Codes of Conduct on Biosecurity

Transcription

Codes of Conduct on
Biosecurity
I
II
Table of Contents:
1. Code of Conduct: Working with Highly Pathogenic Microorganisms
and Toxins (German Research Foundation) – S. 1
2. Scientific Freedom and Scientific Responsibility - Recommendations for
Handling Security-Relevant Research (German Research Foundation and
Leopoldina) – S. 4
3. Guidelines and Rules of the Max Planck Society on a Responsible Approach
to Freedom of Research and Research Risks – S. 18
4. Dual Use Potential of Life Sciences Research (Robert Koch Institute) – S. 29
5. Code of Conduct on Biosecurity for Biological Resource Centres (Global
Biological Resource Centre Network in association with European Consortium
of Microbial Resources Centres) – S. 33
6. Position Paper by BIO Deutschland on the Topic of Biosecurity: The Dual-Use
Dilemma – S. 35
7. Responsible Life Sciences Research for Global Health Security - A Guidance
Document (WHO) – S. 37
8. Harmonized Screening Protocol – Gene Sequence & Customer Screening to
Promote Biosecurity Preamble (International Gene Synthesis Consortium)
- S. 106
9. Proposed Framework for the Oversight of Dual Use Life Sciences Research:
Strategies for Minimizing the Potential Misuse of Research Information
(National Science Advisory Board for Biosecurity) – S. 111
10. United States Government Policy for Oversight of Life Sciences Dual Use
Research of Concern – S. 173
11. United States Government Policy for Institutional Oversight of Life Sciences
Dual Use Research of Concern – S. 177
12. U.S. Government Gain-of-Function Deliberative Process and Research
Funding Pause on Selected Gain-of-Function Research Involving Influenza,
MERS, and SARS Viruses – S. 192
13. A Code of Conduct for Biosecurity - Report by the Biosecurity Working Group
– S. 195
14. Position Statement on Bioterrorism and Biomedical Research (Wellcome
Trust) – S. 239
III
Code of Conduct: Working with Highly Pathogenic Microorganisms
and Toxins
German Research Foundation (DFG) Senate Commission on Genetic Research
13 March 2013
In recent years there has been rapid development in research in the field of infections, immunity and pathogenicity factors. The use of highly pathogenic microorganisms in research
has yielded important scientific findings. The function of bacterial toxins, the entry and
spread of highly pathogenic viruses in host cells and the relationship between cellular and
humoral immunity and highly pathogenic microbes are all examples of areas of research that
offer important potential for both basic research and the development of new diagnostic
methods, treatments and vaccines.
However, the use of highly pathogenic microorganisms and toxins comes with the risk that
research findings could be used to develop biological weapons. This is referred to as the
'dual use problem', and it is not limited to research involving highly pathogenic microorganisms and toxins. Examples of findings which are affected by this problem can also be found
in other fields, such as materials science, computer science and even the social sciences.
There exists a consensus that public safety should be considered the highest priority. However, we must also consider the benefits to human health that can be achieved through research with pathogenic organisms, as well as freedom of research and freedom of publication.
The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has discussed the dual use problem on many occasions in its statutory bodies. The DFG wants to
provide researchers with a code of conduct which addresses the problems of working with
highly pathogenic microorganisms and toxins and responds to the specific situation in Germany. The DFG has therefore drawn up the following recommendations for researchers
working with highly pathogenic microorganisms and toxins:
1.
The DFG agrees with the decision of the National Research Council of the National
Academies in the USA, which believes the following experiments to be particularly relevant to the dual use problem:
•
Efforts to increase the virulence of pathogenic microorganisms or to convert apathogenic microbes into pathogenic microbes
•
Experiments to induce resistance to effective antibiotics and antiviral substances
DFG Senate Commission on Genetic Research
Code of Conduct: Working with Highly Pathogenic Microorganisms and Toxins
13 March 2013
1
•
Experiments to increase the transmissibility of pathogens
•
Experiments to modify the host spectrum and stability of pathogens
•
Efforts to avoid methods of diagnosis and detection
•
Efforts to disclose the ineffectiveness of vaccines
•
Experiments to make biological agents or toxins more suitable for use as weapons
(weaponisation)
2.
The DFG believes it is necessary to carry out research work with pathogenic microorganisms and toxins. This is the only way in which we can develop strategies to combat
dangerous pathogens and protect the population against infections. In addition, many
findings in basic research have been the result of work involving highly pathogenic microorganisms and toxins. The DFG therefore believes that as few restrictions as possible should be imposed on research involving pathogenic microorganisms.
3.
However, the DFG also promotes a responsible approach to work of this type. It expects
researchers to evaluate their experiments at the planning stage and before starting work
with regard to a potential dual use problem and to document this evaluation process in
the laboratory records. This applies to the experiments themselves and to planned publications.
4.
The DFG will continue to fund research which addresses problems relating to highly
pathogenic microorganisms and toxins. However, principal investigators should address
an existing or potential dual use problem in their proposals. Reviewers are requested to
assess the information provided by applicants and make a recommendation to the review boards.
5.
In the case of proposals where the dual use problem is applicable, the review boards
will - if necessary following preparation in an ad hoc working group - carefully examine
the proposals and, if appropriate, make suggestions as to how the proposed work
should be carried out. If necessary the responsible Senate Commission and/or the Senate may be involved in the process.
6.
The DFG does not believe that preventing the publication of sensitive findings is an
effective way of minimising misuse. It believes that researchers must be allowed to continue publishing data relating to highly pathogenic microorganisms and toxins in peerreviewed journals. The publication of research data is a central requirement for scholarly
self-evaluation. Only known dangers can be countered. The specific publication guidelines of the journals in question should always be observed.
13 March 2013
2
7.
The DFG believes it is necessary to continue funding international cooperation, academic exchanges and the sharing of data, materials and methods in relation to research on pathogenic microorganisms and toxins. The appropriate national and international laws and guidelines must of course be observed.
8.
The DFG suggests that universities and non-university institutions should regularly
hold seminars and other events for students, doctoral researchers and postdoctoral
researchers on the subject of working with highly pathogenic microorganisms and
toxins. The annual briefings required by the Genetic Engineering Act also provide an
opportunity to raise awareness of the dual use problem. Research Training Groups,
graduate schools, Collaborative Research Centres, research centres and clusters of
excellence in relevant disciplines also provide suitable opportunities.
9.
The DFG advocates the continued development of best practice in connection with
highly pathogenic microorganisms and toxins and the ongoing adaptation of the scientific framework. Findings should be shared with other organisations within Germany and abroad, for example the Medical Research Council (MRC) and the Wellcome Trust in the UK and the American Society for Microbiology (ASM). Relevant
specialist associations and scientific academies could also make important contributions to this process.
13 March 2013
3
Deutsche Forschungsgemeinschaft / Leopoldina:
Wissenschaftsfreiheit und Wissenschaftsverantwortung – Scientific Freedom and Scientific Responsibility
Scientific Freedom and Scientific
Responsibility
Recommendations for Handling
Security-Relevant Research10
10
This text is based on the “Guidelines and Rules of the Max Planck Society on a Responsible Approach to Freedom
of Research and Research Risks” of March 19, 2010, which the DFG and Leopoldina adapted in their “Approach to
Security-Relevant Research” working group.
19
4
Contents
PREFACE .................................................................................................................................. 21
SUMMARY ................................................................................................................................. 23
I. INTRODUCTORY GUIDELINES ............................................................................................................ 24
A.
FREEDOM OF RESEARCH AND RESPONSIBILITY OF SCIENTISTS ......................................... 24
B.
LEGAL AND ETHICAL CONSTRAINTS ON RESEARCH .......................................................... 25
C.
THE AIM OF THE FOLLOWING RECOMMENDATIONS ............................................................ 25
II. RECOMMENDATIONS ON A RESPONSIBLE APPROACH TO SECURITY-RELEVANT RESEARCH ............. 26
A.
GENERAL RECOMMENDATIONS ON ETHICALLY RESPONSIBLE RESEARCH .......................... 26
1.
General principle ....................................................................................................................... 26
2.
Risk analysis .............................................................................................................................. 27
3.
Minimising risk .......................................................................................................................... 27
4.
Evaluating publications ............................................................................................................. 28
5.
Forgoing research as a last resort ............................................................................................. 28
6.
Documentation and communication of risks ............................................................................ 29
7.
Training and information .......................................................................................................... 29
8.
Persons responsible ................................................................................................................... 29
B.
SUPPLEMENTARY ORGANISATIONAL RECOMMENDATIONS FOR RESEARCH INSTITUTIONS ... 30
1.
Legal provisions and compliance units ...................................................................................... 30
2.
Ethics rules and research ethics committees ............................................................................ 30
3.
Education and training .............................................................................................................. 31
III. MEMBERS OF THE WORKING GROUP ............................................................................................. 32
20
5
Preface
Science needs freedom, freedom entails responsibility
Article 5 of the German Basic Law protects scientific freedom. Freedom of research must be
accorded high priority because it plays a fundamental role in ensuring social progress and
prosperity. And yet in nearly every branch of science, important and useful research findings
can also potentially be misused to do harm. This dilemma of dual use, as it is called, always
sparks wide debate over the benefits and risks of specific research proposals. A current
example involves experiments to determine whether humans can contract highly pathogenic
avian influenza, also known as bird flu viruses. The public debate of this issue has expressed
the expectation that researchers themselves develop ethical principles and mechanisms for a
responsible approach to freedom of research and research risks. In response, the German
Ethics Council published a position paper in May 2014 on behalf of the Federal Government
entitled Biosecurity – Freedom and responsibility of research, which focuses on research
conducted into highly pathogenic viruses and bacteria while also evaluating the validity of
subject-specific codes of conduct in light of recent advances in the life sciences.
In this context, the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)
and the National Academy of Sciences Leopoldina set up an interdisciplinary, cross-institutional
working group in 2013 to debate and analyze the complex relationship between Freedom of
research and responsibility. It aimed to stimulate debate in scientific communities and among
DFG and Leopoldina members as well as to develop general guidelines on handling securityrelevant scientific research based on the “Guidelines and Rules on a Responsible Approach to
Freedom of Research and Research Risks”, which the Max Planck Society approved in 2010. In
doing so, the DFG and Leopoldina are fulfiling their statutory mandate of advising researchers,
policymakers and the public. The members of the working group deserve special thanks for
their great commitment.
Weighing the risk of potential misuse of research findings versus their benefits presents special
challenges for the responsibility and self-control of researchers. This is true for every area of
research. It is therefore necessary to make both researchers and research institutions aware of
the security-relevant aspects of their work and to provide them with a guideline for dealing with
potential risks.
With the present recommendations, the DFG and Leopoldina hope to foster scientific discourse
on the dilemma of dual use and thereby focus the attention of scientific communities and
research institutions on the dilemma. The guidelines are meant as an aid for researchers as
well as a blueprint for research institutions implementing corresponding regulations. They are
aimed primarily at the government-funded research sector but their principles can also be
applied in industrial research.
The recommendations offer assistance in answering ethical questions, thus contributing to
defining standards and codes of conduct beyond statutory norms for scientists dealing with
security-relevant research. The DFG expects those involved in the research projects it funds to
adopt a responsible approach to ethical questions. Furthermore, DFG and Leopoldina offer the
21
6
establishment of a board advising on issues arising from the implementation of these
recommendations.
The DFG and Leopoldina advocate greater awareness of the problem of potential misuse of
research findings and minimising associated risks without disproportionately restricting freedom
of research and its further development for peaceful purposes and the well-being of society.
May 2014
Professor Dr. Jörg Hacker
Professor Dr. Peter Strohschneider
President of the German
President of the Deutsche
National Academy of Sciences Leopoldina
Forschungsgemeinschaft
22
7
Summary
Research plays a fundamental role in ensuring progress. Freedom of research, which is enshrined in the German Basic Law, is a fundamental requirement in this respect. Yet free research is also associated with risks. These risks result primarily from the danger of useful research findings being misused (known as the dual use dilemma). Legal regulations can only
cover these risks to a limited extent.
The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) and the National
Academy of Sciences Leopoldina urge researchers not to content themselves with just complying with legal regulations. After all, researchers’ knowledge, experience and freedom give them
a special ethical responsibility that goes beyond legal obligations. In addition, research institutions should create framework conditions for ethically responsible research. The self-regulatory
tools of science are highly significant in this regard. They are founded on a high level of familiarity with the subject and can react flexibly.
The first section of the DFG and Leopoldina’s recommendations are aimed at individual scientists. They need to be aware of the danger of misused research. In critical cases, these individuals must draw on their knowledge and experience to make a personal decision about what is
responsible in their research. In doing so, they need to weigh the opportunities offered by the
research against the risks for human dignity, life and other important values. The present recommendations specify these considerations in terms of necessary risk analysis, measures for
reducing risk, evaluating the publication of research results, and abstaining from research as a
last resort. The primary goal in all of this is to carry out and communicate research in a responsible way. In isolated cases, a responsible decision on the part of the researcher may even
mean that a high-risk project can only be carried out following a research moratorium or not at
all.
The second section of the recommendations is aimed at research institutions. They need to
raise awareness of the problem, convey the required knowledge of legal constraints on research and support corresponding training measures for scientists. Research institutions need
to develop ethics rules for handling security-relevant research that go beyond compliance with
legal regulations. Each institution should set up a special committee on research ethics to implement these rules and to advise scientists.
23
8
I. Introductory guidelines
A. Freedom of research and responsibility of scientists
Research plays a fundamental role in ensuring the progress of mankind. It serves to increase
knowledge and promote the health, prosperity and security of mankind and the protection of the
environment. The freedom of research, which is enshrined in Article 5 Paragraph 3 of the German Basic Law and may only be legally restricted to protect other important constitutionally
protected values, is the main requirement for this. Furthermore, scientifically successful research requires transparency, which is afforded primarily by the free exchange of knowledge
and the publication of research findings.
Yet free and transparent research is also associated with risks. Such risks do not necessarily
result from negligence or deliberate misconduct by scientists. In all areas of science, there is
also the danger that findings – which are neutral or useful per se – may be misused by third
parties for harmful purposes. In defence technology, materials research and nanotechnology
can lead to the development of offensive weapons; research on industrial robots can enable the
construction of robots for combat; atomic energy can be used for non-peaceful purposes. Research findings on pathogenic microorganisms and toxins can also be used for new biological
weapons and terrorist attacks, and genetic analyses of plants at the molecular level can lead to
biological attacks on seeds. In computer science, research into protecting systems against
computer viruses can facilitate not only their prevention but their spread and new forms of cyber
warfare. Misuse of research is also feasible in medicine as well as in the behavioural sciences
and social sciences. Psychological, medical and neurobiological research can support aggressive interrogation techniques up to and including torture. Optimising the collection, matching
and analysis of personal data can lead to a violation of personal rights. Linguistic research on
speech recognition systems can also be employed to inappropriately monitor communications.
Legal and philosophical publications can be misused to justify human rights abuses. Risks of
misuse therefore exist in most areas of research. At the same time, failing to conduct research
can also entail significant risks, such as when a vaccine needs to be found to avert an imminent
epidemic.
This possibility of using research findings for both beneficial and harmful purposes (known as
the dual use dilemma) makes it difficult to make a clear distinction in many fields between
“good” and “bad” research, defensive and offensive research, and research for peaceful or terrorist purposes. This dual use dilemma also exists in knowledge-oriented basic research, where
results often cannot be predicted and research findings are not good or bad in and of themselves. Judging this kind of research is also difficult because future use chains are often unknown and estimating risks and consequences tricky. These problems are particularly acute
when research findings can be misused as is, without intermediate steps (known as dual use
research of concern – DURC).
Within this complex matrix of benefits and risks, the role of science is to carry out research for
the welfare of humankind and the protection of the environment and other values – especially
those that are constitutionally protected. Scientists must therefore prevent or minimise direct or
indirect harm to values deserving of protection as far as possible. In addition to the feasibility of
research, they should therefore also take its consequences and controllability into account
where possible. In individual areas, they must decide how much protection specific values deserve, assuming the decision has not already been regulated by law. Science is therefore subject to ethical as well as legal constraints.
24
9
B. Legal and ethical constraints on research
Research constraints are in the first instance determined by legal provisions. These may restrict
the freedom of research to protect significant constitutionally protected values, provided this is
proportionate. The relevant provisions have different objectives and approaches. They may
prohibit research objectives (e.g. the development of nuclear and biological weapons), regulate
methods (e.g. certain experiments on humans) or ban the export of knowledge, services and
products to certain countries (e.g. within the framework of German foreign trade law or EU regulation 428/2009 on the control of exports of dual use items and technology).
11
Scientists are individually responsible for adhering to applicable legal provisions. They must
inform themselves of the provisions applicable to their area of research and ensure they are
adhered to within the scope of their responsibilities. Violations of legal provisions can lead to
protracted proceedings with prohibitions, sanctions and penalties as well as a loss of reputation
for the scientist, their institution and their entire field. Research institutions also have a legal
responsibility. They should therefore support their staff in complying with applicable legal provisions (compliance). By doing so, they are also protecting themselves and meeting their legal
duty of supervision, which may require them to intervene in the event of a legal violation.
Yet individual scientists cannot content themselves with just complying with legal regulations.
Their knowledge and experience and the freedom afforded to them gives them a special responsibility that goes beyond legal obligations. They must therefore use their knowledge, experience and skills to recognise, estimate and assess relevant risks. In critical cases, these individuals must make a personal decision about the constraints on their work, and take
responsibility for that decision within the scope of their freedom of research. In some cases, the
result may be that some projects – even those that are not prohibited by law – must be carried
out in a different form or not at all.
In addition to laws imposed by governments, the self-regulation of science is highly significant.
Self-regulatory instruments are founded on a high level of expertise and familiarity with the subject and can take on a preliminary warning function in the face of new problems. They can also
react quickly and flexibly and can autonomously solve problems connected with securityrelevant research. In the process, they are often better able than legal regulations to stay
abreast of the continually changing research landscape, account for difficult dual-use risk estimates, and make the difficult value judgments that follow – especially in cooperation with specialised committees.
Similarly, scientific organisations have a duty to create aids and structural framework conditions
for ethically responsible research. The same is true for influential institutions that promote research.
C. The aim of the following recommendations
With the present guidelines and recommendations, the German Research Foundation (DFG)
and the National Academy of Sciences (Leopoldina) intend to raise awareness of the problems
11
Researchers and institutions in Germany are subject to German law. Outside of Germany, they are subject to the
applicable law of that location. In addition, researchers and institutions working abroad may also be subject to their own
national law. International law also applies (e.g. protection of human rights, international humanitarian law, law of war,
bans on torture and the use of force, Convention on Biological Diversity).
25
10
mentioned above, raise awareness of risks, provide ethical guidelines to assist with answering
ethical questions, and minimise risks through self-regulation.
The following recommendations are aimed at all persons who are involved in scientific research.
They were developed primarily for the government-funded research sector. Statements about
researchers’ personal ethical responsibility for their work and statements about risk analysis and
12
risk reduction requirements also generally apply to researchers in the industrial sector. The
recommendations are also intended to encourage scientific institutions to create corresponding
organisational framework conditions for themselves.
The DFG and Leopoldina urge researchers to reflect on the ethical principles cited in these recommendations and to take them into account and put them in concrete terms during their work.
Research institutions should implement the proposed regulations – after adapting them for their
particular needs – and supplement them if necessary with additional subject-specific self13
regulatory measures (e.g. subject-specific codes and committees) in order to identify and minimise potential risks. The DFG, as an institution for the advancement of research, and the Leopoldina, in its superordinate role as National Academy of Sciences, will provide strong support
for the dissemination and broad acceptance of the recommendations and will work towards
ensuring compliance with the principles laid down.
II. Recommendations on a responsible approach to security-relevant
research
A. General recommendations on ethically responsible research
1. General principle
Science serves to increase knowledge and has a duty to promote human well-being and the
protection of the environment and other values – especially those that are constitutionally protected. Researchers need to prevent direct and indirect harm to these values as far as possible.
When making decisions in this context, they cannot content themselves with complying with
legal regulations but must also observe ethical principles. They need to be fundamentally aware
of the danger of misused research. In critical cases, these individuals must draw on their
knowledge and experience to make a personal decision about what is responsible with regard
to their research. In doing so, they need to weigh the opportunities offered by the research
against the risks for human dignity, life, health, freedom and property, the protection of the environment and other values.
12
However, recommendations regarding how industrial research should be performed as well as those regarding the
integration of ethics committees in industrial research are covered and qualified in particular by labour law.
13
See, for example, for the field of medical research on humans: Declaration of the World Medical Association of Helsinki/Tokyo (1964/75) with various subsequent revisions. For the field of bio-security: German Research Foundation –
Code of Conduct: work with highly pathogenic microorganisms and toxins, 2013; National Science Advisory Board for
Bio Security, Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategy for Minimizing the
Potential Misuse of Research Information, 2007, Strategic Plan for Outreach and Education on Dual Use Research
Issues, 2008; Royal Netherlands Academy of Arts and Sciences, Biosecurity Committee, Improving Bio Security –
Assessment of Dual-Use Research, Advisory Report, 2013. See also the recommendations published by the German
Ethics Council 7 May 2014 entitled “Biosecurity – freedom and responsibility of research”.
26
11
The following concrete measures must not be permitted to inappropriately hinder research and
are subject to feasibility and proportionality.
2. Risk analysis
Awareness of the potential risks is a prerequisite for responsible research. Raising awareness
of the relevant dangers is thus a key requirement in the avoidance, or at least control, of research risks. Researchers should therefore take account of the consequences and opportunities
for application and misuse of their work and its controllability. In doing so, they should also consider the risks of not conducting the research in question.
The identification of research risks not only concerns risks relating to individual conduct. In cases where research is susceptible to risk of misuse, researchers should also take account of the
consequences of their work and the possibility that useful research findings could be misused
for harmful purposes by third parties. Risk analysis and the evaluation of consequences require
an open-minded and responsible approach. It may be necessary for researchers to find out
about the context of the research project or about the commissioning parties and cooperation
partners.
3. Minimising risk
Researchers and other persons involved in their projects should minimise, as far as possible,
the risks associated with the implementation or use of their work. Measures on risk minimisation
should be assessed and carried out both before and during an ongoing research project.
This may result in the implementation of security measures (e.g. to prevent the release or theft
of dangerous substances from laboratories) or special protection of the confidentiality of research results through physical, organisational and information technology means (e.g. encryption of saved and transmitted data). Such security measures and access restrictions do not
conflict with the requirement for transparency because research results are not required to be
made accessible to everyone at all times (see also II.A.4).
Employees and cooperation partners working on research susceptible to misuse must be selected meticulously based on their reliability and sense of responsibility. In the event that the
spread of security-relevant research results poses a particular risk (such as in the context of
weapons of mass destruction or export restrictions), it may be appropriate to work with special
advisory services, legal departments at research organisations, or government security authori14
ties.
Risk minimisation measures may also consist of only carrying out specific research for or with
certain cooperation partners. While international cooperation is a fundamental element of successful research, in individual cases a restriction of international cooperation or avoidance of
partners or staff from certain countries may nevertheless be recommendable from a risk minimisation perspective. National and international provisions and lists on export restrictions may
constitute a basis for identifying countries where misuse of certain research results is a danger.
14
See, for example, regarding biological threats the Centre for Biological Threats and Special Pathogens (ZBS) at the
Robert Koch Institute; for computer security issues the Federal Office for Information Security (BSI); regarding embargo
violations the Federal Office of Economics and Export Control (BAFA).
27
12
4. Evaluating publications
The possible consequences of publishing results in high-risk research areas should be evaluated even before the start of the project. This applies, in particular, in cases where research results alone – without additional knowledge or elaborate implementation or application processes
– can lead to specific dangers or significant damages (dual use research of concern).
In such cases, security interests conflict with the interest of publishing research results. The free
exchange of information and especially the publication of results are important factors for scientific knowledge and scientific progress, particularly in government-funded and knowledgeoriented research. They also benefit transparency, reproducibility, scrutiny and in turn quality
assurance for the research process. Moreover, the publication of results can promote the development of protective measures (e.g. vaccines in healthcare or antivirus programs in IT).
Suppression of research results may prevent effective protection against their misuse by totalitarian regimes, terrorist groups, organised criminal groups or individual criminals.
The requirements for transparency and communication do not, however, prevent scientists from
minimising specific risks of their research by delaying the publication of the results of their work
instead of publishing immediately. In the case of research results with a high degree of potential
for misuse, parts of the results which are particularly susceptible to misuse may be excluded
from the publication or published in an abridged form in special cases – provided that the reader
is made aware of these changes. In certain cases, researchers may only share specific results
of their work with certain persons.
Complete avoidance of the communication and publication of research results may only be considered if there are no other ways of countering the dangers. However, this is only justified in
extraordinary cases.
The above principles also apply to researchers who are involved in the scientific publication
process, for example as peer reviewers or editors. Researchers in such positions working in
relevant risk areas should ensure that the publication of research results and the policy of the
publishing houses and other institutions they are working with conform to the principles set out
here.
5. Forgoing research as a last resort
The primary goal of risk analysis is to carry out and communicate research in a responsible
way. However, responsible decision-making by researchers may in individual cases – when no
other protective mechanisms exist – lead to a high-risk project only being carried out at a later
point in time, following a research moratorium, or perhaps not at all, even when the project is
not prohibited by law.
In dual use research, which can have harmful as well as beneficial effects, it is difficult to determine and apply criteria for the constraints mentioned here. The necessary ethical evaluation of
the remaining risks that follows the definition of possible protective measures may be assisted
by examining whether the potential damages of the research outweigh the potential benefits.
Scientific freedom and the benefit of the research as well as the risk of damages should be taken into account when examining this point. The following factors should be considered: the
probability that damages will occur, the extent of possible damages, the extent to which the
research results could be used for harmful purposes with or without complex implementation
processes. Finally, consideration should be given to whether misuse can be prevented and the
28
13
extent to which the consequences can be controlled. Other decisive factors include the identity
of the cooperation partners, customers, users and funders of the research.
6. Documentation and communication of risks
If research entails risks for human dignity, life or well-being or for the environment or other significant values with constitutional protection, scientists should document these risks, how they
weigh up against possible benefits, and the measures taken to minimise them both before and,
in the event of changes, during their work. Scientists should bring this documentation to the
attention of the research ethics committee responsible for these problems (see II.B.2 below) or
the head of their institution before the research begins.
Relevant risks and measures taken to minimise them should be noted on applications for research funding. Scientific advisory boards and other groups evaluating the research should be
informed of these risks and measures as early as possible and should take a position on them
in their reports.
7. Training and information
In their university teaching and their training of junior scientists, researchers should communicate the principles of a responsible approach to research risks and set a good example. When
doing so, researchers should also cover the subject-specific rules on risk minimisation for their
respective field of research. Researchers should also contribute to raising awareness about
these issues when they carry out their projects (see also II.B.3 below).
8. Persons responsible
Evaluating whether research complies with legal provisions, self-regulatory measures and ethical principles is, in the first instance, the task of the scientists responsible for the project. In addition, the scientists’ superiors bear responsibility, in particular within the scope of their legally
required duty of supervision.
The persons involved in the research should primarily inform the scientist responsible for the
project, but if necessary also that scientist’s supervisor and the responsible research ethics
committee (see II.B.2), of legal violations that have occurred or could occur, as well as any ethical reservations.
The principles set out here also apply when scientists are involved in evaluating the projects of
other researchers. Employees in such positions should ensure that research applications set
15
out and minimise possible risks in risk areas and account for these principles.
15
On the area of application of these recommendations, see also I.C. above.
29
14
B. Supplementary organisational recommendations for research institutions
1. Legal provisions and compliance units
Research institutions need to raise awareness of the issue among their staff and convey the
required knowledge of legal constraints on research in their specific areas of activity.
Research institutions that carry out work at the margins of the law or high-risk work should have
a special unit for ensuring compliance with legal provisions (known as a compliance unit). This
unit should support the head of the institution and their staff in complying with legal provisions
on research constraints, provide relevant policies and train those persons doing the research in
relevant measures. The unit should be able to report directly to the head of the research institution if possible and collect any necessary information from the institution’s staff members. Small
institutions may transfer these tasks to an existing organisational unit (e.g. legal department or
auditing).
Research institution staff members should be able to turn to the compliance unit at any time if
they are of the opinion that the institution or its cooperation partners are not complying with
legal provisions to prevent the misuse of research. Regulations to protect whistleblowers should
be in place and should ensure that people can report incidents without this disadvantaging
16
them.
If research violates legally binding provisions, the institution head must take the necessary
steps.
2. Ethics rules and research ethics committees
Research institutions should also define ethics rules for handling security-relevant research that
meet the provisions listed in II.A and B or that achieve the goals of those provisions in another
equivalent form. Special additional provisions can be considered for specialised areas of research when these must accommodate relevant international regulations and recommendations.
Each research institution should form a special research ethics committee to advise on issues
arising from the implementation of ethics rules. This committee should provide researchers with
support on issues of research ethics, mediate in differences of opinion between researchers on
relevant matters, and issue recommendations on the implementation of research projects. The
committee’s powers and actions must be compatible with researchers’ scientific freedom. This is
particularly true when committee decisions are set to be compulsorily enforced or reinforced
with sanctions.
The process of selecting committee members should lend committee decisions a high degree of
legitimacy (e.g. election of members or nomination by the institution’s research associates).
Committee members should perform their committee responsibilities independently of all binding mandates. The committee should be made up of persons with sufficient scientific expertise
to handle each particular case in question. The committee should be able to request in an appropriate way information from all staff members to ascertain the facts it needs and consult ap-
16
See the DFG’s recommendations on good scientific practice of 2013, No. 17.
30
15
propriate sources in person or in writing. A set of bylaws should regulate the most important
procedural issues (legal hearings of affected scientists, protection of whistleblowers, impartiality
of deciding committee members, powers of committee to collect information) and the committee’s decision-making powers.
Every researcher at the institution should be able to task the research ethics committee with
verifying whether planned and ongoing projects are compatible with the institution’s ethics rules.
3. Education and training
Research institutions should promote the necessary awareness of ethical constraints on research, e.g. through relevant campaigns, educational events and corresponding information
requirements on funding applications. They should promote the training events cited above (in
II.A.7) for their employees at the institutional level and incorporate them in their teaching and
17
training programmes.
17
See also the German Association of University Professors and Lecturers’ (DHV) resolution from the 60th DHV Day
entitled “Wissenschaft im Dienst des Menschen” (science in the service of mankind), published in Forschung und Lehre
2010, p. 324.
31
16
III. Members of the working group
Institutions
 Deutsche Forschungsgemeinschaft (responsible)
 German National Academy of Sciences Leopoldina
Spokespersons
 Prof. Dr. Elisabeth Knust, Max-Planck-Institut für molekulare Zellbiologie und Genetik,
Dresden
 Prof. Dr. Bärbel Friedrich ML, Vice President of the German National Academy of Sciences Leopoldina, Halle (Saale)
Members
 Prof. Dr.-Ing. Frank Allgöwer, Vice President of the Deutsche Forschungsgemeinschaft,
Institut für Systemtheorie und Regelungstechnik, Universität Stuttgart
 Prof. Dr. Stephan Becker, Institut für Virologie, Philipps-Universität Marburg
 Prof. Dr. Alfons Bora, Fakultät für Soziologie, Universität Bielefeld
 Prof. Dr. Jörg Hacker ML, President of the German National Academy of Sciences Leopoldina, Halle (Saale)
 Prof. Dr. Rolf Müller, Helmholtz-Institut für Pharmazeutische Forschung, HelmholtzZentrum für Infektionsforschung, Universität des Saarlandes
 Prof. Dr. Petra Schwille ML, Max-Planck-Institut für Biochemie, Martinsried
 Prof. Dr. Ulrich Sieber, Max-Planck-Institut für ausländisches und internationales Strafrecht, Freiburg
 Prof. Dr. Fritz Strack ML, Lehrstuhl für Psychologie II, Universität Würzburg
 Prof. Dr. Klaus Tanner ML, Theologische Fakultät, Ruprecht-Karls-Universität Heidelberg
 Prof. Dr. Jochen Taupitz ML, Fakultät für Rechtswissenschaft und Volkswirtschaftslehre, Universität Mannheim
 Prof. Dr. Margit Zacharias, Department of Microsystems Engineering (IMTEK), AlbertLudwigs-Universität Freiburg
ML = Member of the Leopoldina
Scientific Officers
Dr. Johannes Fritsch, Scientific Officer, Presidential Office, German National Academy of Sciences Leopoldina, Halle (Saale)
Dr. Ingrid Ohlert, Head of Division Life Sciences 2, Deutsche Forschungsgemeinschaft
32
17
GUIDELINES AND RULES OF THE MAX PLANCK SOCIETY
ON A RESPONSIBLE APPROACH TO FREEDOM OF RESEARCH AND RESEARCH RISKS
* The following “Max Planck Society Guidelines and Rules on a Responsible
Approach to Freedom of Research and Research Risks” were drawn up by the
“Security and Defense Research” Working Group, with the support of the Ethics Council of the Max Planck Society, at the request of the Scientific Council
of the Max Planck Society and were unanimously approved by both bodies. The
Scientific Council of the Max Planck Society acknowledged the rules with approval at its meeting of February 18, 2010 and decided to recommend approval
of the rules to the Senate of the Max Planck Society which also approved it in
its meeting of March 19, 2010.
18
Contents
I. Introduction
A. Freedom of research and the responsibility of scientists
B. Research limitations
II. Rules on a responsible approach to freedom of research and research
risks at the Max Planck Society
A. General objective and scope
1. Objective
2. Scope
3. Status of the rules with regard to other regulations
B. Legal research limitations
C. Principles of ethically responsible research
1. General principle
2. Risk analysis
3. Risk minimization
4. Publications
5. Foregoing irresponsible research as ultima ratio
6. Documentation and communication of risks
7. Training and information
D. Organizational responsibilities
1. Persons responsible
2. Compliance with legal provisions
3. Ethics Commission
E. Applicability
2
19
I. INTRODUCTION
A. Freedom of research and the responsibility of scientists
Research plays a fundamental role in ensuring the progress of mankind. It enables the extension
of the boundaries of knowledge and enhances the welfare, prosperity and security of mankind
and the protection of the environment. The freedom of research, which is enshrined in the Basic
Law and may only be restricted to protect other significant constitutionally protected values, is a
fundamental requirement in this respect.1 Successful basic research also requires transparency,
the free exchange of information and the publication of research results.
However, as well as successes, there are also risks associated with free and transparent research2. Such risks do not necessarily result directly from negligence or deliberate misconduct
by scientists.3 There is also the indirect danger that results of specific individual research projects - which are neutral or useful per se - may be misused by third parties for harmful purposes.4 This possibility of “dual use” prevents or makes it difficult to make a clear differentiation in many fields today between “good” and “bad” research, civil and military research,
defensive and offensive research, and research for “peacekeeping” and “terrorist” purposes. The
dual use issue must also be taken into account in the knowledge-driven field of basic research,
the results of which are often unforeseeable, and therefore not good or bad per se.
In this highly complex relationship between benefits and risks, the Max Planck Society undertakes to carry out research to foster the welfare of mankind and the protection of the environment. Scientists must therefore prevent or minimize direct or indirect harm to man and the environment as far as possible. In addition to the feasibility of the research, they should therefore
also take its consequences and controllability into account where possible. Research at the Max
Planck Society is therefore subject to ethical as well as legal limitations.
1
2
3
4
Article 5 Paragraph 3 of the Basic Law
These risks were particularly prevalent in Germany during the period of National Socialism. The Max
Planck Society and its employees are aware of the previous research carried out by the Kaiser
Wilhelm Society for National Socialist injustices. The history of the Kaiser Wilhelm Society therefore
represents a legacy for the Max Planck Society, ensuring it takes account of the potential misuse of research results in good time, and counters this as effectively as possible. Also see the declaration of the
Max Planck Society and its former President, Hubert Markl, in: Max-Planck-Gesellschaft (Hrsg), Biowissenschaften und Menschenversuche an Kaiser-Wilhelm-Instituten – Die Verbindung nach Auschwitz, Symposium in Berlin, 2001.
Titles such as “researcher” and “scientist” are to be understood as job titles which include both sexes
in this text.
In the field of defense and weapons technology, materials research and nanotechnology could be used
for the development of offensive weapons; research into robots for peaceful purposes may enable the
construction of military robots; the development of bullet-proof materials for armor plating and protective vests also provide improved protection for aggressors; the peaceful use of nuclear power can
also enhance the development of weapons of mass destruction. Research results on pathogenic microorganisms and toxins can also be used for new biological weapons and for terrorist attacks. Research
into molecular plant genetics can be misused for biological attacks on seeds, and stem cell research
misused to create hybrids. In IT, research to combat computer viruses can be used to spread as well as
prevent them.
The issue of dual use of research results also applies in the human sciences: psychological, medical
and neurobiological research can be used to optimize aggressive methods of interrogation and torture.
Criminological and sociological research may infringe upon the privacy and data protection rights of
probands. Legal opinions may favor infringement upon human rights or the sovereignty of states in
complex overlapping areas. Risks of misuse therefore exist in most areas of research.
3
20
B. Research limitations
Research limitations are, in the first instance, determined by legal provisions. These may restrict
the freedom of research to protect significant constitutionally protected values, provided this is
proportionate. The relevant provisions have different objectives and approaches. They may prohibit research objectives (e.g. the development of nuclear and biological weapons), regulate
methods (e.g. certain experiments on humans) or ban the export of knowledge, services and
products to certain countries (e.g. within the framework of German foreign trade law or the EU
regulation on the control of exports of dual-use items and technology). These regulations must
be strictly adhered to at the Max Planck Society. Infringements of them can result in significant
sanctions, lengthy procedures and damage to the reputation of scientists, their institutes and the
Max Planck Society.
However, national law is not always capable of comprehensively and effectively governing the
risks and opportunities for misuse of research. In particular, the potential misuse of specific
individual research cannot be prevented by adopting a generally distrustful approach to research
per se and making it subject to comprehensive government regulation. Even highly detailed
legal regulations would not sufficiently take account of the differentiated and rapidly changing
global issues of area-specific risks and, moreover, would conflict with the freedom of research
enshrined in the constitution. However, individual scientists must not simply satisfy themselves
with adhering to the legal regulations, but must take account of further ethical principles. They
should apply their knowledge, experience and capabilities to recognize and assess the relevant
risks of harm to humans and the environment. In critical cases, they should make personal decisions on the limitations of their work, for which they are themselves responsible within the
scope of their freedom of research. In individual cases, this may result in projects not being
carried out at all or only being carried out in a modified form, even if they are not legally prohibited.
The following rules - approved by the Scientific Council and the Senate of the Max Planck Society - support persons working at the Max Planck Society in the implementation of these principles. They do not constitute enforceable national law. They aim to prevent misuse of research
and to avoid risks through self-regulation by setting out ethical guidelines and, at the same time,
establish a procedure to enable scientists to better resolve ethical uncertainties and prevent accusations of unethical conduct. The rules, which apply to the entire Max Planck Society, are not
exhaustive and are supplemented by additional subject-specific self-regulatory measures.5 The
Max Planck Society welcomes the involvement of its institutes and employees in the development of additional subject and profession-specific regulations outside of the Max Planck Society on the basis of these guidelines and rules to enable risks to be discussed transparently and
avoided. Together with the following rules, these specific codes foster the Max Planck Society’s
commitment to excellent basic research for the benefit of mankind and the environment.
5
See, for example, for the field of research on humans: Declaration of the World Medical Association
of Helsinki/Tokyo (1964/75) with various subsequent revisions. For the field of bio-security: German
Research Foundation – Code of Conduct: work with highly pathogenic microorganisms and toxins,
2008; National Science Advisory Board for Bio Security, Proposed Framework for the Oversight of
Dual Use Life Sciences Research: Strategy for Minimizing the Potential Misuse of Research Information, 2007, Strategic Plan for Outreach and Education On Dual Use Research Issues, 2008; Royal
Netherlands Academy of Arts and Sciences, A Code of Conduct for Bio Security, Report by the Bio
Security Working Group, Amsterdam August 2007.
4
21
II. RULES ON A RESPONSIBLE APPROACH TO FREEDOM
OF RESEARCH AND RESEARCH RISKS AT THE MAX
PLANCK SOCIETY
A. General objective and scope
1.
Objective
These rules aim to prevent misuse of research and avoid risks through self-regulation based on
ethical principles. They also establish a procedure to enable researchers to better resolve ethical
uncertainties and prevent accusations of unethical conduct.
2.
Scope
The rules apply to everyone working at the Max Planck Society’s institutions, or with their resources at other locations. They should also be observed by Max Planck Society researchers in
their scientific activities outside of the society, e.g. within the scope of consultation or joint
responsibility for companies or journals. The status of the various researchers (in particular,
Scientific Members, senior research scientists, external Scientific Members, academic staff,
doctoral students and guest scientists) and non-scientific employees is to be taken into account
in their application to persons working at the Max Planck Society. The status of these persons
may have an influence on their freedom of research and any right of authority the Max Planck
Society may exercise over them.
3.
Status of the rules with regard to other regulations
These rules apply in addition to the “Rules of Good Scientific Practice” of the Max Planck Society. As general provisions for all areas of research, they may be supplemented by specific selfregulatory measures, which have or will be drawn up by other institutions for specific areas of
research. Provided these specific codes conform to the general principles set out here, and do
not infringe upon the freedom of research enshrined in the Basic Law, they may supplement and
more precisely define these rules. Legal provisions take precedence over these rules and other
self-regulatory measures.
5
22
B. Legal research limitations
German law applies to Max Planck Society researchers working in Germany. The locally applicable law applies, in principle, for Max Planck Society institutes and partner institutes abroad.
Researchers working abroad may also be subject to their national law. International law must
also be observed.6 Legal provisions apply provided they do not infringe upon law which takes
precedence or is higher ranking (in particular, international human rights).
Scientists are individually responsible for adhering to the applicable legal provisions. They must
confirm the provisions applicable to them and their area of research, and ensure they are adhered to within the scope of their responsibilities. They are not generally exonerated by ignorance of the applicable law.
The Administrative Headquarters of the Max Planck Society supports the institutes in adhering
to the legal provisions (see D.2 below). It thus performs its statutory supervisory duty, providing
a means of intervention in the event of infringements against the law within the Max Planck
Society.
C. Principles of ethically responsible research
1.
General principle
The Max Planck Society undertakes to carry out research which extends the boundaries of
knowledge and enhances the welfare of mankind and the protection of the environment. Scientists must therefore prevent or minimize direct or indirect harm to humans and the environment
as far as possible.
Researchers must not satisfy themselves with adhering to legal regulations when making applicable decisions, but must also take account of ethical principles. They must essentially be aware
of the danger of misuse of research. In critical cases, they must make a personal decision on the
area of responsibility in their research.
In cases of research susceptible to risk of misuse, a responsible approach to research involves
the following measures in particular - recognizing and minimizing research risks, a meticulous
approach to publications, the documentation of risks, and information and training measures.
However, these measures should not unduly hinder research and are subject to feasibility and
proportionality.
2.
Risk analysis
Awareness of the potential risks is a prerequisite for responsible research. Raising awareness of
the relevant dangers is therefore a key requirement in the avoidance, or at least control, of research risks in both basic research and applied research. As far as possible, researchers should
therefore take account of the consequences and opportunities for application and misuse of their
work and its controllability. Research projects that are potentially susceptible to risk should
therefore be preceded by an evaluation of the associated risks to human dignity, human life and
6
e.g. protection of human rights, international humanitarian law, the prohibition of torture and use of
force, biodiversity convention.
6
23
human welfare, the environment and any other significant values protected under the constitution.
The identification of research risks does not only concern risks relating to individual conduct.
Researchers should also take account of the consequences of research susceptible to risk of misuse, which they carry out for neutral or useful purposes, but the results of which may be applied
for harmful purposes or misused by third parties. Risk analysis and the evaluation of consequences require an open-minded and responsible approach. It may be necessary for researchers
to find out about the context of the research project, the nature of a customer or cooperation
partner or about their customers.
3.
Risk minimization
Researchers and all other persons involved should minimize, as far as possible, the risks associated with the implementation or use of their work to human dignity, life, welfare, freedom and
property, and to the protection of the environment. These measures on risk minimization should
be assessed and carried out both before and during an ongoing research project.
This may result in the implementation of security measures (e.g. to counter the release or theft
of dangerous substances from laboratories) or the enhancement of the confidentiality of research
results through physical, organizational and personal protective measures and more rigorous IT
security. Such security measures and access restrictions do not conflict with the requirement for
transparency as research results are not required to be made accessible to everyone at all times
(also see C.4).
Employees and cooperation partners working on research susceptible to misuse must be selected
meticulously based on their reliability and sense of responsibility. If government authorities
meet security evaluation requirements, cooperation on the risks of proliferation of securityrelevant research results may be appropriate.
Risk minimization measures may also consist of only carrying out specific research for or with
certain cooperation partners. Even though international cooperation is a fundamental element of
successful research, a restriction of international cooperation or avoidance of partners or staff
from certain states may be recommendable in individual cases from a risk minimization perspective. National and international provisions and lists on export restrictions may constitute a
basis for identifying states where a misuse of certain research results is a danger.
4.
Publications
The possible consequences of publication of results in high-risk research areas should be evaluated responsibly and at an early stage, i.e. before the start of the project. This applies, in particular, where easily implementable research results could produce specific dangers or significant
damages without additional knowledge or costly implementation or application processes.
In such cases, security interests conflict with the principles applied at the Max Planck Society
on transparency, the free exchange of information and, in particular, the publication of research
results.7 Their exchange and publication are key factors in scientific progress. In many risk areas, the publication of results also enables the development of protective measures (e.g. vaccines in healthcare or anti-virus programs in IT). In contrast, suppression of research results may
7
See Max Planck Society, Rules of Good Scientific Practice, 2009, Section 1c.
7
24
prevent effective protection against their misuse by totalitarian regimes, terrorist groups, organized criminal groups or individual criminals.
The requirements for transparency and communication do not prevent scientists from minimizing specific risks of their research by modifying communication and publication procedures.
They may delay the publication of the results of their work, rather than publishing immediately.
In the case of research results with a high degree of potential for misuse, parts of the results
which are particularly susceptible to misuse may be excluded from the publication in special
cases.
In certain cases, researchers may only share specific results of their work with certain persons.
Complete avoidance of communication and publication of research results may be considered as
ultima ratio. This is only justified in extraordinary individual cases, and possibly for a certain
period. Research which from the outset is subject to comprehensive confidentiality for an unforeseeable period of time is incongruous with the self-conception of the Max Planck Society.
The aforementioned principles also apply when employees of the Max Planck Society publish
journals or books. Employees in such positions working in relevant risk areas should ensure that
the publication of research results and the policy of the publishing houses and other institutions
they are working with conform to the principles set out here.
5.
Foregoing irresponsible research as ultima ratio
The main aim of the risk analysis is responsible implementation and communication of the research. However, responsible decision-making by researchers may, in individual cases, result as
ultima ratio in specific research projects, where risk potential is disproportionate or cannot be
restricted, not being carried out, even if this is not prohibited by law.
In the case of work which could have harmful as well as beneficial effects, in particular in the
field of dual use research, it is difficult to determine and apply criteria for possible limitations.
The necessary ethical evaluation of the remaining risks after the definition of possible protective
measures may be assisted by considering the question of whether, on balance, the potential
damages outweigh the potential benefits of the research.
The extent of possible damages and the risk of damage occurrence should be taken into account
when examining this question. In cases where there is threat of dangers, the following factors
should be taken into account: the extent of possible damages, the probability of damage risk,
whether the research results could be used directly for harmful purposes, or whether complex
implementation processes are required, and whether the use of the results could be controlled.
Other decisive factors may be who the cooperation partners, customers, users and parties funding the research are. The point of departure should be that if certain research projects at risk of
misuse are being carried out by other parties without corresponding security standards or for
harmful purposes, research aiming to counter such dangers or minimize resulting damages may
be acceptable.
6.
Documentation and communication of risks
If research results in risks for human dignity, life and welfare, the environment and other significant values protected under the constitution, these risks, their weighing up against possible
benefits, the measures taken to minimize them beforehand and, in the event of changes, also
during the work should be documented.
In the case of such risks, scientists should inform the Ethics Commission or the Vice President
responsible about the documentation before the research begins.
8
25
Relevant risks and measures to minimize them should be indicated in research applications to
the Max Planck Society and other funding institutions. The measures foreseen should be set out.
The Scientific Advisory Board of the institute should also be informed about particular risks and
measures to minimize them as soon as possible, and should take a position on them in its report.
7.
Training and information
At institute level, and, above all, in the training of junior scientists at the Max Planck Society,
the principles of a responsible approach to research risks should be communicated and an example should be set. The subject-specific rules on risk minimization in the respective field of
research should also be covered. Where researchers from the Max Planck Society lecture at
universities or other institutions, they should also contribute to raising awareness about these
issues.
D. Organizational responsibilities
1.
Persons responsible
The evaluation of whether research complies with legal provisions, self-regulatory measures and
ethical principles is, in the first instance, the responsibility of the scientists responsible for the
project. Ultimately, the scientists’ superiors bear responsibility, in particular within the scope of
the legal requirement for duty of supervision.
The scientists involved should primarily inform the scientists responsible, but if necessary in
specific cases also the head of the research department, the Managing Director of the institute
concerned, and, in extraordinary cases, the management of the Max Planck Society, of infringements of the law, which have occurred or are set to occur and of ethical reservations without this disadvantaging them.
The principles set out here also apply when scientists from the Max Planck Society act as referees in the evaluation of projects of other researchers. Employees in such positions should ensure that research applications set out and minimize possible risks in risk areas.
Scientific Members, employees and doctoral students of the Max Planck Society can consult the
Compliance Unit and the Legal Affairs Department of Administrative Headquarters on matters
concerning the legal limitations of research and the Ethics Commission of the Max Planck Society on matters concerning ethical limitations. Employees can also consult the ombudsperson
elected at institute level with regard to issues of research risks and research ethics.
2.
Compliance with legal provisions
At Administrative Headquarters, in addition to the Legal Affairs Department, a special Compliance Unit is responsible for supporting the President and the institutes with regard to compliance with legal provisions on research limitations.
This unit advises the President and the institutes, makes the applicable regulations available and
trains persons working at the institutes in applicable measures. It may obtain information from
the institutes to the extent necessary. The Compliance Unit reports directly to the President and
the Vice President concerned.
Persons working at the Max Planck Society may contact the Compliance Unit at any time if, in
their opinion, legal provisions to prevent the misuse of research are not being complied with at
9
26
the Max Planck Society. The regulations on the protection of “whistleblowers”8 apply accordingly.
If research infringes upon legally binding provisions, the President or the institute director responsible undertakes the legal and other measures necessary.
3.
Ethics Commission
An Ethics Commission is to be established to provide advice on issues resulting from the implementation of these rules. This provides support for researchers at the Max Planck Society on
issues of research ethics, mediates in differences of opinion between researchers on relevant
matters and issues recommendations on the implementation of research projects.
The Ethics Commission consists of three permanent Members of the Max Planck Society (Permanent Commission), who belong to different sections and are elected, together with their deputies, by the Scientific Council at the proposal of their section. The three members elect the
chairperson of the Permanent Commission. Their term of office is three years.
In the individual procedures on the evaluation of research projects, the chairperson of the section concerned is also part of the Ethics Commission. In addition, the members of the Permanent Commission and the chairperson of the section responsible can elect up to two other Members, who are eligible to vote and have particular expertise in the scientific field concerned or
other fields relevant to decision-making, to the Commission responsible for a specific procedure. The Commission should have an interdisciplinary composition in terms of Members from
the sciences and human sciences. It may designate a rapporteur for the individual processes.
The Ethics Commission may be requested to examine whether a planned or current project
complies with these rules by any researcher involved in or responsible for a project. In the event
of uncertainty about whether research complies with these ethical rules, it may also be called
upon by the President and, provided a justified interest exists, by any Scientific Member, employee or doctoral student of the Max Planck Society as well as external cooperation partners.
The aforementioned regulations on the protection of whistleblowers apply to persons providing
information (Section. 9, Max Planck Society Rules of Good Scientific Practice).
All researchers responsible are to be informed immediately about uncertainties concerning the
compliance of their research with these rules, and are to be heard by the Ethics Commission.
They have the right to submit a written or oral position statement at any time, and to consult the
relevant documents as far as possible. They are to be informed about the Commission’s main
procedural steps and may participate in hearings and inquiries. They are to be informed immediately of the Ethics Commission’s conclusive recommendation and the grounds on which it is
based through the sending of the Commission’s written position statement.
The Ethics Commission may call upon experts (not eligible to vote) for consultation. It may
request information for clarification of the facts from the institute director or employees and
question relevant holders of information in person or in writing. It may also request a position
statement from the chairperson of the Scientific Advisory Board of the institute concerned.
A recommendation of the Ethics Commission on the compliance or non-compliance of research
with these rules requires the approval of a majority of its members. In the event of a tie, the
chairperson has the casting vote in all votes. The same applies when the Ethics Commission is
issuing recommendations on the method of implementation of a research project or its non-
8
See Max Planck Society, Rules of Good Scientific Practice, 2009, Section 9.
10
27
implementation based on these rules. The Ethics Commission can take the aforementioned decisions based on a proposal by the rapporteur by the written procedure (also by e-mail) provided
those concerned had the opportunity to make a position statement prior to the rapporteur’s proposal.
The Ethics Commission regularly reports to the Scientific Council on its work.
The Ethics Commission may, within the framework of these provisions and with the approval of
the Scientific Council and the Senate, draw up its own rules of procedure for examining the
approach to research risks. Provided no extraordinary regulations apply to the Ethics Commission, the provisions on formal investigation of the rules of procedure in the event of suspicion of
scientific malpractice apply in procedures concerning legal research limitations.
E. Applicability
These rules will enter into force one month after their approval by the Senate.
11
28
RKI - Dual Use - Dual use potential of life sciences research
1 von 4
Homepage
The Institute
Dual Use
http://www.rki.de/EN/Content/Institute/Dual_Use/code_of_conduct.ht...
Dual use potential of life sciences research
Dual use potential of life sciences research
Code of conduct for risk assessment and risk mitigation
– as of March 25, 2013 –
English version June 14, 2013
1 Introduction
2 Basic principles
3 Criteria for assessing the dual use potential of research projects and their results
4 Evaluation of research projects regarding their dual use potential
5 Developing awareness of the dual use problem
1 Introduction
Research and development in the life sciences have crucially contributed to today’s progress and improvement of
living conditions. At the same time, findings in the life sciences often run the risk of being misused to the detriment
of society and environment. This “double applicability” of scientific findings is described as the “dual use dilemma”.
The potential for misuse of scientific findings is especially obvious for research on pathogenic microorganisms and
toxins: on the one hand, research results regarding transmissibility, pathogenesis and genomics of pathogenic
biological agents are indispensable to prevent the agents’ spread and proliferation and to enable or improve the
treatment of infection and exposure to toxins. On the other hand, these results can also potentially be misused to
cause harm to humans, animals or plants.
It is therefore necessary for institutions dealing with pathogens and toxins – such as the Robert Koch Institute
(RKI) – to establish a code of conduct which
on the one hand, preserves freedom of research that benefits society and
on the other hand, prevents the distribution of information and research results that could harm society and
the environment.
2 Basic principles
At the RKI, the code of conduct to prevent or rather minimize dual use risks follows these principles:
Progress in medicine and health protection is impossible without the life sciences. Therefore, it is inherently
necessary to conduct research – particularly in the field of pathogenic and highly pathogenic agents and
toxins – and to publish the results.
Research projects must be reviewed with regard to their potential for misuse.
Any potential for misuse of a research project will be minimized as far as possible by responsible design and
execution of the project as well as by application of a responsible publication policy. In doing so, one must
balance the necessity to do research with safety/security requirements.
Research results will be published only if the potential benefit of the disclosed information surpasses the
risks involved.
The scientist/work-group leader in charge (hereafter: project leader) is primarily responsible for his/her
research project. It is his/her responsibility to acquire the knowledge necessary to assess his/her research
work and to monitor the current relevant publications. He/she must heighten the awareness of his/her staff
accordingly and provide further training. In addition, the heads of divisions and departments are also
29
26.11.2014 14:08
2 von 4
responsible together with the RKI itself as the institution with overall responsibility.
This responsibility forms the basis for effectively preventing or minimizing potential risks, not least by
preserving and reinforcing the confidence that the public has in the RKI as a public health research institute.
It is essential that all scientists and the entire RKI explore the dual use dilemma as well as develop
awareness of the problem. The dual use topic must therefore be included in ongoing education seminars
and the further qualification of scientists.
3 Criteria for assessing the dual use potential of research projects and their results
Findings and research results in the field of life sciences harbor the potential - to varying degrees - of being
misused. The context and misapplication however, is difficult to predict.
In particular, research activities have a dual use potential, when their results, products or technologies, according
to the current state of the art, can be applied directly by third parties who aim to endanger public order, public
health or the environment.
Usually these involve research activities that demonstrate ways or provide products or technologies
to achieve transmissibility of microorganisms or to enhance their infectiousness,
to increase the virulence of microorganisms or toxins,
to increase the tenacity of microorganisms or toxins,
to facilitate the intake of toxins,
to promote or induce the resistance of microorganisms towards therapeutic or prophylactic antimicrobial or
antiviral substances,
to enhance the capacity for spreading or for easy release or making them “weapons-grade”,
to weaken the response of the immune system against microorganisms,
to alter the host tropism of a microorganism or a toxin,
to increase the susceptibility of host organisms,
to generate entirely novel pathogens or to recreate pathogens that had previously disappeared or had been
repressed (eradicated/eliminated/controlled/vanished naturally),
to alter the absorptive characteristics of a biological agent or the toxicokinetics in a manner that enhances
their effect,
to reveal methods to lower the effectiveness of medical countermeasures (vaccinations, therapeutic and
prophylactic means),
to hinder or prevent diagnostic procedures
This rule of procedure and of conduct also applies to those research projects and their results that suggest similar
implications and consequences as those listed above.
In addition, the generation and storage of infectious or toxic materials in quantities considerably exceeding those
necessary for conducting the proposed project or for maintaining a collection of reference stocks will be avoided. In
this respect, all legal requirements and in-house provisions of the RKI must be observed.
4 Evaluation of research projects regarding their dual use potential
4.1 Timepoints of evaluation
Every research project, including those for which no formal application is made, and any collaboration, is reviewed
for its dual use potential at the following time points:
in the planning stages (e.g. when applying for the project),
throughout the course of the project (usually before starting a new phase in the project and when
interpreting the results), particularly in the case of unexpected or critical results (see criteria under section
30
26.11.2014 14:08
3 von 4
3.),
prior to utilization of results, i.e. usually prior to publication.
Contributions from collaborating partners as well as the transfer of results and products to partners have to be
included in the assessment. “Publication” can also mean the presentation of preliminary results and, when
applicable, funding proposals. The presentation of preliminary results (e.g. talks, posters) of those projects is not
required if the initial assessment has found no dual use potential and if there are no suggestions that this
assessment is likely to be altered.
4.2 Risk assessment and risk management
1. When planning a research project the project leader (or the collaborating RKI scientist in case of
collaborative projects) has to complete a checklist containing criteria for assessing dual use potential, and
must include this list with the planning documents. In cases where there are no indications of dual use
potential, the project leader states this conclusion with his/her signature and presents the checklist to his/her
immediate superior (four-eyes principle) for his/her information. By doing so, the review is completed for the
time being. Exempt from this rule are (1) a reassessment in the case that unexpected critical results emerge
and (2) the final assessment prior to publication.
2. If any criterion from the list of dual use criteria is met, the project leader has to perform and document a
risk/benefit analysis with regards to dual use potential.
3. During the risk/benefit analysis of dual use potential the weighing of the possible risks against the potential
benefit has to be carried out and presented by the project leader. If necessary, appropriate action must be
taken to ensure that the risk of misuse is minimized. If this is impossible and the possible benefits do not
outweigh the possible harm, the research project will not be carried out at the RKI.
4. Otherwise the project documents together with the risk/benefit analysis and, where appropriate, the
proposals for avoiding or minimizing a dual use risk have to be submitted to his/her immediate superior for
decision. If the superior does not agree to the project, it will not be pursued any further.
5. If the immediate superior does agree to the project, the case file including the dual use risk/benefit analysis
(and, if necessary, suggestions for risk minimization) will be presented through official channels to the head
of the institute for decision.
6. In case that the head of the institute requests a consultation prior to the final decision, the head of research
coordination is requested to obtain a dual use risk/benefit analysis of the proposed project in writing from
three in-house experts. The head of research coordination prepares a compilation of the statements, gives a
recommendation and submits it again, together with the statements obtained, to the head of the institute for
decision.
7. If preliminary results of the research project indicate a possibly higher dual use potential than expected from
the original dual use risk/benefit analysis, the project must be reassessed (see 1–6).
8. Upon conclusion of the research project the actual results must again be assessed with regard to their dual
use potential. If the level of risk is perceived to be higher than that stated in previous dual use risk/benefit
analyses, the head of the institute must be informed through official channels to allow a decision to be made
regarding utilization of the results/data.
9. The intent to submit announcement for the respective manuscript, when submitted to the head of the RKI,
must be accompanied by documentary evidence that an assessment with regard to possible dual use risks
was performed for the research project, along with the results of this assessment.
10. Those departments which, for the time being, are exempt from having to assess the dual use potential of
projects via the evaluation forms (i.e. Departments 2 and 3) are also required to assess and report projects
with such a potential, following the above-mentioned criteria.
5 Developing awareness of the dual use problem
Sensitizing RKI members with regard to the dual use potential will take place on three levels by conducting further
training.
31
26.11.2014 14:08
4 von 4
1. A one-day seminar for scientists which will be offered several times a year. This seminar will be designed to
provide applicants with such tools and guidance to help make proper decisions and enable them to assess
the dual use potential of their research.
2. Provision of an online self-study tool that every scientist is obliged to work through. Evidence of this will be
filed with the head of the division.
3. One in-house seminar will be conducted each year to address the dual use topic in order to sensitize all
members of RKI to the subject.
Further training will also cover the applicable laws and guidelines that all scientists are required to be familiar with
and to observe (i.e. the Protection Against Infection Act, the Occupational Safety and Health Act, the Biological
Agents Ordinance, the Act on Genetic Engineering, the Genetic Engineering Safety Regulations, the Council
Regulation [EC] No 428/2009 of 5 May 2009 setting up a community regime for the control of exports, transfer,
brokering and transit of dual use items, the so-called dual use regulation). There is a guideline for risk assessment
and management of a research project with dual use potential in Appendix 4, and a guideline for risk/benefit
analysis of publishing research results with dual use potential in Appendix 5 of the article “Proposed Framework for
the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research
Information” of the “National Science Advisory Board for Biosecurity” of the United States of America. We
emphasize the relevance of the Guidelines for Safeguarding Good Scientific Practice.
Further information
National Science Advisory Board for Biosecurity: Strategies for Minimizing the Potential Misuse of Research
Information, 2007
RKI Guidelines for Safeguarding Good Scientific Practice (in German)
Date: 14.06.2013
32
26.11.2014 14:08
Code of Conduct on Biosecurity
for Biological Resource Centres (BRCs)
I. PREAMBLE
Accumulated and advancing knowledge on biological systems offers substantial benefits to mankind,
to research and to development in all areas of basic and applied bio-medical and bio-technological
sciences. However, this improved knowledge is intrinsically associated with the potential for dual
application: for beneficial or malicious purpose. The possibility of using scientific knowledge for
peaceful or non-peaceful purposes reflects the dual-use dilemma and confers a responsibility on both
those with the knowledge and with the biological resources. The responsibilities of those engaged in
the life sciences have an increasing role for in-depth implementation of the Biological and Toxin
Weapons Convention (BTWC). Scientific openness and a sense of security are prerequisites for
freedom of scientific work, publication of findings and exchange of bio-resources to carry out
activities in the life sciences. This Code of Conduct on Biosecurity is to help microbial Biological
Resource Centres (BRCs) promote a basic ethical understanding of science compliant with the
BTWC and raise awareness to prevent misuse in the life-sciences context.
This Code intends to raise awareness on biosecurity within and outside BRCs and to clearly
demonstrate that BRCs are fully compliant with national and international legislation and support the
BTWC as an international norm prohibiting biological weapons. It is not the aim of this Code to
influence the range of bio-resources maintained or life science activities performed at BRCs. Above
all, this Biosecurity Code of Conduct is meant to complement legislative procedures.
II. SCOPE
The aim of this Code of Conduct is to prevent microbial BRCs from directly or indirectly
contributing to the malicious misuse of biological agents and toxins, including the development or
production of biological weapons.
BRCs commit themselves to this Code of Conduct on Biosecurity considering their specific situation
and key role as an essential part of the international infrastructure underpinning biotechnology:
providing the world-wide scientific and industrial communities with authentic biological materials
required in research, application and teaching as well as related information and services. Being part
of the scientific community they conduct activities in the life sciences, offer training courses,
expertise and knowledge and they support the bioeconomy.
Many BRCs are entrusted with the collection and controlled supply of potentially hazardous bioresources. This requires high responsibility, well-established biorisk analyses and management, and
appropriate BRC internal infrastructures, profound knowledge of relevant bio-legislation including
export control and respective protective measures. This Code calls for implementation and
compliance of awareness, accountability and oversight and targets all those engaged in life sciences
activities, laboratory workers, managers, stakeholders and others.
1/2
© GBRCN Global Biological Resource Centre Network
in association with
EMbaRC European Consortium of Microbial Resources Centres
33
III. CODE
(1) BIORISK MANAGEMENT
 Integrate biorisk management throughout the organization and seek its continuous improvement.
 Assign adequate resources and responsibility to guarantee compliance with legal requirements,
communication to staff and relevant third parties, and carry out reliable and appropriate risk
assessment.
(2) RAISING AWARENESS
 Devote specific attention in the education and further training of all staff on:
- the dual use dilemma i.e. the risks of misuse of biological material, information and life
sciences research
- the requirements of regulations in this context.
 Provide regular training and carry out auditing to maintain up to date knowledge on biosecurity.
 Raise awareness of related third parties on their responsibilities.
(3) REPORTING MISUSE
 Encourage a culture of reporting misuse.
 Report any finding or suspicion of misuse of biological material, information or technology
directly to competent persons or commissions.
 Protect persons reporting on misuse and ensure that they do not suffer any harassment as a
consequence.
(4) INTERNAL AND EXTERNAL COMMUNICATION
 Prevent access by unauthorised persons to internal and external e-mails, post, telephone calls and
data concerning information about potential dual-use research or potential dual-use materials.
 Regulate the communication of sensitive information.
(5) RESEARCH AND SHARING KNOWLEDGE
 Assess possible dual-use aspects of research during the application for and the execution of
research projects.
 Minimize the risk that publication of results on potential dual-use organisms will contribute to
misuse of that knowledge.
 Consider biosecurity implications when sharing knowledge.
(6) ACCESSIBILITY
 Ensure physical security of and access control to stored potential dual-use material in accordance
with its risk classification.
 Implement access control for staff and visitors where potential dual-use biological materials are
stored or used.
(7) SUPPLY, SHIPMENT AND TRANSPORT
 Screen recipients of potential dual-use biological materials, in consultation with the relevant
authorities and parties.
 Select transporters suitable to handle potential dual-use biological materials.
 Perform export control in accordance with applicable regulations.
2/2
© GBRCN Global Biological Resource Centre Network
in association with
EMbaRC European Consortium of Microbial Resources Centres
34
Position Paper by BIO Deutschland on the Topic of Biosecurity: The Dual-Use Dilemma
Highly pathogenic micro-organisms and the metabolic poisons they produce are of great interest to
scientific research in the fields of infections, immunity and pathogenicity factors.
However, work and research with these types of pathogenicity factors also leads to the danger of the
dual application of results (the so-called "dual-use dilemma"). Results can be used not only for
scientific advances but also equally in the manufacture of biological weapons. The dual-use dilemma
describes the conflict between the protection and safety of the population and freedom to research and
publish.
The Biotechnology Industry Organisation Deutschland (BIO Deutschland) supports the code of
conduct drafted by the German Research Foundation, "Working with Highly Pathogenic MicroOrganisms and Toxins". In many points, the demands made by the German Research Foundation can
be accepted exactly as they stand.
The maintenance of conduct guidelines for work with these types of pathogenicity factors is necessary:
1. In accord with the DFG and with the votes by the “National Research Councils” and the
“National Academies” of the USA, BIO Deutschland considers the following experiments to
be particularly relevant with regard to the dual-use dilemma:
• work to increase the virulence of pathogenic microorganisms or to convert apathogenic to
pathogenic microbes
• experiments to induce resistance to therapeutically effective antibiotics and antiviral
substances
• experiments to increase the transmissibility of pathogens
• experiments to alter the host range and stability of pathogens
• work to enable the evasion of diagnostic and detection modalities
• work to demonstrate the ineffectiveness of vaccines
• experiments to increase the weaponization of potential of biological agents or toxins.
2. Like the DFG, BIO Germany is of the view that “it remains necessary to conduct research on
highly pathogenic microorganisms and toxins. Not least, such research provides the basis for
protecting society against natural infections with dangerous pathogens and against possible
bioterrorist attacks. Furthermore, many findings in basic research have been achieved with the
help of highly pathogenic microorganisms and toxins. For this reason, as few restrictions as
possible should be imposed on research activities involving work with highly pathogenic
microorganisms.”
3. BIO Deutschland is further in favor of the funding of research projects which tackle the
problems of highly pathogenic microorganisms and toxins. Project leaders should, however,
be made more aware of the dual-use dilemma.
4. It should remain possible to publish articles on work with highly pathogenic microorganisms
and toxins in peer-reviewed journals. The specific rules of individual journals must be
respected in each case.
5. Like the DFG, BIO Deutschland recommends that “international collaboration, the exchange
of scientists and the exchange of data, materials and methods relating to work with pathogenic
microorganisms and toxins should continue to be promoted. The relevant national and
international laws and regulations must be respected in each case.”
6. Like the DFG, BIO Deutschland recommends that seminars and other events on work
with highly pathogenic microorganisms and toxins should be organized regularly at
universities and non-university institutions for undergraduate, doctoral and post-doctoral
35
students. Appropriate starting-points would be graduate colleges and schools in relevant
fields, special areas of research, research centres and clusters of excellence.
7. Like the DFG, BIO Deutschland also advocates that “the best practice process with regard to
work with highly pathogenic microorganisms and toxins be further developed and adapted to
specific scientific circumstances. In this context, findings should be exchanged with other
organizations at home and abroad, for example the Medical Research Council (MRC) and the
Wellcome Trust in the United Kingdom or the American Society for Microbiology (ASM).
The various scientific associations and academies of science can also make major
contributions to this process.”
Number 6 has been translated by the Institute of Public Law, Dep. II, University Freiburg. The
introduction had been translated in a press release of BIO Deutschland, the other numbers in this
statement are based on the DFG Code of Conduct (No. 1 in this collection).
36
Responsible
life sciences research
for global health
security
A guidance
document
37
WHO/HSE/GAR/BDP/2010.2
Responsible life sciences research
for global health security
A guidance document
38
© World Health Organization 2010
All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization,
20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests
for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]).
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion
whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its
authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines
for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by
the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted,
the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable
for damages arising from its use.
Designed by minimum graphics
Printed by the WHO Document Production Services, Geneva, Switzerland
39
1. Introduction
Contents
Acknowledgements
Acronyms
Definitions
v
vi
vii
Executive summary
1. Introduction
1
3
1.1 Context, purpose, audience and scope of the guidance
1.1.1 Context
1.1.2 Purpose and audience
1.1.3 Scope of the guidance: WHA55.16 and the biorisk management framework for responsible
1.2 Methodology
1.2.1 Terminology
1.3 Structure of the guidance
3
3
5
2. Review of experiments and policy options
9
2.1 Examples of experiments of concern
2.1.1 Accidentally increasing the virulence of mousepox as part of an experiment to control mice
as pests in Australia
2.1.2 Variola virus immune evasion design
2.1.3 Chemical synthesis of poliovirus cDNA
2.1.4 Reconstruction of the 1918 flu virus
2.1.5 Creating and synthesizing de novo organisms
2.2 Review of policy options
2.2.1 Research oversight mechanisms
2.2.2 Policies of funding agencies, publishers and editors
2.2.3 Selected national laws and regulations on research oversight and biosafety and
laboratory biosecurity
2.2.4 Codes of conduct and ethics programmes and initiatives
2.2.5 Educational and training initiatives to raise awareness
2.3 Remarks
9
5
7
7
8
9
9
10
10
11
12
12
14
15
17
17
18
3. The biorisk management framework for responsible life sciences research
20
3.1 Pillar 1: Research excellence
3.1.1 Health research systems
3.1.2 Implementing the WHO strategy on research for health
3.1.3 International Health Regulations (IHR)
3.2 Pillar 2: Ethics
3.2.1 Ethical considerations
3.2.2 Towards an ethics framework
3.2.3 Remarks
3.3 Pillar 3: Biosafety and laboratory biosecurity
3.3.1 Elements of biosafety and laboratory biosecurity
3.3.2 Biosafety, laboratory biosecurity and responsible life sciences
21
21
23
23
23
24
25
28
29
29
31
iii
40
Responsible life sciences research for global health security: a guidance document
4. The way forward: the self-assessment questionnaire
32
32
32
34
4.1 Using the self-assessment tool
4.2 Interpreting the results of the self-assessment tool
4.3 The self-assessment questionnaire
References
Annexes
39
45
Annex 1.Contributors
Annex 2.Declaration of interests
Annex 3.Guidelines review group workshop on responsible life science research, WHO, Geneva, 22–24 June 2009
Annex 4.The NSABB’s proposed framework for the oversight of dual-use research
Annex 5.A decision-making tool from the Centre for Applied Philosophy and Public Ethics, Australia
Annex 6.A model from the Center for International and Security Studies
Annex 7.Implementation of oversight mechanisms
Annex 8.Codes of conduct
Annex 9.WHO strategy on research for health
47
48
49
51
53
55
57
58
60
List of figures, tables and boxes
Figure 1 The biorisk spectrum and biorisks reduction measures
Figure 2 Biorisk management framework for responsible life sciences research
6
7
Table 1 Key questions and concerns
19
Box 1
Box 2
Box 3
Box 4
Box 5
Box 6
Box 7
Box 8
9
10
10
11
11
12
13
Box 9
Box 10
Box 11
Box 12
Box 13
Box 14
Box 15
Box 16
Box 17
Box 18
Accidentally increasing the virulence of mousepox as part of an experiment to control mice as pests
Variola virus immune evasion design
Chemical synthesis of poliovirus cDNA
Reconstruction of the 1918 flu virus
Creating and synthesizing a minimal organism
Main policy options
Fink report’s seven classes of experiments
Joint agreement by bbsrc, mrc and Wellcome Trust to modify their respective policies and
procedures in four areas
Three pillars of a biorisk management framework for responsible life sciences research
Hallmarks for effective management policies on responsible life sciences research
Key considerations when implementing the biorisk management framework for responsible life sciences
research
Four core functions of a health research system
Four selected goals of the who strategy on research for health
Summary of research excellence elements for responsible life sciences
Key ethical questions for consideration
Summary of ethics elements for responsible life sciences research
Elements of laboratory biorisk management system
Summary of laboratory elements for responsible life sciences
iv
41
14
20
21
21
22
24
24
25
29
30
31
1. Introduction
Acknowledgements
America); Professor Li Huang (Chinese Academy
of Sciences and the InterAcademy Panel Biosecurity
Working Group, China); Dr Jo Husbands (National
Academy of Sciences, United States of America);
Professor John S. Mackenzie (Curtin University of
Technology, Australia); Dr Caitriona McLeish (Science and Technology Policy Research, University
of Sussex, United Kingdom); Dr Piers Millett (BWC
Implementation Support Unit, United Nations,
Switzerland); Professor Kathryn Nixdorff (Darmstadt University of Technology, Germany); Dr Amy
P. Patterson and staff of the Office of Biotechnology Activities (National Institutes of Health, United States of America); Professor Janusz T. Paweska
(National Institute for Communicable Diseases
of the National Health Laboratory Service, South
Africa); Professor Ian Ramshaw (National Centre for Biosecurity, Australia); Dr Brian Rappert
(University of Exeter, United Kingdom); Professor Julian Perry Robinson (Science and Technology Policy Research, University of Sussex, United
Kingdom); Dr Stefan Wagener (National Microbiology Laboratory, Winnipeg, Public Health Agency
of Canada).
In addition, we would like to acknowledge the
support of WHO staff Mrs Zerthun Alemu Belay,
Mr James Atkinson, Dr May Chu, Dr Ottorino
Cosivi, Dr Ana Estrela, Dr Pierre Formenty, Dr Ali
Mohammadi, Mrs Lily Laryea, Dr Matthew Lim,
Dr Tikki Pang, Dr Carmem Pessoa Da Silva, Dr
Nicoletta Previsani, Dr Andreas Reis, Dr Cathy
Roth and Dr Michael Ryan in this project as well
as the constructive comments made by the WHO
Guidelines Review Committee.
Finally, we would like to acknowledge the financial support provided by the Alfred P. Sloan Foundation and the Ford Foundation that has made
the development and production of this guidance
possible.
This guidance was prepared by Dr Emmanuelle
Tuerlings (WHO department on Global Alert and
Response), with the close collaboration of Dr Chandre Gould (Institute for Security Studies, Hoekwil,
South Africa) and Dr Michael Selgelid (Centre for
Applied Philosophy and Public Ethics (CAPPE),
WHO Collaborating Centre for Bioethics, Australian National University), who respectively worked
on the self-assessment questionnaire and on the
ethics section. This guidance was edited by Ms
Joanne McManus.
We would like to acknowledge the essential contributions of the members of the Guidelines review
group on responsible life science research:
Professor Peter Ian Folb (University of Cape
Town, South Africa); Dr David Franz (Midwest
Research Institute, United States of America); Dr
Chandre Gould (Institute for Security Studies,
South Africa); Professor Raymond Lin (Ministry of
Health, Singapore); Dr Amy P. Patterson (National
Institutes of Health, United States of America); Dr
Michael Selgelid (Centre for Applied Philosophy
and Public Ethics (CAPPE), Australia); Dr Oyewale Tomori (Redeemer’s University, Nigeria); Dr
Lei Zhang (Chinese Academy of Sciences, China).
We would also acknowledge the vital input of the
Chair of Guidelines review group on responsible
life science research, Professor Peter Folb, who over
the years, provided insightful, precious and constructive advice on the project and on this guidance.
No conflict of interests were declared by members
of the Guidelines review group on responsible life
science research (Annex 2).
We would also like to acknowledge the important written comments and critiques made by the
reviewers on previous drafts of this document:
Mrs Elisa D. Harris (Center for International
and Security Studies at Maryland School of Public Policy, University of Maryland, United States of
v
42
Acronyms
BSL
Biosafety level
BWC
Biological and Toxin Weapons Convention
BBSRC
Biotechnology and Biological Sciences Research Council (United Kingdom)
CDC
Centers for Disease Control and Prevention of the Department of Health and Human Services (United States of America)
CSE
Council of Science Editors
EC
European Commission of the European Union
GMO
Genetically modified organism
IAP
InterAcademy Panel
ICLS
International Council for the Life Sciences
ICSU
International Council for Science
IHR
International Health Regulations
IUBMB
International Union of Biochemistry and Molecular Biology
IUMS
International Union of Microbiological Societies
HRS
Health research systems
MRC
Medical Research Council (United Kingdom)
NGO
Nongovernmental organization
NIH
National Institutes of Health of the Department of Health and Human Services (United States
of America)
NRC
National Research Council of the National Academies (United States of America)
NSABB
National Science Advisory Board for Biosecurity (United States of America)
PHEIC
Public Health Emergencies of International Concern
rDNA
Recombinant DNA
RS
Royal Society of the United Kingdom
VBM
Valuable biological materials
WAME
World Association of Medical Editors
WHA
World Health Assembly of the World Health Organization
WHO
World Health Organization
vi
43
Definitions
The following terms are defined in the context in
which they are used in this document.
Laboratory biosafety The containment principles, technologies and practices that are implemented to prevent unintentional exposure to
biological agents and toxins, or their accidental
release (3, 4).
Bioethics The study of the ethical and moral implications of biological discoveries, biomedical
advances and their applications, as in the fields of
genetic engineering and drug research (1).1
Laboratory biosecurity The protection, control
and accountability for valuable biological materials2 within laboratories, in order to prevent
their unauthorized access, loss, theft, misuse,
diversion or intentional release (1).
Biological laboratory A facility within which biological agents, their components or their derivatives, and toxins are collected, handled and/or
stored. Biological laboratories include clinical
laboratories, diagnostic facilities, regional and
national reference centres, public health laboratories, research centres (academic, pharmaceutical, environmental, etc.) and production
facilities (the manufacturing of vaccines, pharmaceuticals, large-scale genetically modified
organisms, etc.) for human, veterinary and agricultural purposes (1).
Dual-use life sciences research Knowledge and
technologies generated by legitimate life sciences research that may be appropriated for illegitimate intentions and applications (2, 5).
Life sciences All sciences that deal with organisms, including humans, animals and plants,
and including but not limited to biology, biotechnology, genomics, proteomics, bioinformatics, pharmaceutical and biomedical research and
techniques.
Biorisk The risk (risk is a function of likelihood
and consequences) that a particular biological
event (in the context of this document: naturally
occurring diseases, accidents, unexpected discovery, or deliberate misuse of biological agents
and toxins), which may affect adversely the
health of human populations, may occur (1, 2).
An assessment of these risks can be both quantitative and qualitative.
Global health security The activities required,
both proactive and reactive, to minimize vulnerability to acute public health events that endanger the collective health of populations living
across geographical regions and international
boundaries (6).
Biorisk spectrum A continuum of biorisks ranging from naturally occurring diseases (chronic
and infectious diseases), to accidents, to the
deliberate misuse of biological agents and toxins
with the intention to cause harm (Figure 1) (2).
International Futures Program of the Organisation for Economic Co-operation and Development (OECD), Biosecurity
oversight and codes (www.biosecuritycodes.org/gloss.htm,
accessed October 2010).
2
Valuable biological materials (VBM) are “Biological materials that require (according to their owners, users, custodians,
caretakers or regulators) administrative oversight, control,
accountability, and specific protective and monitoring measures in laboratories to protect their economic and historical
(archival) value, and/or the population from their potential
to cause harm. VBM may include pathogens and toxins, as
well as non-pathogenic organisms, vaccine strains, foods,
genetically modified organisms (GMOs), cell components,
genetic elements, and extraterrestrial samples.” (1)
1
Biorisk reduction The reduction of the occurrence of risks associated with exposure to biological agents and toxins, whatever their origin
or source, encompassing the full spectrum of
biorisks (2).
vii
44
Health research systems The people, institutions, and activities whose primary purpose in
relation to research is to generate high-quality
knowledge that can be used to promote, restore
and/or maintain the health status of populations; it should include the mechanisms adopted
to encourage the utilization of research (7).
Public health The science and art of preventing
disease, prolonging life, and promoting health
through the organized efforts and informed
choices of society, organizations, public and private, communities and individuals (8). Health is
defined by the Constitution of the World Health
Organization as a state of complete physical,
mental and social well-being and not merely the
absence of disease or infirmity.
Research excellence Research that is of high quality, ethical, rigorous, original and innovative.
viii
45
1. Introduction
Executive summary
However, as recognized by the World Health
Assembly in 2002 (Resolution WHA55.16), one
of the most effective ways to prepare for deliberately caused disease is to strengthen public health
measures for naturally occurring and accidentally
occurring diseases. This guidance contributes to
the implementation of WHA55.16 and promotes a
culture of scientific integrity and excellence, distinguished by openness, honesty, accountability and
responsibility. Such a culture is the best protection
against the possibility of accidents and deliberate
misuse, and the best guarantee of scientific progress and development.
Moreover, countries and institutions may consider drawing on the biorisk management framework
for responsible life sciences research developed by
this guidance. This integrated framework rests on
three pillars supporting public health.
Advances in life sciences research are inextricably
linked to improvements in human, plant and animal health. Promotion of excellent, high-quality
life sciences research that is conducted responsibly, safely and securely can foster global health
security and contribute to economic development,
evidence-informed policy making, public trust and
confidence in science. Yet opportunities may also
be accompanied by risks that need to be acknowledged and addressed. The risks under consideration in this guidance are those associated with
accidents, with research that may pose unexpected
risks and with the potential deliberate misuse of
life sciences research. The opportunities offered by
the life sciences are too important for governments
and the scientific community (including individual
researchers, laboratory managers, research institutions, professional associations, etc.) to leave the
attendant risks unaddressed.
The purpose of this guidance is to inform Member States about the risks posed by accidents or the
potential deliberate misuse of life sciences research
and to propose measures to minimize these risks
within the context of promoting and harnessing
the power of the life sciences to improve health
for all people. Although the issues addressed in
this document can potentially interest a quite large audience, the proposed measures and the selfassessment questionnaire are of a public health
nature. Health researchers, laboratory managers
and research institutions are therefore the primary
audience of this guidance.
There is no single solution or system that will
suit all countries, institutions or laboratories. Each
country or institution that assesses the extent to
which it has systems and practices in place to deal
with the risks posed by accidents or the potential
deliberate misuse of life sciences research will need
to decide which measures are most appropriate and
relevant according to their own national circumstances and contexts.
 Research excellence – this concerns fostering
quality in life sciences activities, which is the
basis for developing new treatments and therapeutics, strengthening health research systems,
and promoting public health surveillance and
response activities. These elements are essential to protecting and improving the health and
well-being of all people.
As such, countries and institutions are invited
to:
— Support capacity development for research as
this is essential for reducing health inequalities and for ensuring the proper use of life
sciences;
— Use existing tools and frameworks, such as
health research systems (HRS), the WHO
strategy on research for health and the International Health Regulations (IHR) as these
can provide useful tools for contributing to
responsible life sciences research.
1
46
 Ethics – this involves the promotion of responsible and good research practices, the provision of
tools and practices to scientists and institutions
that allow them to discuss, analyse and resolve
in an open atmosphere the potential dilemmas
they may face in their research, including those
related to the possibility of accidents or misuse
of the life sciences.
A culture of responsible life sciences practice is
most likely to result when the leadership within
the organization supports and fosters such a management framework.
In implementing the above biorisk management
framework for responsible life sciences research,
countries and institutions are encouraged to consider:
to:
— Reinforcing public health capacities in terms
of research for health, biosafety and laboratory biosecurity management and ethics;
— Investing in training personnel (laboratory
staff and researchers) and students in ethics, the responsible conduct of research, and
biosafety and laboratory biosecurity.
— Ensuring compliance with biosafety and laboratory biosecurity;
— Seeing multi-stakeholder issues, with different layers of responsibilities and encourage
coordination among stakeholders;
— Using existing mechanisms, procedures and
systems and reinforce local institutional bodies (if they exist).
— Use existing ethical platforms, if appropriate;
— Promote ethics education and training for
students and professionals;
— Encourage discussion and reflection on
research practices;
— Hold institutions and researchers to account
and ensure they are aware of their responsibilities;
— Ensure institutions and researchers are
aware of existing and new legislation, regulations at the country but also at the regional
and international levels.
Another major component of this guidance is a
self-assessment questionnaire, which is intended
to help health researchers, laboratory managers,
and research institutions identify and build on
strengths and address weaknesses in each of the
three pillars of the biorisk management framework. Going through this process will provide an
assessment of the extent to which systems are in
place in the national public health system and individual laboratories to address the risks of accidents
and the potential deliberate misuse of science and
to identify priority areas where action is necessary
to ensure high-quality, safe, secure and responsible research practices across the life sciences.
In general, oversight, safety and public security should be pursued in a manner that maximizes
scientific progress and preserves scientific freedom.
Any controls over life sciences research need to be
proportionate and risk-based, should not unduly
hamper the development of the life sciences and
should not discourage scientists from working with
important pathogens. This requires excellent facilities, and the management of them (including laboratories), leadership with integrity, a robust ethical
framework, training and capacity development,
institutional development and regular review.
 Biosafety and laboratory biosecurity – this
concerns the implementation and strengthening of measures and procedures to: minimize
the risk of worker exposure to pathogens and
infections; protect the environment and the
community; and protect, control and account
for valuable biological materials (VBM) within
laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion
or intentional release. Such measures reinforce
good research practices and are aimed at ensuring a safe and secure laboratory environment,
thereby reducing any potential risks of accidents
or deliberate misuse.
to:
— Conduct biosafety and laboratory biosecurity
risk assessments and, based on these, apply
appropriate risk reduction measures;
— Implement a laboratory biorisk management
system;
— Explore the use of existing biorisk management structures (e.g. laboratory biorisk
management adviser and the biosafety committee) to address issues related to the risks
posed by life sciences research;
— Set performance objectives and work on continuous improvement.
2
47
1. Introduction
1. Introduction
1.1Context, purpose, audience and
scope of the guidance
to avoid measures that would go beyond what is
appropriate, have been emphasized (12–14).
The role of WHO in this area has been underlined by several groups, including by the National
Research Council of the US National Academies of
Sciences in their 2004 seminal report on the subject
“Biotechnology Research in an Age of Terrorism:
Confronting the Dual-Use Dilemma, also called
the “Fink report” (15). It has also been noted that
WHO as an international organization with direct
links to policy makers and having wide acceptance
as an authority in preserving public health, is particularly equipped to promote responsible life sciences research. By emphasizing the public health
perspective of dual-use issues, this guidance can
achieve a broad acceptance of the need to raise
awareness in this area and thus be better able to
implement the objectives of promoting responsible
life sciences research in general on a global level.
A scientific working group, which met in WHO
in 2006 to discuss the risks and opportunities of
life sciences research for global health security,
also underlined the important role of WHO to lead,
in coordination with other stakeholders and in line
with its public health mandate, global efforts and
help maintain effective policies that will maximize the benefits of public health research while
minimizing the risks (2). Moreover, participants
at a WHO workshop on responsible life sciences
research also underscored the need to have a foundational document on this topic (see Annex 3). As
this subject is being addressed by many stakeholders with different interests and agendas, this document provides a unique international public health
perspective on this issue, which is important to
complement with other policy measures. Such a
perspective also provides a platform for discussion.
The importance of a public health perspective
on this topic is important for several reasons. The
life sciences have the potential to address a host
of public health, agricultural and environmental
1.1.1Context
When the reconstruction of the 1918 influenza A
(H1N1) pandemic virus, also known as the Spanish Flu virus, was published in 2005, many people
considered it a remarkable achievement that could
help combat future influenza pandemics. At the
same time, it raised concerns that the resurrected
virus might escape from laboratories (as happened
with severe acute respiratory syndrome [SARS]
coronavirus in 2003–2004) or that the knowledge
gained from this research could be deliberately
misused to cause harm. Research-related laboratory accidents have the potential to affect laboratory workers, the environment, and local and more
distant communities. The 2001 anthrax letters in
the United States of America, which killed five
people and infected 22, had a worldwide impact
and underscored the role of public health systems
in responding to the deliberate misuse of a biological agent (9). Other kinds of research misuse
that may be dangerous to public health and have
a significant economic burden include deliberately
neglecting or side-stepping good research practices and codes of conduct, which are meant to
ensure standards of ethics, safety and quality (10,
11).
The reconstruction of the 1918 influenza A
(H1N1) pandemic virus is one of a few experiments
in recent years that have grabbed the media’s
attention and led to calls for better management of
the potential risks associated with accidents or the
deliberate misuse of life sciences research. There is
a wide recognition that there is no “one size fits
all” management measure and that such measures
may be issued by different stakeholders. The need
to have clear guidelines about what researchers,
publishers, funding bodies, governments and other actors are expected to do with research raising
possible risks as well as the need to have guidelines
3
48
challenges, making them a key driver of economic
growth and an important element of health innovation for developing, as well as for developed countries (16–19). It is widely perceived that advances
in the life sciences will continue to be significant
in this century and that the impact will be similar
to that of the life and physical sciences in the 20th
century (20).
Capacity development for research is necessary
for ensuring the proper use of life sciences research
and minimizing accidents and potential for deliberate misuse (21). Research on conditions affecting
the health status of poor people along with access
and delivery tools are crucially needed. Despite the
substantial increase in funding for research and
development (R&D) in developing countries (22)
and the investment in life sciences R&D expertise
by countries such as Brazil, China and India (22),
only a small proportion of the quadrupling global
investments in R&D since 1986 has been spent on
diseases affecting poor people (23). Over the same
time, health status has deteriorated in many developing countries,1 which are increasingly suffering
from the double burden of disease, combining the
so-called diseases of poverty (infectious diseases
and maternal, perinatal and nutrition conditions)
with injuries and chronic noncommunicable diseases such as cancers, diabetes and cardiovascular
diseases (22, 24).
It is well recognized that more needs to be done
to reduce inequities in health conditions among
populations, to bridge the technological gap
between developed and developing countries (16,
25), and to translate new knowledge into health
products. Access to biotechnologies therefore
remains a major aspect for health development
(18). The Millennium Development Goals have
stressed the important role of the life sciences for
human security. Biomedical research and emerging genomics techniques along with international
collaboration and partnerships can help to achieve
these and other development goals (26).
Yet opportunities are often accompanied by a
number of risks. Advances in life sciences research
and new biotechnologies such as genomics, synthetic biology, stem-cell research, and genetically
modified organisms and foods have already raised
a series of complex legal, social and ethical issues.
In response, many countries have designed and
implemented different regulatory frameworks that
reflect their own political cultures, national priorities, local contexts and perceptions of risks (27, 28).
The same country-based approach may be taken
for the equally complex and challenging issues
around the potential risks of accidents or the deliberate misuse of life sciences research.
The field of public health is concerned with protecting and promoting the health of communities and therefore must give due consideration to
both the benefits and the possible risks of life sciences research for public health. At the same time,
managing these risks may potentially harm public
health if controls on research are so stringent that
they stall advances in the life sciences and make
international collaboration difficult (2). Any controls on life sciences research need, therefore, to be
proportionate and balance risks and benefits.
Finding the right balance is essential for several reasons. First, control over research should
not unduly hamper the development of the life
sciences and should not impede access to biological materials and resources necessary to address
public health challenges, including new infectious
diseases. A situation that discourages scientists
from working with important pathogens should be
avoided. At the same time, increasing capacity for
the life sciences should be accompanied by the promotion of responsible life sciences management.
Second, strong public confidence in life sciences
research needs to be established and continuously
nurtured. Research is essential for public health.
Communication, international collaboration and
openness, which are central to a public health perspective, are indispensable for global health security,
scientific discovery and evidence-based measures.
Finally, information on this issue is uneven
among Member States. Providing information
on this topic to the various ministers of health in
WHO Member States will:
 help them to rationally explain the issues to their
constituencies and populations;
 help them to inform, educate and advise colleagues in other ministries;
 help them to plan rational and feasible emergency response plans should an adverse event
occur;
 better equip them to assess what capabilities
(and bioresources, e.g. exotic pathogens) existing within their own countries for the types of
potentially dangerous research;
 should Member States be considering national
regulations, understanding this issue will help
By 2003, the number of people living in developing countries
represented more than 80% of the total world population
(22).
1
4
49
1. Introduction
them formulate workable and effective guidelines and safeguards;
 understanding it will enable them to contribute better to global debate on the topic and, at
the same time, bringing with them their own
unique perspectives.
 assess their needs and capacities using a selfassessment tool to review existing structures
and mechanisms and identify potential needs.
1.1.2Purpose and audience
This document complements previous publications
on the subject published by WHO (2, 5, 29) and
links up with other areas of work of WHO, in particular, biosafety and laboratory biosecurity, ethics
and some areas of work falling under research policy and cooperation. Compared to other documents
and approaches published on this subject, the
WHO approach is unique because it looks at this
issue from a public health angle. As this is a multistakeholder issue, policy measures have been proposed by different sectors, including governments,
security, academic and private sectors. This guidance, its biorisk framework and its self-assessment
tool however only discuss measures based on and
supporting public health. Moreover, this document
looks at life sciences activities in general and does
not focus on a particular field of life sciences. In
addition, it takes a country-based approach, noting
that over time, comparison and sharing of experiences and best practices of country and institutional approaches can be done at regional and global
levels in order to support international cooperation
and ensure that no incompatible measures are put
forward.
The document and its approach are also to be
understood within the context of the World Health
Assembly in 2002 (Resolution WHA55.16). As recognized by resolution WHA55.16, one of the most
effective ways to prepare for deliberately caused
disease is to strengthen public health measures
to address naturally occurring and accidentally
occurring diseases. While recognizing the important role of other actors, such as the security1 and
academic communities, this guidance has a public
health objective and the conceptual framework and
measures proposed re-emphasize the WHA55.16
approach.
This guidance has also been developed within
the wider context of the “biorisk spectrum” in that
it advocates an all-encompassing risk management
approach, in accordance with WHA55.16. The continuum of potential natural, accidental or deliberate exposure of humans, animals and/or plants to
1.1.3Scope of the guidance: WHA55.16 and
the biorisk management framework for
responsible life sciences research
The purpose of this guidance is to inform Member States about the risks posed by accidents or the
deliberate misuse of life sciences research and to
propose measures to minimize them within the
context of promoting and harnessing the power of
the life sciences to improve health for all people.
This guidance aims at strengthening the culture
of scientific integrity and excellence characterized
by openness, honesty, accountability and responsibility: such a culture is the best protection against
accidents and deliberate misuse, and the best guarantee of scientific progress and development.
This guidance provides Member States with a
conceptual framework for individual adaptation
according to national circumstances, contexts,
needs and capacities. Countries, research institutions, and laboratories are encouraged to review
the proposed measures and to adapt them accordingly.
The issues addressed in this document can
potentially interest a quite large audience: from
policy-makers, relevant national regulatory authorities to scientific community (including researchers, laboratory scientists and managers, research
institutions, professional associations, students,
educators and journal editors).
However, the measures proposed under the
biorisk management framework are of a public
health nature and the self-assessment tool has
been designed and field-tested within this framework and with the help of health researchers and
laboratory managers. Health researchers, laboratory managers and research institutions are therefore
the primary audience of this document, noting that
the self-assessment questionnaire can be adapted
to countries and institutions’ needs.
Using this guidance will provide researchers
and institutions with:
 a better understanding of the potential risks
associated with accidents and the deliberate
misuse of life sciences research;
 learn about practical measures that will enable
them to manage some of the risks posed by life
sciences research;
See the 1975 Biological Weapons Convention and the United
Nations Security Council 1540.
1
5
50
Figure 1. The biorisk spectrum and biorisk reduction measures
Biorisk spectrum
Natural occurrence
Accidents
International
Health
Regulations
Disease
surveillance
and outbreak
response
Prevention, early
detection diagnosis and
treatment
Biorisk management
framework for responsible
deliberate
misuse
Laboratory
biosafety
and laboratory
biosecurity
Biorisk reduction measures
diagnosis and treatment of naturally occurring
diseases, disease surveillance, preparedness and
outbreak response, compliance with the International Health Regulations (2005),1 and laboratory
biorisk management through biosafety and laboratory biosecurity.
This guidance document focuses on one measure of biorisk reduction, namely the biorisk management framework for responsible life sciences
research (see Figure 2). The framework focuses
on a vision of promoting excellent, high-quality,
responsible, safe and secure research, where the
results of the research foster advancements in
health, economic development, global health security, evidence-informed policy-making, and public
trust in science. Underpinning this vision is the
importance of managing risks posed by accidents
and the deliberate misuse of life sciences research
activities through an integrated approach that
recommends investing in capacities in three pillars supporting public health: research excellence,
ethics, and biosafety and laboratory biosecurity
(each pillar is discussed in detail in Section 3). At
the foundation are several cross-cutting elements:
communication, education and training, capacity
development, interaction with stakeholders (scientists, publishers and editors, ethicists, national
academies of sciences, security communities, gov-
pathogens or toxins likely to harm public health
encompasses the full spectrum of biological risks to
global health security (see Figure 1) (2). Such risks
include, for instance, new infectious diseases such
as the pandemic influenza A (H1N1) 2009 virus,
avian influenza (H5N1) and severe acute respiratory syndrome (SARS), re-emerging diseases and
modified strains of long-established diseases (e.g.
multi- and extensively drug resistant tuberculosis),
laboratory accidents, the unintended consequences
of research, lack of awareness, negligence, and the
deliberate misuse of life sciences research.
In this guidance, the term “biorisk reduction”
is defined as the reduction of the occurrence of
risks associated with exposure to biological agents
and toxins, whatever their origin or source. Different levels of risk can be assigned across the biorisk spectrum, according to a country’s situation or
institutional contexts (2). Measures put forward
using this approach will both help to address the
consequences of naturally occurring diseases and
reduce the likelihood of accidents or the deliberate
misuse of life sciences research.
Responsible life sciences research that is conducted ethically by well-trained professionals in
laboratories that have safety and security measures in place, constitutes one public health component of biorisk reduction. Other complementary
public health measures that are an integral part
of biorisk reduction, but which are not detailed in
this guidance, include prevention, early detection,
For additional information on the International Health
Regulations (http://www.who.int/ihr/en/, accessed October
2010). See also (9).
1
6
51
1. Introduction
on where it wishes to go and how
to get there. At the same time, it
has to be understood, that in the
national and global interest, certain essential standards of the
Vision:
excellent, responsible, safe and secure
pursuit of science and of scientific
life sciences research activities
research need to be in place: these
promoting public health
are the three pillars (research
excellence, ethics and biosafety
Biorisk management for responsible life sciences research
and laboratory biosecurity) and
to help evaluating those essential standards, a self-assessment
questionnaire has been developed
Biosafety
Research
Ethics
and
laboratory
in Section 4 of this guidance.
excellence
biosecurity
A first draft document was
commented in April/May 2009 by
the Guidelines review group. The
Guidelines review group workCommunication, education and training, capacity development,
interaction with stakeholders, development of norms and standards
shop on responsible life sciences
research was held in Geneva,
22–24 June 2009 to review the
content
of
the
document
and its implementation
ernments and international organizations), and
(Annexes
2
and
3).
The
workshop
re-emphasizes
the development of norms and standards. A selfthe
importance
of
the
document
and
its approach.
assessment questionnaire has also been developed
Sections of this guidance have also been reviewed
and is presented in Section 4 to help countries and
internally with colleagues working on research
institutions assess their strengths and weaknesses
policy, ethics and on biosafety and laboratory
and to support implementation of the biorisk manbiosecurity (Annex 1).
agement framework. The self-assessment quesAfter the tenure of the Guidelines review group
tionnaire is not a tool to evaluate the adequacy of
workshop,
comments were accommodated and the
the measures developed by other sectors (security,
document
was
edited. This second draft was sent
academia, publishers and editors, etc.) but it recfor
peer
review
in December 2009/January 2010
ognizes the importance of collaboration between
(Annex 1).
different sectors.
A pilot test of the self-assessment questionnaire
presented
in Section 4 was conducted in October
1.2Methodology
2009
with
a
small group of scientists at the NationA review of the available evidence of the risks and
al Institute of Communicable Diseases (NICD),
of the policies put forward to manage those risks
South Africa. It helped to strengthen and refine
(see Section 2) has been made by doing a literature
some of the questions and assess the type of inforreview of a variety of different documents. These
mation and results that could be expected from
included peer reviewed journals, background docsuch a questionnaire. Additional pilot tests of the
uments, meeting reports, codes of conducts, laws,
questionnaire will be performed, as appropriate.
information shared at international meetings and
As the issues raised in this document are evolvprovided by countries. Most of this information has
ing,
modifications to this guidance will be made as
been collected over the past four years and builds
additional evidence becomes available. This guidup on previous WHO publications.
ance will be reviewed two years after its publicaSection 3 builds upon the evidence collected in
tion.
Section 2 and develops a conceptual framework,
Figure 2.Biorisk management framework for responsible
which was has been presented and discussed at
several international meetings. This framework
recognizes that “one size does not fit all”, and neither should it; that the uniqueness of countries and
their specific needs should be identified and met,
and that each country would have its own vision
1.2.1 Terminology
Although the use of the word “biosecurity” is
increasing, no universally agreed definition has
emerged. As is the case with biosafety, different
sectors are using the same word with different
7
52
meanings, which in turn may lead to some confusion (30–32). Biosecurity was initially used in reference to animal and plant health;1 more recently,
it has been used by public health, academic (33),
policy and security communities.2 This guidance
uses the WHO concept of “laboratory biosecurity”, which is an extension and a complementary
dimension of laboratory biosafety (1) 3 (see Section
3.3). In other words, by implementing good laboratory biosafety practices, laboratories are already
implementing some of the requirements of laboratory biosecurity.
There is a similar lack of agreement around the
concept of “dual-use research”. Several definitions
have been put forward, but there is no commonly
agreed understanding as to what constitutes dualuse research.4 Some also argue that the dual-use
label is misleading and may cause confusion in
regard to certain types of research that nevertheless need to be undertaken for public health. For
the purpose of this guidance, dual-use research is
understood as knowledge and technologies generated by legitimate life sciences research that may be
appropriated for illegitimate intentions and applications. This working definition has to be understood within WHA55.16, whose language has the
advantage of focusing more on the action and less
on the definition.
This document will refer to the “potential risks
posed by accidents or the deliberate misuse of life
sciences research”. In this guidance, the words
“accidents” (or research accidents) reflects the fact
that research activities may unexpectedly pose
some risks via “accidental” discoveries (such as
the mousepox experiment, see Box 1). Under this
approach, dual-use research can both be associated
with “accidents” and risks caused by “deliberate”
misuse. This guidance is not specifically concerned
with “laboratory accidents”, as this important area
of work is already being covered by the WHO laboratory biosafety manual (3).
pillars of the guidance’s biorisk management
framework for responsible life sciences research:
research excellence, ethics, and biosafety and laboratory biosecurity. It also shows how the pillars
respond to several key issues raised in Section 2
and how investing in these areas is complementary
and self-reinforcing for public health.
Section 4 presents the main steps for carrying
out a self-assessment of national and institutional
biorisk management capacity. It includes a questionnaire, which assesses elements of the three pillars, and can be used to inform a tailored approach
to implementing the biorisk management framework, adapted to each country’s circumstances and
needs.
For animal health, biosecurity refers to good hygiene practices that help prevent the emergence and spread of animal
diseases. For plant health, biosecurity refers to controls
to protect plants against different types of pests but also
against animals or practices that could have adverse effects
on plants. The Food and Agriculture Organization (FAO)
considers biosecurity to be a “strategic and integrated approach that encompasses the policy and regulatory frameworks (including instruments and activities) that analyse
and manage risks in the sectors of food safety, animal life
and health, and plant life and health, including associated
environmental risk.” Biosecurity for agriculture and food
production (http://www.fao.org/biosecurity/, accessed October 2010), (http://www.fao.org/ag/agn/agns/meetings_
consultations_2003_en.asp,accessed October 2010) and
(34).
2
States Parties to the Biological Weapons Convention have
also noted their common understanding on “biosafety “and
“biosecurity” within the context of the Convention (35).
3
The Organisation for Economic Co-operation and Development (OECD) has also developed best practices guidelines
for their Biological Resources Centres (BRCs). OECD refers to biosecurity as the “institutional and personal security measures and procedures designed to prevent the loss,
theft, misuse, diversion or intentional release of pathogens,
or parts of them, and toxin-producing organisms, as well
as such toxins that are held, transferred and/or supplied by
BRCs”. While the OECD and WHO definitions are relatively
similar, they differ in their approach because the OECD
does not link laboratory biosafety to laboratory biosecurity
measures (36).
4
For definitions of dual use, see for instance (5, 15, 37).
1
1.3 Structure of the guidance
This document is organized into four sections.
This section provides an overview of the guidance,
describing the context, purpose, audience, scope
and methodology.
Section 2 reviews cases of life sciences research
that have raised concerns over the past few years
and examines the policy options that have been
put forward by different stakeholders to address
these concerns.
Building on this, Section 3 describes the three
8
53
2. Review of experiments
and policy options
2.1Examples of experiments
of concern
Box 1
The issue of preventing the misuse of legitimate
research is not new – it was recognized by Francis Bacon in the 17th century (38) and is embodied
in the 1972 Biological Weapons Convention1 – but
several recent experiments (39–43) have given salience to the topic within policy and scientific circles.
Although these research activities were carried out
for legitimate purposes, they also raised questions
about biosafety, national security, ethics and the
potential for the research data to be misused. A few
examples from the literature2 illustrate the potential benefits, opportunities and risks.
Accidentally increasing the virulence of
mousepox as part of an experiment to
control mice as pests
Australian researchers were attempting to produce a contraceptive vaccine that could be used
to control the mouse population in Australia. By
inserting interleukin-4 (IL-4), a gene that enhances
antibody production into mousepox, they accidentally increased the virulence of mousepox.
The new virus proved to be highly lethal in
infected mice, including those that had been vaccinated against it.
2.1.1Accidentally increasing the virulence of
mousepox as part of an experiment to
control mice as pests in Australia
Source: Jackson RJ et al. Expression of mouse interleukin-4
by a recombinant ectromelia virus suppresses cytolytic
lymphocyte responses and overcomes genetic resistance to
mousepox. Journal of Virology, 2001, 75:1205–1210.
In an attempt to create a contraceptive vaccine
for mice as a means of pest control, Australian
scientists unexpectedly increased the virulence
of mousepox (see Box 1). After discussion it was
decided to pursue publication of the findings in
part to stimulate public debate on how to handle
such a situation in the future (44).
When the paper was published in the Journal of
Virology in January 2001 (39) widespread media
coverage drew attention to the fact that unexpected
research results could have potentially dangerous
consequences for public health. Questions were
raised about genetic manipulation in general and
there were concerns that similar experiments on
orthopoxviruses, such as smallpox, could potentially increase its virulence. Some warned that the
paper provided information that could be used to
render the smallpox vaccine ineffective (15).
2.1.2 Variola virus immune evasion design
Another controversial experiment investigated the
differences in a virulence gene from variola major
virus, which causes smallpox, and vaccinia virus
to understand the mechanism of the virulence of
variola (see Box 2) (41). The researchers concluded
that the difference between the viruses’ inhibitor
of immune response enzymes could explain the
difference in virulence.
Critics maintained that the paper provided information that could be used to increase the virulence
of the vaccinia virus, which is, unlike variola virus,
widely available. Proponents argued that it was
Robinson J. The General Purpose Criterion and the importance of its implementation. Paper presented at the 19th
Workshop of the Pugwash Study Group on Implementation of
the CBW Conventions, The First CWC Review Conference and
Beyond. Oegstgeest, The Netherlands, 26–27 April 2003. Review conferences to the BWC are also examining every five
years all relevant scientific and technological developments
in relation with the Convention and, since 2008, annual
background papers on possible relevant developments are
published by the Implementation Support Unit of the BWC
(www.unog.ch/bwc, accessed October 2010).
2
For additional experiments, see also Davidson EM et al. Science and security: practical experiences in dual-use review.
Science, 2007, 316:1432–1433. See also the supporting online
material.
1
9
54
unlikely that such an experiment would allow vaccinia to reach the level of pathogenicity of variola
and that the publication would allow scientists to
work on these inhibitors to improve current treatments and vaccines against smallpox (15).
Box 2
Variola virus immune evasion design
Researchers compared the variola complement
regulatory protein (SPICE, smallpox inhibitor of
complement enzymes) with the corresponding protein in vaccinia virus (vaccinia virus complement
control protein or VCP).
2.1.3Chemical synthesis of poliovirus cDNA
In 2002, news of the chemical synthesis of poliovirus set off another debate (see Box 3). Researchers demonstrated that it was possible to assemble
a synthetic virus by piecing together chemically
synthesized oligonucleotides ordered through
the Internet from commercial DNA synthesizing
companies. On the benefit side, this experiment
is reported to have stimulated research into viral
genome synthesis for medical applications, such as
new strategies in vaccine development (45). Chief
among the concerns was that this research could
yield a recipe for reconstructing the poliovirus
(without obtaining a natural virus) or could enable
the artificial synthesis of smallpox (the genome
of which has also been published). Yet it was also
pointed out that, due to the much greater complexity of the smallpox virus, experts doubted that this
same approach would be successful in producing a
working virus. Some were also sceptical about the
scientific value of the research and the need for its
publication (46), arguing the techniques used in
the experiment were not new and the research did
not lead to new knowledge or insights (13, 45–47).
Researchers demonstrated that SPICE is a more
potent inhibitor of human complement than the
corresponding protein in vaccinia virus. Disabling
it could represent one method for the treatment of
smallpox.
In order to generate SPICE, the researchers
mutated the amino acid sequence of the VCP into
that of the variola protein.
This experiment also showed that the recombined vaccinia protein was much more efficient
than its natural counterpart in overcoming human
complement activation, suggesting that the pathogenicity of vaccinia virus could be enhanced by
manipulating the inhibitor.
Source: Rosengard A et al. From the cover: Variola virus
immune evasion design: expression of a highly efficient
inhibitor or human complement. Proceedings of the National
Academy of Sciences of the United States of America, 2002,
99:8808–8813.
2.1.4Reconstruction of the 1918 flu virus
Box 3
In 2005, researchers successfully reconstructed the
influenza A (H1N1) virus responsible for the 1918
Spanish flu pandemic by using reverse genetics to
generate the relevant 1918 viral coding sequences
and outfitting a relatively avirulent influenza virus
with all eight viral gene segments of the 1918
strain, which conferred the unique high-virulence
1918 strain phenotype on the engineered virus.
Two articles on the 1918 flu virus were published
in October 2005 (see Box 4) (42, 43). The article in
Nature published the sequences of the final three
gene segments of the flu virus genome while the
Science article published the recreation of the flu
virus based on the Nature article.
One funding body supporting this research
explained that the aim of the research was to better
understand the virulence of the 1918 Spanish flu
(48). The knowledge gained from the reconstruction of the virus could be used to devise and evaluate current and future public health interventions
should a similar pandemic virus emerge, including
Chemical synthesis of poliovirus cDNA
Researchers synthesized a poliovirus genome
using chemically synthesized oligonucleotides and
the map of the polio genome that has been published on the Internet.
The result was a “live” poliovirus that paralyzed
mice.
The published paper included a description of
methods and materials.
Source: Cello J, Paul A, Wimmer E. Chemical synthesis of
poliovirus cDNA: generation of infections virus in the absence
of natural template. Science, 2002, 297:1016–1018.
10
55
strategies to diagnose, treat and prevent the disease. Further research on macaques infected in
laboratories demonstrated the higher fatality rate
of the resurrected 1918 influenza virus compared
with a contemporary virus (49, 50).
But while some considered this research to represent a landmark breakthrough, others raised
concerns about the risks posed by resurrecting the
virus (51, 52), questioned the safety procedures for
handling the virus (53) and even questioned the
scientific value of the experiment, arguing that the
research had limited utility (52, 54, 55). Others
questioned whether the research findings should
have been published (54, 56).
The article in Science was published with an
accompanying editorial on responsible science (57)
and with a note at the end of the paper stating it
had been examined by the National Science Advisory Board for Biosecurity (NSABB). The Board
concluded that the scientific benefits of the research
far outweighed the biosecurity risks (56). The note
further states:
Box 4
Reconstruction of the 1918 flu virus
The research team re-created the extinct influenza virus using the gene sequences from archived
materials and from lung tissues of an influenza victim who had been buried in permafrost in 1918.
Using reverse genetics, the researchers were
able to generate the 1918 virus with the aim of
increasing understanding of the biological properties responsible for the high virulence of the pandemic virus.
The experiment also indicated that the 1918
virus gene sequences were more closely related to
avian (H1N1) viruses than any other mammalian
influenza H1N1 strains.
Source: Tumpey TM et al. Characterization of the
reconstructed 1918 Spanish influenza pandemic virus.
Science, 2005, 310:77–80 and Taubenberger JK et al.
Characterization of the 1918 influenza virus polymerase
genes. Nature, 2005, 437:889–893.
This research was done by staff taking antiviral
prophylaxis and using stringent biosafety precautions
to protect the researchers, the environment, and the
public. The fundamental purpose of this work was to
provide information critical to protect public health
and to develop measures effective against future
influenza pandemics.
Box 5
Creating and synthesizing a minimal
organism
Research has been done on the creation of a
bacterium with the minimum number of genes necessary for the organism to survive.
2.1.5Creating and synthesizing de novo
organisms
The emerging discipline of synthetic biology,
which is “concerned with producing biological based entities (e.g. parts, devices, systems,
organisms) which perform a new function” (58)
(see Box 5) can through these new processes and
techniques enable the synthesis of de novo organisms and the creation of specific, tailor-made new
organisms (59, 60).1 In May 2010, researchers at the
J. Craig Venter Institute in Rockville, Maryland,
United States of America, synthesized a bacterial
genome and inserted it into a bacteria cell, which
was then able to self-replicate (61). Synthetic biology, which has also been defined as “the design
and construction of new biological parts, devices,
and systems, and re-design of existing, natural
biological systems for useful purposes”2 is building
on the advances in disciplines such as computing,
Mycoplasma genitalium was selected by a team
led by J. Craig Venter. After reducing the bacterium
to the minimum 381 genes necessary for keeping it
alive, the aim was to use the microbe as a “chassis”
for building new synthetic biological devices able
to perform specific tasks (e.g. biofuels).
Researchers reported in Science the construction of the same bacterial genome by chemically
synthesizing small blocks of DNA.
Source: Gibson et al. Complete chemical synthesis, assembly
and cloning of a Mycoplasma genitalium genome. Science,
2008, 319:1215–1220.
The BioBricks Foundation (http://bbf.openwetware.org/, accessed October 2010).
2
Synthetic Biology (http://syntheticbiology.org/, accessed October 2010).
1
11
56
inal report Biotechnology Research in an Age of Terrorism: Confronting the Dual-Use Dilemma, also called
the “Fink report” (15). It thoroughly reviewed the
issues associated with dual-use research and proposed several risk management measures.
The report identified seven classes of experiments of concern that warrant review prior to being
carried out and before publication (see Box 7). As
illustrated in Section 2.1, some of these experiments
have already been conducted and published.
The Fink report proposed that research that
meets any one of these criteria be reviewed utilizing “the already established system for review of
experiments involving recombinant DNA,” that is,
by the National Institutes of Health-based Recombinant DNA Committee. It also emphasized the
need to educate the scientific community about
this issue; to rely on the self-governance of scientists and journals to review research results and
decide whether or not to publish; to rely on current
legislation and regulation regarding the protection
of biological materials; and to harmonize measures
at the international level.
In response to this Report, in 2004 the United
States Government established the National Science Advisory Board for Biosecurity (NSABB) to
ensure continuing dialogue between the scientific
and security communities and to provide specific
advice on dual-use research and on the dissemination of life sciences research information.1
In June 2007, the NSABB issued its Proposed
Framework for the Oversight of Dual Use Life Sciences
Research: Strategies for Minimizing the Potential Misuse of Research Information, which provides recommendations to the United States Government for
the oversight of dual-use research and is intended
to serve as a springboard for the development of an
oversight policy (66). The framework covers federally conducted or funded research and addresses
steps throughout the scientific research process―
from the project concept and design to publication―
where research can be reviewed for its dual-use
potential. The NSABB developed a criterion for
identifying “dual use research of concern” and
described seven categories of information, products or technologies that, if produced from life sciences research, might meet its proposed criterion.
As such, research falling into one of these categories should be considered especially carefully for its
dual-use potential (see Annex 4) (66).
Box 6
Main policy options
Research oversight mechanisms
Policies of funding agencies, publishers and
editors
Selected laws and regulations
Codes of conduct and ethics
Awareness-raising and educational initiatives.
genetic and mechanical engineering, physics and
nanotechnologies.
Synthetic biology has many potential applications in the fields of environment and energy production (e.g. hydrogen production), health care
(e.g. malaria drugs (62) and gene therapy), and
the aeronautical and petrochemical industries (e.g.
biofuels) (63). Along with its potential benefits
come a number of issues associated with biosafety
and laboratory biosecurity, the potential misuse of
synthetic biology and a host of ethical, social and
legal concerns about the impact synthetic biology
may have on society, public health and the environment (64). These are in addition to questions
of ownership, innovation, regulation and oversight
(58, 65).
2.2 Review of policy options
This section summarizes the various policy options
put forward by different stakeholders to manage
the risks of accidents and the potential misuse of
life sciences research. In considering the implementation of approaches for the management of these
potential risks, a range of complementary options
have been developed: 1) research oversight mechanisms; 2) policies for funding agencies, publishers and editors; 3) laws and regulations; 4) codes
of conduct and ethics; and 5) awareness-raising
and educational initiatives for scientific communities, policy-makers and the public. Some of these
approaches – such as awareness raising and codes
of conduct – are bottom-up approaches, others
are top-down (e.g. laws and regulation), and still
others mixed (e.g. research oversight mechanisms)
(see Box 6). These options are not mutually exclusive.
2.2.1Research oversight mechanisms
National Science Advisory Board for Biosecurity (http://oba.
od.nih.gov/biosecurity/about_nsabb.html, accessed October 2010).
1
In 2004, the National Research Council of the US
National Academies of Sciences published the sem12
57
In 2006, the Australian Government commissioned a report on the ethical and philosophical
considerations of the dual-use dilemma in the
biological sciences. The report also identified several salient experiments of concern, which are an
expanded version of the NRC list in Box 7, and provided a set of five options for the regulation of dualuse experiments and information (see Annex  5)
(67). These range from the “least intrusive/restrictive” where individual scientists are autonomous
to the “most intrusive/restrictive” where the whole
system ultimately relies upon the Government.
The report favours in-between options: establishing either a regulatory system composed of
research institutions and the government with
mandatory education and training, mandatory
personnel security and licensing of dual-use technologies, or an independent authority comprising
scientific and security experts.
In another attempt to define a system for research
oversight, the United States Center for International and Security Studies (CISSM) at the University
of Maryland proposes a system of tiered oversight
for certain categories of research, in which the level
of potential risk determines the nature and extent
of oversight requirements. Under the CISSM model, most research would be subject to local, institutional oversight, if at all, with only a small subset
of research considered at a higher level. Its key
elements are licensing of researchers and facilities
engaged in relevant research and independent peer
review of experiments in advance. These requirements would apply to all relevant research institutions (government, academia and industry), would
be mandatory rather than rely on self-governance,
and would be harmonized internationally through
the development of uniform procedures and rules
(see Annex 6) (68).
Since 2003, States Parties to the Biological Weapons Convention, which bans the development, production, stockpiling and transfer of biological and
toxin weapons, have been holding annual meetings with experts from the scientific community,
academia, professional associations and international organizations. The mandate of these meetings is
to discuss and promote common understanding and
effective action on a number of topics, including:
Box 7
Fink report’s seven classes of
experiments
Experiments that:
1. would demonstrate how to render a vaccine
ineffective;
2. would confer resistance to therapeutically
useful antibiotics or antiviral agents;
3. would enhance the virulence of a pathogen or
render a nonpathogen virulent;
4. would increase transmissibility of a pathogen;
5. would alter the host range of a pathogen;
6. would enable evasion of diagnostic/detection
modalities;
7. would enable the weaponization of a biological
agent or toxin.
Source: . U.S. National Academies, National Research Council,
Committee on Research Standards and Practices to Prevent
the Destructive Application of Biotechnology. Biotechnology
research in an age of terrorism. Washington, DC, The National
Academies Press, 2004.
biosafety and biosecurity, including laboratory
safety and security of pathogens and toxins;
 “oversight, education, awareness raising and
adoption and/or development of codes of conduct
with the aim of preventing misuse in the context
of advances in bio-science and bio-technology
research”1
As a result of these exchanges of information States
Parties have agreed on the value of implementing a
series of measures (35, 69).
Implementation of oversight frameworks
To date, implementation of research oversight
mechanisms for dual-use research has primarily
been done on a voluntary basis at the institutional
level (see Annex 7). Experience suggests that incorporating this issue into existing training and education programmes is the most practical approach.
With oversight mechanisms, a common challenge
is developing criteria for identifying research with
the potential for misuse. Current oversight systems
have mostly been implemented using the criteria
identified in the Fink report and by the NSABB.
 “strengthening and broadening national and
international institutional efforts and existing
mechanisms for the surveillance, detection,
diagnosis and combating of infectious diseases
affecting humans, animals and plants;
 “regional and international measures to improve
The United Nations Office at Geneva, the Biological Weapons Convention (http://www.unog.ch/bwc, accessed October 2010).
1
13
58
tion of research; international collaboration and
training; and promoting research best practice and
ensuring public trust” (71, 72). The three agencies
propose that a system based upon self-governance
by the scientific community will be the most effective means of managing the risks of misuse. It is
also suggested that “the community should take
active steps to further develop mechanisms of selfgovernance, and that through doing so the community can ensure that responsibly conducted
research is not unnecessarily obstructed.”
In addition, the three bodies have modified their
policy statements, guidance and procedures in four
areas (see Box 8) (70). The Wellcome Trust has also
inserted a paragraph on the risks of research misuse
in their guidelines on good research practice (73).
The European Commission (EC) has a system in
place regarding the submission of research grant
applications (37, 74). An ethical review panel and
a security scrutiny committee can be convened if
a research project has ethical or security implications. The EC has also published a green paper on
bio-preparedness, including measures against the
potential misuse of research, for the consideration
of European Member States (75). A public–private chemical, biological, radiological and nuclear
(CBRN) task force has been established by the EC
to examine actions in the area of awareness raising, training, codes of conduct, and the role of publishers and funding organizations (37).
Following the concerns posed by the publication of several experiments, 32 editors and authors
representing some of the most prestigious peerreviewed journals, including Nature, New England
Journal of Medicine and Science, agreed in 2003 on a
joint statement on scientific publication and security (76). The statement underlines several significant points:
Box 8
Joint agreement by BBSRC, MRC
and Wellcome Trust to modify their
respective policies and procedures in
four areas
Introduction of a question on application forms
asking applicants to consider risks of misuse associated with their proposal.
Explicit mention of risks of misuse in guidance
to referees as an issue to consider.
Development of clear guidance for funding committees on this issue and the process for assessing
cases where concerns have been raised.
Modification of organizational guidelines on
good practice in research to include specific reference to risks of misuse.
Source: Managing risks of misuse associated with grant
funding activities. A joint Biotechnology and Biological
Sciences Research Council (BBSRC), Medical Research Council
(MRC) and Wellcome Trust policy statement. September 2005.
A point of discussion in policy development is the
scope of dual-use research that is really of concern
and should therefore be subject to formal oversight
(37).
Other critical issues associated with oversight
mechanisms include:
 the appropriate level of reporting (i.e. concerns
should be reported to whom?);
 the composition of review boards (i.e. discussion over whether these should include scientific
experts, ethicists, security experts and/or civil
society);
 the evaluation of research experiments (i.e. subjectivity and replicability of these evaluations);
 the assessment of risks and benefits (i.e. at the
individual level or among peers).
 “We must protect the integrity of the scientific
process by publishing manuscripts of high quality, in sufficient detail to permit reproducibility.
(…)
 “We are committed to dealing responsibly and
effectively with safety and security issues that
may be raised by papers submitted for publication, and to increasing our capacity to identify
such issues as they arise. (…)
 “Scientists and their journals should consider
the appropriate level and design of processes to
accomplish effective review of papers that raise
such security issues.(...)
 “We recognize that on occasion an editor may
conclude that the potential harm of publication
2.2.2Policies of funding agencies, publishers
and editors
In the United Kingdom, three research funding
agencies – the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical
Research Council (MRC) and the Wellcome Trust
– have issued a joint policy statement on managing risks of misuse associated with grant funding
activities (70). The position statement of the three
agencies also addresses the issues of “balancing
benefit and risk; funding decisions; dissemina14
59
level where the research is carried out and by those
funding the research (37).
Available evidence has so far shown that very
few papers have raised concerns. Among the
74 000 biology papers received by the various
Nature journals from 2004–2008, only 28 papers
raised concerns and were forwarded to Nature’s
dual-use review committee. No paper was rejected
due to a potential risk for misuse (37). During this
time other journals (Science, the Proceedings of the
National Academy of Sciences of the United States of
America and the journals of the American Society
for Microbiology) encountered only one or two of
this type of paper each year and no papers have
been rejected for dual-use reasons since 2003.
From 2002–2008, the journal Biosecurity and Bioterrorism, which has developed specific questions for
authors and reviewers on dual-use, received only
three papers that raised concerns. One was published with modification and the remaining two
were rejected by the journal (37).
outweighs the potential societal benefits. Under
such circumstances, the paper should be modified, or not be published. Scientific information
is also communicated by other means: seminars,
meetings, electronic posting, etc. (…)”
Several journal editors have put in place mechanisms for papers that may need additional peerreview because of the potential risks for misuse
(37). The Council of Science Editors (CSE), which
aims to promote excellence in the communication
of scientific information, has published a white
paper that includes a section on the responsibilities
of editors to the public. This white paper encourages editors to “educate journal boards, reviewers,
and authors; establish screening methods to recognize [dual-use research of concern]; obtain reviews
of these manuscripts from individuals with technical and security expertise; create an ongoing network to share experience and further refine ways
for managing [dual-use research of concern];” and
“develop guidelines and procedures to allow the
scientific evaluation as well as evaluation of the
possible risk of communicating information with
dual use potential” (77). In its recommendations
to the United States Government, the NSABB has
included communication tools that contain points
to assist researchers and journal editors when communicating research that may raise some concern
(78).
2.2.3Selected national laws and regulations
on research oversight and biosafety and
laboratory biosecurity
Very few countries have enacted specific laws
establishing the oversight of research with dualuse potential. However, a number of countries have
laws on dangerous pathogens, including lists of
pathogens and microorganisms that are subjected
to several controls. And many more have enacted
national laws to implement their obligations under
the 1972 BWC.
In Israel, a steering committee on Issues in
Biotechnological Research in an Age of Terrorism (COBART) was established in 2006 to address
biosecurity in the areas of biomedical and life sciences research. It recommended the establishment,
at the national level and within the Ministry of
Public Health, of a National Biosecurity Council to
oversee biomedical research at universities, medical centres and biotechnology companies and, at
the local level, a scientist-based oversight model.
These became the basis of a 2008 law (37). Raising
awareness and education were considered top priority areas as this issue is not a well-known topic in
the life sciences or medical communities.
In 2007, Australia enacted the National Health
Security Act, which established a National Authority within the Department of Health and Aging
Implementing the policies of funding agencies,
publishers and editors
Research funding bodies have noted since 2005 that
applicants are increasingly thinking about issues of
misuse and address those topics in their applications. At the same time, very few research proposals have raised concerns (37). The Wellcome Trust
identified only three studies between 2005 and
2008 and among the 10 000 applications received
by the BBSRC over these three years, fewer than a
dozen were found to be of potential concern.
Several journals have adopted policies and
review processes to monitor this issue in submitted
papers. Some of the issues that have been raised
during implementation include: What should a
journal do with a rejected paper? What authority
can legitimately ask a journal to pause the publication of a paper (37)? Given that researchers
may always seek to publish elsewhere, including
in non-journal publishing (i.e. scientific web site,
conference, etc), journals should not be seen as the
only safety net. Efforts should also be developed
upstream of submission to journals, at the institute
For additional information, see the United Nations Office at
Geneva, the Biological Weapons Convention (http://www.
unog.ch/bwc, accessed October 2010).
1
15
60
to regulate and monitor facilities working with
security-sensitive biological agents (79). The
Act includes a list of security-sensitive biological agents; a national register of facilities; security
provisions for handling security-sensitive biological agents; regulations for storage, transport and
handling of those agents; inspection, monitoring
and sanctions; and training and awareness-raising
campaigns (37).
In Brazil, the Biosafety Law N°11.105 of 24
March 2005 provides for safety norms and inspection mechanisms for activities related to genetically
modified organisms (GMOs) and their derivatives
(80, 81). In addition the law establishes a National
Biosafety Council, a National Biosafety Technical
Commission, biosafety internal committees and
a biosafety information system. Brazil has also
established the National Program for the Promotion of Dialogue Between the Private Sector and
the Government in Matters Related to Sensitive
Assets (Pronabens) in order to define procedures
for the control of sensitive goods. This is done
through technical visits, raising awareness, support in the handling of sensitive goods (importing
and exporting) as well as in the maintenance of a
list of sensitive goods.
In China, administrative authorities supervise
and manage biosafety and biosecurity issues from
different aspects, including Ministries of Science
and Technology, Education, Agriculture, Forestry,
Health and Environmental Protection, and National Development and Reform Commission. A series
of regulations, frameworks, rules and standards
have been issued to address biosafety and biosecurity in life sciences research as well as the handling
of GMO and pathogenic biological materials.1
Singapore enacted the Biological Agents and
Toxins Act (Chapter 24A) and the Biological
Agents and Toxins (Transportation) Regulations in
2006 to regulate the possession, use, import, transhipment, transfer and transportation of biological
agents and toxins. The Act and the Regulations are
administered by the Ministry of Health. Under the
Act, facilities handling high-risk biological agents
and toxins are required to be certified as containment facilities and/or gazetted as protected places.
Such facilities are inspected and certified annually. Exports of strategic goods (including a list of
biological agents and toxins) are regulated under
the Strategic Goods (Control) Act (Chapter 300),
administered by Singapore Customs.
Common European Union (EU) legislation on
biosafety has been developed and focuses on the
prevention of risks associated with the handling
of dangerous biological materials by workers as
well as during transport (82). EU Member States
have developed national legislation, regulations
and other measures covering for instance the possession, transport, export and import of biological
materials, and biosafety and biosecurity.2
In the United Kingdom, the 2001 Anti-Terrorism Crime and Security Act establishes security
measures for the possession and transfer of pathogens and toxins (83). Based on a list of pathogens and toxins, approximately 450 laboratories
are registered under this legislation. Laboratories
are required to put in place security procedures
in accordance with the nature of the organisms
they are keeping at their premises, and they are
regularly visited and assessed. The legislation also
establishes policy for personnel security. 3 In addition, a single regulatory framework governing
human and animal pathogens has recently been
developed that merges several existing frameworks (84).
In Germany, the Biological Agents Ordinance of
27 January 1999 contains provisions on the protection of workers from risks related to exposures to
biological agents (85–87). This includes notification of the types of activities involving certain risk
group biological agents to the competent authorities. Germany also has laws and regulations for the
These include: the Safety Administration Regulation on
Genetic Engineering (1993); the Safety Administration Implementation Regulation on Agricultural Biological Genetic
Engineering (1996); the “National biosafety framework”
(2000); Regulations on Safety of Agricultural Genetically
Modified Organisms (2001); Administration Regulation
on Labeling of Agricultural Genetically Modified Organisms (2001); General biosafety standard for microbiological
and biomedical laboratories (2002); Regulation on Inspection and Quarantine of Import and Export of GM Products
(2004); Administration Regulation on Biosafety of Pathogenic Microbiology Laboratories (2004); Laboratories – General Requirements for Biosafety (2004); Laboratory Biosafety
Qualification Standards (CNAS-CL05:2006); Implementation Regulations on Labeling of Agricultural Genetically
Modified Organisms (2007); Laboratories – General Requirements for Biosafety (New version) (2008); Laboratory
Biosafety Qualification Standards (NAS-CL05:2009).
2
For a review of European Union countries laws, regulations
and other measures, see (87).
3
A pilot project reviewing the implementation of the UK legislation found that the new controls were successfully conducted and that there was no substantial disruption, keeping
a satisfactory balance between scientific freedom and security. The study identified three factors that contributed
to this successful implementation: “pre-existing biosafety
measures which ensured a degree of biosecurity; a responsive approach to regulation by the implementing body; and a
flexible and socially responsible reaction to the new controls
by the UK scientific community.”(88).
1
16
61
safe and secure transport of biological agents, the
licensing and registration of facilities and persons
handling biological materials, and the provisions
for the security vetting of personnel handling dangerous biological materials.
The United States has developed a body of laws
to control the possession, use and transfer of biological agents1 based on lists of select pathogens and
toxins that are regulated by the Centers for Disease
Control (CDC) of the Department of Health and
Human Services and the Animal and Plant Health
Inspection Service (APHIS) of the Department of
Agriculture.2 The APHIS/CDC Select Agent Program oversees activities and registers all laboratories and other entities in the country that possess,
use or transfer a select agent or toxin.
In South Africa, legislation to establish measures to account for and secure the safe production,
use and storage of biological materials includes the
Agricultural Pests Act (Act no. 36/1983), the Organisms Act (Act no. 15/1997), the Animal Health Act
(Act no. 7002), the Non-Proliferation of Weapons
of Mass Destruction Act (Act No. 871/1993) and
the Health Act (Act no. 31/2003) (89).
Sciences have dedicated documents on this issue
(see Annex 8).
Other codes include the NSABB’s recommendations on the development of a code of conduct
for scientists and laboratory workers and a code of
ethics for the life sciences proposed by individual
scientists Margaret Somerville and Ronald Atlas
(93). Moreover, the International Committee of the
Red Cross (ICRC) has been working with scientists in the life sciences to adopt “professional and
industrial codes of conduct aimed at preventing the
abuse of biological agents” (see Annex 8).
Implementation of codes
Critics of codes of conduct and codes of ethics often
stress that self-governance will not stop accidents
or the deliberate misapplication of science. They
also point out that conflicts of interests may arise
in the process of self-governance and that some
scientists may not have the knowledge and skills
needed to assess the future implications of their
work (67). Moreover, while codes may have aspirational value, if voluntary, they are not like laws
that can be enforced. Though voluntary codes may
have limitations, it should be noted that institutional and/or legal enforcement of codes is possible.
Nevertheless, an important objective and benefit
of codes is that they catalyze discussion between
the different communities involved in life sciences
research and help to raise awareness of the risks.
Yet, although codes of conduct have received an
important amount of attention, some have provided a mixed assessment of the achievements of
code-related activities until now (94, 95).
2.2.4Codes of conduct and ethics programmes
and initiatives
Codes of conduct and ethics programmes and
initiatives are two other policy options that have
attracted much attention (90, 91). A number of
codes either directly make reference to the potential misuse of life sciences research or give more
general statements. The purposes and functions
of these codes vary in accordance with the extent
to which they are voluntary, or subject to some
form of institutional or legal enforcement. Medical
associations (e.g. the World Medical Association,
the British Medical Association and the American
Medical Association’s Council on Ethical and Judicial Affairs) have reinforced their existing codes to
include issues related to the possibility of accidents
or the deliberate misuse of research (see Annex 8).
In 1974 UNESCO issued the “Recommendation on the Status of Scientific Researchers” (92).
More recently, the International Centre for Genetic
Engineering and Biotechnology (IGCEB) has been
undertaking a review of codes of conduct. Scientific
and academic organizations (such as the American
Society for Microbiology, the Chinese Academy
of Sciences and the Royal Society in the United
Kingdom) have also emphasized the importance
of codes of conduct. The InterAcademy Panel (IAP)
and the Royal Netherlands Academy of Arts and
2.2.5Educational and training initiatives to
raise awareness
Numerous initiatives aimed at different scientific
audiences have been raising awareness on this
topic across several regions (29, 96).3
See for instance, the Antiterrorism and Effective Death Penalty Act of 1996, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the USA
PATRIOT Act (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct
Terrorism Act of 2001).
2
See National Select Agents Registry (www.selectagents.
gov/, accessed October 2010).
3
See also the Center for International and Security Studies at
Maryland, The Controlling Dangerous Pathogens Project (www.
cissm.umd.edu/projects/pathogens.php, accessed October
2010) and The International Council for the Life Sciences
(www.iclscharter.org/eng/index.asp, accessed October
2010).
1
17
62
 Educational workshops on dual-use research
developed in the United Kingdom have been
conducted in several regions (97).
 A course module for practising scientists, science
students and laboratory technicians working on
infectious diseases has been discussed in South
Africa (37).
 A study has assessed education materials for
biosafety, biosecurity and dual-use research at
major universities in the European Union (98).
 The NSABB has recommended to the United
States Government outreach and education
strategies for raising awareness among various
stakeholders about dual-use research of concern
(99).
 On-line educational modules have been developed by:
— the Center for Arms Control and Nonproliferation (CACNP)1
— the Federation of American Scientists (FAS)2
— the Southeast Regional Center of Excellence
for Emerging Infections and Biodefense
(SERCEB).3
on communicable and noncommunicable diseases. This underlines the importance of access to
laboratory infrastructure and biological materials,
research collaboration, developing new tools for
disease prevention and control, and implementation of the IHR. Another priority of many countries
is addressing intellectual property rights concerning microorganisms. With the increasing number
of biological laboratories worldwide and thus an
increasing number of people working with biological agents and pathogenic microorganisms, there
are pressing demands for teaching and training and
demonstrated competency in biosafety, laboratory
biosecurity and ethics. Such activities help reduce
the likelihood of accidents and provide tools for
scientists to discuss the complex ethical questions
they encounter in their everyday work.
Second, the perception of risk associated with
accidents and deliberate misuse of life sciences
research differs from country to country. The
knowledge and awareness of this issue are very
uneven among countries and regions. Some countries are thinking of developing measures while for
others the issue is novel (97).
Third, researcher expertise differs widely from
country to country, as does laboratory capacity.
Different approaches may be required to improve
understanding and practice in different regions
and countries. Some countries will opt for legislation or regulations on biosafety and biosecurity
while others will focus on ethics, research and
funding policy or possibly choose a different path
if regulations already exist.
A 2008 report from the American Association for
the Advancement of Science (AAAS) has examined
14 programmes in the United States that educate
graduate or professional students in the biomedical sciences on dual-use research issues (100). The
report draws attention to the importance of education on dual-use research and the lack of funding
for such activities. It also identifies gaps in current
knowledge on dual-use issues and on the role of
the government, research institutions and scientific organizations.
2.3 Remarks
This section has briefly reviewed some of the
research activities that have raised concerns in
policy circles and within the scientific and publishing communities. Although the available evidence
suggests that, so far, only a small number of published papers have raised concerns, these activities had an important impact within the media
and policy communities. Many questions raised
by these experiments remain unanswered (see
Table  1) and those exposed to such experience,
whether researchers or publishers, have asked for
more clarity as to what should be done. Some have
also put forward the need to have clear guidelines
on the subject to avoid measures that would go
beyond what is appropriate and put unwarranted
restrictions on research activities and international
collaboration (12–14).
Some have also pointed out the difficulty of
Implementation of educational and training initiatives
to raise awareness
The experience of the WHO regional awareness
activities raised several points (29). First, countries emphasize the importance of developing and
maintaining research and laboratory capacity for
public health purposes, for prevention and management of disease outbreaks, and for research
Center for Arms Control and Non-Proliferation. Biosecurity:
Risks, responses, and responsibilities (www.armscontrolcenter.org/policy/biochem/biosecurity_educational_materials/, accessed October 2010).
2
Federation of American Scientists. Case studies in dual use
biological research (www.fas.org/biosecurity/education/
dualuse/index.html, accessed October 2010).
3
Southeast Regional Center of Excellence for Emerging Infections and Biodefense. The dual use dilemma in biological
research (www.serceb.org/dualuse.htm, accessed October
2010).
1
18
63
determining possible hazards associated with single research projects and that, instead of looking
at discrete and individual activities, more attention should be devoted to the cumulative developments in the life sciences (101). Such a macro level
approach would look at what trends are emerging
in the life sciences and what directions of research
are being funded. Whether such an approach would
bring some solutions to the current problems associated with risk assessment however remains to be
seen.
Others have also noted that potential risks can
be found in most areas of the life sciences, leading possibly to far-fetched risk assessments. And
so the focus of risk assessment ought rather to be
whether the magnitude of the potential for misuse
might or might not be great enough to outweigh
the benefit that might be lost by closing down the
research in order to negate that risk.
In any event, many questions remain open in
terms of risk assessment (see Table 1): how best to
identify what is an experiment of concern; what
could be the magnitude of potential misuse; how
to identify trends or path of research in the life sciences that may pose concerns; how to weigh the
risks against the benefits; and who should be in
charge of carrying out such assessment. On this
last point, it has also been noted that adequate
expert input to help carrying out risk assessment
may be much harder to find than it is sometimes
suggested.
The review of the different policy options shows
that addressing this complex issue requires a sense
of shared responsibility among different stakeholders and that an emphasis has been put until
now on the role of self-governance and bottom-up
mechanisms. Despite the lack of a universal agreed
upon definition on dual-use research, research of
concern or dangerous research, some initiatives
have already been implemented at the national and
local levels and some research institutions, funding bodies, publishing houses and journal editors
have established review committees.
Table 1. Key questions and concerns
Key questions
• How to identify life sciences research activities of
concern?
• How to assess benefits against risks? Based on
which criteria?
• How to address the potential risks posed by
accidents or deliberate misuse of life sciences
research activities?
• How to foresee the implications of research?
• Would legislation or self-regulation be more
effective to manage these risks?
• What is expected from the researchers, the
publishers, funding bodies and the authorities?
• Is there a need to be concerned? Is it a priority?
• Is it a global issue? Are there global solutions? What
are they?
• Are developed and developing countries similarly
concerned?
• Are there any best practices from existing
approaches?
• Are there any assessments of different models and
comparisons of approaches?
• What are the costs and benefits of different policy
options?
Key concerns
•
•
•
•
•
•
•
•
•
•
19
64
Risks of accidents and potential misuse of research
Biosafety Scientific value of the experiment
Ethical issues
Publications
Scientific freedom
International collaboration
Public health needs
Capacity for developing countries
Control measures
3. The biorisk management
framework for responsible
oratively reflect on issues related to the risks of life
sciences research. Third, countries and institutions
need to promote the safe and secure handling of
pathogens, assess their specific needs with respect
to education and safety, and implement riskbased laboratory procedures. In light of competing
demands and limited resources, it is worth noting
that each pillar is equally important and that safety
can be achieved without major financial resources.
Meanwhile, practices should be complementary
and self-reinforcing and should remain focused on
public health needs.
How best to do this will depend on available
resources and on national, local and institutional needs, which vary greatly between countries.
However, in most countries, implementation will
require the involvement of different stakeholders (from policy-makers, to laboratory managers,
to individual researchers) and action at all levels.
Coordination among different sectors and stakeholders is essential to establish clear roles and
responsibilities, and to avoid duplicating activities
and overburdening existing regulatory schemes
and public health activities. In this regard, a selfassessment questionnaire has been developed
and is presented in Section 4 to help countries and
institutions assess their strengths and weaknesses
and to support implementation of the biorisk management framework.
In addition, effective biorisk management policies for responsible life sciences research should be:
flexible to incorporate new scientific developments;
sustainable in order to meet the differing needs of
countries and institutions; viable for countries facing competing demands with scarce resources;
developed in collaboration with relevant stakeholders, particularly researchers who are the most
directly affected by the policy, so that it is acceptable
and equitable to all stakeholders; and built on existing frameworks and experiences (see Box 10).
The biorisk management framework has added
value insofar as it incorporates a unique public
On the basis of Section 2, which reviewed the
available evidence of potential risks of accidents
or misuse, along with the policies and positions of
different stakeholders, this section focuses on the
three pillars that support a biorisk management
framework for responsible life sciences research,
from a public health perspective (see Box 9).
Implementing the biorisk management framework for responsible life sciences research will
require investing in, developing and reinforcing
each of its three pillars. First, researchers, institutions and countries need to have the capacity to
respond to public health needs. Second, students,
researchers and laboratory staff need to receive
appropriate education and training on ethics
and best practices in the responsible conduct of
research, and be encouraged to discuss and collabBox 9
Three pillars of a biorisk management
framework for responsible life sciences
research
Pillar 1: Research excellence – this concerns
fostering quality in life science activities, which
is the basis for developing new treatments and
therapeutics; national health research systems
(HRS) and the WHO strategy on research for
health; and disease surveillance and response
activities and the International Health Regulations (IHR). These elements are essential to
protecting and improving the health and wellbeing of all people.
Pillar 2: Ethics – this involves the promotion
of good research practices and ethical conduct
through education and training.
Pillar 3: Biosafety and laboratory biosecurity – this concerns the promotion of safe and
secure laboratory measures to prevent exposure
to pathogens and toxins.
20
65
health approach built on elements that already exist
in countries for other public health activities. Thus,
the framework is a flexible, sustainable and viable
way for countries to invest in reinforcing a number
of core public health capacities that serve different purposes. In addition, it builds on the many
options that have already been put forward by different sectors and groups to manage this issue (see
Section 2). The biorisk management framework for
responsible life sciences research helps make public health communities, policy-makers, institutions
and researchers aware of the risks and encourages thinking about the wider implications of the
research and about how to deal with unexpected
discoveries.
Effective biorisk management policies for
responsible life sciences research should, in turn,
lead to:
Box 10
Hallmarks for effective management
policies on responsible life sciences
research
Flexibility – adjusting for new scientific developments
Sustainability – relevance of the policy to the
needs of countries and institutions and political
feasibility (or political support)
Viability – cost of the policy
Acceptability/equity to stakeholders
Built on existing frameworks
 strengthening research capacity development
 fostering international exchange and collaboration
 fostering scientific freedom, transparency, trust
and accountability
 ensuring safe and secure practices.
Box 11
Key considerations when implementing
the biorisk management framework for
Reinforce public health capacities in terms of
research for health, biosafety and laboratory bio
security, and ethics.
Effective efforts to address the potential risks arising from accidents, serendipity or intentional misuse of life sciences research activities will maintain
public confidence in science, foster the responsible,
ethical conduct of research, and protect laboratory
workers, the environment and the community. At
the same time, such investments will promote the
importance of research for health and assist countries in meeting other significant public health
challenges, including the containment of disease
outbreaks and the development of disease surveillance mechanisms.
Invest in training personnel (laboratory staff and
researchers) and students in ethics, the responsible
conduct of research, and biosafety and laboratory
biosecurity.
Ensure compliance with biosafety and laboratory biosecurity.
Consider multi-stakeholder issues, with different
layers of responsibilities and encourage coordination among stakeholders.
Use existing mechanisms, procedures and systems and reinforce local institutional bodies (if
they exist).
3.1 Pillar 1: Research excellence
National health research systems (HRS), the WHO
strategy on research for health and the International Health Regulations (2005) can all be used
to help build and enhance national research and
laboratory capacities.
3.1.1Health research systems
Since the 1990 landmark report of the Commission on Health Research for Development, there
has been growing interest in the organization and
strengthening of HRS (102–107). For example, in
November 2008, the “Bamako call to action” highlighted a number of priorities that are relevant to
this guidance: among other things, governments
21
66
Box 12
Four core functions of a health research system
Stewardship: Stewardship is synonymous with the oversight of a health research system (HRS). It is usually
performed by governments but other stakeholders such as national health research councils or professional associations may also play a role. Stewardship covers four components:
define and articulate the vision for a national HRS
identify appropriate health research priorities and coordinate adherence to these
set and monitor ethical standards for health research and research partnerships
monitor and evaluate the HRS.
Stewardship is the most relevant function for the responsible management of life sciences research. If the function is well developed, a country would have a national policy on health research involving all key stakeholders.
Partnerships and commitment between different institutions at the national and international level would be
emphasized. Health priorities would be identified and funded (i.e. based on national burden of disease, political
will, human resources, community participation, etc.). Ethics would constitute an important element in addressing the challenges posed by scientific advances. Ethical review boards would operate and HRS would be regularly
reviewed.
Financing: Another central HRS function is to secure research funds in an accountable, transparent and efficient manner and to ensure funding matches national research priorities. This function is especially important
given the financial issues regarding the funding of health research and the importance of life sciences research for
economic development. Resources are needed to address infectious disease priorities (research, facilities, equipment, personnel and training), and to develop and strengthen laboratory infrastructure, equipment, manpower
and training.
Creating and sustaining resources: This function covers the human and physical resources necessary to
conduct health research but also the importance of an enabling environment that leads to good research management, discussions of research data and availability of funding. Another aspect of this function is to ensure
staff are trained and have appropriate facilities to carry out research.
Producing and using research: The production of valid research disseminated in both peer-reviewed
and non-peer-reviewed literature, policy reports, books etc., is an important part of this function. The products of
research – knowledge and technologies – can be deployed to inform health policies and strategies and to develop
new tools (therapeutics, vaccines and other devices) for better health. One challenge is to link health research
with health policy and practice. Communication between the different stakeholders (researchers, publishers,
policy-makers, practitioners, the media and the public) and the role of Internet are important in linking health
research with health needs.
Sources: Pang T et al. Knowledge for better health — a conceptual framework and foundation for health research systems. Bulletin of
the World Health Organization, 2003, 81:815–820. For more information about Health Research System Analysis (HRSA) core indicators
and descriptive variables, Sadana R et al. Health Research System Analysis (HRSA) Initiative: Methods for Collecting Benchmarks and
Systems Analysis Toolkit. Tool #1. A brief overview of WHO Health Research System Analysis initiative and an overview of core indicators
and descriptive variables. Geneva, World Health Organization, 2006 (WHO/EIP/IHRSA/06.1) and (http://www.who.int/rpc/health_
research/en/index.html, accessed October 2010).
22
67
committed themselves to strengthen institutional
research capacity, develop and enforce ethical and
regulatory frameworks, and support open access to
data and sharing of health information (108, 109).
Governments and donors are increasingly focused
on results-based financing for health research and
demonstrating value for money.1 Investing in HRS
should facilitate the achievement of these objectives.
Although HRS are shaped by contextual factors
and existing capacities at national, subnational and
institutional levels, four core functions have been
identified (see Box 12) (7).
The main objectives of HRS are “the production of scientifically-validated research and the
promotion of the use of research results, ultimately
to improve health and health equity” (25, 111).
At the same time, strong national HRS can also
address some of the concerns about the possibility of accidents or the deliberate misuse of life sciences research highlighted in Section 2. Indeed, the
organization and management of some research
activities have been criticized not only because of
potential concerns about accidents or misuse but
also because of doubts about their scientific value
(see Section 2.1). While recognizing the importance
of balancing national research policy and individual leadership, HRS are one way to reinforce the
management of research at national level.
3.1.3 International Health Regulations (IHR)
The IHR (2005) is a binding international legal
instrument in 194 countries, including all Member
States of WHO.2 The aim of the regulations is to
prevent and respond to the international spread
of disease. The IHR (2005) entered into force on
15 June 2007 and requires countries to report public health emergencies of international concern
(PHEIC) to WHO. Laboratories are a key element of
the IHR. Together with WHO and other partners,
countries could use this IHR (2005) requirement
for national capacity to prevent the international
spread of disease as an opportunity to assess their
laboratory capacities and needs associated with the
three pillars.
The IHR (2005) is focused on serious public
health risks with the potential to spread across
international borders. According to Article 2, the
purpose and scope of the Regulations are:
“to prevent, protect against, control and provide a public
health response to the international spread of disease in
ways that are commensurate with and restricted to
public health risks, and which avoid unnecessary interference with international traffic and trade.” [emphasis
added]
Among others, one of the priority areas in the
implementation of IHR (2005) is the capacity
of countries to detect report, verify and control
events. In this regard, Member States are expected
to assess, and strengthen as necessary, national
structures and resources to meet the minimum
core capacity requirements under IHR (2005) (115).
Having access to laboratories is critical for detecting and confirming disease outbreaks as well as
chemical and radionuclear events. This underscores the importance of having reliable laboratory
data, competent staff, appropriate resources and
adequate infrastructure.
3.1.2 Implementing the WHO strategy on
research for health
In January 2009, the WHO Executive Board
endorsed the organization’s strategy on research
for health, which incorporates the central goal of
strengthening research capacities and research
governance tools (112). The resolution on WHO’s
role and responsibilities in health research was
then adopted by the Sixty-third World Health
Assembly in resolution WHA63.21 in May 2010
(113). The WHO strategy recognizes the centrality of research for global health progress, aims to
strengthen WHO’s role in research for health, and
will underpin all of the Secretariat’s research-related activities (114) (see Annex 9). Four of the strategy’s five interrelated goals (the organization goal,
the priorities goal, the capacity goal, the standards
goal, and the translational goal) are important in
addressing the issues and concerns arising from
life sciences research (see Box 13).
3.2 Pillar 2: Ethics
Along with good research practices and research
integrity, ethical considerations are critical elements in the biorisk management framework for
responsible life sciences research. This section
Health research systems have defined as “the people, institutions, and activities whose primary purpose in relation to
research is to generate high-quality knowledge that can be
used to promote, restore and/or maintain the health status
of populations; it should include the mechanism adopted to
encourage the utilization of research.” (7, 110).
2
For additional information on the International Health
Regulations (http://www.who.int/ihr/en/, accessed October
2010).
1
23
68
Box 13
Box 14
Four selected goals of the WHO strategy
on research for health
Summary of research excellence
elements for responsible life
sciences
The organization goal is to strengthen the research
culture across WHO. To achieve this goal, the Secretariat, in collaboration with Member States and other
partners, will, for instance, develop and implement a
WHO code of good research practice for those of its
staff involved with research and the use of evidence;
will reinforce existing mechanisms for ethical and peerreview structures and procedures; will improve the management and coordination of WHO-affiliated research;
and will develop a publicly accessible repository for all
such research.
Capacity development for research is essential for reducing health inequalities and for
ensuring the proper use of life sciences.
Use existing tools and frameworks, such
as health research systems (HRS), the WHO
strategy on research for health and the International Health Regulations (IHR) as these can
provide useful tools for contributing to responsible life sciences research.
The capacity goal is to support the development
of robust national health research systems. To achieve
this goal, the Secretariat, in collaboration with Member
States and other partners, will, for instance, strengthen
advocacy for robust HRS, develop guidelines in the four
core functions of HRS, and develop indicators for monitoring progress.
elaborates on these points and also develops an
ethics framework to address issues associated
with the potential risks posed by accidents or
the deliberate misuse of life sciences research.
3.2.1Ethical considerations
The importance of ethics in life sciences research
is widely recognized. In the past 30 years, oversight systems have been established around the
world to foster the ethical conduct of research,
especially involving human and animal re
search subjects. More recently, ethical issues
associated with genetics, cloning and stem cell
research have been under the spotlight. However, aside from a debate about “environmental
safety and implications for human health” in
the early days of recombinant DNA research,
bioethics (as a discipline) has paid relatively little attention to the safety and security issues
that are central to this guidance document.
The majority of ethical discourse surrounding
genetics has focused on genetic therapy, genetic
testing, genetic discrimination, selective reproduction, DNA fingerprinting and the patenting
of genetic sequences. Discourse surrounding
research ethics and practices related to ethical
oversight of research, meanwhile, have traditionally focused primarily on the protection of
research subjects rather than biosafety (which
is most often handled by institutional biosafety
committees rather than ethics committees) or
risks associated with the deliberate misuse of
research.
Until recently, the debate on the risks posed
by accidents and deliberate misuse of research
has mainly been engaged by science and secu-
The standards goal is to promote good research
practice. Emphasizing the increasing demand for more
accountability and transparency in the conduct of
research, WHO is expected to promote best practices in
research. In this regard, the Secretariat will, for instance,
in collaboration with Member States and partners,
develop norms and standards for best practice in the
management of research. This will cover, for example,
ethical and expert review and the accreditation of ethical review committees; the sharing of research data,
tools and materials; the registration of clinical trials;
and the use of evidence in the development of policy,
practice and products.
The translational goal is to strengthen the links
between the policy, practice and products of research.
To achieve this goal, the Secretariat, in collaboration with Member States and other partners, will, for
instance, support decision-making based on the best
available research evidence; will promote the use of
effective models of technology transfer and their evaluation; will systematically analyse barriers and encourage the creation of mechanisms to promote greater
access to research results, or the enhancement of existing ones; will adopt and articulate a WHO position on
open access to research outputs; and will advocate
databanks, repositories and other mechanisms for maximizing the availability of health-related research findings that are freely accessible in the public domain.
24
69
rity experts rather than ethicists. However, given
the potential conflicting values of promoting scientific progress and protecting public security, and the
questions about responsibility that arise, the dualuse dilemma is inherently ethical in nature. Safety,
meanwhile, is often treated as a technical, rather
than ethical, issue. Given the potential dangers to
the environment and society, however, the safety
of research is obviously ethically important. Finding and maintaining the right mix of policies that
will enable the benefits of life sciences research to
be maximized while minimizing the risks requires
efforts on the part of both the life sciences and the
security communities. Developing and implementing such policies is a complex and dynamic process
that calls for multifaceted solutions forged through
sustained international coordination and engagement, which may uncover value conflicts in need
of resolution. If the full potential of life sciences
research is to be realized, the potential risks of that
research must be managed. This is not just a technical challenge: it is also an ethical one. Box 15 lists
several critical ethical questions that arise from the
issues raised in Section 2.
Questions about values, and how to resolve value conflicts when they arise, fall directly within the
realm of ethics. In addition to addressing issues of
value conflict, ethical analysis is required for assessing the responsibilities of scientists, research institutions, science societies, publishers and national
governments. In light of the need for more ethical input into debates about dual-use research, it is
reassuring that an emerging literature is beginning
to address the issues associated with the potential
risks posed by the deliberate misuse of life sciences
research from an explicitly ethical perspective (67,
116–122).
What can bioethics offer to address this issue?
Ethics can help people identify an ethical problem
and understand as fully as possible the nature of
the decision they have to make (2). Ethical considerations can assist policy-makers, individual
researchers and other stakeholders to discuss their
differing (and sometimes competing) interests and
values and use such deliberations to inform and
influence policy decisions taken at the country and
institutional levels. Going through this process can
help resolve tensions between the responsibilities
of individual researchers and the scientific community as a whole to society; the tensions between
scientific freedom and security concerns; and the
tensions involved in balancing potential benefits
against possible risks.
Box 15
Key ethical questions for consideration
How to weigh the potential benefits of research
against the risks for misuse? On which criteria
should this assessment be based?
How to weigh the individual interests of
researchers against the common good of public
health? Who should make these decisions? How
can tensions between individual researcher and
institutions/society best be managed?
How to best manage the risks associated with
research without hindering its beneficial application to public health?
What are the responsibilities of individual
researchers and of the scientific community as a
whole to society?
3.2.2Towards an ethics framework
The development of an ethics framework should
start with the recognition that the potential risks
associated with accidents or the deliberate misuse
of life sciences research pose dilemmas for numerous actors – with different responsibilities – at
different levels of the hierarchy of scientific governance and oversight in any one country.
Individual scientists
Much of the literature on the potential risks associated with accidents or the deliberate misuse of life
sciences research has thus far focused on the ethical
responsibilities of (individual) scientists in particular. The dual-use phenomenon poses a dilemma
for scientists who want to conduct research that
will benefit humanity but who, at the same time,
want to avoid projects that could potentially cause
harm. Though the promotion of national security
is not usually considered to be a primary responsibility of scientists (as opposed to governments) in
particular, people in general have a duty of nonmaleficence: the duty to do no harm (123).
Some consider scientific knowledge to be inherently good (124). Others believe that it is not scientific knowledge per se that is good or bad but
rather the way that knowledge is used. Despite
conflicting opinions within the life sciences community about the wisdom of restrictions on the
search for new knowledge, the need to place limits on the application of that knowledge in certain
25
70
defined circumstances is broadly accepted. And
there is widespread agreement that all research
in the life sciences must be conducted in a safe
and ethical manner. There are, however, differing
views on the question of whether scientists should
be held responsible for the misapplications of their
research by others, whether foreseeable or not.
This dispute is but one facet of the ongoing debate
about the scope and limits of the responsibility of
researchers.
One important and widely acknowledged duty
of the individual scientist is to follow good research
practices and conduct research responsibly. Good
scientific practice in research is recognized as
essential for the integrity of research, to nurture
confidence within the research community and
with society. Progress and development in scientific research also rely on the honest treatment of
data and on open, transparent research that could
be reproduced, thereby allowing quality control.
This also includes the relevance of bringing the
potential safety and security concerns associated
with research activities to the attention of review
committees and publishers during review processes. Good research practices generally include the
conscientious avoidance of research misconduct
(fabrication, falsification or plagiarism); policies for
handling misconduct, conflicts of interests, data
management, authorship, peer review and collaborative research; and policies regarding the protection of human and animal subjects (125, 126).1
In 2007, at the first world conference “Research
integrity: fostering responsible research,” participants discussed strategies for fostering responsible conduct in research and the possibilities of
implementing international standards for research
integrity (127). In 2010, at the second world conference on Research Integrity, a consensus emerged
that research integrity needed urgent and international attention (128).
In a similar vein, another important responsibility of individual researchers is to consider the possible future implications of their work and, as far
as possible, undertake such an evaluation as part
of the research risk assessment. But there are some
difficulties associated with this. First, enabling
individual researchers to exercise such a responsibility requires raising their awareness about those
potential risks. Empirical research has shown that
life scientists currently lack much awareness on this
topic in general (97). Awareness-raising will not, of
course, make scientists able to predict the future
with certainty. Second, scientists may not have the
security expertise to undertake such assessment,
not to mention possible conflicts of interest that
may arise. So the expectation is merely that scientists, to the best of their ability, make informed
reflective judgements – taking the likelihood and
magnitude of reasonably foreseeable harms and
benefits of research into account – about whether
or not, or the extent to which, precaution is necessary. The ability of scientists to make such judgements could, meanwhile, be enhanced via relevant
education (regarding biorisks, biosafety and laboratory biosecurity, and ethics).
Additional duties of scientists include developing awareness of and maintaining compliance
with existing laws, regulations and procedures
applicable in their respective fields of expertise,
including: those related to research review or oversight whether at a national or institutional level;
safety procedures; and codes of conduct established by relevant science societies. In doing so,
scientists can play a role in influencing the updating of these laws, regulations and procedures, as
and when is necessary. Depending on decisions
made by actors at other levels, one or more of the
above (i.e. research institutions, codes of conduct,
and/or national regulations) may formally require
that individual scientists report potential risks to a
review committee when a research proposal is submitted and/or before results are published. Scientists should also be educated and regularly trained
about ethical issues that may arise in their work
(see Section 2.2.5). Reflection and debate on current working practices or past experiences can help
stimulate discussions on issues that are of interest to them. This could be achieved through ethics education in undergraduate and postgraduate
curricula and also through ongoing professional
education of scientists. Last, but not least, individual researchers may have obligations regarding
whistle-blowing and playing an advocacy role in
science policy debates.
See also European Science Foundation (ESF) Member
Organisation Forum on Research Integrity (www.esf.org/
activities/mo-fora/research-integrity.html, accessed October 2010) and OECD’s Global Science Forum on Best Practices for Ensuring Scientific Integrity and Preventing Misconduct
(www.oecd.org/dataoecd/37/17/40188303.pdf, accessed October 2010).
1
Research institutions
The possibility of accidents or the deliberate misuse of life sciences research also raises ethical
issues for institutions where research takes place.
26
71
Among other things, research institutions should
be encouraged to have mechanisms in place to
address potential risks arising from research taking place within their confines and provide relevant
education, information and support for researchers. Research institutions have a responsibility to
ensure that research is in accordance with national
law and/or relevant codes of conduct. Though
codes of conduct are often considered to be a voluntary governance mechanism, some institutions
have found ways to enforce them, for instance, as a
condition of employment.
A growing trend in recent years has involved
increased provision of, sometimes mandatory,
research ethics education to scientists. In light of
the importance of the safety and security issues
considered in this document, research ethics education of scientists could be expanded to ensure coverage of such topics. Research institutions should,
for example, consider whether to include such education as part of the routine undergraduate and/or
postgraduate training of scientists. Another possibility that has been adopted by certain countries
for researchers involved in clinical trials involving
human subjects is to make research ethics education a condition of research funding.
Given the importance of whistle-blowing in the
event that scientific misconduct occurs, research
institutions should have established procedures for
whistle-blowing and provide adequate protection
to whistle-blowers.
Finally, research institutions should support
researchers in addressing dual-use issues if they
arise. There have been recent cases of scientists
seeking but receiving little, if any, guidance from
research institutions about how to handle dualuse discoveries (129). Because scientists often lack
expertise in matters of security, they should be
provided with institutional assistance in resolving
difficult questions – especially when they explicitly
ask for such help. Ethics committees or biosafety
committees might, in some cases, provide some
support, although it is recognized that some may
not (currently) have the knowledge or mandate to
deal with these issues. If untoward consequences
result from research, then this may adversely affect
the researcher’s career and damage the reputation
of the research institution. These are reasons why
research institutions should aim to provide competent guidance in difficult cases. In the most vexing
cases, research institutions may themselves need
to seek outside assistance/consultation (e.g. from
government) regarding what should be done.
Science societies
To date a good deal of attention has been focused
on the possible incorporation within codes of conduct of guidance on the possibility of accidents or
the deliberate misuse of life sciences research (see
Section 2.2.4). Codes of conduct may be useful in
raising awareness and also in fostering an understanding of and respect for certain norms. They can
also be deployed in efforts to sensitize scientists
and the public health community, and to establish
public confidence and accountability. Although
codes of conduct may be adopted at institutional
level, they are perhaps best suited for adoption and
promulgation at the scientific community level.
One possibility might be the establishment of a
code of conduct for scientists, or life scientists, in
general. Another possibility might be the adoption
of specific codes of conduct by various subspecialties of life sciences research. Relevant science societies should, therefore, be encouraged to decide
whether or not to adopt such codes and/or what
to include in their content. They may also consider
using their professional development processes as
a way to raise awareness on this issue. Likewise, a
decision might be taken as to whether or not, and/
or how, to promote or enforce adherence to codes
on the part of their members. It is common for professional societies (like medicine) to enforce codes
of conduct – i.e. as a condition of official membership and/or licensing (130). Among other things,
life sciences societies must decide whether or not
to go this route. Yet, many questions remain in
terms of commitments, motivations and strategies
to make them meaningful and effective (94, 95).
Science societies and other relevant bodies representing scientific communities, such as scientific
unions, are ultimately concerned with the promotion of excellent science and of the fruits of scientific research. Raising awareness and providing
guidance to researchers about issues such as the
dual-use dilemma – via codes of conduct – may be
one good way to achieve this aim.
Publishers and journal editors
Controversy surrounding some research activities
has to a large extent focused on the publication of
a small number of high-profile dual-use discoveries (see Section 2). Publishers and journal editors
play a crucial role in determining what becomes
publicly available information and are thus ultimately accountable to the public for their decisions.
Regardless of ultimate decisions about the publication of potential dual-use research findings, pub27
72
lishers need to be encouraged to develop criteria for
deciding whether, or not, and/or how, and when to
screen submissions for the risks of such findings
prior to publication. Science publishers and editors
have the responsibility to publish papers that will
promote the advancement of science; but they also
have responsibilities as publishers of papers that
may have adverse societal consequences.
In 2003 a number of important life sciences journals published a joint journal statement on scientific publication and security (see Section 2.2.2),
which includes provisions for the appropriate
level and design of processes to accomplish effective review of papers that raise safety and security
issues. Journals involved in this kind of review will
need to develop mechanisms for assessing risks
and benefits in difficult cases. On the one hand,
science publishers should employ sufficiently vigilant measures to identify submissions that may
raise concerns. On the other hand, review procedures should not be overly restrictive as this would
unnecessarily hinder scientific progress and societal benefits thereby made possible. Because the
assessment of risks and benefits is a complex task
that is beyond the traditional scope and capacity
of scientific publishers, consultation with appropriate experts is an essential part of publication processes.1 Responsible publication decision-making
requires adequate expert input, which may not be
so easy to find.
Governments might therefore consider what, if
any, regulations associated with research oversight
mechanisms might be administered by law and/
or what role governmental institutions could play
in the monitoring of research activities and the
provision of advice and guidance to scientists and
research institutions. National laws (see Section 2)
already include measures to protect workers from
the risks of exposure to biological agents; provisions for licensing laboratories and researchers; for
the transport of biological agents; and other measures.2
Governments can also influence the direction
of science when making decisions about what
projects or areas of research to fund. Consonant
with their aims of promoting and protecting the
good of society, governments should provide more
financial support to areas of research most likely
to have the greatest net societal benefits. Just as
scientists should weigh benefits against the risks
when deciding which projects to pursue, governments should be encouraged to do the same when
deciding which projects to fund. Other ways could
include consideration of this issue during the setting of education agendas (e.g. ethics, biosafety
and labortory biosecurity in science undergraduate and postgraduate education programmes); the
provision of resources to address this issue; and
including scientists in the design of policies.
Finally, at the international level, both international organizations and funding bodies may also
face dilemmas. At the same time as they promote
scientific development and research, in particular
in developing countries, to improve public health,
these actors may consider to promote global health
security and to minimize any risks to public
health.
National governments, international organizations
and funding bodies
The possibility of accidents or deliberate misuse
of life sciences research also poses dilemmas for
policy-makers in government. On the one hand,
government policy should aim to promote the
advancement of science. Scientific progress usually has important societal (including economic)
benefits; and promoting the good of society is a
primary responsibility of government. Promotion
of scientific progress partly requires provision of
financial support for research, and governments
are usually prudent not to overburden scientists
with regulations. At the same time, safety, security and economic development are significant
responsibilities of governments. Science inevitably
affects society in innumerable ways, and so society
(via governments) has set a number of measures
to manage scientific research. Ideally, safety and
security measures should help promote science to
reach its social benefits and maintain public trust
in science.
3.2.3 Remarks
The preceding discussion underscores the complexity of the issues associated with the possibility
of accidents or the deliberate misuse of life sciences
research and highlights the ethical challenges that
confront numerous actors working within different
domains with different types of responsibility. The
possibility of accidents or the deliberate misuse of
science is not just a problem for scientists – it also
poses challenges for research institutions, science
For a list of different journal’s policies, see (37).
For additional information, see the United Nations Office at
Geneva, the Biological Weapons Convention (www.unog.
ch/bwc, accessed October 2010).
1
2
28
73
document on laboratory management has been
published by the CEN (European Committee for
Standardization) (4). The CEN Workshop Agreement (CWA) is based on a management system
approach and promotes the adoption of recognized standards for the management of biological
risks. Such standards should help an organization
to identify, monitor and control the biosafety and
laboratory biosecurity aspects of its activities.
Calls for the use of biosafety and laboratory
biosecurity measures for addressing the risks associated with accidents and the potential misuse of
research have also been emphasized in several
documents, including the InterAcademy Panel
statement on biosecurity (33), the International
Council for Life Sciences (131), Sixth Review Conference of the BWC (132), the OECD guidelines on
biosecurity (36) and the WHO laboratory biosecurity guidance (1).
Box 16
Summary of ethics elements for
Use existing platforms, if appropriate.
Promote ethics education and training for students and professionals.
Encourage discussion and reflection on research
practices.
Hold institutions and researchers to account
and ensure they are aware of their responsibilities.
Ensure institutions and researchers are aware
of existing and new legislation, regulations at the
country but also at the regional and international
levels.
societies, publishers, journal editors, national governments, and regional and international bodies.
At the international level, facilitating the sharing of
experiences and best practices is important so that
no incompatible measures are put forward that
make international collaboration harder. Responsible decision-making is required by actors at all
levels. Decision-makers will need to make judgements to resolve difficult cases of conflicting values. Scientific freedom, scientific progress, public
health, safety and security are all important values,
and none should be given absolute priority over
the others. Conflict between these values, in any
case, is not always inevitable. Wherever possible,
decision-makers should aim to promote all of these
values – and others – at the same time.
3.3.1Elements of biosafety and laboratory
biosecurity
Biosafety and laboratory biosecurity refer to containment principles, technologies and practices
implemented to prevent unintentional exposure to
pathogens and toxins, or their accidental release,
as well as to protect, control and account for valuable biological materials (VBM)1 within laboratories, in order to prevent their unauthorized access,
loss, theft, misuse, diversion or intentional release.
Concerned with the mitigation of different but
related risks, both biosafety and laboratory biosecurity are based on risk assessment (3). In the
WHO approach, effective biosafety practices are
the foundation of laboratory biosecurity activities: indeed, the implementation of good biosafety
practices also addresses certain key dimensions of
laboratory biosecurity.
For any given laboratory activity, procedure
or experiment with any pathogenic agent, a risk
assessment should be carried out to determine the
appropriate combination of risk mitigation measures which currently are captured in distinctive
biosafety levels. Laboratory facilities are divided
into four levels, from basic – Biosafety Level 1 –
to maximum containment – Biosafety Level 4 (3).
Each level has a set of particular design features,
construction, equipment, containment practices,
use of personal protective equipment and operational procedures ascribed to it. Risk assessments
are based on a series of factors, including the
3.3 Pillar 3: Biosafety and laboratory
biosecurity
Based on site-specific risk assessments, laboratory facilities that handle biological materials
should develop and implement appropriate safety
and security measures. These measures are critically important: they serve to minimize the risk of
worker exposure to pathogens and infections, and
to protect the environment and the community.
Despite advances in technology and the sophistication of many instruments, laboratory-acquired
infections still occur, often due to lack of training,
competency and supervision and human errors.
WHO has published guidelines on biosafety since
1983 and, more recently, has provided guidance
for laboratory biosecurity (1). Another important
See footnote under Definitions.
1
29
74
inherent properties of the agent; the consequences
of any exposure and/or infection; the laboratory
activity planned; and local laboratory conditions.
Identified risks should be reduced to acceptable
levels through appropriate risk mitigation measures. Strict adherence to the appropriate risk mitigation measures will help to minimize risks (3).
In terms of laboratory management, biosafety
practices should be based on a comprehensive
laboratory biorisk management system under the
ultimate responsibility of the director of the laboratory. Although all laboratory workers and managers are responsible for their own safety and that of
their colleagues, a laboratory biorisk management
adviser1 should be appointed, whenever possible,
to ensure that the biosafety and laboratory biosecurity measures are followed consistently throughout the laboratory.
According to the Laboratory Biorisk Management Standard (4), the competent individual
providing advice and guidance on biorisk management is often recognized as a biological safety
officer or biological safety adviser. This function
should be regarded as an advisory position and
not directly responsible for managing biorisks, as
this rests with those conducting and managing the
work within the organization. The role and knowledge of the laboratory biorisk management adviser
is important to develop, implement, maintain and
continually improve a biosafety and biosecurity
programme based on a management system. The
adviser should be competent to perform the role,
and allocated sufficient time and other resources
to do the job effectively. In the execution of his/
her biorisk management duties the adviser should
be independent from those responsible for implementing the programme of work and have direct
access to the top management representative when
necessary.
A biosafety committee may support the biorisk
management adviser. Members of this committee should cover the diverse areas of occupations
and expertise of the laboratory, may be in charge
of developing institutional biosafety policies and
codes of practice. Such a committee may also be
Box 17
Elements of laboratory biorisk
management system
Biorisk management system
Risk assessment
Facility physical requirements
Equipment and maintenance
Occupational health and medical programmes
Good microbiological techniques
Emergency response and contingency planning
Personnel and competency
Biological agent and toxin inventory and
information
General safety
Clothing and personal protective equipment
Human factors
Accident/incident investigation
Decontamination, disinfection and sterilization
Transport procedures
Security
Source: CEN Workshop Agreement. Laboratory biorisk
management standard (CWA15793:2008), (ftp://ftp.
cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf,
accessed October 2010).
tasked to review research protocols and may be
asked to carry out other functions such as risk
assessments or the development of new safety
policies and the arbitration of disputes over safety
matters (3).
Laboratory biosecurity, which is not only complementary to good biosafety practices, but also an
integral part of an overall laboratory biorisk management system, addresses the safekeeping of all
valuable biological materials (VBM), which include
pathogens and toxins but also all biological materials which have a scientific, historical or economic
importance (1, 133). This includes collections, references strains, vaccines, food and pharmaceutical
products, GMOs and non-pathogenic microorganisms. It is important to emphasize that implementation of biosafety and laboratory biosecurity can
and should go hand-in-hand.
Based on a laboratory biosecurity risk assess-
A laboratory biorisk management adviser is “an individual
who has expertise in the biohazards encountered in the organization and is competent to advise top management and
staff on biorisk management issues. NOTE Depending on
national guidelines and institutional traditions the role of a
biorisk management adviser may be differently named e.g.
biosafety officer, biosecurity officer, biorisk manager or biorisk management officer.” (4).
1
30
75
ment, a specific laboratory biosecurity plan should
be developed to manage the identified risks; such
a plan should reflect the needs and requirements
of each facility, the type of laboratory work undertaken and other appropriate considerations. Different actors may be part of a laboratory biosecurity
assessment and may include the head of the laboratory, principal investigator, laboratory biorisk management adviser, administrators, and emergency
and law enforcement agencies. Regular competency-based training of personnel regarding mitigation measures is essential for good implementation
of the laboratory biorisk management system.
Box 18
Summary of laboratory elements for
responsible life sciences
Conduct biosafety and laboratory biosecurity
risk assessments and, based on these, apply
appropriate risk reduction measures.
Implement a laboratory biorisk management
system.
Explore the use of existing biorisk management
structures (e.g. laboratory biorisk management
adviser and the biosafety committee) to address
issues related to the risks posed by life sciences
research.
3.3.2Biosafety, laboratory biosecurity and
responsible life sciences
Set performance objectives and work on continuous improvement.
Safe and secure working practices associated with
the conduct of research in laboratory settings are
important elements for addressing the risks that
could potentially arise from accidents or the deliberate misuse of life sciences research. Good laboratory biosafety practices will mitigate the risks posed
by laboratory accidents while laboratory biosecurity
procedures will strengthen the accountability and
responsibility of laboratory workers and their managers and thereby enhance public confidence in the
responsible conduct of scientific experiments.
In the future more and more laboratories will
implement comprehensive systems that allow them
to manage the risks associated with biological
materials in the laboratories. Performance based
systems based on existing international standards (e.g. ISO, CEN) have already made significant
inroads in addressing key performance and quality
issues (e.g. ISO 17025). On the safety and security
side, the risks associated with biological materials
in the laboratory can be comprehensively managed
through the implementation of three key compo-
nents: risk assessment, risk mitigation and performance systems (4).
There is a need for collaboration between
nat ional authorities, researchers, bioethics committees and laboratory biorisk advisers to identify
the appropriate risk management measures under
which activities would be performed. In addition to
the role of the researcher and laboratory manager,
the laboratory biorisk management adviser and
the biosafety committee can also play an important role in the management of risks associated
with accidents and the deliberate misuse of life sciences research.1 In addition to ensuring that safe
and secure practices are established and followed
during the conduct of life sciences research activities, they are also involved with addressing the
risks associated with research protocols and codes
of practice at the laboratory level.
See Section 1.2.1 Terminology for the use of the words “accidents and the deliberate misuse of life science research”.
1
31
76
4. The way forward:
the self-assessment questionnaire
4.1Using the self-assessment tool
This guidance promotes a culture of scientific integrity and excellence, distinguished by openness,
honesty, accountability and responsibility. Such a
culture is the best protection against accidents, the
inadvertent harmful consequences of research and
deliberate misuse, and the best guarantee of scientific progress and development.
This guidance has identified three pillars of a
biorisk management framework for responsible
life sciences research: research excellence, ethics,
and biosafety and laboratory biosecurity. The selfassessment questionnaire presented below (Section 4.3) is intended to help health policy-makers,
health professionals, laboratory managers, professional associations and individual scientists assess
the extent to which elements related to the three
pillars are in place – in the national public health
system and in individual laboratories – to identify
their respective strengths and weaknesses, and to
build on their strengths and address their weaknesses in each of these three pillars. It can be used
in a number of other ways, as explained below in
Section 4.2.
There is no single solution or system that will
suit all countries and all laboratories. Each interested country or institution needs to assess the extent
to which it has systems and practices in place to
deal with this issue at local and national levels, and
to decide which measures need to be reinforced.
In general, oversight, safety and public security
should be pursued in a manner that maximizes scientific progress and preserves scientific freedom.
This requires excellent facilities, and the management of them (including laboratories), leadership
with integrity, a robust ethical framework, training
and capacities development, institutional development and regular review.
Self-assessment is a process that begins with an
identification of strengths, weaknesses and gaps
and concludes with action to address the gaps and
weaknesses and to build on or consolidate the
strengths.
The questionnaire that follows allows users to
assess the extent to which structures, mechanisms
and processes are in place that will facilitate and
ensure excellence in science, safety and security.
The second part of the process of self-assessment
requires users to consider those areas that have
been identified as weaknesses or gaps through
answering the questions. This second stage may
involve meetings with others who are involved in
laboratory management or policy formulation. The
final aspect of self-assessment is corrective action
to address gaps or weaknesses identified.
The questionnaire can be used as a quick assessment for individuals in senior government positions, or even laboratory managers. It can also be
completed by employees at a research facility as a
process of assessing the institution.
Aside from its primary purpose of assessment,
the questionnaire is also intended to stimulate discussion and debate about the issues raised, to raise
awareness about the three pillars of the biorisk
management framework, and to provide a basis for
thinking about what is necessary to ensure good
quality, responsible activities in the life sciences.
4.2Interpreting the results of the
self-assessment tool
If the questionnaire is to be used as a quick assessment for individuals in senior government positions, or laboratory managers the user may find
that the first time they try to answer the questions, many of the answers will be “don’t know”.
In other words, it is likely that many respondents,
particularly senior government officials, may not
have an overview of the detailed implementation
of systems for safety, security and ethics at public
32
77
health facilities. An answer of “don’t know” on any
of the questions should indicate to the user that
they need to find out more information about that
particular issue.
So, answering the questionnaire quickly, before
consulting laboratory managers or public health
care facility managers will enable the user to identify those areas where she or he requires more
information. After consultations to gather information the user may wish to fill in the questionnaire
once again. This time there may be fewer “don’t
know” responses and more that fall into the categories “agree” or “disagree”. Where the answers
are “disagree” the user should be alerted to the fact
that action may need to be taken to address the
situation. For example, if the answer to the question “Facilities and equipment are appropriate to
the level of work being done and are adequately
maintained” is “disagree” or “strongly disagree”
it is clear that the facilities and equipment are not
appropriate to the level of work being done, or are
not adequately maintained. This may present a
safety risk, both to the public and to those working
in the laboratory and suggests that measures need
to be taken to address the problem. On the other
hand, a response of “agree” or “strongly agree”
shows that appropriate measures are already in
place.
If the questionnaire is completed by a group of
laboratory scientists the results may be interpreted slightly differently. In this case a large number
of “don’t know” answers to any one of the questions may indicate that staff is uninformed about
the particular issues being probed. For example
“don’t know” responses to the question “Research
priorities are in line with national health needs”
suggests that laboratory staff do not know what
the national health needs are, or may suggest that
when research projects are initiated consideration
is not given to whether the research is in line with
national health needs. Whichever of the two it is,
the answer “don’t know” should indicate to managerial staff that there is a need to discuss the issue
further with their staff.
In general, for all users of the questionnaire,
answers of “agree” or “strongly agree” to the questions identify strengths; answers of “disagree”
or “strongly disagree” indicate weaknesses and
answers of “don’t know” indicate gaps in knowledge (in other words issues for which more information may be required).
33
78
4.3The self-assessment questionnaire
Self-assessment: Responsible life sciences research
Good quality, ethical research activities that are conducted in safe and secure
facilities strengthens public health
PILLAR 1: RESEARCH EXCELLENCE (see Section 3.1)1
Answers to the questions in this section will assess the
extent to which the basic requirements for excellent
public health research are in place
1.1 Scientific collaboration within institutions is
encouraged and facilitated
 Strongly agree
 Agree
 Disagree
 Strongly disagree
 Don’t know
1.2 Scientific collaboration between
institutions and countries is encouraged
and facilitated
 Strongly agree
 Agree
 Disagree
 Don’t know
1.6
Research matches research priorities
 Strongly agree
 Agree
 Disagree
 Don’t know
1.7
Research findings are routinely published
 Strongly agree
 Agree
 Disagree
 Don’t know
1.8 Good communication exists between policymakers and the research community
 Strongly agree
 Agree
 Disagree
 Don’t know
1.9
1.3 Research funding is transparent
(i.e. it is known who funds research, and
what research is funded at institutional level)
 Strongly agree
 Agree
 Disagree
 Don’t know
On-going research training takes place
 Strongly agree
 Agree
 Disagree
 Don’t know
1.10 Junior researchers are nurtured and
supported
 Strongly agree
 Agree
 Disagree
 Don’t know
1.4 Accountability is required (e.g. through
regular reporting of financial expenditure as
well as scientific progress)
 Strongly agree
 Agree
 Disagree
 Don’t know
1.12 Education and/or training is offered on dualuse issues
 Strongly agree
 Agree
 Disagree
 Don’t know
1.5 Research priorities are in line with national
health needs
 Strongly agree
 Agree
 Disagree
 Don’t know
For more information about Health Research System Analysis (HRSA) core indicators and descriptive variables, see
(111).
1
34
79
1.13
Skilled researchers are valued and retained
 Strongly agree
 Agree
 Disagree
 Don’t know
2.5 Researchers are competent to assess the
potential societal impact of researchStrongly  Strongly agree
 Agree
 Disagree
 Don’t know
1.14. National legislation and policy fosters
scientific development and freedom
 Strongly agree
 Agree
 Disagree
 Don’t know
2.6 Research is subject to a risk assessment that
includes potential environmental impact
 Strongly agree
 Agree
 Disagree
 Don’t know
2.7 Researchers are competent to make the
assessment of the potential environmental
impact of research
 Strongly agree
 Agree
 Disagree
 Don’t know
PILLAR 2: ETHICS (see Section 3.2)
Answers to the questions in this section will assess the
extent to which measures to ensure that research conducted is ethical are in place
2.1 Education and/or training is offered on
research ethics
 Strongly agree
 Agree
 Disagree
 Don’t know
2.8 Potential for misuse of the research is
considered at all stages and appropriate
action taken if necessary
 Strongly agree
 Agree
 Disagree
 Don’t know
2.2 Appropriate ethical research guidelines
and practices have been published and
implemented
 Strongly agree
 Agree
 Disagree
 Don’t know
2.9 Researchers know how to assess whether the
risk outweighs the benefit of continuing with
their research or activities
 Strongly agree
 Agree
 Disagree
 Don’t know
2.3 Adequate mechanisms exist for investigating
and responding to non-adherence to ethical
standards
 Strongly agree
 Agree
 Disagree
 Don’t know
2.10 A code of conduct/practice for life scientists
exists at national or institutional level
 Strongly agree
 Agree
 Disagree
 Don’t know
2.4 Research is subject to a risk assessment that
includes the societal impact of the research
 Strongly agree
 Agree
 Disagree
 Don’t know
35
80
2.11 Researchers are aware of and informed about
national and international conventions, laws
and regulations related to their research
 Strongly agree
 Agree
 Disagree
 Don’t know
PILLAR 3: BIOSAFETY AND LABORATORY
BIOSECURITY (see Section 3.3)
Answers to the questions in this section will assess
whether measures to ensure laboratory safety and security are in place
3.1 Facilities and equipment are appropriate
to the level of work being done and are
adequately maintained
 Strongly agree
 Agree
 Disagree
 Don’t know
2.12 An ethics committee assesses research
proposals involving human subjects
 Strongly agree
 Agree
 Disagree
 Don’t know
3.2 Researchers have somewhere to turn to
get competent advice if they have safety or
security questions relating to their research
 Strongly agree
 Agree
 Disagree
 Don’t know
2.13 A review process exists to assess ethical
issues raised by research proposals not
involving human or animal subjects
 Strongly agree
 Agree
 Disagree
 Don’t know
3.3 National legislation/regulation exists that
sets safety and security practices and
procedures for laboratories
 Strongly agree
 Agree
 Disagree
 Don’t know
2.14 Information about the national and
international conventions and regulations
related to all fields of science is easily
accessible
 Strongly agree
 Agree
 Disagree
 Don’t know
3.4 An assessment of the risk associated with
research activities is conducted
 Strongly agree
 Agree
 Disagree
 Don’t know
2.15 National legislation and policy relevant to
the life sciences provides protection against
the misuse of science
 Strongly agree
 Agree
 Disagree
 Don’t know
3.5 Risk assessments are able to identify
requirements for risk reduction measures
including the level of containment required
 Strongly agree
 Agree
 Disagree
 Don’t know
36
81
3.6 Biosafety and laboratory biosecurity
training is provided to all those working in
laboratories
 Strongly agree
 Agree
 Disagree
 Don’t know
3.12 Legislation/regulations regarding hazardous
waste disposal are followed
 Strongly agree
 Agree
 Disagree
 Don’t know
3.13 Health surveillance mechanisms exist and
are followed (at institutional level)
 Strongly agree
 Agree
 Disagree
 Don’t know
3.7 Biosafety and laboratory biosecurity training
includes a test of competence
 Strongly agree
 Agree
 Disagree
 Don’t know
3.14 Health reporting mechanisms exist and are
effective at institutional level
 Strongly agree
 Agree
 Disagree
 Don’t know
3.8 Standard Operating Procedures have been
developed (at institutional level)
 Strongly agree
 Agree
 Disagree
 Don’t know
3.15 Staff are required to report laboratory
accidents, incidents and near misses
 Strongly agree
 Agree
 Disagree
 Don’t know
3.9 Staff are trained to work according to the
Standard Operating Procedures
 Strongly agree
 Agree
 Disagree
 Don’t know
3.16 A record of research projects exists and is
maintained at institutional level
 Strongly agree
 Agree
 Disagree
 Don’t know
3.10 Staff are regularly tested to ensure
competence in the Standard Operating
Procedures
 Strongly agree
 Agree
 Disagree
 Don’t know
3.17 A record of valuable biological materials
exists and is maintained at institutional level
 Strongly agree
 Agree
 Disagree
 Don’t know
3.11 Legislation/regulations exist to address
hazardous waste disposal
 Strongly agree
 Agree
 Disagree
 Don’t know
3.18 Valuable biological material is safely and
securely stored
 Strongly agree
 Agree
 Disagree
 Don’t know
37
82
3.19 Mechanisms exist for staff to report unlawful
or irregular conduct (i.e. whistle-blowing
mechanisms exist)
 Strongly agree
 Agree
 Disagree
 Don’t know
3.20 Measures exist to protect staff who report
unlawful or irregular conduct from
occupational detriment
 Strongly agree
 Agree
 Disagree
 Don’t know
38
83
References
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Laboratory biosecurity guidance. Geneva, World
Health Organization, 2006.
Scientific working group on life science research and
global health security. Report of the first meeting.
Geneva, World Health Organization, 2007 (WHO/
CDS/EPR/2007.4).
Laboratory biosafety manual. Third edition. Geneva,
World Health Organization, 2004.
CEN Workshop Agreement. Laboratory biorisk
management standard (CWA15793:2008), (ftp://
f t p.cenor m.be / PU BLIC / C WA s /wok rshop31/
CWA15793. pdf, accessed October 2010).
Life science research: opportunities and risks for public
health. Mapping the issues. Geneva, World Health
Organization, 2005 (WHO/CDS/CSR/LYO/2005.
20).
The world health report 2007 – A safer future: global
public health security in the 21st century. Geneva,
Pang T et al. Knowledge for better health – a conceptual framework and foundation for health research
systems. Bulletin of the World Health Organization,
2003, 81:815–820.
Winslow CE. The untilled fields of public health.
Science, 1920, 51:23–33.
Public health response to biological and chemical weapons: WHO guidance. Geneva, World Health Organization, 2004.
Cyranoski D. Woo Suk Hwang convicted, but not
of fraud. Nature, 2009, 461:1181.
Kennedy D. Responding to fraud. Science, 2006,
314:1353.
Editorial. Risks and benefits of dual-use research.
Nature, 2005, 435:855.
Campbell P. Empowerment and restraint in scientific communication. New developments make it
easier to share information, but more difficult to
deal with dual-use biology. The European Molecular Biology Organization Reports. Special Issue, 2006,
7:S18–S22.
Editorial. Towards better biosecurity. Nature, 2006,
440:715.
U.S. National Academies, National Research
Council, Committee on Research Standards and
Practices to Prevent the Destructive Application
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
39
84
of Biotechnology. Biotechnology research in an age
of terrorism. Washington, DC, The National Academies Press, 2004.
Genomics and world health: report of the Advisory
Committee on Health Research. Geneva, World
Dowdeswell E et al. Increasing human security
through biotechnology. International Journal of Biotechnology, 2006, 8:119–131.
Daar AS et al. Top 10 biotechnologies for improving health in developing countries. Nature Genetics,
2002, 32:229–232.
Morel CM et al. Health innovation networks to
help developing countries address neglected diseases. Science, 2005, 309:401–404.
The RNA revolution: Biology’s big bang. The Economist, 14 June 2007.
DNA for Peace. Reconciling biodevelopment and biosecurity. Toronto, University of Toronto Joint Centre
for Bioethics, 2006.
Public health innovation and intellectual property
rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva,
Ijsselmuiden C et al. From Mexico to Mali: a new
course for global health. The Lancet, 2008, 371:91–
93.
The global burden of disease: 2004 update. Geneva,
World report on knowledge for better health: strengthening health systems. Geneva, World Health Organization, 2004.
Juma C, Yee-Cheong L. Reinventing global health:
the role of science, technology, and innovation. The
Lancet, 2005, 365:1105–1107.
Jasanoff S. Designs on nature: science and democracy
in Europe and the United States. Princeton, New Jersey, Princeton University Press, 2005.
Kinderlerer J. Biotechnology: A comparative look at
governing science. Science, 2005, 309:704–706.
Research policy and management of risks in life sciences research for global health security. Report of the
meeting. Bangkok, Thailand, 10–12 December 2007.
Geneva, World Health Organization, 2008 (WHO/
HSE/EPR/2008.4).
30. Rappert B, Gould C (eds). Biosecurity: Origins, transformations and practices. New Security Challenges
Series, Basingstoke, Palgrave Macmillan, 2009.
31. Zmorzynska A, Hunger I. Restricting the role of
biosecurity. Op-Eds, Bulletin of the Atomic Scientists,
December 2008.
32. The Sunshine Project. Biosafety, biosecurity, and bioweapons. Three agreements on biotechnology, health,
and the environment, and their potential contribution
to biological weapons control. Background Paper 11,
2003.
33. The InterAcademy Panel on International Issues
(IAP). IAP statement on biosecurity. November
2005.
34. Food and Agriculture Organization of the United
Nations. Technical consultation on biological risk management in food and agriculture. Report of the technical
consultation. Bangkok, Thailand, 13–17 January 2003
(TC/BRM/Rep).
35. United Nations (UN) Meeting of the States Parties
to the Convention on the prohibition of the development, production and stockpiling of bacteriological (biological) and toxin weapons and on their
destruction. Report of the meeting of states parties.
December 2008 (BWC/MSP/2008/5).
36. Organisation for Economic Co-operation and
Development (OECD). Best practice guidelines on
biosecurity for Biological Resources Centres. Paris,
OECD Publishing, 2007.
37. National Science Advisory Board for Biosecurity.
3rd International roundtable. Sustaining progress in the
life sciences: strategies for managing dual use research
of concern. National Science Advisory Board for
Biosecurity, Bethesda, Maryland, November 2008.
38. McLeish C, Nightingale P. Biosecurity, bioterrorism and the governance of science: the increasing
convergence of science and security policy. Research
Policy, 2007, 36:1635–1654.
39. Jackson RJ et al. Expression of mouse interleukin-4
by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic
resistance to mousepox. Journal of Virology, 2001,
75:1205–1210.
40. Cello J et al. Chemical synthesis of poliovirus
cDNA: generation of infections virus in the absence
of natural template. Science, 2002, 297:1016–1018.
41. Rosengard AM et al. Variola virus immune evasion
design: expression of a highly efficient inhibitor
of human complement. Proceedings of the National
Academy of Sciences of the United States of America,
2002, 99:8808–8813.
42. Tumpey TM et al. Characterization of the reconstructed 1918 Spanish influenza pandemic virus.
Science, 2005, 310:77–80.
43. Taubenberger JK et al. Characterization of the 1918
influenza virus polymerase genes. Nature, 2005,
437:889–893.
44. Dennis C. The bugs of war. Nature, 2001, 411:232–
235.
45. Wimmer E. The test-tube synthesis of a chemical
called poliovirus. The simple synthesis of a virus
has far-reaching societal implications. The European Molecular Biology Organization Reports. Special
Issue, 2006, 7:S3–S9.
46. Block SM. A not-so-cheap stunt. Science, 2002, 297:
769.
47. Kennedy D. Response. Science, 2002, 297:769–770.
48. Centers for Disease Control and Prevention (CDC).
Questions & answers. Reconstruction of the 1918 influenza pandemic virus (www.cdc.gov/FLU/ABOUT/
QA/1918flupandemic.htm, accessed October 2010).
49. Kobasa D et al. Aberrant innate immune response
in lethal infection of macaques with the 1918 influenza virus. Nature, 2007, 445:319–323.
50. Kobasa D et al. Enhanced virulence of influenza A
viruses with the haemagglutinin of the 1918 pandemic virus. Nature, 2004, 431:703–707.
51. von Bubnoff A. The 1918 flu virus is resurrected.
Nature, 2005, 437:794–795.
52. Smith K. Concern as revived 1918 flu virus kills
monkey. Nature, 2007, 445:237.
53. Kaiser J. Virology: Resurrected influenza virus
yields secrets of deadly 1918 pandemic. Science,
2005, 310:28–29.
54. Rappert B. Biotechnology, security and the search for
limits: an inquiry into research and methods. New
Security Challenges Series, Basingstoke, Palgrave
Macmillan, 2007.
55. van Aken J. When risk outweighs benefit. Dual-use
research needs a scientifically sound risk–benefit
analysis and legally binding biosecurity measures.
The European Molecular Biology Organization Reports.
Special Issue, 2006, 7:S10–S13.
56. Kennedy D. Better never than late. Science, 2005,
310:195.
57. Sharp PA. 1918 flu and responsible science. Science,
2005, 310:17.
58. Royal Society. Synthetic biology Scientific Discussion Meeting Summary. RS policy document 16/08,
2008.
59. Gibson DG et al. Complete chemical synthesis,
assembly and cloning of a Mycoplasma genitalium
genome. Science, 2008, 319:1215–1220.
to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and their
Destruction. Background information on scientific
and technological developments that may be relevant to
the convention. November 2008 (BWC/MSP/2008/
INF.1).
61. Gibson DG et al. Creation of a bacterial cell controlled by a chemically synthesized genome.
Science, 2010, 329:52–56.
40
85
References
62. Ro D-K et al. Production of the antimalarial drug
precursor artemisinic acid in engineered yeast.
Nature, 2006, 440:940–943.
63. Synthetic biology. Applying engineering to biology.
Report of a NEST High-Level Expert Group, Brussels, European Commission, 2005.
64. The European Group on Ethics in Science and New
Technologies to the European Commission. Ethics of
synthetic biology. Opinion No 25. Brussels, 17 November 2009. Luxembourg, European Union, 2010.
65. Editorial. Policing ourselves. Nature, 2006, 441:
383.
Proposed framework for the oversight of dual use life
sciences research: strategies for minimizing the potential
misuse of research information. A report of the National
Science Advisory Board for Biosecurity (NSABB). June
2007.
67. Miller S and Selgelid MJ. Ethical and philosophical
consideration of the dual-use dilemma in the biological sciences. Dordrecht NE, Springer, 2008. Report
prepared by the Centre for Applied Philosophy and
Public Ethics at the Australian National University
for the Australian Department of Prime Minister
and Cabinet, National Security Science and Technology Unit, November 2006.
68. Steinbruner J et al. Controlling dangerous pathogens.
A prototype protective oversight system. The Center
for International and Security Studies at Maryland
(CISSM), The University of Maryland, College
Park, Maryland, March 2007.
to the Convention on the Prohibition of the Development, production and stockpiling of bacteriological (biological) and toxin weapons and on their
destruction. Report of the meeting of States Parties.
December 2005 (BWC/MSP/2005/3).
70. Managing risks of misuse associated with grant funding activities. A joint Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research
Council (MRC) and Wellcome Trust policy statement.
September 2005.
71. Medical Research Council position statement on bioterrorism and biomedical research. September 2005.
72. BBSRC statement on misuse of bioscience research.
November 2007.
73. Wellcome Trust. Guidelines on good research practice.
November 2005.
74. Pauwels E. Ethics for researchers. Facilitating Research
Excellence in FP7. European Commission. Luxembourg, Office for Official Publications of the European Communities, 2007.
75. Commission of the European Communities.
Green paper on bio-preparedness. Brussels, 11.7.2007
COM(2007) 399 final, 2007.
76. Statement on the scientific publication and security. Science, 2003, 299:1149.
77. Council of Science Editors (CSE). White paper on
promoting integrity in scientific journal publications.
March 2009.
78. National Science Advisory Board. APPENDIX 5.
Points To consider in assessing the risks and benefits of communicating research information with
dual use potential in national science advisory
board for biosecurity. In: National Science Advisory Board for Biosecurity. Proposed framework for
the oversight of dual use life sciences research: strategies for minimizing the potential misuse of research
information. A report of the National Science Advisory
Board for Biosecurity (NSABB). June 2007:53–54.
79. Australia, National Health Security Act 2007, Act
No. 174 of 2007 as amended.
80. United Nations (UN) Meeting of the States Parties to the Convention on the Prohibition of the
Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and
their Destruction. National measures and views on
biosafety and biosecurity. Submitted by Brazil. August
2008 (BWC/MSP/2008/MX/WP.28).
81. Valle S, Barreira Y. Biossegurança – engenharia
genética. Legislação brasileira. Rio de janeiro, Publit
Editora, 2007.
Destruction. European Union legislation and recommendations related to biosafety and biosecurity. Submitted by Germany on behalf of the European Union.
August 2008 (BWC/MSP/2008/MX/WP.13).
83. United Nations (UN) Meeting of the States Parties to the Convention on the Prohibition of the
Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and
their Destruction. Implementation of the UK anti-terrorism, crime and security act (ATCSA) 2001: Biosecurity aspects. Submitted by the United Kingdom of
Great Britain and Northern Ireland. July 2008 (BWC/
MSP/2008/MX/WP.6).
Destruction. Revision to the UK regulatory framework
governing human and animal pathogens. Submitted by
United Kingdom of Great Britain and Northern Ireland.
July 2008 (BWC/MSP/2008/MX/WP.7).
Destruction. Registration and licensing of facilities
and persons handling biological materials. Submitted
by Germany. August 2008 (BWC/MSP/2008/MX/
WP.14).
41
86
Destruction. Security vetting of personnel handling
dangerous biological materials. Submitted by Germany. August 2008 (BWC/MSP/2008/MX/WP.15).
Destruction. Implementation of legislation and measures related to biosafety and biosecurity in EU member
states. Submitted by Germany on behalf of the European Union. August 2008 (BWC/MSP/2008/MX/
WP.16).
88. McLeish C, Nightingale P. The impact of dual use
controls on UK science: results from a pilot study.
Report of ESRC Science and Society Project: Dualuse controls and genomic research. SPRU Electronic
Working Paper Series, paper no 132, April 2005.
89. United Nations Security Council. Security Council
Committee established pursuant to resolution 1540
(2004) Note verbale dated 3 January 2006 from the
Permanent Mission of South Africa to the United
Nations addressed to the Chairman of the Committee.
January 2006 (S/AC.44/2004/(02)/lO2/Add. 1).
90. Rappert B. Responsibility in the life sciences:
Assessing the role of professional codes. Biosecurity
and bioterrorism: Biodefense strategy, practice and science, 2004, 2:164–174.
91. Rappert B. Towards a life sciences code: Countering
the threats from biological weapons. In: Pearson
GS, Dando MR (eds). Strengthening the Biological
Weapons Convention. Briefing Paper (second series),
University of Bradford, Department of Peace Studies, 13, 2004.
92. The United Nations Educational, Scientific and
Cultural Organization (UNESCO). Recommendation adopted on the report of the Commission for
Science at the thirty-eighth plenary meeting on 20
November 1974.
93. Somerville MA, Atlas RM. Ethics: a weapon to
counter bioterrorism. Science, 2005, 307:1881–1882.
94. Rappert B. Codes of conduct and biological weapons: an in-process assessment. Biosecurity and bioterrorism: Biodefense strategy, practice and science,
2007, 5:145–154.
95. Rappert B. Experimental secrets: international security, codes, and the future of research. New York, University Press of America, 2009.
96. Rappert B. Education for the life sciences: choices
and challenges. In: Rappert B, McLeish C. A web
of prevention: biological weapons, life sciences and the
governance of research. London, Earthscan, 2007,
51–65.
97. Dando M, Rappert B. Codes of conduct for the life
sciences: Some insights from UK academia. Briefing
Paper No. 16 (Second series), Bradford, UK, University of Bradford, May 2005.
98. Mancini G, Revill J. Fostering the biosecurity norm:
Biosecurity education for the next generation of life scientists. Landau Network-Centro Volta (LNCV) and
University of Bradford, November 2008.
Strategic plan for outreach and education on dual use
research issues. Report of the National Science Advisory Board for Biosecurity (NSABB). December 2008.
100. Berger KM et al. Professional and graduate-level
programs on dual use research and biosecurity for scientists working in the biological sciences: Workshop
report. Washington, DC, American Association for
the Advancement of Science, 2008.
101. Rappert B. The benefits, risks, and threats of biotechnology. Science and Public Policy, 2008, 35:37–
43.
102. Hanney SR et al. The utilisation of health research
in policy-making: concepts, examples and methods
of assessment. Health Research Policy and Systems,
2003, 1, no. 2.
103. Ali N et al. What factors influence national health
research agendas in low and middle income countries? COHRED Record Paper 5. Geneva, Council
on Health Research for Development (COHRED),
2006.
104. Kennedy A et al. National health research system
mapping in 10 Eastern Mediterranean countries.
La Revue de Santé de la Méditerranée orientale, 2008,
14:502–517.
105. Investing in Health Research and Development: report
of the ad hoc committee on health research relating to
future intervention options. Geneva, World Health
Organization, 1996.
106. Report of the International Conference on Health
Research for Development, Bangkok, 10–13 October
2000. Geneva, International Organizing Committee, Council on Health Research for Development,
2001.
107. Report from the Ministerial Summit on Health Research:
identify challenges, inform actions, correct inequities.
Mexico City, 16–20 November 2004. Geneva, World
108. Editorial. The Bamako call to action: research for
health. The Lancet, 2008, 372:1855.
109. McKee M. Global research for health. British Medical Journal, 2008, 337:1249–1250.
110. International Workshop on National Health Research
Systems (2001: Cha-am, Thailand) National health
research systems: report of an international workshop.
Geneva, World Health Organization, 2002.
42
87
References
111. Sadana R et al. Health Research System Analysis
(HRSA) Initiative: Methods for Collecting Benchmarks
and Systems Analysis Toolkit. Tool #1. A brief overview
of WHO Health Research System Analysis initiative
and an overview of core indicators and descriptive variables. Geneva, World Health Organization, 2006
(WHO/EIP/IHRSA/06.1) and (www.who.int/rpc/
health_research/en/index.html, accessed October
2010).
112. Resolution EB124.R12. WHO’s role and responsibilities in health research. In: 124th session of the
Executive Board, Geneva, 19–26 January 2009. Resolutions and Decisions Annexes. Geneva, World Health
Organization, 2009 (EB124/2009/REC/1).
113. Resolution WHA63.21. WHO’s role and responsibilities in health research. In: Sixty-third World
Health Assembly, Geneva, 17–21 May 2010, Resolutions and Decisions Annexes. Geneva, World Health
Organization, 2010 (WHA63/2010/REC/1).
114. Executive Board. WHO’s role and responsibilities
in health research. Draft WHO strategy on research
for health. Report by the Secretariat. Geneva, World
Health Organization, December 2008 (EB124/12).
115. International Health Regulations (2005) Toolkit for
implementation in national legislation. Geneva, World
Health Organization, January 2009 (WHO/HSE/
IHR/2009.3).
116. Resnik DB, Shamoo AE. Bioterrorism and the
responsible conduct of biomedical research. Drug
Development Research, 2005, 63:121–133.
117. Green SK et al. Guidelines to prevent malevolent
use of biomedical research. Cambridge Quarterly of
Healthcare Ethics, 2006, 15:432–439.
118. Selgelid MJ. A tale of two studies: ethics, bioterrorism, and the censorship of science. Hastings Center
Report, 2007, 37:35–43.
119. Ehni HJ. Dual use and the ethical responsibility
of scientists. Archivum Immunologiae et Therapiae
Experimentali., 2008, 56:147–152.
120. Kuhlau F et al. Taking due care: Moral obligations
in dual use research. Bioethics, 2008, 22:477–487.
121. Dando M. Bioethicists enter the dual-use debate.
Bulletin of the Atomic Scientists, 20 April 2009.
122. Kuhlau F et al. A precautionary principle for dual
use research in the life sciences. Bioethics, July 2009,
no. doi: 10.1111/j.1467-8519.2009.01740.x.
123. Beauchamp TL, Childress JF. Principles of biomedical ethics, Fifth Edition. New York, Oxford University Press, 2001.
124. Kitcher P. Science, truth and democracy. New York,
Oxford University Press, 2001.
125. Steneck NH. Office of Research Integrity (ORI) –
Introduction to the responsible conduct of research.
United States Department of Health and Human
Services (HHS), Washington, DC, USPO, 2007.
126. OECD Global Science Forum. Workshop on best
practices for ensuring scientific integrity and preventing misconduct, 22–23 February 2007, Mita
Conference Hall, Tokyo, Japan.
127. Mayer T, Steneck N. Final report to ESF and ORI.
First world conference on research integrity: fostering
responsible research. Lisbon, Portugal, 16–19 September 2007.
128. Kleinert S. Singapore embraces international
research integrity. The Lancet, 2010, 376:400–401.
129. Selgelid MJ, Weir L. The mousepox experience. An
interview with Ronald Jackson and Ian Ramshaw
on dual-use research. The European Molecular Biology Organization Reports, 2010, 11:18–24.
130. Weir L, Selgelid MJ. Professionalization as a governance strategy for synthetic biology. Systems and
Synthetic Biology, 2009, 3:91–97.
131. Taylor T. Safeguarding advances in the life sciences. The European Molecular Biology Organization
Reports. Special Issue, 2006, 7:S61–S64, 2006.
132. Sixth review conference of the states parties to the
Convention on the prohibition of the development,
production and stockpiling of bacteriological (biological) and toxin weapons and on their destruction. Final document (BWC/CONF.VI/6), 2006.
133. Salerno RM, Gaudioso J. Laboratory biosecurity
handbook. Boca Raton FL, CRC Press, 2007.
43
88
89
Annexes
90
91
Annex 1
Contributors
Authors
External
This guidance has been prepared by Dr Emmanuelle
TUERLINGS.
Dr Chandre GOULD worked on the self-assessment questionnaire (Section 4) and Dr Michael
SELGELID worked on the ethics section (Section 3.3).
Mrs Elisa D. HARRIS, Center for International and
Security Studies at Maryland School of Public
Policy, University of Maryland, United States of
America
Professor Li HUANG, Chinese Academy of Sciences and the InterAcademy Panel Biosecurity
Working Group, China
Dr Jo HUSBANDS, National Academy of Sciences,
United States of America
Professor John S. MACKENZIE, Curtin University
of Technology, Australia
Dr Caitriona McLEISH, Science and Technology
Policy Research, University of Sussex, United
Kingdom
Dr Piers MILLETT, BWC Implementation Support
Unit, United Nations, Switzerland
Professor Kathryn NIXDORFF, Darmstadt University of Technology, Germany
Dr Amy P. PATTERSON and staff of the Office of
Biotechnology Activities, National Institutes of
Health, United States of America
Professor Janusz T. PAWESKA, National Institute
for Communicable Diseases of the National
Health Laboratory Service, South Africa
Professor Ian RAMSHAW, National Centre for
Biosecurity, Australia
Dr Brian RAPPERT, University of Exeter, United
Kingdom
Professor Julian Perry ROBINSON, Science and
Technology Policy Research, University of Sussex, United Kingdom
Dr Stefan WAGENER, National Microbiology
Laboratory, Winnipeg, Public Health Agency of
Canada
WHO Guidelines Review Group
Chair
Professor Peter Ian FOLB, University of Cape
Town, South Africa
Members
Dr David FRANZ, Midwest Research Institute,
Dr Chandre GOULD, Institute for Security Studies, South Africa
Professor Raymond LIN, Ministry of Health, Singapore
Dr Amy P. PATTERSON, National Institutes of
Dr Michael SELGELID, Centre for Applied Philosophy and Public Ethics (CAPPE), WHO Collaborating Centre for Bioethics, Australia
Dr Oyewale TOMORI, Redeemer’s University,
Nigeria
Dr Lei ZHANG, Chinese Academy of Sciences,
China
Editor
Ms Joanne McMANUS
Reviewers
WHO
Dr Tikki PANGESTU
Dr Nicoletta PREVISANI
Dr Andreas REIS
47
92
Annex 2
Declaration of interests
In line with WHO policy, participants of the “Guidelines review group workshop on responsible life sciences research, 22–24 June, 2009, Geneva” have completed and signed a declaration of interests. The WHO
Secretariat reviewed these declarations and concluded that there were no conflict of interests.
Guidelines review group workshop on responsible life sciences research,
22–24 June 2009, WHO, Geneva
Participants
Videoconference
22 June, E232, 15:00–17:00
Professor Peter Ian FOLB, University of Cape
Town, South Africa
Dr David FRANZ, Midwest Research Institute,
Dr Chandre GOULD, Institute for Security Studies, South Africa
Professor Raymond LIN, Ministry of Health, Singapore
Dr Michael SELGELID, Centre for Applied, Philosophy and Public Ethics (CAPPE), Australia
(WHO collaborating centre on ethics)
Dr Oyewale TOMORI, Redeemer’s University,
Nigeria
Dr Lei ZHANG, Chinese Academy of Sciences,
China
Dr Stuart L. NIGHTINGALE, National Institutes
of Health, United States of America
Dr Amy P. PATTERSON, National Institutes of
Dr Abigail RIVES, National Institutes of Health,
48
93
Annex 3. Guidelines review group workshop on responsible life sciences research, WHO, Geneva, 22–24 June 2009
Annex 3
Guidelines review group workshop
on responsible life sciences research,
WHO, Geneva, 22–24 June 2009
Executive summary
These are the best protection against accidents
and potential misuse, and the best guarantees
of progress and development.
6. The document identifies the following key
activities in attaining these objectives: review
including self-assessment, strengthening systems (including laboratories and their operations), capacity development, including facilities
and human potential, robust ethical frameworks
and the central role of the WHO.
Underlying principle governing these considerations is that one size does not fit all,
and neither should it; that the uniqueness of
countries and their specific needs should be
respected and cherished, and that each country
would have its own vision on where it wishes
to go and how to get there. At the same time, it
has to be understood, that in the national and
global interest, certain essential standards of
the pursuit of science and of scientific research
need to be in place.
7. A process for review and assessment, including
self-assessment, is set out in the document that
will enable countries and their policy makers to identify their respective strengths and
weaknesses, and to build on their strengths
and address their weaknesses. It includes
human resources, operational issues, training,
filling the gaps, funding strategies, standards
of performance and ethics. Encompassed here
is human subject research, animal experiments
and basic science. A conceptual matrix has
been developed (and will need to be further
developed by a small expert group) that will
make possible a process of measurement and
scoring to allow for evaluation of progress and
responsiveness.
8. With regard to ethics, it is acknowledged that
there has been some neglect of this issue,
which call out to be addressed at a number of
levels: individual, institutional, science community, journals and editors, national gov-
1. The meeting recognized that good science
and sound scientific research are inextricably
linked with the health, development and good
policies of a country. Moreover, the confidence
of the people and their trust in government
and policies depends to a large extent on trustworthy science. Achieving this involves partnerships, a partnership that includes the World
Health Organization.
2. The World Health Assembly resolution
WHA55.16 of 18 May 2002 drew attention to
the converse of this: the accidental or deliberate misuse of biological and chemical agents
or radionuclear materials that affect adversely
affect health, including the dual use potential of these agents, and the enormous public
health implication of this – nationally and globally.
3. The readership of this document is envisaged
to be health policy makers and those who
implement policy, health professionals, scientific community, the general public including
educators, the WHO itself and governments.
It is clear that the scope of the document goes
beyond the health sector to industry, trade and
commerce and the government departments
that manage those activities.
4. The purpose of the document is to balance
maximum scientific potential and freedom
against the need for scrutiny, safety and public
security. The pillars on which such an approach
rest include the following: excellent facilities,
and the management of them (including laboratories); leadership; a robust ethical framework; training and capacities development;
institutional development; and review. Success
will depend on a range of mechanisms.
5. In the end, the document aims at the culture of
scientific integrity and excellence characterized
by openness, honesty (which is paramount),
accountability, responsibility and relevance.
49
94
ernments and international organizations. All
these affect codes of conducts, requirements of
the law, the ethics of policy, resolution of the
inherent tensions between the primacy of the
individual and utilitarian public imperatives
of security, safety and scientific progress. This
document argues that one should build on
what is already in place, and that the system
should be alert of serendipitous discoveries
and capable of responding to it.
9. These considerations apply as much to research
applied in the private sector and industry as
they do to public scientific and health institutions. (The private sector is vast and growing
in this regard).
10. Two points in particular are argued in the ethics section of the paper; namely,
i. the importance and value of an independent ombudsman; and,
ii. ethics alone will not be sufficient; ethics is
a crucial element but not the whole story.
11. The implications of not getting this right are
several and severe: poor science, public health
risks, policy failure, a defective culture of research, weak public confidence, impaired funding opportunities and lack of development, and,
inevitably the potential risk of misuse.
12. The document briefly considers case examples
such as avian flu, smallpox, mousepox and others as illustrative of the potential global impact
of misusing science.
13. The World Health Organization should lead
the way for reasons that were developed at a
previous meeting held on 16 October 2006,
which identified 5 priorities areas leading to a
five points plan set out in a note for the record
of the internal meeting held at WHO on 6 February 2009. This plan was guided by the following principles:
i. work should be done with the regions;
ii. working with countries is a two way street;
iii. efforts should be evaluable;
iv. evaluation tools presently available are
insufficient and should be developed
v. an important element of this activity is
capacity development that would include
ethics, leadership, networks and surveillance.
14. In its conclusions, the meeting identified the
potential value and importance of centers of
excellence; that countries with an interest in
responding to these challenges and at varying
stages of their development should be identified in the first instance (altogether 6, one from
each region would be ideal); the need to identify best practices from experience; identification
and fostering of expertise, including those with
potential expertise in the country; and capacity
assessment and ways of filling the gaps.
50
95
Annex 4. The NSABB’s proposed framework for the oversight of dual-use research
Annex 4
The NSABB’s proposed framework for the
oversight of dual-use research
 compliance and enforcement;
 evaluation of the efficacy, impact, and burden of
the oversight system.
The NSABB’s proposed system for the oversight
of dual-use life sciences research that has been
recommended to the United States Government
includes:
The NSABB proposed framework1 focuses on the
local oversight of dual-use research, on researchers who continually assess their work for dual-use
potential, and on institutional review of research
that includes risk assessment and risk management (see below).
Within this framework, researchers are considered the most critical element of oversight as they
are likely to be most familiar with their work and its
potential applications. To assist in the assessment
of research for its dual-use potential, the NSABB
developed a criterion for identifying research that
constitutes “dual use research of concern.” The
 the development of federal guidelines for the
oversight, conduct and responsible communication of dual-use research;
 raising researchers’ awareness about dual-use
research issues;
 ongoing and mandatory education about dualuse research issues and policies;
 local evaluation and review of research with
dual-use potential by the investigator and the
research institution;
 risk assessment and risk management as a foundation for oversight;
Proposed steps in local oversight of dual-use research
Education
Training
Guidance
Initial Evaluation
for Dual Use
Potential by PI
Dual use research
of concern identified
Institutional Review
• Risk Assessment
• Risk Management
Work conducted in
accordance with risk
management strategies
Responsible
Communication of
Research
No dual use
potential identified
PI Responsibilities
Periodic Reassessment of
Dual Use Potential, Especially
at Times of Communication
Institutional
Responsibilities
Source: Adapted, with permission, from National Science Advisory Board for Biosecurity. Proposed framework for the oversight of dual use life
sciences research: strategies for minimizing the potential misuse of research information. A report of the National Science Advisory Board for Biosecurity (NSABB), June 2007.
1
National Science Advisory Board for Biosecurity. Proposed framework for the oversight of dual use life sciences research: strategies for
minimizing the potential misuse of research information. A report of the National Science Advisory Board for Biosecurity (NSABB), June
2007.
51
96
Examples of points of communication of dual-use research during the research process
Project
Concept and
Design
Funding
Application and
Award Process
Institutional
Approval
Ongoing
Research
Development of
Manuscript or
other Research
Product
Publication of
Manuscript or
other Research
Product
Presentation
of preliminary
data
Review by
IC staff and
study section
Review by
Institutional
Committee
Members
Training of lab
staff, students,
visiting scientists
Discussions
with
collaborators
Research
award notices/
description on
CRISP etc.
Peer review
of
manuscript/
research
product
Public
dissemination
of research
findings or
products
Draft
application
review by peers,
institution
administration
etc.
Project
descriptions on
institution Web
page or in
PI CV
Presentations at
departmental
seminars
Presentations
or posters at
National or
International
Conferences
Evaluation by
other faculty if
thesis project
Key: IC: Institutes and Centers; CRISP: As of December 30, 2009, the CRISP database, a NIH system, has been replaced with the Research Portfolio
Online Reporting Tools (RePORT) Expenditures and Results (RePORTER) http://projectreporter.nih.gov/reporter.cfm, accessed October 2010);
PI CV: Principal Investigator Curriculum Vitae
Source: Adapted, with permission, from National Science Advisory Board for Biosecurity. Proposed framework for the oversight of dual use life
sciences research: strategies for minimizing the potential misuse of research information. A report of the National Science Advisory Board for Biosecurity (NSABB), June 2007.
NSABB’s criterion for identifying dual-use
research of concern is “research that, based
on current understanding, can be reasonably
anticipated to provide knowledge, products, or
technologies that could be directly misapplied
by others to pose a threat to public health
and safety, agriculture, plants, animals, the
environment, or materiel.” The NSABB also
identified seven categories of experiments
that describe information, products or technologies that if produced from life sciences
research mean the research warrants careful
consideration for its dual-use potential (see
box below). These categories are informed by
the NRC experiments of concern.
The NSABB report also provides tools to
assist in the responsible communication of
research results throughout the research continuum (see figure below) and considerations
for the development of codes of conduct for
life sciences researchers.
NSABB categories of research that warrant
careful consideration for dual-use potential
1. Enhance the harmful consequences of a biological
agent or toxin.
2. Disrupt immunity or the effectiveness of an immunization without clinical and/or agricultural justification.
3. Confer to a biological agent or toxin, resistance to
clinically and/or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin
or facilitate their ability to evade detection methodologies.
4. Increase the stability, transmissibility, or the ability to
disseminate a biological agent or toxin.
5. Alter the host range or tropism of a biological agent
or toxin.
6. Enhance the susceptibility of a host population.
7. Generate a novel pathogenic agent or toxin or reconstitute an eradicated or extinct biological agent.
52
97
Annex 5. A decision-making tool from the Centre for Applied Philosophy and Public Ethics, Australia
Annex 5
A decision-making tool from the Centre for
Applied Philosophy and Public Ethics, Australia
The identification of several salient experiments of concern (see box below) prompted the Center for Applied
Philosophy and Public Ethics in Australia to develop a decision-making tool regarding dual-use dilemmas
in the biological sciences (see table below).1
Experiments of concern
According to the Center for Applied Philosophy and Public Ethics, experiments of concern are those that attempt
to do any one of the following:
1. demonstrate how to render a vaccine ineffective;
2. confer resistance to therapeutically useful antibiotics or antiviral agents;
3. enhance the virulence of a pathogen or render a non-pathogen virulent;
4. increase the transmissibility of a pathogen;
5. alter the host range of a pathogen;
6. enable the evasion of diagnosis and/or detection by established methods;
7. enable the weaponization of a biological agent or toxin;
8. sequence the genes of a pathogen;
9. synthesize a pathogenic microorganism;
10. experiment in any way with variola virus (smallpox);
11. attempt to recover/revive past pathogens.
Miller S and Selgelid MJ. Ethical and philosophical consideration of the dual-use dilemma in the biological sciences. Dordrecht NE, Springer, 2008. Report prepared by the Centre
for Applied Philosophy and Public Ethics at the Australian
National University for the Australian Department of Prime
Minister and Cabinet, National Security Science and Technology Unit, November 2006.
1
53
98
Decision-making for dual-use dilemmas in the biological sciences
Options
Option 1
the Complete
autonomy of
the individual
scientist
Option 2
Institutional control
Option 3
Institutional &
governmental control
Individual
researcher
i) Scientists in
university (collegial)
(ii) Corporation
(iii)Govt. Res. Centre
i) Scientists in
Independent
university (collegial) authority
(ii) Corporation
Government
Should compliance
with physical safety &
security regulation be
mandatory?
No
Yes
Yes
Yes
Yes
Should dual-use
technology be
licensed?
No
No
Yes
Yes
Yes
Should education &
No
training be mandatory?
No
Yes
Yes
Yes
Should personnel
security regulation be
mandatory?
No
No
Yes
Yes
Yes
Individual
editor
i) Individual editor
(ii) Corporation
(i) Individual editor
(ii) Corporation
Independent
Authority
Government
Decisions
Who are the decisionmakers regarding im/
permissible research?
Who are the decisionmakers regarding
censorship/constraint
of material proposed
for dissemination?
Option 4
An independent
authority
Option 5
Governmental
control
NB: The decision-making in question pertains only to dual-use research in the biological sciences identified as potentially problematic by virtue of
coming under one of the pre-established headings of Experiments of Concern
54
99
Annex 6. A model from the Center for International and Security Studies
Annex 6
A model from the Center for
International and Security Studies
The prototype oversight system, known as the
Biological Research Security System, developed
by the Center for International and Security Studies (CISSM) at the University of Maryland, USA,
rests on two key elements: national licensing of
personnel and research facilities and independent peer review of relevant projects before their
initiation. As the table on “Illustrative categories
of research activities” shows, for the activities of
extreme concern, there would be a global standard
setting and review body – the International Pathogens Research Authority. This body would oversee
those activities and would be in charge of defining the research activities falling under the different categories of oversight. At the next level, there
would be a national review body – the National
Pathogens Research Authority – to oversee activities of moderate concern. The national body would
also oversee the work of local review bodies and
the licensing of researchers and facilities. Finally, the local review body – the Local Pathogens
Research Committee – would be in charge of overseeing activities of potential concern. According
to CISSM, most of the microbiological research
would either fall under this last category or not be
covered at all.
Illustrative Categories of Research Activities
Activities of Extreme Concern (AEC)
Work with eradicated agents; a work with an agent
assigned as BL-4/ABL-4; de novo synthesis of above;
expanding the host range of an agent to a new host
(in humans, other animals and plants) or changing
the tissue range of a listed agent; b construction of
antibiotic- or vaccine-resistant listed agent.
Activities of Moderate Concern (AMC)
Increasing virulence of listed agent or related agent;
insertion of host genes into listed agent or related
agent; increasing transmissibility or environmental
stability of listed agent or related agent; powder or
aerosol production of listed agent or related agent;
powder or aerosol dispersal of listed agent or related
agent; de novo synthesis of listed agent or related
agent; construction of antibiotic- or vaccine-resistant related agent; genome transfer, genome replacement, or cellular reconstitution of listed agent or
related agent.
Activities of Potential Concern (APC)
Work with listed agents – or exempt avirulent,
attenuated, or vaccine strain of a listed agent –
not covered by AEC/AMC; Increasing virulence of
non-listed agent; increasing transmissibility or environmental stability of non-listed agent; powder or
aerosol production of non-listed agent; powder or
aerosol dispersal of non-listed agent; de novo synthesis of non-listed agent; genome transfer, genome
replacement, or cellular reconstitution of non-listed
agent.
This would include, for example, activities with the 1918
influenza virus and chimeric influenza viruses with at least
one gene from the 1918 influenza virus.
a
This would include, for example, activities with chimeric
influenza viruses with at least one gene from a human
influenza virus and at least one gene from an avian
influenza virus.
b
Steinbruner J et al. Controlling dangerous pathogens. A prototype protective oversight system. The Center for International
and Security Studies at Maryland (CISSM), The University
of Maryland, College Park, Maryland, March 2007.
1
55
100
Table Definitions
Agent: fungus, protozoan, bacterium or archaeon, virus, viroid, or prion; or genetic element, recombinant nucleic
acid, or recombinant organism.
Listed Agent: agent on CDC Select Agent list, USDA High-Consequence Livestock Pathogens list, or USDA/
APHIS/PPQ Plant Pathogens list.
Related agent: for fungi, protozoans, or bacteria or archaea, an agent that currently is, or in the last two years
was, assigned to the same genus as a listed agent; for viruses, viroids, or prions, an agent that currently is, or
in the last two years was, assigned to the same family as a listed agent; for genetic elements, recombinant
nucleic acids, or recombinant organisms, an agent orthologous to a listed agent. (This includes any avirulent,
attenuated, or vaccine strain of a listed agent, if said strain is exempt under the CDC Select Agent list, USDA
High-Consequence Livestock Pathogens list, or USDA/APHIS/PPQ Plant Pathogens list.)
Non-listed agent: agent other than a listed agent or related agent.
Eradicated agent: agent previously in circulation in nature but not within the last decade, as determined by cases
of or isolation from humans, animals, or plants, or by detection of antibodies to the agent from individuals
younger than the time-span elapsed since the last recorded isolation.
De novo synthesis: construction of agent using synthetic genomic nucleic acid (non-prion agents) or synthetic
protein (prions), irrespective of whether said construction require additional reagents, extracts, cells, or ‘helper’
entities. For purposes of this definition, ‘synthetic genomic nucleic acid’ refers to nucleic acid that corresponds
to an agent genome and that is prepared using, in any step or set of steps, chemically synthesized oligonucleotides, corresponding to at least 5% of said agent genome.
Powder: powder other than lyophilized reference specimen (<10 mg).
Antibiotic: antibiotic of therapeutic utility against listed agent.
Vaccine: vaccine of therapeutic utility against listed agent.
Source: Steinbruner J et al. Controlling dangerous pathogens. A prototype protective oversight system. The Center for International and
Security Studies at Maryland (CISSM), The University of Maryland, College Park, Maryland, March 2007.
56
101
Annex 7. Implementation of oversight mechanisms
Annex 7
Implementation of
oversight mechanisms
A report of practical experiences in dual-use review
published by the Southeast Regional Center of
Excellence for Emerging Infections and Biodefense
(SERCEB) in Chapel Hill, North Carolina1 has
identified two significant issues: the lack of awareness about the dual-use dilemma and the need for
technical expertise when assessing dual-use risks.
Through its Policy, Ethics, and Law (PEL) Core, the
centre reviews all proposals for dual-use issues,
using the criteria of the Fink report (see Box 7) and
the NSABB (see Annex 4).2 The Center has developed an online module on the dual-use dilemma
in biological research aimed at graduate and postdoctoral students, faculty members and biosafety
professionals involved in the conduct, oversight
or analysis of life sciences research.3 According to
the Center, “incorporating dual-use training and
oversight mechanisms into existing programs,
regulations, and requirements may be the most
practical approach to devising a process for dualuse review”.
The US Centers for Disease Control and Prevention (CDC) has implemented several processes for
dual-use review.4 It has, for instance, developed a
policy brief for reviewers and an on-line training
module that addresses these issues. The Coordinating Center for Infectious Diseases (CCID) reviews
all research documents before their submission for
publication, including for dual-use concerns. The
publication of the two papers on the characterization of the 1918 influenza virus in 2005 (see Box
4) led to the pre-publication review by CCID and
to the establishment of the Institutional Biosecurity Board (IBB), which reviews proposals that may
raise dual-use issues with the help of a risk-benefit
analysis questionnaire. However, the paucity of
proposals raising concerns has often led to the cancellation of the IBB monthly meetings.
Finally, proposals for self-governance have also
been put forward by those working in synthetic
biology. These include proposals for firms to screen
orders of synthetic DNA, to license DNA synthesizers, to educate users of synthetic DNA, and to
peer review experiments.5 Private synthetic biology companies in some high-income countries have
also started to voluntarily screen DNA orders. They
are using specific programmes to look for certain
sequences of DNA. Some of these companies find
it difficult to identify which criteria should be used
to screen orders and recognize that not all companies currently screen orders and customers.
Davidson EM et al. Practical experiences in dual-use review.
Science, 2007, 316:1432–1433.
2
National Science Advisory Board for Biosecurity. 3rd International roundtable. Sustaining progress in the life sciences:
strategies for managing dual use research of concern. National
Science Advisory Board for Biosecurity, Bethesda, Maryland, 5–6 November 2008.
3
Southeast Regional Center of Excellence for Emerging Infections and Biodefense. The dual use dilemma in biological
research (www.serceb.org/dualuse.htm, accessed October
2010).
4
5
Check E. Synthetic biologists try to calm fears. Nature,
441:388–389; Garfinkel MS et al. Synthetic genomics: Options
for governance. The J. Craig Venter Institute, Massachusetts
Institute of Technology & Center for Strategic and International Studies, 2007; Bugl et al. DNA synthesis and biological security. Nature Biotechnology, 2007, 25:627–629; National
Science Advisory Board for Biosecurity. 3rd International
roundtable. Sustaining progress in the life sciences: strategies
for managing dual use research of concern. National Science
Advisory Board for Biosecurity, Bethesda, Maryland, 5–6
November 2008.
1
57
102
Annex 8
Codes of conduct
The following examples of codes of conduct are in
addition to the codes described in Section 2.2.4.
authorities misuses of microbiology or of information derived from microbiology.”5
 The World Medical Association urges “all who
participate in biomedical research to consider
the implications and possible applications of
their work and to weigh carefully in the balance
the pursuit of scientific knowledge with their
ethical responsibilities to society.”1
 The Chinese Academy of Sciences (CAS), a
leading academic institution and comprehensive
research and development centre in natural science, technological science and high-tech innovation in China, published in 2007 the Statements
on the Notion of Science to guide the scientific
and technical community in forming a correct
scientific value system, to promote and develop
a scientific spirit, to abide by scientific ethics and
moral standards, and to fulfil its social responsibility. CAS also established biosafety committees and started biosafety training programmes
at all its life sciences institutes.
 The American Medical Association’s Council
on Ethical and Judicial Affairs has guidelines to
prevent malevolent use of biomedical research.
These are now part of the AMA’s code of medical ethics.2
 The British Medical Association has stated:
“Professional scientists and physicians have an
ethical responsibility to reinforce the central
norm that biological and genetic weapons are
unacceptable. This should be explicitly stated in
codes of professional conduct in order to safeguard the public interest in matters of health
and safety.”3
 The Royal Netherlands Academy of Arts and Sciences has developed a national biosecurity code
of conduct for scientists.6 The code puts forward
several provisions that would need to be applied
at the individual level and at the research institutions, financing, publishing and monitoring
levels. The implementation of the provisions
 In November 2005, the Interacademy Panel
(IAP) issued a statement on biosecurity, which
was endorsed by 68 national academies of science.4 This statement noted: “Scientists have a
special responsibility when it comes to problems
of ‘dual use’ and the misuse of science and technology.” The statement presents several guiding
principles for individual scientists and local scientific communities who wish to develop codes
of conduct. These principles include awareness,
safety and security in laboratories, education
and information, accountability and oversight.
The World Medical Association. The World Medical Association Declaration of Washington on biological weapons. Adopted
by the WMA General Assembly, Washington 2002; editorial
changes made during the May 2003 Council Session, (Document 17.400).
2
Green SK et al. Council on Ethical and Judicial Affairs of the
American Medical Association. Guidelines to prevent the
malevolent use of biomedical research. Cambridge Quarterly
of Healthcare Ethics, 2006, 15:432–447.
3
British Medical Association (BMA). Biotechnology, weapons and humanity. London, Harwood Academic Publishers,
1999.
4
The InterAcademy Panel on International Issues (IAP). IAP
Statement on Biosecurity. 7 November 2005.
5
American Society for Microbiology (ASM). Code of ethics (Revised and Approved by Council 2005). 2005 (http://forms.asm.
org/ASM/files/ccLibraryFiles/FILENAME/000000001596/
ASMCodeofEthics05.pdf, accessed October 2010).
6
Royal Netherlands Academy of Arts and Sciences. A Code
of Conduct for Biosecurity. Report by the Biosecurity Working
Group. Amsterdam, Royal Netherlands Academy of Arts and
Sciences, August 2008.
1
 The American Society for Microbiology (ASM)
has added the following statement to its code
of ethics: “ASM members are obligated to discourage any use of microbiology contrary to
the welfare of humankind, including the use
of microbes as biological weapons and will call
to the attention of the public or the appropriate
58
103
Annex 8. Codes of conduct
– which cover raising awareness, research and
publication policy, accountability and oversight,
internal and external communication, accessibility, shipment and transport – will need to be
tailored to the needs of organizations and will
remain under their responsibility. The Royal
Netherlands Academy of Arts and Sciences
also noted that the most important objective of
the Code of Conduct for Biosecurity is to raise
awareness and to prompt debate on the topic of
dual-use research.
al and industrial codes of conduct aimed at
preventing the abuse of biological agents”.6
 Although not promoting the idea of a universal
code of conduct on this subject, the International
Council for Science (ICSU) has also linked scientific rights and freedoms with responsibilities.
Researchers have an individual responsibility to
conduct research with honesty, integrity, openness and respect and a collective responsibility
to maximize the benefits and minimize risks of
the misuse of science for society.7
 The Royal Society in the United Kingdom has
emphasized that codes may raise awareness and
foster discussion on the subject and that codes
should be based where possible on existing
guidelines and principles: “Introducing extended codes of conduct or practice based on existing health and safety regulations will provide an
opportunity for education and training to reinforce these regulations.”1
 Other related developments include:2
— the NSABB’s recommendations for the development of a code of conduct for scientists and
laboratory workers; 3
— the code of ethics for the life sciences that has
been proposed by individual scientists Margaret Somerville and Ronald Atlas; 4
— the International Union of Biochemistry and
Molecular Biology (IUBMB) has a code of
ethics which makes reference to the misuse
of science;
The Royal Society. The roles of codes of conduct in preventing
the misuse of scientific research. RS policy document 03/05,
June 2005.
2
3
National Science Advisory Board for Biosecurity. Proposed
framework for the oversight of dual use life sciences research:
strategies for minimizing the potential misuse of research information. A report of the National Science Advisory Board for Biosecurity (NSABB). June 2007.
4
Atlas RM, Somerville M. Life sciences or death sciences: tipping the balance towards life with ethics, codes and laws.
In: Rappert B, McLeish A (eds). A web of prevention: biological weapons, life sciences and the governance of research, London, Earthscan, 2007:15–33; and Somerville MA, Atlas RM.
Ethics: A weapon to counter bioterrorism. Science, 2005,
307:1881–1882.
5
National Science Advisory Board for Biosecurity. 3rd International roundtable. Sustaining progress in the life Sciences:
6
International Committee of the Red Cross (ICRC). Responsibilities of actors in the life sciences to prevent hostile use. Geneva,
ICRC, 2004.
7
International Council for Science (ICSU). Freedom, responsibility and universality of science. Paris, International Council
for Science (ICSU), 2008.
1
— the International Union of Microbiological
Societies (IUMS) has a very general statement on ethics; 5
— in 2006, the China Association for Science
and Technology published the Code of Conduct for Chinese Scientists to uphold the
ethics of scientific research and maintain
academic self-discipline;
— the International Centre for Genetic Engineering and Biotechnology (ICGEB) is
assisting the United Nations Secretariat in
fulfilling a mandate received by the Security
Council to reinforce ethical norms and advocate the creation of national codes of conduct
for scientists;
— the International Committee of the Red
Cross (ICRC) has been working with scientists in the life sciences to adopt “profession59
104
Annex 9
WHO strategy on research for health
The WHO strategy on research for health defines a
common framework for how research is approached
in WHO and the role WHO is taking in global
health research. The resolution on WHO’s role and
responsibilities in health research was endorsed by
the Sixty-third World Health Assembly in resolution WHA63.21 in 2010.1
The box below highlights the actions that the
resolution specifically recommends for Member
States.
Highlights from the World Health
Assembly resolution on WHO’s role and
responsibilities in health research
The Sixty-third World Health Assembly,
1. Endorses the WHO strategy on research for
health;
2. Urges Member States:
— to recognize the importance of research for
improving health and health equity and to
adopt and implement policies for research
for health;
— to consider drawing on the strategy on
research for health according to their own
national circumstances and contexts;
— to strengthen their national health research
systems;
— to establish, as necessary and appropriate,
governance mechanisms for research for
health;
— to improve the collection of reliable health
information and data and maximize, where
appropriate, their free and unrestricted
availability in the public domain;
— to promote intersectoral collaboration and
high-quality research;
— to initiate or strengthen intercountry
collaboration;
— to consider, where appropriate, the
establishment of regional collaborating
mechanisms, such as centres of excellence;
— to continue to pursue financing of research
for health.
1
For additional information, see (http://www.who.int/rpc/
research_strategy/en/index.html, accessed October 2010).
60
105
INTERNATIONAL GENE SYNTHESIS CONSORTIUM (IGSC)
HARMONIZED SCREENING PROTOCOL
Gene Sequence & Customer Screening to Promote Biosecurity
Preamble
This document outlines the standards and practices that IGSC gene synthesis companies
apply to prevent the misuse of synthetic genes. By screening the sequences of ordered genes
and vetting customers, IGSC companies help to ensure that science and industry realize the
many benefits of gene synthesis technology while minimizing risk.
The ICGS companies together represent approximately 80% of commercial gene synthesis
capacity world-wide.
1. Gene Sequence Screening
IGSC companies screen synthetic gene orders to identify regulated pathogen sequences and
other potentially dangerous sequences.
1. IGSC companies screen the complete DNA sequence of every synthetic gene order against
the DNA sequences in a Regulated Pathogen Database, and against all entries found in one
or more of the internationally coordinated sequence reference databanks (i.e.,
NCBI/GenBank, EBI/EMBL, or DDBJ). The IGSC is currently assembling a Regulated
Pathogen Database that will include data from all organisms on the Select Agent list, the
Australia Group List, and any other national list of regulated pathogens. Until this is
deployed, each company is using its own database of pathogen sequences. At a minimum,
IGSC companies screen for all pathogen and toxin genes from the US Select Agents and
Toxins List and/or from the list specified in paragraphs 1C351-1C354 of European Union
Council Regulation 428/2009.
2. IGSC companies translate all six reading frames of each synthetic gene into an amino acid
sequence. This sequence is screened against the protein sequences derived from the
databases described above.
106
3. IGSC companies use automated screening as a filter to identify pathogen and toxin DNA
sequences. When automated screening identifies a potential pathogen or toxin sequence, the
order is reviewed by a human expert and is either accepted, accepted with a requirement for
additional customer review, or rejected.
2. Gene Customer Screening
1. IGSC companies require identification data from all potential customers for synthetic
genes, including at a minimum a shipping address, institution name, country, telephone
number, and email address. We do not ship to PO Boxes.
2. Potential customers are screened against OFAC’s SDN List, the Department of State’s
Debarred List, and BIS’s Denied Persons, Entity, and Unverified lists, or the HADDEX list,
and/or any other list required by applicable national regulations.
3. IGSC companies require additional customer screening before accepting orders for DNA
sequences from regulated pathogens. Although the U.S. Select Agent Regulations and the
European Commission regulations do not restrict access to all Select Agent genes, IGSC
companies supply genes from regulated pathogens only to researchers in government
laboratories, universities, non-profit research institutions, or industrial laboratories
demonstrably engaged in legitimate research. Customers ordering Select Agent or Australia
Group DNA fragments must provide a written description of the intended use of the
synthetic product; we verify independently a) the identity of the potential customer and
purchasing organization, and b) that the described use is consistent with the activities of the
purchasing organization.
IGSC companies use the current recommendations from the U.S. CDC and/or the
Department of Agriculture and/or the European Commission (CR42) to determine which
DNA sequences are Select Agents as recombinant DNA fragments. We supply genes with
such sequences only if the supplier and the customer are able to comply with all Select Agent
regulations applicable to that gene.
In general, IGSC companies only sell DNA or fragments of regulated pathogens to bone fide
end-users. We do not sell or ship such material to distributers or other resellers, unless those
companies identify the end-user receiving the products and demonstrate their compliance
with every requirement otherwise applicable to that end-user.
107
3. Record keeping
1. Sequence Screen Results: IGSC companies retain records of every gene sequence
screening result for at least 8 years.
2. Customer Screen Results: IGSC companies retain records of every customer screening
result for at least 8 years.
3. Product & Delivery Information: IGSC companies retain records of every gene
synthesized and delivered for a minimum of 8 years after shipping, including at least the
following: (a) the synthetic DNA sequence; (b) the vector; and (c) the recipient’s identity and
shipping address.
4. Order Refusal & Reporting
1. IGSC companies reserve the right to refuse to fill any order and to notify authorities upon
identifying potentially problematic orders.
2. IGSC companies have established relationships with local and national law enforcement
and intelligence authorities with whom we can share information to report and to prevent
the potential misuse of synthetic genes.
3. IGSC companies will report any request for a gene associated with the pathogenicity of an
organism received from a suspicious potential customer and/or potential customer failing to
establish its bone fides in application of the practices set forth in section 2.
5. Regulatory Compliance
1. IGSC companies comply with all applicable laws and regulations governing the synthesis,
possession, transport, export, and import of gene synthesis and other products.
2. We comply with World Health Organization recommendations concerning the
distribution, handling, and synthesis of Variola virus DNA.
108
Consortium Collaborative Activities
IGSC companies intend to work together in order to:
1. Develop and update a Regulated Pathogen Database to include all gene sequences
identified as potentially hazardous by authoritative groups such as the CDC, the Australia
Group, and the U.S. and European governments.
2. Ensure that we use the best and most effective algorithms to screen gene sequences
against the Regulated Pathogen Database.
3. Collaborate with our respective national governments in support of effective oversight of
gene synthesis technology, and to encourage international coordination.
4. Incorporate recommendations from the regulatory, scientific, and public interest
communities into our screening and other biosecurity processes.
Revisions to the Harmonized Screening Protocol
This document represents an initial effort by a group of companies committed to the
responsible use of gene synthesis technology. IGSC companies welcome comments and
suggestions to improve the Harmonized Screening Protocol from scientists, regulators, and
other interested parties. This document will be revised periodically in response to these
suggestions and to changes in the scientific, technical, or regulatory environment.
Terminology
Gene Synthesis. This document uses the phrase “gene synthesis” to refer to the production
of double-stranded, recombinant DNA fragments from oligonucleotides. Synthetic genes are
typically provided in plasmid vectors.
Oligonucleotides. Chemically-synthesized, single-stranded DNA fragments, typically
supplied as a solution in a tube or a multi-well plate.
Synthetic Gene. A gene or other DNA fragment produced by gene synthesis, typically
between 50 and 50,000 base pairs in length.
109
Related Links
Select Agents and Toxins List
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html
EU Council Resolution 428
http://www.consilium.europa.eu/showPage.aspx?id=408&lang=en
HADDEX
http://www.ausfuhrkontrolle.info/ausfuhrkontrolle/de/arbeitshilfen/haddex/index.html
OFAC’s SDN List
http://www.treas.gov/offices/enforcement/ofac/sdn/
Department of State’s Debarred List
http://www.pmddtc.state.gov/compliance/debar.html
BIS’s Denied Persons, Entity, and Unverified lists
http://www.bis.doc.gov/complianceandenforcement/liststocheck.htm
Current Recommendations from the U.S. CDC
http://www.selectagents.gov/SyntheticGenomics.html
Australia Group Listed Source Organisms
http://www.australiagroup.net/en/biological_agents.html
World Health Organization Recommendations Concerning the Distribution,
Handling, and Synthesis of Variola Virus DNA
http://www.who.int/csr/disease/smallpox/SummaryrecommendationsMay08.pdf
110
NATIONAL
SCIENCE
ADVISORY
BOARD FOR
BIOSECURITY
Proposed Framework for the Oversight
of Dual Use Life Sciences Research:
Strategies for Minimizing the Potential
Misuse of Research Information
A Report of the National Science Advisory Board for Biosecurity (NSABB)
June 2007
111
CONTENTS
Abbreviations and Acronyms................................................................................................................. i
Executive Summary............................................................................................................................... ii
Introduction........................................................................................................................................... 1
Purpose of T his Document
The Critical Role of Life Sciences Research
The Dual Use Research Issue
Calls to Action
U.S. Government Response NSABB Considerations Need for Engagement of the Life Sciences Community Guiding Principles for Oversight of Dual Use Life Sciences Research ................................................ 7
Key Features of the Proposed Oversight System.................................................................................. 8
Federal Guidelines
Awareness
Ongoing, Mandatory Education
Evaluation and Review of Research for Dual Use Potential
Risk Assessment and Risk Management
Periodic Evaluation
Compliance
Roles and Responsibilities in Oversight of Life Sciences Research With Dual Use Potential ........... 11
Researchers
Research Institutions
Institutional Review Entity
NSABB
Federal Government
Major Steps in Local Oversight of Dual Use Life Sciences Research ................................................ 15
Figure 1. Steps in Local Oversight of Dual Use Research
Criterion and Considerations for Identifying Dual Use Research of Concern.................................. 16
Evaluation of Life Sciences Research for Dual Use Potential............................................................. 22
Review of Research That is Potentially Dual Use of Concern: Risk Assessment and Risk
Management ........................................................................................................................................ 22
Responsible Communication of Life Sciences Research With Dual Use Potential ............................ 23
Principles for the Responsible Communication of Research With Dual Use Potential
Figure 2. Examples of Points of Communication of Dual Use Research During the Research
Process
Points To Consider in Assessing the Risks and Benefits of Communicating Research
Information With Dual Use Potential
Considerations in the Development of a Communication Plan
112
Considerations in Developing a Code of Conduct for Dual Use Research in the Life Sciences......... 28
Outreach and Education ..................................................................................................................... 29
Appendices........................................................................................................................................... 32
Appendix 1.
NSABB Charter and Roster
Appendix 2.
Questions for Comment
Appendix 3.
Considerations in Developing a Code of Conduct for Dual Use Research in the
Life Sciences
Appendix 4.
Points To Consider in Risk Assessment and Management of Research That Is
Potentially Dual Use of Concern
Appendix 5.
Points To Consider in Assessing the Risks and Benefits of Communicating
Research Information With Dual Use Potential
113
ABBREVIATIONS AND ACRONYMS
DNA
Deoxyribonucleic acid
EMBO
European Molecular Biology Organization
HHS
(U.S. Department of) Health and Human Services
IACUC
Institutional Animal Care and Use Committee
IBC
Institutional Biosafety Committee
IRB
Institutional Review Board
NIH
National Institutes of Health
NIH Guidelines
NIH Guidelines for Research Involving Recombinant DNA Molecules
NRC
National Research Council (of the U.S. National Academies)
NSABB
National Science Advisory Board for Biosecurity
PI
Principal Investigator
Qs&As
Questions & Answers
RAC
(NIH) Recombinant DNA Advisory Committee
RNA
Ribonucleic acid
RNAi
RNA interference
U.S.
United States
U.S.C.
United States Code
siRNA
Small interfering RNA
i
114
Executive Summary
Life sciences research has a critical role in understanding life at the ecosystem, organism,
biological system, organ, cellular, and molecular levels. Advances in the life sciences have led
to new pharmaceuticals, diagnostic procedures, preventive strategies, treatments, and cures for
myriad acute and chronic diseases and conditions and has contributed to improvements in animal
and plant health and the food supply.
However, the information gained from life sciences research also could be used for destructive
purposes that could threaten the health and safety of life on our planet. Over the past several
years, especially following the terrorist attacks of September 11 and the subsequent anthrax
attacks utilizing the U.S. Postal Service, there have been increasing calls to consider the
possibility that new information from life sciences research could be subverted for malevolent
purposes and that new biosecurity measures should be instituted to minimize this risk.
This threat has been recognized and articulated by individuals, organizations, and governments
around the world. In this country, the National Science Advisory Board for Biosecurity
(NSABB) was established by the U.S. Government to advise on strategies for dealing with the
generation and communication of information and new technologies from life sciences research
that have the potential for both benevolent and malevolent application—referred to in this report
as “dual use research”—along with the subset of dual use research with significant potential for
generating information that could be misused—referred to as “dual use research of concern.”
The NSABB’s tasks include proposing an oversight framework for the identification, review,
conduct, and communication of life sciences research with dual use potential in consideration of
protecting both national security concerns and the progress of the life sciences. The NSABB
strongly promotes the free and open exchange of information in the life sciences to the maximum
extent possible and believes that the best way to address concerns regarding dual use research is
to raise awareness of the issue and strengthen the culture of understanding and responsibility
within the scientific community and the public as well as instituting new oversight procedures to
minimize the risk of misuse of research information.
The recommendations of the NSABB in the report that follows are not intended as guidelines but
rather as a framework for the development—by the federal government—of a comprehensive
system for the responsible identification, review, conduct, and communication of dual use
research. In this report, the NSABB identifies principles that should underpin the oversight of
dual use life sciences research, lists key features of such oversight (e.g., federal guidelines,
awareness and education, evaluation and review of research for dual use potential, assessment
and management of risk, compliance, and periodic evaluation at the local (e.g., research
institution) and federal levels of the impact and effectiveness of oversight procedures) and
proposes roles and responsibilities for researchers, institutions, the institutional review entity,
and the NSABB and other federal government entities. The report also describes the major steps
in local oversight of dual use life sciences research, including evaluation of life sciences research
for its dual use potential, review of research identified as being potentially dual use of concern,
conduct of dual use research of concern in accordance with risk management strategies, and
responsible communication of research with dual use potential.
ii
115
One of the fundamental tasks of the NSABB was to develop criteria for identifying dual use
research of concern. The proposed criterion is “research that, based on current understanding,
can be reasonably anticipated to provide knowledge, products, or technologies that could be
directly misapplied by others to pose a threat to public health and safety, agricultural crops and
other plants, animals, the environment, or materiel.” As guidance for those assessing research
for its dual use potential, the NSABB identified seven broad categories of information that might
be generated by life sciences research that has a high potential for being dual use of concern.
NSABB members agreed that the principal investigator, using the criterion set forth above,
should conduct the initial evaluation of his or her research for its potential as dual use research of
concern. Those projects initially identified as dual use research of concern—and NSABB
members anticipate that there will be very few projects that are truly dual use of concern—would
undergo additional institutional review that involves interactive discussion among reviewers to
assess the potential for and the ways in which information, technologies, or biological agents
from the research could be misused to pose a threat; the likelihood that the information might be
misused; the potential impacts of misuse; and the strategies for mitigating the risks that
information from the research could be misused. To guide this review process, the NSABB
developed “Points To Consider in Risk Assessment and Management of Research Information
That Is Potentially Dual Use of Concern.”
The NSABB also recommends strategies and has developed tools to help ensure that research
information with dual use potential is communicated responsibly, and in a manner that addresses
both biosecurity concerns and the need for open sharing of research results and technologies.
These tools include a set of principles for the responsible communication of research with dual
use potential; points to consider for identifying and assessing the risks and benefits of
communicating research information with dual use potential, including options for the
communication of such research information; and considerations for the development of a
communication plan for research with dual use potential.
In fulfillment of one of its specific charges, the NSABB also provides recommendations on the
development of a code of conduct for scientists and all laboratory personnel that could be
adopted by professional organizations and institutions engaged in the performance of life
sciences research. These are articulated in “Considerations in Developing a Code of Conduct for
Dual Use Research in the Life Sciences,” which provides a conceptual foundation for
understanding the dual use issue, describes the nature and utility of codes of conduct, articulates
the fundamental principles of responsible conduct with regard to dual use research, and provides
guidance on addressing the dual use issue in specific phases of the research process.
This report also addresses the importance of education and training in biosecurity issues for all
life scientists and describes previous, ongoing, and future approaches to meet these goals,
including the use of focus groups and roundtables, presentations at meetings of scientists and
other stakeholders, exhibits at scientific meetings to educate attendees about biosecurity matters
and the development of related federal policy and international dialogs. During the federal
policymaking process, the NSABB recommends soliciting comment through notice in the
Federal Register, federal government sponsorship of town-hall style regional meetings, and the
iii
116
establishment of a publicly accessible docket for the collection of public comments on policy.
Once requirements on the oversight of dual use research are formally agreed on by the federal
government, a communications plan should be prepared for the rollout of the new federal
policies as well as an intensive and ongoing campaign of workshops, presentations, print and
electronic materials, exhibits, and other activities to educate all affected constituencies and
promote compliance with the new requirements.
The NSABB intends to address in more detail additional aspects of oversight of dual use
research issues, including outreach and education and compliance and enforcement strategies.
These topics are better addressed once federal policies are more fully developed. The NSABB
also strongly recommends that the U.S. Government seek broad input from the public on these
and other issues presented in this report and encourage the development of education and
guidance tools concerning dual use research issues by institutions, scientific associations, and
professional societies. Because research is a global activity, the NSABB also recommends that
the U.S. engage in dialog on these issues with other countries.
iv
117
Introduction
Purpose of This Document. This document sets forth recommendations of the National Science
Advisory Board for Biosecurity (NSABB) for the oversight of publicly funded life sciences
research as a means of minimizing the potential that information, products, or technologies
resulting from this research will be misused for harmful purposes. These recommendations are
not intended as comprehensive guidelines for such oversight but rather to serve as a framework
or springboard for the U.S. Government to develop a comprehensive and coordinated oversight
policy. The NSABB hopes and expects that there will be an iterative process of consultation
with the public and the government and anticipates modifying this framework in response to this
input and as it addresses additional oversight issues in the future.
The Critical Role of Life Sciences Research. Life sciences research encompasses a diverse array
of approaches to understanding life at the level of ecosystems, organisms, biological systems,
organs, cells, and molecules. Advances in molecular and cell biology, genetics, microbiology,
and other life sciences disciplines have made it possible to routinely manipulate aspects of
biological systems as part of an ongoing quest to better understand the health and disease states
and the life cycles of humans, animals, plants, insects and microorganisms.
Advances in the life sciences have led to new pharmaceuticals, diagnostic procedures, preventive
strategies, treatments, and cures for myriad acute and chronic diseases and conditions and for
emerging and reemerging infectious diseases that affect humans and exact a heavy toll in terms
of quality of life, medical costs, and productivity. Similar advances have contributed to
improvements in animal and plant health and the food supply.
Across the globe, researchers are manipulating microorganisms to gain a deeper understanding
of how they cause disease to identify new targets for the development of novel and improved
treatments for the diseases these microbes cause, identify new strategies for the control of
microorganisms, and develop measures to prevent infection with or illness caused by
microorganisms.
Plant biologists are utilizing similar approaches to enhance crop yield and nutritional content and
explore the potential for using plants to manufacture products such as vaccines, antibodies, and
other biological products. Similar efforts are underway in the field of animal husbandry in an
effort to produce animals for human consumption that are heartier and better sources of nutrition.
In other arenas, life scientists are developing environmental remediation technologies and
creating new materials and even energy sources.1
The Dual Use Research Issue. Information from life sciences research is clearly vital to
improving public health, agriculture, and the environment and maintaining and strengthening our
national security and economy. Yet the very information and tools developed to better the
health, welfare, and safety of humankind also can be misused for harmful purposes. Information
1
Globalization, Biosecurity, and the Future of the Life Sciences, a 2006 report of the National Research Council’s
Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare
Threats, pp. 1, 83.
1
118
from legitimate life sciences research can be misapplied to create dangerous pathogens for
employment as weapons, bypass countermeasures or threaten in other ways the health and safety
of humans, animals, plants, and the environment or to cause harmful consequences to materiel.2
This was recognized by the European Molecular Biology Organization (EMBO) at its 2006
meeting3 and was also eloquently articulated in a statement by an august group of scientific
journal editors and authors: “The process of scientific publication, through which new findings
are reviewed for quality and then presented to the rest of the scientific community and the public,
is a vital element in our national life. New discoveries reported in research papers have helped
improve the human condition in myriad ways: protecting public health, multiplying agricultural
yields, fostering technological development and economic growth, and enhancing global stability
and security. But new science, as we know, may sometimes have costs as well as benefits. . . .
As a result, questions have been asked by the scientists themselves and by some political leaders
about the possibility that new information published in research journals might give aid to those
with malevolent ends.” 4
The development of new technologies and the generation of information with the potential for
benevolent and malevolent purposes are referred to in this report as “dual use research.”5 This
dual use quality is inherent in a significant portion of life sciences research. In fact, it can be
argued that virtually all life sciences research has dual use potential. Later in this report, we
describe a subset of dual use research that has the highest potential for generating information
that could be misused, which we call “dual use research of concern.”
The NSABB gave a great deal of thought to the issue of how much life sciences research might
reasonably be considered dual use research of concern. Although it was not possible to quantify
the exact amount of dual use research of concern that is generated in the U.S. or elsewhere in a
given period such as a year, preliminary analyses suggested that the number of cases of true dual
use research of concern will be quite small. Similarly, it was not possible to quantify the risk of
misuse of information from that research, but there was a consensus among NSABB members
that there is indeed the potential for misuse with severe consequences to public health and safety
and other areas presented herein. Misuse of dual use research of concern is therefore a lowprobability but potentially high-consequence event, and this is a significant factor in the
NSABB’s formulation of oversight recommendations.
Calls to Action. Over the past several years, especially following the terrorist attacks of
September 11, 2001 and the subsequent anthrax attacks utilizing the U.S. Postal Service over the
course of several weeks beginning on September 18, 2001, there have been increasing calls to
consider the possibility that new information from life sciences research could be subverted for
malevolent purposes and to institute new biosecurity measures to minimize this risk.
2
Materiel includes food, water, equipment, supplies, or material of any kind.
EMBO Reports, vol. 7, Special Issue on Science and Society (2006).
4
Journal Editors and Authors Group, Statement on the Consideration of Biodefence and Biosecurity. Nature vol. 421, February 20, 2003.
5
The NSABB Charter also describes dual use research. See Appendix 1.
3
2
119
Concerns about the dual use potential of biotechnology research have been articulated in reports
from the National Research Council (NRC) of the U.S. National Academies, together with a
number of recommendations for addressing such concerns. 6,7 One o f the reports noted that,
“[w]ith regard to oversight of research, no country has developed guidelines and practices to
address all aspects of biotechnology research. . . . [E]xisting domestic and international
guidelines and regulations for the conduct of basic or applied genetic engineering research may
ensure the physical safety of laboratory workers and the surrounding environment from contact
with or exposure to pathogenic agents or ‘novel’ organisms. However, they do not currently
address the potential for misuse of the tools, technology, or knowledge base of the research
enterprise for offensive military or terrorist purposes. In addition, no national or international
review body currently has the legal authority or self-governance responsibility to evaluate a
proposed research activity prior to its conduct to determine whether the risks associated with the
proposed research, and its potential for misuses outweigh its potential benefits. . . . [T]he
existing fragmentary system must be adapted, enhanced, supplemented, and linked to provide a
system of oversight that will give confidence that the potential risks of misuse of dual use
research are being adequately addressed while enabling vital research to go forward.”8
Similarly, the Royal Society and the Wellcome Trust noted that “[r]esearch institutions and
funding agencies need to consider how to build on existing processes for reviewing research
projects to ensure that risks of misuse are assessed in an appropriate and timely manner.”9
Likewise, a group of distinguished journal editors and authors convened to consider biodefense
and biosecurity recommended that “[s]cientists and their journals should consider the appropriate
level and design of processes to accomplish effective review of papers that raise such security
issues.”10
U.S. Government Response. In acknowledgment that the threat of the misuse of research
information is important and real, the U.S. Government agreed that new biosecurity measures
were warranted to minimize the risk that information from life sciences research might be
misused to threaten public health and safety and other aspects of national security. One of these
biosecurity initiatives was the establishment of an advisory body, the NSABB. The NSABB
charter states that its purpose is to recommend strategies for the efficient and effective oversight
of federally conducted or supported dual use biological research (see Appendix 1 for the NSABB
charter and the current roster of NSABB members.)
The NSABB is charged with a significant set of specific tasks, including proposing an oversight
framework for the identification, review, conduct, and communication of life sciences research
with dual use potential. In doing so, the NSABB was instructed to consider both national
security concerns and the needs of the life sciences research community. The latter directive
acknowledges the vital role of life sciences research in public health and in national security and
6
Biotechnology Research in an Age of Terrorism. Committee on Research Standards and Practices to Prevent the
Destructive Application of Biotechnology, National Research Council. National Academies Press, Washington, DC (2004).
7
Globalization, Biosecurity, and the Future of the Life Sciences. Op. cit.
8
Biotechnology Research in an Age of Terrorism, p.3. Op. cit.
9
Report of a Royal Society-Wellcome Trust meeting. Do no harm: Reducing the potential for the misuse of life science research. October 7, 2004, p.1.
10
Statement on the Consideration of Biodefence and Biosecurity. Op. cit.
3
120
the need to ensure that whatever oversight measures are put in place for dual use research do not
unduly burden or slow the progress of life sciences research. Although the purview of the
NSABB is life sciences research, the Board acknowledges that there is increasing overlap
between biology and other disciplines and recommends that the oversight of dual use research
extend beyond the traditional life sciences disciplines. The same concerns about not unduly
hindering the progress of science would apply to these other fields as well.
NSABB Considerations. Although the potential for misuse of scientific information exists, and
the consequences could be severe, one of the major concerns of the NSABB is that the response
to this threat be carefully measured lest more harm than good be done in the name of biosecurity.
No oversight system can bring the risk of misuse of information to zero, nor can it completely
prevent those that are intent on doing harm from doing so. The goal is to implement reasonable
precautions to minimize the risk of misuse while still maintaining a vibrant research enterprise.
Oversight measures should not create impediments to legitimate life sciences research.
The continued rapid progress of the life sciences is paramount since findings from life sciences
research directly and indirectly underpin medical progress, the safety and quality of the food
supply, the quality of our environment, advances and productivity in numerous commercial
sectors, and the status of public health and safety.
Indeed, in a statement on science and security in an age of terrorism that predates the formation
of the NSABB, presidents of the three U.S. National Academies (National Academy of Sciences,
National Academy of Engineering, and Institute of Medicine) noted that, “[i]n meeting this
responsibility, the scientific, engineering, and health research community also recognizes a need
to achieve an appropriate balance between scientific openness and restrictions on public
information. Restrictions are clearly needed to safeguard strategic secrets; but openness also is
needed to accelerate the progress of technical knowledge and enhance the nation’s understanding
of potential threats.”11
Subsequently, a report from the National Academies emphasized the need to promote the free
and open exchange of information in the life sciences to the maximum extent possible, noting
“the many ways that biological knowledge and its associated technologies have improved and
can continue to improve biosecurity, health, agriculture. . . . [C]onversely, restrictive regulations
and the imposition of constraints on the flow of information are not likely to reduce the risks that
advances in the life sciences will be utilized with malevolent intent in the future. In fact, they
will make it more difficult for civil society to protect itself against such threats and ultimately are
likely to weaken national and human security. Such regulation and constraints would also limit
the tremendous potential for continuing advances in the life sciences and its related technologies
to improve health, provide secure sources of food and energy, contribute to economic
development in both resource-rich and resource-poor parts of the world, and enhance the overall
quality of human life.” The report further recommended ensuring “that any biosecurity policies
or regulations implemented are scientifically sound and are likely to reduce risks without unduly
hindering progress in the biological sciences and associated technologies.”12
11
12
Alberts B, Wulf WA, Fineberg H. Statement on Science and Security in an Age of Terrorism. October 18, 2002.
Globalization, Biosecurity, and the Future of the Life Sciences., pp. 6-8. Op. cit.
4
121
Similar concerns have been voiced elsewhere. For example, a report from the Royal Society and
Wellcome Trust noted that “the threat of advances in the life sciences being used for harmful
purposes is a real one” and that “the challenge that the scientific community faces is to identify
what measures can be taken to manage or reduce this risk without jeopardizing the enormous
potential benefits from research advances. . . . Research institutions and funding agencies need
to consider how to build on existing processes for reviewing research projects to ensure that risks
of misuse are assessed in an appropriate and timely manner.”13
The current inability to quantify dual use research of concern and the risk of misuse of research
information raises challenges for proposing an oversight framework. The NSABB recognized
some parallels with recombinant deoxyribonucleic acid (DNA) research, which provides an
important historical precedent for managing risk when its magnitude is unknown. The system of
oversight for recombinant DNA has stood the test of time in part because it is capable of
evolving with technological developments and new scientific understanding. Oversight of
recombinant DNA research is not imbedded in regulation; this provides greater facility to adapt
to advancing science while nonetheless establishing a standard of practice that is embraced by
public and private sectors.
The NSABB has drawn from the recombinant DNA research oversight system in proposing
oversight measures for dual use research of concern. The current proposals are for guidelines
rather than regulations so that course corrections can be made more easily and new technological
advances can be addressed as needed with relative ease. One concern that has been raised by
NSABB members and also by members of the public is that the NSABB charter currently states
that the scope of oversight for dual use research is federally conducted or supported biological
research. The NSABB recognizes that a significant amount of life sciences research, some of
which may be dual use of concern, is conducted with private funds. Regardless of whether life
sciences research is publicly or privately funded, the fundamental principles regarding the
responsible conduct and communication of dual use research should be followed.
Need for Engagement of the Life Sciences Community. The NSABB strongly believes that one
of the best ways to address concerns regarding dual use research is to raise awareness of dual use
research issues and strengthen the culture of responsibility within the scientific community. The
stakes are high for public health, national security and the vitality of the life sciences research
enterprise. Responsible scientists have a duty to be aware of the potential for misuse of their
scientific findings and of their obligation to help inform and shape critical policy decisions about
biosecurity in the life sciences.
As noted previously, there have been numerous calls for consideration of the security
implications of life sciences research findings and for establishing processes to minimize the risk
of misuse of those findings with dual use potential. This has been voiced in many different
quarters: the scientific community, including journal authors and editors, researchers, academies
(national and international), and professional societies; the U.S. Congress and other legislative
and policymaking bodies; the federal agencies that fund and conduct life sciences research; the
federal entities involved in national security; and members of the public. Thus, it is almost a
13
Report of a Royal Society -Wellcome Trust meeting. Op. cit.
5
122
certainty that new oversight procedures will be implemented in the life sciences to protect
against the threat of misuse of research information.
Participating in the development of those measures is an opportunity to ensure that the open
process of scientific discovery that has been so critical to the progress and achievements in life
sciences research remains open. Life scientists have been and must continue to be fully
committed to the free flow of scientific inquiry. It is in the life sciences community’s interest to
engage and demonstrate to the public and policymakers that life scientists are taking
responsibility for the implications of their work.
This view has been echoed in commentaries and editorials in prestigious international scientific
journals. For example, one commentator noted that “[b]iologists must begin a process of selfregulation for projects that have potential applications in developing bioweapons—or risk the
imposition of restrictive controls from outside.”14 Another stated that “[b]iologists should
involve themselves in the debate over biological weapons—both to ensure that we have the
means to counter the threats that such weapons pose and to help keep those threats in
perspective. . . . By becoming more aware of the issues and engaging more vigorously in
discussions on bioweapons, biologists can also help to ensure that threats are not blown out of
proportion. . . . But if biologists stick their heads in the sand and pretend that their work has
nothing to do with warfare, they will be doing the world a disservice.”15 Yet another noted that
“[t]he greatest concern is in the need for clarity. It is important to develop clear guidelines about
what research is considered sensitive, what is expected of researchers whose work produces
dual-use outcomes, and how the government should in practice respond without losing the
priceless virtues of open scientific scrutiny. Without such clarity, officials insensitive to those
virtues may institute precautionary measures that reach far beyond what is appropriate.” 16
Indeed, a senior official of the U.S. Government cautioned that “[t]he science community ought
to come up with a process before the public demands the government do it for them, and that will
be driven by the rate at which controversial papers hit the streets.”17
The NSABB recognizes that broad consultation with the scientific and security communities and
with the public is essential in order for its recommendations regarding an oversight system to be
useful, relevant, practicable and acceptable. As the three Presidents of the National Academies
observed, “[a]chieving the purpose of scientific and technological activity—to promote the
welfare of society and to strengthen national security—will require ingenuity from our science,
engineering, and health community, as well as from the many agencies of the federal, state, and
local governments involved in counterterrorism. The nation’s safety and the continued
improvement of our standard of living depend on careful, informed action on the part of both
governments and the scientific, engineering, and health community. A continuing, meaningful
dialogue needs to begin—one that produces a true collaboration for the many decisions that need
to be made.”18 Similar thoughts were articulated in a report of the Royal Society and the
Wellcome Trust: “The challenge is to think beyond the obvious and identify those avenues of
14
Aldous P. Biologists urged to address risk of data aiding bioweapon design. Nature 2001. 414(6861):237 -8.
A call to arms. Nature 2001. 411(6835):223.
16
Risks and benefits of dual-use research. Nature 2005. 435(7044):855.
17
Check E. US officials urge biologists to vet publications for bioterror risk. Nature 2003. 421(6920):197.
18
Alberts B. et al. Op. cit.
15
6
123
research and technologies that present risks of being misused for harmful purposes that are quite
distinct from the original aims of the work. This needs imaginative thinking as the vast majority
of work falls into the grey area of having some potential for misuse.”19
It is the NSABB’s expectation that its recommendations will be a useful springboard for the U.S.
Government in the development and implementation of a comprehensive system for the
responsible identification, review, conduct, and communication of dual use research. To this
end, the NSABB emphasizes that comments are welcome on any and all aspects of this report.
Specific questions are posed in Appendix 2, but input need not be limited to these questions. In
addition, the NSABB notes that, in keeping with its charge, as the oversight system is further
developed by the U.S. Government, the Board will address certain issues in more detail in the
near future, including compliance and enforcement and education and outreach.
Guiding Principles for Oversight of Dual Use Life Sciences Research
As a first step in proposing a framework for oversight, the NSABB identified a number of
principles that should underpin any oversight of dual use life sciences research:
• Life sciences research underpins advances in public health, agriculture, the environment,
and other pertinent areas and contributes significantly to a strong national security and
economy. The life sciences are a global enterprise and becoming ever more so. The free
and open conduct and communication of life sciences research is vital to a robust
scientific enterprise; thus the “default” position should be the unfettered progress and
communication of science. Any decision to do otherwise should be undertaken very
carefully.
• However, life sciences research has the potential to produce information or technology
that can be misused to pose a threat to public health and safety, and therefore it is
appropriate to have in place a framework and tools for the responsible oversight, conduct,
and communication of such research.
• Effective oversight will help maintain public trust in the life sciences research enterprise
by demonstrating that the scientific community recognizes the implications of dual use
research and is acting responsibly to protect public welfare and security. The federal
agencies that fund life sciences research, the institutions that are the recipients of those
public funds, and the individuals who conduct this research share this oversight
responsibility.
• Any oversight system must balance the need for security with the need for research
progress. The degree of oversight should be consistent with the likelihood and possible
consequences of misuse.
• The foundation of oversight of dual use research includes investigator awareness, peer
review, and local institutional responsibility. Such oversight allows input directly from
19
Report of a Royal Society -Wellcome Trust meeting, p.1. Op. cit.
7
124
the investigators, facilitates timely review, offers appropriate opportunities for public
input, and demonstrates to the public that scientists are taking responsibility for their
research.
• The responsible conduct and communication of dual use research of concern depend
largely on the individual conducting such activities. No criterion or guidance document
can anticipate every possible situation. Motivation, awareness of the dual use issue, and
good judgment are key to the responsible evaluation of research for dual use potential. It
is incumbent on the institution and the investigator to adhere to the intent of such
guidance as well as to the specifics.
• Life sciences research is by nature dynamic and can produce unanticipated results and
therefore must be periodically evaluated for dual use potential.
• For the oversight system to be effective, it is essential that the various federal government
agencies involved pursue a harmonized approach to the oversight of dual use research.
• The effectiveness of an oversight framework depends on awareness by the scientific
community and the public of the dual use potential of research.
• An efficient and effective oversight system also requires ongoing dialogs among the
scientific communities, governmental agencies, and the public.
• The responsible communication of dual use research of concern is essential to maintain
public confidence in the scientific community.
• The oversight process for dual use research must be periodically evaluated both for
effectiveness and impact on the research enterprise.
Below are the key features and roles and responsibilities proposed by the NSABB for the
oversight of life sciences research with dual use potential.
Key Features of the Proposed Oversight System
Following are descriptions of seven key features of the proposed oversight system:
Federal Guidelines. Federal guidelines for oversight of dual use life sciences research should be
developed by the relevant federal agencies with a role or interest in life sciences research. The
guidelines should take into consideration the recommendations of the NSABB, including the
considerations for a code of conduct and the specific tools/guidances developed for identifying
dual use research of concern, for assessing and managing risk, and for communicating dual use
research responsibly—as well as public comments on the NSABB recommendations.
The guidelines will assist scientists, institutions, other entities, and the federal government in
determining and implementing safeguards regarding dual use research. The guidelines should
address at a minimum:
• Scope and applicability of the guidelines
8
125
• Definitions
• Research covered by the guidelines, including criteria for identifying dual use research of
concern and points to consider in applying the criteria
• Guidance for the review of research that is potentially dual use of concern, including
points to consider in risk assessment and strategies for risk management
• Roles and responsibilities of entities and individuals engaged in life sciences research
• Criteria for referring issues from the local level to the federal level
• Processes and procedures for addressing dual use research issues at the federal level
• Compliance and penalties for noncompliance
The guidelines should be clearly written, well organized, and understandable to both the
scientific community and the general public. The guidelines should also be periodically updated
to keep pace with developments in the life sciences.
Awareness. Researchers, research personnel, and research administrators should be fully aware
of dual use research concerns, issues, and policies. An enhanced culture of awareness is
essential to an effective system of oversight and is a critical step in scientists taking
responsibility for the dual use potential of their work.
Education. Awareness will be enhanced through ongoing, mandatory education about dual use
research issues and policies. This will ensure that all individuals engaged in life sciences
research are aware of the concerns and issues regarding dual use research and their roles and
responsibilities in the oversight of such research.
The federal government should develop training and guidance materials on federal requirements
that can be used as educational resources at the local level. Furthermore, scientific societies,
professional associations, and others in the private sector have an important contribution to
make in promoting a culture of awareness and responsibility by educating broadly about dual use
research, the associated tenets of responsible research, and the best practices in identifying and
overseeing dual use research. The federal government can foster the development of such
private sector training and education initiatives by providing appropriate resources for their
development. Research institutions and associations should utilize these materials, tailoring
them as needed to different audiences as part of promoting an awareness of dual use research
issues among those involved in life sciences research.
Local Evaluation and Review of Research for Dual Use Potential. The initial evaluation of the
dual use potential of life sciences research should be conducted by the investigator, after
appropriate training. Additional review by others at the research institution may also be
appropriate to ensure an unbiased and comprehensive evaluation and application of the criteria
for identifying dual use research of concern. Local evaluation and review ensure that those with
the appropriate expertise and the best understanding of local personnel, facilities, and ethos are
assessing research for dual use potential. Local evaluation and review also demonstrate to the
public that scientists and their institutions are attending to the biosecurity implications of dual
use research and facilitates the timeliness of the oversight process.
9
126
Risk Assessment and Risk Management. The degree of oversight should be commensurate with
the degree of risk and the potential impact of any misuse of research information. Risk
assessment and management should be the foundation for local oversight of dual use research of
concern. This will help minimize the potential for misuse of dual use research information while
minimizing any negative impact on the conduct of science and will facilitate the responsible
conduct of life sciences research.
Periodic Evaluation. There is a need for periodic evaluation, at the local and federal levels, of
the need for oversight of dual use life sciences research, of the effectiveness of the oversight
system, and of the administrative burden of the oversight system. Assessing the need for and
effectiveness of the oversight system in minimizing the risks associated with dual use research of
concern, while allowing important research to go forward, will promote the conduct of life
sciences research and its efficient and effective governance and will facilitate the implementation
of course corrections as appropriate.
Compliance. As the oversight framework is formalized into policy and guidelines by the U.S.
Government, mechanisms at both the federal and local level for ensuring compliance will be an
important consideration and will need to be addressed in detail. The NSABB will advise on this
topic as necessary in the future. Thus, the NSABB recommends that federal agencies develop
consistent mechanisms for enforcement, including penalties for noncompliance, perhaps by
making compliance a term and condition of funding.
It is also understood that the applicability of the federal policy for oversight of dual use research,
at least initially, will be to federally conducted or funded dual use life sciences research. The
NSABB recommends that the applicability of federal policy for dual use research be as wide as
possible. For example, the applicability of the NIH Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines) goes beyond research that is funded by the
National Institutes of Health (NIH); it extends to all research that is conducted at or sponsored by
an institution that receives any support for recombinant DNA research from the NIH, including
research that is privately funded. Such a mechanism should be considered for dual use life
sciences research as well. The NSABB recognizes that this still will not cover all entities
engaged in dual use life sciences research. Nonetheless, the NSABB anticipates that the dual use
research issue will be appreciated by those entities engaged in life sciences research that are not
subject to the federal policy and that these entities will voluntarily comply with dual use research
oversight guidelines. The effectiveness of voluntary compliance by noncovered entities should
be evaluated at a designated time after Federal policies are implemented to inform decisions as to
whether other federal enforcement mechanisms should be contemplated.
The NSABB also notes that lines between biology and other disciplines are increasingly blurred
as multidisciplinary approaches are employed for addressing complex biological problems. For
example, mathematical modeling and chemical engineering approaches are often combined with
more traditional biologic techniques to solve a problem. Consequently, disciplines not ordinarily
considered to fall within the life sciences may yield dual use biological information. Therefore,
the NSABB recommends that the U.S. Government consider the need to apply dual use research
oversight measures beyond what is usually thought of as the traditional life sciences disciplines.
10
127
Roles and Responsibilities in Oversight of Life Sciences Research With Dual Use Potential
Researchers. Researchers are the most critical element in the oversight of dual use life sciences
research. They know the work best and are in the best position to anticipate the types of
knowledge, products, or technologies that might be generated, the potential for misuse, and the
degree of immediacy of that threat. However, to fulfill this responsibility, the principal
investigator (PI) must be cognizant of the concept of dual use research of concern and aware of
the risk that technologies or information produced by life sciences research may be misused.
Researchers thus have a professional responsibility to be aware of dual use research issues and
concerns, to be aware of the implications of their work and the various ways in which
information from their work could be misused, and to take steps to minimize misuse of their
work. This includes being knowledgeable about and complying with all local and federal
policies for oversight of dual use research, ensuring that their own dual use research training and
that of their staff is current, assessing their own work and that of their research personnel for dual
use potential on an ongoing basis, and communicating dual use research in a responsible manner.
Researchers should carry out their work in an ethical and responsible manner, adhering to the
standards of conduct described in the NSABB document “Considerations in Developing a Code
of Conduct for Dual Use Research in the Life Sciences” (see Appendix 3).
On an annual basis, researchers should also provide formal assurance to their institutions that
they are assessing their work for potential dual use of concern. The NSABB also recommends
that there be a mechanism, such as a check box, on new grant applications and competing
renewals, indicating that the dual use potential of the proposed work has been evaluated and
whether there is such potential. The NSABB recognizes that these mechanisms will need to be
implemented by science funding entities.
Research Institutions. Institutions have a number of general responsibilities regarding the
oversight of life sciences dual use research:
• Ensuring that life sciences research is conducted in conformance with applicable federal,
state, local (e.g., municipal), and institutional policies.
• Establishing and implementing internal policies and practices that provide for the
effective and efficient oversight of dual use research of concern. The degree of oversight
should be consonant with the degree of risk of misuse and the potential impact of misuse
of research information. Policies and practices for oversight of dual use research should
minimize any negative impact on the conduct of life sciences research.
• Establishing mechanism(s) for advising on dual use research issues and assisting
investigators in complying with dual use research policies. This should include the
designation of a point of contact within the institution for questions regarding dual use
research.
11
128
• Providing appropriate education on dual use research for individuals involved in life
sciences research. This can utilize educational and training materials developed by the
federal government.
• As necessary, assisting the PI in deciding whether her or his research meets the criterion
for dual use research of concern and thus requires further review or oversight. In the
great majority of cases, it is anticipated that the institution will rely on the judgment of
the researcher. In some cases, however, the researcher may request additional review by
an individual with sufficient knowledge and/or expertise to assist in these determinations.
Such an independent evaluation of the dual use potential of the research may bring to
bear additional objectivity, perspective, and knowledge and may assist in considering the
ways in which the information from the research could be misused.
• Establishing an internal mechanism for investigators to appeal local decisions regarding
dual use research.
• Addressing internal requests for referral of dual use research issues to the federal level.
• Upon request and as appropriate and consistent with applicable laws, making available to
the public information pertaining to institutional oversight of dual use research.
• Periodically assessing the effectiveness of internal policies for oversight of dual use
research, including feedback from investigators and other stakeholders.
• Reporting significant violations of federal dual use research policies as specified by an
institution or by federal policy.
Institutions also have specific responsibilities regarding the evaluation of research for dual use
potential and the review of research that has been identified as dual use of concern:
• Establishing an institutional mechanism for expert committee review (including risk
assessment and risk management) of research that has been identified as dual use of
concern.
o This local committee should be constituted in a manner so as to have the
necessary expertise to consider the dual use implications of research and to
recommend and oversee risk management strategies.
o When institutions already have an Institutional Biosafety Committee (IBC) in
place, they should consider using this existing mechanism for the review of dual
use research of concern. Many of the kinds of experiments raising dual use
considerations entail recombinant DNA and would otherwise be subject to IBC
review, helping minimize any additional burdens. Dual use expertise could be
brought to the IBC through the use of ad hoc members.
o Alternative approaches should also be acceptable—such as establishing a
committee exclusively for dual use review or utilizing an externally administered
committee (e.g., an IBC at a neighboring institution or a commercial IBC)—as
long as the committee is competent to conduct dual use review.
12
129
• Institutions should strive to develop review processes that do not encumber the conduct
of life sciences research that is not dual use of concern.
Institutions also have some administrative responsibilities regarding the oversight of dual use life
sciences research:
• As may be required by federal policy, registering their review mechanism and updating
that registration annually
• Designating an institutional point of contact on dual use research issues
• Collecting and maintaining records of personnel training on dual use research and of
investigator assurances, provided on an annual basis, that the researchers are assessing
their research for dual use potential
Institutional Review Entity. The review entity utilized to fulfill the institution’s responsibility to
review work that has been identified as dual use research of concern should have, or be able to
provide on an ad hoc basis, sufficient breadth of scientific expertise to assess the dual use
potential of the range of research conducted at a given research facility. The review entity must
have knowledge of dual use issues, concerns, and policies and understand risk assessment and
risk management considerations. Risk assessment and management considerations should
include, but not necessarily be limited to, those in the guidance developed by the NSABB and
described below.
At institutions subject to the NIH Guidelines, the most suitable review entity will likely be the
IBC, supplemented as appropriate with expertise pertinent to dual use research. Alternatively,
institutions may wish to establish a committee exclusively dedicated to the review of dual use
research. However this review function is established, the review entity should be sufficiently
empowered by the institution to be able to ensure compliance with dual use research policies.
NSABB. The NSABB should continue to carry out the functions specified in its charter. This
includes recommending strategies for the efficient and effective oversight of dual use life
sciences research, taking into consideration both national security concerns and the needs of the
research community. This includes, but is not limited to, advising on federal and local oversight
of dual use research, contributing to the development of federal guidelines for dual use research,
recommending procedures and practices for communicating dual use research results and
methodologies, advising on interpretation and application of federal guidelines for dual use
research, and recommending strategies for outreach and education at national and international
levels.
In addition, the NSABB should also periodically evaluate the oversight system for dual use
research, both for effectiveness and impact on the research enterprise.
As requested and appropriate, the NSABB should also serve as a resource to the research
community, including the scientific publishing community, on dual use research issues.
13
130
U.S. Federal Government. The government is responsible for ensuring that any oversight
system is efficient and effective and should also ensure that any negative impact on life sciences
research is minimized. This includes ensuring a harmonized governmental approach to the
oversight of dual use research. Thus, those federal entities with a role or interest in dual use
research should work together on the development of policy that aligns with their agency mission
and organizational function for the effective oversight of dual use research, including compliance
mechanisms, penalties for noncompliance, and processes for adjudication. There will also need
to be harmonized interpretations of policy in the future. A related and key responsibility is
periodic federal government evaluation of the oversight system, for both effectiveness and
impact on the research enterprise.
Proper oversight of dual use research should not be an unfunded mandate. Thus, the federal
government should ensure that sufficient resources are provided to institutions in the fulfillment
of this responsibility. The provision of resources for oversight should not be at the expense of
existing research programs.
Additional roles and responsibilities include education and outreach to affected entities about
dual use issues, policies, and applicable regulations and the development and encouragement of
the development of training tools and materials for use at the local level to educate employees
about dual use issues and their responsibilities.
The federal government is also responsible for the support and administration of the NSABB and
should conduct expert consultations and solicit public comment as appropriate on dual use
research and biosecurity issues.
14
131
Major Steps in Local Oversight of Dual Use Life Sciences Research
Figure 1 : Steps in Local Oversight of Dual Use Research
Education
Training
Guidance
Initial Evaluation
for Dual Use
Potential by PI
Dual use research of
concern identified
•
•
Institutional Review
Risk Assessment
Risk Management
Work conducted in
accordance with risk
management
strategies
Responsible
Communication of
Research
No dual use
potential
identified
PI Responsibilities
Institutional Responsibilities
Periodic Reassessment
of Dual Use Potential,
Especially at Times of
Communication
The critical underpinnings of the oversight system will be education about dual use issues and all
applicable policies as well as the provision of guidance and tools that facilitate compliance with
the policies.
With that as a backdrop, the major steps or stages of local oversight are as follows (see also
Figure 1 above):
• Evaluation of life sciences research for its dual use potential. This should be done at the
inception of any research and periodically throughout the research process.
• Review of research identified as being potentially dual use of concern.
o Assessment of any biosecurity risk(s) associated with the findings, technologies,
or biological agents20 that might be generated from the research. This includes:
– Identification of the ways in which the information, technologies, or
biological agents could be misused
– Consideration of the potential consequences if the research information,
technologies, or biological agents are misused
o Recommendation of strategies for mitigating or managing the risk of misuse.
• Conduct of dual use research of concern in accordance with risk management strategies.
20
As is consistent with 18 U.S.C. § 178, a biological agent is “any microorganism (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substance, or any naturally occurring, bioengineered or
synthesized component of any such microorganism or infectious substance, capable of causing - (A) death, disease,
or other biological malfunction in a human, an animal, a plant, or another living organism; (B) deterioration of food,
water, equipment, supplies, or material of any kind; or (C) deleterious alteration of the environment; . . “
15
132
• Responsible communication of research with dual use potential. This should be done
throughout the research process.
Each of these steps will be further elaborated in the text that follows.
Criterion and Considerations for Identifying Dual Use Research of Concern
The biosecurity concerns that the NSABB is tasked with addressing pertain to the misapplication
of information, technologies, or biological agents resulting from legitimate dual use research, not
the conduct of the research itself. The goal of identifying dual use research of concern is to
initiate a process aimed at reducing the potential that knowledge, products, or technology derived
from certain life sciences research could be misapplied to threaten public health and safety or
other aspects of national security. To facilitate consistent determinations of the dual use
potential of research, the NSABB developed a criterion as a tool for those involved in any aspect
of life sciences research.
During the process of developing the criterion, the NSABB identified a number of considerations
and key concepts that are discussed below and are reflected in the final criterion:
• Because arguably most life sciences research has some potential for dual use, the NSABB
strove to delineate a threshold that would identify that subset of life sciences research
with the highest potential for yielding knowledge, products, or technology that could be
misapplied to threaten public health or other aspects of national security. This subset of
research is referred to herein as “dual use research of concern.”
• It is important to emphasize that evaluation of the dual use potential of research should be
based on a current understanding of the implications of the research results and whether
it is reasonable to anticipate that such information could be misapplied to pose a threat.
The results of research are of concern when they can be directly misapplied to pose a
threat.
• In addition, the NSABB focused on the scope of a potential threat as a key consideration
in evaluating research for dual use potential. Thus, the criterion captures threats with
broad potential consequences to public health or other aspects of national security (e.g.,
that threaten populations rather than individuals).
• It cannot be overemphasized that characterization of research as dual use research of
concern should not be viewed pejoratively. Such a characterization does not
automatically mean that this type of research should not be conducted or communicated,
rather that the conduct and communication of that research should be carefully
considered from the outset and throughout the research process. The oversight process is
about the responsible conduct and communication of research, not the restriction of
research.
16
133
• The concern regarding dual use research is that the information, technologies, or products
developed from it could be misused to threaten national security. The NSABB found that
there are many different understandings of the term “national security,” so it identified
the relevant aspects and used the collective terms. Thus, the criterion refers to the
potential for threats to public health and safety, agricultural crops and other plants,
animals, the environment, and/or materiel. This would include threats to farming,
livestock, aquaculture, terrestrial and marine wildlife, companion animals, domestic and
wild plants and trees, ecological systems, and other natural resources, as well as
manmade resources.
• An evaluation of research for its dual use potential will require scientific expertise and
logical, sound judgment about the probability or foreseeability that others could
misapply/misuse research results. It is important to acknowledge, however, that any such
evaluation is subjective and will be influenced by the individual’s knowledge,
experience, and judgment.
• Life sciences research is an extraordinarily dynamic field that encompasses many diverse
disciplines; therefore, it will be important to periodically review the criterion and modify
it as necessary to ensure its relevance in the face of new advances and technologies.
With these concepts in mind, the NSABB proposes the following criterion for identifying dual
use research of concern:
Criterion for Identifying Dual Use Research of Concern
Research that, based on current understanding, can be reasonably
anticipated to provide knowledge, products, or technologies that
could be directly misapplied by others to pose a threat to public
health and safety, agricultural crops and other plants, animals, the
environment, or materiel.
Determining the applicability of this criterion is a subjective and sometimes challenging task. To
assist those who need to make a determination as to whether research is potentially dual use of
concern, the NSABB also delineated some categories of information, products, or technologies
that might be especially likely to meet the threshold within the criterion for dual use research of
concern, and thus deserve careful consideration with regard to the applicability of the criterion.
It is important to emphasize that not all research that fits the categories below is necessarily dual
use research of concern; rather, it is research for which the criterion needs to be especially
carefully considered. Moreover, it is also the case that research that does not fall into the
categories below might also meet the criterion for being dual use research of concern.
Finally, it is important to acknowledge that the starting point for the categories below was the
seven “experiments of concern” from the NRC report referenced in footnote 1. However, the
17
134
NSABB categories have a different purpose and meaning from those of the NRC report. In the
NRC report, the seven experiments of concern are classes of experiments that the NRC
Committee believed illustrated the types of endeavors or discoveries that would require review
and discussion by informed members of the scientific and medical community before they are
undertaken or, if carried out, before they are published in full detail. The NSABB categories
below, which in some cases are modifications of the NRC categories, are descriptors of
information, products, or technologies that, if produced from life sciences research, might define
that research as meeting the criterion for being dual use research of concern. Therefore, such
research should be especially carefully assessed for meeting the criterion for dual use research of
concern.
The NSABB categories are knowledge, products, or technologies that could enable any of the
following:
1. Enhance the harmful consequences21 of a biological agent22 or toxin.23 The
rationale for this category is that enhancing the pathogenic consequences of an agent
or toxin could increase the likelihood of disease and compromise the ability to treat the
disease(s) they cause if extant therapeutics are no longer effective. Of note, enhancing
the pathogenic consequences of an agent includes rendering a nonpathogenic microbe
pathogenic. Information that would fall into this category and would likely be
considered dual use of concern would be how to make a seasonal strain of the
influenza virus as deadly as the 1918 pandemic strain.
An example of information that would fall under this category, but is unlikely to be
dual use of concern, includes routine techniques for restoring the virulence of viral
stocks by back-passaging in animal hosts, identification of virulence factors through
genome-wide screening or gene knockout techniques, and standard genetic
manipulation to study the virulence of an organism.
21
Harmful consequences: The ability of a biological agent or toxin to critically alter normal biological functions,
inflict damage on public health resources, materiel, and public safety. This would include augmenting properties
such as virulence, infectivity, stability, transmissibility, or the ability of the biological agent or toxin to be
disseminated.
22
Biological agent: As is consistent with 18 U.S.C. § 178, “any microorganism (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substance, or any naturally occurring, bioengineered or
synthesized component of any such microorganism or infectious substance, capable of causing - (A) death, disease,
or other biological malfunction in a human, an animal, a plant, or another living organism; (B) deterioration of food,
wat er, equipment, supplies, or material of any kind; or (C) deleterious alteration of the environment; . .”
23
Toxin: As is consistent with 18 U.S.C. § 178, “the toxic material or product of plants, animals, microorganisms
(including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substances, or a
recombinant or synthesized molecule, whatever the origin and method of production, and includes - (A) any
poisonous substance or biological product that may be engineered as a result of biotechnology that is produced by a
living organism; or (B) any poisonous isomer or biological product, homolog, or derivative of such a substance; . .”
18
135
2. Disrupt immunity24 or the effectiveness of an immunization25 without clinical and/or
agricultural justification. The rationale for this category is that immunity is a key
component in a host’s defense against pathogens and toxins, thus rendering an
immunization ineffective or disrupting immunity could have harmful consequences for
public health, agricultural crops and other plants, and animals. For instance, rendering
an immunization ineffective could make a host population vulnerable to the
pathogenic consequences of a microbe from which the host population would have
otherwise been protected or for which protection, such as a vaccine, was available.
An example of information that fits this category and might qualify as dual use of
concern is the insertion of an immunosuppressive cytokine into a viral genome to
render the antiviral immune response less effective. Information about the
immunosuppressive properties of chemotherapeutic drugs for cancer or autoimmune
disorders could also fit this category, although it is unlikely to be dual use of concern.
3. Confer to a biological agent or toxin, resistance to clinically and/or agriculturally
useful prophylactic or therapeutic interventions26 against that agent or toxin or
facilitate their ability to evade detection methodologies. The main concept is that
anything that might compromise the ability to detect, treat, or prevent disease or illness
(human or agricultural) caused by biological agents or toxins could result in a
significant public health and/or economic burden.
Examples of information that might fit this category and be considered dual use of
concern include conferring doxycycline resistance to Vibrio vulnificus or conferring
antibiotic resistance to agriculturally relevant microbes, such as rendering Ralstonia
solanacearum (a bacterium on the U.S. Department of Agriculture list of highconsequence organisms) resistant to rifampin. Examples of research that might fit this
category, but are unlikely to be dual use of concern, include the use of standard
laboratory selection procedures with antibiotics using host-vector systems that do not
present a significant risk to health or the environment (e.g., transforming a
nonpathogenic/nontoxigenic Escherichia coli strain with a construct for the expression
of a nontoxin protein or conferring rifampin resistance to Pseudomonas fluorescens.
24
Immunity: Encompasses all aspects of host immunity (e.g., active, adaptive, adoptive, passive, innate, and immune modulators).
25
Immunization: Refers to the active or passive induction of immunity through inoculation (e.g., natural inoculation or vaccination) with an immunizing agent or with antibodies; this includes antitoxins and toxoids.
26
Clinically and/or agriculturally useful prophylactic or therapeutic interventions: Includes first - or second-line prevention and treatment measures or alternative therapeutics used with special populations (e.g., pregnant women and pediatric patients) in the form of vaccines, antibiotics, antivirals, antiparasitics, antibodies, herbicides, fungicides, algaecides, insecticides, etc. “Agriculture” encompasses all methods of production and management of livestock, crops, vegetation, and soil. Therefore, useful prophylaxes and therapeutics would include herbicides, fungicides, algaecides, insecticides, rodenticides, etc. 19
136
4. Increase the stability,27 transmissibility,28 or the ability to disseminate29 a biological
agent or toxin. The rationale for this category is that increasing an agent’s stability,
transmissibility, or ability to disseminate could facilitate the purposeful malevolent use
of a biological agent or toxin and increase the rate or ease by which an agent could
spread, impeding attempts to contain disease outbreak. Uncontained outbreaks could
lead to a large infected host population, which may not receive adequate care and
treatment due to limited resources, allowing the disease to spread. Effective
dissemination of a pathogenic agent or toxin could result in large-scale exposure and
the inability to prevent or treat ensuing disease and/or damage in a host population.
The inability to prevent or treat the disease or toxicity due to the lack of resources or
therapeutics could result in a significant threat to the health of the host population(s).
Of note, this category includes transmission between hosts of the same species or
between hosts of differing species. The use of the term “weaponization” was carefully
considered for this category, but since the term is not uniformly understood within the
life sciences community, the concept of dissemination, which is a key component of
weaponization, seems more appropriate.
Examples of research that falls within this category and that might be considered dual
use of concern include changing genetic factors to increase transmissibility and
altering the route of transmission or vector to increase the ease and effectiveness by
which an agent may be transmitted. With regard to increasing the capability of an
agent or toxin to be disseminated, there are inherent challenges in deciding whether
information that falls into this category is dual use of concern. Some of the challenge
relates to issues of scale and intent. For example, work on vectors to increase their
activity for gene therapy may also enable the wide-scale dissemination of a pathogenic
agent or toxin. Research on adjuvants, methods, and tools for the increased efficacy of
biocontrol agents in agriculture may also encompass work with equipment such as
agricultural sprayers that may need to be examined for their dual use potential.
5. Alter the host range30 or tropism31 of a biological agent or toxin. The rationale for
this category is that altering the host range or tropism of a pathogenic agent or toxin
could endanger a host population that normally would not be susceptible. Prevention
and therapy measures for the newly vulnerable host population may be lacking,
possibly allowing for the uncontrolled spread of disease. An example of research
information that would fall under this category and that may be dual use of concern
27
Stability: The ability of a biological agent to remain viable when exposed to various environmental factors, including temperature, relative humidity, atmospheric pollution, and sunlight. Stability also includes persistence in a host. 28
Transmissibility: The ease with which an agent spreads from host to host or from vector to host, e.g., via arthropod vectors. 29
Dissemination: The process by which in fectious diseases or toxins are dispersed. The same routes of entry pertinent to the natural spread of diseases are also relevant when their etiologic agents are delivered intentionally (e.g., inhalation of biological agent disseminated as an aerosol or ingestion of a biological agent disseminated through a water supply).
30
Host range: The number of different species or populations that can become infected by a biological agent, causing disease in the host or allowing the host to become a carrier.
31
Tropism: The specificity of a biological agent or toxin for a particular host tissue or cell.
20
137
includes converting nonzoonotic agents into zoonotic agents, altering the tropism of
viruses, and expanding the varieties of the same plant that a pathogenic agent could
infect. Certain vaccine research and the development of animal models for infectious
disease, which may involve alterations of the host range or tropism, are unlikely to
constitute dual use research of concern. Specifically, the attenuation of viruses for
vaccine development, whereby the attenuation procedure relies on a change in host
range to reduce human virulence, is unlikely to constitute dual use research of concern.
6. Enhance the susceptibility of a host population.32 Information about rendering host
populations more susceptible to the pathogenic consequences of an agent or toxin
could be used to compromise immune responses and enable the acquisition and spread
of disease on an epidemic scale. Of note, the distinction should be made that research
applicable to this category would not alter the susceptibility of an individual host or
research cohort but rather that of a host population.
Thus, examples of research information that would fall under this category and might
be considered dual use of concern include creation of a stable recombinant
Lactobacillus casei that could effectively block the host’s ability to synthesize an
important immune signal, such as tumor necrosis factor alpha, which may directly
facilitate the evasion of normal host defenses. Examples of research that generates
information unlikely to be considered dual use of concern are research on the systemic
exposure to immunostimulatory and immunosuppressive DNA and their effect on host
susceptibility to local inflammatory challenge, studies to develop immunosuppressive
drugs for cancer or transplantation, and delivery of a small interfering ribonucleic acid
(RNA) (siRNA)33 to a mouse that makes it hypersensitive to ionizing radiation, an
infectious agent, or a toxin.
7. Generate a novel pathogenic agent34 or toxin or reconstitute an eradicated35 or
extinct36 biological agent. The rationale for this category is that host populations may
not be immune to novel agents and reconstituted eradicated agents and there may not
32
Host population: A collection of organisms that constitutes a specific group or occurs in a specified habitat. In the
context of the criteria, this phrase implies that the misapplication of the knowledge, products, or technologies
derived from the research has the potential to broadly impact a population of host organisms.
33
Small interfering RNA (siRNA): Known as “short interfering RNA” or “silencing RNA”; a class of RNA molecules
that play a variety of roles in biology, most notably, siRNA is involved in the RNA interference (RNAi) pathway
where the siRNA interferes with the expression of a specific gene.
34
Novel agent: An agent that has not existed previously and is considered unique based on biological or other
properties and traits (e.g., genotype and phenotype). Novel agents of concern are those for which there is no known
or widely available prophylactic or therapeutic interventions, those that could evade detection, or those for which
there is no known immunity.
35
Eradicated agent: A biological agent that has been exterminated through surveillance and containment resulting
in the permanent reduction to zero of the worldwide incidence in the transmission of the agent and the
infection/disease it causes; intervention measures are no longer needed. Eradicated agents are thought to no longer
exist in circulation in plants, animals, or the environment. Note: Reconstituted eradicated agents of concern are those
for which there are no known or widely available prophylactic or therapeutic interventions, those that could evade
diagnostics, or those for which there is no known immunity.
36
Extinct agent: These agents are thought to no longer exist in nature or in the laboratory.
21
138
be existing diagnostics or known or widely available prophylaxes or therapeutics for
such agents.
Examples that would fall into this category and that might be considered dual use of
concern include the de novo construction of a microbial pathogen using wholly unique
gene sequences or combinations of sequences that do not exist in nature and
reconstitution of a pathogen that no longer exists in nature, such as the reconstruction
of the 1918 pandemic influenza virus. Research that is not likely to be dual use of
concern includes standard experimentation that generates knockouts, mutants,
reassortants, complement strains, or infectious molecular clones of viruses that are
similar to naturally occurring agents.
Evaluation of Life Sciences Research for Dual Use Potential
The NSABB members agreed that the PI should conduct the initial evaluation of his or her
research for its potential as dual use research of concern, using the criterion set forth above as
guidance for decision-making. This observation notwithstanding, an independent assessment can
be valuable. It is important to emphasize, however, that there may be significant variation in the
assessment of the dual use potential of any particular research project when it is considered by
two or more different, equally expert reviewers. In many cases, there may be no clearly right or
wrong answer. During the NSABB discussions of the oversight process and how the criterion
would be applied in the initial evaluation for dual use of concern potential, the Board found
significant differences in assessments made by individual NSABB members. In such cases,
interactive discussion among multiple evaluators helped in the development of consensus
regarding the dual use potential. Given the difficulties inherent in explicitly defining the point at
which the magnitude and/or immediacy of the threat of misuse makes dual use research “of
concern,” there should be an emphasis at the institutional level on education and enhanced PI
awareness of the dual use issue. In the long term, an enhanced awareness and understanding of
the risks of dual use research is likely to be the greatest benefit of the oversight system.
The NSABB also recommends a formal, annual attestation by researchers that they have been
evaluating their work on an ongoing basis for its potential as dual use research of concern.
Review of Research That Is Potentially Dual Use of Concern: Risk Assessment and Risk
Management
After life sciences research is initially evaluated for its potential as dual use research of concern,
the subset that may be considered dual use of concern should undergo more thorough review to
determine whether the research in question does indeed constitute dual use research of concern
and, if so, how the potential for misuse should be managed. The review should address:
• The potential for, and the ways in which, information, technologies, or biological agents
from the research could be misused to pose a threat to public health and safety,
agricultural crops and other plants, animals, the environment or materiel
22
139
• The likelihood that the information might be misused
• The potential impacts of misuse
• Strategies for mitigating the risks that information from the research could be misused
The NSABB developed a tool for guiding this review process, “Points To Consider in Risk
Assessment and Management of Research That Is Potentially Dual Use of Concern,” which can
be found in Appendix 4 for consideration and comment.
Responsible Communication of Life Sciences Research With Dual Use Potential
One of the major charges to the NSABB is to recommend strategies to help ensure that research
information with dual use potential is communicated responsibly, in a manner that addresses
both biosecurity concerns and the need for open sharing of research results and technologies so
that the research can be validated and used for further research. Toward this end, the NSABB
developed a set of tools to facilitate consistent decisionmaking about the responsible
communication of research information with dual use potential.
These tools consist of:
•
A set of principles for the responsible communication of research with dual use potential
•
Points to consider for identifying and assessing the risks and benefits of communicating
research information with dual use potential, including options for the communication of
such research information
•
Considerations for the development of a communication plan for research with dual use
potential
It is important to note that it is not the intent of the NSABB that every potential communication
of research—be it an abstract, poster, seminar, or manuscript—be assessed using the
communication tools. Rather, the tools may be utilized for the subset of life sciences research or
research information determined to be dual use research of concern.
Because research findings are communicated at many points along the research continuum (e.g.,
during project concept and design, in funding applications, in seminars, and in publication of
manuscripts), it is important to be aware of the potential for misuse of information at every point.
The communication tools are designed to help individuals identify and assess the risks and
benefits of communicating information with dual use potential. The tools can be employed by a
variety of users in a number of settings. These include researchers who are developing research
proposals; investigators engaged in dual use research who are preparing abstracts, posters,
seminars, and manuscripts about their work; and individuals involved in the prepublication
review of such information, such as research supervisors and administrators, peers, and dual use
23
140
research review entities. The tools might also be useful to the scientific publishing community
and for science ethics courses.
The variety of potential uses and users of these communication tools makes it likely that not all
aspects of the tools will be applicable at all times. Thus, users are encouraged to tailor and
format the tools for their specific purpose(s). For example, students in an ethics course might
use the “Points To Consider in Assessing the Risks and Benefits of Communicating Research
Information With Dual Use Potential” (see Appendix 5) to analyze actual manuscripts, and so
would need to provide detailed answers to the questions posed. Alternatively, an institution
might want a researcher developing a manuscript or poster about research with dual use potential
to attest to having considered the risks and benefits of communicating that research; thus, it
might be helpful to format the assessment framework with checkboxes to indicate that the points
had been considered and perhaps to add a signature line. Scientific journals might find this
“Points To Consider” tool most useful as a hyperlink in whatever system the journal employs for
instructing authors and manuscript reviewers, especially those reviewing for biosecurity
concerns.
Principles for the Responsible Communication of Research With Dual Use Potential.
1. The open and unfettered sharing of information and technologies has been a hallmark of the
life sciences and has fostered a steady stream of scientific advances that underpin public
health and safety, a strong and safe food supply, a healthy environment, and a vigorous
economy.
2. Progress in the life sciences relies heavily on the communication of research findings so that
the findings can be both validated and used for further research.
3. Life sciences research should be communicated to the fullest extent possible to ensure the
continued advancement of human, animal, plant, and environmental health. Consequently,
any restriction of scientific communication should be the rare exception rather than the rule.
4. There is a need for reasonable balance in decisions about the communication of research with
dual use potential. It is important to recognize the potential for the deliberate and malevolent
misuse of dual use research findings and to consider whether the disclosure of certain
information might reasonably pose a threat to national security (i.e., public health and safety,
agricultural crops and other plants, animals, the environment, or materiel). If the
communication of dual use research does pose potential security risks, the logical next step is
a risk-benefit analysis of communicating the information.
5. After weighing the risks and benefits of communicating dual use research findings, the
decision regarding communication is not necessarily a binary (yes/no) one. Rather, a range
of options for communication should be identified and considered. The options available
will depend on the research setting (e.g., academia, government, or private). They could
range from full and immediate communication, to delayed and/or modified communication,
to restricted/no communication, and could be recommended singly or in appropriate
24
141
combinations on a case-by-case basis, depending on the nature of the dual use finding and the
potential risks associated with its communication.
6. Paradigms for the responsible communication of research with dual use potential should also
take into consideration that the communication of dual use research can occur at multiple
points throughout the research process, that is, at points well upstream of the publication
stage (see Figure 2 below). Thus, it is important to apply principles and practices of
responsible communication at these early stages as well.
7. It is important to consider not only what is communicated but also the way in which it is
communicated. Investigators and sponsors of research with dual use potential should
recognize that the communication of certain dual use information is likely to raise biosecurity
concerns, not only within the scientific community but also within the general public.
Consideration should be given to the potential for public concern and misunderstanding and
for sensationalism. Thought should be given to the need for the inclusion of contextual and
explanatory information that might minimize such concerns and misunderstanding.
8. Public trust is essential to the vitality of the life sciences research enterprise. It has always
been important for life scientists to participate in activities that enhance public understanding
of their research. However, because of the potential for public misunderstanding of and
concerns about dual use research, it is especially important that life scientists conducting
research with dual use potential engage in outreach on a regular basis to increase awareness
of the importance of the research and to reassure the public that the research is being
conducted and communicated responsibly.
25
142
Figure 2. Examples of Points of Communication of Dual Use Research During the Research Process
Project
Concept and
Design
Funding
Application
and Award
Process
Presentation of
preliminary
data
Review by IC
staff and
study section
Discussions
with
collaborators
Draft
application
review by peers,
institution
administration
etc.
Research
award
notices/
description on
CRISP etc.
Institutional
Approval
Ongoing
Research
Review by
Institutional
Committee
Members
Training of
lab staff,
students,
visiting
scientists
Project
descriptions
on institution
Web page or
in PI CV
Presentations at
departmental
seminars
Development of
Manuscript or
Other Research
Product
Peer review of
manuscript/
research
product
Publication of
Manuscript or
Other Research
Product
Public
dissemination of
research
findings or
products
Presentations or
posters at
National or
International
Conferences
Evaluation by
other faculty if
thesis project
Points To Consider in Assessing the Risks and Benefits of Communicating Research Information
With Dual Use Potential. The NSABB developed a tool to guide researchers, manuscript
reviewers, and others in identifying and assessing the risks and benefits of communicating
research information that may be dual use of concern. This tool includes a series of questions
that can be considered as well as options for the communication of research information judged
to be dual use of concern; this tool is found at Appendix 5 for consideration and comment.
Considerations in the Development of a Communication Plan. Because of the potential for
misuse of dual use research results, concerns on the part of the public, including members of the
scientific community, about the sharing of such information can be anticipated. In addition, the
public is increasingly sensitive to issues pertaining to research involving dangerous microbes and
the risk of accidental or intentional release of such agents. A lack of public understanding and
appreciation for the reason for conducting and communicating dual use research, sensationalism
of dual use research findings, and concerns about public safety and national security all serve to
undermine public trust in the life sciences research enterprise. Therefore, it is the responsibility
of the scientific community to ensure that dual use research results and technologies are
communicated responsibly.
Depending on the nature of the dual use research result/technology being communicated and the
potential impact of communicating the information, it may be prudent to consider steps to
maximize public understanding of, and appreciation for, the research effort and the decision to
communicate the information. This can be achieved through the development of a plan for the
responsible communication of dual use research information. For example, it may be important
26
143
to address the following issues, both in the content of the work product and in the activities
associated with dissemination of the work product:
• The significance of the research findings for public health and/or safety, agriculture, the
environment, or materiel
• How the new information or technology will be useful to the scientific community
• The biosafety measures in place during the conduct of the research
• The dual use aspects of the information and the careful consideration given to biosecurity
concerns in the decision to publish
In addition to including this type of information in the content of the work product, the following
are some additional means for conveying the types of contextual information listed above. These
means can be employed either singly or in any combination as deemed appropriate:
• Editorials are useful tools for providing contextual information, messages, and opinions.
Editorials may be in the journal that publishes the dual use research manuscript. This
type of editorial could be written by an individual who is not directly involved with the
work, perhaps is not even in the same field, but who is nevertheless held in high regard
by the scientific community. The editorial might speak to the significance of the research
findings for public health, agriculture, the environment, or materiel; how the new
information or technology will be useful to the scientific community; and the biosafety
measures in place as the research was carried out and might acknowledge the dual use
aspects of the information and that careful consideration was given to the biosecurity
concerns in the decision to publish.
Editorials may also be in the popular press and issued at the same time as the manuscript
or shortly afterwards. This type of editorial would be geared toward the general public
and should be written in nontechnical language to the greatest extent possible.
Nevertheless, it should address the same issues as described above (i.e., the nature and
importance of the scientific discovery/technology; the significance of the research
findings for public health, agriculture, the environment, or materiel; the safety
precautions in place as the work was conducted; the dual use aspects of the information;
and the consideration that was given to the biosecurity concerns in the decision to
publish). Ideally, the author would be an individual who is known to and trusted by the
general public.
• Press releases are commonly used by research institutions to highlight significant
scientific advances for the media. They also provide an opportunity to provide contextual
information (regarding issues that may be of concern to the public) and scientific
perspectives on the findings (via quotes from other scientists). If the project involves
investigators from multiple institutions, it will be important to coordinate the preparation
and release of the announcement. In addition to including a description of the findings
and their scientific significance, a press release might also address the significance of the
research findings for public health, agriculture, the environment, or materiel; the
biosafety and biocontainment measures in place as the work was conducted; the dual use
27
144
aspects of the information; and the consideration that was given to the biosecurity
concerns in the decision to publish.
• A press conference is usually reserved for highlighting the most significant and/or
sensitive advances and provides an opportunity for direct interaction with the media. The
investigator(s) and institutional representatives are usually present, but press conference
organizers also should consider having other experts on hand who can address questions
about the potential for misuse of the dual use information, biosafety, etc. A press release
is usually provided to the media at a press conference (see above), but additional relevant
materials can also be made available, such as backgrounders and fact sheets.
• Questions and Answers (Qs&As) are useful tools for preparing to respond to queries
from the press, the general public, or others. They might address:
o The nature of the dual use advance
o Reasons for conducting the work
o Whether the public is/was at risk from the work
o The potential for misuse of the research findings
o Safety procedures utilized during experimentation
o The review process prior to publication
• Talking Points are developed and employed for responding to questions from the press,
the general public, or others. Talking points might include:
o An explanation of the biosafety and biocontainment conditions that were
employed to safeguard laboratory workers and the public (if applicable)
o Acknowledgment that, along with significant benefits (to public health,
agriculture, the environment, or materiel) of sharing the information widely, there
are also some potential risks to publicly disseminating the information
o Assurances that the national security implications of making such information
publicly available was thoroughly considered
o A description of how the information contained within the research findings is
critical for developing public health countermeasures
Considerations in Developing a Code of Conduct for Dual Use Research in the Life
Sciences
One of the charges to the NSABB is to provide recommendations on the development of a code
of conduct for scientists and laboratory workers that could be adopted by professional
organizations and institutions engaged in the performance of life sciences research. The NSABB
has taken this charge to heart, recognizing that the process of developing, adopting, and adhering
to a code of conduct can serve a critically important educational role in raising the awareness of
the scientific community to the dual use issue and in sustaining a culture of responsibility.
In fulfillment of its charge, the NSABB developed Considerations in Developing a Code of
Conduct for Dual Use Research in the Life Sciences as a resource for scientific societies,
28
145
professional associations, and research institutions to use in the development of codes on this
topic. This document:
• Provides a conceptual foundation for understanding the dual use issue
• Describes the nature and utility of codes of conduct
• Articulates the fundamental principles of responsible conduct with regard to dual use
research
• Provides guidance on addressing the dual use issue in specific phases of the research
process
Organizations can adopt portions of the document verbatim in developing their own codes, or
modify the content as appropriate to the research activities of their members and
employees. Either way, the concepts presented in the NSABB's resource document should be
considered and discussed broadly as part of the process of educating scientists and laboratory
staff about their responsibilities in this arena.
“Considerations in Developing a Code of Conduct for Dual Use Research in the Life Sciences”
is presented in Appendix 3 for consideration and comment.
Outreach and Education
One of the charges to the NSABB is to advise on mandatory programs of education and training
in biosecurity issues for all life scientists at federally funded institutions. The educational
content of these training programs will derive in part from specific federal policy and
requirements, which are still under development.
In the meantime, the NSABB has conducted outreach with two key purposes in mind: (1) to
hone the development of its recommendations by taking into account the concerns and
perspectives of diverse stakeholders and (2) to promote broader awareness of the dual use issue
and to sensitize life scientists to its importance. Indeed, the NSABB has observed throughout
this document that creating awareness about the dual use issue is of fundamental importance and
critical to the success of an effective oversight system.
Toward these ends, NSABB members and staff have been engaged in the efforts described
below:
• The development of all of the NSABB work products and recommendations entailed
stakeholder consultation solicited through such means as focus groups and roundtables.
This process helped the NSABB better understand the concerns of these groups and led to
the development of recommendations that were meant to be reflective of the diverse
perspectives of the various communities within the life sciences. These activities had the
collateral benefit of raising awareness of the issue with key thought leaders and
promoting dialog within the organizations they represent.
29
146
• The NSABB members and staff37 regularly deliver presentations on the dual use issue
and the NSABB’s activities at meetings of scientists, biosafety officers, IBC members,
research compliance staff, the public and other stakeholders. These presentations are an
essential means of sensitizing the research community to this issue and keeping it
apprised of evolving federal policymaking activities. These interactions also provide
opportunities for feedback from stakeholder groups as the NSABB develops
recommendations in this area. There should be continued efforts to identify key
stakeholder groups and find opportunities to present to their memberships.
• The NIH staff has developed and staffed at major scientific and professional society
meetings an exhibit about dual use research issues to educate attendees about dual use
research and biosecurity matters and the development of related federal policy. Exhibits
represent an opportunity to educate at the individual level and enhance the visibility of
the issue with key constituencies. These activities should continue to highlight
educational materials and specific federal requirements as they are developed.
• Under the aegis of the NSABB’s Working Group on International Collaboration, the
Board hosted a successful international roundtable with individuals from 20 countries and
international organizations. The purpose of the meeting was to share perspectives on the
dual use issue and to inform participants about the NSABB’s activities. This effort was
an important first step in awareness building and information sharing at the international
level, and the momentum created by this event will be sustained through continuing
activities of this Working Group.
As NSABB recommendations are transformed into federal policy, additional types of outreach
and education will become appropriate, initially to ensure public input into the policymaking
process and subsequently to educate about emerging federal requirements. Thus, the NSABB
believes that a vigorous program of outreach to the research community and education of those
involved in life sciences research is a logical and essential follow-on to the formal transmittal of
its oversight recommendations to the U.S. Government.
With those considerations in mind, the NSABB makes the following observations and
recommendations about public outreach during the federal policymaking process:
• By definition, “outreach” means going out into the community, and thus the federal
government should sponsor town-hall style regional meetings orchestrated in conjunction
with nongovernmental partners (such as universities) as a means of heightening
awareness locally and creating more locally accessible forums for scientists and others to
have input into the federal policymaking process.
As formal federal policy is developed, it will be key to solicit public comment through
formal channels. This includes notice in the Federal Register and the establishment of a
publicly accessible docket for the collection of public comments on policy that the
government is considering or proposing, as well as formal analysis by federal agencies.
37
The NSABB is funded by the U.S. Government and is staffed by the NIH, an agency of the U.S. Department of
Health and Human Services.
30
147
Other outreach efforts described here would supplement these important and federally
required modes of informing and soliciting input from the public.
Finally, when requirements on the oversight of dual use research are formally adopted by
the U.S. Government, a communications plan will be needed for the rollout of the new
federal policies, as well as an intensive and ongoing campaign of workshops,
presentations, print and electronic materials, exhibits, and other activities to educate
about and promote compliance with new requirements. These materials and venues will
be used by the federal government to educate institutions and their staffs, as well as by
institutions in training their own investigators.
The NSABB also makes the following observations and recommendations regarding ongoing
educational and awareness-building strategies:
• The NSABB should play a continuing advisory role in outreach and education strategies,
consulting as appropriate with representatives of professional societies and government
who are knowledgeable and involved in education and public relations. Specifically, the
NSABB should advise on the (1) identification of key stakeholder groups, (2)
formulation of message points and educational content to promote awareness of the dual
use issue, (3) development of training curricula mapped to federal policy when it
emerges, and (4) development of tools to convey educational content effectively to the
research community. The NSABB would also advise as appropriate on the development
and implementation of specific efforts, such as those described below.
• Educational programs help foster a culture of responsibility, which is important to
cultivate early in the development of future scientific talent. Consequently, educational
efforts on dual use research should have a broad reach. Although instruction in the
responsible conduct of research is an essential ingredient of collegiate and graduate
education, instructional materials and resources should be developed for incorporation
into high school and even junior high school science programs. Programs should also be
developed for U.S. commercial research entities and international audiences.
• The NIH currently requires formal training in the responsible conduct of research for all
recipients of NIH-funded training grants and fellowships. The NIH outlines various
topics that these training programs may include, and institutions should routinely
incorporate the topic of dual use research into the content of NIH-mandated training
programs.
• Although the federal government has a responsibility and is best poised to educate about
federal policies and requirements, domestic and international nongovernmental
organizations—particularly scientific associations and professional societies—have
special contributions to make with respect to promoting responsible research conduct
generally, including best practices, and a number of important and impressive efforts are
already underway. The federal government should stimulate educational initiatives on
the part of nongovernmental organizations, including the development of case studies,
course curricula, and multimedia educational tools.
31
148
APPENDICES
1. NSABB Charter and Roster
2. Questions for Comment
3. Considerations in Developing a Code of Conduct for Dual Use Research in the Life
Sciences
4. Points To Consider in Risk Assessment and Management of Research Information
That Is Potentially Dual Use of Concern
5. Points To Consider in Assessing the Risks and Benefits of Communicating Research
Information With Dual Use Potential
32
149
APPENDIX 1.
NSABB Charter and Roster
THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201
CHARTER
NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY
PURPOSE
The purpose of the National Science Advisory Board for Biosecurity (NSABB) is to provide
advice, guidance, and leadership regarding biosecurity oversight of dual use research, defined as
biological research with legitimate scientific purpose that may be misused to pose a biologic threat
to public health and/or national security. The NSABB will advise the Secretary of the Department
of Health and Human Services (HHS), the Director of the National Institutes of Health (NIH), and the
heads of all federal departments and agencies that conduct or support life sciences research. The
NSABB will advise on and recommend specific strategies for the efficient and effective oversight
of federally conducted or supported dual use biological research, taking into consideration both
national security concerns and the needs of the research community. The NIH shall manage and
provide support services for the NSABB.
AUTHORITY
42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The NSABB is
governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C.
Appendix 2), which sets forth standards for the formation and use of advisory committees.
FUNCTION
The NSABB will advise the Secretary of HHS, the Director of NIH, and the heads of all federal
departments and agencies that conduct or support life sciences research. The NSABB will advise
on and recommend specific strategies for the efficient and effective oversight of federally
conducted or supported dual use biological research, taking into consideration both national security
concerns and the needs of the research community.
The NSABB will be composed of nongovernmental subject matter experts as well as ex officio
members from the federal departments and agencies listed below and will perform the following
activities:
•
•
•
Develop criteria for identifying dual use research and research results.
Develop guidelines for the oversight of dual use research, including guidelines for the riskbenefit analysis of dual use biological research and research results.
Provide recommendations on the development of a code of conduct for scientists and
laboratory workers that can be adopted by professional organizations and institutions engaged in
the performance of life sciences research.
33
150
•
•
•
•
•
•
•
•
•
Provide recommendations on the development of mandatory programs for education and
training in biosecurity issues for all scientists and laboratory workers at federally
funded institutions.
Advise on national policies regarding the conduct of dual use biological research. This
includes strategies for addressing national security concerns while at the same time
fostering continued rapid progress in public health research and food and agriculture
research (e.g., new diagnostics, treatments, vaccines and other prophylactic measures, and
detection methods).
Advise on national policies governing the publication, public communication, and dissemination of dual use research methodologies and results.
Advise on national policies governing local review and approval processes for dual use
biological research, including the development of guidelines for the case-by-case review and
approval by Institutional Biosafety Committees (IBCs).
Advise on criteria and processes for referral of classes of research or specific experiments
by IBCs to the NSABB for guidance.
Review and provide guidance on specific experiments insofar as they exemplify a significant or
particularly complex permutation of an existing category of dual use research or represent a
novel category of dual use research that requires additional guidance from the NSABB.
Respond to requests submitted by research institutions for the interpretation and application of
the guidelines to specific research proposals in instances where a proposal has been denied
by an IBC and the institution seeks additional advice.
Recommend strategies for fostering international collaboration for the effective oversight of
dual use biological research.
Address any other issues as directed by the Secretary of HHS.
As necessary, subcommittees may be established to perform functions within the Board’s jurisdiction.
The advice/recommendations of that subcommittee must be deliberated by the parent advisory
committee. A subcommittee may not report directly to a federal official unless there is statutory
authority to so.
Subcommittee membership may be drawn in whole or in part from the parent advisory committee. All
subcommittee members may vote on subcommittee actions and all subcommittee members count toward
the quorum for a subcommittee meeting. Ad hoc consultants do not count toward the quorum and
may not vote. Subcommittee members who are not members of the parent committee may attend
closed sessions of the parent committee meeting, but they may not count toward the quor um of the
parent committee, and they cannot vote on committee actions. The NSABB may call upon special
consultants; assemble ad hoc working groups; and convene conferences, workshops, and other
activities necessary to the fulfillment of the NSABB’s responsibilities.
STRUCTURE
The NSABB shall consist of not more than 25 voting members, including the Chair. Members will be
appointed by the Secretary of HHS in consultation with the heads of federal departments and agencies that
conduct or support life sciences research. The Secretary will designate the Chair. All members will hold
security clearances at the level of Secret or higher. A member of the NIH Recombinant DNA Advisory
Committee (RAC) will serve as a voting member of the NSABB.
Areas of expertise/perspectives to be represented on the NSABB, include inter alia:
• Molecular Biology/Genomics
• Microbiology (Bacteriology)
34
151
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Microbiology (Virology)
Clinical Infectious Diseases/Diagnostics
Laboratory Biosafety and Biosecurity
Public Health/Epidemiology
Health Physicist/Radiation Safety
Pharmaceutical Production
Veterinary Medicine
Plant Health
Food Production
Bioethics
National Security
Military Biodefense Programs and Military Medicine
Intelligence
Biodefense
Law
Law Enforcement
Academia
Scientific Publishin g
Industry Perspective
NIH RAC Experience/Perspective
Public Perspective
IBC Perspective
Export Controls
There may be nonvoting ex officio members from each of the following departments and agencies:
• Executive Office of the President
• Department of Health and Human Services
• Department of Energy
• Department of Homeland Security
• Department of Veterans Affairs
• Department of Defense
• Department of the Interior
• Environmental Protection Agency
• Department of Agriculture
• National Science Foundation
• Department of Justice
• Department of State
• Department of Commerce
• Intelligence Community
• National Aeronautics and Space Administration
• Others as appropriate
Members shall be invited to serve for overlapping terms of two to four years; terms of more than
two years are contingent upon the renewal of the NSABB’s Charter by appropriate action prior to its
expiration. A member may serve after the expiration of the member’s term until a successor has been
appointed.
35
152
Management and support services for the NSABB shall be provided by the Office of Biotechnology
Activities, the Office of Science Policy, and the Office of the Director, NIH. HHS and NIH staff
will hold security clearances at the level of Secret or higher, as needed, to provide support to the
NSABB.
MEETINGS
Meetings shall be held at least twice a year and may be convened on an as-needed basis, at the call
of the HHS Designated Federal Official who shall also approve the agenda. The Designated
Federal Official shall be present at all meetings.
Meetings of the NSABB will be open to the public except as determined otherwise by the Secretary
of HHS, in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the
Federal Advisory Committee Act. Notice of all meetings will be given t o t h e p u b l i c . M eetings
will be conducted, and records of the proceedings kept, as required by applicable laws and
Departmental policies.
QUORUM
A quorum for the NSABB and each of its subcommittees shall consist of a majority of the appointed
members eligible to vote. The nonvoting agency representatives shall not be counted in calculating
a quorum. Of the voting members, any who are disqualified from participating in an action on a
particular issue (e.g., due of a conflict of interest) shall not be counted in calculating the quorum. All
votes relating to any review of a recommendation by the NSABB shall be open to the public unless
the meeting has been closed to the public in accordance with the Government in the Sunshine Act
and the Federal Advisory Committee Act.
COMPENSATION
Members shall be paid at the rate of $200 per day for each meeting day, plus per diem and travel
expenses as authorized by Section 5703, Title 5 U.S.C., as amended, for persons in Government
service employed intermittently. Members who are officers or employees of the U.S.
Government shall not receive compensation for service on the NSABB.
ANNUAL COST ESTIMATE
The estimated annual cost for operating the Committee, including compensation and travel
expenses for members but excluding staff support, is $449,527. The estimated annual personyears of staff support are 4.5, at an estimated cost of $650,073.
REPORTS
Annual reviews and reports will be prepared, filed, and retained as required by applicable laws and
Departmental policies. In the event a portion of a meeting is closed to the public, an annual
report shall be prepared that shall contain, at a minimum, a list of the members and their business
addresses; the NSABB’s functions, dates, and places of meetings; and a summary of the NSABB’s
activities and recommendations made during the fiscal year. A copy of the report shall be provided to
the Department Committee Management Officer.
36
153
TERMINATION DATE
Unless renewed by appropriate action prior to its expiration, the Charter for the National Science
Advisory Board for Biosecurity shall expire April 7, 2008.
APPROVED
MAR 16
Date
2006
Secretary
37
154
Roster
Chair
David R. Franz, D.V.M., Ph.D.
Vice President and Chief Biological Scientist
Midwest Research Institute
Director
National Agricultural Biosecurity Center
Kansas State University
Frederick, MD
Dennis L. Kasper, M.D.
William Ellery Channing Professor of Medicine and
Professor of Microbiology and Molecular Genetics
Harvard Medical School
Director
Channing Laboratory
Department of Medicine
Brigham and Women’s Hospital
Boston, MA
Claire M. Fraser-Liggett, Ph.D.
Director
Institute of Genome Sciences
University of Maryland School of Medicine
Baltimore, MD
Other Voting Members
Arturo Casadevall, M.D., Ph.D.
Professor and Chairman
Department of Microbiology and Immunology
Division of Infectious Diseases
Albert Einstein School of Medicine
Bronx, NY
General John A. Gordon (Ret.)
General, USAF (Retired)
Alexandria, VA
Michael J. Imperiale, Ph.D.
Professor
Department of Microbiology and Immunology
University of Michigan Medical School
Ann Arbor, MI
Murray L. Cohen, Ph.D., M.P.H., C.I.H.
President and Chairman
Frontline Healthcare Workers®
Safety Foundation, Ltd.
Atlanta, GA
Paul S. Keim, Ph.D.
Division Director, Pathogen Genomics
Translational Genomics Research Institute
Cowden Endowed Chair in Microbiology
Northern Arizona University
Flagstaff, AZ
Susan A. Ehrlich, J.D.
Judge
Arizona Court of Appeals
Phoenix, AZ
Stanley M. Lemon, M.D.
Director
Institute for Human Infections and Immunity
University of Texas Medical Branch at
Galveston
Galveston, TX
Lynn W. Enquist, Ph.D.
Professor and Chair
Department of Molecular Biology
Princeton University
Editor and Chief
Journal of Virology
Princeton, NJ
Stuart B. Levy, M.D.
Director
Center for Adaptation Genetics and Drug Resistance
Professor of Medicine and Molecular Biology and
Microbiology
Tufts University School of Medicine
Boston, MA
Barry J. Erlick, Ph.D.
President
BJE Associates, Inc.
Affiliate Professor
Auburn University
Adjunct Professor
Kansas State University
Alexandria, VA
38
155
John R. Lumpkin, M.D., M.P.H.
Senior Vice President and Director of the Health
Care Group
Robert Wood Johnson Foundation
Princeton, NJ
Andrew A. Sorensen, Ph.D.
President
University of South Carolina
Columbia, SC
Admiral William O. Studeman (Ret.)
Consultant
Retired Northrup Grumman Corporation Vice
President
Great Falls, VA
Adel A.F. Mahmoud, M.D., Ph.D.
Professor
Department of Molecular Biology
Woodrow Wilson School
Princeton, NJ
Anne K. Vidaver, Ph.D.
Professor and Head
Department of Plant Pathology
University of Nebraska-Lincoln
Lincoln, NE
Mark E. Nance, J.D.
General Counsel
Medical Diagnostics
GE Healthcare
Princeton, NJ
Michael T. Osterholm, Ph.D., M.P.H.
Director
Center for Infectious Disease Research and Policy
Associate Director
Department of Homeland Security
National Center for Food Protection and Disease
Professor
School of Public Health
University of Minnesota
Minneapolis, MN
Nonvoting Ex Officio Members
Jason Boehm, Ph.D.
Office of the Director
National Institute of Standards and Technology
Department of Commerce
Brenda A. Cuccherini, Ph.D., M.P.H.
Special Assistant to the Chief R&D Officer
Office of Research and Development
Veterans Health Administration
Department of Veterans Affairs
David A. Relman, M.D.
Associate Professor of Medicine, Microbiology &
Immunology
Stanford University School of Medicine
Stanford, CA
Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Disease
Department of Health and Human Services
James A. Roth, D.V.M., Ph.D.
Distinguished Professor
Department of Veterinary Microbiology and
Preventive Medicine
College of Veterinary Medicine
Iowa State University
Ames, IA
Elizabeth George, Ph.D.
Deputy Director
Biological Countermeasures Portfolio
Department of Homeland Security
Sue D. Haseltine, Ph.D.
Associate Director for Biology
U.S. Geological Survey
Department of the Interior
Harvey Rubin, M.D., Ph.D.
Professor of Medicine
University of Pennsylvania School of Medicine
Philadelphia, PA
Maryanna Henkart, Ph.D.
Director
Division of Molecular and Cellular Biology
National Science Foundation
Thomas E. Shenk, Ph.D.
James A. Elkins, Jr. Professor in the Life Sciences
Department of Microbiology
Princeton University
Princeton, NJ
Tom Hopkins, Ph.D.
Assistant to the Secretary of Defense for Nuclear and
Chemical and Biological Programs (Acting)
Department of Defense
39
156
Peter R. Jutro, Ph.D.
Deputy Director
National Homeland Security Research Center
Environmental Protection Agency
Ronald A. Walters, Ph.D.
Senior Scientist
Intelligence Technology Innovation Center
Boris D. Lushniak, M.D., M.P.H.
Chief Medical Officer
Office of the Commissioner
Office of Counter-terrorism Policy
Food and Drug Administration
Executive Director
Amy P. Patterson, M.D.
Executive Director, NSABB
Director
Office of Biotechnology Activities
Office of Science Policy
Office of the Director
Mary Mazanec, M.D., J.D.
Acting Director
Office of Medicine, Science and Public Health
Office of the Assistant Secretary for
Preparedness and Response
Jeffrey Miotke
Deputy Assistant Secretary
Bureau of Oceans and International
Environment and Scientific Affairs
Department of State
Janet K.A. Nicholson, Ph.D.
Associate Director for Laboratory Science
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Caird E. Rexroad, Jr., Ph.D.
Associate Administrator
Agricultural Research Service
Department of Agriculture
Jenifer Smith, Ph.D.
Supervisory Special Agent
Federal Bureau of Investigation
Department of Justice
Scott Steele, Ph.D.
NSTC Representative
Office of Science and Technology Policy
Executive Office of the President
David G. Thomassen, Ph.D.
Chief Scientist
Office of Biological & Environmental Research
Department of Energy
40
157
APPENDIX 2.
Questions for Comment
1. The proposed institutional responsibility for expert review of research that has been
identified by the principal investigator (PI) as dual use of concern may have significant
implications for institutions in terms of cost, administrative burden, and workload. We
are especially interested in feedback regarding these concerns and estimates of the
number of projects conducted at a given institution that might meet the criterion for dual
use research of concern and therefore warrant specific local review for dual use risk
assessment and management.
–
What is the most appropriate entity for conducting risk assessment of research
that has been identified as potential dual use research of concern? For example,
should it be the Institutional Biosafety Committee (IBC), augmented with
additional expertise, or should it be a separate committee?
–
If the IBC, what additional expertise would be needed to facilitate the review of
dual use research of concern?
–
Is a single institution likely to have the necessary in-house expertise for this
review?
–
Depending on how many projects an institution anticipates will require dual use
review, would it be more efficient and effective to have the option to utilize a
regional or central review entity? Would it be helpful to have the option of
utilizing a commercial review entity or the review entity at another institution?
2. We anticipate that true instances of dual use research of concern will be fairly rare and so
tried to design a criterion and guidance that would result in the identification of only
those few cases. At the same time, we wanted to make the criterion sufficiently inclusive
that it would indeed capture those instances of genuine dual use research of concern.
–
Is the criterion sufficiently specific and understandable so that research personnel
can apply it consistently?
–
Will the criterion capture research that is not appropriately considered as being
dual use of concern?
–
Does the criterion need to capture additional types of information?
3. Is the guidance (considerations) that follows the criterion for identifying dual use research of concern helpful and sufficient? Is it clear and understandable?
–
Should additional categories of research that may yield dual use findings of
concern be included in the guidance (e.g., bioinformatics, synthetic biology,
development of bioregulators, psychological/psychosocial studies of terrorists,
etc.)?
41
158
–
How much research at your institution would be captured with this criterion for
dual use research of concern?
4. Is it sufficient to have the PI make the initial determination as to whether his or her
research might be considered dual use of concern in a supportive environment, or should
the initial evaluation always be made with input from others? If the latter, who else
should participate in the initial evaluation?
5. Is additional guidance needed for any aspect of the proposed oversight process?
6. The NSABB is very concerned that the oversight system put in place achieves a
reasonable balance between protecting against the misuse of information from life
sciences and maintaining the free and open communication of life sciences research. We
are especially mindful of the potential burden imposed by the proposed requirement for
specific, additional review of that subset of research identified by investigators as
possibly being dual use research of concern. We are aware that there are concerns that all
institutions do not have the expertise for this and that additional resources would be
required, in addition to the increased workload.
–
How much of a burden would this proposed oversight system pose to your
institution? Please keep in mind that while it is a (proposed) institutional
responsibility to ensure review of research that is potentially dual use of concern,
it may not be necessary to conduct the review “in house” (i.e., it may be possible
to conduct the reviews at a regional or central locus and/or to use commercial
review entities).
42
159
APPENDIX 3.
Considerations in Developing a Code of Conduct
for Dual Use Research in the Life Sciences
INTRODUCTION
Important benefits to society have been achieved in no small measure by scientists who have
strived to conduct their work conscientiously and with integrity. This commitment forms the
basis of a culture of responsibility in which scientists consider the risks and implications of their
research and take appropriate measures to ensure that they carry out their work safely, ethically,
and in a manner that warrants continued public trust and support. To achieve this aim, scientists
should consider the relevant standards and guideposts for ethical and responsible research
conduct as well as the potential impact their research may have on society. The importance of
thoughtful consideration of ethics and research is amplified when scientists engaged in wellintended research are confronted with its potential for misuse.
In recent years, increased attention has been directed to the possibility that the knowledge,
products, or technologies derived from some life sciences research may be misapplied to pose a
threat to public health, agriculture, plants, animals, the environment, or materiel. Research with
this potential is known as “dual use research of concern.” All those involved in life sciences
research have a responsibility to avoid or minimize the foreseeable risks and harm that could
result from malevolent use of research outcomes.
The National Science Advisory Board for Biosecurity (NSABB) has given extensive
consideration to the characteristics that define dual use research of concern. Following its
charge, the NSABB is proposing a series of recommendations and tools to help the scientific
community identify and manage the risks associated with this type of research. The NSABB has
observed that there is a need not only to raise life scientists’ awareness of the dual use potential
of their research but also to provide and promote principles of research conduct that will sustain
a culture of responsibility within the scientific community.
One useful tool for raising awareness of the potential for dual use research and promoting
responsible research behavior is a code of conduct. Typically developed by societies,
associations, and institutions, a code of conduct articulates shared values and standards of
conduct. Codes also can be used to educate people regarding their ethical responsibilities. The
value of a code is reinforced when it is discussed in training sessions, at meetings, and during the
course of routine activities.
Using This Document
The following document lays a foundation for a code of conduct that explicitly addresses dual
use research of concern by:
• Describing the general utility and potential applications of such a code
• Articulating a core set of responsibilities related to dual use research that can serve as a
foundation for a code
43
160
• Delineating additional responsibilities related to specific phases of the research process and
research-related activities
The core set of responsibilities and the additional specific responsibilities outlined below provide
a template that users of this document can adopt verbatim, modify, or use as the basis for
developing more specific guidance on ethical behavior. This document is intended to be used in
tandem with other elements of the framework of policy and guidance pertinent to this issue that
are now under development.
Audiences for This Document
Every individual associated with the life sciences should be aware of the potential dual use of
scientific knowledge, products, or technology and be knowledgeable of the ethical obligations
that ensue in regard to research that can be considered “dual use of concern.” Specifically, the
considerations in this document are intended to apply to the following audiences:
Life sciences societies and associations. Life sciences societies and associations are important
sources of guidance for scientists on the ethical standards that apply to their disciplines. These
organizations are encouraged to enhance their bylaws or codes of conduct to address the
considerations within this document. They may choose to adopt any portion of this document
into an existing code or to modify its contents in order to adapt them to a specific discipline and
context. Alternatively, organizations may choose to adopt or create a stand-alone document to
give it particular salience. In either case, organizations generally adopt or modify their codes
through a governance process involving broad discussion with the membership; therefore, the
process of considering the ethical standards applicable to dual use research of concern is a
valuable exercise in its own right. Whatever the manner in which a society chooses to develop
and adopt a code on dual use research of concern, the code should be widely disseminated to
members (for example, by publishing it in society newsletters and journals). It should be
revisited frequently at annual membership meetings and other events in order to refresh and
reinforce its impact and to address evolving issues.
Research institutions. Whether public or private, academic or industrial, research institutions
are responsible for the integrity of their research programs. Institutions that oversee a body of
research typically have rules, guidelines, and standard operating procedures to guide staff on
how to conduct research in an ethical and legal manner, as well how to conform to institutionspecific policies and requirements. Institutions should consider the adoption and dissemination
of specific guidance on dual use research in faculty handbooks, procedures manuals, institutional
Web sites, training and education of students and staff, and other appropriate venues. Many such
institutions also offer formalized employee orientation programs and courses of instruction in the
responsible conduct of research. It would be appropriate and helpful to incorporate the topic of
dual use research, along with related guidance on ethical and legal responsibilities, in such
courses and programs.
Industry. Life scientists who are engaged in research for commercial purposes share the same
responsibilities for safeguarding the public welfare as their colleagues in the academic or public
44
161
sectors. Each commercial organization will have its own mechanisms for raising awareness of
dual use research of concern and for developing policies to address related issues.
Research leadership. Scientists who have risen to leadership positions (for example, society
presidents, medical school deans, and department chairs in universities) serve as role models for
other scientists. In particular, those who are responsible for oversight of research programs
should consider how their institutions are addressing the responsibilities outlined in this
document. For example, it is important to ensure that issues related to dual use research of
concern are well understood by life scientists, that dual use research of concern is reported in
accordance with institutional policies, and that life scientists are aware of and compliant with
other applicable requirements. All those who have gained the respect of other scientists through
their work can play a critical role in assuring that the issues associated with dual use research of
concern are thoughtfully addressed.
Individual life scientists. Scientists bear the primary responsibility for the integrity of their own
research. By their actions and explicit guidance, they can foster a sense of ethical responsibility
in the research team and an awareness of applicable laws and guidelines. This document may
aid in increasing their awareness of their responsibilities in the area of dual use research of
concern and help them mentor students, trainees, and technical staff. Mentors are encouraged to
involve these individuals in laboratory discussions of dual use research of concern, the ethical
responsibilities that are outlined in this document, and the relevance of these responsibilities to
their work.
Technicians, trainees, and others involved in the research process. Technical staff,
postdoctoral fellows, students, and others who contribute to research activities bear their own
measure of responsibility for the integrity of these projects. These individuals are also
encouraged to review this document carefully, consider how it may apply to current work, and
engage their instructors and mentors in addressing any questions they may have regarding its
relevance.
Funding agencies/institutions. Institutions and agencies that fund research establish the
framework for decisions about the research considered eligible for funding and provide oversight
to ensure responsible stewardship of funds. In order to avoid endangering public health,
agriculture, plants, animals, the environment, or materiel, they are responsible for ensuring that
projects that could be considered dual use research of concern are identified prior to funding.
When a project meets the criteria for this type of research, the funders should ensure that a
process is in place to manage risks through a thoughtful and informed consideration of options
that could mitigate or manage them.
Journal editors, reviewers, and publishers. Those who play decisionmaking roles in the
process of communicating scientific information have an ethical responsibility to consider
whether the information being considered for publication could be used to endanger public
health, agriculture, plants, animals, the environment, or materiel. Depending on their analysis of
the risks and benefits of communications regarding information or technology that meet criteria
for dual use research of concern, they may choose to proceed in a way that mitigates or manages
the risks associated with communication, for example, by adding contextual information not
45
162
found in the original article or delaying communication until a time at which the risks would be
reduced.
CORE RESPONSIBILITIES OF LIFE S CIENTISTS IN REGARD TO DUAL USE RESEARCH OF
CONCERN
The following page identifies the fundamental responsibilities of all life scientists with regard to
dual use research of concern. These obligations flow from the underlying principle of concern
for the public good and should lie at the heart of any code of conduct that addresses this topic.
46
163
LI FE SCI ENTI STS:
CORE RESPONSI BI LI TI ES REGARDI NG
DUAL USE RES EARCH OF CONCERN
Life sciences research is a critically important endeavor that has
benefited society by advancing our understanding of living systems.
Critical to the future of scientific progress and freedom is the
preservation of public trust and support, which scientists have earned
through their attention to responsible research practice. Despite a
scientist’s conscientious approach to research conduct, the knowledge,
products, or technologies derived from some life sciences research may
be misused by others to pose a threat to public health, agriculture,
plants, animals, the environment, or materiel. Research with this
potential is known as “dual use research of concern.”
Individuals involved in any stage of life sciences research have an
ethical obligation to avoid or minimize the risks and harm that
could result from malevolent use of research outcomes.
Toward that end, scientists should:
•
Assess their own research efforts for dual use potential and
report as appropriate
•
Seek to stay informed of literature, guidance, and requirements
related to dual use research
•
Train others to identify dual use research of concern, manage it
appropriately, and communicate it responsibly
•
Serve as role models of responsible behavior, especially when
involved in research that meets the criteria for dual use research
of concern
•
Be alert to potential misuse of research
47
164
RESPONSIBILITIES IN THE RESEARCH PROCESS
Research is a complex, iterative process, and the potential for dual use may be recognized at
many junctures and through different activities. Consequently, while it is valuable to be mindful
of the core responsibilities articulated above, those involved in life sciences research may also
benefit from a more specific review of their responsibilities in regard to dual use research of
concern.
Proposing Research
When designing and proposing research, the ethical responsibilities of life scientists include:
1. Considering whether the knowledge, products, or technology resulting from the research
could be deliberately misused to endanger public health, agriculture, plants, animals, the
environment, or materiel
2. Striving to design research that promotes beneficial scientific advances, while avoiding or
minimizing elements of study design that raise concerns about dual use
3. Weighing carefully the benefits of study elements presenting dual use concerns that
cannot be completely eliminated against the harm that could occur through their
deliberate misuse
4. Considering ways to modify the research design to manage and mitigate potential misuse
when it is clear that the benefits of the research with dual use potential outweigh the
potential harm
Managing Research
The ethical responsibilities of persons who manage research programs, whether within the public
or private sector, include the following:
1. Promoting awareness of dual use research of concern and the ethical responsibilities it
entails
2. Developing and maintaining systems, policies, and training to ensure that dual use
research of concern is identified and managed appropriately
3. Implementing federal, state, and other appropriate guidelines specific to dual use research
of concern
Reviewing Research
The ethical responsibilities of those responsible for establishing and managing the review
process (e.g., funding agencies) include the following:
1. Ensuring that when research proposals are reviewed, appropriate systems are in place to
identify the possibility of dual use of concern and to address related issues. Examples of
common means of reviewing research proposals include Institutional Animal Care and
Use Committees (IACUCs), Institutional Biosafety Committees (IBCs), Institutional
Review Boards (IRBs), and peer review groups.
48
165
2. Ensuring that both researchers and reviewers are knowledgeable of, and adhere to, all
ethical, institutional, and legal requirements that apply to the review of possible dual use
research of concern.
3. Reconsidering institutional review systems periodically to ensure that they reflect current
criteria defining dual use research of concern and are consistent with applicable federal
and state guidelines.
The ethical responsibilities of individuals serving on peer review groups or otherwise engaged in
research review include the following:
1. Becoming well educated about dual use research of concern and related ethical, legal, and
institutional requirements, as well as applicable federal and state guidelines
2. Being mindful during the review process of whether the research could meet the criteria
for dual use of concern
3. Using methods in keeping with the reviewer’s charge and context to make appropriate
people aware that the research being reviewed meets the criteria for dual use research of
concern
Conducting Research
The ethical responsibilities of life scientists engaged in research include the following:
1. Observing safe practices1 and ethical behaviors in the laboratory, clinic, field, and classroom and ensuring that subordinate personnel do so as well
2. Using appropriate security measures and continually reassessing their adequacy as
concerns about potential misuse evolve
3. Observing applicable guidelines for the responsible conduct of dual use research of
concern
4. Being attentive to the dual use potential of the knowledge, products, or technology
resulting from research activities as they emerge
5. Alerting responsible institutional officials when dual use research of concern is identified
and when decisions must be made to manage associated risks
Collaborating on Research
Research endeavors frequently involve the participation and cooperation of multiple laboratories
and disciplines, which can be subject to different management, codes of conduct, cultural values,
or operating procedures. Besides the ethical responsibilities associated with conducting research,
scientists involved in such collaborations have the additional obligations of:
1
Safe laboratory practices are embodied in such documents as CDC-NIH Biosafety in Microbiological and
Biomedical Laboratories (http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm), NIH Guidelines for Research
Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html), and
Biological Safety: Principles and Practices (ASM Press, http://www.asm.org/), and applicable occupational and
safety regulations and standards.
49
166
1. Engaging in open dialog regarding whether knowledge, products, or technology resulting
from the research could be considered dual use research of concern; when such research
is pursued, ensuring that all parties are aware of their ethical responsibilities
2. Agreeing on specifically assigned responsibilities to ensure ethical oversight of all
aspects of research with dual research potential, including its outcomes.
3. Considering and respecting expressions of concern regarding the possible dual use of
knowledge, products, or technology resulting from the research and ensuring that these
concerns are raised with those charged with responsibility for research oversight
4. Considering appropriate measures to reduce or eliminate risks to public health,
agriculture, plants, animals, the environment, or materiel resulting from the research
project
5. Maintaining a current awareness of national and international standards and policies
regarding dual use research of concern
Communicating the Results of Dual Use Research of Concern
Regardless of the stage of the research process and the form of the communication, those
involved in communications regarding knowledge, products, or technology that can be
considered dual use research of concern have the following ethical responsibilities:
1. Being aware of ethical and legal considerations relevant to communications regarding
knowledge, products, or technology that can be considered dual use research of concern.
2. Analyzing potential risks to public health, agriculture, plants, animals, the environment,
or materiel that could result from research-related communications, balancing them
against the potential benefits.
3. Considering options for communication that may reduce or eliminate risks when
communicating information with dual use potential is clearly warranted by its benefits.
Examples of mitigating strategies may include a delay in releasing the information, the
addition of appropriate contextual information, or communicating the information to a
more limited audience.
Scientific Education and Mentorship
Practicing scientists who serve as role models to developing scientists (e.g., their trainees,
students, and staff) have the following ethical responsibilities:
1. Raising developing scientists’ awareness of what constitutes dual use research of concern
and why it matters
2. Informing developing scientists of their ethical, legal, and institutional responsibilities
when engaged in dual use research of concern, as well as applicable federal and state
guidelines
– Encouraging open and respectful discussion of issues related to dual use research
of concern, including whether or not a particular project could be considered dual
use research of concern
50
167
APPENDIX 4.
Points To Consider in Risk Assessment and Management
of Research That is Potentially Dual Use of Concern
Could this research yield information that could be intentionally misused to threaten public
health and safety or other aspects of national security?
• What is the nature of that information?
• Is the information novel?
• Is the information applicable to other, perhaps common, organisms, biologics, etc.?
• Could the information be directly misused to pose a threat? For example, even if the
information would need to be combined with other information/technologies in order
to pose a threat, is that other information/technology currently available?
• Does the information need to be combined with other information to pose a threat?
• If so, is that other information already available?
What is the nature of the threat that could be posed from intentional misapplication of the
information, and what are the potential consequences?
• What is the potential nature (e.g., economic, agricultural, public health, and/or public
terror), and what is the potential impact of the threat?
• What is the scope of the potential threat (e.g., how many/which people, plants,
animals might be adversely affected?
• Are there currently countermeasures for this threat?
• What type of technical expertise and/or physical resources would be needed to apply
the information for malevolent purposes?
• In what timeframe might the information be misused? Is there concern about
immediate or near-future potential use, or is the concern about misuse in the distant
future?
• Would it require a low or high degree of technical skill and sophistication to use the
dual use information for harmful purposes?
Based on the above considerations, how likely (reasonably anticipated) is it that the
information could be used to pose a threat to public health and safety or other aspects of
national security?
(If there is no discernable potential threat, then there is no need to continue the analysis.)
Could this research yield information that could potentially benefit the life sciences and/or
public health and safety and other aspects of national security?
• If so, what is the nature of that information?
• What is the nature of the potential benefit?
• How much of a benefit might there be?
Do the potential risks outweigh the potential benefits?
• If not, determine applicable risk management strategies (see below).
• If so, consider whether the research should be modified or discontinued.
51
168
Potential Risk Management Strategies (more than one may be applicable)
• Ongoing review or monitoring of research
• Modification of experiment (e.g., can an alternative antibiotic or a different strain of
organism be used?).
• Discontinuation of experiment. This may need to be discussed at a higher level,
either within the local institution or at the federal level.
• Utilize the “Points to Consider in Assessing the Risks and Benefits of
Communicating Research Information With Dual Use Potential” (Appendix 5):
– Identify and assess the risks and benefits of communicating research with dual
use potential
– Weigh the risks versus the benefits
– Formulate a decision for responsible communication; address the content,
timing, and extent of communication
• Develop a comprehensive communication plan:
– Consider the need to address the following issues in a communication:
o The significance of the research findings for public health and safety,
agriculture, the environment, and/or materiel
o How the new information or technology will be useful to the scientific
community
o The biosafety measures in place as the research was conducted
o The communication of less detailed findings
o The dual use aspects of the information and that careful consideration
was given to the biosecurity concerns in the decision to publish
– Determine whether additional venues are appropriate for conveying the
research information and contextual/background information.
52
169
APPENDIX 5. Points To Consider in Assessing the Risks and Benefits of
Communicating Research Information with Dual Use Potential
1. General Overview of the Research Information With Dual Use Potential
a. What information is provided?
b. To what extent is it novel?
2. Risk Analysis
a. Are there reasonably anticipated risks to public health and safety from direct misapplication of this information?
i. E.g., is novel scientific information provided that could be intentionally misused to
threaten public health and/or safety?
ii. E.g., does the information point out a vulnerability in public health and/or safety
preparedness?
b. Is it reasonably anticipated that this information could be directly misused to pose a threat
to agriculture, plants, animals, the environment, or materiel (e.g., does the information
point out a vulnerability with respect to agriculture, plants, animals, the environment, or
materiel)?
c. If a risk has been identified, in what timeframe (e.g., immediate, near future, years from
now) might this information be used to pose a threat to public health and/or safety,
agriculture, plants, animals, the environment, or materiel?
d. If the information were to be broadly communicated “as is,” what is the potential for:
i. Public misunderstanding, that is, what might be the implications of such
misunderstandings (e.g., psychological, social, health/dietary decisions, economic,
commercial etc.)?
ii. Sensationalism (i.e., in what way might it result in widespread concern or even panic
about public health or other safety/security issues?)
If no risk has been identified, no further dual use communication considerations are necessary.
If a risk has been identified, continue on.
3. Benefit Analysis
a. Are there potential benefits to public health and/or safety from application or utilization
of this information?
b. Are there potential benefits of the information for agriculture, plants, animals, the
environment, or materiel (e.g., what potential solution does it offer to an identified
problem or vulnerability)?
c. Will this information be useful to the scientific community? If so, how?
d. If a benefit has been identified, in what timeframe (e.g., immediate, near future, years
from now) might this information be used to benefit science, public health, agriculture,
plants, animals, the environment, or materiel?
4. Risk versus Benefit Assessment
Based on the risks and benefits identified and considering the timeframe in which these
might be realized:
a. Do the benefits of communicating the information outweigh the risks?
53
170
b. Do the risks outweigh the benefits?
5. Formulation of Recommendation Regarding Communication
Decisions about how to responsibly communicate research with dual use potential should
address content, timing, and possibly extent of distribution1 of the information.
a. Content
i. Communicate as is.
ii. Communicate with addition of appropriate contextual information. For example, it
may be important to address:
(1) The significance of the research findings for public health and/or safety,
agriculture, the environment, or materiel
(2) How the new information or technology will be useful to the scientific community
(3) The biosafety measures in place as the research was conducted
(4) The dual use potential of the information
(5) The careful consideration that was given to the dual use concerns in the decision
to publish
iii. Recommend communicating a modified version of the product. For example, is it
possible to “decouple” the material that poses security concerns from some or all of
the potentially useful scientific information, or should specific information be
removed (e.g., technical details about an enabling technology)?
b. Timing
i. Communicate immediately.
ii. Recommend that communication be deferred until a clearly defined and agreed-upon
endpoint is reached (e.g. a condition is met such that communication no longer poses
the same degree of risk).
c. Distribution2
i. No limit on distribution.
ii. Limit access to selected individuals on a “need to know” basis. It will be necessary to
identify categories of individuals who should have access and under what
circumstances.
iii. Recommend that the product not be published or otherwise made accessible to the
public.
1
The relevance and/or feasibility of considering limits on the distribution of dual use research will depend on the
specific situation (e.g., timing of the communication in terms of the maturity of the research, the nature of the
information and the risks associated with its communication, and the relevant audience for the information). For
example, while limiting distribution is not a consideration for most scientific journals, it might be a reasonable
consideration early on in a research project that yielded information of special significance to public health or
homeland security experts and for which countermeasures might need to be initiated prior to broader communication
of the information.
2
Ibid.
54
171
Filename:
Framework for transmittal 0807_Sept07.doc
Directory:
C:\Documents and Settings\tylerda\Desktop
Template:
C:\Documents and Settings\tylerda\Application
Data\Microsoft\Templates\Normal.dot
Title:
Subject:
Author:
Mary Groesch
Keywords:
Comments:
Creation Date:
9/10/2007 3:12:00 PM
Change Number:
2
Last Saved On:
9/10/2007 3:12:00 PM
Last Saved By:
hillro
Total Editing Time: 5 Minutes
Last Printed On:
9/26/2007 9:14:00 AM
As of Last Complete Printing
Number of Pages: 61
Number of Words:
21,674 (approx.)
Number of Characters: 123,547 (approx.)
172
United States Government Policy for Oversight of
Life Sciences Dual Use Research of Concern
Section I: Purpose and Principles
1) The purpose of this Policy is to establish regular review of United States Government funded or
conducted research with certain high-consequence pathogens and toxins for its potential to be dual
use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect
information needed to inform the development of an updated policy, as needed, for the oversight of
DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research
while minimizing the risk of misuse of the knowledge, information, products, or technologies
provided by such research.
2) This Policy complements existing United States Government regulations and policies governing the
possession and handling of pathogens and toxins. Currently, the Select Agent Regulations ensure
appropriate oversight of biosafety and biosecurity of the possession and handling of pathogens and
toxins that have the potential to pose a severe threat to human, animal, or plant health, or to
animal and plant products. In addition, recommendations from Federal advisory bodies such as the
National Science Advisory Board for Biosecurity (NSABB) have helped inform United States
Government policies for identifying and managing DURC. This Policy will be updated, as needed,
following domestic dialogue, engagement with our international partners, and input from interested
communities including scientists, national security officials, and global health specialists.
3) The following principles guide implementation of this Policy:
a) Life sciences research is essential to the scientific advances that underpin improvements in
the health and safety of the public, agricultural crops and other plants, animals, the
environment, materiel, and national security. Despite its value and benefits, some research
may provide knowledge, information, products, or technologies that could be misused for
harmful purposes.
b) Accordingly, some degree of Federal and institutional oversight of DURC is critical to
reducing the risks to public health and safety, agricultural crops and other plants, animals,
the environment, materiel, and national security.
c) Measures that mitigate the risks of DURC should be applied, where appropriate, in a manner
that minimizes, to the extent possible, adverse impact on legitimate research, is
commensurate with the risk, includes flexible approaches that leverage existing processes,
and endeavors to preserve and foster the benefits of research.
d) The United States Government will facilitate the sharing of the results and products of life
sciences research conducted or funded by United States Government agencies, and honor
United States Government obligations within relevant international frameworks and
agreements, while taking into account United States’ national security interests.
e) In executing this Policy, the United States Government will abide by and enforce all relevant
Presidential Directives and Executive Orders, all applicable laws and regulations, and
support the implementation of legally binding treaties, commitments, and United Nations
Security Council resolutions prohibiting the development and use of biological agents as
weapons.
Section II: Definitions
1) For the purpose of this Policy, DURC is life sciences research that, based on current understanding,
can be reasonably anticipated to provide knowledge, information, products, or technologies that
could be directly misapplied to pose a significant threat with broad potential consequences to public
173
health and safety, agricultural crops and other plants, animals, the environment, materiel, or
national security 1.
2) “Life sciences” pertains to living organisms (e.g., microbes, human beings, animals, and plants) and
their products, including all disciplines and methodologies of biology such as aerobiology,
agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic
biology, environmental science, public health, modeling, engineering of living systems, and all
applications of the biological sciences. The term is meant to encompass the diverse approaches for
understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules.
3) Extramural research is that which is funded by a department or agency under a grant, contract,
cooperative agreement, or other agreement and not conducted directly by the department or
agency.
4) Intramural research is that which is directly conducted by a department or agency.
Section III: Scope
Under this Policy, review will focus on research that involves one or more of the agents or toxins listed
in Section (III.1) below, which pose the greatest risk of deliberate misuse with most significant potential
for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence,
and produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed
in Section (III.2) below:
1) Agents and toxins 2:
a) Avian influenza virus (highly pathogenic)
b) Bacillus anthracis
c) Botulinum neurotoxin
d) Burkholderia mallei
e) Burkholderia pseudomallei
f) Ebola virus
g) Foot-and-mouth disease virus
h) Francisella tularensis
i) Marburg virus
j) Reconstructed 1918 Influenza virus
k) Rinderpest virus
l) Toxin-producing strains of Clostridium botulinum
m) Variola major virus
n) Variola minor virus
o) Yersinia pestis
2) Categories of experiments:
a) Enhances the harmful consequences of the agent or toxin;
b) Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical or agricultural justification;
c) Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade
detection methodologies;
d) Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
e) Alters the host range or tropism of the agent or toxin;
1
This definition of DURC is derived from the NSABB definition, but is modified for purposes of this Policy.
These agents and toxins are regulated by the Select Agent Program under Federal Law (7 C.F.R. part 331, 9 C.F.R.
part 121, and 42 C.F.R. part 73), and have the potential to pose a severe threat to human, animal, or plant health,
or to animal and plant products.
2
174
f) Enhances the susceptibility of a host population to the agent or toxin; or
g) Generates or reconstitutes an eradicated or extinct agent or toxin listed in Section (III.1) above.
Section IV: Department and Agency Responsibilities
1) Federal departments and agencies that conduct or fund life sciences research should implement the
following actions:
a) Conduct a review to identify all current or proposed, unclassified intramural or extramural, life
sciences research projects that fall within the scope of Section III. This review will include, at a
minimum, initial proposals and any progress reports.
b) Determine which, if any, of the projects identified in Section (IV.1.a) meet the definition of
DURC in Section (II.1) of this document.
c) Assess the risks and benefits of such projects, including how research methodologies may
generate risks and/or whether open access to the knowledge, information, products, or
technologies generates risk.
d) Based on the risk assessment, in collaboration with the institution or researcher, develop a risk
mitigation plan to apply any necessary and appropriate risk mitigation measures. In addition:
i)
For DURC that is proposed and not yet funded, departments and agencies will assess
whether to incorporate risk mitigation measures in the grant, contract, or agreement.
ii)
For currently funded DURC, funding departments and agencies will consider modifying
the grant, contract, or agreement to incorporate risk mitigation measures. If such
modifications are not possible or desirable, departments and agencies will seek
voluntary implementation of mitigation measures by the institution.
e) A risk mitigation plan may include, but not be limited to, the following risk mitigation measures:
i)
Modifying the design or conduct of the research.
ii)
Applying specific or enhanced biosecurity or biosafety measures.
iii)
Evaluating existing evidence of medical countermeasures (MCM) efficacy, or conducting
experiments to determine MCM efficacy against agents or toxins resulting from DURC,
and where effective MCM exist, including that information in publications.
iv)
Referring the institution to available DURC educational tools such as:
http://oba.od.nih.gov/biosecurity/biosecurity.html
v)
Regularly reviewing, at the institutional level, emerging research findings for additional
DURC.
vi)
Requesting that institutions notify funding departments or agencies if additional DURC is
identified, and propose modifications to the risk mitigation plan, as needed.
vii)
Determining the venue and mode of communication (addressing content, timing, and
possibly the extent of distribution of the information) to communicate the research
responsibly.
viii)
Reviewing annual progress reports from Principal Investigators to determine if DURC
results have been generated, and if so, flagging them for institutional attention and
applying potential mitigation measures as described above, as necessary.
ix)
If the risks posed by the research cannot be adequately mitigated with the measures
above, Federal departments and agencies will determine whether it is appropriate to:
(a)
Request voluntary redaction of the research publications or communications 3;
(b)
Classify the research:
(i)
In accordance with National Security Decision Directive/NSDD-189,
departments and agencies will make classification determinations within
3
Actions taken to restrict the publication of technology may have implications under export control laws and
regulations (e.g., 15 CFR parts 730-774 and 22 CFR parts 120-130).
175
2)
3)
4)
5)
the scope of their classification authorities and appropriate classification
guidelines or may consult with other departments and agencies to make
these determinations.
(ii)
Departments and agencies may consider whether to refer classified
research to another department or agency for funding.
(c) Not provide or terminate research funding.
Federal departments and agencies are requested to report the following to the Assistant to the
President for Homeland Security and Counterterrorism:
a)
Within 60 days of issuance of this Policy, the following results of the review conducted in
response to Section (IV.1.a):
i)
Aggregate number of current and proposed unclassified, intramural, and extramural
research projects identified that include work with one or more of the agents and toxins
in Section (III.1).
ii)
Aggregate number of current and proposed unclassified, intramural, and extramural
research projects that include work with one or more of the agents and toxins in Section
(III.1) and produces, aims to produce, or are reasonably anticipated to produce one or
more of the effects listed in Section (III.2).
b)
Within 90 days of issuance of this Policy, the following results of the review conducted in
response to Sections (IV.1. b. c. and d):
i)
Number of unclassified current and proposed DURC projects. 4
ii)
Number of current projects identified as DURC through initial proposals versus progress
reports.5
iii)
Summary of risks, mitigation measures already in place that address those risks, any
additional mitigation measures that have been proposed or implemented, and number
of projects to which each mitigation measure would be applied.
Following completion of the reporting requirements in Section (IV.2), Federal departments and
agencies are requested to submit periodic reports on items in Section (IV.2.a. and b) biannually.
Federal departments and agencies should implement Section IV in accordance with their relevant
and applicable authorities, regulations, and statutes.
For additional guidance on how to conduct the risk assessment identified in Section (IV. 1.c),
departments and agencies may refer to the “Proposed Framework for the Oversight of Dual Use Life
Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information,” which
identifies useful assessment tools and is available at:
http://oba.od.nih.gov/biosecurity/biosecurity_documents.html .
Section V: Consultation
As necessary and appropriate, the United States Government will continue to consult with the NSABB (in
compliance with provisions of the Federal Advisory Committee Act) or convene the Countering
Biological Threats Interagency Policy Committee for guidance on matters relating to the review and
conduct of DURC and the mitigation of DURC risks.
4,5
Report the number of projects by agent and/or toxin plus the category of experiment.
176
United States Government Policy for Institutional Oversight
of Life Sciences Dual Use Research of Concern
Contents
Section 1. Introduction................................................................................................................................. 2
Section 2. Purpose ....................................................................................................................................... 4
Section 3. Guiding Principles for Oversight of Life Sciences Dual Use Research ......................................... 4
Section 4. Definitions ................................................................................................................................... 5
Section 5. Policy Statement ......................................................................................................................... 6
Section 6. Applicability of this Policy and Scope of Oversight of DURC ....................................................... 6
6.1. Applicability........................................................................................................................................ 6
6.2. Scope of Oversight Required Under this Policy ................................................................................ 7
6.2.1. Agents and toxins ....................................................................................................................... 7
6.2.2. Categories of experiments ......................................................................................................... 7
Section 7. Organizational Framework for Oversight of DURC ..................................................................... 8
7.1. Responsibilities of Principal Investigators of Research that is Subject to Institutional DURC
Oversight ................................................................................................................................................... 9
7.2. Responsibilities of Research Institutions that Conduct Research that is Subject to Institutional
DURC Oversight....................................................................................................................................... 10
7.3. Responsibilities of Federal Departments and Agencies that Fund Research that is Subject to DURC
Oversight ................................................................................................................................................. 13
7.4. Responsibilities of the USG ............................................................................................................. 13
Section 8. Resources for Institutional Oversight of DURC ......................................................................... 14
177
Section 1. Introduction
Life sciences research is essential to the scientific advances that underpin improvements in the
health and safety of the public, agricultural crops and other plants, animals, the environment,
materiel 1, and national security. Despite its value and benefits, however, certain types of
research conducted for legitimate purposes can be utilized for benevolent or harmful purposes.
Such research is called “dual use research.” Dual use research of concern (DURC) is a subset of
dual use research defined as life sciences research that, based on current understanding, can be
reasonably anticipated to provide knowledge, information, products, or technologies that could
be directly misapplied to pose a significant threat with broad potential consequences to public
health and safety, agricultural crops and other plants, animals, the environment, materiel, or
national security.
In general, there are risks associated with life sciences research, such as accidental exposure of
personnel or the environment to a pathogen or toxin. Many existing and synergistic statutes,
regulations, and guidelines are in place to address risks associated with biosafety, physical
security, and personnel reliability. 2 Some risks relate directly to the characteristics of DURC –
the risk that knowledge, information, products, or technologies resulting from the research
could be used in a manner that results in harm or threatens society. DURC should be evaluated
for possible risks, as well as benefits, in all these domains, to ensure that risks are appropriately
managed and benefits realized. This Policy addresses dual use research risks holistically, that is,
the risk that knowledge, information, products, or technologies generated from life sciences
research could be used in a manner that results in harm.
Funders of life sciences research and the institutions and scientists who receive those funds
have a shared responsibility for oversight of DURC and for promoting the responsible conduct
and communication of such research. A comprehensive oversight system must include both
Federal and institutional oversight processes. The goal of oversight is to preserve the benefits
of life sciences research while minimizing the risk that knowledge, information, products, or
technologies generated by such research could be used in a manner that results in harm. On
March 29, 2012, the U.S. Government (USG) issued its “Policy for Oversight of Life Sciences Dual
Use Research of Concern” (March 29 Policy). That policy formalized a process of regular
Federal review of USG-funded or -conducted research with certain high-consequence
pathogens and toxins to identify DURC and implement mitigation measures, where applicable.
The Policy herein, “United States Government Policy for Institutional Oversight of Life Sciences
Dual Use Research of Concern,” addresses institutional oversight of DURC. Oversight includes
policies, practices, and procedures to ensure DURC is identified and risk mitigation measures
1
Materiel includes food, water, equipment, supplies, or material of any kind.
e.g. Select Agents and Toxins Program (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331); National Institutes of
Health Guidelines on Research Involving Recombinant DNA Molecules
(http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf); Biosafety in Microbiological and Biomedical
Laboratories 5th Edition (http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf)
2
178
are implemented, where applicable. Institutional oversight of DURC is a critical component of a
comprehensive oversight system because institutions are most familiar with the life sciences
research conducted in their facilities and are in the best position to promote and strengthen
the responsible conduct and communication of DURC. This Policy, in addition to the March 29
Policy, emphasizes a culture of responsibility by reminding all involved parties of the shared
duty to uphold the integrity of science and prevent its misuse.3 The components outlined in
the March 29 Policy and in this Policy will be updated, as needed, following domestic dialogue,
international engagement, and input from interested communities including scientists, national
security officials, and global health specialists.
Because institutional oversight of DURC will be a new undertaking for many institutions, the
USG is currently limiting the requirements in this Policy, as well as the March 29 Policy, to
research that meets the scope in Section 6.2, which focuses on a well-defined subset of life
sciences research that involves 15 agents and toxins and seven categories of experiments. The
USG will solicit feedback on the experience of institutions in implementing the Policy; will
evaluate the impact of DURC oversight on the life sciences research enterprise; will assess the
benefits and risks of expanding the scope of the Policy to encompass additional agents and
toxins and/or categories of experiments; and will update the Policy, as warranted. Research
institutions are encouraged to be mindful that research outside of the categories articulated in
this Policy may also constitute DURC. Institutions have the discretion to consider other
categories of research for DURC potential and may expand their oversight to other types of life
sciences research as they deem appropriate.
It is important to note that research that meets the definition of DURC often increases our
understanding of the biology of pathogens and makes critical contributions to the development
of new diagnostic, prevention, and treatment measures, improvements in public, animal, and
plant health surveillance, and the enhancement of emergency preparedness and response
efforts. Thus, designating research as DURC should not be seen as a negative categorization,
but simply an indication that the research may warrant additional oversight in order to reduce
the risks that the knowledge, information, products, or technologies generated could be used in
a manner that results in harm. As a general matter, designation of research as DURC does not
mean that the research should not be conducted or communicated.
Nothing in this Policy supersedes the Department of Health and Human Services and the United
States Department of Agriculture Select Agents and Toxins Program’s (SAP) statutory authority
or SAP regulations as published in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331.
3
The March 29 Policy and this Policy are complemented by other extant laws and treaties (e.g. United States Code
Title 18 Section 175 part a, 175 part b, and 175b and Biological and Toxin Weapons Convention) that prohibit the
development, production, acquisition, or stockpiling of biological agents or toxins of types and in quantities that
have no justification for prophylactic, protective or other peaceful purposes and that prohibit the use of biological
agents and toxins as weapons.
179
Section 2. Purpose
The purpose of this Policy is to strengthen regular institutional review and oversight of certain
life sciences research with high-consequence pathogens and toxins in order to identify potential
DURC and mitigate risks where appropriate. This Policy delineates the roles and responsibilities
of Federal funding agencies, research institutions, and life scientists, and establishes
requirements and performance standards for review of research, identification of potential
DURC, and development and implementation of risk mitigation measures for DURC, where
applicable. In so doing, the Policy seeks to preserve the benefits of DURC while minimizing the
risk that the knowledge, information, products, or technologies generated from such research
could be used in a manner that results in harm to public health and safety, agricultural crops
and other plants, animals, the environment, materiel, or national security.
Section 3. Guiding Principles for Oversight of Life Sciences Dual Use Research
The following principles serve as a guide for oversight of life sciences dual use research
generally:
A. Life sciences research makes possible advances in public health, agriculture, the
environment, and other pertinent areas and contributes significantly to a strong
national security and economy.
B. Life sciences research has the potential to produce beneficial knowledge, information,
technology, or products that can also be used in a manner that results in harm to public
health and safety, agricultural crops and other plants, animals, or the environment.
Therefore, it is appropriate to have in place a framework and tools for the responsible
oversight, conduct, and communication of such research.
C. Life sciences research is by nature dynamic and can produce unanticipated results, and
therefore must be evaluated on an ongoing basis for dual use potential.
D. Oversight of DURC must recognize both the need for security and the need for research
progress; as such, the degree of oversight should be consistent with the possible
consequences of misuse.
E. Effective oversight helps maintain public trust in the life sciences research enterprise by
demonstrating that the scientific community recognizes the implications of DURC and is
acting responsibly to protect public welfare and security.
F. Federal agencies that fund DURC, the recipients of those public funds, and individuals
who conduct this research share the oversight responsibility.
G. It is essential to have a consistent approach to the oversight of DURC.
H. Any oversight process for DURC should be periodically evaluated both for effectiveness
and impact on the research enterprise.
180
I. The free and open conduct and communication of life sciences research is vital to a
robust scientific enterprise and will continue to be the goal of the USG. It also should
continue to be the goal of institutions engaged in life sciences research.
J. Educating the scientific community about the dual use potential of life sciences research
and cultivating a sense of responsibility for dual use research among life scientists is
essential for promoting responsible research behavior.
K. No policy or set of guidelines can anticipate every possible situation. Motivation,
awareness of the dual use issue, and good judgment are key considerations in the
responsible evaluation of research for dual use potential. It is incumbent on those
engaged in life sciences research to adhere to the intent of this Policy as well as to the
performance standards described herein.
Section 4. Definitions
For the purpose of this Policy the following terms are defined:
A. “Dual use research” is research conducted for legitimate purposes that generates
knowledge, information, technologies, and/or products that can be utilized for
benevolent or harmful purposes.
B. “Dual use research of concern,” or “DURC,” is life sciences research that, based on
current understanding, can be reasonably anticipated to provide knowledge,
information, products, or technologies that could be directly misapplied to pose a
significant threat with broad potential consequences to public health and safety,
agricultural crops and other plants, animals, the environment, materiel, or national
security.
C. “Institution” is any government agency (Federal, State, or local), academic institution,
corporation, company, partnership, society, association, firm, sole proprietorship, or
other legal entity involved in funding, conducting, or sponsoring research.
D. “Institutional Contact for Dual Use Research,” or “ICDUR,” is designated by the
institution to serve as an internal resource for issues regarding compliance with and
implementation of the requirements for the oversight of DURC as well as the liaison (as
necessary) between the institution and the relevant Federal funding agency.
E. “Institutional review entity” is established by the institution to execute the
requirements in Section 7.2.B.i-7.2.B.v below and has the attributes described in Section
7.2.E below.
F. “Life sciences” pertains to living organisms (e.g., microbes, human beings, animals, and
plants) and their products, including all disciplines and methodologies of biology such as
agricultural science, plant science, animal science, bioinformatics, genomics,
proteomics, synthetic biology, environmental science, public health, modeling,
181
engineering of living systems, and all applications of the biological sciences. The term is
meant to encompass the diverse approaches to understanding life at the level of
ecosystems, populations, organisms, organs, tissues, cells, and molecules.
G. “National Science Advisory Board for Biosecurity” (NSABB) is a Federal advisory
committee established to advise the USG on dual use research issues.
Section 5. Policy Statement
It is the policy of the USG that:
A. Life sciences research that meets the scope specified in Section 6.2 of this Policy is
subject to Federal as well as institutional oversight. The purpose of this oversight is to
preserve the benefits of such research while minimizing the risk that the knowledge,
information, products, or technologies generated by DURC could be used in a manner
that results in harm to public health and safety, agricultural crops and other plants,
animals, the environment, materiel, or national security; and
B. Oversight includes the identification of life sciences research that raises dual use
concerns as well as the implementation of measures to mitigate the risk that DURC is
used in a manner that results in harm. Measures that mitigate the risks of DURC should
be applied in a manner that minimizes, to the maximum extent possible, adverse impact
on legitimate research, is commensurate with the risk, includes flexible approaches that
leverage existing processes, and endeavors to preserve and foster the benefits of
research.
Section 6. Applicability of this Policy and Scope of Oversight of DURC
6.1. Applicability
This Policy and its oversight requirements apply to:
A. Federal departments and agencies that fund or conduct life sciences research.
B. Institutions within the United States that receive Federal funds to conduct or
sponsor life sciences research, and conduct or sponsor research that is within the
scope identified in Section 6.2, regardless of source of funding.
C. Institutions outside of the United States that receive Federal funds to conduct or
sponsor research that is within the scope identified in Section 6.2.
Non-compliance with this Policy may result in suspension, limitation, or termination of
Federal funding, or loss of future Federal funding opportunities for the non-compliant
Federally-funded research project and of Federal funds for other life sciences research at
the institution. While each Federal funding agency is responsible, in accordance with their
182
relevant statutory authorities, for determining how best to ensure compliance with the
oversight requirements set forth in this Policy for research it funds, the USG, to the
maximum degree possible, will develop and promulgate consistent processes for this
purpose.
Institutions that do not receive any Federal funds for life sciences research, but that
nevertheless conduct life sciences research that has the potential to generate knowledge,
information, products, or technologies that could be used in a manner that results in harm,
are strongly encouraged to implement similar oversight procedures consistent with the
culture of shared responsibility underpinning this Policy.
6.2. Scope of Oversight Required Under this Policy
Consistent with the March 29 Policy, under this Policy, life sciences research that uses one
or more of the agents or toxins listed in Section 6.2.1, and produces, aims to produce, or
can be reasonably anticipated to produce one or more of the effects listed in Section 6.2.2
will be evaluated for DURC potential.
6.2.1. Agents and toxins 4
a) Avian influenza virus (highly pathogenic)
b) Bacillus anthracis
c) Botulinum neurotoxin 5
d) Burkholderia mallei
e) Burkholderia pseudomallei
f) Ebola virus
g) Foot-and-mouth disease virus
h) Francisella tularensis
i) Marburg virus
j) Reconstructed 1918 Influenza virus
k) Rinderpest virus
l) Toxin-producing strains of Clostridium botulinum
m) Variola major virus
n) Variola minor virus
o) Yersinia pestis
6.2.2. Categories of experiments
a) Enhances the harmful consequences of the agent or toxin
b) Disrupts immunity or the effectiveness of an immunization against the agent or toxin
without clinical and/or agricultural justification
4
These agents and toxins are regulated by the Select Agent Program under Federal law (7 C.F.R. part 331, 9 C.F.R.
part 121, 42 C.F.R. part 73), and have the potential to pose a severe threat to human, animal, or plant health, or to
animal and plant products.
5
For the purposes of this Policy, there are no exempt quantities of toxin. Research involving any quantity of
Botulinum neurotoxin should be evaluated for DURC potential.
183
c) Confers to the agent or toxin resistance to clinically and/or agriculturally useful
prophylactic or therapeutic interventions against that agent or toxin or facilitates
their ability to evade detection methodologies
d) Increases the stability, transmissibility, or the ability to disseminate the agent or
toxin
e) Alters the host range or tropism of the agent or toxin
f) Enhances the susceptibility of a host population to the agent or toxin
g) Generates or reconstitutes an eradicated or extinct agent or toxin listed in 6.2.1,
above.
Section 7. Organizational Framework for Oversight of DURC
This Section describes the organizational framework for the oversight of DURC and articulates
the roles and responsibilities of PIs, institutions, Federal funding agencies, and the USG under
this Policy. Generally, components of the oversight system for DURC include:
A. Identification, by the PI, of life sciences research that falls within the scope of Section
6.2.1 (described in Section 7.1 below);
B. An institutional review process for assessing whether the research produces, aims to
produce, or is reasonably anticipated to produce one or more of the effects listed in
Section 6.2.2, and if so, determining whether the research meets the definition of DURC
in Section 4.B. This includes assessing the benefits and risks associated with its conduct
and communication, developing a plan for mitigating identified risks, and ensuring that
research is conducted in accordance with the risk mitigation plan (described in Section
7.2 below);
C. Notification of the results of this review process and provision of the risk mitigation plan
by the institution to the Federal funding agency or for non-Federally funded research, to
the National Institutes of Health (NIH) (which will receive for administrative purposes on
behalf of all of the institution's Federal funders) and annual assurance of compliance
with the Policy described in Section 7.2 below; and
D. Oversight by Federal funding agencies and the USG as articulated in the March 29 Policy
with additional responsibilities with respect to this Policy described in Section 7.3 and
7.4 below.
Figure 1 provides an overview of the institutional oversight process.
184
7.1. Responsibilities of Principal Investigators of Research that is Subject to Institutional
DURC Oversight
In accordance with this Policy, PIs are to:
A. Identify his or her research involving one or more of the agents or toxins listed in
Section 6.2.1 and refer that research to an appropriate institutional review entity to
be reviewed for its DURC potential. If a PI determines that his or her research does
not utilize any of the agents or toxins listed in Section 6.2.1, no further action by the
PI is needed in terms of DURC oversight (Figure 1).
B. Work with the institutional review entity to develop risk mitigation measures where
appropriate.
C. Conduct DURC in accordance with the provisions in the risk mitigation plan.
D. Be knowledgeable about and comply with all institutional and Federal policies and
requirements for oversight of DURC.
E. Ensure that laboratory personnel conducting life sciences research that falls within
the scope of this Policy (i.e., those under the supervision of laboratory leadership,
185
including graduate students, postdoctoral fellows, research technicians, laboratory
staff, and visiting scientists) have received education and training on DURC.
F. Communicate DURC in a responsible manner. Communication of research and
research findings is an essential activity for all researchers, and occurs throughout
the research process, not simply at the point of publication. When researchers are
planning to communicate DURC, it is their duty to ensure that it is done in a
responsible manner, and in compliance with any risk mitigation plan stipulated by
the institutional review entity.
7.2. Responsibilities of Research Institutions that Conduct Research that is Subject to
Institutional DURC Oversight
In accordance with this Policy, research institutions are to:
A. Establish and implement internal policies and practices that provide for the
identification and effective oversight of DURC.
B. When research is identified by a PI as utilizing one of the agents or toxins listed in
Section 6.2.1, initiate an institutional oversight process that includes (Figure 1):
i. Verification that research utilizes one or more of the agents or toxins listed in
Section 6.2.1;
ii. Determination of whether the research produces, aims to produce, or is
reasonably anticipated to produce one or more of the effects listed in Section
6.2.2;
iii. Determination of whether the research meets the DURC definition (Section
4.B) and is therefore DURC. If the institutional review determines that the
research in question does not fall within the scope of Section 6.2.2 or does not
meet the definition of DURC, the research can continue without additional
DURC oversight;
iv. Assessment of the dual use risks and the benefits of the research;
v. Development of a risk mitigation plan for DURC, as necessary;
vi. Implementation of the risk mitigation plan. After a risk mitigation plan is
developed, the research must be conducted in accordance with that plan and
must be periodically reviewed by the institution to determine if additional
modifications to the risk mitigation plan are appropriate. For research that has
been proposed but not yet initiated, the DURC component of the project
should not be initiated until a risk mitigation plan is implemented;
vii. Within 30 calendar days of the institutional review of the research for DURC
potential, notification of the Federal funding agency of any research that falls
within the scope of 6.2, including whether it meets or does not meet the
definition of DURC. For non-Federally funded research, notification may be
made to NIH (who may in turn notify the appropriate Federal funding agency,
based upon the nature of the research); and
186
viii.
Within 90 calendar days from the time that the institution determined the
research to be DURC, provision of a copy of the risk mitigation plan to the
funding agency for review – or for non-Federally funded research, provision of
the plan to NIH for review (or referral to the appropriate funding agency).
C. Ensure that internal policies establish a mechanism for the PI to refer a project to
the institutional review entity if, at any time, his or her work with one or more of the
agents or toxins listed in Section 6.2.1 also produces or can be reasonably
anticipated to produce one or more of the 7 effects listed in Section 6.2.2, or may
meet the definition of DURC.
D. Designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an
internal resource for issues regarding compliance with and implementation of the
requirements for the oversight of research that falls within the scope of Section 6.2
and/or meets the definition of DURC. If questions arise regarding compliance,
implementation of this Policy, or the March 29 Policy, or when guidance is needed
about identifying DURC or developing risk mitigation plans, the ICDUR serves as the
liaison (as necessary) between the institution and the relevant program officers at
the Federal funding agencies, or for non-Federally funded research, between the
institution and NIH (or the appropriate Federal funding agency to which NIH refers
the institution).
E. Establish an institutional review entity to execute the requirements in Section
7.2.B.i-7.2.B.v above. A range of mechanisms for fulfilling the role of an institutional
review entity are acceptable as long as the review entity is appropriately constituted
and authorized by the institution to conduct the dual use review. Options include:
(1) a committee established for dual use review; (2) an extant committee (such as an
Institutional Biosafety Committee[IBC]) whose constitution meets or could meet,
with the addition of ad hoc members, the requirements outlined below; or (3) an
externally administered committee (e.g., an IBC or review entity at a neighboring or
regional institution or a commercial entity).
Regardless of the mechanism selected to fulfill the institutional responsibility of
reviewing research that falls within the scope of Section 6.2.1, the review entity
must:
i. Be sufficiently empowered by the institution to ensure compliance with the
institution’s dual use research policies.
ii. Have sufficient breadth of expertise to assess the dual use potential of the
range of relevant life sciences research conducted at a given research facility.
iii. Have knowledge of dual use issues, concerns, and related institutional and
Federal policies and understand risk assessment and risk management
considerations. The review entity should be aware that a variety of risk
mitigation measures are available and that designating research as DURC does
187
iv.
v.
vi.
vii.
not necessarily mean that the research should not be conducted or
communicated.
Make its procedures for reviewing life sciences research for dual use potential
accessible to the public. The posted policies of the institution should include
an overview of the institution’s procedures or review process, but should not
include details of particular cases or the minutes of the DURC review entity’s
proceedings.
On a case by case basis, recuse any member of an institutional review entity
who is involved in the research project in question or has a direct financial
interest, except to provide specific information requested by the review entity.
Engage in an ongoing dialogue with the PI of the research in question when
developing appropriate risk mitigation plans.
Maintain records of institutional DURC reviews and completed risk mitigation
plans for three years.
F. Provide education and training on DURC for individuals conducting life sciences
research that falls within the scope of this Policy. Institutions may also wish to
address dual use topics in existing courses on research ethics or the responsible
conduct of research.
G. Maintain records of personnel training on dual use research for three years.
H. Report instances of noncompliance with this Policy, as well as mitigation measures
undertaken by the institution to prevent recurrences of similar noncompliance,
within 30 calendar days to the Federal funding agency or, for non-Federally funded
research, to NIH (which will receive for administrative purposes on behalf of all of
the institution’s Federal funders).
I. As necessary, assist the PIs of life sciences research when questions arise about
whether their research may require further review or oversight.
J. Establish an internal mechanism for PIs to appeal institutional decisions regarding
research that is determined by the institutional review entity to meet the definition
of DURC.
K. On an annual basis, provide a formal assurance to the Federal funding agencies that
the institution is in compliance with all aspects of this Policy.
Note: The USG recognizes that there will be situations where a PI is conducting potential
DURC at multiple institutions. It is under the purview of each institution to review these
projects and if DURC is being conducted at their institution, develop and implement risk
mitigation plans as appropriate.
188
7.3. Responsibilities of Federal Departments and Agencies that Fund Research that is
Subject to DURC Oversight
The oversight process and the roles and responsibilities of the Federal departments and
agencies that fund life sciences research are delineated in the complementary March 29
Policy. In accordance with this Policy aimed at institutions, Federal departments and
agencies that fund DURC are to:
A. Require all institutions they fund that meet the applicability criteria in Section 6.1 to
implement this Policy. One mechanism for implementing the Policy is through a
term and condition of award.
B. Respond to questions from institutions regarding the oversight of DURC and provide
guidance to institutions regarding compliance with this Policy.
C. For department- or agency-funded and proposed life sciences research that meets
the criteria listed in Section 6.2.1, assess the applicability of the criteria listed in
Section 6.2.2, and for such research that also meets the definition of DURC,
complete a risk assessment prior to the funding decision and when progress reports
are submitted by PIs. Federal departments and agencies will review projects on an
ongoing basis for DURC and are to:
i. For research that meets the criteria in Section 6.2.1, notify an institution when
the department or agency assesses that the research meets the criteria listed
in Section 6.2.2 and meets the definition of DURC;
ii. Notify an institution when the department or agency does not agree with an
institution’s assessment of the applicability of the criteria listed in Section 6.2.2
or with an institution’s determination of the DURC status of such research;
iii. Review institutional risk mitigation plans and notify an institution of any
concerns or disagreements with a risk mitigation plan; and
iv. Prior to reaching its final determination, the funding agency will consult with
institutions to address any disagreements identified in accordance with
sections 7.3.D.i, ii, and iii above.
D. Respond to reports of non-compliance with this Policy and work with institutions to
address such non-compliance.
E. For research institutions in low-resource environments outside of the United States
that receive USG funds, the funding department or agency may elect to serve as the
implementing institutional review entity if appropriate.
7.4. Responsibilities of the USG
In accordance with this Policy, the USG is to:
A. Develop training tools and materials for use by the USG agencies and by institutions
implementing this Policy.
189
B. Provide education and outreach to affected stakeholders about dual use policies and
issues.
C. Provide guidance to institutions on the distribution of DURC research products and
on the communication of DURC.
D. Convene advisory bodies such as NSABB, as necessary, to develop recommendations
on particularly complex cases of DURC.
E. Periodically assess the impact of this Policy on life sciences research programs and
institutions, and update the Federal and institutional dual use research oversight
policies as appropriate. This should be informed by national and international
dialogue with interested communities, including scientists, research administrators,
security experts, and public health officials.
Section 8. Resources for Institutional Oversight of DURC
It is the expectation of the USG that PIs and institutions will be able to identify, assess, and
appropriately manage DURC. To assist in these processes, the following resources are available
for optional use:
A. Guidance Documents for DURC Oversight. The USG has developed a compendium of
tools to assist investigators and research institutions in the implementation of DURC
oversight outlined in this Policy and the March 29 Policy. These tools will aid in the
understanding and identification of DURC, the risk assessment and development of risk
mitigation plans and risk management processes, the responsible communication of
DURC, and training and education on DURC.
B. Consultation with the Federal Funding Agency. Institutions may consult with the
Federal department or agency that is funding the research in question for advice on
matters related to DURC. Such consultations should involve the ICDUR. The funding
agency program officers can provide guidance on DURC issues. Questions regarding
non-Federally funded research can be directed to the NIH or to the Federal funding
agency to which NIH refers the institution based on the nature of the research in
question. Consultation with the funding agency is not mandatory or intended as a
substitute for institutional dual use review or the reporting requirement (see Section
7.2.B above). Such consultations may be appropriate when:
i.
ii.
The institutional review entity requires guidance on developing an adequate risk
mitigation plan in cases where the potential risks are perceived as particularly
high;
The institutional review entity considers the only viable risk mitigation measure to
be not conducting or not communicating the research in question;
190
iii.
iv.
v.
The PI does not agree with the finding of the institutional review entity and so the
institution would like to request outside advice;
The research in question represents a particularly complex case or appears to fall
outside the current definition of DURC, but still seems to present significant
concerns; or
Guidance is required to ensure a clear understanding of how the Federal
government interprets the definition of DURC and related terms.
191
U.S. Government Gain-of-Function
Deliberative Process and Research Funding
Pause on Selected Gain-of-Function
Research Involving Influenza, MERS, and
SARS Viruses
October 17, 2014
192
U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on
Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses
Gain-of-function studies, or research that improves the ability of a pathogen to cause disease,
help define the fundamental nature of human-pathogen interactions, thereby enabling assessment
of the pandemic potential of emerging infectious agents, informing public health and
preparedness efforts, and furthering medical countermeasure development. Gain-of-function
studies may entail biosafety and biosecurity risks; therefore, the risks and benefits of gain-offunction research must be evaluated, both in the context of recent U.S. biosafety incidents and to
keep pace with new technological developments, in order to determine which types of studies
should go forward and under what conditions.
In light of recent concerns regarding biosafety and biosecurity, effective immediately, the U.S.
Government (USG) will pause new USG funding for gain-of-function research on influenza,
MERS or SARS viruses, as defined below. This research funding pause will be effective until a
robust and broad deliberative process is completed that results in the adoption of a new USG
gain-of-function research policy1. Restrictions on new funding will apply as follows:
New USG funding will not be released for gain-of-function research projects that may be
reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that
the virus would have enhanced pathogenicity and/or transmissibility in mammals via the
respiratory route. The research funding pause would not apply to characterization or
testing of naturally occurring influenza, MERS, and SARS viruses, unless the tests are
reasonably anticipated to increase transmissibility and/or pathogenicity.
In parallel, we will encourage the currently-funded USG and non-USG funded research
community to join in adopting a voluntary pause on research that meets the stated definition.
The deliberative process that will ensue during the period of the research pause will explicitly
evaluate the risks and potential benefits of gain-of-function research with potential pandemic
pathogens. The presumptive benefits that are generally identified in pursuing this type of
research are stated in terms of enhanced ability for earlier awareness of naturally emerging
dangerous pandemic pathogens or in the development of medical products in anticipation of such
emergence.
However the relative merits of gain-of-function experimental approaches must be compared
ultimately to potentially safer approaches. The deliberative process will offer recommendations
for risk mitigation, potential courses of action in light of this assessment, and propose
methodologies for the objective and rigorous assessment of risks and potential benefits that
might be applied to the approval and conduct of individual experiments or classes of
experiments. Although the gain-of-function studies that fall within the scope of research subject
to the funding pause will be a starting point for deliberations, the suitability of other types of
gain-of-function studies will be discussed. It is feasible that the discussion could lead to
suggestions of broadening the funding pause to include research with additional pathogens,
1
An exception from the research pause may be obtained if the head of the USG funding agency determines that the
research is urgently necessary to protect the public health or national security.
193
however, federal Departments and Agencies who fund, support, or perform research should be
consulted prior to any additional pathogens being added to the scope of the funding pause.
The deliberative process is envisioned to be time-limited, to involve two distinct, but
collaborating, entities, and to be structured to enable robust engagement with the life sciences
community. As a first step, the National Science Advisory Board for Biosecurity (NSABB) will
be asked to conduct the deliberative process described above and to draft a set of resulting
recommendations for gain-of-function research that will be reviewed by the broader life sciences
community. The NSABB will serve as the official federal advisory body for providing advice on
oversight of this area of dual use research, in keeping with federal rules and regulations.
As a second step, coincident with NSABB recommendations, the National Research Council
(NRC) of the National Academies then will be asked to convene a scientific conference focused
on the issues associated with gain-of-function research and will include the review and
discussion of the NSABB draft recommendations. This NRC conference will provide a
mechanism both to engage the life sciences community as well as solicit feedback on optimal
approaches to ensure effective federal oversight of gain-of-function research. The life sciences
community will be encouraged to provide input through both the NRC and NSABB deliberative
processes.
The NSABB, informed by NRC feedback, will deliver recommendations to the Secretary of
Health and Human Services, the Director of the National Institutes of Health, and the heads of all
federal entities that conduct, support, or have an interest in life sciences research (including the
Assistants to the President for Homeland Security and Counterterrorism and for Science and
Technology). The final NSABB recommendations and the outcomes of the NRC conference will
inform the development and adoption of a new U.S. Government policy governing the funding
and conduct of gain-of-function research. Upon adoption of a federal gain-of-function policy, the
U.S. Government will declare the end of the research funding pause.
The life sciences community will be informed of progress at regular intervals. The estimated
time-line is six months for completion of the two deliberative steps (culminating in delivery of
the NSABB recommendations to the HHS Secretary) and three months for the development,
approval, and publication of the policy, with the goal of completing the entire process in less
than one year from declaration of the research funding pause.
194
A
1 Code of Conduct for Biosecurity
195
Voorwoord
2
1
196
A Code of Conduct for Biosecurity
Report by the Biosecurity Working Group
Royal Netherlands Academy of Arts and Sciences
Amsterdam, August 2007
3
197
© 2007. Royal Netherlands Academy of Arts and Sciences
No part of this publication may be reproduced, stored in a retrieval system or
transmitted in any form or by any means, electronic, mechanical, photo-copying, recording or otherwise, without the prior written permission of the publisher.
P.O. Box 19121, 1000 GC Amsterdam, The Netherlands
T +31 20 551 07 00
F +31 20 620 49 41
E [email protected]
www.knaw.nl
isbn 987-90-6984-535-7
The paper in this publication meets the requirements of °° iso-norm 9706
(1994) for permanence.
4
Voor-
198
Contents
1.Introduction and background 7
2.Biosecurity Code of Conduct 9
2.1 Introduction 9
2.2 Implementation and compliance with the code of conduct 9
2.3 Supervision and oversight 9
3.Explanatory notes to the text of the code of conduct 13
4.Background to a Biosecurity Code of Conduct 17
4.1 Background and prior history 17
4.2 Biological weapons 18
4.3 Dual use 19
4.4 Threat analysis 20
4.5 Life sciences and biological weapons 21
4.6 Existing legislation 22
4.7 What is a code of conduct? 23
4.8 Why a code of conduct on biosecurity? 25
Appendices 27
1. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (1972) (Entry into force: 26 March 1975) 29
2.iap Statement on Biosecurity 34
3.Laws and rules on genetic modification 37
4.Biosecurity Working Group 40
Biosecurity Focus Group 40
5
Contents
199
6
200
1.
Introduction and background
The Dutch Ministry of Education, Culture and Science asked the Royal Netherlands
Academy of Arts and Sciences (knaw) to provide it with advice and input for a national Biosecurity Code of Conduct for scientists, as required by the Biological and
Toxin Weapons Convention (btwc), which was ratified in 1972. The request arose
in part from the knaw’s active contribution to the Statement on Biosecurity issued
by the InterAcademy Panel (iap) in 2005. The knaw is the iap’s ‘lead academy’ for
activities relating to biosecurity.
The knaw agreed to the ministry’s request and carried out a study into the
possibilities and conditions for a code of conduct on Biosecurity. That project
was supervised by a working group made up of Professor L. van Vloten-Doting
(chairman), Professor S.S. Blume, Professor P. Crous and Professor A. van der
Eb. The project was carried out by J.J.G. van der Bruggen, who was seconded
for this purpose from the Rathenau Institute.
If a code of conduct is to have the intended effect, it must reflect the experience and practice of the relevant actors. It was therefore decided to establish a
focus group whose members would make comments and suggestions based on
their practical experience as researchers and policymakers. The members of the
focus group will also be able to help in the promotion and dissemination of the
final product in research institutions and laboratories. A list of the members of
the focus group is included in an appendix.
The first step of the project was to conduct a survey of measures already taken
by central governments, fellow academies and research institutions in other
countries, including the usa and the uk. The information was gathered by studying relevant literature, holding discussions with personal contacts and attending
conferences in Edinburgh, Berlin and Washington dc.
A further survey was made of current legislation and existing codes of conduct
for biotechnology and microbiology with relevance for biosecurity.
The findings of these surveys were used to identify how the adoption of a code
of conduct can help to ensure that biosecurity issues are effectively addressed
in scientific research. This led to the formulation of the contours of a code of
conduct on biosecurity. The first draft of this code of conduct was submitted to
the working group and the biosecurity focus group at the end of January 2007.
A workshop was then organised in March. Most of the participants were
researchers and other professionals working in laboratories. The discussion was
lively and yielded a number of useful suggestions for practical improvements in
the code of conduct.
Following these discussions, a new draft was presented to the focus group and
the working group at the end of April. The version presented here is that draft,
with a few final corrections and additions. This document was adopted by the
Board of Management of the knaw on 29 May 2007. The Biosecurity Code of
Conduct is accompanied by an explanatory memorandum and a background
review which were also submitted to the working group and the focus group for
comment.
7
201
The presentation of the code of conduct completes this phase of the biosecurity project. The knaw is currently holding talks with the Ministry of Education,
Culture and Science on a follow-up project. During this second phase the knaw
will organise debates, workshops and other activities to publicise the code of
conduct and promote awareness of the topic of biosecurity. This process is essential for promoting adherence to the code of conduct by scientists.
8
202
2.
Biosecurity Code of Conduct
2.1
Introduction
Research in the life sciences generates knowledge and understanding that make a
significant contribution to global health and welfare. However, the same knowledge
and understanding can also be misused to develop biological and toxin weapons. A
large number of countries took an important step towards ending the development,
production, stockpiling and acquisition of biological and toxin weapons by signing
and ratifying the 1972 Biological and Toxin Weapons Convention (btwc). However,
this has not eliminated the risk of misuse of biosciences research. Some states have
still not signed the convention, while there is also the risk that terrorists will use
biological agents and toxins (bioterrorism).
Scientists and other professionals engaged in biological, biomedical, biotechnological and other life sciences research are bound by the codes of ethics of
their professions and their responsibilities as scientists. Their actions are also
governed by legislation and by numerous codes of practice. Many of these rules
and regulations greatly reduce the risk that research in the life sciences can be
misused to develop biological or toxin weapons.
Nevertheless, it is important to continue highlighting the potential for misuse
(dual use) of life science research. This was recently reaffirmed in the final declaration issued at the end of the sixth btwc review conference (November-December 2006), which also referred to the importance of raising awareness of the
issue, for example by adopting codes of conduct. At the request of the Ministry
of Education, Culture and Science, the Royal Netherlands Academy of Arts and
Sciences (knaw) has assumed the task of formulating a Biosecurity Code of
Conduct for the Netherlands.
2.2
Implementation and compliance with the code of conduct
The rules laid down in the Biosecurity Code of Conduct call for implementation
and compliance at different levels. These levels correspond with the various target
groups identified in the code. Calls for awareness, accountability and oversight
are targeted mainly at individuals: researchers, laboratory workers, managers and
others. Other provisions apply to research institutions or financing or monitoring
agencies.
Because the provisions of the code of conduct apply at different levels and
to different types of organisation, it is the responsibility of the organisations
themselves to tailor the practical implementation of the code of conduct to the
needs of their institution. In practice, many of the rules in the code of conduct
will already be implemented by virtue of existing rules and guidelines based on
biosafety policy or occupational health and safety legislation. However, additional rules and provisions will sometimes be necessary.
2.3
Supervision and oversight
The organisations and institutions will be able to monitor compliance with these
additional rules and instructions themselves. The organisations and institutions will
9
203
have to appoint compliance officers with responsibility for this supervision. There is
therefore no need for a central supervisory body. However, in the interests of oversight and coordination it would be useful to create a National Biosecurity Centre.1
The centre’s activities would include:
– monitoring relevant developments in the field of biosecurity;
– coordinating the publication of information and educational materials,
including maintaining a website with up-to-date information;
– organising conferences;
– maintaining contacts with relevant actors in the government and civil society;
– consulting experts who can provide advice on whether the results of potential
dual use life science research should be published;
– performing regular evaluations of awareness of and compliance with the
Biosecurity Code of Conduct.
1 The government could, for example, delegate this task to the knaw.
10
204
Code of conduct on biosecurity
BASIC PRINCIPLES
The aim of this code of conduct is to prevent life sciences research or its application
from directly or indirectly contributing to the development, production or stockpiling of biological weapons, as described in the Biological and Toxin Weapons
Convention (btwc), or to any other misuse of biological agents and toxins.
TARGET GROUP
The Biosecurity Code of Conduct is intended for:
1.professionals engaged in the performance of biological, biomedical, biotechnological and other life sciences research;
2.organisations, institutions and companies that conduct life sciences research;
3.organisations, institutions and companies that provide education and training
in life sciences;
4.organisations and institutions that issue permits for life sciences research or
which subsidise, facilitate and monitor or evaluate that research;
5.scientific organisations, professional associations and organisations of employers and employees in the field of life sciences;
6.organisations, institutions and companies where relevant biological materials
or toxins are managed, stored, stockpiled or shipped;
7.authors, editors and publishers of life sciences publications and administrators
of websites dedicated to life sciences.
Rules of conduct
RAISING AWARENESS

Devote specific attention in the education and further training of professionals
in the life sciences to the risks of misuse of biological, biomedical, biotechnological and other life sciences research and the constraints imposed by the
btwc and other regulations in that context.

Devote regular attention to the theme of biosecurity in professional journals
and on websites.
RESEARCH AND PUBLICATION POLICY

Screen for possible dual-use aspects during the application and assessment
procedure and during the execution of research projects.

Weigh the anticipated results against the risks of the research if possible dualuse aspects are identified.

Reduce the risk that the publication of the results of potential dual-use life
sciences research in scientific publications will unintentionally contribute to
misuse of that knowledge.
11
205
ACCOUNTABILITY AND OVERSIGHT

Report any finding or suspicion of misuse of dual-use technology directly to
the competent persons or commissions.

Take whistleblowers seriously and ensure that they do not suffer any adverse
effects from their actions.
INTERNAL AND EXTERNAL COMMUNICATION

Provide (additional) security for internal and external e-mails, post, telephone
calls and data storage concerning information about potential dual-use research or potential dual-use materials.
ACCESSIBILITY

Carry out (additional) screening with attention to biosecurity aspects of staff
and visitors to institutions and companies where potential dual-use life sciences
research is performed or potential dual-use biological materials are stored.
SHIPMENT AND TRANSPORT

Carry out (additional) screening with attention to biosecurity aspects of transporters and recipients of potential dual-use biological materials, in consultation with the competent authorities and other parties.
12
206
3.
Explanatory notes to the text of the code of conduct
Grateful use was made of the comments of numerous stakeholders and experts in developing the Biosecurity Code of Conduct. Existing codes were also studied. These
codes provided useful illustrations of the ‘unique’ style and sometimes specific
vocabulary used in codes. It became clear that the code of conduct should not lay
down specific procedures. These can be found in the existing rules and regulations
or, where there are none, a company or organisation can develop its own specific
guidelines for putting the code of conduct into practice.
The rules in the code of conduct are briefly explained below.
Raising awareness
Devote specific attention in the education and further training of professionals in the life sciences to the risks of misuse of biological, biomedical,
biotechnological and other life sciences research and the constraints
imposed by the BTWC and other regulations in that context.
Devote regular attention to the theme of biosecurity in professional journals and on websites.
Creating and promoting awareness are the most important reasons for adopting a
code of conduct. This subject therefore comes first. The first section is addressed
mainly to trainers and managers in the scientific community and the business community who must incorporate biosecurity as a regular and permanent component
of training, not only in the initial phase of a scientist’s education but also in further
training and on other occasions.
Professional journals and websites of professional associations should also devote attention to the subject of biosecurity, for example by writing about current
developments, publishing interviews with experts and – especially on websites
– devoting a special page to relevant information on the subject.
A great many people working in the life sciences regularly consult these
sources for up-to-date information about developments in their profession or
perhaps to look for jobs or courses they can follow. Their attention can then be
drawn to the possible risks of potential dual-use applications.
Research and publication policy
Screen for possible dual-use aspects during the application and assessment procedure and during the execution of research projects.
Weigh the anticipated results against the risks of the research if possible
dual-use aspects are identified.
Reduce the risk that the publication of the results of potential dual-use life
sciences research in scientific publications will unintentionally contribute
to misuse of that knowledge.
The first thing that has to be said is that these rules of conduct are not intended to
impede (new) research or scientific publications. The point of departure is to allow
13
Explanatory notes to the text of
the code of conduct
207
scientific research and the inseparably linked publication of research results to proceed unimpaired.
However, it is legitimate to demand that every individual or institution with
direct or indirect responsibility for initiating, financing or conducting research in
the life sciences should consider the potential dual-use character of the research
as one of the criteria in deciding whether to conduct that research. Biosecurity
should be explicitly included in the check list of issues to be considered in application and assessment forms for life sciences research. In the vast majority
of cases, this aspect will not affect the final decision, either because the risk
is extremely small or because the benefits of the research outweigh the risks,
although in the latter case adequate security measures must be taken throughout
the course of the research. Only in those cases where the risks of a study are
demonstrably greater than the expected benefits does the code of conduct advise
against performing the relevant research.
The rules governing the publication of research results follow from the rules
for the performance of research. Here too, publication is the rule and non-publication the rare exception. This is apparent from the experience in the United
States, for example, where the screening of thousands of articles for dual-use aspects has raised questions in only five or six cases and up to now has never led to
a decision not to publish the article. Even if the results of research clearly have
a dual-use character, it does not mean that the results should not be published.
They can be published in such a way that they do not produce ready-made instructions for individuals who may wish to misuse them.
Publishers, editors and reviewers may be asked to consider the possible dualuse nature of the information when assessing articles. In those exceptional cases
where doubts arise about whether or not to publish an article, the final decision
could be taken by a specially appointed committee of experts.
Finally, once an article has been published, information contained in it that
was not initially regarded as risky may in time prove to have a dual-use character, for example because of new scientific developments. This is an almost
inevitable fact of life.
Accountability and oversight
Report any finding or suspicion of misuse of dual-use technology directly
to the competent persons or commissions.
Take whistleblowers seriously and ensure that they do not suffer any
adverse effects from their actions.
Calling for accountability and oversight is not intended to create a culture of mistrust
in a company or scientific institution. It is always important to assume that colleagues and visitors are acting in good faith. But history – particularly in the Netherlands – has shown that abuses can occur. A well-known example is the action of the
Pakistani nuclear physicist Khan who took the ‘recipe’ for the atomic bomb from the
Dutch company Urenco, where he worked for many years. Behaviour or actions that
are out of the ordinary should therefore be reported to a specially designated officer
14
208
in a company or laboratory. Any such reports should of course be dealt with in confidence and prudently, especially if the warning concerns an individual.
On the other hand, it is important to ensure that whistleblowers do not suffer
reprisals for their intervention. For example, their privacy must be guaranteed
even if their tips prove unfounded, although in that case the ombudsman can
investigate whether the whistleblower had ulterior motives for providing the tip.
Internal and external communication
Provide (additional) security for internal and external e-mails, post, telephone calls and data storage concerning information about potential dualuse research or potential dual-use materials.
Nowadays a lot of internal and external communication is conducted electronically.
This brings with it the risk that e-mails can be intercepted, websites can be hacked,
USB sticks can be lost, etc. Institutions must therefore ensure that anyone who transmits information or saves data about potential dual-use research or potential dualuse materials employs additional security for their communication, for example by
using separate e-mail circuits, encoding or encrypting the information, protecting
usb sticks with security mechanisms, etc.
It goes without saying that appropriate security measures must also be taken
when information is sent using the traditional means of communication such as
post, telephone or fax or when employees take documents home from work.
Primary responsibility for implementing the additional security in these areas
rests with the ICT managers, although they will require the assistance of the
individuals responsible for the information itself in identifying potential risks.
Accessibility
Carry out (additional) screening with attention to biosecurity aspects of
staff and visitors to institutions and companies where potential dual-use
life sciences research is performed or potential dual-use biological materials are stored.
Shipment and transport
Carry out (additional) screening with attention to biosecurity aspects of
transporters and recipients of potential dual-use biological materials, in
consultation with the competent authorities and other parties.
Various laws and regulations concerning biosafety already contain numerous rules
and guidelines governing access to laboratories and research institutions. These rules
will generally be adequate to guarantee safety in the context of biosecurity. However, it is important for laboratories and research institutions to investigate whether
additional security measures may be needed, both with respect to materials and in
terms of screening procedures for employees and visitors.
Quasi-public institutions such as universities, institutions of higher professional education and hospitals in particular should investigate whether potential
15
Explanatory notes to the text of
the code of conduct
209
dual-use materials are adequately safeguarded in areas to which the public does
not have access.
Many regulations are already in place governing the transport of biological
materials from the perspective of biosafety. In the context of biosecurity, attention should focus on the transporters and recipients of dual-use agents. In consultation with the competent authorities, organisations can investigate whether
additional screening requirements can or should be imposed on the transporters
and their staff in relation to biosecurity. The forwarding party must satisfy itself
that the recipients of dual-use agents will only use the materials they receive for
scientific purposes. If any doubt exists, further enquiries may lead to the decision not to send the relevant materials.
The responsible security officials should receive any additional training and
information they need to recognise risks related to biosecurity.
16
210
4.
Background to a Biosecurity Code of Conduct
The anthrax letters, September 2001
Shortly after 11 September 2001 the United States received another scare,
this time caused by the so-called anthrax letters. These letters arrived in two
waves. The first set was sent from Trenton, New Jersey to newspapers and
media in New York and Boca Raton (Florida) on 18 September 2001. Only
two of these letters were found but the outbreak of anthrax infections led to
the conclusion that there were others. On 9 October two more letters were
sent, again from Trenton, addressed to two Democratic senators at the Capitol in Washington DC. The material in these two letters was stronger than
the substance in the first set. The letters contained approximately one gram
of almost pure anthrax spores. According to researchers, the anthrax was
‘weaponised’, although this was later denied. More than 22 people were
infected, 11 of them with a life-threatening variant. Five people ultimately
died. The anthrax letters created a worldwide panic and prompted additional security measures in the handling of post. On several occasions these
measures led to the suspicion of new attacks, usually because some inevitable ‘jokers’ sent envelopes containing a different type of white powder.
4.1
Background and prior history
The decision to draft a code of conduct on biosecurity was taken in response to the
widespread recognition of the increased threat of the production and use of biological weapons. The above examples are an illustration of this. The risk of bioterrorism
is regarded as more serious than the threat that biological and toxin weapons2 will
be used by governments. The efforts to develop a code of conduct are also related to
the Biological and Toxin Weapons Convention (btwc), which the Netherlands has
ratified (see Appendix 1). During the fifth review conference in 2002 and at interim
expert meetings of the States Parties to the btwc, there were calls for the adoption of
codes of conduct. This call was repeated at the sixth review conference of the btwc
in the autumn of 2006. ‘The Conference encourages States Parties to take necessary measures to promote awareness amongst relevant professionals of the need to
report activities conducted within their territory or under their jurisdiction or under
their control that could constitute a violation of the Convention or related national
criminal law. In this context, the Conference recognises the importance of codes of
conduct and self-regulatory mechanisms in raising awareness, and calls upon States
Parties to support and encourage their development, promulgation and adoption’
(point 15 (of Article IV) in the Final Document Sixth Review Conference of the
States Parties to the Convention on the Prohibition of the Development, Production
2 The term toxin is usually used to describe a potent, complex organic compound of biological origin.
There are mineral, vegetable, bacterial and animal toxins.
17
Background to a Biosecurity Code
211of Conduct
and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their
Destruction).
The warnings from the btwc were picked up by the academic world, including the InterAcademy Panel (iap), a body that includes representatives of academies of sciences from around the world. Consequently, 68 academies of science
signed the iap’s ‘Statement on Biosecurity’. This statement was issued in 2005
and sets out the principles that should be taken into account when formulating a
code of conduct on biosecurity (see Appendix 2).
At the request of the Ministry of Education, Culture and Science, the Royal
Netherlands Academy of Arts and Sciences (knaw) has drawn up a Biosecurity
Code of Conduct for the Netherlands.
4.2
Biological weapons
What do we mean by biological and toxicological weapons? There are many different definitions and descriptions. An explanatory memorandum to the btwc describes these weapons as follows3:
‘Biological weapons are devices which disseminate disease-causing organisms or poisons to kill or harm humans, animals or plants. They generally
comprise two parts – an agent and a delivery device. In addition to their military
use as strategic weapons or on a battlefield, they can be used for assassinations
(having a political effect), can cause social disruption (for example, through enforced quarantine), kill or remove from the food-chain livestock or agricultural
produce (thereby causing economic losses), or create environmental problems.
Almost any disease-causing organism (such as bacteria, viruses, fungi, prions
or rickettsiae) or toxin (poisons derived from animals, plants or microorganisms,
or similar substances synthetically produced) can be used in biological weapons. Historical efforts to produce biological weapons have included: aflatoxin;
anthrax; botulinum toxin; foot-and-mouth disease; glanders; plague; Q fever;
rice blast; ricin; Rocky Mountain spotted fever; smallpox; and tularaemia. The
agents can be enhanced from their natural state to make them more suitable for
use as weapons.
Delivery devices can also take any number of different forms. Some more
closely resemble weapons than others. Past programmes have constructed missiles, bombs, hand grenades and rockets. A number of programmes also constructed spray-tanks to be fitted to aircraft, cars, trucks, and boats. Efforts have
also been documented to develop delivery devices for use in assassination or
sabotage missions, including a variety of sprays, brushes, and injection systems
as well as contaminated food and clothes.
As well as concerns that these weapons could be developed or used by states,
modern technology is making it increasingly likely they could be acquired by
private organisations, groups of people or even individuals. The use of these
weapons by such non-state actors is known as bioterrorism. Biological weapons
have been used in politically-motivated or criminal acts on a number of occasions during the 20th century.’
3 http://www.unog.ch/80256EE600585943/(httpPages)/
29B727532FecBE96C12571860035A6DB?OpenDocument
18
212
4.3
Dual use
As the extract quoted above explicitly states, there are many different disease-causing organisms that can be used in biological weapons. On the other hand, many
of these organisms are extremely important for research and development in the
domains of medicine, biology and agriculture. These organisms can therefore be
used for two purposes. The term used by the international community for these types
of organism is ‘dual use’.
‘Dual use’ is one of the key terms employed in discussions of the risks of
misuse of biological agents. One general description of the term is given by
the American National Science Advisory Board for Biosecurity (nsabb). Its
description is as follows: ‘Research that, based on current understanding, can
be reasonably anticipated to provide knowledge, products or technologies that
could be directly misapplied by others to pose a threat to public health, agriculture, plants, animals, the environment or material.’
Elsewhere, the nsabb argues that special attention is required for knowledge,
products or technologies that:
– enhance the harmful consequences of a biological agent or toxin;
– disrupt immunity or the effectiveness of an immunisation without clinical
and/or agricultural justification;
– confer to a biological agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or
toxin, or facilitate their ability to evade detection methodologies;
– increase the stability, transmissibility or the ability to disseminate a biological
agent or a toxin;
– alter the ‘host range’ or ‘tropism’ of a biological agent or toxin;
– enhance the susceptibility of a host population; and/or
– generate a novel pathogenic agent or toxin, or reconstitute an eradicated or
extinct biological agent.
This list of features does not necessarily lead to definitive conclusions for research
policy in practice, as is apparent from a number of other considerations mentioned
by members of the nsabb. For example, nsabb member Anne Vidaver remarked that
‘dual use concerns pertain to misapplication of technologies yielded by the research,
not the conduct of the research itself’. Consequently, identifying research as ‘dual
use’ does not necessarily mean that the research should not be conducted or that the
results should not be published. Interestingly, the nsabb adds the words ‘of concern’
to the term dual-use research. This implies that not all dual-use research is a cause
for concern. Concerns arise if the results of the research can be directly misapplied
(immediacy) and when such misuse would have major consequences (scope), which
does not have to mean a large number of victims but can also refer to large-scale
social disruption.
However, even these two criteria do not immediately produce clarity. The aim
of terrorists in particular does indeed seem to be to strike immediately and on
a large scale. But is that always the case? The anthrax attacks in the us (2001)
ultimately caused ‘only’ five fatalities, but the panic they caused was enormous!
19
213of Conduct
So there are thousands of biological agents that can potentially be misused.
But documents, treaties and reports – such as the text quoted above – often refer
to specific agents that are particularly susceptible to misuse. A detailed list can
be found in the article CBRNE – Biological Warfare Agents.4 Many states, including the us, have their own lists.5 The Health Council in the Netherlands has
a far shorter list6: variola major virus (smallpox); Bacillus anthracis (anthrax);
Yersinia pestis (the plague); clostridium botulinum toxin (botulism); Francisella
tularensis (tularaemia); and the influenza virus. Moreover, there is growing need
to take account of genetic modification of existing pathogens.
The Ministry of Economic Affairs has also published a Manual on Strategic
Goods, which contains a list of dual use micro-organisms and toxins. Other
initiatives have been taken at international level. One of the best known is the
Australia Group, an informal arrangement in which 39 states (including the
Netherlands) and the European Commission currently cooperate in efforts to
minimise the risk that exports or transhipments from the countries concerned
will (unintentionally) contribute to chemical or biological weapon proliferation.
The participating states do this by exchanging information about suspicious
shipments and by compiling lists of potentially suspect materials and agents.7
4.4
Threat analysis
How great is the threat that biological weapons will actually be used? Historically
speaking, until the beginning of the 20th century the use of biological weapons took
three forms: 1) the poisoning of food or water with infectious agents; 2) the use of
micro-organisms or toxic substances in weapon systems; 3) the spread of infected
substances and materials.
For example, Emperor Frederik I (Barbarossa) threw corpses into sources
of drinking water and American Indians were given sheets or clothing used by
smallpox patients.
The methods adopted during World War I were more refined. Relatively little
use was actually made of biological weapons, although there is evidence that the
Germans spread bubonic plague in St. Petersburg. In 1925, 108 countries signed
the Geneva Protocol prohibiting the use of biological weapons. However, some
countries, including the us and the Soviet Union, continued with production and
research. Japan carried out experiments on Chinese prisoners during the World
War II. Great Britain, Canada and the United States conducted experiments
with anthrax on the Scottish island of Gruinard. The island was only ‘cleared’
in the 1990s. The experiments continued after the war, sometimes with fatal
consequences. It is generally assumed that a mistake during an experiment with
anthrax in Sverdlovsk in Russia caused more than 70 deaths in April 1979.
This accident occurred after the signing of the Biological and Toxin Weapons
4 http://www.emedicine.com/emerg/topic853.htm
5 http://www.cdc.gov/od/sap/docs/salist.pdf;
6 Health Council. Verdediging tegen bioterrorisme. [Defence against Bioterrorism] The Hague: Health
Council, 2001; publication no. 2001/16
7 See: http://www.australiagroup.net/en/control_list/bio_agents.htm
20
214
Convention (btwc) in 1972. This convention prohibits the development and production of biological weapons. Consequently, almost every country has disabled
or destroyed its stockpile of weapons, although 17 countries are still suspected
of possessing or producing biological weapons.
But the greatest threat is now thought to come from the use of biological
weapons by terrorists. These fears increased after 9/11 and after letters containing anthrax were posted in the us a short time later.
The General Intelligence and Security Service (aivd) and the National Coordinator for Anti-Terrorism (nctb) are constantly carrying out analyses of the actual threat of a terrorist attack, including the risk that biological weapons might
be used. It is reasonably safe to assume that even now there is no really serious
threat of such weapons being used. One reason for this is that few people possess the biological and medical knowledge required to produce disease-causing
agents. Fantastical reports that any schoolchild can simply download instructions for producing biological weapons from the internet are greatly exaggerated. And in this day and age, clothes and blankets infected with chickenpox are
not widely available. Nevertheless, however small the threat, the risk is so great
that it must not be underestimated or trivialised. This warning applies above all
to the scientific community.
4.5
Life sciences and biological weapons
Given the revolutionary developments in the field, public interest in the life sciences
is greater than ever before. Many people expect the breakthroughs that have been
achieved in recent years to make a major contribution to solving health, food and
environmental problems. And progress is being made all the time. Research in the
fields of genomics and proteomics is still in its infancy. There has also been a lot of
attention recently for the emergence of synthetic biology. Synthetic biology can be
defined as the design and replication of biological components, devices and systems
(dna) and the redesign of existing, natural biological systems (for example a virus or
bacteria) for specific purposes, such as the development of medicines.
There is also a potential downside to many of these developments. They can
be misused to produce biological weapons or to carry out bioterrorist attacks.
Since cutting-edge knowledge is needed to produce biological weapons, it
is particularly important that scientists who possess this expertise are aware of
the potential risks associated with the application or misuse of their knowledge.
Recent research, by Brian Rappert8 among others, has shown that relatively few
scientists are aware of those risks. It is therefore vital to raise awareness among
scientists. This is also one of the conclusions from Biotechnology Research in
an Age of Terrorism, a report written by a committee of the American National
Research Council chaired by the biologist Gerald Fink (mit).9 This authoritative
8 Rappert, B. (2003). Expertise, Responsibility and the Regulation of Research in the uk. Presented at
Foreign and Commonwealth Office seminar entitled ‘Managing the Threats from Biological Weapons:
Science, Society, and Secrecy’, 28 July.
9 Committee on Research, Standards and Practices to prevent the Destructive Application of Biotechnology (2004), Biotechnology Research in an Age of Terrorism. National Research Council, Washington
dc.
21
215of Conduct
report prompted the us government to establish the National Science Advisory
Board for Biosecurity (nsabb).
Researchers, laboratory workers and other employees of large research laboratories have traditionally displayed a great deal of vigilance and alertness, since
even without the danger of (efforts to) misuse the findings, there are numerous risks attached to biological and genetic research, such as infection and the
spread of potentially harmful agents in the natural environment, etc. Many laws
and regulations have been promulgated at national and international level to address these risks. Most of these rules have been translated into practical guidelines in research institutions, companies and laboratories. The following section
discusses these laws and regulations.
It is also important to note that various agencies are increasingly alert to the
possibility of disease-causing agents being dispersed intentionally. In the Netherlands, for example, the National Coordinator for Infectious Disease Control
(lci) has revised numerous protocols to ensure that additional attention is devoted to the aspect of biosecurity10 in compliance with one of the recommendations
made by a committee of the Health Council in 2001 (before 11 September!).11
4.6
Existing legislation
Numerous laws and regulations have been drawn up in the last few decades at both
national and international level to guarantee the safety and health of employees,
visitors to and people living close to biological research laboratories and research
institutions. The attention to health and safety has intensified further in recent years
following the emergence of new epidemics such as sars and avian influenza (bird
flu). Many of the instructions and rules designed to promote biosafety are also relevant to efforts to combat the misuse of bioscientific research for terrorism.
The legislation can be broken down into general legislation, which also
applies to other industries, and legislation specifically targeted at scientific
institutions. General legislation includes occupational health and safety laws
and environmental legislation, legislation governing the transport of hazardous
substances (adr) and the Building Decree. These laws and regulations generally
include separate chapters on specific substances or activities, for example the
transport of hazardous substances.
There are also regulations that relate specifically to research and which can
cover various different aspects. For example, the website of the Platform of
Biological Safety Officers (bvf) contains a section with rules on how to handle
biological agents.12 To give another example, Appendix 3 contains a list of laws
and regulations pertaining to genetic modification. The table below lists some
examples of laws and regulations together with the body that promulgated them
and their scope.
10 See website lci: http://www.infectieziekten.info/index.php3
11 ‘Existing lci protocols (lci: National Coordinator for Infectious Disease Prevention) for some priority agents should be expanded with an appendix on possible bioterrorist applications’, in: Health Council,
op.cit. 2001.
12 http://www.bvfplatform.nl/wetregelgeving/voorschriften.html
22
216
Table 1: Examples of laws and regulations
Global and
International
European
National
Regional/local
Company, organisation,
sector
General
Stockholm Convention
on Persistent Organic
Pollutants
Kyoto protocol
Biosciences
Convention on biological
diversity/Cartagena protocol
adr Convention (transport)
Working Conditions
Act
Building Regulations
Environmental legislation
Dangerous Substances
Act
Environmental permit
Organisation’s Safety,
Health and Environment rules.
Protection of workers exposed
to biological agents at work
Decree on Genetically Modified Organisms
Biosecurity
Biological and Toxin
Weapons Convention
(btwc)
Guidelines For Transfers of
Sensitive Chemical or
Biological Items (Australia
Group)
List of Strategic Goods
Measures for working safely
with cells and tissue cultures
(bvf Platform)
Practical guidelines for the
shipment and transport of
biological materials intended
for human or animal diagnosis
(Netherlands Association for
Microbiology)
What stands out is that there are few if any agreements and rules specifically
addressing the issue of biosecurity, particularly at institutional level. There is a
growing realisation among biosafety officials that biosecurity could become an
increasingly important aspect of their duties. Nevertheless, measures have been
and still are being taken in that area. For example, many establishments have
tightened up the rules on access, which were already in place under the biosafety
procedures, in the context of biosecurity. Additional measures have also been
taken in the areas of transport and exports.
4.7
What is a code of conduct?
Many organisations have adopted codes of conduct for various aspects of their activities in recent years. A code is a set of principles and instructions that are binding
on members of a particular group in a profession or industry. Codes should not be
confused with guidelines (which are less binding) and contracts or treaties (which
are more binding).13
13 Pearson, Graham S., and Dando, Malcolm R. Towards a life sciences code: countering the threats
from biological weapons. Bradford Briefing Papers, University of Bradford Department of Peace Studies,
uk. 2004.
23
217of Conduct
A further distinction can be made according to the agency that drafts the
code. Some codes are formulated by government bodies. For example, the
Municipalities Act provides that the local councils must adopt a code of
conduct for their members, the aldermen and the mayor. Institutions and
companies also draw up codes laying down how their employees should
act. Philips, for instance, has a General Code of Conduct setting out the
company’s ethical standards for conducting business. The code of conduct
lays down the basic principles to be followed in all of Philips’s business
activities.14 Then of course there are codes drawn up by and for specific
professional groups. More and more professions have adopted professional codes in recent decades. The medical world has traditionally observed
the ‘Hippocratic Oath’, but other professions have also adopted general
professional codes. One example is the code of the Netherlands Institute
for Biology.15 Finally, there are also codes that are drawn up ‘externally’
for specific groups of individuals or organisations. One example is the
Code of Ethics for Persons and Institutions Engaged in the Life Sciences
drafted by the influential Pugwash movement.16
Finally, codes can also be categorised according to their content and
their target group. The three categories are codes of ethics, codes of conduct and codes of practice.17 A code of ethics describes in more general
terms the personal and professional standards and ideals that practitioners
should uphold; a code of conduct lays down guidelines for appropriate
behaviour; and a code of practice describes how individuals should act in
specific situations. The latter category is the most specific.
The table below, courtesy of Brian Rappert, fleshes out this typology.
Table 2: Types of code
Type
Aspirational codes
Educational/
Advisory codes
Enforceable codes
Name
Code of ethics
Code of conduct
Code of practice
Main Aims
Alert; set realistic or idealistic standards
Provide guidelines, raise awareness & debate; foster
moral agents
Prescribe or proscribe certain acts
The table below presents a number of existing codes of the various types and
categories that could serve as possible examples for a code of conduct for
biosciences and biosecurity.
14 http://www.philips.nl/About/company/local/corporategovernance/Index.html
15 http://www.nibi.nl/
16 http://www.pugwash.org/reports/cbw/cbwlist.htm
17 Brian Rappert, Towards a life sciences code: countering the threats from biological weapons.
Strengthening the Biological Weapons Convention, Briefing paper 13, Second Series. Department
of Peace Studies, University of Bradford. Available online: www.brad.ac.uk/acad/sbtwc/BP_13_
2ndseries.pdf
24
218
Table 3: Examples of codes
Government code
Institutional code
Professional code
External code
4.8
Code of Ethics
Rigour, Respect and Responsibility: a universal ethical
code for scientists (uk
government)
EuropaBio’s core ethical
values (EuropaBio)
Dutch medical oath (knmg)
Code of Conduct
Code of scientific ethics for
the United States Department of Agriculture
Code of Practice
Code of conduct for
prudent forest management
Philips’s general code of
conduct
Code of conduct of the pharmaceutical industry
Code of conduct for
pharmaceutical advertising
Rules of conduct for doctors
(knmg)
Guideline on online
doctor-patient contact
(knmg)
ines Appeal to engineers and
scientists
Why a code of conduct on biosecurity?
A code of conduct can make good people better, but probably has negligible impact
on intentionally malicious behaviour (nsabb).
If this is true – and there is little reason to doubt that it is – the question is why
there should be a code of conduct on biosecurity. What is its added value alongside existing codes and existing legislation at different levels? And will a code of
conduct provide this added value or would new or amended legislation be more
appropriate?
In a formal sense, the why is fairly easy to answer. By formulating a code of
conduct the academic world in the Netherlands is meeting the wishes of national
and international authorities: the States Parties to the btwc and the Dutch government. It is also in line with the statement of the iap, to which the knaw made
a major contribution.
But this formal argument is inadequate. According to a survey of the academies of science that endorsed the iap statement, only three countries, Albania,
France and the Netherlands, have started drafting a national code of conduct on
biosecurity. That is not to say that no steps have been taken in the other countries, but merely that they have not yet decided to develop a code of conduct.
What is happening in many places is that debates about biosecurity are being
conducted in the academic world. For example, Dando and Rappert have been
organising workshops in various countries.18 These have helped to raise awareness of the possible risks of the misuse of biological knowledge.
18 Brian Rappert, Marie Chevrier and Malcolm Dando, In-depth Implementation of the BTWC: Education and Outreach. University of Bradford 2006.
25
219of Conduct
The knaw is of the opinion that drawing up a code of conduct on biosecurity is not a goal in itself. There is no point in having a document that simply
disappears into a desk drawer or a filing cabinet. Raising awareness is the most
important objective of a code of conduct on biosecurity, which is why the code
of conduct presented here was developed in dialogue with practitioners and with
stakeholders from the world of science, the business community and government. After all, the content of the code of conduct must reflect relevant scientific, social and political developments and, equally importantly, the day-to-day
practice of individuals and organisations working in the field.
The process of drafting the code of conduct has already helped to raise awareness. It has prompted regular debates and encouraged various organisations and
professional associations to discuss the subject. The added value of the code
of conduct will have to be seen in practice. Here too, actions speak louder than
words. There must be a change of attitude and behaviour. There will have to be
regular evaluation of questions such as: How is the code being implemented?
How effectively is it being disseminated and communicated? Is the code being
complied with?
The code of conduct on biosecurity will be publicised by organising debates
and meetings in relevant laboratories and research institutes of universities and
companies and through publications in trade journals.
26
220
Appendices
221
222
1. Convention on the Prohibition of the Development, Production and
Stockpiling of Bacteriological (Biological) and Toxin Weapons and
on Their Destruction (1972)
(Entry into force: 26 March 1975)
The States Parties to this Convention,
Determined to act with a view to achieving effective progress toward general and
complete disarmament, including the prohibition and elimination of all types of
weapons of mass destruction, and convinced that the prohibition of the development,
production and stockpiling of chemical and bacteriological (biological) weapons
and their elimination, through effective measures, will facilitate the achievement of
general and complete disarmament under strict and effective control,
Recognizing the important significance of the Protocol for the Prohibition of
the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare, signed at Geneva on June 17, 1925, and conscious also
of the contribution which the said Protocol has already made and continues to
make, to mitigating the horrors of war,
Reaffirming their adherence to the principles and objectives of that Protocol
and calling upon all States to comply strictly with them,
Recalling that the General Assembly of the United Nations has repeatedly
condemned all actions contrary to the principles and objectives of the Geneva
Protocol of June 17, 1925,
Desiring to contribute to the strengthening of confidence between peoples and
the general improvement of the international atmosphere,
Desiring also to contribute to the realization of the purposes and principles of
the Charter of the United Nations,
Convinced of the importance and urgency of eliminating from the arsenals of
States, through effective measures, such dangerous weapons of mass destruction
as those using chemical or bacteriological (biological) agents,
Recognizing that an agreement on the prohibition of bacteriological (biological) and toxin weapons represents a first possible step towards the achievement
of agreement on effective measures also for the prohibition of the development,
production and stockpiling of chemical weapons, and determined to continue
negotiations to that end,
Determined, for the sake of all mankind, to exclude completely the possibility
of bacteriological (biological) agents and toxins being used as weapons,
Convinced that such use would be repugnant to the conscience of mankind
and that no effort should be spared to minimize this risk,
Have agreed as follows:
Article I
Each State Party to this Convention undertakes never in any circumstance to develop, produce, stockpile or otherwise acquire or retain:
1.Microbial or other biological agents, or toxins whatever their origin or method
of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes;
29
Appendices
223
2.Weapons, equipment or means of delivery designed to use such agents or
toxins for hostile purposes or in armed conflict.
Article II
Each State Party to this Convention undertakes to destroy, or to divert to peaceful
purposes, as soon as possible but not later than nine months after the entry into force
of the Convention, all agents, toxins, weapons, equipment and means of delivery
specified in article I of the Convention, which are in its possession or under its jurisdiction or control. In implementing the provisions of this article all necessary safety
precautions shall be observed to protect populations and the environment.
Article III
Each State Party to this Convention undertakes not to transfer to any recipient
whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce
any State, group of States or international organizations to manufacture or otherwise
acquire any of the agents, toxins, weapons, equipment or means of delivery specified
in Article I of the Convention.
Article IV
Each State Party to this Convention shall, in accordance with its constitutional
processes, take any necessary measures to prohibit and prevent the development,
production, stockpiling, acquisition or retention of the agents, toxins, weapons,
equipment and means of delivery specified in Article I of the Convention, within the
territory of such State, under its jurisdiction or under its control anywhere.
Article V
The States Parties to this Convention undertake to consult one another and to cooperate in solving any problems which may arise in relation to the objective of, or in
the application of the provisions of, the Convention. Consultation and cooperation
pursuant to this article may also be undertaken through appropriate international
procedures within the framework of the United Nations and in accordance with its
Charter.
Article VI
1.Any State Party to this Convention which finds that any other State Party is
acting in breach of obligations deriving from the provisions of the Convention
may lodge a complaint with the Security Council of the United Nations. Such
a complaint should include all possible evidence confirming its validity, as
well as a request for its consideration by the Security Council.
2.Each State Party to this Convention undertakes to cooperate in carrying out
any investigation which the Security Council may initiate, in accordance with
the provisions of the Charter of the United Nations, on the basis of the complaint received by the Council. The Security Council shall inform the States
Parties to the Convention of the results of the investigation.
30
Appendices
224
Article VII
Each State Party to this Convention undertakes to provide or support assistance, in
accordance with the United Nations Charter, to any Party to the Convention which
so requests, if the Security Council decides that such Party has been exposed to
danger as a result of violation of the Convention.
Article VIII
Nothing in this Convention shall be interpreted as in any way limiting or detracting
from the obligations assumed by any State under the Protocol for the Prohibition of
the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological
Methods of Warfare, signed at Geneva on June 17, 1925.
Article IX
Each State Party to this Convention affirms the recognized objective of effective prohibition of chemical weapons and, to this end, undertakes to continue negotiations in
good faith with a view to reaching early agreement on effective measures for the prohibition of their development, production and stockpiling and for their destruction,
and on appropriate measures concerning equipment and means of delivery specifically designed for the production or use of chemical agents for weapons purposes.
Article X
1.The States Parties to this Convention undertake to facilitate, and have the right
to participate in, the fullest possible exchange of equipment, materials and
scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes. Parties to the Convention in
a position to do so shall also cooperate in contributing individually or together
with other States or international organizations to the further development and
application of scientific discoveries in the field of bacteriology (biology) for
prevention of disease, or for other peaceful purposes.
2.This Convention shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention or international cooperation in the field of peaceful bacteriological
(biological) activities, including the international exchange of bacteriological
(biological) agents and toxins and equipment for the processing, use or production of bacteriological (biological) agents and toxins for peaceful purposes
in accordance with the provisions of the Convention.
Article XI
Any State Party may propose amendments to this Convention. Amendments shall
enter into force for each State Party accepting the amendments upon their acceptance by a majority of the States Parties to the Convention and thereafter for each
remaining State Party on the date of acceptance by it.
31
Appendices
225
Article XII
Five years after the entry into force of this Convention, or earlier if it is requested by
a majority of the Parties to the Convention by submitting a proposal to this effect to
the Depositary Governments, a conference of States Parties to the Convention shall
be held at Geneva, Switzerland, to review the operation of the Convention, with a
view to assuring that the purposes of the preamble and the provisions of the Convention, including the provisions concerning negotiations on chemical weapons, are
being realized. Such review shall take into account any new scientific and technological developments relevant to the Convention.
Article XIII
1.This Convention shall be of unlimited duration.
2.Each State Party to this Convention shall in exercising its natural sovereignty
have the right to withdraw from the Convention if it decides that extraordinary events, related to the subject matter of the Convention, have jeopardized
the supreme interests of its country. It shall give notice of such withdrawal to
all other States Parties to the Convention and to the United Nations Security
Council three months in advance. Such notice shall include a statement of the
extraordinary events it regards as having jeopardized its supreme interests.
Article XIV
1.This Convention shall be open to all States for signature. Any State which
does not sign the Convention before its entry into force in accordance with
paragraph (3) of this Article may accede to it at any time.
2.This Convention shall be subject to ratification by signatory States. Instruments of ratification and instruments of accession shall be deposited with the
Governments of the United States of America, the United Kingdom of Great
Britain and Northern Ireland and the Union of Soviet Socialist Republics,
which are hereby designated the Depositary Governments.
3.This Convention shall enter into force after the deposit of instruments of ratification by twenty-two Governments, including the Governments designated as
Depositaries of the Convention.
4.For States whose instruments of ratification or accession are deposited subsequent to the entry into force of this Convention, it shall enter into force on the
date of the deposit of their instrument of ratification or accession.
5.The Depositary Governments shall promptly inform all signatory and acceding States of the date of each signature, the date of deposit of each instrument
of ratification or of accession and the date of the entry into force of this Convention, and of the receipt of other notices.
6.This Convention shall be registered by the Depositary Governments pursuant
to Article 102 of the Charter of the United Nations.
32
Appendices
226
Article XV
This Convention, the English, Russian, French, Spanish and Chinese texts of which
are equally authentic, shall be deposited in the archives of the Depositary Governments. Duly certified copies of the Convention shall be transmitted by the Depositary Governments of the signatory and acceding States.
In evidence whereof the undersigned, duly authorised, have signed this Convention.
Done in three copies at London, Moscow and Washington on the 10th of April
1972.
33
Appendices
227
2.
IAP Statement on Biosecurity
Knowledge without conscience
is simply the ruin of the soul.
F. Rabelais, 153219
In recent decades scientific research has created new and unexpected knowledge and
technologies that give unprecedented opportunities to improve human and animal
health and the conditions of the environment. But some science and technology can
be used for destructive purposes as well as for constructive purposes. Scientists have
a special responsibility when it comes to problems of ‘dual use’ and the misuse of
science and technology.
The 1972 Biological and Toxin Weapons Convention reinforced the international norm prohibiting biological weapons, stating in its provisions that ‘each
state party to this Convention undertakes never in any circumstances to develop,
produce, stockpile or otherwise acquire or retain: microbial or other biological
agents, or toxins whatever their origin or method of production, of types and in
quantities that have no justification for prophylactic or other peaceful purposes.’
Nevertheless, the threat from biological weapons is again a live issue. This
document presents principles to guide individual scientists and local scientific
communities who may wish to define a code of conduct for their own use.
These principles represent fundamental issues that should be taken into
account when formulating codes of conduct. They are not intended to be a
comprehensive list of considerations. These principles have been endorsed by
the national Academies of science, working through the InterAcademy Panel,
whose names appear below.
1.Awareness. Scientists have the obligation to do no harm. They should always
take into consideration the reasonably foreseeable consequences of their own
activities. They should therefore:
–
always bear in mind the potential consequences – possibly harmful – of
their research and recognize that individual good conscience does not justify ignoring the possible misuse of their scientific endeavour;
–
refuse to undertake research that has only harmful consequences for humankind.
2.Safety and Security. Scientists working with agents such as pathogenic organisms or dangerous toxins have a responsibility to use good, safe and secure
laboratory procedures, whether codified by law or by common practice.20
3.Education and Information. Scientists should be aware of, disseminate and
teach the national and international law and regulations, as well as policies
and principles aimed at preventing the misuse of biological research.
19 ‘Science sans conscience nest que ruïne de l’âme.’
20 Such as the WHO Biosafety Manual, Second Edition (Revised).
34
Appendices
228
4.Accountability. Scientists who become aware of activities that violate the
Biological and Toxin Weapons Convention or international customary law
should raise their concerns with appropriate people, authorities and agencies.
5.Oversight. Scientists with responsibility for oversight of research or for
evaluation of projects or publications should promote adherence to these principles by those under their control, supervision or evaluation.
These principles have been endorsed by the following national academies of science,
working through the Inter Academy Panel:
Albanian Academy of Sciences
National Academy of Exact, Physical and Natural Sciences, Argentina
The National Academy of Sciences of Armenia
Australian Academy of Science
Austrian Academy of Sciences
Bangladesh Academy of Sciences
National Academy of Sciences of Belarus
The Royal Academies for Science and the Arts of Belgium
Academy of Sciences and Arts of Bosnia and Herzegovina
Brazilian Academy of Sciences
Bulgarian Academy of Sciences
Cameroon Academy of Sciences
The Royal Society of Canada
Chinese Academy of Sciences
Academia Sinica, China Taiwan
Colombian Academy of Exact, Physical and Natural Sciences
Croatian Academy of Arts and Sciences
Cuban Academy of Sciences
Academy of Sciences of the Czech Republic
Royal Danish Academy of Sciences and Letters
Academy of Scientific Research and Technology, Egypt
Estonian Academy of Sciences
The Delegation of the Finnish Academies of Science and Letters
Académie des Sciences, France
Union of German Academies of Sciences and Humanities
Academy of Athens, Greece
Hungarian Academy of Sciences
Indian National Science Academy
Indonesian Academy of Sciences
Royal Irish Academy
Israel Academy of Sciences and Humanities
Accademia Nazionale dei Lincei, Italy
Science Council of Japan
African Academy of Sciences
Kenya National Academy of Sciences
35
Appendices
229
The National Academy of Sciences, The Republic of Korea
National Academy of Sciences of the Kyrgyz Republic
Latvian Academy of Sciences
Lithuanian Academy of Sciences
Macedonian Academy of Sciences and Arts
Akademi Sains Malaysia
Academia Mexicana de Ciencias
Academy of the Kingdom of Morocco
The Royal Netherlands Academy of Arts and Sciences
Academy Council of the Royal Society of New Zealand
Nigerian Academy of Sciences
Pakistan Academy of Sciences
Palestine Academy for Science and Technology
Academia Nacional de Ciencias del Peru
National Academy of Science and Technology, Philippines
Polska Akademia Nauk, Poland
Russian Academy of Sciences
Académie des Sciences et Techniques du Sénégal
Serbian Academy of Sciences and Arts
Singapore National Academy of Sciences
Slovak Academy of Sciences
Slovenian Academy of Sciences and Arts
Academy of Science of South Africa
Royal Academy of Exact, Physical and Natural Sciences of Spain
Royal Swedish Academy of Sciences
Council of the Swiss Scientific Academies
Turkish Academy of Sciences
The Uganda National Academy of Sciences
The Royal Society, uk
us National Academy of Sciences
Academia de Ciencias Físicas, Matemáticas y Naturales de Venezuela
Zimbabwe Academy of Sciences
twas, the Academy of Sciences for the Developing World
36
Appendices
230
3.
Laws and rules on genetic modification
National
Anyone working with genetically modified organisms in the Netherlands must possess a permit. These permits are issued by the Ministry of Housing, Spatial Planning
and the Environment.
Decree on Genetically Modified Organisms (GMO Decree)21
A permit is required under the gmo Decree for activities involving gmos within
establishments such as laboratories (‘contained use’). The establishment must also
have a permit under the Environmental Management Act. There is a central European procedure governing activities involving gmos outside establishments (‘introduction into the environment’). This procedure is described in Directive 2001/18/ec.
The gmo Decree provides that a permit is required if the gmos are only introduced
into the environment for research purposes and are not brought onto the market.
Ministerial Regulation on Genetically Modified Organisms (GMO
Regulation)22
The gmo Regulation is linked to the gmo Decree and contains more detailed rules,
general safety prescriptions and rules for specific types of facility and for working
with gmos. The gmo Regulation applies primarily to the contained use of gmos.
Environmental Management Act23 and the Establishments and Permits
Decree
The Environmental Management Act and the Establishments and Permits Decree
provide that an institution must have a permit for the contained use of gmos. The Environmental Management Act permit lays down the requirements that a facility must
comply with. These permits are generally issued by the municipality or province in
which the establishment is located.
Other national legislation governing GMOs
Other permits are also needed for some activities involving the use of gmos.
In addition to an environmental permit, institutions require a permit under the
Decree on biotechnology with animals24 for genetic modification of animals. The
competent authority is the Ministry of Agriculture, Nature Management and Food
Quality. The Act on Animal Testing25 also provides that the animal experiments
committee (dec) must give its permission. The Ministry of Health, Welfare and
Sport is the competent authority.
21 http://www.wetten.nl/besluit%20genetisch%20gemodificeerde%20organismen%20wet%20milieuge
vaarlijke%20stoffen
22 http://www.wetten.nl/regeling%20genetisch%20gemodificeerde%20organismen
23 http://www.wetten.nl/wet%20milieubeheer
24 http://wetten.overheid.nl/cgi-bin/deeplink/law1/title=Besluit%20biotechnologie%20bij%20dieren
25 http://wetten.overheid.nl/cgi-bin/deeplink/law1/title=Wet%20op%20de%20dierproeven
37
Appendices
231
The Central Committee on Research involving Human Subjects26 (ccmo) must
also give its permission for research on people, for example in the case of gene
therapy.
Naturally, in addition to the regulations listed above, institutions must comply
with all the other rules that also apply for activities not involving genetically
modified organisms (e.g. the Pesticides Act, Commodities Act, the Working
Conditions Act, the Decree on Immunological Pharmaceutical Products, etc.).
European
The legislation governing biotechnology is based primarily on European directives
and regulations. The difference between a directive and a regulation is that a regulation has direct application in every European Member State. A directive must first be
transposed into the national legislation of the member states and the member state
can adopt its own form and methods of implementation.
Directive 98/81/EC27
This directive lays down the framework for tests with gmos in laboratories (contained use). This directive is implemented in Dutch legislation through the gmo
Decree, the gmo Regulation and the Environmental Management Act.
Directive 2001/18/EC28
This directive lays down the framework for the deliberate introduction into the
environment of genetically modified organisms. The directive was implemented in
Dutch legislation on 12 May 2004.
Regulation (EC) no. 1829/200329
This regulation relates to genetically modified food and animal feed.
Regulation (EC) no. 1830/200330
This regulation relates to the traceability and labelling of genetically modified organisms and the traceability of food and animal feed produced with genetically modified organisms.
Global
Convention on biological diversity31
The objective of the convention is the conservation of biological diversity, the
sustainable use of its components and the fair and equitable sharing of the benefits
arising from the utilisation of genetic resources. The value of biological diversity is
seen not only from a human perspective but also from the perspective of the unique
intrinsic value of nature.
26 http://www.ccmo.nl/
27 http://europa.eu.int/eur-lex/pri/nl/oj/dat/1998/l_330/l_33019981205nl00130031.pdf
31 http://www.biodiv.org/convention/articles.asp?lg=0
38
Appendices
232
The Convention obliges the parties to the convention to develop national strategies for concrete activities.
Cartagena Protocol (Biosafety Protocol)32
The Cartagena Protocol is also known as the Biosafety Protocol (bsp). It is a supplementary protocol implementing the UN Convention on biological diversity (see
above). The objective of the protocol is to contribute to ensuring an adequate level
of protection in the field of safe transfer, handling and use of gmos that may have
adverse effects on the conservation and sustainable use of biodiversity. It contains
primarily rules on the cross-border movement of gmos.
The protocol prescribes that in the case of cross-border movements of living
gmos that are intended to be introduced into the environment (for field trials,
for example), the exporter must notify the country of import in advance of the
proposed movement and must wait for approval from the country of import. The
protocol also established a clearing house (the BioSafety Clearing House, bch)
for the exchange of information about cross-border movements of gmos which
are intended to be used as food or animal feed or directly for processing in products. Ninety countries have so far ratified the protocol.
Aarhus convention33
The Aarhus Convention regulates access to environmental information, public
participation in decision-making and access to justice in environmental matters. The
convention includes a provision on gmos (section 11 of Article 6). This clause states
that countries must allow, within the framework of their national legislation, to the
extent feasible and appropriate, public participation in decisions on whether to allow
the deliberate release of gmos into the environment. The Netherlands complies with
this section, since the General Administrative Law Act, which provides for public
participation in political decision-making, applies to decisions to permit the introduction of gmos into the environment.
32 http://www.biodiv.org/doc/legal/cartagena-protocol-en.pdf
33 http://unece.org/env/pp/gmo.htm
39
Appendices
233
4. Biosecurity Working Group
Chairman:
Prof. L. van Vloten-Doting
Ministry of Agriculture, Nature Management and Food Quality and Groene Kennis
Coöperatie
Prof. S.S. Blume
Professor of Science and Technology Studies, University of Amsterdam
Prof. P.W. Crous
Director of Fungal Biodiversity Centre (cbs-knaw) and Professor of Evolutionary
Phytopathology, Wageningen University
Prof. A.J. van der Eb
Chairman of knaw’s Animal Trials and Biotechnology Committee (cdb)
Emeritus Professor of Molecular Biology, University of Leiden
Biosecurity Focus Group
Prof. P. Baas
Chairman of knaw’s Biology Section, Emeritus Professor of Biology, University of
Leiden, Biology Council
Dr E.P. Beem
Co-director ZonMw
Dr J.E.N. Bergmans
Head of the Office for Genetically Modified Organisms, rivm, Bilthoven
Dr P. Bertens
Netherlands Biotechnological Society
Netherlands Biotechnology Association (niaba)
Prof. G.M.A. van Beynum
knaw’s Committee for Biochemistry and Biophysics
H. Bout
Co-author of nibi professional code
ConScience
Prof. J. Bunders
Member of knaw’s Biology Council
Professor of Biology and Society, Vrije Universiteit Amsterdam
40
Appendices
234
Dr R. Busker
Manager, Biological and Chemical Protection, tno Defence, Security and Safety
Prof. T. de Cock Buning
Co-author of nibi professional code
Vrije Universiteit Amsterdam, Department of Biology and Society
Prof. M.C.E. van Dam-Mieras
Vice chancellor, University of Leiden
Former Professor of Natural Sciences, Open University
Prof. H.M. Dupuis
Emeritus Professor of Medical Ethics, University of Leiden
Upper House of Parliament
Prof. J. van Eijndhoven
Professor of Sustainable Management, Erasmus University Rotterdam
Dr R. Fouchier
Member of Jonge Academy, knaw
Erasmus mc, Virology department
Prof. H. Goossens
Clinical Microbiology, Centre for Infectious Diseases, lumc Leiden
Dr M. van der Graaff
Policy assistant, Pharmaceutical Biotechnology Nefarma
Prof. I. Helsloot
Professor of Crises and Security, Vrije Universiteit Amsterdam
Prof. W.P.M. Hoekstra
Member of knaw’s Biology Council
Emeritus Professor of Biology, University of Utrecht
Dr S. Hoffer
Expert in biological / chemical disasters, rivm Bilthoven
R.T.A. Janssen
Netherlands Biotechnology Association, director niaba
E. Kampert
Biosafety Officer bsl3/4 rivm
41
Appendices
235
M.W. Leeuw
Operations Manager, tno Defence, Security and Safety
Dr A. M’charek
Faculty of Social and Behavioural Sciences, University of Amsterdam
I. Malsch
Consultant on (bio)technology and society; expert on btwc,
Malsch Techno Valuation
Dr M. Netea
Member of Young Academy, knaw
Organisation: umc St. Radboud, Internal Medicine
L. van den Oever
Director, Netherlands Institute for Biology (nibi)
Prof. B. Oudega
Member of knaw Biology Council,
Professor of Microbiology, Vrije Universiteit Amsterdam
Dr B.P.H. Peeters
Central Institute for Animal Disease Control
Prof. J.P.M. van Putten
Faculty of Veterinary Medicine, University of Utrecht
J.W.C. Remmerswaal
owb Directorate, Ministry of Education, Culture and Science
Prof. P.H. van Tienderen
Director, Institute for Biodiversity and Ecosystem Dynamics (ibed), University of
Amsterdam
Dr T. Tijmstra
gzw-Metamedica (sociology), University of Groningen, umc
T.E. Venema
Office of the National Coordinator for Anti-Terrorism (nctb)
Dr J.M. Verduin
Laboratory of Virology, Wageningen University
Biologisch Veiligheidsplatform (Biological Security Platform)
42
Appendices
236
Dr F. van der Wilk
Secretary, Netherlands Commission on Genetic Modification (cogem)
Dr G. van Willigen
Department of Working Conditions and Risk Management / vsm, lumc Leiden,
Biologisch Veiligheidsplatform (Biological Security Platform)
W.J. Wormgoor
Ministry of Foreign Affairs, Security Policy Directorate, Department of Nuclear
Affairs and Non-Proliferation
Prof. B.A.M. van der Zeijst
Director, Netherlands Vaccine Institute, rivm
Dr D. Zijderveld MPA
Director, Netherlands Genomics Initiative
43
Appendices
237
44
238
Position statement on bioterrorism and biomedical research | Wellcome...
1 von 5
http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-stat...
We use cookies on this website. By continuing to use this site without changing your cookie settings, you agree
that you are happy to accept our cookies and for us to access these on your device. Find out more about how
we use cookies and how to change your cookie settings.
Continue
eGrants:
About
Login
Gibbs Building, 215 Euston Road, London NW1 2BE, UK T:+44 (0)20 7611 8888
Home > About us > Policy > Policy and position statements > Position statement on bioterrorism and
biomedical research
Search
Introduction
Balancing benefit and risk
Wellcome Trust funding decisions
Dissemination of research
International collaboration and training
Promoting research best practice and ensuring public trust.
1. The mission of the Wellcome Trust (the 'Trust') is to foster and promote
research with the aim of improving human and animal health.
2. In furthering its charitable mission, the Trust funds a significant body of basic
and clinical research in the fields of infection and immunity, pathogen and host
genetics, and tropical medicine, both in the UK and at centres of excellence in
developing countries. Such research is essential in order to improve our
understanding of the pathology of infectious diseases of humans and animals.
This knowledge will enable the development of improved diagnostics, vaccines,
therapeutics and other control strategies to alleviate the suffering and the social
and economic burden that such diseases cause throughout the world.
3. The Trust is aware, however, that in light of global events, biomedical
research that involves the use of potentially harmful pathogens and toxins has
come under increased scrutiny, and that there are heightened concerns that the
misuse of this research could increase the potential threat of bioterrorist attacks.
239
07.03.2013 15:33
2 von 5
4. The Trust recognises that there are particular concerns regarding research that
could directly result in, or enable the future development of, pathogens and
toxins which could potentially serve as bioweapons. A committee convened by
the US National Academy of Sciences recently identified seven classes of
experiment to illustrate the types of endeavour that would require careful review
by informed experts1. The experiments this committee specified are those that
would:
demonstrate how to render a vaccine ineffective
confer resistance to therapeutically useful antibiotics or antiviral agents
enhance the virulence of a pathogen, or render a non-pathogen virulent
increase transmissibility of a pathogen
alter the host range of a pathogen
enable the evasion of diagnostic and detection modalities
enable the weaponisation of a biological agent or toxin.
5. The Trust considers that in order to address these legitimate concerns, it is
important that appropriate processes exist at institutional, national and
international levels for the review and oversight of research that could result in
such outcomes.
6. The Trust would emphasise, however, that further research involving harmful
biological pathogens and toxins will be crucial in the fight to combat the
diseases that these agents cause and to improve our ability to respond to
bioterrorist attacks. In most cases the risks associated with such research will be
minor in comparison with the potential benefits. The Trust considers that the
creation and dissemination of scientific knowledge is a definite and tangible
public good, which would need to be set against risks that may sometimes be
hypothetical and hard to quantify.
7. The Trust believes, therefore, that regulatory processes must not unduly
restrict this essential research. Any additional regulatory requirements that may
be introduced should apply only to those research projects where there is
tangible cause for concern. The Trust expects that this will represent a very
small proportion of the many research projects undertaken in academic research
laboratories that involve the use of pathogens and toxins.
8. To ensure that the research the Trust funds is in line with its mission and is of
the highest scientific quality, all Trust-funded research is independently peer
reviewed by experts. Reviewers are required to consider whether the proposed
methodology is appropriate for achieving the stated objective and they may
raise any ethical or safety concerns that they have regarding a particular
application. The Trust will develop specific guidance for reviewers and
applicants on the issues addressed in this statement.
9. The Trust would emphasise, however, that it will often be extremely difficult
at the grant application stage to identify projects which could generate results
that might theoretically be misused, and assess accurately the extent of any such
risk.
10. As a condition of grant support, institutions in receipt of Wellcome Trust
240
07.03.2013 15:33
3 von 5
funds are responsible for ensuring that they comply fully with the requirements
of all regulatory authorities for the storage, use and transfer of harmful
biological materials, and any additional provisions to safeguard security that
may be specified by such authorities. Institutions also accept full responsibility
for the management, monitoring and control of all research work funded by
grants, and for ensuring that permanent and temporary staff and students
employed to undertake such work receive training appropriate to their duties.
11. The Wellcome Trust Sanger Institute ensures that it meets the requirements
of all regulatory authorities, and that any ethical implications are considered
through appropriate mechanisms in developing its research programme. With
regard to its work on pathogen genomics, the Sanger Institute has robust
mechanisms in place to ensure compliance with relevant regulatory instruments
for safe use, security and transfer of the agents and genetic materials derived
from them.
12. The Trust has established a Standing Advisory Group on Ethics (SAGE) to
consider and advise the Trust on any major ethical issues associated with
applications for funding that cannot be addressed through the standard
procedures of local ethical review, and the Home Office Inspectorate (for animal
experiments) or Research Ethics Committee (in the case of studies involving
human subjects).
13. If a situation arose where concerns had been raised that an application had a
serious risk of misuse associated with it, and such concerns could not be
resolved through these mechanisms, then the Trust would not fund that
application. The Trust would anticipate, however, that such circumstances
would be extremely rare.
14. The Trust considers that it is essential to the progress of biomedical research
and its ultimate application to healthcare that researchers the world over have
access to research findings so that they can verify, build upon and apply this
knowledge. In the vast majority of cases, the interests of the international
research community, and ultimately the public, will best be served when the
results of research are disseminated through publication in peer-reviewed
journals.
15. The Trust would be concerned by the introduction of any limits on
publication which threatened the principle of open communication in science. It
endorses fully the view stated by the National Academy of Sciences Committee
that the dissemination of research results in the context of scientific publication
should be based on the voluntary self-governance of the scientific community,
and not be subject to formal regulation by governments.
16. The pre-publication release of fundamental genomic information into public
domain resources, including data pertaining to pathogenic organisms, has been
of enormous benefit to the research community. It is the Trust's view that the
benefits of sharing such data greatly outweigh any potential risk of misuse. The
Trust will continue to support pathogen genomics projects at the Sanger
Institute and elsewhere that generate data on infectious disease agents and make
this information freely available to all.
241
07.03.2013 15:33
4 von 5
17. The Trust would likewise be concerned by the introduction of processes that
could unreasonably restrict the ability of talented scientists from overseas to
work and train in UK laboratories, or inhibit the ability of scientists in the UK to
collaborate with scientists overseas. In considering the introduction of any
changes to existing regulatory processes, the Trust would urge the UK
Government to consider the immense contribution made by these individuals to
the UK science base and the crucial importance of international collaboration to
the scientific enterprise.
18. It is the Trust's view that a system based upon self-governance by the
scientific community will ultimately provide the most effective means of
managing risks of misuse, the assessment of which will often require expert
scientific judgement. The Trust considers that the community should take active
steps to further develop mechanisms of self-governance, and that through doing
so it can ensure that responsibly conducted research is not unnecessarily
obstructed.
19. Discussions on such mechanisms will need to involve scientists from
relevant disciplines and representatives of professional societies, funding
agencies, regulatory bodies and other key stakeholders. The Trust intends to
participate actively in these discussions, and will explore how it can work to
stimulate this process. In taking these discussions forward it will be important
for the scientific community to maintain an active dialogue with governments
and security services to ensure that their requirements and concerns are
addressed.
20. In order to promote best practice in the conduct of research and maintain
public trust, the Trust considers that the international scientific community must
take proactive steps to ensure that its members are aware of potential risks and
concerns relating to terrorist misuse of research, and of the regulatory and
ethical responsibilities that they hold.
21. The Trust considers that the development of a 'code of conduct' for scientists
could play an important role in this regard. The Trust intends to engage with the
UK Government and other scientific organisations in further discussions on this
issue.
22. It is essential that the international scientific community engages effectively
with society in addressing these risks. The Trust is committed to fostering
public engagement on the issues raised by advances in biomedical science, and
will consider how it can work in partnership with other organisations to engage
the public on the issues addressed in this statement.
23. The Trust considers that the risks associated with the potential misuse of
scientific research for terrorist purposes must ultimately be addressed
internationally, and that efforts to raise awareness and develop best practice
242
07.03.2013 15:33
5 von 5
among the research community will need to be implemented globally in order to
be effective. The further development of processes to build international
consensus on these issues will therefore be crucial.
1See: 'Biotechnology Research in an Age of Terrorism' (The National
Academies Press, October 2003).
Wellcome Trust, Gibbs Building, 215 Euston Road, London NW1 2BE, UK T:+44 (0)20 7611 8888
243
07.03.2013 15:33

Codes of Conduct on Biosecurity

Transcription

Similar documents

4. Select the “My Lexile Range” drop down. Now, click search. 2

Start Here -‐ Log on to www.applytexas.org • Select

Tools and Thoughts for Building Dual Enrollment Opportunities

K – 5 Spanish Dual Language Program - West Linn

youth leadership 2016-2017

Studio A Info - ghost city recordings

KYMCO Grandvista 250

Dual Credit Saving Students Time and Money Annice Brave: Teacher

1300 Lower Rodi Road - Langholz Wilson Ellis

Sikorsky S-76B - PlaneSayling Aviation Limited