classifier of Educational Trades as well as it is not mentioned in the List
of Scientific Specialist Trades. Therefore, targeted training of specialists
including specialists of higher qualification (masters and doctors of science)
in regard to bioethics is not provided. However, theses or dissertations
for master or doctor degree covering to some extent bioethics issues are
defended using reference numbers of other trades such as philosophy,
sociology, public health.
Currently training of medical doctors and pharmacists is conducted in
47 universities and academies subjected to the Federal Agency on health
care and social development as well as 25 departments and institutions of
the Russian education ministry, 5 military medical educational facilities, 10
private higher educational facilities as well as in the Kyrgyz-Russian Slavic
University accredited in Russia.
Typical unified program of education in higher medical educational
facilities in Russia was developed in 2001 by the group of Moscow scientists,
and in 2003 the reference curriculum on bioethics for Pharmacy trade was
published (authors – workers of the Moscow Medical Academy named after
Sechenov I.M.), which are planned for 36 academic hours of class work (18
hours of lectures and 18 hours of seminars) and 18 hours of independent
work in the 2nd semester. The curriculum stipulates learning of history and
traditions of Russian ethics, theoretical basics of biomedical ethics, models
and rules of relationships between doctor and patient, patient rights, analysis
of bioethical issues of experimental medicine, reproductive technologies,
euthanasia, transplantology and medical genetics, HIV infection, ethics in
psychiatry, moral issues of distribution of health care resources. Working
educational programs that the education is based upon are developed by
departments implementing them.
Currently training in bioethics at the specialized department is conducted
only in one higher educational facility, the Russian State Medical University.
Three cities (Ivanovo, Kazan, Samara) have departments on bioethics and
law associated with other subjects (forensics medicine, history of medicine)
or without it. Five educational facilities provide such education at the
departments of philosophy, another five changed department titles to mention
“philosophy and bioethics”. Three cities delegated this coaching to health
care management department. In every third of medical educational facilities
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bioethics is learned at departments of humanitarian and social and economic
type. Finally, another three higher educational facilities (Astrakhan Medical
Academy, St-Petersburg Medical University named after Pavlov I.P. and
Stavropol Medical Academy) formed interdepartmental teams for teaching
the subject involving clinicians (clinical pharmacologists, psychiatrists).
Majority of medical academies and universities has the amount of
academic hours complying with the curriculum stipulated one – 36 hours,
two – shrank it insignificantly up to 32 hours, and in one academy – to 19
hours.
More than a half of medical educational facilities in Russia managed in
their curriculum to move the classes from 1st year students to more trained
ones up to the pre-graduates at their last year training (Volgograd, Kursk,
Ryazan, St-Petersburg Pediatric Medical Academy).
An important feature of the modern stage of development of biomedical
education in medical education facilities is its close organizational and
methodical association with coaching in jurisprudence and medical law. It
is not by chance that one of the main magazines publishing articles and
other materials on bioethics-related topics is Medical Law included into the
list of magazines recommended by the Higher Attestation Commission for
publication of results of dissertation research.
Special departments on medical law were established in two Moscow
facilities (Moscow Medical Academy named after Sechenov I.M. and
Moscow State Medical and Dentistry University), in 11 cities the law
training is provided in the departments, which titles mention law. In 7
cases these are departments of humanitarian and social and economic field:
bioethics, philosophy, political sciences, economics, sociology, psychology
and pedagogics; in 4 cases – forensics medicine.
Four universities set up the educational process on jurisprudence
at humanitarian departments (humanitarian sciences - 2, social and
humanitarian - 2), four – at departments of forensics medicine and four –
at departments of public health and health care. In Astrakhan they decided
to involve professors of three departments: philosophy, public health and
forensic medicine.
Objectives of bioethics and law coaching are to identify, formulate
and bring to students those norms of morals and law that will protect their
patient and, at the same time, will not hinder innovations in medicine and,
264
moreover, beneficial use of modern diagnostic and medicinal technologies.
Achievement of this goal is based on complex, interdisciplinary approach
to the educational process as it is required by the essence of bioethics.
Bioethics as it is should be in the Centre integrating common efforts of men
of law, forensic medicine specialists, philosophers and other representative
of humanitarian departments and, naturally, clinicians and health care
managers as well as university administration for training and education
of future specialists. Some actions in this respect are performed (Moscow
State Medical and Dentistry University, etc.). Maybe, it makes sense to
set a task to prepare a typical reference curriculum at the federal level that
could be an assistance and incentive for universities. We should also take
into account strong and weak points of the Interdepartmental Curriculum
on medical ethics and deontology implemented in the USSR in 70’s and
80’s of the ХХ century. That curriculum could be considered as a historical
prerequisite for education in the field of bioethics for all Post-Soviet
countries. At the same time, the XXI century requirements show necessity
for inclusion into the training course of completely new issues. In particular,
it seems of significant importance to include there issues on evidence-based
medicine. Nowadays this field of medical science is unfairly considered as
the outskirts of educational curriculums, while it allows giving grounds to
clinical practice with quantitative and qualitative analysis of world research
data rather than basing it on intuition, traditions and experience which young
specialists just do not possess.
Educational and methodical basis for bioethics currently cannot be
called as perfect but despite that currently there are good monographs that,
regretfully, are not fully available in university libraries. Such publications
are: Biomedical Ethics//Edited by Pokrovsky V.I.Vol.1. - M., 1997 and
Biomedical Ethics//Edited by Pokrovsky V.I. and Lopukhin Y.M. Vol.2. M., 1999;. Bioethics: principles, rules, issues//Edited by Yudin B.G.- M.,
1998; . Introduction for Bioethics. - M., 1998, etc.
In 2005 a handbook for higher educational facilities fir the Pharmacy
trade edited by Lopatin P.V. was published, and a year before – a teaching
aid Medical Ethics edited by Academician of the Russian Academy of
Medical Sciences, Professor Lopukhin Y.M. and Corresponding member of
the Russian academy of Sciences, Professor Yudin B.G. (translated from
English). In 2006 Publishing House Meditsina (Medicine) issued a handbook
265
on medical ethics by Shamov I.A. where the author suggested introducing
continuous education of the subject and provides a curriculum for the entire
period of study.
A handbook for students in medical schools recommended by the
Education and Methodical Association of medical and pharmaceutical
universities of Russia is handbook Medical Ethics (Bioethics) by Yarovinsky
M.Ya. (M., 2006). Besides, there are publications prepared directly by
educational facilities, for instance, by the Samara State Medical University
(Sergeyev V.V., Nasledkov V.N. et al. Lectures on Bioethics. Samara,
2005), as well as monographs and collections of articles, foreign manual,
for instance, the ones approved in the Republic of Belarus. Some role was
played by monograph Ethics of Treatment by Siluyanova I.V. (M., 2001).
Also departments providing bioethics education start to interact. In 2005
the All-Russian Educational and Methodical Conference Biomedical Ethics
in the higher medical educational facilities of Russia (the Russian State
Medical University) was held which summarized experience accumulated
in the field of bioethics education in various universities and schools.
Motivation to study bioethics among students and specialists is quite
high. Sociological polls found that more than 80% of students and young
medical doctors realize necessity to master bioethics knowledge. And
experienced doctors who, in their majority, never studied biomedical ethics,
as it is currently understood, quite often do not express any determined
opinion.
Importance of specific training for doctors with more than 10-year
professional experience, and they are the basis of the industry human
resources, in regard to ethical and legal issues, is rather considerable. It
is confirmed with the questionnaire data we obtained. “Is there a need in
ethical committees in treatment and prevention facilities?” The answer is
“No” among more than 25% (!) of MD’s vs. students. Such prevalence of
answers is caused, naturally, not by neglecting of ethical values but with
ignorance of the subject. Obviously, post-graduate education shall become
a foremost objective.
Nowadays, there is no practice of systematic organization of training
course on bioethics issues for medical doctors and other specialists at the postgraduate period. The exclusion is a regular topical post-graduate education
cycle for medical doctors and researchers Methods for Set-up and Conduct
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of Clinical Studies of Pharmaceutical Products in the Russian State Medical
University. On their own Russian specialists can get bioethical training
within the framework of programs supported by international organizations
or universities, for instance in the school on bioethics in Vilnius at the
Vilnius University and Albany Medical College-Graduate College of Union
University Bioethics Program (Schenectady, New York).
Improvement of doctor and researcher knowledge in regard to protection
of rights of biomedical research participants is significantly facilitated with
the conduct of training cycles on rules of Good Clinical Practice by medical
universities (Moscow Medical Academy, Russian State Medical University)
and large contract research organizations (Smolensk, Saint-Petersburg).
A specific value for ethical review system setup in the country is
provided by training of the ethical committee members. Such trainings
are organized under the aegis of the Forum for Ethics Committees in CIS
Countries as well as by initiatives of particular ethical committees.
The Russian Federation joining to the Bologna Club (September, 2004),
that is, to states participating in processes of reforming of European education
on the basis of Bologna Declaration principles (1998), raised necessity in
resolving of some new issues by those organizing bioethical education.
It includes struggle for the place of the subject of bioethics in the part of
curriculums that is compiled in accordance with the Bologna Declaration
requirements to be implemented on mandatory rather than optional basis;
for appropriate rate of work content and assessment in the system of ECTS
credits; preparation of various educational and methodical materials for
independent work of students (multimedia aids, readers, case collections,
business games, tests); development of control and measurement materials
and, naturally, targeted specialized training of professor competitive in
conditions of higher educational mobility of their students.
In general, one can come to a conclusion on a need for creation in the
Russian Federation specialized educational facilities of organizational,
design and methodical basis for teaching bioethics. During the last years
one can observe a notable trend for transformation of bioethics education
into specialized courses and departments. At the same time, it is necessary
to make efforts to develop state educational standards, typical unified and
working educational programs to comply with scientific and practical
267
requirements, to coordinate activities of university departments on teaching
issues of legal and ethical control in medicine.
The main task is to be planned preparation of qualified staff of professors,
which requires set up of special post-graduate study system, including postgraduate research and vocational training at the course of general and topical
post-graduate education, establishment of the bioethics grade.
3.8.4. System of Ethical Review
The Russian legislation in the field of ethical and legal provision for
biomedical research is represented with a range of documents. First of all, it
is the Constitution of the Russian Federation (Art.21), which states: “… no
one can be made undergo medical, scientific or other experiments without
his/her consent.” Beside, there is the Basics of the Legislation of the Russian
Federation on Protection of Health of Citizens where Article 43 considers
issues on application of new methods of prevention, diagnostics, treatment;
medical agents, immunobiological agents and disinfecting agents and
biomedical research conduct. However, this article is declarative to a large
extent: rights of citizens involved in biomedical studies stipulated there do
not have any mechanisms of implementation and enforcement, including
the ones via ethical review of applications for research conduct. At the
same time, in accordance with this document children of age below 15 can
participate in studies of new medicinal agents, methods, etc, only in case of
vital indications though in real life this statement is constantly breached that
is inevitable and determined with realia of medical practice development
and scientific progress. Article 29 of this document prohibits involvement
into studies of those arrested or convicted though, in some cases these
persons can benefit from their participation in clinical biomedical research.
In this respect the Russian legislation differs from European norms that
allow in case of specific and clearly defined conditions to hold studies with
involvement of those categories of citizens. Another document regulating
possibility for conduct of biomedical studies in the Russian Federation is
the Law on Psychiatric Care where Article 5 proclaims the right of a person
with mental disorder to consent or to refuse of participation in such studies
though necessity for such action is not stipulated. The Law on Pharmaceutical
Products analyzes quite profoundly those norms regulating research on new
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medicinal agents but, regretfully, it covers only one though rather important
sphere of biomedical research – studies of pharmaceuticals. This law as it
is shown by the text is written basing on an assumption that each study is
premised with an examination held by an ethical committee but either status,
or authority, or order of creation, or composition of ethical committees are
not stipulated by the Law; there only guidelines that “the ethical committee
acts at the federal executive authority which competence covers state control
and surveillance in the sphere of pharmaceuticals” (Art. 37). There is also no
such mechanism for creation and activities of such organization in any other
Russian legal document. The National standard of the Russian Federation
GOST R52379-2005 “Good Clinical Practice” adopted in 2006 defines the
term “Independent Ethical Committee” as an independent group (review
council or committee acting at the facility, regional or international level)
consisting of medical workers as well as persons not related to medical trade
that provides protection of rights, safety and well-being of study subjects
and for the society it is a guarantor for such protection, in particular, through
review, adoption/approval of study protocol, investigator personalities,
study sites as well as materials and methods to be used for obtaining and
documenting informed consent from the study subjects. EC should function
in compliance with the principles of good clinical practice“.
Thus, basing on analysis of existing legislation one can conclude that the
biomedical research ethical review in the Russian Federation is conducted
by ethical committees acting in health care or research facilities including
the ones of the Ministry of Health Care of the Russian Federation, Russian
Academy of Medical Sciences, medical associations, research medical
Centres, hospitals. In majority of cases such activity is borne by local ethical
committees.
First ethical committees in Russia were created not more than 10 years
ago. Initially such committees were created at research Centres where multiCentre international studies were held and the need of their creation was
caused when studies were initiated by foreign sponsors, pharmaceutical
companies requiring the EC approval for their initiatives (local EC). In
the 90’s there were created 5 central ethical committees and the National
Committees on Bioethics at the Russian Academy of Sciences was the first
established among them (1993), then committees at the Presidium of the
Russian Academy of Medical Sciences, at the Russian Medical Association,
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at the Medical Doctor Association and at the Ministry of Health Care of
the Russian Federation followed. After the Law on Pharmaceutical Products
(1998) was adopted according to Article 37 the Ethical Committee at the
Federal Agency for Control on Pharmaceutical Products was established.
In 2000 the independent interdisciplinary Committee on ethical review of
clinical studies appeared, and in 2005 the Russian Committee on bioethics
at the Governmental Commission of the Russian Federation on UNESCO
Issues was established. Simultaneously during the last years the process of
creation of local ethical committees at research Centres, medical universities
and academies, hospitals became more active.
Ethical committees examine applications prior to initiation of studies
and provide ethical support for research projects including review during
the study and upon its completion.
Main objective of the ethical review prior to study initiation is to
determine compliance of the planned clinical study of a pharmaceutical
agent or another reviewed application to approved ethical requirements.
With this purpose the ethical committee prior to the study shall consider
the following aspects: qualification of a Principal investigator and members
of a research team, suitability of applied site for the study; a study protocol
with a rationale on potential benefits/risks; principles and criteria for
patient inclusion in the study, the ways to obtain written consent, presence
of certificates on insurance for all study subjects in case of making harm
to them, confidentiality guarantees. Tasks of the ethical committee include
review of scientific rationale for the study, assessment of compliance of the
clinical protocol outline to its objectives as well as to GCP requirements,
guarantees of complete protection of the study subject interests.
To fulfill its mission and to conduct ethical review the ethical committee
needs the following documents: signed and dated application for document
review (the application is usually submitted by a project sponsor or principal
investigator); a protocol and its amendments (if these amendments were
introduced prior to the biomedical research onset in a particular study site);
an Investigator Brochure; an clinical research form for study participants;
a patient information and informed consent form (some ethical committees
have a standard patient informed consent form, others observe that the
informed consent being written in arbitrary way should contain all necessary
elements); diaries and questionnaires (if stipulated by the protocol);
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description for all compensations for the study subjects (if stipulated); an
insurance policy and certificate with clear indication of insurance terms and
conditions, number of insured persons; signed and dated researchers’ CV’s;
materials including promotional ones used to attract study candidates; all
previous decisions produced by other EC’s (if any); a list of study sites; an
approval from the Federal Service on Control in the sphere of Health Care
and Social Development for conduct of this particular clinical study.
Documents on the clinical study are to be examined by experienced
specialists in the methodology of studying efficacy and safety of new
medicinal agents, medical doctors with experience in clinical studies.
Objectives of the ethical review prior to the study onset are to minimize risks
for clinical study subjects if it is well justified, to provide fair selection of
them, to provide control over complete and adequate informing the patients
and obtaining the informed consent, confidentiality terms, protection for
vulnerable population groups.
When examining the clinical study protocol, specialists consider
possibility of reaching study objectives with involvement of less amount
of subjects, assess inclusion and exclusion criteria, early exclusion criteria
from participating in the clinical study, conditions of the study termination,
objective control methods, expected adverse events and inconveniences
for patients.
Reviewing the Investigator Brochure there are examined data on efficacy
and safety, pharmacological, pharmaceutical and toxicological properties of
the tested medical agent as well as data on results of previously conducted
preclinical and clinical studies.
Requirements for information on the study provided to a candidate
subject are very strict. It must correspond to a level of understanding of
those to be involved in the study, to be easy to read and not to contain many
medical terms. This document must describe the following: study purpose and
objectives; description of the tested medicinal article; concomitant treatment
permitted or prohibited in the given the trial’s subjects. probability of random
assignment in one of the study groups (including the control that might be
treated with placebo. Explanations for all terms and concepts, for instance,
placebo, is obligatory!); objectively expected benefit for the patient as well
as inconveniences and objectively expected risks for both patients/healthy
volunteers and a fetus or infants; all study procedures (especially accurately
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there shall be highlighted issues on all invasive procedures planned during
the study); obligations of the subject-participant; compensation and/or
treatment the subject might expect in case the damage is incurred to his/her
health during the study. The information note for the patient must contain
a declaration that his/her participation in the study is voluntary and that
he/she can in any moment of time refuse of participation in the study or to
discontinue it without any sanctions or his/her rights infringement; there
shall be clearly identified a list of persons that will be granted with direct
access to information in the primary medical documentation (investigators,
auditors, regulatory authorities, ethical committee members), and provided
assurance that data identifying personality of the study subject will be
kept secret and its disclosure is possible only within the limits stipulated
with corresponding laws and/or by-laws. For instance, in case of public
representation and publication of the study results anonymity of its subjects
(confidentiality of information about them) is guaranteed. The patient
information note must indicate investigator obligations in case of appearance
of new data in the given CT that can influence the subject decision on
continuing participation in the study to immediately inform the study subject
or his/her legal representative about them, define a list of persons that one
can address if it is necessary to obtain additional data concerning this CT the
subject-participant and the rights of the subject as well as other specialists
that the study subject can contact in case his/her health is compromised
during the study (these are representative of the study team, local EC). It is
obligatory to provide conditions when participation of the patient/healthy
volunteer can be discontinued without his/her consent, suggested duration
of the study, and approximate number of the subjects in different regions
and in the given clinical site. The information provided to the patient shall
be logically completed with the informed consent form, which exhibits, if
signed by the patient or his/her legal representative, that he/she agrees on
participation in the study, grants permission to stakeholders to access the
documentation showing his/her health status. Any medical interventions in
regard to patients can be performed only after he/she gets acquainted with
the information on the clinical study, signs and dates himself/herself the
informed consent sheet.
An ethical committee can approve clinical study conduct only in case
if its potential benefits for study subjects exceeds all known and expected
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kinds of risk for them. If it is necessary, EC has the right to request from an
applicant (an investigator and a sponsor) any additional information on the
given project if it can influence risk assessment for study subjects.
Special attention is paid to issues of ethical acceptability in case a study is
to involve so called vulnerable population groups (minors, pregnant women,
patients in urgent situations, incurable patients, military people, prisoners,
students, persons living in retirement home, homeless, refugees, unemployed,
low-income people, persons incapable of signing the IC form).
An integral part of the biomedical research ethical review is
examination during the study which becomes necessary if the sponsoring
company introduces amendments into the protocol, changes conditions for
rights protection of the study subjects, corrections into patient information
note when new data on a tested medicinal article or method appear. The
Ethics Committee is to review the following: study protocol amendments
introduced after project run onset, new data on on-going or completed studies
of the given medicinal agent or method, messages on serious adverse events
developed during its use, makes decisions on interventions into course of
the study if there is high probability to expose to danger the subjects.
Any changes in study design can be associated with potential risk
increase for its subjects, which is quite possible in case of adding or
cancelling treatment, any changes of inclusion/exclusion criteria, alterations
of the drug introduction routes, its doses, and significant changes in number
of the CT subjects. An ethics committee can approve amendments to the
clinical study conduct only if presented changes do not lead to worsening of
conditions for subjects.
After the application review an ethics committee can make one of the
following decisions: to approve study conduct; to approve a study with
minor changes, and after they are introduced the EC decision on the study
can be granted to an investigator with no need of repeated examination;
to require amendments of study procedures and materials and to submit
documents once again for examination; not to approve study conduct
(indicating reasons for refusal, if necessary – with recommendations on
elimination of identified defects). When reviewing amendments the EC
decisions can vary as well: as an approval for amendments and continuance
of the study, a request for additional information with or without the study
suspension, non-approval of amendments. The EC decision has to contain
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how often the particular project shall undergo interim reviews. Usually in
case of low risk for subjects ethical review during a study is performed once
a year; if decreed population groups are involved into CT, in case of high
risk due to peculiarities of a protocol, other decisions are possible (once
every 1, 3, 6 months, with enrollment of each new subject). EC obtains
information on all cases of adverse events and reviews them, produces
current decisions on suspension/prohibition of study conduct on supervised
sites if serious adverse events emerged. Interim review can be conducted
via remote examination of the study data and by visiting clinical sites. The
latter is utilized when a Principal investigator is a person that carries out
such functions for the 1st time; if it is the 1st time for the given study site
to participate in the study; if there are reports on serious adverse events in
the given site; if there are doubts that investigators comply with items of the
CT protocol; if earlier there were issues with providing reports (interim or
final) in the given study site, if there are complaints of the study subjects.
In such a case a reviewer will assess how the given site works basing not
on presented reports but getting acquainted with the work “in the field”,
assessing document management, interviewing participants.
On completion of a research project an ethics committee gets a report
on the study completion, and on completion of data statistical processing
and sizing up the results – conclusions on efficacy and safety of application
of the tested medicinal agent or methods.
Regretfully, in Russia we still do not have an efficient vertical for
ethical review with clear reporting system and hierarchy. Though with
some certainty one can claim that a role of the central EC is played by the
committee at the Federal Agency on Control of Quality of Pharmaceutical
Products by sanctioning or turning down main multi-Centreed studies
initiated by large pharmaceutical and, often, foreign companies at the
territory of Russia. Local EC in different regions of the Russian Federation
can be considered as guarantors of these studies in their respected areas
providing the research project supervision at all stages thereof. If CT is
not initiated by a large Russian manufacturer, in case of post-marketing
research launched in a particular site (locality) – all the work is fulfilled by
a local ethics committee taking full responsibility for such study. Similar
situation appears in case of initiative CT conducted as a part of R&D works
in research Centres. In majority of cases, when planning research projects
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for “academic” science, researchers cannot guarantee to subject a safety
level that is reached in case of large, multicentre Ct, they do not provide
study subjects with insurance, therefore, ethics committees bear additional
responsibility on ethical support for the given CT.
Regretfully, in Russia there is still no integral system of hierarchy and
interaction of ethics committees. The following model can be considered
as an ideal one: a national EC determining strategy for various ethics
fields, participating in development of regulatory acts, initiating various
scientific and practical activities and coordinating them. Then there follow
regional committees making decisions on “tactical” level and bearing
functions of practical management with local committees, providing
methodical assistance, being aware of local situations, and they are those
to whom can appeal local EC in case of some problems or non-standard
issues. And the main part is local ethics committees with clearly defined
objectives and functions.
Possibilities for researchers to appeal against ethics committee
actions are not regulated yet due to absence of actually working vertical
structure of ethical review boards. If an ethical committee is not satisfied
with activities at a study site it has a possibility to turn to the Ethics
Committee at the Federal Agency on Control of Pharmaceutical Products,
which, in turn, can apply sanctions up to withdrawal of the approval for
CT of a medicinal agent.
Russia gradually is integrating into the international system of biomedical
research. During the last year an international trend for improving of ethical
review was a process of harmonization of ethical review standards at the
world scale that was reflected with the project of SIDCER under the aegis of
WHO (2000). Within the framework of this project development forums of
ethics committees are being formed everywhere around the world. Currently
6 of them were created in different world regions: Africa, Latin America, Asia
and Pacific region, North America (along with Canada and the USA), CIS.
The next step became the existing issue for consolidation of the Forums, and
in this regard harmonization of ethical review of biomedical research repeats
the path passed with the world community in regard to harmonization of
GCP rules. The first guidelines for SIDCER became Operational Guidelines
for Ethics Committees that Review Biomedical Research (2000), and then
Surveying and Evaluating Ethical Review Practices (2002).
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The Forum for Ethics Committees in CIS Countries was established in 2001
(Saint-Petersburg). Its main objective was to facilitate bioethics development
in the regions of post-Soviet space focusing on biomedical research. It fully
implements WHO initiatives: it provides opportunities for meetings and
discussion of problematic bioethics issues; facilitates development of regional
traditions and peculiarities in ethics and bioethics, assists in distribution of
information and organization of trainings on bioethics issues for EC members;
provides methodological assistance to the CIS member states on issues of
bioethics and ethical review of biomedical research; holds international
meetings, conferences and symposia; provides representation at international
agencies and meeting on bioethics issues.
FECCIS established permanently acting seminar that is held annually
in different Commonwealth countries; participates in improvements of
regulatory basis for ethical review that was exhibited with adopted law On
Protection of Human Rights and Dignity in Biomedical Researches in the CIS
(IPA CIS), development of standard operational procedures for activities of
Ethics Committees in the CIS (2004, 2005), translation, adaptation for local
conditions and distribution of WHO guidelines that is also facilitated with
creation of FECCIS web site.
Nowadays our country comes to forming a system for EC accreditation,
certification and inspection under the guidance of the Forum for Ethics
Committees in CIS Countries that will bring it to the international level.
In general, one can state that the ethical review conduct at all CT stages is
an efficient mechanisms for protection of rights of the study subjects involved
in the biomedical research and in Russia there is established mechanism
for practical implementation of its principles. There are shortcomings and
serious issues to be addressed, there is insufficient regulatory basis for this
process but it was started and its results are on hand.
Observing the number of clinical studies of medicinal agents approved
to be held in Russia at the period of 2000 to 2005 one can notice more than
double positive dynamics during the 5-year period.
As per the data of the Committees on Ethics at the Federal Agency on
Control over Quality of Pharmaceutical Products in regard to changes of
submission of materials for CT of medicinal agents during the last 5 tears
a number of submissions for the CT ethical review increased in 3.6 times
– from 431 in 2001 to 810 in 2003 and to 1568 in 2005.
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As per the data of the Committees on Ethics at the Federal Agency on
Control over Quality of Pharmaceutical Products in regard to changes of
submission of materials for CT of medicinal agents during the last 5 tears
a number of submissions for the CT ethical review increased in 3.6 times
– from 431 in 2001 to 810 in 2003 and to 1568 in 2005.
Ratio of CT types as per the data of the given committee is the following:
20% - Russian medicinal agents, 47% - multicentre international CT of
medicinal agents, 5% - local CT of foreign medicinal agents, 7% - postmarketing CT of medicinal agents and 21% - researches of bioequivalence
of medicinal agents. Prevailing research fields are cardiology, psychiatry,
neurology and oncology.
Every year in Russia each hundred biomedical research is rejected,
decision on other 7% of protocols is postponed until the study organizers
correct serious planning defects, 31% of CT requires changes of the materials
for CT of medicinal agents (in most of cases it is necessary to rework text in
the patient information and informed consent note), which are not fatal, and
only about 61% do not give rise to doubts on their ethical features and are
approved by ethical review (from the speech of Academician of the Russian
Academy of Medical Sciences, Professor Komarov F.I. Principles and
Results of Work of the Ethics Committee at the Federal Agency on Control
over Quality of Pharmaceutical Products, 2006), similar data were presented
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with LEC of the Russian State Medical University and Republican EC of
the Republic of Tatarstan. Such principled approach is a notable barrier
non-admitting researches with high probability for making harm to the
biomedical research potential subjects.
Perspectives for cooperation in the field of ethical review are related
to creation of common ethical and legal environment in the countries of
the Commonwealth of Independent States, Europe and the world. There
are three main areas of activities in cooperation with foreign partners are
especially important for Russia: legislation harmonization, joint research
and educational activities.
In regard to legislation unification quite significant event was adoption
in 2005 of the National Standard of the Russian Federation GOST R 523792005 “Good Clinical Practice” (approved by the Order of the Federal Agency
on technical regulations and metrology of September 27, 2005, No.232). This
document completely implemented GCP, which is an international ethical
and scientific standard of design and conduct of research involving human
subjects as well as a standard of documentary registration and presentation
of results of such studies, into the Russian legislation. It was identical to the
Guidelines for Good Clinical Practice of the International Conference on
Harmonization of Technical Requirements for Registration Pharmaceuticals
for Human Use, which, in turn, was developed with consideration of acting
requirements of good clinical practice of the European Union, the USA
and Japan, as well as Australia, Canada and WHO. Compliance with this
document makes possible to our country to adhere to united rules with
countries of the European Union, the USA and Japan, that should facilitate
mutual recognition of clinical study results with authorized agencies in
these countries and become a basis to extend conduct of multicentre studies,
eliminate practice of duplicating medical and biological studies in different
regions of the world allowing to Russia to become full-fledged participant
in process of international studies and, eventually, to result in mutual
acknowledgement of pharmaceuticals approval.
To secure state guarantees for protection of personal rights, dignity,
autonomy and integrity conducting biomedical research in the CIS member
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states in 2005 there was issuesd a model Law On Protection of Human Rights
and Dignity in Biomedical Researches in the CIS, which corresponded to
all principles of biomedical ethics and medical law, interstate agreements
in the field of biomedical research ethics. This document allows attaining
common understanding of protection of human rights and fundamental
freedoms in the sphere of biology and medicine application, to unite
efforts of scientists and politicians from all CIS countries in the common
legal and ethical environment for biomedical researches that covers all
types of impacting a man, including studies on embryos in vivo. Along
with that, the law enforcement is secured via creation of interstate and
national systems of ethical review that is designed in accordance with
ideology of the WHO program SIDCER and initiated by the Forum for
Ethics Committees in the CIS.
Currently we came to understanding that all biomedical projects held in
the CIS countries shall undergo independent ethical review at the national
level; there were established ethics committees forming a mechanism for
provision of ethical review quality and research project safety through
control at all stages of informed consent obtaining from candidate study
subjects (in case of participation of subjects unable to provide such consent
independently – from their legal representatives), ethical research support at
all stages until project completion. Special situation of biomedical research
conduct are specially controlled by ethical committees when study subjects
are related to vulnerable population categories (due to their age, intellectual,
mental, or social immaturity or vulnerability) or when studies stipulate
obtaining information on genetic code of the study subject.
Ethical committees of the CIS countries reached common understanding
on necessity of ethical review, they approved common basics for their
activities, and the next stage is building up the ethical control vertical
system and making this process transparent both within the country and the
Commonwealth that is possible through implementation of Acknowledgement
program initiated by WHO and suggested for implementation in the postSoviet countries by FECCIS. This program stipulated ethical committee
certification that was a guarantee for compliance to highest quality standards
of ethical review and development of a system of effective control over
research activities in the country for the world community. Russia started
preparation of ethical committees for participation in this procedure.
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Realization of significance of ethical review of biomedical studies
facilitates attraction of grants from various funds and organizations to this
field: these are foreign educational grants offered at the territory of Russia,
for instance, by the Fogarty Fund, U.S. Civilian Research and Development
Foundation (CRDF), or support for research projects in particular entities
of the Russian Federation (for instance, a grant of the Academy of Sciences
of the Republic of Tatarstan). They all facilitate wide spread of bioethical
knowledge, realization of necessity for conduct of civilized ethical review
of research projects in the sphere of medicine and provision of population
safety during their conduct. In perspective, it will make possible for
Russia to become a fully-functional participant in international biomedical
researches and, eventually, result in closer cooperation of various countries
in this sphere, strengthening of mutual trust, and at the next stage – mutual
acknowledgement of approval for medicinal agents, new methods of
treatment, products for medical use.
There is the UNESCO Moscow Office (www.unesco.ru), which
objectives are cooperation with Russia and post-Soviet countries in various
educational and scientific programs including the ones on bioethics. Its
activity Social and Humanitarian Sciences for promotion of knowledge,
development of norms and establishment of intellectual cooperation in order
to assist to social transformations includes cluster on Ethics of Science and
Technology with emphasis on bioethics. The UNESCO Office facilitates
development of institutions in the field of protection of human rights and
dignity due to advances of biomedical researches. And starting from 2002
as to an initiative and with support of this organization there were conducted
educational workshops, conferences for experience and knowledge exchange
on bioethics issues – for instance, the International meeting of experts for
development of cooperation in the sphere of ethics and bioethics in Minsk,
2005, for CIS and Baltic state, Promotion of knowledge in bioethics,
Moldova, 2005; Social justice in health care: justice and human rights,
Moscow, 2005.
Current international scientific cooperation allows presenting scientific
research results at conferences, meetings, and other scientific forums with
bioethical orientation. At the same time, possibilities for joint organization
of research conduct in this important field are still utilized insufficiently.
It seems to be advisable to use financial support of international funds
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for transcultural studies, to set-up a specialized magazine to publish their
results, to conduct on a regular basis specific scientific meetings within
CIS that will provide opportunities for experience exchange, analysis of
complex cases, collisions, and, possibly, for search for consensus in case
of discrepancies and disagreements within CIS. Possibly, it makes sense
to establish the Centre on Bioethics coordinating researches in this field,
training specialists, promoting bioethics ideas and principles among various
population groups. Also it appears to be of similar importance to introduce a
separate trade, bioethics, within the list approved by the Higher Attestation
Commission that will facilitate activation of research with participation of
specialists of highest qualification.
It is still of importance to provide methodical assistance to some of the
CIS states for development of the ethical review system there, for helping
them in developing positive public attitude in regard to necessity of such
structures within the state, for training specialists able of conducting
ethical review of biomedical researches. Ethical committees that have been
created quite recently were yet unable to find their place in the society;
they make just their first steps and require assistance. For that those ethical
committees actually working in Russia through involving specialists of
appropriate trade – full professors and professors of departments working
on issues of biomedical ethics and medical law – are ready to set up and
conduct educational cycles for members of ethical committees, clinical
researchers, medical community. Ethical committees of Russia are open
for discussion of joint scientific research for all comers. They are ready
to assist in preparation of constituent documents and basics for methods
of practical activities, to participate in development of ethical programs in
various fields.
From the point of view of harmonization of curriculum in different
countries and, first of all, Europe, new opportunities are provided by
the Bologna process. Joining of Russia to this process (de jure since
September 2003) did not formally mean that the country should develop
curriculum of set content but the very spirit of Bologna process (which main
essence is consolidation of resources in Europe for effective competition
at the educational market) implies convergence. Otherwise it would be
impossible to attain mutual acknowledgement of educational qualifications
and mobility of students and professors.
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In regard to bioethical and legal education for the entire population
Russia is in conditions bringing it closer to other post-Soviet states and
making it different from countries of traditional democracy, since democratic
changes emerged there in last decades only. Therefore, it seems of paramount
importance to acquaint Russians with problems, tasks and possibilities of
legal and bioethical regulation in the field of health care and biomedical
science basing on effective experience of other countries and, especially, the
ones of the so-called “near abroad”. It could be attained through creation of
topical TV shows, round tables with specialists in various fields of biology
and medicine, publications series of articles on pressing issues of bioethics
and medical legislation, creation of Internet resources with this orientation.
Changes of the Russian legislation that are awaited for a long time and,
which is important, proper execution of legal and bioethical norms, without
which it is impossible to secure respectful attitude to human rights and
dignity in the sphere of bioethics, depend on general legal culture of people,
their bioethical “maturity”.
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3.9 Republic of Tajikistan
(S.D.Achrorova)
Nowadays in Republic of Tajikistan, like all over the world, the need
for biomedical research is growing steadily, as well as the concern for such
human values as a person’s health, rights and dignity. Therefore, people
of different professions, religions and nationalities have come together to
form medical ethics committees that would perform ethical review of each
research involving human subjects.
The first Tajik State with the centre in Bukhara was founded by Ismail
Samani in 875. In 999 the Samanide State was destroyed because of
dissensions concerning territorial claims of Ismail Samani’s heirs.
Later the land of Tajikistan formed a part of different states (Iran:
1212-1220 and 1740-1747; Genghis Khan Mongol Empire: 1220-1370;
the State of Timurids: 1370-1740; Bukhara Khanate – the so called East
Bukhara: 1747-1920). In 1867 northern territories of Tajikistan with the
city of Khodjent entered the Russian Empire and were industrialized. In
1925 the Tajik Autonomous Soviet Socialist Republic was created as a part
of Uzbekistan Republic, but in 1929 the Tajik Soviet Socialist Republic
was made a separate constituent republic with the city of Dushanbe as its
capital. In 1991 the Soviet Union collapsed, and Tajikistan declared its
independence.
Tajikistan is a mountainous landlocked country in Central Asia.
Afghanistan borders to the south, Uzbekistan to the west, Kyrgyzstan to
the North, and China to the east. The total area of Tajikistan Republic is
143.1 thousands of square km, and it has a population of 7,163,506 citizens.
Tajikistan consists of 4 administrative divisions: 2 provinces (Sughd in the
north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
- Pamir), and disrtricts of republican subordination around Dushanbe.
Tajikistan is an agrarian-industrial country and has a considerable
potential. Lengthy wars caused devastations and human losses, which
resulted in a dramatic economic recession. However, during the last peaceful
years the economics and living standard have notably increased.
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The Tajik people have a rich and ancient culture. Since antiquity to
the period of feudalism moral and ethical issues took an important place
in religious and philosophical outlook. Until the IX century it had been
developing in the context of Iranian philosophy, and later, since the 9th
to the XV century in the context of Arabic philosophy. Due to the ethnic,
language, social and political commonality in antiquity and the early Middle
Ages particularly close relations were between East-Iranian (ancestors of
the Tajiks) and West-Iranian (ancestors of the Persians) people. The TajikPersian philosophical thought had also a connection with Indian and Greek
philosophy. However the closest links connected the Tajik culture and
spiritual and philosophic outlook with cultures of Turkic peoples of Central
Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
values and scientific achievements.
Religious and philosophical ideas of Tajik ancestors roots back to
an ancient monument of spiritual culture “Avesta” the holy canon of
Zoroastrism (Mazdeism) containing not only religious dogmas but also
ideas on cosmogony, philosophy, morals and law. The characteristic feature
of Zoroastrianism is dualism, i.e. the view that two fundamental concepts
exist, such as good and evil, and the struggle between these is the pivot
and content of the universe. Zoroastrianism formulated a ternary ideal of
the righteous man (“good thoughts”, “good words” and “good deeds”)
opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked
words” and “wicked deeds”). The Zoroastrian idea about infinite time as
an initial substance gave rise to zervanism – a teaching in the framework
of which a materialistic trend developed that denied the creation, and god
as the creator of the universe, and affirmed the belief in the eternity of
the world. In the end of the slave-owning system and in the beginning of
feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the
end of the V - the beginning of the VI century) became very influential.
Those philosophical trends assimilated the Zoroastrian ideal about the
struggle between the good and the evil. The social doctrine of Mazdakism
proclaimed ideas of justice and equality.
The earliest written evidence that peoples of Central Asia had a good
knowledge of mathematics and astronomy is “Avesta” containing data
on the movement of celestial bodies, the system of time count and some
mathematical rules. In that period, early states in Central Asia achieved a high
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level of material production and culture: crafts, agriculture, architecture and
art. That was the time when many written monuments of religious, political
and scientific thought were created, many of which were destroyed during
the invasion of the army of the Arab Caliphate (VII-VIII centuries).
During the VIII-XV centuries philosophical, social and political ideas
were developing in the atmosphere of Arabian conquests and a forcible
spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became
most closely linked. During the VIII-IX centuries, in Maverannahr (the right
bank of Amudarya) and Khorosan the tendency to the territorial, language
and cultural integration broken by the Arabian conquest had been growing.
During the period of the Samanids rule (874-1005 AD), the Tajiks
developed as a nation with its State system and literary language. In the
IX-XI centuries, Central Asia was one of the most important centres of
oriental science. That was the time when astronomical observatories,
“Houses of Wisdom” and libraries were built. Scientists from Central Asia
translated and commented the scientific heritage of ancient Greece and
India and wrote original works on mathematics, astronomy, mineralogy,
applied mechanics, physics, chemistry and medicine. Mohammed ibn Musa
al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa
al-Buzjani, Abulmahmud Hudjani (X c.) and many others made an essential
contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
Merv, Gazna and other towns, and later, in the XV century, Samarkand
with the Ulugbek’s observatory, were outstanding scientific centres. The
names of Biruni (X-XI c.), Omar Khayyam (XI-XII c.), al-Djurjani (XII
c.), Naseeruddin Tusi, Shamsiddine Samarkandi, Djamaleddine Bukhoroi,
Alishakh Buhoroi (XIIc.), Mohammed Samarkandi, Ansori (XIV c.) and
others are associated with medieval towns. The leading scientists of the
Samarkand scientific school were Kazi-zade ar-Rumi, Djemshid al-Kashi
(XIV-XV c.), Ali Kushchi (XV c.), Abu Ali Ibn Sina and others.
Ethics as a scientific trend had a significant place in works of prominent
oriental thinkers, and Ali Ibn Sina (Abu Ali al-Husain ibn Sina-e Balkhi
(Latinized Avicenna) one of them; a philosopher, musician, poet, physician,
the follower of Aristotle, he was a scientist of encyclopaedic knowledge and
one of the greatest minds of the Middle Ages. Roger Bacon was certainly
right when he wrote that Ibn Sina was “the greatest teacher of philosophy
after Aristotle”. The Tajik by birth, he was born in the suburb of Bukhara
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(Afshon) in 980, lived in different cities of the Central Asia and Iran,
served various rulers as a court physician and vizier, and died in 1037 near
Hamadan.
Abu Ali Ibn Sina wrote in the Arabic and Tajik languages. He left a rich
scientific heritage – about 300 works, and among those “Book of Healing”,
“Book of Knowledge”, “Book of Directions and Remarks”, “Book of
Salvation” and “Canon of Medical Science”. The latter had been considered
as one of the fundamental medical guidelines during five centuries. He
was the author of works on philosophy (e.g. commentaries on Aristotle’s
“Poetics”), wrote lyrical poetry, and some poems have survived to out time.
Ibn Sina’s “Book of Healing” was the highest achievement of the medieval
philosophy, particularly, as it tried to reconcile rationalistic thinking and
religion. A great number of his works were translated into Latin in the
second half of the XII century.
“Book of Healing” in 18 volumes included “Logic”, “Poetics”,
“Rhetoric”, “Physics” (in eight chapters; the sixth chapter was entitled
“On the Soul”) and “Metaphysics”. Dominique Gundisalvi from Toledo
completed the latter in 1180.
Following Aristotle, Abu Ali Ibn Sina classified knowledge into
theoretical and practical trends, and attributed ethics, economics and politics
to the practical area. He considered problems of essence and existence in the
light of Neoplatonism.
The starting point of Aristotle’s ethical teaching was the theory that
social life of human beings is realized in actions and in their interaction.
Already in the first paragraph of “Great Ethics” Aristotle wrote that to act
in social life, one should have certain ethical qualities and be a worthy man.
To be a worthy man means to have virtues. Therefore, the one who intends
to act in social and political life should be a virtuous man. Substance and
form cannot exist independently, they are interconnected. In the so called
“dispute of universalia”– one of the fundamental problems in medieval
scholasticism – Abu Ali Ibn Sina followed Aristotle’s theory of interrelation
of substance and form and believed that universalia exist both in things and
in human mind. The latter elicits universalia from things, and even ante
things (ante res) and after things (post res). Ibn Sina did not doubt that the
world is intelligible and stressed the importance of logic considering it as
an introduction to every science. With regard to psychology, Ibn Sina also
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followed Aristotle and distinguished the vegetable, animal and rational
soul. He gave a special attention to the human soul and did not deny its
immortality, not in the direct, but in the philosophical sense, i.e. he did
not believe in metempsychosis. Neoplatonic ideas of Aristotle are present
also in those philosophical views of Abu Ali Ibn Sina that contain elements
of Sufism. Aristotle’s philosophy developed by Abu Ali Ibn Sina and his
followers (including Omar Khayyam) was very popular in the orient. The
teaching of Ibn Sina contained some materialistic elements (the idea of the
eternal material world, sensualist elements in the theory of cognition, etc.).
Ibn Sina’s talent shows itself most fully in the analysis of Neoplatonism
philosophy. His works “Book of Healing” and “Book of Salvation” are still
considered encyclopaedias of Muslim Neoplatonism. Another work by Ibn
Sina “The Justice” that has not survived to our days presented an analysis and
comparison of views of Alexandria and Baghdad schools of Neoplatonism.
In “The Justice” Abu Ali Ibn Sina is an arbitrator between the two quite
famous medieval philosophical schools. His book “Oriental Wisdom”,
probably, also offered an analysis of works by oriental philosophers who
commented on Neoplatonism considering views of Alexandria scientists.
“Book of Directions” that was, by legend, Ibn Sina’s last work shows the
author’s Sufi views. A number of works consider the problem of free will.
Abu Ibn Sina associated free will with active, practical intellect, which
stressed a purely ethical, not psychological, nature of his theory. A.K.Zakuev
rightly noted that Ibn Sina’s teaching covers problems of regulating human
behaviour, moral judgments, and of ethical compliance of human behaviour
with commonly recognized moral principles and with an individual’s own
views derived from those principles for regulating his/her behaviour of his/
her own volition.
Some works by Ibn Sina show us his adherence to certain aspects of
Sufism and mystical symbolism. Famous for its encyclopaedic character,
his philosophy served for reconciliation of religious views and rationalistic
sciences, which alone would suffice to consider him an original philosopher.
Avicenna had a noticeable influence on views of Thomas d’Aquin and
Albert the Great – the two prominent medieval philosophers. Agiographic
texts abound in evidences on remarkable abilities of Hadji Naseeruddin
Obaidullah Ahmar from Maverannahr (1404-1490), a religious figure, who
worked miracles to protect order, justice and the oppressed. His actions
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showed his mercy to the oppressed and sternness towards oppressors and their
accomplices who forgot the moral norms of Sharia. His style of behaviour
demonstrated norms of righteousness, good deeds and ethical conduct.
Abu Ali Ibn Sina was very popular among European scholastics
(especially in the XIII c.). In the Middle Ages separate chapters from
Avicenna’s “Book of Healing”, such as “Logic”, “On the Soul” and
“Metaphysics” were translated into Latin, and Christian philosophers all
over Europe considered themselves either followers of admirers of Abu Ali
Ibn Sina.
Ethical views of another great Tajik scientist, thinker and political
figure of the XIII century Naseeruddin Tusi on the essence and norms of
morals we find in his work “Ahloki Nosiri” composed of two parts: “On the
fundamentals of morals” and “Doctrine of the purpose”. For him ethics as
a science of behaviour is an essence of not only innate but also of acquired
qualities, and being a product of social relations it may change according to
social events. The author describes factors causing ethical changes.
Ar-Razi proceeded from the materialistic tradition of Democritus
who recognized natural regularities of nature and society and affirmed the
cognoscibility of the world. Advanced ideas of Biruni who opposed the
natural-science approach to the religious worldview were widespread. During
the IX-XIV century, kalam, a scholastic philosophy of Islam that emerged
in the VIII century, gained popularity and was opposing progressive views
of Ibn Sina and his followers. Kalam defenders (Gazalii Fahruddin Rosi)
advocated the idea of the Creation and believed that the world depends on
the divine will. In the XI century, the teachings of Ismailism (a philosophical
doctrine of Ismailism based on Neoplatonic and Aristotle’s views) became
very influential (Nasir Hisrov). In their teaching on the harmony of the
universe the Ismailis likened the constitution of the universe (“macrocosm”)
to the constitution of human body (“microcosm”).
Continuous internal wars in khanates of the Central Asia over XVI-XIX
centuries resulted in the decline of productive forces, and living conditions
of working masses changed for the worse. During that period, reactionary
clergy was extremely influential, and repressed any scientific thought. The
main attention was given to Muslim theology and ethics. The influence of
the Sufi doctrine and literature with biographies of Sufi sheikhs and moral
regulations of various Sufi Orders was particularly strong. Progressive
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tendencies and anti-feudal views were expressed in works by Tajik poets and
thinkers, such as Binoi (1453-1512), Vasifi (1485-1551), Hiloli (executed
in 1529), Saiido Nasafi (died in 1707 or in 1711), Bedil (1644-1721) and
others. Their works reflected interests of working people and their protest
against a feudal exploitation.
Starting from the second half of the XIX century, the Russian Empire
had a favourable influence on the development of philosophical and sociopolitical thought of the Tajik and other peoples of the Central Asia. Under the
influence of Russian culture, democratic and enlightening views paved the
way to Marxist-Leninist ideology. The involvement in the sphere of economic
and scientific interests of Russia, despite an imperial policy of tsarism,
facilitated the process of the implementation in Tajikistan of new and more
developed agricultural and industrial machinery, transport equipment, new
methods of farming and new crops. In the period from the end of the XIX to the
beginning of the XX century, Russian culture influenced the development of
the Tajik philosophical, scientific and engineering thought. Ahmad Donish,
Hodji Halif, Hodji Jusup, Yakubi Farang, Hairat, Somi, Sobir, Asiri, Siddiki,
Aini and others advocated ideas of national progress and social justice and
criticized medieval feudal system. Scientific centres of Moscow, Leningrad
and other cities were helpful in rising Tajik philosophers. The study of the
history of Tajik philosophy and teachings of ancient peoples of the Central
Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and
others analyzed in their works problems of the unity of the national and the
international in the history of Tajik culture and philosophy, revealed special
regularities of their development, the character of interaction with other
philosophical trends and unmasked reactionary nature of Europocentric and
Asiacentric concepts. Tajik scientists carried out studies in the sphere of
dialectical, historical materialism and philosophy of natural sciences; they
analyzed laws and categories of materialistic dialectics, objective regularities
of historical development and conscious human activity, problems of
education, formation of socialist nations, methodology of modern science,
etc. (S.Umarov, M.S.Asimov, S.B.Morochnik, V.I.Pripisnov, M.Gafarova,
A.Tursunov, I.Sharipov, S.A.Radjabov, K.Sabirov, M.Kamilov). The works
on scientific atheism analyzed problems of developing a scientific and
materialistic worldview, causes for survival of religious views and ways
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to overcome the problem; gave a critical analysis of various religious
concepts (A.Bazarov, R.Madjiev). There were also new studies in the field
of sociology, ethics and aesthetics.
The late eighties and early nineties were marked with complicated and
contradictory events, the most significant of which was a disappearance
of such a state as the USSR on the map of the world. Instead, about 15
new independent states appeared, and Tajikistan among those. Thus, within
a short historical interval Tajikistan moved from one historical period to
another; the state and power structure changed, as well as its attributes.
The former political system was destroyed, which resulted in the change of
ownership patterns and social relations.
The development of Tajikistan as an independent secular republic
in the post-Soviet space was accompanied with economic, political and
social instability. A significant support from the international community
was directed to the needs associated with the civil was (1992-1995) and
its consequences. Emergency measures of providing medicines, vaccines,
bandaging material taken by the international community made an essential
contribution into the solution of healthcare problems. At the same time, there
was a need in more thorough structural changes that would help to overcome
existing problems and facilitate the development of safe mechanisms for
providing healthcare and safeguarding patients’ rights.
As current biomedical researches are carried out at a large scale and
at many Centres, they affect interests of many people and many countries.
New problems emerge, because “rich” countries carry over their biomedical
research to other, “poorer” countries, and use the results of the research at
home, as, “poor” countries cannot afford to use the research findings for
economic reasons. To eliminate this injustice, the medical community took
certain measures. The WMA Declaration of Helsinki and the additional
Protocol to the CE Convention on Human Rights and Biomedicine require
that in the countries where a biomedical research is planned the permission
should be sought from state structures, and interests of people who live there
and who are potential research subjects should be considered.
The involvement of Republic of Tajikistan, as an independent state,
in international research projects requiring ethical review to ensure the
compliance with international regulations triggered the process of establishing
in Tajikistan the Committee on Medical Ethics and developing the system
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of State registration of pharmaceutical products, medical facilities and other
medical goods.
For a further development of medical ethical review of scientific-research
projects, the Ministry of Health established the Republican Committee on
Medical Ethics at the Department of the Management of Medical Personnel
and Science (Order No 250; 4 of June 2004). The first research project that
had to undergo ethical review to ensure the compliance with documents
setting international rules in ethics was a joint Tajik-American research on
AIDS and hepatitis C in drug addicts. 3.9.2. Legal Regulations
One of fundamental human rights is the right for life and health
protection. Health is a natural, absolute and vitally important value taking
the top position in the hierarchy of human values and in the system of such
categories of human existence as interests and ideals, harmony and beauty,
the meaning of life, happiness, creative labour and rhythm of life.
The execution and efficiency of legal regulations depends on how much
they correspond with moral requirements. Quite often legal regulations fix
moral norms directly and reinforce them with legal sanctions. Thus, many
legal norms prohibit actions that are hazardous to the society and human
health.
In healthcare, the integration of moral and ethical norms into the legal
system should be a priority. Therefore, the moral and ethical components
in the work of medical professionals should correspond to legislative
principles referring to the protection of the patient’s rights and dignity. By
now, the Committee on Medical Ethics at the Health Ministry of Republic
of Tajikistan (HM RT) has worked out a number of important documents
adapted to the needs of Tajikistan:
• the Statement “On the Committee on Medical Ethics” (HM RT
Order of No 118, 10 of March 2005);
• “Ethical Aspects of Regulations for Clinical Practice in Republic of
Tajikistan” (Supplement to the HM RT Order No 118, 10 of March 2005)
and
• “Guidelines for Laboratory Practice in Republic Tajikistan”
(Supplement to the HM RT Order No 118, 10 of March 2005).
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To protect both an individual and the community, these legislative acts
state that ethical and scientific review should precede a biomedical research
including the evaluation of inform consent to participate in the research
and special procedures aiming to protect interests of individuals who
cannot consent. In developing national regulative documents, we followed
international guidelines and documents of the Forum for Ethics Committees
in the Commonwealth of Independent States such as International Ethical
Guidelines for Biomedical Research Involving Human Subjects and Guidance
on Good Clinical Practice developed by the World Health Organization and
International Conference on Harmonization of Technical Requirements got
the Registration of Pharmaceuticals for Human Use, materials of FECCIS
international conferences (2003-2005). Compliance with these documents
ensures the protection of rights, honour, dignity, safety and well-being of
research participants, as well as reliability of research findings. We were
also guided by the Constitution of Republic of Tajikistan and by Tajikistan
Laws “On the Protection of the Population Health”, “On Pharmaceutical
Products and Pharmaceutical Practice”, “On Narcotic Drugs, Psychoactive
Drugs and Precursors”, “The Concept of Healthcare Reformation in Republic
of Tajikistan” (2002). These documents are focused on the international
practice; implementation of new, more efficient organization approaches,
improving the quality and availability of medical and sanitary care and a
further development of international cooperation.
In the context of democratization processes in Tajikistan, when conducting
a biomedical research we have to proceed from the principle of the respect
for a person’s freedom and, hence, from the principle of the respect for an
individual’s convictions. One of the factors that might limit the physician’s
freedom in decision-making is the religious and cultural milieu that formed
an individual’s consciousness. Without the knowledge of cultural details, a
competent design of biomedical research in Tajikistan – a Moslem country and
an officially secular State – is not possible. Besides, there are strong believers
practicing Islam and observing all religious holidays. Thus, many people
keep the strict fast during the Ramadan. In this period people suffering from
severe diseases, refuse taking medicines both per os and by injection, which is
harmful to their health. Thus, for example, patients who have had operations
for glaucoma refuse courses of conservative supportive therapy or keep the
fast, which weakens visual functions. Quite often during the Ramadan people
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get to the surgery department of the emergency station with pancreonecrosis
after having a rich and fat meal (pilaw) in the night after fasting during the day.
In some cases this situation has a lethal outcome. Islamic traditions dictate a
respectful attitude to the human body even after a person’s death and therefore
relatives of the deceased do not consent to the post-mortem examination and
removal of organs for transplantation. According to Moslem religion, the soul
of the embryo appears in the first week of the fourth month of pregnancy, and
the law prohibits abortion after this term. Besides, Tajikistan population is not
disposed to contraception measures or abortion, and therefore Tajik families
are commonly having many children. When carrying out preventive health
examination of strong believers, it is important to divide them into separate
streams according to sex.
Artificial fertilization in Tajikistan is permitted. It is desirable to use
sperm of the woman’s husband provided that his consent has been obtained.
There are no strict religious restrictions with regard to transplantation and
removal donor organs. Sharia laws state that medical professionals should
struggle for a patient’s life to the last moment and totally reject euthanasia.
These and other similar examples emphasize the necessity to consider
cultural aspects with regard to providing medical care and conducting
biomedical research in Tajikistan.
Biomedical research if conducted without considering cultural and
religious aspects may have negative consequences. The physician should
follow certain rules not to harm religious feelings. This is essential both in
planned and emergency treatment. However, often, particularly in providing
emergency care, the physician, voluntarily or not, may be in a situation when
he/she is violating a religious rule.
When developing legislative acts referring to healthcare in Tajikistan
we have followed the fundamental principles of the protection of human
rights and dignity in biomedicine. The basic document is the Constitution
of Tajikistan. The current Constitution is ensuring the priority of providing
healthcare to the population of Tajikistan.
The Constitution of Tajikistan proclaims citizens’ rights and freedoms
and determines responsibilities of natural and juridical persons. One of
the rights guaranteed by the Constitution is the right for health protection
implying the following:
- medical care and social protection;
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- safe environment, food products and drinking water;
- qualified medical and sanitary care including a free choice of a
physician and healthcare institution;
- safe and healthy living and working conditions, as well as safe and
healthy conditions for rest, education and upbringing;
- sanitary and epidemiologic well-being in the territory where a person
lives;
- truthful and timely information about an individual’s health including
existing and potential risks and the degree of risk;
- participation in measures on health protection and public expertise
with regard to these issues;
- possibility to create public organizations for the purpose of facilitating
health protection and protection of human rights;
- legal assistance in any case of discrimination referring to health
condition;
- compensation for a caused harm;
- making an appeal in the event of wrongful decisions or actions of
healthcare professionals;
- independent medical expertise in case of discordance with the decision
of the State expertise.
The healthcare legislation in Tajikistan includes Constitution norms,
Tajikistan law “On the Protection of Population Health” and other
national legislation acts, international regulations adopted by Tajikistan,
international treaties and normative documents issued by state structures.
All these documents state that the society and government are responsible to
contemporaries and future generations for the health level of the Tajikistan
population. The current legislation is regulating social relations in the sphere
of healthcare covering a wide range of issues from a harmonious physical
and spiritual development and the improvement of heredity to social and
legal protection of the patient. The laws aim at improving conditions of
work, life and rest, resolving ecological problems, developing the quality of
medical care and promoting a healthy life-style.
The first steps of the independent Tajikistan were accompanied with
economic crisis in all fields including healthcare. Economic, political and
social recession affected indices of the population health. Most urgent were
problems concerning food, water supply, sanitary situation, the growth of
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infectious diseases (typhoid, malaria, tuberculosis, diphtheria, acute viral
hepatitis) acute respiratory diseases, anemia, diseases caused by iodine
deficit and reproductive health. Despite instability in political and socioeconomic life during the first years of independence, Tajikistan Government
took comprehensive measures on the protection of the population health.
During that period, Tajikistan ratified important international documents
referring to the protection of human rights such as the Convention on the
Elimination of All Forms of Discrimination against Women (ratified in
1993), Convention on Children’s Rights (ratified in 1993). Presently, the
following documents form the legislative basis in healthcare:
- Constitution of Republic of Tajikistan (RT) (1994)
- RT law “On AIDS Prevention” (No 904; 23 of December 1993)
- RT law “On Donorship of Blood and its Components” (No 901; 23
December 1993)
- RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
- RT law “On the Protection of Population Health” (No 419; 15 of
May 1997)
- RT Labour Code (1997).
- Family Code (1997).
- RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874,
10 of December 1999)
- RT law “On Pharmaceutical Products and Pharmaceutical Activity”
(No 39; 6 of August 2001)
- RT law “On Psychiatric Care” (No 90, 2 of December 2000)
- RT law “On Reproductive Health and Reproductive Rights” (No 72;
2 of December 2002)
- RT law “On Private Medical Practice” (No 60; 3 of December 2000)
- RT law “On Salt Iodination” (No 85; 2 of December 2002)
- Decree of the RT Government “On the Approval of the National
Programme for the Control of Tropical Diseases (Malaria) in Republic of
Tajikistan in 1997-2005” (No 342, 4 of December 1997)
Programme for the Control of Viral Hepatitis “B” in Tajikistan in 20002007” (No 100; 11 of March 2000)
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- Decree of the RT Government “On the Approval of the Concept of
Healthcare Reformation in Republic of Tajikistan” (No 94; 4 of March
2002)
Programme for the Prevention and Control of HIV/AIDS/STD in Republic
of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
- Decree of the RT Government “On the RT Strategy for Preventing
the Menace of AIDS Spreading for the Period of 2002-2005” (No 389; 1 of
October 2002)
- Decree of the RT Government “On the Approval of the RT Strategy
for the Protection of Population Health in the Period to 2010” (No 436; 5 of
November 2002)
Programme for Tuberculosis Control for the Period 2003-2010” (№ 524; 31
of December 2002)
- Decree of the RT Government “On Family Medicine” (2000)
Programme for the Development of a Healthy Life-Style in the Period to
2010 (No84; 3 of March 2003)
The problem of protection of research subjects’ health and rights
is reflected in strategic documents “The RT Strategy for the Protection
of the Population Health in the Period to 2010”, “The RT Strategy of
Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the
Development of the Millennium”. The documents aim at reducing mortality
of children under 5 years of age by 2/3 and mortality of mothers by ¾; at
improving access to the service of reproductive health, at preventing HIV/
AIDS spreading and at eliminating sex discrimination in the field of primary
and secondary education. To ensure the national demographic policy, the
Government approved and adopted the programme “The Concept of RT
State Demographic Policy for the Period 2003-2015” (2002).
The independent Tajikistan with its scientific potential in healthcare has
reached a new, international level of science development, and therefore it is
necessary to carry out ethical review of biomedical research in compliance
with international regulations. The controlling body is the Committee on
Medical Ethics (CME) at the RT Health Ministry. In its activity, the CME is
guided by the Constitution of Republic Tajikistan. Documents regulating the
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CME practice comply with international legal standards and RT laws. The
CME forms a part of the Forum for Ethics Committees in the Commonwealth
of Independent States. The CME is to review and monitor scientific research
in medicine and the compliance with ethical regulations to protect right and
dignity of a research subject. Presently, the RT Government is considering
the law “On the Protection of Human Rights and Dignity in Biomedical
Research” based on the IPA CIS model Law “On the Protection of Human
Rights and Dignity in Biomedical Research in CIS”.
In Tajikistan biomedical ethics is considered as a interdisciplinary field of
knowledge analyzing moral problems of human attitude to living organisms.
However meanwhile we do not have either a system of organizational and
legal support or objective conditions for a proper development of bioethics.
This implies an insufficient propagation of scientific knowledge and juridical
culture both in medical community and public at large. Another factor is
scarce technical equipment for biomedical research, though much is being
done to improve the situation.
In the XXI century, the reform of healthcare in Tajikistan is inseparably
linked with scientific studies in the fields where the issues of bioethics are of
vital importance. In western countries, bioethics is an advanced educational
discipline. In the last decade some CIS countries, such as Russia, Ukraine,
etc. have been introducing courses on bioethics into the syllabus of medical,
philosophical and sociological faculties.
At the Tajikistan Medical University ethics is taught within a Course
on Ethics and Deontology at the Department of Philosophy. Education in
ethics for undergraduate medical students helps them to develop their moral
and ethical outlook and to make an appropriate and just decision when
conducting a medical research. Unfortunately today bioethics as a special
discipline is not included into the system of education in Tajikistan.
Introduction of a course on biomedical ethics into the course of higher
educational institutions in RT is the demand of the times as Tajikistan has
taken the path of democratic development of the juridical civil state where
reforms cover the total sphere of education for the purpose of forming a new
outlook in professional training.
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Humanities are essential components of professional training of a future
physician as they enhance moral development and mutual understanding.
We share the opinion that bioethics is a subject of interdisciplinary
communication, and, with regard to medicine, it should be taught at institutes
of higher medical education as moral and ethical knowledge used in patientphysician communication.
Bioethics in CT is developing in several directions: education (medical,
pedagogical, social, and economic); legislative regulation and establishment
of ethics committees. Considering WHO recommendations (1994) on the
introduction of a course on bioethics into the syllabi of medical educational
institutions all over the world, and the necessity to work out and study
moral and legal regulation and to implement into healthcare practice
new biomedical technologies, it is essential to introduce into the practice
of undergraduate and postgraduate education a systematic training of
CT medical professionals in biomedical ethics. To achieve this goal, it is
necessary to introduce into the State Standard of Higher Medical Education
of RT the discipline “Biomedical Ethics” and to develop a programme of
a general and special course. Already at the stage of master training and
postgraduate studies, it is necessary to introduce a programme on ethical
and legal problems of each medical specialty. One of the key elements here
concerns ethical aspects of planning and conducting biomedical research,
approbating and implementing new technologies. It is essential to develop
a firm ethical position with regard to biomedical research, to introduce
teaching programmes covering basic ethical principles for investigators
and to establish a system of local ethics committees that review biomedical
research.
In the process of the formation of the Republican Committee on Medical
Ethics (RCME) a seminar organized by a representative from J.Hopkins
University (Baltimore, USA) was held in Dushanbe (2004) to train future
RCME members. On completing the seminar, the students took exams and
received certificates. In 2004 we also accomplished a project within the
framework of a LIGP/ACTR/ACCELS Programme of the American Council
for International Education and Culture at the Department of States.
During the last two years from one to three professionals annually
have attended courses on ethical review held in Almaty (Kazakhstan) at the
Higher School of Public Healthcare.
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The implementation of European standards in CT and a new model
of the teaching process require a cardinal change and structuring of all
teaching programmes in compliance with the principles of the Bologna
educational system.
The current international system of a public and state control of
safeguarding rights, dignity and autonomy of human subjects participating
in biomedical research, and of compliance with universal ethical principles
of biomedical research involving human subjects, implies the creation of
independent public institutions – ethics committees.
Ethics committees are analytical, consultative and monitoring units of
various composition and status. They have to work out moral regulations for
biomedical research, to carry out ethical review and give recommendations
in case of conflicts arising in biomedical research or in medical practice. The
Committee on Medical Ethics (CME) at the Health Ministry of Tajikistan
performs these functions. To undergo ethical review, investigators should
submit research proposals and their supporting documents to the CME
secretary. Ethical review of biomedical research is carried out at the CME
meeting in compliance with adopted regulations. The CME members may
make positive, conditional (with clear suggestions for revision) and negative
(in case of potential harm to research subjects’ rights and dignity) decisions
on applications for the ethical review. They may monitor the compliance
with ethical regulations throughout the research.
Another significant aspect of the creation and development of the
ethical review system is the review of dissertation works. There is an
agreement between the Russian Federation and Tajikistan according to
which certification and approval of candidate and doctoral dissertations
is performed by the Expert Council for Medicine at the Higher Certifying
Commission of the Ministry of Education of the Russian Federation.
According to the Bulletin of the Higher Certifying Commission “On the
Procedure of Biomedical Research Involving Human Subjects” (No 3,
2002), the Expert Council for Medicine emphasized that the chairpersons
of dissertation councils should review both registered and new methods
of diagnostics and treatment with regard to their compliance with
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international and Russian legislation on biomedical research involving
human subjects.
When planning clinical research within the framework of a dissertation
work investigators should follow regulating documents of the health
ministries of Tajikistan and the Russian Federation and obtain a written
informed consent from research subjects or their legal representatives. The
research project should be approved by the CME at the Health ministry of
Tajikistan. Dissertation councils may only accept dissertations for review if
they meet the abovementioned requirements.
Though the CME at the Health Ministry of CT has been partially
equipped with technical facilities, there are, unfortunately, a number of
administrative and technical problems caused by the lack of a real financial
support. This is the reason why the CME members cannot receive their
education abroad, except participation in international conferences held by
the FECCIS. Besides, we need funds to organize specialized seminars and
courses for training members of regional and local ECs. There are serious
financial problems concerning the publication of methodical materials.
There is a pressing need to introduce a course on medical ethics into
syllabi of institutes of higher medical education and medical colleges.
Currently, a methodical manual on the principles of ethical review for
undergraduate and post-graduate students is in active preparation.
In 2003-2004, a group of physicians from the Republican Oncological
Centre implemented a six-month educational project “The Initiative for
the Protection of Patients’ Rights in Tajikistan”. The physicians found that,
unfortunately, medical professionals lack knowledge on legislation referring
to patient’s rights. The project’s objective was to conduct 20 educational
seminars on ethical aspects of the patient—physician communication and
mechanisms for safeguarding patients’ rights for physicians of healthcare
institutions in Dushanbe and five other regions (Rudaki, Gissar, TursunZade, Varzob and Vahdat). Unfortunately, medical professionals showed a
low level of knowledge referring to patients’ rights. Thus, 50% of responding
physicians in Dushanbe and about 100% of physicians in the regions did
not have a proper knowledge on the relevant legislation. A survey revealed
frequent cases of the violation of patients’ rights on different levels of
medical and social services (50% of physicians mentioned healthcare
institutions, 20% - institutions of social service, 30% - public authorities).
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Only 2% of respondents mentioned that patients might defend their rights
via public institutions. According to the survey data, all physicians (100%)
believe that medical secrecy implies non-disclosure of a diagnosis and that
information on a patient’s health should be concealed from him/her, which
conflicts with the Declaration of Patients’ Rights. However the majority
of respondents gave correct answers to questions about the physician’s
responsibility for a patient’s health if the patient refuses to follow medical
prescriptions or regimen. As to legitimization of euthanasia in Tajikistan,
95% of respondents gave negative answers. The survey results show that the
development of a mechanism for safeguarding patient’ rights should be in the
centre of all healthcare reforms in Tajikistan. To develop the ethical review
system, it is necessary to raise the level of professional ethical knowledge
and to provide an access to information on human rights and their protection
in biomedicine for public at large.
The process of harmonization on a global scale is a characteristic feature
of the development of standards for ethical review. This situation implies the
development of national systems for ethical review. A necessary condition
for the functioning of the CME at the Health Ministry of Tajikistan is to
develop its activity and to widen its contacts with ECs in other countries. It
is necessary to raise the level of ethical knowledge in the CME members and
investigators, and to participate in training seminars on ethical review held
outside Tajikistan. Professional discussions of ethical issues are also of great
importance. Cooperation with the FECCIS and other leading international
institutions has great potential with regard to harmonization of international
relations in this sphere within the CIS region and in all countries of the
world community.
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3.10 Ukraine
(Yu.I.Kundiev, N.A.Chaschin, A.N. Chaschin,
S.V.Pustovit, P.N.Vitte)
Bioethics in Ukraine, as in many other countries, has been developing in the
context of preceding millennial experience of medical ethics and deontology.
Many legends about humanism and high moral qualities of leading physicians
survived to our time. There are amazing examples of how physicians of the
past observed the rules of medical ethics and of their dedicated and unselfish
service. The Christian ethics was the source of this tradition.
Agapit (XI c.) was one of the first physicians among those who founded
cloistral medicine. He was equally assiduous in treating princes and common
people who needed his help and avoided in every way accepting any gifts.
Outstanding physicians who lived and worked in Ukraine during
different periods (M.Maksimovich-Ambodic, D.Saimolovich, M.Pirogov,
V.Obraztsov, N.Strazhesko, F.Yanovski, D.Zabolotny, A.Bogomolets and
many others) not only followed high ethical standards and rules but also
developed and extended those. They used new methods of diagnostics,
treatment and prevention only after having studied those in research on
animals and often in “autoexperiments”. That was their nature – to serve
people unselfishly and be ready for self-sacrifice if need be.
A bright example of this is life and work of professor F.Yanovsky (1860
– 1928) whom citizens of Kiev justly named “the Holy Physician”. He wrote:
“All people have equal rights to earthly goods. I cannot start living solely for
myself and shut my eyes to others who might need me, and it is not because
I am so kind but because to behave otherwise would be unfair”.
Zemstvo (primary health care) physicians41 who had been working
in Kherson and other southern provinces (N.S.Uvarov, A.V.KorchakZemstvo Medicine is a special form of medical and sanitary care of the rural population
in Russia in 1864-1917. The administrative districts were divided into physician’s areas (1040 and more km) with about 25,000 rural residents. The activities of zemstvo physicians
included: rendering medical care to the rural population; infection control; smallpox
vaccination; obstetrical care; sanitary surveillance at schools; hygienic education of the
population and sanitary measures.
41
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Chepurovski, O.N.Teziakov, A.I.Smidovich et al.) tended to develop a new
system of public healthcare based on democratic principles, equity, creative
approach and with the emphasis on preventive medicine. Like V.V.Veresaev42,
they were against an abnormal system of private medical practice that made
physicians to live on those rubles and kopecks they received from their
patients, and to live better they should wish to have more patients. In short,
there was a conflict with ethical principles and morals – to build up one’s
well-being on illnesses and sufferings of others.
There were attempts to oppose those abnormal tendencies, and one
of them was adoption of “The Code of Medical Ethics” proposed by the
Society of Uman Physicians.
In the Soviet period medical ethics used the best of what had been
accumulated by preceding generations. All graduates from medical institutes
took The Oath of the Soviet Physician that outlined main ethical principles.
However in medicine, as in other fields, ethics principles were often marked
with dogmatism which depreciated their role.
At the beginning of the 1990s the process of establishing bioethics
committees began in Ukraine. It was stimulated by the joint international
projects with scientists from the USA and west European countries. In 1998
the National Committee on Bioethics at the National Academy of Sciences
was established on UNESCO’s recommendation. In 2001 it was transformed
into the Commission for Bioethics at the Ukrainian Cabinet. Later, in the
end of 2005, its activity was suspended. The Committee at the National
Academy of Sciences became the central national organization again. Within
this period two National Congresses with foreign participants were held in
2001 and 2004 as well as a number of international seminars and symposia
on different aspects of bioethics, particularly on implementation of standard
operational procedures for ethical review. Presently the third Congress is in
active preparation.
The Commission prepared for the Supreme Soviet recommendations on
ratification of Convention on Human Rights and Biomedicine adopted by the
Council of Europe and signed by Ukraine. In cooperation with the Ministry
of Justice much work was done on comparing our legislation with main
statements of every article of the Convention. It turned out that the existing
V.V. Veresaev (1867 – 1945) – a famous physician and writer, the author of “Notes of a
Doctor”
42
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Ukraine legislation for the most part correspond to the Convention, and there
are but some statements to be harmonized. This issue was discussed at the
bilateral meeting in Strasbourg (2002). After that the Commission initiated
the process of ratification. Currently the process is in its completion stage.
After the ratification the Convention of the Council of Europe will have the
force of law.
Today commissions and committees on bioethics are actively working at
the National Academy of Sciences, Ukrainian Academy of Medical Sciences
and all medical universities, at research institutes and other biomedical
institutions. Presently there are about 100 bioethics committe es and
commissions functioning on different levels. Their work is particularly active
in the Crimea, Lvov, Odessa and Kharkov. The main task of commissions and
committees on bioethics is to promote ethical principles in all spheres of their
institutions’ activity and perform ethical review of research projects. In the
institutes of higher education they have to participate in teaching bioethics.
Now we are facing a new stage: each committee or commission
functioning at the local level should be accredited by the central institution
and continuously provided with all relevant information. For this purpose we
need to develop the system of accreditation and to establish the information
centre. These are the principal directions of our current active work.
Over the last two years the Supreme Certifying Commission of Ukraine have
been carrying out ethical review of all dissertations in medicine and biology.
We have established an effective cooperation with the Division on
Bioethics at the Council of Europe. Within this period two bilateral meetings
in Strasbourg and Kiev were held with the participation of authoritative
experts Anna Maclaren (United Kingdom) and Maria Louisa Labat (France).
Preparation for the Convention ratification and problems relating to the
use of stem cells were on the agenda. That was not only mutual exchange
of information but also the search of adequate decisions. All participants
agreed that fundamental research should go on the use of stem cells should
go on and that too much of advertising and commercialization discredits the
whole thing. The third bilateral meeting is to be held in the end of 2007.
The greatest achievement, however, is that bioethics gradually enters
into the life of scientific laboratories and institutes as well as into syllabi of
medical universities. Ethical review of new research projects has become a
routine practice.
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The protection of human rights in biomedical research is a particularly
important field requiring a special legislative approach. In Ukraine
legislation there is a number of general and special acts setting both general
principles concerning the protection of human rights in biomedical research
and detailed statements regulating the order of conducting those.
The Constitution of Ukraine (1966) is the main law proclaiming the
priority of the individual, his/her life and health, dignity, honour, personal
inviolability and safety, protection of human rights and freedoms (Art. 3).
The Constitution states the principle of freedom and equality with regard to
human rights and dignity (Art. 21); non-admission of discrimination (Art.
24); person’s inalienable right to life (Art. 27); everyone’s right to respect of
his/her dignity, (Art. 28). Article 28 states in particular: “No person shall be
subjected to medical, scientific or other experiments without his or her free
consent”. Article 32 states that the collection, storage, use and dissemination
of confidential information about a person without his or her consent shall not
be permitted. The Constitution declares that everyone has the right to health
protection, medical care and medical insurance (Art. 49); and that everyone
has the right to an environment that is safe for life and health is guaranteed
the right of free access to information about the environmental situation,
the quality of food and consumer goods (Art. 50). Thus, The Constitution
secures the fundamental human rights with regard to biomedical research.
Another important document is “Basic Legislation on Public Health
Service in Ukraine “. This law adopted in 1992 is continuously revised
and amended. It sets general healthcare principles and those concerning
biomedical research, defines state and public responsibility for the health
level and preservation of the Ukraine gene pool.
The “Basic Legislation” contains statements on professional
standards. It stipulates that only those who have an appropriate education
and qualification meeting uniform qualification requirements may take up
medical and pharmacological practice (Art. 74.1). All methods used for
diagnostics, treatment and prevention of diseases, as well as pharmaceutical
products should be authorized by the Ministry of Health (Art. 44.1). The Law
establishes the mechanism of state regulation ensuring adherence to medical
legislation, state standards, criteria and requirements relating to providing
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a healthy environment and conditions for sanitary-and-epidemiologic wellbeing (Art. 22). The regulatory mechanism set out in this Article concerns also
norms of professional activity in healthcare, standards of medical service,
medicinal products and technologies and rules of the State Pharmacopoeia.
The Law stipulates for a possibility that the Ukrainian Cabinet of Ministers
and other authorized institutions, including local governing bodies, may
terminate the activity of any institution if it violates medical legislation
or state requirements or, else, performs acts conflicting with the statute of
the institution (Art. 16.5). Finally, the Law ensures an individual’s right to
choose a physician and a healthcare institution (Art. 6d) and the right to
change the physician (Art. 34.1).
One of the cardinal bioethics principles is that of a person’s voluntary
informed consent. The law obliges the physician to explain to the patient
the state of his or her health, the goal of suggested research and treatment
measures, a prognosis for a possible disease evolution including potential
risk for person’s health and life. The patient has the right to be acquainted
with his or her case history and other documents that may be necessary
for a further treatment (Art. 39). The patient’s consent should be sought
before applying methods for diagnostics, treatment and prevention of a
disease (Art. 43.1). This general rule extends over cases of the application,
in the patient’s best interests, of new and scientifically justified medicinal
products or methods not yet authorized for general use (Art. 44.2). The rule
concerns also blood transfusion (46) and biomedical research involving
human subjects provided that the research is scientifically justified and the
potential benefit overweighs risks of harmful consequences for the research
subjects’ health or life. Information on biomedical research should be
open to public on condition that personal data are confidential. The rule of
informed consent relates also to organ transplantation performed according
to the order prescribed by the law if the use of other life-sustaining methods
does not yield desired results, and the harm for a donor’s health is less than
that threatening the recipient (Art. 47).
The rule of voluntary informed consent is present in practically all special
normative acts relating to medical interventions, use of pharmaceutical
products and biomedical research.
Article 43 of the “Basic Legislation on Public Health Service in
Ukraine”, states that in case of minors under 15 or adults who according to
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law do not have capacity to consent any intervention may be possible only
with the authorization of his or her legal representative. At the same time, an
essential item about the opinion of the minor that, according to Convention
on Human Rights and Biomedicine, should be taken into consideration as an
increasingly determining factor in proportion to his or her age and degree
of maturity (Convention, Art. 6) is not included into Ukrainian legislation.
Neither is the item that adults who according to law do not have capacity to
consent shall as far as possible take part in the decision-making procedure.
However, there is a similar rule about informed consent to the application of
new methods or pharmaceutical products concerning minors from 15 to 18
years of age and individuals with a limited capacity to consent (Art. 44.2 of
Basic Legislation).
The right to withdraw consent is not clearly stated either in the
law or in the majority of other special laws but the Ukrainian law “On
Pharmaceutical Products” (Art. 8). According to this law, a volunteer or
the person’s legal representative can freely withdraw his or her consent to
participate in clinical trials.
There is no regulation relating to medical interventions for the benefit
of the health of the person concerned in emergency situations when the
appropriate informed consent cannot be obtained. For this case we need a
legal norm stating that the previously expressed wishes relating to a medical
intervention by a patient who is not, at the time of the intervention, in a
condition to express his or her wishes should be taken into account.
The law “On Pharmaceutical Products” states the necessity to obtain a
written consent from a potential subject of a clinical trial or from his or her
legal representative (Art. 8). This additional measure is connected with the
danger of abuse and infringement of human rights.
The right to information is closely related to the concept of informed
consent. Recognition of this right is particularly essential for former soviet
republics with their traditional paternalistic approach to physician-patient
relationship. The transition to the concept of cooperation signifies the respect
for the patient’s will, for his or her dignity and free choice. This is especially
important for the sphere of biomedical research involving human subjects.
The general rule is fixed in Ukrainian legislation – in Basic Legislation
and in special laws. However, Basic Legislation says nothing about the
confidentiality of private information, and corresponding statements can
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be found only in the Ukrainian laws “On Prevention of AIDS Disease and
Social Protection of Population” (Art. 8) and “On Providing Psychiatric
Care” where only the patient or his/her legal representative have the right
to private information.
The Ukrainian law “On Prohibition of Reproductive Human Cloning”
is restricted to the sphere defined in the law title and does not regulate in any
way embryo cloning “for therapeutic purposes”. It only prohibits importing
cloned human embryos into Ukraine and exporting them from the country.
Apart from abovementioned laws, there are many other legislative acts
regulating, one way or another, issues relating to biomedical experiments.
These are Ukrainian laws “On Scientific and Scientific/Technical Expertise”,
“On Ensuring Sanitary and Epidemiologic Well-Being of the Population”,
“On Healthcare”, “On Protection of People from Ionizing Radiation”,
“On Measures against Tuberculosis”, “On Implantation of Pace-makers”,
“On the Animal World” and “On Veterinary Medicine” and a number of
other laws and Decrees of the Ukrainian Cabinet of Ministers, President’s
Decrees and orders of the Ministry of Health. Noteworthy is the order of
the Ukrainian Ministry of Health No 66 on February 2006 “On Rules of
Conducting Clinical Trials of Pharmaceutical Products and Reviewing
Materials of Clinical Trials”.
With all this considerable number of regulating documents, there is
no legislation in the sphere of human genome with regard to both general
and specific principles. Almost unregulated is one of the most significant
bioethics fields - in vitro research on embryos. Article 19 of the law “On
Transplantation of Organs and Other Anatomical Materials” stipulates
that it may be possible to use fetal material for transplantation, while issues
relating to research on embryos and creation of human embryos for research
purposes are not regulated.
One of stimulating events that should facilitate the process of legal
regulation in the sphere of biomedical research was signing of Convention
for the Protection of Human Rights and Dignity of the Human Being with
Regard to the Application of Biology and Medicine: Convention on Human
Rights and Biomedicine in March 2002. This implied assuming political
obligations to introduce relevant norms into national legislation (signing and
ratification of an additional Protocol on biomedical research is meanwhile
a more remote perspective). Today, on the instructions of the Cabinet on
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the necessity to ratify the Convention efforts are underway towards the
development of a relevant legal and normative basis. There was an attempt
to adopt a complex law on human rights and biomedicine by analogy with
the Convention but the institutions where the draft law was submitted for
consideration decided that it required an essential revision.
There are 17 institutes of higher medical education of the 4th level of
accreditation (undergraduate level) and 3 institutes for postgraduate training
located in 14 provinces of Ukraine.
Starting from 1990s some bioethics problems began to appear in the
course of undergraduate and postgraduate training of medical professionals,
biologists, social workers and veterinaries, and eventually special training
modules and courses in bioethics have been designed.
In 2004 the Ministry of Health approved an elective course in bioethics
for students of the 5th year at medical universities and institutes of the 4th
level of accreditation. The course consists of lectures (10 academic hours),
practical seminars (17 academic hours) and students’ individual work (54
academic hours)
Although the elective course in bioethics was adopted as a special
course for institutes of higher medical education, today bioethics in
Ukraine is usually taught not as a separate course but as a fragment of
compulsory courses in philosophy of science and medicine, ethics, ethics
and deontology of social work, valeology et al. The list of topics and
number of hours depend on different teachers and their views on bioethics
and the place it has in their courses.
Bioethics is also taught at medical institutions for postgraduate training,
at universities and polytechnic institutes, at veterinary academies and other
institutes of higher education in Kiev, Lvov, Kharkov, Odessa, Vinnitsa and
other Ukrainian cities.
Thus the Department of Philosophy at National Medical Academy for
Postgraduate Studies named after P.L.Shupik was one of the first in Ukraine
to introduce in 2000 a compulsory course “Bioethics as Modern Medical
Ethics” (12 hours) for postgraduate students. Bioethics is also included into
some other courses offered by the Academy: “Sociocultural, Ethical and
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Deontological Aspects of Physician’s Activity” (18 h) for clinical residents;
“Philosophy of Medicine” (36 h) for PhD students and PhD candidates;
“Organization and Performance of Ethical Review of Biomedical Research”
(36 h) for physicians and members of ethics committees at research institutes
and institutes of higher medical education in Ukraine.
A considerable experience in teaching bioethics has been accumulated
at National Medical University named after A.A.Bogomolets and at
Ukrainian Medical College (Kiev). A programme on experimental studies
of bioethics basic principles was launched in 2000 at Ukrainian Medical
College at National Medical University named after A.A.Bogomolets
and has been successfully functioning since then. Within the framework
of teaching seminar the following activities are carried out during every
academic year:
• Individual work – analysis of actual bioethical problems and
situations; assistance in the preparation of a computer presentation; report
presentation and a follow-up discussion;
• Regular public open lectures by leading Ukrainian and Russian
scientists on actual ethical problems relating to biomedical technologies;
• Visiting teaching seminars on the basis of the Institute of Experimental
and Theoretical Biophysics at the Russian Academy of Sciences (town of
Pushchino, Russia)
In Kiev compulsory courses in bioethics are also taught at the National
Technical University (Department of Political Sciences, Sociology and
Social Work), Academy of Labour and Social Relations (Department of
Practical Psychology and Social Work), T. Schevchenko National University
(Faculties of Ethics and Aesthetics, Biochemistry and Science Methodology),
at the National Agrarian University et al.
In the western region of Ukraine bioethics is taught in the context
of fundamental principles of Christian moral (Ivano-Frankovsk Medical
Academy, Lvov Theological Academy, Lvov State Academy of Veterinary
Medicine named by S.Z.Gzhitsky, Lvov State Medical University named
after D. Galitsky, The Western Branch of Interregional Academy of
Personnel Management et al.). Thus Lvov Medical University offers an
elective course in bioethics for students in the 3rd year at every faculty.
There are also seminars (16 h) for physicians and teaching staff held at the
Department of Healthcare Organization and Management. To provide the
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teaching process with methodical materials, The Training and Methodical
Centre for Bioethics was established at the University.
Institutes of higher education in Kharkov became methodical centres
of teaching bioethics in the Eastearn Ukraine. Since 2004 the Department
of Valeology at the Faculty of Philosophy of Kharkov National University
named after V.Karazin has been offering a special course “Bioethics as
the Ethics of Health” (90 hours). The course was designed for students
of the 2nd year who are trained as teachers in valeology. At all faculties
of Kharkov Medical University bioethics is taught as an elective seminar
course. Kharkov Zoo-Veterinary Academy has a noteworthy experience
of teaching bioethics based on the use of alternative methods of studying
anatomy and physiology of human beings and animals.
At Vinnitsa National Medical University named after N.I. Pirogov
bioethics is taught to students of the 3rd year (Faculty of Dentistry, 27h) and
to students of the 5th year (Faculty of Pharmacology, 54 h). Both courses
end with a test. Bioethics is also taught at institutes of higher education in
Dnepropetrovsk, Zaporozhye, Lugansk, Odessa, Poltava, Sumy et al.
Different public associations play an essential role in distribution of
bioethical knowledge - such as All-Ukraine Public Organization “Ukraine
Association on Bioethics”; Kiev Ecological and Cultural Centre; Kharkov
Regional Society for Animal Protection and others. Due to their efforts a
number of foreign materials were translated into Ukrainian language, books
and manuals on teaching bioethics were written to be used in Ukrainian
universities and institutes.
The existing experience of teaching bioethics at Ukrainian institutes of
higher education allows us to draw the following conclusions.
The introduction of courses in bioethics in Ukraine, as in other postsoviet countries, is complicated by the fact that for a long time scientists and
teachers had no opportunity to study foreign materials on the subject. The
lack of home studies in the field of bioethics and the lack of comprehensive
knowledge on theoretical, methodological, historical and cultural contexts
of the development of bioethical discourse affects negatively the level and
quality of teaching bioethics.
On the other hand, in Ukraine, as in other European countries, there
is a tendency of teaching bioethics as an applied biomedical ethics of
a narrow professional character. At UNESCO seminar on problems of
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teaching bioethics in East European countries (Moscow, January 2005) it
was mentioned that 70% of those who teach bioethics are physicians with a
classical medical education. Thus, the majority of bioethics teachers have not
studied ethics as an independent or philosophical discipline, which certainly
affects the general tendency of education in bioethics and interpretation of
basic bioethics problems.
Currently there is an urgent need to teach bioethics as a special form of
worldview, as an interdisciplinary science uniting separate fields of natural
sciences and humanities. Bioethics should be considered and studied as
global ethics (knowledge of humanity global problems and ways how to
resolve those) and as a field involving different cultural traditions.
Today opportunities for education in the field bioethics and Good
Clinical Practice on the international level for specialists from Ukraine are
restricted to separate training courses and seminars (including conferences,
symposiums or congresses on bioethics and clinical research) held by public
organizations, institutes of higher medical education, research institutes,
National Academy of Sciences, National Academy of Medical Sciences and
State Pharmacological centre of Ukraine.
We do not have a system of education in GCP principles. The only course
for training members of ethics committees “Organization and Performance
of Ethical Review of Biomedical research” (36 h) was designed and adopted
at the Department of Philosophy of National Academy for Postgraduate
Training named after P.L.Shupik (Kiev).
Over last 5 years several PhD dissertations in specialties “science
philosophy” and “public management” directly related to medical and
ecological ethics have been defended.
Nowadays teaching bioethics as an academic discipline requires the
combination of instrumental principles, approaches and standards of natural
sciences with theoretical models and principles of humanities.
Although teaching bioethics as a separate discipline has begun only
5-6 years ago, a high level of higher medical and humanitarian education,
highly professional teachers, a sufficient number of libraries, internet
offer a favorable opportunity for a further development of education
in bioethics. Teaching bioethics as a compulsory discipline at medical,
biological and humanitarian institutions of higher education will facilitate
not only humanization but also algorithmization of specialists’ thought,
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democratization of professional activity, interdisciplinary integration of
theoretical and practical knowledge as well as improving of teaching process
as a whole.
References
1 Vekovshina S.V., Kulichenko V.L. Bioethics: Origins and
[Theoretical] Grounds (A Philosophical and Methodological Analysis) Kiev,
2002 (in Russian).
2 Potter W.R. Bioethics – Bridge to the Future. /Ed. Vekovshinina,
V.L. Kulinichenko. Kiev, 2992 (Translated from English).
3 Ethics Committees. Establishment, structure, functions. /Ed. V.L.
Kulinichenko, S.V. Vekovshinina. Kiev, 2002 (in Ukranian & Russian)
4 Bioethics Anthology / Ed. Yu.Kundiev. Lvov, 2003 (in Ukranian &
Russian).
5 Ethics Committees: the present and the future. /Ed. S.V. Vekovshinina,
V.L. Kulinichenko. Kiev, 2004 (in Russian).
6 Moskalenko V.F., Popov M.V. Bioethics: philosophical,
methodological, social and medical problems. Vinnitsa, 2005 (in
Ukranian).
7 Egorenkov A.I. Methods of Studying Basics of Bioethics for
Students of Medical and Biological Faculties. Manual for teachers. Kiev,
2001 (in Russian).
8 Egorenkov A.I. Acquiring Skills for Systems Analysis of Bioethical
Problems in Teaching the Students of Medical and Biological Faculties.
Kiev, 2003 (in Russian).
9 Bioethics in Medicine and Food Industry. The Necessity and
Meaning of Moral Behaviour. /Ed. J. Hodges, S. Timchenko. Kiev, 2005 (in
Russian).
Modern medicine is to a considerable degree the medicine of research,
experiments and clinical trials conducted on animals and human subjects.
Today there are well-developed and time-proved norms of conducting
biomedical research, as well as structures and mechanisms allowing us to
control adherence to the norms. The fundamental principle in conducting
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clinical research is the protection of the research subjects’ rights and health.
A mechanism of implementing this principle is ethical monitoring of any
clinical research – not only clinical trials of new pharmaceutical products, but
also trials of new medical equipment and other medical facilities, methods
of surgical intervention, epidemiological studies, research in genetics and
psychology and others.
Before the 1990s the majority of research in Ukraine was conducted
without any ethical control.
In the beginning of the 1990s Ukrainian scientists started participating
more actively in international scientific projects and clinical research, which
stimulated implementation of ethical review. By that time, Ukraine had a
negative experience when international projects could not be developed
just because there was no procedure of ethical review. Starting from 1992
leading research institutions begin to establish local ethics committees
for considering ethical aspects of actual international projects with the
participation of Ukraine. In 1995 the Pharmacological Centre of the
Ministry of Health established Ethics Committee to harmonize the system
of conducting clinical trials and registration of pharmaceutical products.
In 1998 on the initiative of UNESCO the International Committee
on Bioethics was established which followed by establishing national
ethics committees in many countries. In the same year, on the proposal
of the National Commission of Ukraine for UNESCO submitted to the
National Academy of Sciences the Bioethics Committee was established
at the Presidium of National Academy of Science of Ukraine. Leading
academicians in the fields of biology, medicine, philosophy, as well as
representatives of Ministry of Health, Ministry of Environmental Safety,
Ministry of Education and Science, Ministry of Justice and of Academy of
Medical Sciences and Academy of Agrarian Sciences were invited to take
part in the work of the Committee.
In 2002 Bioethics Committee at the Presidium of Academy of Medical
Sciences of Ukraine was established. In cooperation with Ministry of Health
it developed model regulations for medical ethics committees at scientific
and medical institutions in line with modern international requirements.
During these years a number of public organizations having a concern in
bioethics have emerged, and the implementation of the system of ethical
review for biomedical research has begun on a large scale.
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Today we have the following system of ethical review. Firstly, there
are different laws and by-laws regulating biomedical research. The order of
conducting clinical trials of pharmaceutical products and reviewing materials
of clinical trials has been developed in compliance with the Articles 7 and
8 of the Ukrainian Law “On Pharmaceutical Products”43 and in line with
requirements of the Directive 2001/20/EC of the European Parliament
and of the Council EC ICH GCP44 and Declaration of Helsinki45. It was
approved by the Order of the Ministry of health of Ukraine No 6646. The
responsibility for reviewing documentation on clinical drug trials rests with
the State Pharmacological Centre of the Ukrainian Ministry of Health.
General principles of conducting clinical trials:
• According to the sponsor’s choice, clinical trials are mostly
conducted at specialized medical institutions the list of which is submitted
by the Centre in accordance with established procedure and approved by the
Ministry of Health.
• All clinical trials are conducted in compliance with ethical principles
set by Helsinki Declaration, and on the condition that the basic requirements
relating to the protection of research subjects (patients or healthy volunteers)
are observed. Clinical trials may only be conducted if the expected benefit
justifies the risk.
• All clinical trials are conducted only after a compulsory review of
trial protocol by ethics committees established to protect trial subjects’ rights,
safety and well-being, and to guarantee the protection for the society.
• Planning, conducting and reporting at all phases of clinical trials,
including studies of bioavailability and bioequivalence, should meet GCP
requirements adopted by the Ukrainian Ministry of Health.
• Trial management, data handling, documentation and an assessment
of results obtained in a trial should comply with requirements set in standard
operational procedures.
• Registration, processing and archiving of information obtained in a
trial should ensure an accurate presentation, interpretation and verification
http://www.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=123/96-вр
europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf
45
http://www.wma.net/e/policy/b3.htm
46
http://www.pharma-Centre.kiev.ua/files/2006/Nakaz_66_d.doc
43
44
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of the data. Main trial related documents are archived and retained at the site
of the trial and at the sponsor’s for no less than 15 years after the trial.
• Manufacturing, storage and use of pharmaceutical products should
be in accordance with established procedure and in compliance with
principles of GMP. Investigational product may only be used in accordance
with an approve trial protocol.
• If necessary, the State Pharmacological Centre of the Ukraine
Ministry of Health may carry out an inspection at any stage of a clinical trial
or after the trial has been completed. The inspection should be performed in
compliance with preset standard operational procedures.
According to internationally recognized standards, ethical guarantee
on protection of the rights, health and personal data confidentiality of trial
participants is ensured by the activity of an independent body – ethics
committee – and by the procedure of obtaining informed consent from
potential trial subjects. Therefore, the system of ethical review implies a
network of ethics committees (commissions) established on national,
regional and local levels.
Until recently Ukraine lacked a well-developed system of interaction
between ethics committees of different levels. The Commission on Ethics
at the State Pharmacological Centre at the Ukrainian Ministry of Health
was providing a review and general monitoring of all clinical trials of
pharmaceutical products. Ethics committees at medical institutions
conducting the trials were only to control the compliance of a trial with
the approved protocol. This excessive centralization of ethical review often
resulted in a low efficiency of existing local ethics committees/commissions,
and sometimes local ethics committees were absent.
National congresses on bioethics held in 2001 and 2004 and the first
scientific and practical conference “Clinical Trials of Pharmaceutical
Products in Ukraine” (Kiev, 2006)47 played an essential role in establishing
ethics committees of different level and profile and providing interaction
between those.
Presently, a rather harmonious system of interaction between ethics
committees is developing. First of all, it concerns committees that review
documents on clinical trials of pharmaceutical products. The Commission
on Ethics at the Pharmacological Centre was reorganized into the Central
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Commission on Ethics of the Ukrainian Ministry of Health. According to the
Order of the Ministry of Health No 66 of 13.02.2006, a part of the Central
Commission’s functions are to be delegated to local committees on the
condition that their practices are certified and surveyed. According to this
Order the Central Commission and local committees (commissions) have
equal authorities with regard to ethical review of clinical trials. Compulsory
ethical review by the Central Commission is performed only in case of
multicentre trials and if the medical institution conducting the trial does not
have ethics committee or if its performance does not comply with normative
requirements. Such an order serves to relieve the Central Commission of
an excessive load and makes its work more efficient due to the role and
responsibility of local committees/commissions.
During last ten years, over 2000 clinical trials have been conducted;
over 500 of those have been international multicentre trials. Before 2000,
the annual number of international trials was slightly over 10, while later
this number began to grow, and in the recent years the annual number of
international multicentre trials exceeds 100. These are mainly Phase II
and Phase III trials in the fields of cardiology, oncology, psychiatry, etc.
However, now, despite a limited number of specialized clinics, the number
of Phase I clinical trials and bioequivalence studies is also growing.
Alongside with the growing number of clinical trials there is a growth
of medical institutions authorized by the Ukraine Ministry of Health where
clinical trials may be conducted. Thus, 166 medical institutions were
authorized in 1996, by 2001 there were over 200 institutions and today there
are 400 medical institutions that may conduct clinical trials.
As normally the term for the ethical review of trial related documents
and decision making is no longer than 60 days, it is easy to imagine the
heavy load of the shoulders of ethics committees/commissions members.
The role and responsibility of ethics committees/commissions at scientificresearch institutions in the sphere of medicine and biology grows also due
to the requirement to carry out a compulsory ethical review of scientific
projects (earlier it concerned mainly international projects). Ethical review
of publications in scientific journals is also becoming a routine practice.
In 2005 a compulsory ethical review of dissertation works in medicine,
biology and veterinary medicine. The continuously growing amount of
www.pharma-Centre.kiev.ua/clinic/programm.doc
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work performed by ethics committees/commissions makes us think about
the necessity of financing this work.
New demands on the quality of ethical review require improving the
work of existing local ethics committees. It is necessary to organize a
continuing education of ethics committees members and to develop legal
regulation of operation and interaction of committees at different levels.
World tendencies of bioethics development have an essential influence
on its development in Ukraine. First local ethics committees in Ukraine
were established in 1992. They were approved at the Board Meeting of
the Ukrainian Ministry of Health, and thus became legitimate to carry
out ethical review of scientific projects. This idea can be illustrated with
two large international projects. The Institute of Pediatrics, Obstetrics and
Gynecology of the Ukraine Academy of Medical Sciences participated in
an international multicentre epidemiological study “Mother and Child”,
and the Institute of Occupational Medicine of the Ukrainian Academy of
Medical Sciences in cooperation with colleagues from USA conducted an
ophthalmologic research in rescuers who had participated in the elimination
of the Chernobyl accident. Both projects were carried out in cooperation
with the University of Illinois and Columbia University (USA). Within
the framework of the projects the teaching staff of universities provided
a basic training in bioethics for Ukrainian medical specialists involved in
the projects.
Since 1998 Ukraine cooperates with different UN organizations
including UNESCO that has initiated establishing the National Committee
on Bioethics in Ukraine. In 1998 the Committee on Bioethics was established
at the Presidium of the Ukraine National Academy of Sciences that had been
functioning as a national agency till 2001. After the First National Congress on
Bioethics with many participants from abroad (Kiev, 2001) the Commission
on Bioethics at the Ukrainian Cabinet of Ministers was established. From
the very beginning of its activity, the Commission established contacts with
UNESCO, WHO, bioethics organizations at Council of Europe, European
Parliament and European Union, in CIS countries, USA, Canada, Belgium,
England and other countries. Our activity attracted attention of Vatican and
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of representatives of other confessions. Members of the Commission on
Bioethics and other experts are taking part as delegates, participants and
guests in different international congresses, conferences, seminars and
working groups relating to bioethics.
Ukraine is actively participating in conducting clinical trials of
pharmaceutical products in the framework of multicentre international
research. The National Pharmacological Centre of the Ukraine Ministry of
Health, in cooperation with WHO, organizes clinical trials according GCP
regulations in which compliance with bioethics principles is one of the
cardinal elements.
In the framework of national congresses, conferences and bilateral
working groups with participants from Ukraine and the European
Parliament joint seminars and workshops are held. Thus in March 2006,
with the support of the Revival Foundation, in the framework of the Project
“East-East: Partnership Beyond Borders” an international seminar was held
where problems of standardization of rules for ethical review and ethics
committees practice were considered with a particular emphasis on the
issue of compliance with GCP requirements. Representatives from Latvia,
Lithuania, Moldova, Estonia, the European Council and the GCP AllianceEurope took part in the seminar. The seminar was held in the format of
SIDCER “Recognition Programme” in the CIS. Such events are a unique
experience for many countries of CIS, East and Central Europe.
There is a continuing multilateral cooperation with FECCIS, with
international unions of bioethics-related organizations of USA (PRIM&R),
of Baltic countries and countries of Central Europe (2001-2007). This
cooperation intensifies information exchange, structure development and
training specialists in bioethics. In the framework of this work, information
networks of bioethics committees at all levels is developing in countries
of Central and East Europe. The main fields of cooperation are training in
bioethics, ethics in the practice of scientific research and the development
of the structure of ethics committees and organizations so as to improve the
practice of ethical review.
The practice of ethical review and an ethical follow-up procedure for
research projects conducted in cooperation with the USA shows itself in the
implementation of joint projects. The development of this practice ensures a
high quality of ethical review of international projects which later is extended
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to the national level. Thus in 2005 the Ethics Committee of the Occupational
Medicine at the Ukraine Academy of Medical Sciences was registered at the
Office for Human Research Protection at the USA Government and received
the Federalwide Assurance FWA00007871. Several local committees in
Ukraine also have international registration numbers.
Since November 1995 when Ukraine became a permanent member of the
Council of Europe, a Ukraine representative has been working actively at the
Steering Committee on Bioethics in Strasbourg (France). In the framework
of this activity Ukraine participated in the development of international
documents including the revised text of the “Convention of Human Rights
and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was
elected to the Board of the Steering Committee on Bioethics as a Committee
Reporter on the activity of Ethics Committees at medical research institutions.
Two seminars on topical ethical problems in transplantology and cell therapy
were held in Ukraine with the assistance and participation of CE experts. The
representative of Ukraine takes part as a reporter in the educational project
of the CE on implementation of CE documents on bioethics in the countries
of the former Soviet Union. Currently, in the framework of the Steering
Committee on Bioethics at the CE, Ukraine participates in the development
of guidelines for a fetus and embryo protection and in the design of a protocol
relating to genetic testing.
International Seminar “Development of the Recommendations on
Application of Standard Operational Procedures for Ethical Review of
Biomedical Research” was held in the framework of the Second National
Congress on Bioethics (Kiev, 2004) organized in cooperation with FECCIS
and UNESCO. Experts and participants from CIS, Baltic States, the USA
and Japan attended the Seminar.
The main objective of the seminar was to discuss ways and methods
of implementing Standard Operational Procedures into the practice of
ethical evaluation of biomedical research in the countries of the former
Soviet Union and neighbouring Baltic countries and countries of Eastern
Europe. High ethical standards and requirements outlined in this document
should be implemented into the practice of local ethics committees. At the
same time we should consider specific local features of a particular region.
Therefore we have to focus our attention on issues of interaction between
regional, national and local ethics committees. Another important problem
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is raising the qualification level of members of the ethics committees that
review biomedical research. The seminar facilitated a further harmonization
of international ethical standards with regard to regional conditions. It had
both scientific and practical significance for the countries of the region.
The next step in this direction may be the Interregional Seminar
“Exchange of Experience in Implementing Standard Operational Procedures
into the Practice of Ethical Review of Biomedical Research” within the
framework of the Third National Congress on Bioethics that is to be held
in autumn 2007 with the support of UNESCO. A certain experience that
has been accumulated during several years in different countries of the
region should be analyzed and evaluated for a further adaptation of SOPs,
development of an efficient network of ethics committees and a system
of training members of ethics committees on a national and international
level. Representatives of over 15 countries (East European countries, CIS
countries, Belgium, USA and Canada) expressed their wish to participate in
the seminar.
The above said illustrates the integration of national programmes into
international projects. One of such processes is the cooperation in the field
of biomedical review of international multicentre research and its ethical
monitoring and evaluation in each country. All this allows us to develop an
integrated structure of data banks of joint ethical reviews. The exchange
of information between cooperating Centres should be on continuing basis
(e.g. electronic newsletters). Joint works on developing and implementing
international standards for medical services and regulations on bioethics
to achieve the best compliance with the GCP requirements seem to be
another important direction. An international programme “The Support
for the Development of the System of Medical Standards in Ukraine”
received a CE grant in the framework of the TACIS-ЕU Programme for
Ukraine (2004-2006).
Main directions of a future international cooperation in the field of
bioethics are the extension and intensification of contacts with the CE
Commission for Ethics in Science and Commission for Ethics at the European
Parliament; organization of bilateral conferences on topical bioethics issues
with the Ethics Committee of the European Commission. We are planning
to organize interregional training seminars for raising the professional level
of members of ethics committees (with the support of UNESCO and other
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organizations). The work on the development of an efficient network of
ethics committees and on the harmonization of international and national
standards for ethical review of biomedical research will be continued.
References
1. Programme in Bioethics. General Course for Students of Higher
medical Institutes. - М., 2001. 40 p. (in Russian)
2. An Outline of the Programme in BIOETHICS for the speciality
040500 -Pharmacia. М., 2003. 18 p. (in Russian)
3. http://www.med-law.ru
4. Bioethics Manual. / Ed. P.V. Lopatin. М., 2005. 240 p. (in Russian)
5. Medical Ethics Manual. Translated from English. /Ed. Yu.M.
Lopukhin, B.G.Yudin. М., 2004. 400 p. (in Russian)
6. http://www.bioethics.union.edu
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3.11 Republic of Uzbekistan
(M.S. Abdullakhodjaeva)
The history of bioethics in Uzbekistan roots back to interpretations of
ethical teachings in pre-Islamic tradition and in the Koran.
Syncretism of the oriental philosophical tradition gave rise to a term
that has no analogues in European culture – “adab” and “adabnoma” – a
teaching describing the due behaviour of a well-brought-up person. The term
combines the general education, the theory of ethics and norms of a polite
behaviour. Both in a strictly scientific sense and by birth terms “ethics” and
“adabnoma” are not identical; they differ in the approach to the study of
ethics, in argumentation and in the focus of their attention (general abstract
principles and/or a code of behaviour). Central Asian codes of behaviour
“Kobusnoma” by Unsurmaol Kaykovus, the treatise “On Ethics” by Ibn
Sina, “Four Conversations” be Arusi Samarkandi, “The Oriental Code of
Decencies” by Sadyk Kashgari and many other works are fundamental
methodological sources of Uzbek model of bioethics. Adabnoma, rather
than Islam, provided a basis for the development of research ethics and
medical practice in pre-Soviet time. Thus, distinctive features of national
historical and cultural, philosophical and methodological sources of
biomedical ethics in Uzbekistan are the pedagogical orientation and a
pronounced didactic character. Such were traditions, norms and values
of Zoroastrism and Islam and achievements in medicine and philosophy
of the Moslem (Arabic) Renaissance, creative heritage of Central Asian
thinkers and physicians Abu Ali Ibn Sina, Abu Abdullah Khorezmi, Abu
Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures
representing Islamic philosophical and religious thought (Al Kindi, Abu
Hamida Gazali, Ibn Rushda, Abu Bakra Ar-Razi). However, nowadays
syncretism of oriental philosophy reveals itself in the fact that modern Uzbek
philosophers and physicians do not make a clear distinction between secular
and religious argumentation. Sacred texts have traditionally been a source
of philosophical thought for Uzbek investigators. Western scientists usually
state their positions. The Western bio[medical] ethics distinguishes between
biomedical ethics based on religious teachings and secular biomedical ethics
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that uses ethical argumentation as such. Sacred texts offer a comprehensive
collection of thoughts, and one may find in them confirmation from “above”
of nearly any statement.
Moslem teaching has developed special canons of the attitude to
patients and disabled persons that, to a large extent, formed the basis for
patient-physician relationship. First of all, Al Bukhari’s khadises remind
Moslems that the Prophet suffered severely, and therefore, who, if not Him,
knows better what it means to be ill and suffer (Abu Abdullah Muhammad
ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam.
Tashkent, Komuslar bosh takhririiati, 1992. B. 3 – in Uzbek). Everything
that befalls human beings is of God’s will. To visit the sick, even infants,
is a duty of each Moslem. It is a tradition not to ask about the disease or
name the disease aloud; one should ask about the general state of health
and use euphemisms in telling the diagnosis: “that very illness”, “caught
some cold”, “a bad illness”, etc. There are many variants. This is a kind of
medical secrecy observed by persons in the patient’s environment. In the
end of the visit the physician should say some words of support, to express
his firm belief that the patient will recover, even if the physician knows that
it is hardly possible. Moslems should support all disabled people and have
mercy to ugly persons, because they are what they are of God’s will. To care
for the disabled is the duty of all relatives and people from the community.
Patients too have their duties. They have to bear their suffering as much
as they can, not to grumble or fall into despair, to suppress one’s moans,
not to ask for death. If a Moslem anticipates his death he should pay his
debts, make his will and directions concerning funerals, beg everyone’s
forgiveness and to repent of his sins (Sadyk-i-Kashgari M. Oriental Code
of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The
precept “Thou should not ask for your death” suggests a direct answer to the
question what Islamic teaching says about euthanasia. The person’s right to
euthanasia, both active and passive still remains a topic of heated debates.
Islam may not approve of either kind of euthanasia, as it is nothing but a
conscious murder of a human being (even if he/she has a terminal illness)
committed by another person, particularly by a physician. If the patient has
a terminal illness, the physician’s duty is to relieve his/her suffering with
various analgesics and to render moral support in the face of impending
death, so that the patient would leave this world as a sensible person who
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completed all his/her earthy tasks, bid farewell to his/her relatives and
repented before the Almighty Allah.
Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in
his “Biography” wrote that a seriously ill person consciously “broke the
regimen for the last time”, which hastened his death. Here we have to
mention his views on medical and ethical problems of dying and natural
death. These views expand the scope of modern bioethics, which allows us
to retransmit from the past entire strata of knowledge about the physician’s
duty and search of new ways for applying ethics when it is necessary to care
for a dying patient, to form behaviour standards in seriously ill patients, to
safeguard their rights for a good death and to maintain their faith in spiritual
and moral immortality of human soul.
In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is
not widely known among researches is of a particular interest. The treatise
adds to concepts of natural death presented in “Canon”. In modern terms,
the treatise suggests that the philosophy of death ensues logically from a
moral comprehension of life. Ibn Sina offers a systemic substantiation of
the natural death from the viewpoint of the right to a good death and in the
light of the theory that death means “the return” to an origin. This idea was
developed in many works, particularly in works by Ilya Mechnikov (18451916) who attempted to explain the concept of “the instinct of natural death”
from the viewpoint of biology and psychophysiology.
With regard to ethical principles, “Canon of medical Science” is a
literary source containing elements of bioethics. It differs from its antiquity
analogues in the attempt to characterize medicine not only as a system of
medical and biological knowledge, but also as a canon of spiritual and ethical
basis of the entire medical science (“Avicenna and the ethics of science and
technology today”. Division of Science and Technology Ethics, UNESCO,
France, 2006, p. 1-16). There were many reasons why “Canon” excited much
interest in different historical periods including the European Renaissance.
However, there are no doubts that in “Canon of Medical Science” a human
being for the first time becomes not merely a subject of an anatomical or
physiological research but a person. It is noteworthy that the “Canon” is
really permeated with humanistic ideas. It has a powerful spiritual and moral
potential for the development of medical science the subject of which is not
just a human being but also his/her life style with all the variety of cultural,
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legal, religious and other features. According to Ibn Sina, it is essential to
humanize the process of bringing up healthy people and to find the ways for
maintaining and developing spiritual harmony throughout a person’s life.
Ethical views of Ibn Sina are still topical nowadays. He saw a physician
as a patient’s friend, tutor and helper. To fulfill this noble mission, the
physician, apart from professional knowledge and experience, should have
many positive qualities – mercy, respect for human dignity, readiness to
self-sacrifice in a patient’s interests, etc.
When analyzing Ibn Sina’s ethical precepts we should note that those
were in line with Hippocrates’s teaching. Ibn Sina wrote: “The physician
should read Hippocrates’s precepts so as to be able to show honesty and
frankness when treating patients. He should keep his clothes clean, be neat
and perfumed. When he visits a patient he should be amiable, and cheerful,
and witty so that he could cheer the ill person, because support offered by
the physician multiplies the strength of natural warmth”. He was tireless in
calling upon physicians to develop their general and special knowledge, to
exchange professional experience and travel. In those times, travels served
to extend scientific contacts. In the Middle Ages, there were many charlatan
“healers” and even physicians deceiving their patients. Reasons for that Ibn
Sina saw in a poor medical training, as physicians were not taught to see
in each person his/her unique world of his/her experience, sufferings and
hopes. “Treat the person, not the disease” – that was his motto.
Ibn Sina’s views on childhood are noteworthy. “Canon of Medical
Science” states that child’s life and health should be objects of care, protection
and a special regimen from the moment of conception, not just from the
moment of birth. A newborn baby needs a wet nurse with a stable nervous
system. Games are essential, as all educational and formative processes,
starting from very early years, should proceed from games. One may not
punish a child, as the task of a tutor and physician if to protect the child’s soul,
to facilitate the development of the feeling of self-respect. It is particularly
important to prohibit any punishment for children under age of five, i.e. at
the age when a child does not realize the meaning of his/her actions. Abu
Ali Ibn Sina believed that, irrespective of state and public benefits, a child
should receive a good intellectual, moral and ethical education in the family
and at school. In his works, Ali Abu Ibn Sina gave much attention to school
education. Kind and well-educated teachers may only teach at school,
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where children are brought up and educated until the age of fourteen. A
teacher should know well the subject he teaches; he should follow the moral
principles and be an honest, loving and courageous person.
In the system of Ibn Sina’s ethical views, a concept of mizaj implying the
necessity of an entirely individual approach to each individual, irrespective
of the person’s age of health condition and considering a unique combination
of qualities on the individual and his/her living and working conditions.
The knowledge of human nature and temperament is the basis of a
physician’s strategy when maintaining a proper level of health, and, if need
be, planning the therapy. A comprehensive study of the “Canon” helps us
to tell a sanguine person from a phlegmatic one or a choleric person from a
melancholy one, and to mark out characteristic biotypes. If we translate it into
the language of modern bioethics, we can see clearly the logical construct
of Hippocrates, Galen and Avicenna; treat not a disease but a person, and
not just a person but also a biotype whose psychological responses are
subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
Pavlov mentioned the biotypological approach used widely by Ibn Sina as a
fruitful one, revealing “fundamental features” of human nature.
Thus, “Canon of Medical Science” written in the times of the Oriental
Renaissance, and very popular during the European Renaissance, nowadays,
if profoundly studied, can contribute essentially to the theory of bioethics,
and humanize modern medicine and healthcare. Fundamental ethical ideas
of “Canon of Medical Science” uniting medicine and a worthy life in the
philosophy of health are still topical nowadays. Moreover, it outruns, in
many respects, our ideas on medical ethics. Indeed, Ibn Sina’s attempts to
link problems of medicine with the mode of life and to create conditions
for maintaining spiritual harmony throughout a person’s life are particularly
significant nowadays. According Ibn Sina’s precepts, the physician should
do not only his/her professional duties but also his/her moral duty (Kasymov
A.I. Ethical Views of Abu Ali Ibn Sina (Avicenna). In: “Bioethics in
Uzbekistan – Clinical, Philosophical and Legal Aspects.” Tashkent, 2006,
pp. 57-62).
In 2003, the Islamic Republic of Iran and UNESCO instituted the
Avicenna prize for the development of modern bioethics in science. The role
of Avicenna in the development of current bioethical views runs all through
the book “Avicenna and the Ethics of Science Technology Today” published
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by UNESCO in 2006. Avicenna’s life and works invite us to think about
the ethics of science. (“Avicenna and the Ethics of Science and Technology
Today”. UNESCO, France, 2006, pp.1-18).
The Moslem etiquette of attitude to the patient has been and is certainly
influencing the content of professional ethics of Uzbekistan physicians.
However, a transformation of the socio-economic development model
that began after Uzbekistan had declared its independence in 1991, and,
as a consequence, commercialization of medicine, resulted in a too rapid
and radical transition to the principles of informed consent. In particularly
difficult cases, Uzbekistan physicians prefer an indirect informing – they
inform not the patient but his/her relatives. Physicians in countries with the
domination of Roman Catholicism act in a similar way.
Indeed, we find Moslem views on certain dilemmas of modern
biomedical ethics have much in common with views of other orthodox
religions. Islam having undergone many trials by the Soviet atheism and
political extremism provides an ideological foundation for the development
of bioethical values. However, it would be incorrect merely to reduce
Uzbekistan ethical norms to Islamic ones. Uzbekistan is a secular state,
and Islam adherents form but one of society segments, and religious norms
are but one of the components of biomedical ethics in Uzbekistan. Many
ethical and medical rules of social life exist not only in form of religious
dogmas but also as traditions, rituals and folklore, which helps to observe
the norms across generations.
Biomedical ethics in Uzbekistan is open to world tendencies, such as
globalization and westernization that have a strong impact on Uzbekistan
science. Achievements in the field of informed consent, reproductive
behaviour, etc. prove the response to world tendencies. The protection of
universal human values, as well as traditional values is a key issue of the
contemporary medical ethics in Uzbekistan.
Thus, the Uzbekistan model of biomedical ethics is at the stage of
intensive development. The intensity of research development in this
field is predetermined by ethical tendencies in Uzbekistan education and
philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
F.B. Peculiarities of Biomedical Ethics in Uzbekistan. In: “”Bioethics in
Uzbekistan – Clinical, Philosophical and Legal Aspects.” Tashkent, 2006,
pp. pp. 122-128).
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The State plays a key role in safeguarding social and economic
rights of its citizens, and therefore the State social policy should be
directed at maintaining social health, which is described by three groups
of characteristics: 1) population health (physical, mental and social); 2)
intellectual potential and the level of professional knowledge; 3) spiritual
and moral values.
To maintain and improve population health and to raise a healthy
generation, the Ministry of Public Health of the Republic of Uzbekistan
undertakes a considerable work on reforming healthcare based on a number
of principles and with a special attention to:
• the observance of constitutional rights to receive a qualified medical
care and
• the principle of an equitable access to medical service.
Issues relating to social relations in medicine are regulated by the
Constitution of the Republic of Uzbekistan (Art. 24, 26, 40, 43; 1922) and
by laws directed to the protection of citizens’ rights in medicine.
1. “On the State Control” (3 of July 1992; revised editions: 6 of May
1995; 15 of April 1999; 31 of August 2000);
2. “On the Protection of Consumers’ Rights” (26 of April 1996; revised
edition: 5 of April 2002);
3. “On the Protection of Citizens’ Health” (29 of August 1997);
4. “On Drugs and Pharmaceutical Activity” (25 of April 1997);
5. “On Narcotic and Psychoactive Drugs (19 of August 1999; revised
edition: 15 of December 2000);
6. “On the Prevention of Diseases Caused by HIV” (19 of August
1999);
7. “On Providing Psychiatric Care” (31 of August 2000);
8. “Radiation Safety” (2001);
9. “On the Protection of Population from Tuberculosis” (11 of May
2001);
10.“On Donor Blood and Its Components” (12 of August 2002).
Constitution of the Republic of Uzbekistan states that every citizen has
the right to a qualified medical care (Art. 40).
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The law “On Protection of Citizens’ Health” adopted in 1996 sets out
relevant principles of health protection and guarantees medical care for the
citizens. In other words, the State safeguards citizens’ rights to the protection
of health, stimulates the development of a healthy mode of life and regulates
the activity of state structures, national enterprises, institutions and public
unions in the field of healthcare (Kolesnikova L. Some Legal Aspects of
Regulating Physician--Patient Relationship. Materials of the First National
Congress on Bioethics with International Participation. Tashkent, 2005, pp.
58-59; Kolesnikova L. Relations of Doctor and Patient in the Light of Laws
in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent,
2006, pp. 129-135).
Article 3 of the Law defines main principles of citizens’ health
protection:
- observance of human rights in the field of health protection;
- availability of medical care for all social strata;
- the priority of preventive measures;
- social protection of citizens in cases of health loss;
- the unity of medical science and practice.
According to Article 13 of the Law, “…the State ensures the protection
against discrimination irrespective of a disease the citizen has. Appropriate
sanctions should be applied in the event of infringement of the provisions
contained in this Article”.
Nevertheless, in current practice of physician—patient relationship
there are cases of marginalization and stigmatization, which shows itself
in relation to most vulnerable social groups – drug and alcohol addicts, sex
workers, etc. In the event of diagnosing an “improper disease” (venereal
diseases, AIDS) a patient is labeled as “shameful”. A suspicious attitude
of medical staff to patients with such a diagnosis infringes patients’ rights,
which affects their moral and psychological state and, consequently, has a
negative impact on the treatment efficiency.
According to Article 24 of the Law, the patient has the right to:
- respectful and humane attitude of medical staff;
- choice of a physician;
- medical aid (examination, treatment, etc.) provided in compliance
with relevant sanitary requirements;
- consultation by a medical specialist on the patient’s request;
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aid;
- confidentiality with regard to information about applying for medical
- voluntary consent to a medical intervention or refusal of it;
- receiving information about his/her rights and responsibilities and his/
her health condition;
- compensation in the event of a damage to his/her health;
- access to a lawyer or another representative for the protection of his/
her rights.
In case of infringement of a patient’s rights, his/her legal representative
may make a complaint to any instance.
Article 34 of the law “On the Protection of Citizens’ Health” permits to
conduct biomedical research involving human subjects at state institutions
after laboratory experiments and with informed consent from a research
participant.
To protect patients’rights and dignity,Article 25 prohibits propagandizing,
including information in mass media, methods of prevention, diagnostics and
treatment, as well as pharmaceutical products unless they undergo trials.
The law “On Protection of Citizens’ Health” is closely linked with the
law of the Republic of Uzbekistan “On Protection of Consumers’ Rights”.
The title reflects the essence of the law – to protect consumers of any services
(general, community, trade services, etc.) including medical ones. According
to the Law, “a consumer is a citizen (natural person) who purchases, orders
or has an intention to purchase or order goods or a service for personal use
or a private non-profit household”.
A consumer of medical services is a patient having certain rights
defined by the Law. It is difficult enough to put a patient on the same
level as the consumer of general, community or trade services. To provide
a comprehensive protection of a patient’s rights a special law is needed,
however, in the absence of such a law, provisions of the law “On Protection
of Consumers’ Rights” are applied.
It is noteworthy that in the events of a damage to a patient’s life and health
the guilty part (medical professionals) are liable to criminal prosecution or
to disciplinary or financial sanctions as prescribed by Articles 989 and 1022
of the Civil Code of the Republic of Uzbekistan. According to the Articles
mentioned, the person who has suffered undue harm and/or moral damage
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resulting from an intervention is entitled to fair financial compensation
estimated according to the conditions and procedures prescribed by law.
Currently, there are but single instances of suits brought by patients or
their relatives against medical institutions. Uzbekistan has little experience
in considering such complaints at court, because citizens are not properly
informed about their rights. The lack of knowledge in this field negatively
affects physician-patient relationships and the treatment efficiency. It is
physicians’ professional duty to know patients’ and physicians’ rights and
responsibilities. Incidentally, while the patient may be ignorant of his rights
and responsibilities relating to medical care, the physician usually has
this knowledge but intentionally conceals it from the patient, which is a
disadvantage to both the patient and the physician.
To involve medical professionals in educational activity aiming at
informing patients about their rights, as well as physicians’ rights is one of
urgent tasks for the healthcare system of Uzbekistan. .
Ethical norms considering special features in relationship with patients
from various age and social groups should have a significant place in the
system regulating medical activity, particularly the rule of confidentiality
relating to information obtained from the patient. This rule applies to adults
(capable), minors (incapable or partially capable) and to persons with
restricted capabilities who need a constant care.
Ethical principles are essential in providing medical care to patients
with sexually transmitted diseases. A more tolerant attitude of the society
and law-enforcement bodies to patients from risk groups (sex workers,
truckers, etc.) requires the development of legislation and social tolerance
via public institutions (mahalline committees).
The law of the Republic of Uzbekistan “On the Protection of Citizen’s
Health” contains a number of articles concerning ethical issues. Thus, Article
46 sets out main principles safeguarding patents’ rights. The law of the
Republic of Uzbekistan “On Pharmaceutical Products and Pharmaceutical
Activity” (1997) also protects patients’ rights in biomedical research. It
defines the State authorities and competence of the Ministry of Public Health
of the Republic of Uzbekistan in the sphere of clinical trials.
Article 10 states that the decision about a clinical trial (CT) is based on
- consent obtained from a patient or volunteer to participate in CT;
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- findings of a pre-clinical study of safety and efficiency of
pharmaceutical products;
- available data testifying that a potential risk is essentially lower than
an expected benefit.
Article 11 sets out provisions with regard to the patient’s or a volunteer’s
rights in a clinical trial. Before the patient/volunteer signs written consents to
participate in a clinical trial of a pharmaceutical, the physician (investigator)
should inform him/her about the research purpose and nature, as well as on
its consequences and potential risks.
These issues are reflected in the Order of the President of the Republic
of Uzbekistan “On the State Programme for Reforming Healthcare” (1998),
in the Laws of the Republic of Uzbekistan “On the Protection of Consumers’
Rights” (1996) and “On Advertising” (1998), as well as in the decrees of
the Cabinet of Republic Uzbekistan “On Measures for Enhancing Public
Participation with Regard to Protection of Consumers’ Rights” (No 404,
2002) and “On Implementation of Measures for Improving the Procedure
of Importing Consumer Goods” (No 427, 2002). The procedure for
conducting clinical trials is specified in Guidelines on Conducting Clinical
Trials and Determining Clinical Sites approved by the Ministry of Public
Health of the Republic of Uzbekistan in 2001. The Guidelines are based
on WHO Guidelines for Good Clinical Practice. When conducting CT, the
Pharmacological Committee of the Central Department for Controlling
the Quality of Pharmaceuticals and Medical Equipment an the Ministry of
Public Health of the Republic of Uzbekistan is following this document.
The Guidelines reflect the following aspects:
- informing patients about CT;
- obtaining written informed consent from patients;
- independent ethical review;
- insurance;
- operational standard procedures.
A number of other documents (decrees of the President of Republic
Uzbekistan, decrees of the Cabinet of the Republic of Uzbekistan, orders and
guidelines of the Ministry of Public Health) have been adopted for a further
healthcare development (reforming the system of medical service, creating
necessary material and technical conditions for providing healthcare at state
and private medical institutions, etc.).
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Uzbekistan adopted basic international documents in the field of
bioethics, such as
1. Declaration of Helsinki
2. Universal Declaration on Human Rights (1948)
3. The Universal Declaration on the Human Genome and Human Rights
(1997)
4. Monaco Declaration (18 of July 2001),
5. International Declaration on Human Genetic Data (adopted by
UNESCO General Assembly; 16 of Octobe, 2003
6. Universal Declaration on Bioethics and Human Rights (UNESCO,
2005)
7. United Nations Declaration on Human Cloning (8 of March 2005)
8. ECOSOS Resolution “Genetic privacy and non-discrimination” (21
of July 2004)
9. Resolutions of ECOSOS Commission for Human Rights:
- Human Rights and Bioethics (25 of April 2003);
- Principles of biomedical ethics with regard to the role of medical
professionals, particularly physicians, in the protection of prisoners or
persons under arrest against tortures and other cruel, inhuman or disgracing
attitude and punishment (18 of December 1982);
- Declaration on the Use of Scientific and Technological Progress in the
Interests of Peace and for the Benefit of Mankind (10 of November 1975).
In its activity the National Ethics Committee (NEC) of the Republic of
Uzbekistan at the Ministry of Public Health of Uzbekistan uses also other
international documents, such as
1. Final Act of the International Conference on Healthcare (New-York,
22 July 1946)
2. The Nuremberg Code (1947)
3. Universal Declaration on Human Rights 1948
4. Declaration of Helsinki (WHO, 1964, 2002)
5. European Agreement on Providing Medical Assistance to Persons
Temporarily Residing in Other [Member] (Geneva, 17 of October 1980)
6. Convention on Biological (Rio de Janeiro, 5 of June 1992)
7. Budapest Summit Decisions. Human Dimension (Budapest, 1994)
8. Agreement on Collaboration in Public Health Protection (Minsk, 26
of June 1992)
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9. The Charter of Social Rights and Guarantees to the Citizens of
Independent States (approved by the Inter-parliamentary Assembly of the
Commonwealth of Independent States, 29 of October 1994)
10.Convention on Human Rights and Biomedicine (Council of Europe,
1996)
11.Note for Guidance on Good Clinical Practice (ICH, 1996)
12.WHO Operational Guidelines for Ethics Committees that Review
Biomedical Research (2000)
13.Model Law of IPA CIS “On the Protection of Human Rights and
Dignity in Biomedical Research in the CIS” (2005)
14.International Ethical guidelines for Biomedical research Involving
Human Subjects (WHO/CIOMS, 13 of June 1993/2003)
15.Report of the International Bioethics Committee on the Possibility
of Elaborating a Universal Instrument on Bioethics (13 of June 2003)
16.UNESCO Programme on Bioethics: Priorities and Perspectives (17
of October 1999)
17.Implementation of the Universal Declaration on the Human.
Genome and Human Rights (17 of November 1999)
A number of national laws of the Republic of Uzbekistan relating to the
implementation of international agreements in healthcare imply a possibility
of a joint regulation by the national Uzbekistan legislation and international
norms. Article 1 of the Law “on the Protection of Citizen’s Health” (No
265-I; 29 of August 1996) states that “if an international agreement sets out
rules others than those in the national legislation, norms of the international
agreement are applied”.
Substantiation of certain approaches to resolving bioethics problems is
nowadays in the centre of political, philosophical and religious investigations
that are to offer guiding lines in our rapidly changing world. Thus, the necessity
to consider existing religious moral norms and cultural traditions in making
decisions on key bioethical problems was discussed at the International
Congress of Bioethics (Teheran, 2005). For the independent the Republic
of Uzbekistan this issue is particularly topical. Despite the secular character
of Uzbekistan, many residents are practicing Islam and other religions. The
clause on the liberty of conscience in the Constitution of the Republic of
Uzbekistan reflects the respect for the feelings of believers in our country,
and therefore specific features of religious thinking are to be considered in
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adopting the Code of the Republic of Uzbekistan on Bioethical Problems
(Mukhamedova Z.M. Islamic Bioethics in Historical Context. In: “Materials
of the First National Congress on Bioethics”, Tashkent, 2005, pp. 98-100).
It is necessary to note that nowadays there is a number of ethical codes
interpreting teachings of the Koran and Sunnah with regard to complicated
medical and biological problems. Thus, there are the Islamic Code of
Medical Ethics48 and Islamic Bioethics49 correlating their statements with
the Islam teachings: the Koran, Shariat and Hasid.50 These Codes are used
in Kuwait, Egypt, Saudi Arabia, Iran, Pakistan and in other countries with
Moslem communities (Canada, USA et al.). These documents pave the way
to the development of ethical and religious regulations for biomedicine in
Uzbekistan.
Despite measures taken in our country, there remain problems relating
to the protection of human rights in healthcare.
Monitoring surveys carried out by the Ombudsman of the Republic of
Uzbekistan showed that citizens apply to different state structures not only
because of a poor material and technical basis of healthcare institutions or
lack of pharmaceuticals, but also because the violation of patients’ rights
to information about their diseases and methods of their treatment. The
majority of patients, particularly in rural areas, do not have any knowledge
on their rights, as healthcare institutions have not established procedures
for providing relevant information. Mostly, patients are informed of their
responsibilities and regulations the patient has to observe at a healthcare
institution.
Violation patients’ rights frequently result also from a low level of legal
knowledge in medical professionals. The analysis of complaints submitted
The Islamic code of medical ethics. World Med J 1982, Kuwait Document, Islamic Code
of Medical Ethics, International Organization of Islamic Medicine, 1981, Proposed Medical
Research Projects, edited by: Abdul Jawad M. As Sawai, Commission on Scientific Signs of
Qur,an and Sunnah, 1992.
49
Abdallah S. Daar, A.Binsumeit Al Khitamy. Bioethics for clinicians: 21. Islamic bioethics
CMAJ 2001; 164(1):60-3
50
Hathout H. Why an Islamic perspective? In: El-Gindy AR, editor. Health policy, ethics and
human values:
Islamic perspective. Kuwait: Islamic Organization of Medical Sciences; 1995. p. 815.;Hamdani DH. Canadian Muslims on the eve of the twenty-first century. J Muslim Minority
Affairs 1999; 19(2):197-209.
48
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to various state structures with regard to violation of citizens’ rights in
healthcare show that conditions causing violation of citizens’ rights in this
sphere are determined by a number of factors, such as:
1. imperfection of legislation referring to medical practice;
2. a low level of implementing normative and legal documents
regulating the practice of healthcare system;
3. an inadequate level of citizens’ awareness of their rights and
responsibilities in medicine.
All abovementioned problems are the object of bioethics – a new field
of knowledge rapidly developing all over the world for working out ways
and methods for resolving problem situations in healthcare and in the sphere
of new medical technologies. To improve the situation, the Republic of
Uzbekistan worked out a draft law on medical practice.
When designing the law attention has been paid to the following issues:
1. Modern medicine is a high-tech field; a rapid development of new
biotechnologies, new treatment methods is continuously expanding ways
of medical intervention in human body. Therefore, an individual needs new
mechanisms of protection in the sphere of medicine, because a person’s
health, life and dignity depend on them.
2. Issues concerning an appropriate quality of medical assistance, its
availability, social justice, equality and non-discrimination in healthcare are
also essential.
3. It is necessary to create a model of patient—physician relationship
that would imply cooperation and dialogue between two parties equal in
rights based on the respect for a person’s autonomy.
4. A patient has certain rights the violation of which entails not only
moral but also judicial responsibility. Appropriate sanctions should be
applied to a physician in the event of a damage done to a patient that resulted
from unqualified and careless actions.
5. In setting out principles of medical practice, we have to think not
only about an individual’s rights and freedoms but also about his/her dignity
and integrity. The concept of human integrity covers an individual’s genetic
structures, intellect and psyche. Any medical intervention is only possible
with a voluntary and informed consent obtained from a person.
6. A necessary condition for a medical intervention is a patient’s
voluntary and informed consent. A voluntary consent implies that it has been
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obtained without deception, concealing information or pressure. Consent is
informed when it is given by a person who has been informed, in a plain
and understandable language, about the purpose and nature of the suggested
intervention, its possible risks and alternative treatment methods.
7. It is necessary to define in national legislation the status of embryos
at different stages of their development. The lack of legal regulation
here opens up opportunities for their commercial use or for a groundless
accusation of physicians studying embryos. We need laws on human
reproduction, human genetic structures, confidentiality of information
obtained in genetic testing, etc.
8. Any restrictions of rights and freedoms of a patient with socially
dangerous diseases may only be introduced in compliance with laws, but not
following subordinate legislation adopted by healthcare bodies.
9. To improve legislation referring to healthcare, it is essential to
remove merely declarative norms having no mechanisms or procedures for
their implementation. The lack of mechanisms and procedures for a practical
implementation of legal regulations results in violation of patients’ rights, an
insufficient level of healthcare system efficiency, and, consequently, lowers
patients’ trust in healthcare reforms carried out by the State.
In the light of the above said, the draft project of the Law “On Medical
Practice” has been designed. Chapter III of the Law (Articles 29-50) defines
patients’ rights and responsibilities:
• Article 29 sets out provisions for implementing patients’ rights;
• Article 30 declares patients’ right to life;
• Article 31 states patients’ right to non-discrimination;
• Article 32 states patients’ right to a free choice;
• Article 33 ensures patients’ safety in the field of healthcare;
• Article 34 protects patients’ right to physical integrity with regard to
medical interventions;
• Article 35 ensures patients’ rights to religious freedom;
• Article 36 states patients’ rights to pain relief;
• Article 37 prohibits any measures putting pressure on patients for
behavioural reasons;
• Article 38 sets out patients’ right to participate in planning and
conducting a treatment;
• Article 39 states the right to receive medical information;
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• Article 40 sets out the right to introduce changes and amendments
into medical information;
• Article 41 ensures personal immunity when providing medical
assistance;
• Article 42 sets out the rule of informed consent;
• Article 43 states patients’ right to refuse medical treatment;
• Article 44 ensures patients’ right to receive a necessary medical care
and its availability;
• Article 45 states patients’ right to receive all necessary types and
forms of medical care;
• Article 46 sets out the right to medical care for non-residents of the
Republic of Uzbekistan;
• Article 47 ensures the right to medical care for residents of the
Republic of Uzbekistan staying in the territory of other countries.
The draft project of the Law includes provisions referring to the
protection of patients’ rights in medical research. Thus, Article 48 states that
any biomedical research involving human subjects may only be carried out
after the person concerned has given consent to it, and the research project
has been approved by the National Ethics Committee (NEC).
When designing a research involving human subjects the physician
should weigh thoroughly predictable risks to cause harm against potential
benefit of the research.
Biomedical research or a clinical trial may only be carried out after
the person concerned has given free and informed consent to it based on
information provided by the investigator.
Physician-investigator should safeguard the patient’s right to withdraw
his/her consent to participate in a research at any time and for any reason.
This draft project of the law has been submitted to the Legislative
Chamber of Uzbekistan Parliament; it has been discussed, and will be
adopted in 2007.
Alongside the patients’ rights, the Law “On Medical Practice” implies
patients’ responsibilities. Thus, Article 47 states that the patient should
- to show tact and respect towards medical professionals;
- to give comprehensive information necessary for the diagnostics and
treatment of a disease;
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- to follow the physician’s prescriptions after having given consent to a
medical intervention;
- to comply with the routine of the healthcare institution;
- to collaborate with the physician in the process of treatment;
- to inform the physician without delay about a change in his/her health
condition in the process of diagnostics and treatment;
- to apply to the physician immediately if there is a suspicion of a disease
or a disease posing hazard of a wide spreading;
- to avoid any actions that may infringe other patients’ rights.
It is essential to include into the draft project of the Law provisions
on the physician’s rights and responsibilities that enhance the rapport with
the patient, as both the patient and the physician become partners having
reciprocal rights and responsibilities, and the right for one party, is the
responsibility of another one.
The Law “On Medical Practice” will facilitate the regulation of
independent ethical review and safeguard the protection of rights and dignity
of Uzbekistan citizens in biomedical trials.
Legislative measures undertaken in Uzbekistan will be able to protect
individuals, the society and humankind as a whole against undesirable
or sometimes harmful consequences from the implementation of new
biomedical technologies.
Problems of teaching bioethics arouse much discussion at all
international forums on bioethics. According to UNESCO Ethics Education
Programme (EEP), for the biennium 2004-2005 the activities in the area of
ethics teaching have primarily focused on East and Central Europe. During
2006-2007 priority has been given to South-East Europe and part of the
Arab region (Gulf region).
To facilitate the development of new relations in Uzbekistan healthcare
that would more adequately comply with current political and social
conditions, all Uzbekistan institutes of higher medical institutions and
universities (faculties of law, philosophy and biology) introduced regular
courses on bioethics into the syllabi of undergraduate and postgraduate
education.
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According to the State Standard of Education, at institutes of higher
medical education bioethics is taught at two levels: 1st level --”Introduction
to Bioethics” and 2nd level – “Biomedical ethics” for senior students (3rd
year).
In 1998, Tashkent Medical Academy (TMA) included the study of basic
bioethical problems in the baccalaureate programme on social sciences and
humanities. Since 2002 TMA is offering modules on bioethics for magistracy
residents; in 2003 the Faculty of Post-Graduate Education at the Tashkent
Medical Academy included topics on bioethics into the programme for
post-graduate education, and since 2004 bioethics is taught as an elective
course.
The Chair of Philosophy has designed a programme on bioethics and
published a manual “Introduction to Bioethics” in Russian and Uzbek
(2004). In 2005, an anonymous questionnaire on key bioethical problems
was offered to medical students of the second year to assess the level of their
training and the system of their values and general worldview [1].
In the second year students study philosophical and legal aspects
of bioethics. The course consists of lectures (10 hours) and seminars
(10 hours).
In the third year, bioethics is taught at all faculties (general medicine,
dentistry, pediatrics, biomedicine, etc.).
The course aims at raising the level of education in biomedical ethics
and the professional level of future physicians. Their knowledge of bioethics
will help them to avoid deontological and professional mistakes and to make
decisions in difficult situations.
The working group of the NEC in collaboration with the TMA
professionals teaching bioethics has designed a programme on biomedical
ethics for baccalaureate students. The course consists of five lectures
(10 hours), 8 seminars (17 hours) and 54 hours are given to individual work.
The course ends up with a test.
Themes vary depending on the course. The syllabus on bioethics covers
the following topics: categorical issues of bioethics as a science (relation of
the concepts “bioethics”, “biomedical ethics”, “medical ethics”, “ecological
ethics”, “research ethics”; subject and tasks of bioethics; theory, principles
and methods of biomedical ethics, etc.); international legislation on bioethics;
history of medical ethics (including issues of spiritual development and
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education, of life and death reflected in works by scientists of different times
and peoples; secular and religious aspects of modern biomedical ethics;
specific features of biomedical ethics in Islamic countries and Zoroastrian
medicine), etc. In addition to that, students should study the Constitution of
the Republic of Uzbekistan (1992), as well as laws and normative documents
regulating public relations in healthcare. All cardinal problems of theoretical
and applied bioethics are considered including ethical problems in clinical
trials and biomedical research involving human subjects and animals. Specific
ethical problems associated with students’ specialization are also considered.
The NEC of the Republic of Uzbekistan is carrying on an essential work
on the development of a regular education in bioethics and on training home
specialists in the field of modern bioethics.
Since 2000, members of the NEC and of regional and local ethics
committees have participated in training seminars on bioethics (2001 – SaintPetersburg, Russia; 2001 – Kiev, Ukraine; 2002 – Almaty, Kazakhstan; 2003
– Saint-Petersburg, Russia and Tashkent, Uzbekistan; 2004 – Kiev, Ukraine
and Baku, Azerbaijan; 2005 – Yerevan, Armenia; Almaty, Kazakhstan and
Tashkent, Uzbekistan; 2006 – Tashkent, Uzbekistan). Training seminars were
organized by the Forum for Ethics in the Commonwealth of Independent
States, US National Healthcare Union and American Centers for Disease
Control and Prevention (CDCP) in collaboration with UNDP (World
Bank/WHO), IPA CIS, EFGCP, UNESCO, EC and other international and
national organizations. Training seminar on research ethics for members of
NEC and local ECs of Uzbekistan that was held in Tashkent, Uzbekistan
was conducted in the framework of SIDCER “Recognition Programme”.
Within this seminar there were a training courses “Standard Operational
Procedures” and “Human Subject Protection”. The training seminars
covered the following issues:
- The role of ethical review in biomedical research;
- The role of SOPs in conducting ethical review, establishing ECs,
choosing independent consultants and confidentiality agreement.
The teaching programmes on ethics for EC members and programmes
on GCP for postgraduate education were discussed at the seminars (C.Jankw,
Austria) as well as Fogarty Programme (B.Yudin, Russia):
- the procedure of establishing an EC and EC meetings;
- legislative basis for the ethical review of biomedical research;
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- the procedure of obtaining informed consent.
There were also training seminars for EC members from countries of
Central Asia. Tashkent hosted training seminars “Principles of Ethics in
Biomedical Research”(CDCP, 2003), “Principles of Conducting Ethical
Review and Obtaining Informed Consent” (CDCP, 2005).
In addition to training EC members, NEC of the Republic of Uzbekistan
provides assistance in educating students and physicians with regard to the
protection of human rights and dignity in modern medicine and biology.
The introduction of a course on bioethics pursues the following goals: 1)
to provide new knowledge; 2) to develop practical abilities; 3) to develop a
conscious need for moral development [2].
Recognizing the necessity of training professionals with a high level of
proficiency, we shall use the following three variants of a course programme
designed in the framework of the project “Bioethics for CIS Countries” (the
head of the Project – B.G.Yudin):
- Short-term course for investigators and EC members (held in Tashkent,
2005);
- A programme for bioethics teachers;
- A programme for training professionals with a high level of proficiency
in bioethics.
The introduction of a course on bioethics into syllabi of institutes of
higher medical institutions in Uzbekistan meets the demands of the time and
is connected with reformation processes in health care and education aiming
at humanization and development of a new worldview in the context of the
National model of training professionals and building a democratic and jural
civil society.
References
1. Atakhanov Sh.E., Mukhamedova Z.M. On the Necessity to Introduce
the Course on Bioethics into the Higher Education. In: Materials of the First
National Congress on Bioethics of the Republic of Uzbekistan. Tashkent,
2005, pp. 88-89 (in Russian).
2. Nazhmetdinova D.K., Mukhamedova Z.M. Problems of Bioethics
in the Context of Moral Components of Medical Knowledge of Future
Physicians. In: Materials of the First National Congress on Bioethics of the
Republic of Uzbekistan. Tashkent, 2005, pp. 100-103 (in Russian).
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3. Rustamova M.T. Ethical Education of Medical Students and its Role
in the Protection of Patients’ Rights. In: Materials of the First National
Congress on Bioethics of the Republic of Uzbekistan. Tashkent, 2005, pp.
105-106 (in Russian).
4. Abdullakhodjaeva M.S., Mukhamedova Z.M., Rustamova M.T..
Avicenna and the ethics of science and technology today. In: Ethics of
science and technology Exploration of the frontiers of science and ethics.
UNESCO, France, 2006.
5. Zagrytdinova F. On Biomedical Ethical Problems. Tashkent, 2005, p.
131 (in Russian).
6. Mukhamedova Z.M. Introduction in Bioethics. Tashkent, 2004, p.
110 (in Russian).
7. Mukhamedova Z.M. Bioethics. Tashkent, 2006, p. 148.
8. Zagrytdinova F. Ethics: A Manual. Tashkent, 2005, p. 134.
A rapid development of biology, pharmaceutical industry and new
biotechnologies for diseases diagnostics, treatment and prevention required
the review of clinical efficiency of new and generic pharmaceutical products
and put in the forefront the necessity to protect human rights in biomedical
research involving human subjects.
The establishment of national, regional and local ECs facilitated a
wide implementation of ethical review of biomedical research performed
in Uzbekistan in compliance with international ethical principles and WHO
Operational Guidelines for Ethics Committees that Review Biomedical
Research (2000).
The necessity to establish EC for conducting ethical review of clinical
trials (CT) emerged in Uzbekistan in the end of the nineteenth. It was
connected with involvement of Uzbekistan in international scientific projects,
which implied conducting an ethical review in conformity with international
ethical norms. Another important reason was the establishment of the State
Registration of Pharmaceutical Products and Medical Facilities. Presently,
the NEC conducts ethical review of CT of home and foreign pharmaceutical
products and multi-centre research. From the very beginning the NEC has
been conducted ethical review of biomedical research involving human
344
subjects. The NEC controls the procedure of obtaining informed consent
and other ethical aspects including the safety of research participants’
insurance and monitors the process of medical research to check the risks of
the research. The NEC also controls educational programmes on bioethics in
institutes of higher education, training seminars and conferences on bioethics
and publications in medical journals and mass media. It is responsible for
a prompt notification of authorized bodies in the case of any unexpected
adverse effects that are hazardous to research participants or other persons
associated with the research, in the event of any serious violation of ethical
norms or in the case of the suspension/termination of a research involving
human subjects that was previously approved by the NEC and conducted in
Uzbekistan or with the participation of Uzbekistan.
In 2000, the minister of public health approved the document Regulations
for the National Ethics Committee at the Medical Scientific Council of the
Ministry of Public Health of the Republic of Uzbekistan”. The Regulations
define the tasks, responsibilities and rights of the Committee, as well as its
structure and procedures.
In 2003, the document was revised. It included a wider range of tasks,
a more detailed description of the NEC organization activity, procedures,
rights and responsibilities (in particular, a new clause “Responsibilities
of Investigators and Research Directors” was added). The NEC is an
independent institution created on a voluntary basis at the Ministry of Public
Health for the protection of human rights, health and safety in biomedical
research. Currently, the Regulations for the NEC (adopted on June 20, 2005)
are in full compliance with relevant international principles and norms.
In connection with the completion of establishing local ECs throughout
the Republic of Uzbekistan, and to improve their activity, a new and more
comprehensive version of the Regulations for local ECs was discussed
and adopted at the First National Congress on Bioethics with international
participation. The Regulations state that local ECs are created under the
aegis of the NEC at patient care institutions and research institutes in form
of a public unit that is not registered as a juridical person. Local ECs are
responsible for monitoring biomedical research approved by the NEC at the
site of the research with regard to compliance with the review procedures,
obtaining informed consent from the research subjects, research safety
(serious adverse effects, inadequate reaction) and notifying NEC if the
345
research should be terminated because of complications arising in the course
of the biomedical research). Local ECs describe the results of their activity
in form of an annual report that are archived and retained at local ECs.
Operational procedures and rules relating to documenting and archiving
should ensure confidentiality of local ECs performance. At the same time
the activity of ECs at all levels should be open to the society, which is stated
in relevant documents. Information about ECs members, work schedule and
decisions may not be confidential.
Thus, Republic of Uzbekistan created a multilevel system for ethical
review of biomedical research. In compliance with WHO recommendations
the NEC members are leading Uzbekistan scientists with experience in various
fields of medical and other sciences (biology, law, genetics, philosophy)
and representatives of religious and public institutions, ombudsmen and a
representative of the National Centre for Human Rights. Regional and local
ECs established at regional centers (Samarkand, Bukhara, Andijan, Nukus)
and large clinical sites at institutes of higher medical education and research
institutes are also headed by eminent Uzbekistan scientists.
The NEC reviews international research projects involving human
subjects and makes its decisions about the project. The NEC of Republic
Uzbekistan has been registered at American Centers for Information Disease
Control (Atlanta) and American Centers for Disease Control and Prevention
(NAMRO-3, Cairo).
The NEC functions in conformity with Standard Operational Procedures
(SOPs) designed in the process of a regular work. According to the NEC
procedures, the documents should be reviewed within 7-30 days (expedited
or regular review). Since the time of its establishment, the NEC has reviewed
over 320 various projects including joint international research projects,
research projects designed by Uzbekistan scientists and dissertations based
on biomedical research involving human subjects.
The NEC review also projects of clinical trials of pharmaceutical products,
of medical equipment and other products for medical needs. Usually research
projects meet ethical requirements, and the NEC makes positive decisions.
Sometimes, however, there are cases when the NEC declines a project. This
usually concerns clinical trials of a non-registered pharmaceutical product
or of a new rout of a known drug administration when there is no approval
by the Pharmacological Committee or the drug is hazardous to a patient’s
346
health. Negative decisions are also made if the risk of complications or
adverse effects is very high. The main criterion for an objective and reliable
judgment about efficiency and safety of a pharmaceutical product is a
clinical trial that ensures the safety of its participants. The Pharmacological
Committee established in 1992 at the Central Department for Control of
Pharmaceutical Products and Medical Equipment within the Ministry of
Public Health of the Republic of Uzbekistan conducts a scientific review
of research projects. Acknowledging the importance of ethical review for
a biomedical research the Pharmacological Committee closely collaborates
with the NEC, which is very helpful with regard to such ethical problems as
the protection of rights and interests of CT subjects. To obtain the permission
for a CT the relevant documents are first submitted to the Pharmacological
Committee that conducts its own review, and only after approval by the
Committee the documents may be submitted to the NEC for the ethical
review. Chairpersons of local ECs representing institutions that are planning
to conduct clinical trials are present at the NEC meetings.
In the period from 1992 to 2005 inclusive, the Pharmacological
Committee reviewed 910 clinical trials of pharmaceutical products (312 of
those were from domestic and 598 from foreign manufacturers) belonging to
various pharmaco-logical groups. Starting from 2001 the number of clinical
trials has increased, which is mainly connected with new requirements
relating to the registration of pharmaceutical products. It is noteworthy,
that starting from 2001 all clinical trials have been conducted according
to uniform guidelines complying with GCP for both domestic and foreign
manufacturers. Clinical trials have been carried out at more than 60 medical
institutions authorized by the Ministry of Public Health. During that period,
25 pharmaceutical products from both domestic and foreign manufacturers
have been declined because of their low efficiency and/or expressed adverse
effects.
The first experience in actual application of ethical principles strictly
according to GCP was gained in multicentre trials organized by large foreign
pharmaceutical firms.
To safeguard the protection of CT subjects, all documents relating to
preclinical trials of toxicity and pharmaceutical activity of both new and
generic pharmaceutical products should be most thoroughly studied and
analyzed. Preclinical trials are conducted according to “Guidelines on
347
Preclinical Trials of Pharmaceutical Products Safety” stating that placebo is
used only to study pharmaceutical products for adjuvant therapy in patients
with a mild or medium degree of a disease. Besides, there are special
conditions for research participants from vulnerable groups.
In 2001 paragraphs referring to CT ethics were included into the
“Guidelines for Conducting Clinical Trials of Pharmaceutical Products and
Expertise of Trial Materials”. Now, apart from the research Protocol and
individual registration form, documentation submitted by the applicant to
the NEC should include written informed consent forms signed by potential
trial participants.
The NEC activity in the sphere of implementing ethical principles into
medical science and healthcare enhanced the quality of patient—physician
relationship and of medical services provided by healthcare institutions.
This also served to reduce the number of complaints from patients.
The NEC coordinates its activity with the Centre of Science and
Technology. The latter considers applied, fundamental and innovation
grant projects relating to biomedical research after they were approved by
the NEC.
The NEC collaborates with the Higher Certifying Commission at the
Cabinet of the Republic of Uzbekistan. According to the petition of the
NEC Medical Council “On the Necessity to Conduct Ethical Review of
Dissertation Works Involving Patients or Volunteers as Research Subjects”
(Protocol No 25, 2002) the Commission considers dissertation works only
after the NEC permission to carry out the research (including biomedical
research with animals) was obtained.
The NEC participated in the organization of the First National Congress
on Bioethics with international participation (2005) and a scientific conference
“Ethical Aspects of New Biotechnologies in Biology and Medicine” (2006). It
facilitated the publication of the Conference papers and of a book “Bioethics
in Uzbekistan. Clinical, Philosophical and Legal Aspects” (2006).
At the First National Congress four trends in bioethics were discussed:
- ethical problems in science;
- legal aspects of bioethics;
- bioethics and education;
- bioethics and the environment.
348
A special attention was given to ethical aspects of new biotechnologies,
patient-physician relationships in various fields of healthcare (pediatrics,
neonatology, surgery, neurosurgery, emergency care, neurology, psychiatry)
and bioethical education.
The Congress adopted a Resolution that will facilitate the development
of bioethics in Uzbekistan.
The main tasks of the Congress were to promote legislation with
regard to the protection of human rights and dignity in biomedical research
involving human subjects; to outline the strategy for developing the activity
of the NEC in the field of bioethics; to discuss educational programmes on
bioethics for students of higher educational establishments.
The Congress participants discussed and adopted the Ethical Code
of Uzbekistan Physician-Investigator” setting out basic principles of
ethical review of biomedical research involving human subjects. The
implementation of the Ethical Code will form a basis for a legal solution of
bioethical problems. This, in its turn, will allow us to provide medical care
corresponding to the level of modern biomedical technologies and to observe
patients’ rights in compliance with adopted international documents.
The adopted Resolution and the Ethical Code of Uzbekistan PhysicianInvestigator not only mark a new stage in the development of the NEC
activity, but also evidence the growth and prospects with regard to solving
key problems of bioethics relating to the protection of human rights and
dignity in Uzbekistan.
To summarize, we should emphasize that a social, cultural, historical
and scientific level ensures a harmonious integration of the Republic of
Uzbekistan into the process of developing research ethics and establishing
system of ethical review.
3.11.5. Perspectives and Forms
of International Cooperation
According to the UNESCO strategy for 2002-2007, the NEC of
Uzbekistan facilitates the promotion of ethical principles and norms as
guiding lines for scientific and technological development and social reforms
through international, regional and global cooperation. The UNESCO
Executive Committee instituted the Avicenna Prize in the field of ethics of
349
science and bioethics, which inspires and stimulates the NEC for a further
development.
In 2000, the NEC of the Republic of Uzbekistan entered the Forum
for Ethics Committees in the Commonwealth of Independent States and the
European Forum for Bioethics. The Forums aim at supporting and reinforcing
the protection of biomedical research participants. Members of the NEC and
local ECs participated in international conferences and training seminars
organized by the FECCIS in St.-Petersburg (Russia), Almaty (Kazakhstan),
Minsk (Belarus), Kiev (Ukraine), Baku (Azerbaijan), Yerevan (Armenia),
Tashkent (Uzbekistan) and in the sub-regional conference held in Teheran
(October 2006). The NEC members made an essential contribution to the
development of normative and methodical recommendations of the IPA
CIS, the model law, and to the volume of SOPs.
Nearly all NEC members gave their presentations at scientific symposia
and conferences on bioethics held in the CIS and other countries. In 2005, the
NEC held the First National Congress on Bioethics in Tashkent. Television,
all leading newspapers and scientific journals broadly covered issues of
biomedical ethics discussed at the Congress.
The idea to combine scientific progress and ethics brought together
about 200 medical scientists and members of teaching staff, investigators,
physicians, biologists, experts in law, philosophers, theologists, journalists,
deputies of the Legislative Chamber of Uzbekistan Parliament, representatives
of various public organizations, delegates from different Uzbekistan cities, as
well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia, Belgium,
South Africa, Philippines, Singapore and other countries.
The Congress participants discussed key issues of bioethics relating to
the protection of human rights and dignity of biomedical research subjects
in connection with the use of achievements in biology and medicine.
The Congress participants made many interesting presentations. The
Minister of Healthcare of Uzbekistan, prof. F.G.Nazirov spoke about ethical
aspects of using new technologies in medicine; Doctor of Philosophy, professor
Moshin Ebrahim from the Islamic University of South African Republic shared
his opinion on the rights of a fetus; scientists from Philippines, Ukraine and
Russia touched upon ethical problems concerning the use of embryonic and
stromal human stem cells in treating various diseases. The Chairperson of the
FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U. Sharapov gave a talk
350
on ethical aspects of clinical trials concerning HIV/AIDS; physicians from
the Republican Specialized Surgery Centre at the Ministry of Public Health of
Uzbekistan spoke about bioethical aspects of organ and tissue transplantation,
and specialists from the Scientific Centre for Emergency Medical Care
presented talks on similar problems in emergency medicine.
J.N.Franco from Singapore and a group of physicians from Belgium
spoke about problems of patient—physician relationship in the conditions
of a rapid development of new biotechnologies and about truth-telling
with regard to patients with terminal diseases. M.Baimukhamedov gave a
talk on ethical aspects of the protection of patients’ rights in TV-medical
consultations. The Congress participants discussed problems of ecological
ethics and the use of genetically modified products and their effect on integral
health (presentations by academician T.I.Iskanderov from Uzbekistan,
Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan).
The Head of the WHO Office in Uzbekistan Dr. Arun Nanda, prof.
E.I.Musabaev (Uzbekistan), physicians from Russia, The Tashkent Medical
Academy and Samarkand Scientific Center presented talks on legal aspects
of bioethics.
The Chairperson of the NEC and of the Medical Council of the
Ministry of Public Health, academician M.S.Abdullakhodjaeva spoke about
ethics in science, and professors from the Tashkent Medical Academy
Sh.E.Atakhanov, M.T.Rustamova and others discussed issues on teaching
ethics to medical students.
In the framework of the Congress a training seminar was held for
considering fundamental problems of bioethics. Members of ECs from
Uzbekistan, Kyrgyzstan and Tajikistan took part in the seminar.
The First National Congress on Bioethics adopted a Resolution that
reflected basic priorities of biomedical ethics in Uzbekistan and set out a
programme for the NEC activity relating to the development of bioethics
in Uzbekistan. The Ethical Code of Uzbekistan Physician-Investigator
regulates moral aspects of physicians’ relationships with patients and their
relatives in everyday work and in biomedical research. The Code formed a
basis for a further development of legal regulation in the field of bioethics.
In the framework of the FECCIS international seminar according to
the SIDCER “Recognition programme “, a scientific conference “Ethical
Aspects of New Biotechnologies in Biology and Medicine” was held
351
(Tashkent, 2006). Scientists from Uzbekistan, Kyrgyzstan, Russia and
Tajikistan presented their talks.
The initiative to extend the NEC relations with the countries of Central
Asian Region (CAR) - Kazakhstan, Kyrgyzstan, Tajikistan and Turkmenistan is also very important. The cluster meeting of chairpersons and members of the
CAR ECs held in Tashkent (2006) adopted a Resolution about establishing in
the framework of the FECCIS a Bioethics Association for the CAR countries.
The Association aims at providing a high-quality and efficient ethical review.
Resolution emphasizes the importance of training EC members. For this
purpose, we intend to create the UNESCO Chair of Bioethics at institutes
of higher medical education for training specialists, establishing relations
with European and other international organizations. Much attention is given
to the collaboration with the countries of Central Asia (Iran, Afghanistan,
Pakistan). Two members of the NEC of the Republic of Uzbekistan have
been elected honorary members of the Iran Association of Bioethicists
(academician the Uzbekistan Academy of Science, M.S.Abdullakhodjaeva
and assistant professor Z.M.Mykhamedova). We plan to open the Association
Representative Office at the NEC of the Republic of Uzbekistan. The Statute
of the Association of National Ethics Committees has been designed.
In the last years, the process of harmonization of ethical review standards
has been in the focus of the NEC attention. In its work the NEC is consistent
with the current tendencies of the international process of developing ethical
review at a global scale and developing conditions for creating national
systems, which is reflected in the NEC activity directed at collaboration
with WHO, WMA, UNESCO, European Commission and other leading
organizations in the field of bioethics.
Much attention is given to creating school of bioethics in Uzbekistan and
training new scientific and medical specialists in this field. The collaboration
with UNESCO allows us to implement at a broader scale the UNESCO
Ethics Education Programme. On the instructions of The Cabinet of the
Republic of Uzbekistan, programmes on bioethics for Masters of Medicine
and doctoral students of institutes of higher medical education are under
preparation. The NEC members take part in designing the programmes in a
close collaboration with the UNESCO Ethics Education Programme.
352
Chapter 4. The Perspectives for Global
International Harmonization
the Ethical Review of Biomedical Research
in CIS Countries
(O.I.Kubar, G.L.Mikirtichian)
Review of materials presented by the Republic of Armenia, the
Republic of Azerbaijan, the Republic of Belarus, Georgia, the Republic of
Kazakhstan, the Kyrgyz Republic, the Republic of Moldova, the Russian
Federation, the Republic of Tajikistan, the Ukraine and the Republic of
Uzbekistan on issue of historical and cultural basics of development of
ethical self-consciousness and its practical implementation in medicine;
dynamic process of law generation in the field of protection of human
rights in medicine and biology; establishing of bioethics as educational
subject and introduction of an ethical component into the state system of
control of biomedical studies, is a unique resource to analyze perspectives
and potential forms of cooperation with both each of 11 mentioned and the
Commonwealth of Independent States as a whole in the global development
of research ethics and bioethics.
Grounding on profound historical experience of highly moral attitude to
medical trade and treatment, the region countries contributed significantly
into formation of modern universal concept of protection of human rights
and dignity in medicine and biology. Such conclusion is a direct result of
analysis of cultural and historical unity of nations and states of the CIS
region and only confirms a concept of humanitarian unity of the humanity
development.
The field of regulatory and legislative control has a situation of harmonic
interaction of the region countries with the world society. A legal scale of the
Commonwealth states presented as a basic regulation allows seeing explicit
desire to correspond to international standards in legislation development
and direct introduction of international standards as an instrument for legal
regulation in the field of biomedical studies and ethical examination. In this
respect the fact of mutual interests of parties seems to be symbolical. The
CIS countries become members of international organizations and structures
at various levels that directly impacts establishing of universal standards for
protection of human rights and their legalization. The Commonwealth states
353
within the framework of IPA CIS are full fledged international members
for all significant world events in the sphere of social and humanitarian
development of society, and by themselves they form a wonderful example
of collective law development in the form of model laws providing
reference points for national law and order. Determining value of model law
development in health care, science and education aimed for improvement
of the bioethical component is demonstrated during presentation of both
general trends of construction of an ethical examination system in the
region and when national specific features are described. Attractiveness of
the region countries for biomedical research and mutual responsibility of
both international organizations and parliaments and governments of the
Commonwealth countries for provision of adequate, complying to universal
standards, regulatory framework for human rights protection are also a
serious incentive. This sphere has multiple in their forms components of
collaboration: counseling, joint law development, adaptation and ratification,
international system of legal responsibility for their breaching and interstate
appeal options.
In the field of development of bioethical education and training
for members of ethical committees there is well established system of
interregional cooperation. Significant contribution is made by creation of
national UNESCO commissions in the region countries with common policy
aimed on the following priorities:
- access to information and intellectual exchange;
- development of educational programs and approaches;
- strengthening capacities of national agencies working on ethical
issues;
- implementation of ethical norms aimed on protection of human rights
in the sphere of biomedicine;
- improvement of information awareness and training in the sphere of
bioethics;
- distribution of knowledge on bioethics among professional and public
groups including via mass media;
- counseling and education to bioethics issues among social sphere
facilities;
- extension of availability of information about regulatory documents,
human rights and procedures of their protection;
354
- development of training programs on ethics and their integration into
educational process.
It is noteworthy that cooperation in this sphere becomes both bilateral
and multilateral. Advantage of the region in this sphere is preservation
of communication on one language and traditional mutual penetration
of cultures and standards becoming a root system of information bases,
educational materials and educational testing.
Especially advantageous situation for cooperation is created in
the sphere of development and establishment of the system of ethical
examination. Simultaneous start of development of this field and unique
support of the global community through establishment of the Forum
for Ethics Committees in the CIS and inclusion of this region as a single
constituent of the global WHO Project SIDCER provided permanent
international dialogue on key issues of research ethics with international
agencies leading in this sphere – such as WHO, the European Commission,
the Council of Europe, UNESCO, the European Forum for Good Clinical
Practice, the World Medical Association as well as authoritative national
agencies: DHHS, USA and Ethics Committees of countries of all Continents.
Such dialogue became a basis for experience exchange and real integration
of ethical examination systems of the CIS countries into global discussion
and research process.
Integrity and value of cooperation with international organization
is also presented with equal access for the CIS countries to discussion
and development of international documents and guidelines on ethics of
biomedical studies such as the Operational Guidelines for Ethics Committees
that Review Biomedical Research (WHO, 2000, 2002); work on new edition
of the Declaration of Helsinki, documents of the Council of Europe, new
version of the International Ethical Guidelines for Biomedical Research
Involving Human Subjects (CIOMS), the Universal Declaration on the
Human Genome and Human Rights, the International Declaration on Human
Genetic Data, the Declaration on Common Bioethics Standards (UNESCO),
guidelines on bioethics, legal and social consequences of genetic testing (the
European Commission) and other universal documents and guidelines in
which development members of the FECCIS participated.
In general, cooperation within the framework of the FECCIS is
developed with the purpose to facilitate creation of systems of good ethical
355
practice and development of ethical responsibility in researchers, sponsors,
authorized regulatory agencies and the society as a whole. This process
in combination with advancements of science and social and legal trends
facilitates appearance of constitutional society and state regulation in the
CIS region. Inclusion of the CIS countries in the process of establishment
of good practices of ethical review at international scale is focused on
understanding of necessity of reaching independence, competence, openness
and responsibility in the field of human rights protection when conducting
biomedical studies. Development of cooperation facilitates free discussion
among colleagues, exchange with experience, problems and successes,
formation of collective recognition of ethics role in research and individual
ethical thought of all participants of biomedical process.
In conclusion of this chapter we consider as our priority tight to express
our assurance that the given work will become a token and impulse of the
new age of international cooperation among the region countries in the
sphere of ethical regulation of biomedical studies. Publication of this book
will provide informational access to the following data:
• conditions and perspectives for development of ethical review of
biomedical research in the CIS countries (historical and culture roots,
economic and social prerequisites, regulatory legislation, staff training
system, management);
• description of model legislation of IPA CIS in issues of regulation of
research in the field of biology and medicine and protection of human rights
and dignity;
• methodology and structure of national programs and their interaction
in the region and beyond for implementation of a strategy for compliance
with international ethical standards;
• general trends and specificity of development of ethical review to
form priority directions for cooperation at the regional and global scale;
• information concerning experience of regional cooperation within the
framework of the FECCIS;
• approach to harmonization of norms and standards of ethical review
of biomedical research in the region and at the global scale.
Objective and open knowledge of wide-scaled layer of national and
regional realia of ethics of biomedical studies in the Commonwealth
countries unveils a whole range of opportunities for all stakeholders in
356
regard to search for ways to further collaboration in this sphere basing on
adherence to universal values and ethical principles.
In general, contribution to the world society harmonizing standards
is based upon respect to human dignity, right and freedoms; recognition
of achievements of scientific and technical progress; facilitation of equal
access to scientific achievements through support of maximal, as much
as possible free flow and exchange of knowledge and mutual benefiting
from such exchange; protection of interests of existing and future human
generations that the current publication is dedicated to.
357
ABBREVIATION
BMR – Biomedical Research
CIOMS – Council for International Organizations of Medical Science
CIS – Commonwealth of Independent States
CT – Clinical Trials
EC/ECs – Ethics Committee/Ethics Committees
EFGCP – European Forum for Good Clinical Practice
FECCIS – Forum for Ethics Committees in the CIS
GCP – Good Clinical Practice
GLP Good Laboratory Practice
GMP – Good Manufacture Practice
ICH – International Conference on Harmonization of Technical
Requirements for the Registration of Pharmaceuticals for Human Use
IPA CIS – Inter-Parliamentary Assembly of the Commonwealth of
Independent States
SIDCER – Strategic Initiative for Developing Capacity in Ethical
Review
SOP – Standard Operating Procedures
TDR – Special Programme for Research and Training in Tropical
Diseases)
UNESCO – United National Educational, Scientific and Cultural
Organization
WHO – World Health Organization
WMA – World Medical Association
358
The authors of the Book wish to express their gratitude to their
colleagues from the Forum for Ethics Committee in Commonwealth
of Independent States; experts and specialists from all other national,
regional and international organizations who contributed in the process of
establishment and development ethical review system in the Commonwealth
of Independent States, which became the background of this Book.
It is the special pleasure to thank the UNESCO Office in Moscow,
Saint-Petersburg Pasteur Institute and the Inter-Parliamentary Assembly of
the Commonwealth of Independent States for their constant support and
fruitful cooperation during the process of the preparation of this BookWe
also thank the following organizations for their financial support that enabled
us to have this Book printed and presented.
359
Stem Cells Bank of Kazan State Medical University,
Republic of Tatarstan, Russia
Ethics Committee of Health Care Ministry,
Republic of Tatarstan, Russia
Republican Centre of Expertise and Trials in Healthcare,
Republic of Belarus
Foundation Internationale A.S.Pouchkine
International A.S.Pushkin Foundation,
Kingdom of Belgium
Accel Clinical Research, llc
Printed by Phoenix, Ltd.
27, Engelsa pr., Saint-Petersburg, 194156.
Order № , Circulation 500.
360

Ethical Review of Biomedical Research in the CIS Countries

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