Carrick 2

Transcription

Carrick 2

13th World Congress of
the International
Association of Bioethics
14-17 June 2016
EICC, Edinburgh
BOOK OF ABSTRACTS
www.iab2016.com
@iab2016 #IAB2016
2016
Edinburgh
WEDNESDAY 15TH JUNE 2016 14:00-15:30
Pentland Auditorium
S34: Sponsored Symposium – Nuffield Council on Bioethics PN: 627
Chair: Jonathan Montgomery
Chair, Nuffield Council on Bioethics; Professor of Health Care Law, University College London, United
Kingdom
Are We Making Progress in Bioethics?
1
2
3
4
Erica Haimes, Calvin Ho, Ruth Macklin, Christian Munthe
1
2
PEALS Research Centre, Newcastle University, Newcastle Upon Tyne, United Kingdom, National
3
4
University of Singapore, Singapore, Albert Einstein College of Medicine, Bronx, New York, USA, University
of Gothenburg, Sweden
Abstract:
th
The Nuffield Council on Bioethics celebrates its 25 anniversary in 2016. The Council has brought together
an international panel for a discussion about whether bioethics has made progress over that time, what
making progress means for bioethics, and the impact of bioethics around the world. Each speaker will be
invited to give a short presentation on the following key questions, which will be followed by an open
discussion:
Has bioethics contributed to progress? What might be meant by ‘progress’ here? Has bioethics made science
‘better’ or contributed to ‘better science’? Has it contributed to a thawing of relations between science and
society? Has it been a force for spreading good practice internationally?
Has bioethics itself progressed? Was bioethics developed as an influential discourse? Has it evolved in its
approach? Has it developed distinctive methods and argumentative forms? Has it progressed internationally,
e.g. into a global ethics?
Kilsyth
Arts+Ethics in Practice: Gallery Tour
Come join Emma Barnard, Arts & Ethics Research Group Member and Gallery Curator, and the organisers
of the Arts & Ethics Stream in the Kilsyth Room for a walking tour of the IAB 2016 Arts & Ethics Gallery. You
will have the chance to view, interact with, and discuss the unique pieces that have been accepted for the
Congress, and to interact with some of the artists. The tour will begin at approximately 14:10. This will be the
only formal tour offered during the Congress. If you are unable to join this, we still encourage you to view the
pieces throughout the Congress, and to talk to those artists who are present.
Sidlaw
S66: Symposium: Ethical Questions in Mitochondrial Donation PN: 618
1
2
1
3
4
Reuven Brandt , Ainsley Newson , Stephen Wilkinson , Colin Gavaghan , Rosamund Scott
2
3
1
Lancaster University, United Kingdom, University of Sydney, Australia, University of Otago, Dunedin, New
4
Zealand, King's College London, United Kingdom
Keywords – Mitochondria; Germline; Donor Anonymity; Reproduction
Discipline(s) – Bioethics; Philosphy
Abstract
Symposium Description
Mitochondrial donation provides a means for women who have pathological mutations in their mitochondrial
DNA to greatly reduce the risk of their offspring inheriting mitochondrial disease, while also allowing them to
IAB 2016 EDINBURGH SCOTLAND | BOOK OF ABSTRACTS
1
have genetically related children. Mitochondrial donation thus has the potential to be of great benefit.
However, the technologies and procedures involved raise many pressing ethical and philosophical questions.
In particular, this panel of researchers from three different countries will discuss: (a) the ways in which
questions about personal identity are relevant to the ethical discourse on mitochondrial donation, (b) the
weight that should be placed on reproductive choice when deciding the appropriateness of mitochondrial
donation, (c) the nature of the relationship created between mitochondrial donors and their resultant children,
and (d) the roll of public consultation in developing regulations.
Individual Paper Abstracts
“Mitochondrial donation and donor anonymity”
Both the Nuffield Committee on Bioethics and the HFE Authority recommend that children created using
mitochondrial donation not have a legal right to identifying information about their mitochondrial donors. A
key premise in their arguments is that mitochondrial DNA does not encode the kinds of resemblances
between the donor and resultant child that are relevant to personal identity. I argue that this premise is prone
to two lines of attack: (a) empirical disputes about the traits affected by mitochondrial DNA and, (b)
philosophical disputes about what traits are important to personal identity. However, I further argue that even
if we grant this premise, the major justifications given for the right to know in adoption and IVF do not equally
apply in mitochondrial donation. Consequently, an appeal to symmetry with cases where a right to know is
recognized is not sufficient for establishing a right to know in mitochondrial donation.
“Mitochondrial donation and the normative weight of parental wishes”
Two features of mitochondrial donation that have ethical relevance are that: (i) its absolute risk is (and will, for
some time, remain) unknown; and (ii) it is an expensive technology, yet one that will nonetheless allow
couples to have children who are genetically related to both parents. These are interesting ethical issues in
their own right, but they also give rise to an interesting over-arching question: what is the normative weight
that we should (or should not?) ascribe to parental wishes? If a couple is willing to accept a certain level of
risk to access this technology, whose decision should it be to take on that risk? If a couple desires children
who are genetically related to them both, is that preference enough to justify an offer of mitochondrial
donation over some alternative means to found a family? In this presentation, I will consider the normative
weight that we might apply to ‘parental preferences’. Weight is often placed on such an aspect, yet the
validity of this is seldom unpacked.
“Identity and the Mitochondrial Replacement Debate”
The paper starts by exploring (descriptively) some of the ways in which the concept of ‘identity’ has been
used in recent ethics and policy discussions regarding MRTs. It then proceeds to offer a more
critical/explanatory analysis of the various different types of identity argument in play and contextualises this
analysis by moving the discussion beyond MRTs to reproductive ethics more widely. It is argued that, while
identity arguments are often confused and overworked, there are nonetheless some important identity-related
arguments and distinctions that do, or should, have an impact on reproductive ethics and policy.
“Public voices, private choices? The role of public consultation in the regulation of assisted
reproductive technologies”
In common with many of its other decisions, the HFEA’s recent approach to mitochondrial donation was
informed by a process of public consultation. It is easy to see the value in such an approach. It allows
regulation to stay connected to community values, and maintains public confidence in the technology and the
regulators. There are, however, questions to be asked about the appropriate role of public consultation.
Some relate to the manner in which questions are presented, others to the interpretation and use that is
made of responses. However, some more fundamental of regulatory legitimacy also arise.
Fintry
S1: Health Research Consortia
Chair: Anneli Törrönen
Ministerial Advisor, Ministry of Social Affairs and Health, Government of Finland, Helsinki, Finland
2
PN: 83
Biobank Networks, Medical Research and the Challenge of Globalisation
1
1
1,2
Wendy Lipworth , Paul Mason , Ian Kerridge
2
Centre for Values, Ethics and the Law in Medicine, University of Sydney, Australia, Royal North Shore
Hospital, Sydney, Australia
1
Keywords – Biobanks; Globalisation; Transnational Cooperation; Research Ethics; Public Goods
Discipline(s) – Global Health Ethics; Research Ethics
Abstract
Biomedical research has traditionally privileged clinical trials and epidemiological analysis of defined study
populations. Increasingly, however, research relies on biobanks that store data and samples from large
numbers of people. Over the past decade, international networks of biobanks have been established in order
to maximise their utility and sustainability. While the ethical, legal and political issues raised by isolated
biobanks are well understood (relating mostly to tensions between individual autonomy and the common
good), less attention has been paid to the issues raised by global biobank networks. In order to address this
lacuna, we conducted a narrative review of the literature on biobanking, and generated a taxonomy of the
ethical, legal and political issues associated with globalisation, and the formation of biobank networks. We
found that these issues are numerous and relate to the fact that research is less constrained by institutional,
academic, cultural or national boundaries. Specific issues that need to be addressed if biobank networks are
to be morally, legally and politically sound, include difficulties relating to consent, commercialisation, privacy,
treatment of tissue, transnational cooperation, return of results, benefit sharing, “ownership” of data and
tissue, and intellectual property. Given that the globalisation and networking of biobanks is necessary to
optimize their benefits, then it is essential that we devise ways of managing the numerous and difficult ethical,
legal and political challenges that arise.
PN: 296
Human Tissue as a Public Good?
1
1
Imogen Goold , Simon Douglas
1
University of Oxford, United Kingdom
Keywords – Human Tissue; Property; Public Goods; Public Interests
Discipline(s) – Law; Bioethics
Abstract
Considerable legal and ethical attention has focused on what rights, if any, may be exercised in relation to
human tissue. Legally, in some common law jurisdictions, a number of approaches have emerged over the
past twenty years, with some decisions following the according a right to possession to individuals over tissue
that has been transformed via ‘work and skill’. In other cases, an attempt has been made to justify
recognizing that individuals hold a range of rights generally associated with ownership over their own tissue.
Various Australian state courts have also granted women the right to obtain and use sperm from a deceased
partner to become pregnant. Some scholars, however, have argued in favour of some kind of public property
approach. By this, some mean that tissue should be publicly owned by the State. Others support some kind
of public trust model, while it is has also been suggested that tissue should be regarded as some kind of
public commons. Such assertions are often a rejection of an individual or personal property approach. In this
paper, we defend an approach based on the law of personal property. We argue that such an approach can
encompass the use of gametes, research use and banking for the benefit of the public generally. We
demonstrate the problems associated with a common property approach and explain how a personal
property approach can enable a solution (via the mechanism of charitable trusts) that avoids hiving off tissue
solely for personally-directed use.
3
PN: 506
The Obligation to Notify Human Subjects about Incidental Findings: Why
Research in Biobanking is Different
Markus Labude1
1
Centre for Biomedical Ethics, National University of Singapore, Singapore
Keywords – Incident Findings; Biobanking; Tissue banking; Relationship
Discipline(s) – Bioethics; Research Ethics
Abstract
It remains a contested issue whether researchers are morally required to respond to incidental findings (IFs)
that occur in biomedical research. A recent line of argument grounds researchers’ obligations to disclose IFs
to research participants in the nature of the investigator-subject relationship, which is characterized by a
professional’s privileged access to private information along with her competence to identify the potential
significance of this information. This line of argument has two main advantages. First, it detaches any
potential obligation to disclose IFs from the professional duties of physicians. Hence, the argument explains
why even non-physicians are under an obligation to notify research subjects about IFs. Second, the appeal to
the particular relationship between investigator and subject as well as the investigator’s unique position offers
a stronger basis than an unspecified general duty of beneficence. The current paper points out a limitation of
the argument: the argument cannot ground the obligation to disclose IFs in much of biobanking research
since the relevant investigator-subject relationship giving rise to privileged access is absent. Those who insist
that investigators have an obligation to disclose IFs arising in the context of biobanking research, have to find
alternative grounds in order to justify this obligation. Alternatively, one can accept the argument’s limitation
and concede that the obligation to disclose IFs is indeed absent in biobanking research. I argue for the latter
the position.
PN: 700
Constructions of Public Benefit in Data Linkage Research
1
1
1
1
Sarah Cunningham-Burley , Mhairi Aitken , Claudia Pagliari , Gemma Phillips , Carol Porteous
University of Edinburgh, United Kingdom
1
1
Keywords – Public engagement; Public Benefit; Public interest
Discipline(s) – Sociology and interdisciplinary bioethics
Abstract
The use of linked data, generated within the health care and other environments is increasingly being utilised
for research purposes. While a myriad of ethical issues, around key concerns of consent and anonymity
continue to dominate public and academic debate and influence governance arrangements, the public good
argument that serves as a warrant for research use, requires some empirical attention if such appeals are to
move beyond the rhetorical and its assessment confined to approval bodies. This paper draws on a range of
public engagement activities as part of two UK data linkage for research initiatives: the FARR Institute and
Administrative Data Research Centre, in Scotland, to begin to identify the multiple meanings of public good
and researching in the public interest and how these might be deployed in governance structures moving
forward. Our dialogues have taken a number of different forms, including a public panel, outreach events,
interviews and workshops. They have included researchers as well as a range of citizens discussing what
types of research might be deemed in the public interest, how elastic that concept is, and the kinds of factors
that publics take into account when making judgements about research, at the individual project level and in
terms of their wider institutional contexts.
4
Tinto
S45: Symposium: Perspectives from the Global South: Problematizing
Assumptions Underlying the ‘Global South-Global North’ Geographical
Imaginary: Who is 'Building Capacity' or 'Achieving Competency' in
Global Health and Global Health Ethics Initiatives? PN: 626
Chair: Catherine Myser
Rosalind Franklin University of Medicine and Science, Lake Forest, United States
1
2
7
8
6
3
Catherine Myser , Patricia Kingori , Sapna Desai , Rajani Ved , Alba Amaya-Burns , Devaki Nambiar ,
4, 5
Maru Mormina
2
1
Rosalind Franklin University of Medicine and Science, Lake Forest, United States, University of Oxford,
3
4
Ethox Centre, United Kingdom, Public Health Foundation of India, India, University of Winchester, United
5
6
7
Kingdom, King's College London, London, United Kingdom , Duke Kunshan University, China, SEWA
8
Health Cooperative, National Health Systems Resource Centre, Ministry of Health, India
Discipline(s): Bioethics/Global Bioethics; Public Health; Social Sciences; Physician; Global Health; Global
Health Ethics
Keywords: Global Health; Global Health Ethics; Global South-Global North; Partnerships; Building
Capacity/Achieving Competency
Abstract
Our focus is on the borders of global public health and global bioethics, specifically “global health” and “global
health ethics,” where bioethicists have inadequately engaged to date. Our goal is to take a critical look at
core structuring concepts in these two emerging fields to problematize: the “Global South-Global North”
geographic imaginary; “partnerships” as a means of: building “egalitarian” collaborations and “avoiding
neocolonialist relations” between low and middle income & high income countries; and who is “building
capacity” and who is “achieving competency.” Excluding the Chair, we feature (six) scholars/perspectives
originating from low and middle income, “Global South” countries, including Africa, India, South and Central
America, and China (including two “early career researchers”). Our goals in doing so are: 1. to acknowledge
the reality that, in actual numbers, these are “majority” global perspectives, although still a “minority” of those
voiced/represented at/in global bioethics and global health conferences/publications; 2. to privilege “global
South” perspectives inadequately consulted/represented in the global health and global health ethics
literature (originating almost exclusively from high income, “Global North” countries); 3. to problematize who
should be doing the teaching and who should be doing the learning/”capacity building” (as opposed to
“achieving competency”); and 4. in these and other ways challenge and “decenter” high income country and
“Global North” concepts and perspectives to learn from - the real majority - “minority” perspectives and
concepts – all to improve global health and global health ethics structuring concepts and initiatives around the
globe.
Global Health ‘Collaborations’ and ‘Capacity Building’ Initiatives in African Spaces: The Views and
Experiences of Senior African Scientists
Since the 1970s, there has been a postcolonial narrative that African scientific infrastructure lacks the
necessary resources to lead its own scientific agenda. For decades, Global North institutions and nation
states have conducted collaboration and capacity building initiatives invoking a variety of geo-political,
disease-specific, institutional and disciplinary funding rationales. The last decade has witnessed augmented
funders and institutions investing in collaboration and capacity building as practical and ethical global health
solutions in the Global South. This qualitative research paper presents views of senior African scientists in
over ten African countries/spaces on their experiences of collaboration and capacity building, what these
terms mean in practice, and who they regard as beneficiaries. The seniority of these scientists allows their
insights into the relative success and failure of different initiatives over their careers and the types of criteria
they employ to assess how these initiatives are designed, funded, executed and evaluated.
5
The Asymmetry of English: Localising Language in Global Health
English is the undeniable lingua franca of “global” development, as: communication mode across “partners;”
default technical guidance language; and conference exchange medium. Language is typically seen as a
logistics issue, overcome through - unidirectional – translation, but it is also about power–symbolic,
experiential and structural issues privileging certain people, skills, and modes of communication. Based on
Indian public health practitioner experiences, we explore (i) ethical and practical implications of an Englishcentric global health; and (ii) methods to de-centre language and redress power asymmetries, amplifying
local voices in global conversations. We encourage the global health community to consider: (i) the role of
English beyond translation, e.g., how language allows connection to local realities; (ii) that public health work
needs to address and budget for the role of language, and translation of public health concepts and idioms;
and (iii) how we visit places, do research, and who represents the “national” and “global.”
Equalizing ‘Partnerships’ & ‘Capacity Building’ to Improve Local and Global Genomic Research
Involving Low and Middle Income & High Income Countries
Genomic research in low and middle income countries continues to be driven by high income countries. This
prevents LMIC’s from developing indigenous capacity to address local health needs and boost economic
growth, and limits access to indigenous communities and opportunities to build a comprehensive unbiased
map of worldwide human genetic variation. Global genomic research requires engaging LMIC’s as equal
partners providing local knowledge to dissect genetic influences on pathological phenotypes. Equitable
research partnerships building local research capacity are essential to promote global genomic research, but
can reinforce colonialist views of LMIC’s as vulnerable, and negatively influence research policies and
funding strategies design. This paper argues for an ethical approach based on a cosmopolitan vision of
global solidarity and focused on avoiding exploitation, enabling LMIC’s to steer their own research and
funding agendas. This replaces colonialist models, better grounds mutual obligations, and promotes
egalitarian global partnerships for sustainable development.
China and El Salvador: Defying Ethical Dilemmas
This presentation focuses on how bioethical dilemmas are encountered, practiced, and addressed within
local communities, among local health practitioners, and global health researchers. Ethical conduct must be
recognized, researched, and put into practice in educational, policy, and health care delivery. Ethical issues,
privacy, beneficence, and professional practice affect health personnel in training and practice. Despite
current educational efforts and lessons learned, communities are still experiencing bioethical dilemmas from
external researchers and local public health practitioners in both El Salvador and China, suggesting these are
global bioethics problems that need to be addressed. Through workshops, curriculum development, and
outreach to both public and private sectors, bioethical dilemmas can be made more visible and solutions
collaboratively found. Global health professionals are obligated to build social capital around bioethical
concerns, and in that way develop equitable and sustainable solutions. Data are drawn from the author’s
personal working experiences in El Salvador and China.
Moorfoot
S37: Symposium: "Art + Bioéthique": Interdisciplinary Dialogue on Art
as a Catalyst for Exchanges and Knowledge Transfer PN: 622
Chair: Vardit Ravitsky
Université de Montréal, Québec, Canada
1
1
Maude Laliberté , Victoria Doudenkova , Jean-Christophe Bélisle Pipon
1
Université de Montréal, Québec, Canada
1
Keywords – Art Exhibition; General Public; Collaborative Work; Practical Interdisciplinarity; ResearchCreation
Discipline(s) – Aesthetics; Art; Bioethics; Ethics; Knowledge Transfer; Art History
Abstract
The exhibition “Art + Bioéthique” was held in a gallery in Montréal (Canada) in March 2016. This project was
based on an interdisciplinary and collaborative strategy to shed light on critical issues in bioethics. The
expression of bioethics through art represents an innovative way to convey the "sensitive" aspect of so many
6
ethical issues in health. Art stimulates reflection and discussion on the distress, vulnerability, the uncertainty
of technological innovation and the daily lives of human beings. Since scholar writing faces limitations in
transmitting underlying tensions of ethical dilemmas, the use of artworks provides an alternative approach to
the dissemination and media coverage of bioethical issues to the general public. The aim of the project was
twofold. First, to co-construct a dialogue between art and bioethics. Second, to engage a discussion on
bioethical issues with the public through an exhibition and cultural & scientific mediation activities. The
exhibition consisted of the artworks and essays of six duos of young researchers and emerging artists. Each
duo worked on a variety of issues such as the social inclusion of disabled people to the challenges of
practical applications of nanomedicine and regenerative medicine, and the holistic approach of contemporary
diseases. During the symposium, the intervention of the organizers, exhibition curators and a researcherartist duo will present the project’s genesis, its organization and its outcomes. This is an opportunity to
engage in interdisciplinary dialogue between bioethics, art and innovation in knowledge transfer.
Chair:
1. Presentation by the organizers: Jean-Christophe Bélisle Pipon and Maude Laliberté (presenting
author)
In 2015, we – a group of young scholars in bioethics – decided to find innovative ways to engage the general
public in exchanges on contemporary and compelling bioethics issues. The art exhibition “Art + Bioéthique”,
held in a gallery in Montréal (Canada) in March 2016, is a result of this project. In this presentation, we will
discuss the genesis of the project, the different steps of its development and the main facilitators and
obstacles we encountered. This introduction will pave the way to a discussion about interdisciplinary dialogue
between bioethics and art, involving a variety of actors from – of course – bioethics, but also the history of art,
law, knowledge transfer, veterinary medicine and biosciences.
2. Presentation of the artworks and essays: Jean-Christophe Bélisle Pipon and Maude Laliberté
(presenting author)
How separate fields like art and bioethics can learn from each other? How can the imaginary and
creativeness help to understand the concepts of bioethics that, nonetheless, concern all of us? How can art
bring the citizen to a personal encounter with this field and to a more enlightened perception about pressing
issues of our time? These questions guided the curatorial approach for “Art+Bioéthique.” This presentation
will cover the genesis of the creative process of the six artists (Canada, France and UK) of the exhibition.
During six months, they worked with a bioethicist and their dialogues inspired the final artwork. We will
explore how these works are rooted in each artist’s practice, and how new concepts and ideas emerged from
their interactions with the researchers. We will also present the six pieces and how, with a diversity of
mediums and aesthetic strategies, the artists brought contemporary bioethics to the general public.
3. Presentation of a duo: Victoria Doudenkova (presenting author)
Among all the participants of “Art + Bioéthique”, a duo composed of one young scholar in bioethics and one
emerging artist will present their experience. For the bioethicist, it is the opportunity to show how the meeting
with the artist – and more generally art – changed her approach to her research topic, her perception of the
sensitive dimension of her research as well as on modalities to interact and communicate more effectively
with the general public. For the artist, it is an opportunity to share how the encounter with bioethics allowed to
explore and unwind (in her own way) a series of issues related to health, the human body, science and
general knowledge as well as morality. Between these points of view lie the meeting of two worlds that were
able to talk and better understand each other, as a starting point initiating an unfinished dialogue to be
continued.
4. Conclusion on the outcomes and contribution of the project: Jean-Christophe Bélisle Pipon and
Maude Laliberté (presenting author)
In the concluding note of this symposium, we will present the current outcomes of the project for the
organizers, the general public and the artist-scholar duo. We will discuss of the already planned next steps of
this project to pursue the interdisciplinary dialogue between bioethics and art. We will also expose the
implications of the project for the local community in bioethics and present some ideas for the development of
knowledge transfer initiatives and the future of bioethics.
7
Carrick 2
S2: Pharmaceuticals/Drug Development
Chair: Gerard Porter
PN: 90
Risk, Benefit, and the Ethics of New TB Drugs
1
2
3
Diego Silva , Angus Dawson , Ross Upshur
2
3
1
Simon Fraser University , Burnaby, Canada, University of Sydney, Sydney, Australia, University of Toronto,
Toronto, Canada
Keywords – Tuberculosis; risk-benefit analysis; infectious diseases; public health ethics; global health ethics
Discipline(s) – Philosophy; applied ethics
Abstract
Tuberculosis (TB) kills approximately 1.5 million people per year globally. Multi-drug resistant TB (MDR-TB)
accounts for 200,000 deaths annually, approximately half of those infected. After waiting 40 years, in 2012
and 2013, two new antitubercular drugs were conditionally approved for use in treating MDR-TB, bedaquiline
and delamanid; however, both have serious side effects (e.g., unaccounted deaths in the treatment arm of
the bedaquiline study, increased QT intervals in the treatment arm of the delamanid study). Given the
morbidity associated with MDR-TB and the uncertain safety profile of new antituberculars, patients and
communities are required to balance the risks and benefits of new treatments with incomplete or suboptimal
information. Building on Jonathan Wolff’s distinction between an individual’s perception of risk versus the
perception of the imposition of risk, we argue that the balancing of risks and benefits, both from the
perspective of individuals with TB and their communities, requires a careful understanding of the social and
political contexts in which the risk of MDR-TB and new antituberculars are introduced. How supported or
unsupported a TB patient feels may affect not only psychologically, but also morally, how patients and the
public do, and ought to, balance the risks associated with new TB drugs and the disease itself.
PN: 159
Are Pharmaceutical Companies Who Conduct Research in Developing
Countries Ethically Obligated to Share Intellectual Property (IP) Rights
With Host Countries?
1, 2
Suchana Sova
2
1
Monash University, Clayton, Australia, Jagannath University, Dhaka, Bangladesh
Keywords – Health; Justice; Contributions; Clinical Trials; Intellectual Property Rights; Adding Value of
Labour Theory
Discipline(s) – Bioethics
Abstract
Access to existing essential medicines is severely inadequate in the developing world. Although considerable
international biomedical (IB) research is conducted in collaboration with developing nations, the IP and
patents derived from such research are exclusively owned by the developed nations or pharmaceutical
companies sponsoring the research. The current TRIPS (Agreements on Trade Related Aspects of
Intellectual Property Rights) regime poses significant additional threats to the health of the poor in developing
nations. IB research and development typically yields a net benefit to sponsors but not to the co-contributorhost nations, who bear enormous burdens. Therefore, this paper questions whether the currently accepted
meaning and application of IP rights by global and national institutions provides a morally justifiable
foundation for the fair distribution of the benefits and burdens of human research. I argue in this paper that,
instead of rejecting patents themselves, the basic principle of justice in frameworks designed to ensure
fairness in distributing benefits from IB research should include a recognition of developing nation’s human
resource contributions by sharing the IP rights to successfully tested drugs. Consequently, TRIPS should be
shaped by a principle of just property acquisition based on an inclusive notion of contribution. Drawing on the
notion of Adding Value, from Lockean labour theory, this paper highlights the nature of host nation’s
8
contributions, for establishing the moral rights of developing nations for a share of pharmaceutical IP rights.
Consequently, I also argue that developing nations are legally entitled to claim a fair share of derived benefits
of IP.
PN: 260
Trial Design During Epidemics: What Can We Learn from Ebola?
1
Dr Annette Rid
King's College London, London, United Kingdom
1
Keywords – 2014 Ebola Epidemic; Randomized-Controlled Trials; Alternative Trial Designs; Risk-Benefit
Assessment
Discipline(s) – Research Ethics; Global Health Ethics
Abstract
In 2013, the world began to witness an unprecedented Ebola epidemic in West Africa. Clinical trials of
experimental vaccines and targeted treatments for Ebola soon emerged as a key component of the global
response. These experimental interventions were in the earliest phases of testing at the beginning of the
epidemic, and whether and how they should be deployed caused heated controversy not only among
investigators, sponsors and host communities, but also among bioethicists. A key point of contention was
how clinical trials should be designed and, in particular, whether it was acceptable to conduct trials that
withhold the experimental vaccines or treatments from a control group. This talk reviews the respective
ethical debate and tries to distil some “lessons learned” for how to design clinical trials in future epidemics.
PN: 635
An Ethical Analysis of the SUPPORT Study: Addressing Challenges
Posed by Randomized Controlled Trials Comparing Treatments Used
Routinely in Medical Practice
1,2
1,2
2,3,4
Austin Horn , Charles Weijer , Monica Taljaard
2
3
1
Western University, London, Canada, Rotman Institute of Philosophy, London, Canada, Ottawa Hospital
4
Research Institute, Ottawa, Canada, University of Ottawa, Ottawa, Canada
Keywords: Standard of Care Randomized Controlled Trials; Research Ethics; Bioethics; Clinical Trials;
Health Policy and Systems Research
Discipline(s): Philosophy; Bioethics
Abstract
Standard of care randomized controlled trials (scRCTs) test the comparative effectiveness of interventions
used routinely in medical practice, providing information critical to health care delivery. scRCTs present
difficult ethical challenges because they intermingle interventions routinely used in practice with research.
Consider the SUPPORT trial (NEJM, 2010). It compared the effects of two routinely used oxygenation ranges
on outcomes of mortality and retinopathy in preterm infants. Investigators found lower oxygen levels reduced
retinopathy, but increased mortality. The U.S. government launched an investigation into the trial, determining
investigators failed to adequately inform parents of “reasonably foreseeable risks,” as consent materials did
not list visual impairment and death as research risks. The question raised by the SUPPORT trial is: ought
routine medical interventions in scRCTs be regulated as practice or research? Recent commentators,
including Lantos (Hastings Center Report, 2015), have argued that such interventions should be regulated as
practice as they pose no incremental risk to study participants. We argue that there are compelling reasons to
regulate routine medical interventions in scRCTs as research interventions. In medical practice, treatment is
the product of joint deliberation between the physician and patient; in a scRCT, treatment is assigned to the
patient randomly. As a result, the treatment a patient receives is neither the product of a physician
recommendation nor the patient’s values. We argue these are sufficient grounds to regulate such
interventions as research. Our analysis has implications for the scope of authority of research ethics
committees, harm-benefit analysis, and informed consent for scRCTs.
9
Carrick 3
S4: Public Health
Chair: Marcel Verweij
Wageningen University and Research Centre, Wageningen, the Netherlands
PN:46
Health as a Dimension of Freedom
1
François Hudon
1
Institute for Ethics, History, and the Humanities - Faculty of Medicine, University of Geneva, Geneva,
Switzerland
Keywords – Health; Freedom; Public Health; Public Policy
Discipline(s) – Public Health Ethics; Political Philosophy; Bioethics
Abstract
Recent results in cognitive psychology and epidemiology have inspired a wave of public health proposals that
target food habits. Predictably, these proposals have triggered a revival of the debate on paternalism in public
health ethics. However, given the centrality of freedom in this debate, it is surprising that the rich political
philosophy literature on freedom is barely referenced. The aim of this paper is to use this literature in order to
clarify the conceptual relation between health and freedom. This clarification could help resolve apparent
conflicts between health and freedom. We hope to show that health can be conceived as a dimension of
freedom; that is, illnesses are potential constraints and healthy states are potential objects of freedoms.
Contrary to Daniels, health is not approached here as a condition for a fair equality of opportunity but rather
as a dimension of freedom. In that sense, it is much closer to Sen’s capability approach to health. The main
distinctions from Sen include a focus on the paternalism issue rather than on the currency of health justice
and direct engagement with the contemporary freedom literature. In this approach, freedom is never simply in
conflict with health. Instead, we have trade-offs between health-related freedoms and other freedoms. Only if
we define freedom in a narrow way can health policies constrain some freedoms without increasing other
freedoms.
PN: 503
Implementing a New Model of Public Health Regulation: Looking
Forward, Looking Back
1
1
2
2
Brenda McGivern , Catherine Kelly , Tarun Weeramanthri , Bronwyn Peters
2
1
University of Western Australia, Crawley, Australia, Department of Health (WA Health), East Perth,
Australia
Keywords – Public Health Regulation; History of Public Health; Implementation
Discipline(s) – Law; Public Health
Abstract
Public health regulation in Australia is moving away from its colonial origins, largely concerned with sanitation
and infection control, towards a broader model reflecting the evolving and expanding understanding of public
health itself. Using the exemplar of Western Australia’s recent Public Health Bill (‘Bill’), the first
comprehensive reform of public health legislation in this State in well over a century, this paper considers the
implications and challenges of moving away from a largely prescriptive model of regulation to a risk-based
framework, underpinned by a general public health duty. This paper arises from the initial phase of a
research-led implementation initiative, undertaken collaboratively by researchers at the University of Western
Australia and Southampton University Law Schools and the WA Department of Health. By examining the
historical context of the reforms, the authors identify their significance. The operation of, and exercise of
power under, this modern model is expressly intended to be more responsive to current and emerging public
health challenges. The flexibility it introduces will, however, require a new approach to decision making by
those charged with its implementation, including at different levels of government. The authors suggest that
bioethical principlism may be a useful framework against which to model and assess the exercise of
10
discretion, with the particular aim of promoting and facilitating principled decision making, informed by the
ethical underpinnings and objectives of the Bill.
PN: 97
From the Asilomar Conference to the Napa Meeting – Opportunities and
Limits of Self-Regulation in Life Sciences
1
1
Daniel Gregorowius , Anna Deplazes Zemp
1
Institute for Biomedical Ethics and History of Medicine, University of Zurich, Switzerland
Keywords – Life Sciences; Asilomar; Napa; Self-Regulation; Minimal Consensus
Discipline(s) – Biomedical Ethics; Congress Theme: Global Bioethics
Abstract
This paper discusses the role of the scientific community and their forums in global debates on controversial
issues in biotechnology to foster self-restrain and stimulate self-regulation. The role of science is exemplifies
by pointing to the impact of the famous Asilomar conference and the recent meeting in Napa in 2015 where
the application of the CRISPR-Cas9 technology was critically discussed. These two meetings are compared
regarding their opportunities and limits in guiding future developments and regulations in life sciences. We
argue that with respect to safety issues the self-regulatory approach is effective. However, when culturally
relevant values and norms are concerned the process of finding a general consensus and initiating selfregulation comes to its limits. The paper concludes that the regulation of novel developments that rise safety
issues and moral concerns should be regulated at different levels: at a global and a national level. Moreover it
stresses the importance of including experts from bioethics and law in the process of self-regulation. At a
global level, the scientific community together with these experts should elaborate guidelines based on a
minimal consensus on potentially unacceptable procedures and the purposes that should be pursued with
new technologies. These guidelines will be enforced through the scientific system. At the national level,
however, the legal regulation of a technology can go beyond the global minimal consensus and must take
into account cultural values and public concerns. It should be the result of a participatory process in which
scientists are one of several stakeholders.
PN: 384
Reckless Use of Antibiotics in China: Reflections on Global Health
Ethics
1
Yali Cong
Peking University Health Science Center, Beijing, China
Keywords – Gap Between Clinical treatment and Public Health Prevention; Values; Profession Authority;
Global Health Challenges
Discipline(s) – Global Health Ethics
1
Abstract
Antibiotic resistance is becoming a global health issue. It represents one of the biggest threats to global
health today, and can affect any one, of any age, in any country. WHO took a survey among 12 countries in
2015, and found that Antibiotic use is widespread: 65% of respondents across the 12 countries included in
the survey report having taken antibiotics in the past six month. WHO advises that patients should always
take the full prescription, even if they feel better earlier. Respondents in Sudan, Egypt and China were
particularly likely to state that they should stop taking antibiotics when they feel better, with 62%, 55% and
53% of survey participants respectively choosing this response. Due to the large, dense population and close
interactions between people and livestock, it makes China represent the biggest threat to this global health
issue. Besides this, farmers also contributed lot to the content of antibiotics in soil and water. To control the
problem, the wise strategy is to control it in China first. Corresponding to this, the author and her team have
started the interview to doctors in 2015 about the reckless use and values and attitude towards china’s
burden to this global health issue. The research in on going, but from the interview of the limited number till
now, we can find the complex situation, including the bad environment to make patients vulnerable to be
infectious which make doctors to overly prescribe for prevention; family member and patients request due to
their incorrect knowledge, but doctors tend to satisfy them instead of insist on profession authority; hospitals
11
live on drug sell in last decade makes big prescription on antibiotics; very low sense from doctors on their role
to undertake the responsibility of global health, etc. More findings will be out with the progress of interviews.
Harris 1 & 2
S70: ECR Session: Presenting
1
2
3
4
Bartha Maria Knoppers , Inez de Beaufort , Florencia Luna and Julian Savulescu
1
2
Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada, Erasmus MC, Rotterdam,
3
4
Netherlands, Facultad Latinoamericana de Ciencias Sociales (FLACSO), Buenos Aires, Argentina, Oxford
Uehiro Centre for Practical Ethics, University of Oxford, United Kingdom
Presenting can be quite an ordeal, even for experienced colleagues. This session will provide delegates with
some helpful advice on presenting work. Our panel will offer advice on the following topics: What makes a
great presentation?; What makes a terrible presentation?; How to deal with diverse audiences; how to deal
with time-keeping balancing limited time with deep ideas; how to make an impact on your audience, and how
to communicate complexity through simple language without compromising quality.
Ochil 1
S14: (Surrogate) Decision-making
Chair: Stuart Nicholls
Children’s Hospital of Eastern Ontario Research Institute, Otttawa, Ontario, Canada
PN: 534
Thinking About Decision Making on Behalf of Adults Who Can No
Longer Make Decisions for Themselves
1
1
2
Helen Convey , Janet Holt , Barbara Summers
2
1
School of Healthcare, University of Leeds, Leeds, United Kingdom , Centre for Decision Research, Leeds
University Business School, University of Leeds, Leeds, United Kingdom
Keywords – Ethical Dilemma; Proxy Decision Making; Psychological Distance; Dementia
Discipline(s) – Philosophy; Psychology
Abstract
Decision makers sometimes encounter ethical dilemmas when making everyday decisions on behalf of
incapacitated individuals who are living with dementia. These individuals have interests and desires,
regarding daily and social activities, which may be demonstrated through their behaviour and verbal
communication. However, memory loss results in a lack of psychological continuity between the past and the
present self. When contemporary interests and desires conflict with past interests and desires proxy decision
makers experience an ethical dilemma because they must choose which interests and desires should take
precedence. This mixed methods study applies Construal Level Theory to proxy decision making.
Participants are presented with ethical dilemmas in semistructured interviews. Thematic analysis is used and
responses are analysed for abstractness of language using the Linguistic Category Method. Levels of
abstraction in responses and influences on abstraction are measured. To the best of our knowledge
Construal Level Theory has not been applied to proxy decision making. Using mental construal to traverse
psychological distance involves thinking about choices, alternatives and perspectives in different dimensions;
temporal, spatial, social and hypothetical. In mental construal abstraction is used to move beyond direct, real
experiences of the self, across psychological distance, to form a subjective view of an object or action. Lowlevel construal is concrete, detailed and contextualised. High-level construal is more abstract, central values
receive attention. Proxy decision makers may use abstraction to connect with the whole life narrative of the
individual when evaluating benefits and burdens.
12
PN: 341
Exception to consent in a pediatric resuscitation Randomized Control
Trial (RCT): Exploring the experiences of substitute decision makers
1
1,2
1,3
Lisa Schwartz , Sonya de Laat , Melissa Parker
2
3
1
McMaster University, Hamilton, Canada, Western University, London, Canada, McMaster Children's
Hospital, Hamilton, Canada
Keywords – Consent; Research; Emergency; Paediatric; Qualitative
Discipline(s) – Research Ethics; Paediatric Intensive Care; Qualitative Methods
Abstract
International research ethics standards endorse an exception to prospective informed consent for research in
medical emergencies. While an exception to consent may be ethically justifiable to facilitate rigorous
evaluation of time-sensitive interventions in acute life-threatening conditions, little information is available
regarding the experiences of participants and substitute decision-makers (SDM). Recognizing the importance
of an evidence-based approach to research ethics, we sought to better understand the experience of
parents/guardians within a pilot RCT involving children with septic shock. The Pilot study for the SQUEEZE
Trial [NCT01973907] is a 2-arm parallel group pilot RCT designed to evaluate two different and accepted
resuscitation (emergency treatment) strategies in children with septic shock. Because the SQUEEZE Trial
intervention occurs during emergency resuscitation procedures, children are randomized for the study without
parental/guardian consent. After resuscitation is attempted, a member of the SQUEEZE Trial team
approaches parents/guardians, provides information and seeks consent for continued participation. The
fragility of post-enrolment consent motivated this qualitative ethics study. Methods: We performed openended interviews with parents/guardians and examined limited clinical data from the SQUEEZE trial. Here we
present findings on the experiences, affect, information retention, and intervention interpretation by
parents/guardians in relation to supporting development of evidence-based ethics guidelines which will be
used to inform implementation of the exception to consent process in the fullscale multicenter RCT and may
be implemented in other essential emergency paediatric research evaluating promising time-sensitive
interventions. Funded by a CIHR Catalyst Grant – Ethics.
PN: 205
Decision Making About Screening: Public Interests, Paternalism and
Public Health Policy
1
2
Stacy Carter , Vikki Entwistle
2
University of Sydney, Australia, University of Aberdeen, United Kingdom
1
Keywords – Informed Decision Making; Relational Autonomy; Paternalism; Public Health; Screening
Discipline(s) – Public health ethics
Abstract
Publicly organised cancer screening programs are well-established and popular in many high-income
countries. They arguably serve only a weak public interest; the benefit-harm balance for individuals
increasingly seems uncertain or unfavorable. Policymakers are responding in part by encouraging citizens to
make informed decisions about participation. This, unlike persuasive social marketing, allegedly avoids
paternalism. On decisional conceptions, giving people clear, accurate and relevant information on which to
base personal decisions about whether to participate in screening will usually suffice to avoid paternalism.
Relational conceptions of paternalism attend to a broader range of ways in which a person’s autonomy can
be undermined, so are arguably more demanding. In particular, they deem communication about screening
that undermines the self-governance or self-authorisation of individuals to be paternalistic. They suggest a
need for critical attention, for example, to messages with potentially negative implications for people’s selfrespect or authenticity, such as social marketing messages implying that only bad or unworthy mothers would
reject offers of screening for women’s cancers. Revising screening communication to include support for
informed decision-making might avoid paternalism on decisional conceptions, but relational conceptions
suggest that more comprehensive correctives might be needed to avoid paternalistic screening
communication practices.
13
PN: 69
Maintaining Nursing Students’ Moral Sensitivity in a Clinical
Environment through the Ethical Decision-Making Model (Four-Topic
Approach) and Support
1
1
Hsiao Lu Lee , ling Ing Lee
1
Yuhing Junior College of Health Care & Management, Kaohsiung City, Taiwan
The Taiwan Nursing Accreditation Council has proposed eight core professional nursing qualities. Nursing
students often encounter frustrations in clinical work. This can cause moral distress. Should they reduce their
moral sensitivity? This study explores explore whether we can maintain nursing students' moral sensitivity
and reduce their moral distress in clinical environments by using the ethical decision-making model (FourTopic Approach) and support. This study used experimental research design. The participants were
practicing in clinical environments. The participants were a randomized an "experimental group" and a
"control group". A pre-test and post-test involving the moral sensitivity and moral distress of subjects was
administered before Week 1 and after Week 4. Experimental group intervention was performed by practicing
the ethical decision-making model and giving teacher support for 3 weeks. Comparison was made between
the "experimental group" and the "control group" using the moral sensitivity, the moral distress. Comparison
of the pre-test and post-test results revealed that the participants’ moral sensitivity and moral distress scores
increased significantly(p㸻.005;p㸻.000). Comparison of the "experimental group" and "control group" in
moral sensitivity and moral distress showed no difference (p>.05). Nursing students who practiced ethical
decision-making model (Four-Topic Approach) with teacher support got higher moral distress and moral
distress scores.
Ochil 2
S47: Symposium: Towards the Development of Ethics Guidance for the
Conduct and Review of Health Policy and Systems Research PN: 48
1
4
3
2
Bridget Pratt , Joseph Ali , Aminu Yakubu , Adnan Hyder
2
1
University of Melbourne, Melbourne, Australia, Johns Hopkins Bloomberg School of Public Health,
3
4
Baltimore, USA, Federal Ministry of Health, Nigeria, Abuja, Nigeria, Johns Hopkins Berman Institute of
Bioethics, Baltimore, USA
Discipline(s) – International Research Ethics
Keywords – Health Systems Research; Ethics Guidance; Scoping Review; Research Ethics Committees
Abstract
Health policy and systems research (HPSR) is increasingly being funded as part of health system
strengthening efforts worldwide. How research ethics principles are interpreted and applied within HPSR can
be quite distinct from biomedical research. Yet no comprehensive guidance currently exists on what ethical
issues are relevant for the conduct of HPSR or how to address them. This symposium will characterize the
central ethics issues in HPSR, the nature of available scholarly and professional guidance on these issues,
and make recommendations for addressing gaps in international policy and guidance.
Introductory remarks (moderator): These remarks will frame the problem focused on by the symposium
and explain the need for developing ethics guidance for HPSR. They will describe the rationale for why the
World Health Organization and the Alliance for Health Policy & Systems Research commissioned a scoping
review of literature on HPSR ethics and the process its outputs have fed into towards the development of
such guidance. It will summarise the aims of the scoping review: 1) identify the key ethics issues relevant to
the conduct of HPSR–with a deliberate (though not exclusive) focus on issues that may be relevant to HPSR
conducted in low and middle-income country settings, and 2) identify and describe existing guidance on the
key ethics issues relevant to HPSR. (Adnan A. Hyder – Johns Hopkins Bloomberg School of Public
Health)
14
Paper 1: Ethical issues in HPSR: Mapping the literature
This paper will detail the methods used to map the literature on HPSR ethics and, based on the analysis of
that literature, describe what ethical issues arise globally during the conduct and oversight of HPSR. Using
the Cochrane methods as a basis, the scoping review identified 109 documents on HPSR ethics by searching
PubMed’s Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs,
OpenDOAR, and Bielefeld Academic Search Engine. Ethical issues in four main categories were identified
through thematic analysis: upholding autonomy, identifying and balancing risks and benefits, justice, and
determination of ethical review requirements. The review indicated that the ethical goals behind HPSR place
an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical
considerations and concerns relating to justice arise in HPSR, including that disadvantaged populations are
not adequately included and that global/donor priorities overly influence what HPSR is performed. (Joseph
Ali – Johns Hopkins Berman Institute of Bioethics)
Paper 2: Available guidance and gaps in guidance: Recommendations for future work
This paper will describe the available guidance on HPSR ethics that was identified by the scoping review and
highlight where gaps in this guidance lie, i.e. where little to no guidance exists for particular ethical issues
arising in HPSR. The majority of the guidance found primarily comes from scholarly literature. Thematic
analysis identified general guidance on ethical issues in four main categories: upholding autonomy,
identifying and balancing risks and benefits, justice, and determination of ethical review requirements.
Although numerous ethical considerations and concerns relating to justice arise in HPSR, the majority of
guidance focuses on obtaining or waiving informed consent. In terms of guidance on HPSR methods, the
vast majority focuses on cluster trials. A list of priority ethics issues in HPSR in need of guidance
development will be provided. (Bridget Pratt – Nossal Institute of Global Health and Centre for Health
Equity, University of Melbourne)
Paper 3: A national perspective on ethical oversight of HPSR: Experiences from the Nigerian National
Health Research Ethics Committee
This paper provides reflections on the types of ethics concerns that have been raised when proposed HPSR
projects come to the author’s REC [and the Nigerian Ministry of Health]. Specific examples include: dilemmas
as to whether to present HPSR projects as research or not; whether consent as understood in biomedical
research applies in HPSR; whether age of consent requirements for biomedical research ought to remain the
same for Health Services Utilisation surveys. Whether these ethical issues are consistent with those reported
in the literature identified by the scoping review or whether there are concerns that the scoping review did not
uncover is discussed. In doing so, the paper compares what is documented in the literature to what is actually
experienced in practice in Nigeria. It will also identify areas where RECs are especially in need of guidance in
order to be better able to systematically review HPSR projects. (Aminu Yakubu – Federal Ministry of
Health, Nigeria)
Ochil 3
S15: (New) Technologies
Chair: Tamra Maree Lysaght
Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
PN: 236
Ethical Issues on Human Germline Gene Editing: A Perspective from
China
1
Di Zhang
Peking Union Medical College, Beijing, China
1
Keywords – Gene Editing; Germline Modification; Bioethics; Justice; Eugenics
Abstract
Gene editing offers efficient targeting of genomic sequences, which is more reliable and less expensive than
previous techniques to alter the genome. This suggests that human germline genetic modification will be
15
effective and safe in the near future. Concerns have been raised about human germline gene editing,
especially after Chinese scientists published their research on human embryos. In December 2015, experts
from China, US, and the UK released an international summit statement on Human Gene Editing, with four
key conclusions: 1. Basic and Preclinical Research is clearly needed and should proceed, but modified cells
should not be used to establish a pregnancy. 2. Clinical research in somatic cells is already well covered by
existing regulatory frameworks. 3. Clinical research which involves alterations of the germline requires that
safety and efficacy issues have been resolved and that “there is broad societal consensus about the
appropriateness of the proposed applications”. In addition, an appropriate regulatory framework must be
developed as this research is currently prohibited in many countries. Finally, an ongoing forum must
“establish norms concerning acceptable uses of human germline editing and harmonize regulations”. China is
already a country that is at the forefront of human genetics research. The perspective from China is therefore
vital when international norms are developed and harmonized. This paper will present the Chinese discussion
of the ethics of germline modification, both in the popular media and in academic fora, as a first step in the
process of international dialogue and harmonization.
PN: 483
The Safety Issue of Human Germ-Line Modifications in the Era of
Precise Genome Editing
1
Peter Sykora
1
Centre for Bioethics, University of St. Cyril and Methodius, Trnava, Slovakia
Keywords – CRISPR/Cas9, Gene-editing, Germ-line; Off-Target; Safety
Discipline(s) – Bioethics; Genetics
Abstract
Until recently, off-target changes in the genome caused by gene transfer technologies were seen as a major
safety obstacle for using them for human germ-line modifications. However, recent rapid improvements of
new genome editing technologies like CRISPR/Cat 9 in effectivity as well as in precision are able in near
future to minimize the problem of unintended, off-target changes in the genome to the acceptable risk level.
The safety issue then will turn to a question of how compatible are well-intended, in-target gene interventions
with a delicate balance of the human genome regulatory network. The problem is that we are still at the
beginning of understanding the whole complexity of human genome. According to the ENCODE Project a
human genome is not a collection of independent genes, but rather a complex network of genes, regulatory
elements and other types of DNA sequences interacting in overlapping ways. How much the findings support
“human genome as the house of cards” analogy (F. Fukuyama) or its criticism (A. Buchanan) has to be
resolved empirically. I will argue that in the meantime the red line should not be drawn between human
somatic modifications and germ-line interventions, as it was reaffirmed by broad consensus during the last
year in reaction to CRISPR/Cas9 editing of non-viable human embryos. Instead, the red line for clinical
experiments should be running between permitted restorations of wild-type DNA sequences in defective
genes and the restriction on creation of new DNA sequences in human genome (for both therapeutic and
enhancement purposes).
PN: 416
Smart Technology and Ethical Care Relationships
1
1
2
Anita Ho , Nigel Hee , Oliver Quick
2
1
National University of Singapore, Singapore, University of Bristol Law School, Bristol, United Kingdom
Keywords – Smart Technology; Regulation; Physician-Patient Relationship; Patient Safety
Discipline(s) – Medical Ethics
Abstract
This presentation considers the impact of smart technology on the quality of patient care and the therapeutic
relationship. Making health monitoring devices commercially available will likely become an important aspect
of self-care and preventive medicine. However, these devices pose ethical challenges for clinicians. On the
one hand, these technologies may promote patient autonomy by empowering people to take charge of their
own health and promote efficient sharing of health information that can facilitate more equal professionalpatient relationships. On the other hand, if they are not regulated or incorporated appropriately into clinical
16
care, or that patients and providers are not adequately educated, these technologies can pose significant
professional and safety concerns. Furthermore, data accuracy from some devices is doubtful, raising the
question of how seriously clinicians should consider and incorporate patient-generated data in developing
care plans. Depending on when/how smart technologies are acquired and utilized (e.g., purchased as
consumer products versus prescribed by clinicians), the development, marketing, and employment of such
technology can have ethical implications for confidentiality, therapeutic relationships, and patient safety. We
argue for the need of unified regulatory guidelines and better alliance of incentives for both healthcare
providers and patients.
PN: 235
The Ethics of Organoid Technology: Perspectives of Patients with
Cystic Fibrosis
1
1
3
3
2
Sarah Boers , JJM van Delden , Jacquelien Noordhoek , Vincent Gulmans , Karin Winter-de Groot , Kors
2
1
van der Ent , Annelien Bredenoord
1
Julius Center, department of Medical Ethics, University Medical Center Utrecht, Utrecht, the Netherlands,
2
Department of Pediatric Pulmonology. Wilhelmina Children's Hospital, University Medical Center Utrecht,
3
Utrecht, the Netherlands, Dutch Cystic Fibrosis Foundation (NCFS), Baarn, the Netherlands
Keywords – 1) Organoids; 2) Ethics; 3) Perspectives of patients; 4) Biobank; 5) Cystic Fibrosis
Discipline(s) – Bioethics; Social Sciences
Abstract
Organoids are chunks of cells, that are grown out of stem cells, and that mimic the real-life organ. This novel
technology is applied in several fields, among which Cystic Fibrosis (CF) research and care, where organoids
of CF patients hold a promise for personalised medicine. These three-dimensional immortalized cell lines
have a broad potential for scientific, clinical, and commercial use, but are paired with ethical challenges, like
questions about ownership, consent, the acceptability of commercialisation, and fair distribution. Little is
known, however, about the viewpoints of CF patients. Therefore, we aim to examine the opinions, attitudes,
and experiences of patients with CF and their parents regarding organoid technology. We conducted in-depth
interviews with 14 CF patients and 9 parents. Important themes that emerged from the interviews are control,
trust, an ambiguous perception of organoids, and return of individual results. Furthermore, the respondents
are ambivalent about the involvement of commercial parties. We find that the perspective of patients with CF
and their parents should be taken into account to achieve ethically sound development and implementation of
organoid technology.
17
WEDNESDAY 15TH JUNE 2016 16:00-17:30
Pentland Auditorium
S44: Symposium: Implementing Ethical Guidelines in Response to
Epidemics PN: 403
Chair: Lisa Schwartz
1
McMaster University, Hamilton, Canada
1
2
3
4
4
Stephen Kennedy , Carl Coleman , Michele Loi , Abha Saxena , Andreas Reis
2
Louisville Center (LC) of the Pacific Institute for Research and Evaluation, Calverton, Maryland, USA, Seton
3
4
Hall University School of Law, Newark, New Jersey, USA, ETH Zurich, Switzerland, World Health
Organization, Geneva, Switzerland
1
Disciplines – Ethics; Public Health; Social Science
Keywords – Epidemics; Communicable Diseases; Emergencies; Surveillance; Human Rights
Abstract
Among the public health activities pursued in the public interest, prevention and control of epidemics is one of
the most fundamental. Recent responses to infectious disease outbreaks have revealed several significant
ethical challenges for all parties involved, including policy makers, researchers, clinicians, health care
workers, other frontline workers, and the common citizen. Ethical guidelines are needed to support a
coordinated response by the different stakeholders directly or indirectly involved in the public health response
whether the response involves restrictions of freedom of movement of citizens, or contact tracing or the care
and treatment of patients in the context of limited resources, or the trial of new and experimental
interventions. There is already a significant literature exploring the difficult balance between measures
intended to protect the public interest and the rights of the affected individuals and groups. Guidelines already
exist on disease specific epidemic response, and on public health and research ethics. Here we present the
approach taken by the WHO to synthesize existing ethics approaches and guidelines through engaging with
an ethics working group for managing infectious disease outbreaks. This ethics working group included
expertise from a multisectoral group, including patients and patient representatives. We also draw attention to
the less commonly addressed problem of translating ethical guidelines into concrete, practical steps to
improve epidemics management, at the system- as well as the individual- response level. We present the
results of our deliberation with a synthesis of the major recommendations that have been put forward and the
WHO process of translation of ethics guidelines for use by policy-makers and practitioners, including a
recently published WHO training manual on “Ethics in epidemics, emergencies and disasters: Research,
surveillance and patient care.”
Chair: (Lisa Schwartz)
Individual paper abstracts:
1. Dr. Stephen Kennedy, Coordinator, EVD Research, Incident Management System (IMS), Liberia
Response to the Ebola epidemics in West Africa
Implementing adequate responses to epidemics during Ebola raises several challenges for countries and
communities in West Africa. Here we illustrate ethical questions raised by implementing public health
programs and research in a non-ideal context, characterized by inadequate infrastructure and resources,
insufficient coordination between national and international actors, and notable cultural and educational
differences between the stakeholders.
2. Carl Coleman, Consultant, WHO
The WHO normative guidance on response to epidemics
The Ebola epidemic has highlighted the importance of developing robust ethics guidance for managing
epidemics, so that the next time when an emergency arises, first responders, public health professionals,
researchers, and policy makers have a clear guidance on the ethical approaches to be used. However,
ethical issues vary depending on whether the epidemic is of a disease with a high mortality or high morbidity,
whether therapeutic interventions or vaccines against the epidemic exist and so on. Most contemporary
18
epidemics principally affect low and middle income countries where higher vulnerability and reduced capacity
to respond already exist. High-income countries contribute to international relief and must address crosscultural issues. All epidemics are steeped in risk and uncertainty, topics increasingly recognised as
permeating many ethically problematic situations. This presentation illustrates the process of development of
the WHO ethics guidelines for responses to epidemics and, its outcome.
3. Michele Loi, Consultant, WHO
Ethical responses to epidemics: some hard cases
Some questions concerning ethical responses to epidemics are more likely than others to spark moral
disagreement. I will mention a selection of such hard questions to test the reactions of this audience and
stimulate reflection on how to overcome disagreement, in particular: the permissibility of forced treatment in
extreme circumstances; the utility principle as a justification of giving priority, in health resource allocation, to
health care and frontline workers; the shifting of resource allocation decisions from treating clinicians to
independent committees; the sharing of surveillance information with law enforcement agencies; the adoption
of country-level restrictions of movement; the emphasis on sex and gender differences in analyzing and
designing responses to epidemics; opportunities for abortion in case of epidemics causing mild malformation
and handicaps, such as Zica.
4. Abha Saxena and Andreas Reis
The role of WHO in promoting ethics in responses to epidemics
The first presentation focuses on operationalization of ethics guidance. Just as translational science supports
the translation of clinical and technical guidelines into policy and practice, this presentation will focus on the
process of translation of ethics guidelines for use by policy-makers and into practice. We will describe the
methodology that we have used and the challenges encountered, especially in embedding ethics within
existing policies, procedures and knowledge base. In the second presentation, we will introduce a WHO
training tool that helps policy makers, public health professionals, epidemiologists and front line workers to
implement the epidemic ethics guidelines that have been presented in this session, and explain how this tool
can be used.
Sidlaw
S51: Symposium: Changing Regimes of Research Ethics Governance: A
Comparative Perspective PN: 340
1
2
3
1
Teck Chuan Voo , J.J.M. van Delden, , David Wendler , G. Owen Schaefer
1
Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore,
2
3
Council for International Organizations of Medical Sciences (CIOMS), Geneva, Switzerland, Section on
Research Ethics, Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, USA
Discipline(s) – Bioethics; Law and Policy
Keywords – Research Ethics; Biomedical Research Governance; Human Participant Protection; Ethics
Review; Human Tissue
Abstract:
The ‘Common Rule’ (US federal regulations governing research involving human subjects) and the CIOMS
Ethical Guidelines for Biomedical Research are undergoing a revision process. Recently, the Singapore
Parliament passed the Human Biomedical Research Act (HBRA)—a first-in-the-world legislative framework
for the regulation of human biomedical research and the handling of human tissue. Broadly speaking, these
regulatory reforms are responding to shifts and innovation in research activities and in research ethics, with
the goals of enhancing respect for human subjects and/or improving efficiency in ethics review and research.
This symposium will outline key (proposed) changes in the Common Rule and the CIOMs guidelines and how
the HBRA will affect the research and ethics review environment in Singapore; raise issues and challenges in
effecting changes; draw lessons about general trends in research governance while exploring different
directions taken; and discuss which directions are the right ones in responding to ongoing and anticipated
changes in the research landscape, and ensuring an ethical framework for future biomedical research. The
symposium will begin with short presentations on the Common Rule, CIOMS and on the HBRA (three
speakers, each an expert on one of these frameworks). The fourth presentation will provide a comparative
19
understanding and normative assessment of changes proposed or made (e.g., biobanking regulations, scope
of oversight) in terms of enhancing human subject protection and research efficiency (or other normative
criteria). Questions and discussion, chaired by the fourth presenter, will follow in line with the session’s novel
theme of a normative-comparative evaluation of changes in research governance regimes.
Individual Paper Abstracts:
Abstract 1: Proposed Revisions to the Common Rule
I will focus on four proposed changes to the US regulations. First, expanding the scope of the regulations to
cover all clinical trials conducted at institutions which receive federal funding for human subjects research.
Second, requiring a single IRB for multisite studies. Third, stipulating that the consent form should be limited
to “essential information that a reasonable person would want to know.” Fourth, requiring consent, and
endorsing one-time broad consent, for research on biospecimens, independent of the context in which the
samples are collected and whether identifiers will be retained. Finally, I will briefly describe the process for
revising the US regulations, highlighting how difficult it is to make changes and raising a question regarding
the proper balance between ease of changes versus the reliability and authority of the regulations.
Abstract 2: The CIOMS Revisions
In this contribution I will highlight some of the major changes in the currently revised draft of the CIOMS
ethics guidelines for health related research. These involve among others (1) an emphasis on the importance
of social value as a prerequisite for research, (2) a rebalancing of the possibilities to involve vulnerable
groups, such as children, in research and (3) a proposal for the ethical governance of research infrastructures
such as biobanks and databases. I will show how these changes aim to answer the current needs in research
and how we have tried to create guidelines that both reflect the discussions of the past and the needs of the
future.
Abstract 3: The Human Biomedical Research Act in Singapore: Impetus, Impact and Implementation
The Human Biomedical Research Act (HBRA), passed by the Singapore Parliament in August 2015, is a
complex piece of legislation that will significantly impact the way human biomedical research is conducted in
Singapore. HBRA is not yet in force and detailed regulations pursuant to the Act have yet to be promulgated.
What is certain is that it provides for new and criminally enforceable provisions for consent taking and
documentation; institutional review board organization and administration; research institution, institutional
review board, and individual researcher’s responsibilities; and human tissue collection and banking. In this
presentation, I will describe the scope of the HBRA as defined by the term ‘human biomedical research’, its
requirements for appropriate consent, and its provisions for donation and use of human tissue in research. I
will also discuss the impetus for introducing HBRA and measures taken to ensure its implementation and
compliance.
Abstract 4: Comparisons of Changes in 3 Regimes
The Chair will draw connections between the previous three talks to compare the changes in research ethics
governance by the US, Singapore and CIOMS. Following the prior talks, this will focus in particular on 1)
Tissue/data banking provisions; 2) the scope of governance; 3) the role of social value in governance. On
(1), there is a trend in all 3 regimes towards more stringent consent requirements. On (2), both the US and
Singapore are expanding the scope of direct governmental oversight of research (CIOMS guidelines remain
wide-scope). So there is evidence of international continuity on these norms. But on (3) there is some
difference, perhaps reflecting a lack of normative consensus – social value plays only a minor role in the US
and Singaporean regulations, but it is now emphasized as a primary requirement of CIOMS. Other points of
comparison may be brought up at the Chair’s discretion.
Fintry
S55: Symposium: Exchanging Experiences of Dealing with Facts and
Values: STS and Bioethics PN: 763
1
2
2
2
3
David Rodriguez-Arias , Catherine Heeney , Jane Calvert , Sam Taylor-Alexander , Carissa Véliz , Mark
3
3
4
5
Sheehan , Mikey Dunn , Alex McKeown , Emma Frow
1
2
3
University of Granada, Spain, University of Edinburgh, United Kingdom, University of Oxford, United
4
5
Kingdom, University of Bristol, United Kingdom, Arizona State University, Tempe, Arizona, USA
20
Abstract
Social scientists and ethicists must meet the demand, often coming from scientific collaborators and policy
makers, to be practically relevant. However, whilst empirical researchers are often asked to connect with
claims about how the world ought to be, demanding an engagement with values, those working on ethics are
asked to contextualise ethical arguments empirically. The session will address this problem of integration
drawing upon experiences and insights from both fields. Speakers will share the main tenants of their
approaches, including challenges and insights gained, with a view to forging new collaborative working
relationships between scholars who might otherwise be antagonistic towards each other’s contributions.
Speakers share an interest in how and how far to integrate empirical research with ethical analysis, and how
to address assumptions and associations embedded in key concepts such as “data” and “ethics”.
Individual Abstract Papers
Jane Calvert, University of Edinburgh
The reluctant ethicist
I am a researcher in the field of Science and Technology Studies (STS), but I am increasingly expected to
make normative interventions into my field of study (synthetic biology). I am uncomfortable when referred to
as an ethicist, but equally uncomfortable when I am told that the ethical is missing from my analysis. In this
short presentation, I discuss my attempts, based on experiences of being on working groups at the Hastings
Centre and the Nuffield Council on Bioethics, to develop a normative/ethical agenda that is consistent with
the ‘values’ of STS (i.e. reflexivity, ‘opening up’, critique, and the idea ‘that things could be otherwise’).
Alex McKeown, University of Bristol
Critical Realism and Empirical Bioethics
I used critical realism (CR) to integrate qualitative empirical data with normative
philosophical analysis in an 'empirical ethics' PhD project. My decision was motivated by what I perceived to
be a need for mutual vindication of the significance of both data and philosophical analysis in applied ethics,
following conversations with colleagues working from diverse disciplinary perspectives. CR's account of the
irreducibility of ontology to epistemology enables discussion of objective states of affairs in a way that goes
beyond individual subjective representations of them. It grounds analysis in a rationally apprehendable
shared reality to circumvent strong constructionist critiques, allowing the development of non-relative
normative conclusions in a more effective way than in - at least some - previous methodologies. The project
analysed the therapy / enhancement distinction, and the data provided perspectives thereon from clinicians
and scientists. Using CR's abductive approach, I constructed a new theoretical model grounded in relevant
data.
David Rodríguez-Arias, University of Granada
Added Value of Empirical Methods in Bioethics
Social sciences can contribute to bioethics in at least three ways. First, empirical bioethics can open avenues
for consensus where speculative bioethics fails, and helps to provide a common basis from which different
ideological adversaries can sit and discuss. Moral disagreements are often based just in disagreement about
how the world is, and this explains why empirical information has sometimes constituted genuine milestones
in the development of certain debates, with his actors having been forced to abandon traditionally accepted
beliefs and invited to reasonably leave their ideological entrenchments. This is particularly true when moral
arguments are based on empirical premises or claims about what people want, think, or how they behave.
Second, empirical data provide an opportunity to weigh the extent to which fundamental theoretical issues
are relevant in practice. Third, empirical studies in bioethics fulfill the task of encouraging the refinement and,
in some occasions, the abandonment of widely shared but erroneous beliefs. In this presentation I will share
my own experience in conducting empirical research in the field of transplantation ethics and the
controversies surrounding death determination.
Mark Sheehan and Michael Dunn
The Ethox Centre, University of Oxford
On the nature of bioethics: Clarifying disciplinary alignments in bioethical inquiry
In this paper, we claim that uncertainty about the place of science and technology studies (STS) in bioethics
hinges on more general uncertainty about the nature and boundaries of the field of bioethics itself. Such
uncertainty can lead to defensiveness or confusion as attempts are made to colonise (or re-colonise)
bioethics in ways that adhere to various disciplinary conventions. In this paper, we aim to settle these
disputes by providing a positive account of bioethics. This account does justice to the content of the field, the
range of questions that belong within this field, and the justificatory standards (and methodological
21
orientations) that can provide convincing answers to these questions. By arguing that bioethics is primarily
concerned with answering ‘practical ought’ questions, we show this primary focus of bioethics research gives
rise to numerous secondary questions that different disciplinary approaches, including those drawn from
STS, are best-placed to engage with.
Sam Taylor-Alexander, University of Edinburgh
Ethics in ethnography, or Protecting who, what and how?
How does the duty to protect research subjects influence modes of ethnographic analysis? In this paper I
unpack this question by discussing the power relations at play during my ethnographic fieldwork in Mexico. I
suggest that bioethical policy and the rationality of institutional review boards assume that the researcher is
always in an unequal power relationship with the researched. This assumption posits the researcher in a
position of power while research subjects are assumed to be vulnerable. Showing that to the contrary I was in
a vulnerable position in relation to many of my interlocutors, I reflect on how this precariousness shaped my
research enterprise and analysis. In particular, I discuss why I decided to omit data that could cast a negative
light on interviewees and the ethics of working with people whose identities cannot be made truly
anonymous.
Emma Frow, Arizona State University
Navigating ‘ethics’ and ‘science’ with biomedical engineers
Among the biological engineers I study and work with, ‘ethics’ seems to be used as shorthand for everything
that is not the ‘scientific’ work being done. This binary is troublesome for the science & technology studies
(STS) researcher, who sees a clear distinction between facts and values as difficult to sustain. I am an STS
researcher with no formal training in ethics, nor do I call myself an ethicist (although I am often labelled as
such by the scientists and engineers I engage with). Yet many of my research and teaching activities are
devoted to exploring how values permeate even the most seemingly technical of activities. Here I will draw on
some of my recent experiences with teaching undergraduate biomedical engineers to reflect on how STS
approaches might complement more traditional biomedical ethics teaching for bioengineers.
Kilsyth
Keynote Address S84: Paul Macneill
Art and Aesthetics: Bioethics and Health Care Re-considered
Chair: Catherine Belling
Center for Bioethics and Medical Humanities, Northwestern University Feinberg School of Medicine
This Keynote Address will enlarge on the talk on Arts+Ethics given in the Opening Ceremony.
It will propose that ‘art’ goes to the heart of bioethics. Art and aesthetics will be explored for what they reveal
about ourselves as human beings, and what they offer to bioethics and health care. The presentation will
include examples of art works, and extracts from a video dance performance (‘Michelle’s Story’ by Meryl
Tankard, Australia’s leading contemporary choreographer). My contention is that bioethics has been too
narrowly defined (failing for example to take account of Kant’s later work on aesthetics and morality). More
broadly understood, the arts provide a major contribution to both understanding and teaching of
ethics/bioethics, as can be illustrated from workshops offered in Sydney, London and elsewhere. This
approach suggests a radical shift in the manner in which ethics and bioethics are defined and taught. Current
approaches, with their emphasis on ethical reasoning, fail to adequately address the motivation of
students and practitioners to behave ethically. The paper will draw on some of the discussions in a recently
published collection of essays (Macneill, 2014). Macneill, Paul (Editor).͒2014. Ethics and the Arts. Springer:
Amsterdam.
22
Tinto
S38: Ibero-American Network: Mesa 1 (Session 1)
Chair: Florencia Luna
World Health Organization, Geneva, Switzerland
Consentimiento y Explotación: Razones Públicas y Privadas
1
Eduardo Rivera López
1
Universidad Torcuato Di Tella/Conicet
Palabras clave: Explotación; Paternalismo; Consentimiento; Autoridad Moral; Equidad
Abstract
En este trabajo me concentro en casos de lo que Wertheimer llama “explotación beneficiosa”, es decir, casos
en los que la objeción a una transacción explotativa no es (i) que el consentimiento de la parte explotada no
es genuino, ni que (ii) que la parte explotada sufre un daño. En estos casos ((i) y (ii)) el remedio, por parte
del estado, es el de las medidas paternalistas. No así en los casos en los que la parte explotada da un
consentimiento genuino y se beneficia de la transacción. El caso de la explotación beneficiosa es muy
relevante para la bioética. Por ejemplo, se prohíbe a las personas vender sus riñones, aun cuando pudiera
constatarse un consentimiento libre y genuino a favor de realizar la venta, y no sea obvio que la venta
perjudicará al vendedor. En el campo de la investigación biomédica, se prohíbe a las personas participar de
protocolos de investigación si no se dan una serie de condiciones que van mucho más allá de la mera
ausencia de daño, aun cuando exista un consentimiento informado genuino a favor de participar. Mi
argumento es que, en situaciones de explotación beneficiosa, existen razones morales de carácter privado
para que la parte fuerte contrate en términos no explotativos (o más equitativos), en lugar de hacerlo en
términos explotativos, con la parte más débil. Sin embargo, desde el punto de vista público, es decir, el
referido al uso de la coacción por parte del estado, la cuestión es más compleja. Argumento que la
explotación beneficiosa no genera una razón para que el estado prohíba este tipo de contratos, si todo lo
demás permanece igual. El estado sólo tiene razones morales para impedir coercitivamente este tipo de
contratos si, además, realiza creíblemente otras acciones tendientes a generar condiciones en las que el
contratante explotado posea alternativas más favorables (transformándose así la prohibición en una medida
paternalista). Si no cumple esta condición, mi argumento es que el estado carece de autoridad moral para
intervenir. Discuto, finalmente, cuestiones referidas a la transición del status quo a la situación en la que se
justificaría la medida paternalista.
Accountability for Reasonableness: ¿Garantiza la Justicia en la
Distribución de Recursos Sanitarios?
M. Róderic Molins Mota
Palabras clave: sistema universal de salud; Accountability for Reasonableness; gobernabilidad; justicia
social; OMS/OPS
Abstract
En los últimos años, la distribución de recursos en salud se ha convertido en un problema central del debate
ético. La Organización Mundial de la Salud (OMS) y la Organización Panamericana de la Salud (OPS) han
fijado como uno de sus objetivos de cooperación técnica la integración de la justicia en el ámbito de la salud
y el avance hacia sistemas universales de salud. Para ello, ambas instituciones se basan en la propuesta de
Daniels y Sabin, Accountabilty for Reasonableness (A4R). La comunicación propuesta pretende responder a
la pregunta de si A4R resulta suficiente para garantizar un avance justo hacia la cobertura universal de
salud. Para ello, prestará atención especial al hecho de que el marco de justicia procedimental que
constituye A4R no contempla el análisis de variables externas a la estructura de los sistemas sanitarios,
tales como el presupuesto asignado a sanidad, la regulación del precio de los medicamentos, las
desigualdades económicas, la educación, etc. Para ello se analizará en profundidad el modelo de Daniels y
Sabin de acuerdo con los instrumentos metodológicos propios de la filosofía política analítica. Se espera
llegar a la conclusión de que, para garantizar un avance justo hacia la cobertura universal de salud, es
necesario ampliar el modelo A4R de manera que sea capaz de incidir en factores políticos y sociales ajenos
23
a la estructura del sistema sanitario, como los ya mencionados. La originalidad de la investigación radica en
una crítica de A4R basada en una comprensión multisectorial de la gestión sanitaria en la que deben
concurrir distintos niveles de gobernabilidad. Con ello, se espera apoyar a la OPS/OMS en el desarrollo de
A4R como modelo de justicia procedimental en la guía a los estados hacia la cobertura universal de salud.
Solidaridad y Salud Pública. Entre lo Público y lo Privado
1
Angel Puyol
1
Universitat Autònoma de Barcelona
Abstract
La salud pública está dominada por casos en que aparece el principio de solidaridad, como la justificación de
los sistemas de atención sanitaria, las políticas de vacunación y de donaciones (sangre, óvulos,…) o la
reducción de las desigualdades en salud. No obstante, el concepto de solidaridad ha tenido muy poca
discusion en la literatura sobre bioética. Como dicen Praynsack and Buyx (2011), “no hay un modo
coherente en que el término solidaridad se esté usando en bioética”. Por ejemplo, ¿la bioética debe apoyar
determinadas visiones de la justicia o son conceptos diferentes? ¿implica una obligación?... Hay mucho
trabajo por hacer aquí”, señalan Dawson y Verweij (2012). En mi comunicación, ofrezco un intento inicial de
responder a la llamada de Dawson y Verweij “para realizar una mayor reflexion sistemática sobre la idea de
solidaridad” y un mayor “examen de su implicación en la teoría ética y la justificación de las políticas de salud
pública”. Específicamente, existe un problema grave sobre el que quiero detenerme. En los actuales análisis
sobre la solidaridad en salud pública (e.g. Praynsack y Buyx, o Dawson y Jennings) se cae en una
confusion a) entre la concepción descriptiva y normativa de la solidaridad, b) entre la solidaridad como
motivación para actuar y la solidaridad como justificación de una acción, y c) entre la solidaridad entendida
como un sentimiento y la solidaridad como un derecho. Sin duda, tenemos que evitar esas confusiones si
pretendemos que la solidaridad ocupe un papel relevante en los desafíos éticos y políticos de la salud
pública, así como en al discusion más amplia entre lo público y lo privado en bioética.
Torquato Direitos Humanos, Patrimônio Genético e Dados Genéticos
Humanos: Crítica à Doutrina dos Dados Genéticos como Interesse
Difuso
Dr. Bruno Torquato de Oliveira Naves
Sarah Rêgo Goiatá (apresentadora)
Palavras-Chave: Dados Genéticos; Direitos Humanos; Bioética; Interesses Difusos; Biodireito
Abstract
A proteção jurídica dos dados genéticos é tema fundamental para a reconstrução da teoria dos direitos
humanos e dos direitos de personalidade no Estado Democrático de Direito. Os dados genéticos são
expressões biológicas da personalidade humana. Logo, não é difícil relacioná-los aos direitos humanos. Mas
quem são seus titulares? A tutela destes se dá em razão do “interesse coletivo”? Metodologicamente,
utilizou-se do modo teóricodocumental perfazendo uma revisão da literatura concernente ao tema e uma
análise investigativa e reflexiva de caráter hermenêutico. Partindo da tensão já demonstrada por Habermas
entre faticidade e validade, o discurso dos interesses difusos é esvaziado de validade, porquanto são
vinculados a meros fatos, isto é, sua proteção jurídica decorreria da relevância social. O interesse fático,
desvinculado da validade normativa do sistema jurídico, preocupa e os direitos humanos, revisitados como
direitos subjetivos em uma concepção mais consentânea com a democracia, poderiam lançar o novo
caminho para a validade pretendida. As normas jurídicas que contêm interesses aparentemente públicos
não podem negligenciar o sistema de direitos humanos. Da mesma forma, normas que contêm interesses
aparentemente privados não podem descuidar do entorno social em que se faz contextualizado. Há
interdependência entre interesse público e interesse privado, posto que aquele nada mais é do que o
resultado dos vários interesses privados. No campo da Moral e do discurso de justificação, a axiologia não
pode conceber uma valorização “a priori” do interesse público sobre o interesse privado. No entanto, no
discurso de aplicação tal consideração não se faz presente. Não são os dados genéticos interesses difusos.
Em verdade, não há espaço para esse discurso na aplicação jurídica. A consideração da juridicidade dos
24
interesses pressupõe a generalização de valores a um número indeterminado de pessoas (universalidade)
somada a um aspecto de eficácia, que somente os direitos humanos podem garantir.
El Estatuto Jurídico de los Biomateriales Humanos: Una Crítica del
Enfoque Propietarista
1
Ricardo García-Manrique
1
OBD, Universidad de Barcelona
Palabras Clave: Biomateriales humanos; propiedad privada; interés público; derechos fundamentales
Abstract
Las transferencias de biomateriales humanos se han extendido rápidamente durante los últimos años. La
regulación jurídica de este tipo de transferencias ha sido profusa, pero precipitada, heterogénea y acaso no
suficientemente ponderada. Estas características son la causa de serios y diversos problemas normativos.
Todo ello da lugar a un panorama regulatorio que requiere con urgencia una revisión general y bien
fundamentada. Un razonable punto de partida para dicha revisión puede ser la búsqueda de un estatuto
jurídico apropiado y unitario, para los biomateriales humanos. Nuestro problema será: ¿es la propiedad
privada, tal y como se ha propuesto con frecuencia, un candidato adecuado para dotar de estatuto jurídico a
los biomateriales humanos? Para responder, identificaremos y evaluaremos los argumentos más relevantes
a favor y en contra; esperamos llegar a la conclusión de que hay poderosas razones para rechazar un
enfoque propietarista o patrimonial. En cambio, un estatuto jurídico similar al de los bienes protegidos por
derechos fundamentales muestra mejores perspectivas. Ayudaría a evitar los peligros de la cosificación y
mercantilización y serviría mejor a los intereses públicos involucrados.
Reivindicando la Noción del Genoma Humano como Bien Común: la Necesidad de
un Modelo Alternativo a las Patentes de Invención
1
Liliana Spinella
1
CONICET - UBA
Palabras clave: Genoma Humano; Patentes de Invención; Bien Común; Modelo Normative; John
Locke.
Abstract
Durante los últimos años se ha comenzado a difundir la problemática de los derechos de propiedad
intelectual que se conceden sobre los avances de la biomedicina y de la información genética en particular.
El examen de las pretendidas justificaciones sobre las patentes de genes humanos -tanto utilitaristas o
consecuencialistas como deontológicas- muestra la inconsistencia de tales planteos.
Metodología
La propuesta se centra en un análisis de índole filosófica. A través de una interpretación alternativa a la
tradicional concepción lockeana de la tesis de la apropiación originaria, se comienzan a delinear los
rudimentos de un modelo normativo de regulación del genoma humano que no implique la apropiación
privada y exclusiva de un bien con características tan peculiares como los genes humanos, fragmentos y
demás material relacionado.
Originalidad
La concepción tradicional sobre la tesis de la apropiación originaria de John Locke abreva en la lectura de
Macpherson, se centra en el individualismo posesivo y supone la legitimidad de una apropiación ilimitada
sobre los recursos comunes. James Tully y Peter Drahos proponen lecturas alternativas a ese intérprete
lockeano que implican, entre otras cuestiones, el reconocimiento de límites a la apropiación. Nuestra
propuesta pretende recuperar algunas nociones de estos últimos autores para comenzar a bosquejar los
principios que le dan forma a un modelo de regulación que defiende la idea del genoma humano como
patrimonio común de la humanidad.
Conclusión
25
Es posible bosquejar los rudimentos de un modelo de regulación del genoma humano prescindente de la
concesión de las patentes de invención -que no se encuentran justificadas satisfactoriamente desde un
punto de vista normativo.
Inflación o Deflación de Derechos?
1
Rodolfo Vázquez
1
Departamento Académicco de Derecho, Instituto Tecnológico Autónomo de México (ITAM).
Abstract
En su más reciente libro, Mark Platts hace suya una cita de Jim Griffin: “Hay fuertes presiones inflacionarias
sobre el término [“derechos humanos”], las cuales han provocado su devaluación […], y esas fuerzas siguen
operando” . Esta “inflación” de los derechos humanos ha operado a nivel institucional y es un hecho que la
lista nominal de derechos, especialmente, en el ámbito constitucional, se ha incrementado
exponencialmente. En la reciente reforma constitucional en México, se establece en el artículo 1 de la
Constitución, el llamado bloque de constitucionalidad, es decir, la sistematización jurídica de todas las
normas materialmente constitucionales, que no necesariamente se encuentran contenidas en la constitución,
como por ejemplo los derechos reconocidos en los tratados internacionales y que forman parte del orden
jurídico mexicano. En esta ponencia se analizará este crucial problema
Moorfoot
S54: Symposium: UK Mitochondrial Research and Legislation: Cutting
Edge or Out on a Limb? PN: 8
1
2
3
4
1
Erica Haimes , Annelien Bredenoord , Cathy Herbrand , Ilke Turkmendag , Ken Taylor , Sheryl de
5
Lacey
1
2
PEALS Research Centre, Newcastle University, United Kingdom, University Medical Centre and
3
Department of Medical Humanities Julius Center, Utrecht, Netherlands, De Montfort University, Leicester,
4
5
UK, Sheffield University, United Kingdom, Flinders University, Adelaide, Australia
Discipline(s) – Bioethics, Sociology, Law
Keywords – Mitochondria; Socio-ethical Challenges; International Governance; Germline Alteration;
Interdisciplinary
Abstract
In 2015 the UK legalised the alteration of the human germline by approving the use of ‘three-genome
embryos’ (Haimes & Taylor, in press) in treatment for women at risk of transmitting mitochondrial disease to
their children. This germline alteration is currently not allowed elsewhere; however some jurisdictions are
under pressure to follow suit. Speakers in this symposium will draw on their current research to identify
challenges and opportunities raised by the UK legislation and to suggest lessons for jurisdictions elsewhere.
The symposium as a whole identifies and addresses lessons that can be learned by other jurisdictions from
the UK legislation. Haimes and Taylor will provide an overview of the questions posed by the UK debates.
Herbrand and Turkmendag will then address more focused topics: first, interrogating assumptions about the
supposed beneficiaries of these interventions; second, questioning why the rights of UK people conceived
from these interventions buck international trends towards ‘the right to know’ about gamete donors. Finally
Bredenoord will demonstrate the limitations of the UK model for the USA. The Discussant, Professor de
Lacey, will suggest further questions for debate, from experience as a practice and policy adviser in Australia.
Individual Abstract Papers
Mitochondrial disease, research and therapy: the limitations of the UK debates.
Erica Haimes and Ken Taylor
The UK debates on the acceptability of IVF-based therapeutic interventions for women affected by
mitochondrial diseases have generally lacked nuance. This presentation draws on Wellcome Trust-funded
research to identify areas in those debates that require further detailed consideration, including: the
terminology of ‘mitochondrial donation’; claims about the number of affected families; the capacity of the
Human Fertilisation and Embryology Authority to conduct case-by-case reviews; alternative means for
women affected by mitochondrial disease to have a child; evaluations of the contributions of women providing
26
eggs for mitochondrial research and therapy; attempts at the quantification of genetic relatedness; the
decision to focus the debates on children currently and potentially affected. Identifying and clarifying these
socio-ethical issues will enable jurisdictions elsewhere to ensure that a more rounded debate occurs prior to
any further legislation.
Mitochondrial therapeutic interventions: who will benefit?
Cathy Herbrand
In the recent high-profile UK parliamentary and public debates, mitochondrial replacement techniques
(MRTs) were positioned as the solution for the ‘eradication’ of mitochondrial disorders, enabling hundreds of
women to have a healthy, biologically-related child. Despite these claims, questions regarding their future
application remain. For example, who will be eligible to use them in practice? Will patients engage with the
techniques? Who will fund their use? Drawing on discussions with families living with mitochondrial disorders
and key experts in the field, I contrast the public discourses around MRTs with the complex reproductive
choices faced by families affected by these disorders. An examination of the legalisation of these
technologies in the UK illuminates the complexities other countries may face as they consider their position
on mitochondrial replacement techniques.
The 'right to know' in mitochondrial therapeutic interventions
Ilke Turkmendag
Nowadays, the presumption that genetic information is essential to personal identity is linked to a rightsbased argument: children have a right to know their genetic origins. This trend is evident in Strasbourg caselaw, in the UN Convention on the Rights of the Child, and in the European Convention on Human Rights.
Accordingly, some European countries removed anonymity from gamete donors; similar debates occur in
North America and Australia. However, in the UK, where gamete donors have been identifiable since 2005,
the government decided that individuals conceived through mitochondrial replacement therapies should not
have access to identifiable information about the egg donors. This was partly because of the alleged
quantitative insignificance of mitochondria. In this paper I explore whether the perceived significance of
donated genetic material is a valid basis for the differential treatment of donors and people conceived.
The road to mitochondrial therapeutic interventions: context matters
Annelien L Bredenoord
After the UK Parliament voted to permit mitochondrial gene transfer (MGT), the United States Food and Drug
Administration requested the Institute of Medicine (IOM) to produce a consensus report regarding the ethical
and policy issues related to MGT. In weighing whether to proceed down the road to MGT, might the US
benefit from the UK experience as a reliable course to follow? Recently, the ethical and policy considerations
of MGT were discussed at the first IOM workshop in Washington DC. As a speaker at this workshop, I
observed that the UK cannot serve as an immediate road map for the US context. In this presentation I will
discuss three differences that make a ‘copy-and-paste’ transposition of the UK decision impossible: (1)
oversight and regulation, (2) funding of embryo research and (3) political and socio-ethical discourses over
emerging biotechnologies.
Discussant
Sheryl de Lacey
Public debate on mitochondrial therapies is imminent in Australia. As a member of the two Australian National
Health and Medical Research Council committees that are currently addressing mitochondrial transfer issues,
as well as being a member of the Ethics Health Advisory Council in South Australia, Professor de Lacey will
draw out the challenges around mitochondrial and germline therapies facing other, non-UK, jurisdictions and
set the stage for the open debate.
27
Carrick 1
S73: Got Originality?
Chair: Graeme Laurie
An Evaluation of the Ethical Concerns of Research Ethics Committees in
Cameroon, Using the Principles and Benchmarks Proposed by Emanuel
et al. (2004) PN: 166
1
Justice Abinyui Muh
1
University of KwaZulu Natal, Pietermaritzburg, South Africa
The Emanuel et al framework is becoming a vade mecum in Research Ethics Committees (RECs) around the
world. However, concerns remain on the adequacy of ethics review in African countries due to limited
understanding of the issues raise when Africans RECs review research proposals. A recent paper presents
such findings for one South African REC but there are no other data with which to compare such findings. A
closer and systematic examination of the ethical issues raised by an REC in Cameroon may shed more
comparative light on this and reveal areas of concerns raised during the review of study protocols which
ultimately leads the REC to arrive at a particular decision. Using a qualitative approach, the minutes of REC
meetings will be analysed to evaluate their decision-making processes, according to the Emanuel, Wendler,
Killen and Grady (2004) framework. It will thus also consider the applicability of the framework in an African
context.
PN: 217
Autonomy – Is This Selfish?
1
Anne Williams
1
Scottish Council on Human Bioethics, Edinburgh, United Kingdom
Discipline(s) – General Bioethics
Methodology – Bioethical Analysis
Abstract
In our Western Christian heritage we had the negative moral principles "Thou shalt not ..." as absolute no go
areas. The enlightenment threw off these shackles - we do not want to accept limitations to personal choice.
Freedom is the overriding cry! The UN Declaration of Human Rights made an attempt to establish limitations
beyond which we do not trespass so as not to compromise the rights of others, where there are competing
rights. However "rights" imply "duties", but have these been forgotten? Do we need new universally
acceptable criteria, with which to replace the old commandments, if we are rejecting this "wisdom"? Do we
need to consider the common good and not just the individual good, for example, as with global warming?
Maybe with this large meeting of minds we can begin to explore a framework to fill this vacuum?
PN: 583
Antibiotic Prescribing in Primary Care – Preserving the Doctor-Patient
Relationship or Acting in the Public Interest?
1
Selena Knight
1
King's College London, United Kingdom
Discipline(s): Primary Care Ethics
Abstract
This potential proposed thesis would explore ethical issues related to antibiotic prescribing in primary care.
The work would focus on the challenging interface between the GP’s personal relationship with individual
patients and the themes of paternalism and respecting autonomy, versus the overarching responsibility to
avoiding over-prescribing antibiotics which may contribute to the increasing global antibiotic resistance. The
28
presenter would like to undertake qualitative research during her academic clinical fellowship in which she
would interview patients and GPs to explore these important issues, and would value the opportunity for
feedback on such a proposal.
Assistance with Living Entails Assistance with Dying: What We can
Learn from the Ethics Inherent in the Ruling of Fleming v Ireland and the
Oireachtas, 2013 PN: 471
Annie McKeown O'Donovan1
1
National University of Ireland, Galway, Ireland
Discipline(s): Philosophy – Ethics and Law
Abstract
I will present on the case of Fleming v Ireland and the Oireachtas, 2013. Marie Fleming was suffering from
multiple sclerosis and wanted to have an assisted death; currently illegal in Ireland. She brought her case to
the Supreme Court, where she challenged the Criminal Law (Suicide) Act 1993, Article 40 of the Irish
Constitution, saying that it conflicted with her rights under the UN Convention on the Rights of Persons with
Disabilities. Her case was denied. I will argue that the court’s decision was morally wrong and constitutional
reform is in the interest of individuals and the public.
Carrick 2
S3: Clinical Trials
Chair: Joseph Millium
Clinical Center Deptartment of Bioethics and Fogarty International Center, National Institutes of Health,
Maryland, USA, Bethesda, Maryland, USA
PN: 272
Participant Perspectives on Clinical Trials: Exploratory Study in Three
Locations in India
1
Ms Sarojini Nadimpally
1
Sama Resource Group for Women & Health, New Delhi, India
Keywords – Clinical Trials; India, Exploratory Qualitative Study; Participant Perspectives; Informed Consent
Abstract
Clinical trials in India have been in news for a multitude of reasons in the recent years. The sector received
criticism for unethical conduct of trials and slack regulatory mechanisms and patient protection measures.
This paper reflects on the perspectives of clinical trial subjects on their experiences of trial participation. It
offers insights into how human subjects conceptualize their participation and their perspectives regarding
involvement in the various facets and issues associated with the trial. The paper is an attempt to bring to the
fore and give voice to the most important albeit most neglected views – that of the trial participants.
The exploratory qualitative study was conducted across 3 locations in India. In depth interviews were
conducted with 36 respondents. In addition to trial participants, other stakeholders like Principal Investigators
and clinical research associates were also included in the study so as to get a comprehensive understanding
of the processes. Additionally data from research field notes, observation etc. were systematically analysed
using ethnographic approach. The results highlight the participant perspectives with respect to various
components like reasons for participation, the recruitment process, informed consent, adverse events,
compensation and post trial access. The role played by the push and pull factors in recruitment, the
information asymmetry, the power imbalance between the health care provider and seeker, the role of sociocultural factors etc. are explored in the paper. Combined with the insights from other stakeholders, the study
gives an understanding about the chasm between regulations and realities in the Indian clinical trial sector.
29
PN: 490
An Unintended Consequence? Some Pragmatic Cluster Randomized
Trials May be Impossible Under New Legislative Research Framework
1
Sumytra Menon
1
Keywords – Research Ethics; Biomedical Research Governance; Human Participant Protection; Ethics
Review
Discipline(s) – Bioethics; Law and Policy
Abstract
The new Singapore Human Biomedical Research Act (HBRA) has codified the rules for conducting research,
which were previously governed by various guidelines. Clinical trials are excluded from the HBRA because it
is regulated elsewhere. Consent is a significant feature of the new HBRA, which lists the requirements for
obtaining appropriate consent for human biomedical research. The requirements for competent adults are
that consent should be in writing, obtained from the subject personally, after the relevant information about
the study has been provided and explained, and witnessed. The HBRA also specifies the information
researchers must provide to potential participants before taking appropriate consent. A pragmatic randomized
cluster trial randomly assigns groups of people in an area of interest, and measures at an individual level the
effect of an intervention. From a purely ethical perspective, whether individual participant consent should be
required, and the nature of that consent, depends on the type of intervention and its anticipated effects.
Where entire wards or hospitals are randomized to an intervention, obtaining appropriate consent from
individual participants may be challenging. In this paper, I will explore whether pragmatic cluster randomized
trials involving human biomedical research on competent adults may be able to satisfy the consent provisions
in the HBRA. I will also consider whether such trials may qualify for waiver of consent under the HBRA. I will
argue that researchers conducting these types of trials may struggle to meet the new consent standards and
this may hinder research.
PN: 554
The Social Value of Pragmatic Trials
1
1
1
2
1
Shona Kalkman , Ghislaine JMW van Thiel , Rieke van der Graaf , Iris Goetz , Mira G Zuidgeest , Diederick
1
1
E Grobbee , Johannes JM van Delden
1
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht,
2
Netherlands, Global Health Outcomes, Eli Lilly Research Centre, Windlesham, United Kingdom
Keywords – Research Ethics; Social Value; Pragmatic trials; Comparative Effectiveness
Discipline(s) – Research Ethics; Clinical Epidemiology
Abstract
Pragmatic trials aim to directly inform health care decision-making regarding the comparative effectiveness of
biomedical interventions. To yield reliable results, some pragmatic trials may, however, require design
characteristics that deviate from current ethical guidelines and regulations. The extent to which such
deviations are morally acceptable, will at least depend on the countervailing benefits of a pragmatic trial. The
social value of the research is one of those benefits that can put moral weight in the balance, but as a
concept has not been elucidated yet for pragmatic trials. We demonstrate how a specification of social value
can aid the assessment of a pragmatic trial’s ethical acceptability.
PN: 419
First-in-Human Clinical Trials: Risk or Payment
1
Dr. Yoichi Yamamoto
1
Osaka University Hospital, Suita, Japan
Keywords – First-in-Human Clinical Trial Risk; Payment; Research Ethics Committee; Informed Consent
30
Discipline(s) – Clinical Trial; Research Ethics
Abstract
The first-in-human clinical trial is defined as the first step of clinical trials and that an investigational medical
product is tested on human subjects for the first time. A questionnaire was conducted on persons including
healthy volunteers, medical doctors, review committee members in order to determine the response to firstin-human clinical trials. Results showed that some general public misunderstood that new drugs were
developed only by testing patients, not healthy volunteers. The primary reason for participation of healthy
volunteers was the payment, not the low risk of the clinical trial. Interestingly, the majority of subjects
answered that the higher the risk, the higher the payment should be. However, interviews with some healthy
volunteers revealed that if they had judged that the risk was high, they would never participated. Clinical trials
are carefully reviewed in research ethics committees, but as shown by the cases of TGN1412 and BIA 102474, serious adverse effects including death have occurred. With the acceleration of the development of
innovative drugs, ethics committees are obliged to review more clinical trials at high or unknown risks. We
should make more efforts to inform the public about the entire process of developing new medicines,
including the contribution of healthy volunteers, and we should establish more safety measures to enhance
protection of healthy volunteers. A centralized research ethics committee specialized for first-in-human
clinical trials and informed consent by the third person are to be discussed.
Carrick 3
S7: Research and care
Chair: Kevin Behrens
University of the Witwatersrand, South Africa
PN: 28
Beneficial Coercion in Psychiatric Care: What Can we Learn from
African Ethico-Cultural System
1
Cornelius Ewuoso
1
Center for Applied Ethics, Department of Philosophy, Stellenbosch University, Cape Town, South Africa
Keywords: Coercion; Autonomy; Public Safety; Psychiatry; African Ethical System
Discipline(s): Bioethics; Clinical Psychology and Ethics; Applied Ethics
Abstract:
There is a ‘catch 22’ situation about applying coercion in psychiatric care. Autonomous choices undeniably
are rights of patients. However, emphasizing rights for individuals with diminished competence, would stress
autonomy at the expense of treatment or public safety. Conversely, the beneficial effects of coercion are
difficult to predict. Furthermore, emphasizing incompetence and dangerousness to self/public – conditions for
involuntary admission/treatment -- may promote strong public view of the mentally ill as ‘uncontrollable’,
which may increase stigmatization. Moreover, current regulations lack well-framed guidelines for assessing
dangerousness. The South-African Mental Healthcare Act, for example, recommends involuntary admission
for an individual if a physician reasonable believes that the individual suffers from mental illness of a degree
that s/he lacks competence to make sound healthcare decisions. Without clarifying conditions, such
discretional use of reasonable belief is open to abuse, and will negatively accelerate involuntary
admission/treatment. Hence, applying coercion in psychiatric care requires delicate balancing, which has not
been achieved by current frameworks, of autonomy, individual well-being and public safety. To bridge this
gap, this study will propose a new ethical framework for applying coercion in psychiatric care. Specifically, I
1
will draw insights from African ethico-cultural system by using the communitarian Yoruba concept Omo-oluiwabi to balance the competing interests of patient autonomy, public safety and appropriate care. This
concept will used to highlight the interconnectedness between the individual, individual’s well-being, and
society/community. Finally, this study outcome will be used to propose a reform of existing regulations on
care of mentally ill patients
31
PN 623
The Ethics of Nutrition Research in Canadian Aboriginal Communities
and Residential Schools
1
Kirstin Borgerson
Dalhousie University, Halifax, Canada
1
Keywords – Canadian Aboriginal Communities; Research Ethics; History; Public Interest
Discipline(s) – Philosophy
Abstract
In 1942, scientific experts, with the support of the Canadian government, began a series of nutrition
experiments on Aboriginal subjects that continued until 1952. The details of these studies were buried for
over sixty years. In 2013, historian Ian Mosby published the results of archival research on these
experiments. In his detailed description of events, Mosby frequently mentioned ethical issues raised by the
studies, though he did not explore those issues in any detail. Three years later, the experiments have not yet
been subjected to close scrutiny by bioethicists. In this paper, I provide a comprehensive ethical analysis of
the experiments Mosby uncovered. This task is especially important given that when these cases gained
national attention the Canadian public seemed genuinely divided on whether or not the research had been
ethical. One of the original experimenters went on record with his defense of the studies, and this view seems
to have some popular support. Yet the experiments were certainly unethical, and the historical excuse – that
people didn’t know any better at the time – needs to be carefully and decisively refuted. Understanding why
these studies were unethical is important first and foremost because people were wronged through these
experiments and these wrongs must be publicly acknowledged. It is also in the public interest that we
understand why these studies were unethical because researchers working in international contexts today
are faced with many of the same incentives, and are tempted by much of the same reasoning, as researchers
were in this case.
PN: 221
The Ethics of Crowdfunding: Medical Research as an Intermediate and
Structured Public Good
1
Lorenzo Del Savio
Christian-Albrechts-Universität zu Kiel, Kiel, Germany
1
Keywords – Crowdfunding; Public Goods; Resource Allocation; Citizen Science
Disciplines – Bioethics; Research Ethics
Abstract
Crowdfunding is becoming common in medical research. Critics are concerned as it may sidestep ordinary
reviews (e.g. IRBs) of social and scientific value of studies (impacts on disease burden; issues of justice;
etc.). I argue that such concerns are misplaced. In diversified systems of funding, crowdfunding can
appropriately allocate resources for research. I present the idea that medical knowledge is an intermediate
and structured public good. Medical knowledge is intermediate in the production of further private and public
goods (cures, population health, etc.). It is structured because its components are differentially useful in the
production of these heterogeneous final goods. Since the relative value of the latter is controversial, the
appropriate allocation of resources for research (skills, time, equipment, etc.) remains uncertain. For this
reason, medical knowledge is an unusual public good, as its optimal provision (both levels and contents) is
undetermined. To handle such complexity, research funding systems comprise a variety of public and private
channels. Should they incorporate crowdfunding? Crowdfunding complements funding systems by directing
research towards neglected and rare conditions. Although crowdfunded research needs ethics review to
prevent harms, crowdfunding is a complementary mechanism for the discovery of what research is valuable.
As such it sidesteps extant value reviews by definition and, if my argument is sound, unproblematically so.
32
PN: 61
Sharing Indigenous Genomes in Research
1
Rebekah McWhirter
Menzies Institute for Medical Research and Centre for Law and Genetics, University of Tasmania, Hobart,
Australia
1
Keywords – Indigenous Health; Genomics; Personalised Medicine; Group Harms
Discipline(s) – Research Ethics
Abstract
Genetic research presents serious risks to indigenous populations, and in Australia the perceived difficulties
of such research has meant that Indigenous Australians have largely been excluded as research participants.
Recently, several research teams have worked with Indigenous communities to mitigate risks and safely
conduct genetic research projects. One component of this has been promising not to share the resultant
genetic data with other researchers. Simultaneously, the wider genetics community has moved towards
greater sharing of genetic research data, to identify preventive, diagnostic and therapeutic targets for a wide
range of illnesses. Balancing the potential harms of exclusion against the risks of inclusion, as well as the
rights of individuals to involve themselves in research against the risks to their community, represents a major
challenge for genetic research today. Successful strategies will need to be Indigenous-led and require
community consent based on participatory models. Changes need to be integrated into national ethical
review frameworks to ensure consistency across ethics committees.
Harris 1 & 2
S53: Symposium: Ethical Judgments: Re-Writing Medical Law PN: 286
1
2
3
2
Sorcha Ui Chonnachtaigh , Stephen W Smith , Richard Huxtable , Clark Hobson
2
3
1
Keele University, Staffordshire, United Kingdom, Birmingham Law School, United Kingdom, University of
Bristol, United Kingdom
Discipline(s) – Law; Bioethics
Keywords – Judicial Decision-Making; Bioethics; Law; Judges
Abstract
The Ethical Judgments Project (EJP) explores what would happen if judges were required to decide cases
along ethically defensible, as well as legally valid, lines. Cases which come before the courts in medical law
tend to be both legally and ethically complex and controversial. Judicial decisions are often based on
reasoning that comes from sources other than law, or respond to significant legal ambiguities. EJP
reconsidered nine important medico-legal cases. Two academic authors ‘re-wrote’ each judgment, with the
requirement that their decisions be ethically as well as legally valid. These new judgments are then analysed
in two (one legal, one ethical) academic commentaries. The end result, soon to be published with Hart, is a
rich collection, in which landmark medico-legal cases are subjected to a range of different ethical and legal
views in order to explore the influence of ethics on judicial decision-making.
The symposium will contain four papers which explore various aspects of the project:
(1) An introductory paper outlining the project, its methodology, and aims.
(2) A paper considering what it was like to act as a judge, exposing insights on the potential to bring ethics
into medical law.
(3) A paper discussing what it was like to act as a commentator for the project focusing on how responding to
an academic ‘judge’ is different from commentating on a real judgment.
(4) The final paper summarises the results of the project highlighting the potential impact and importance of
the project, and the scope for future developments.
Individual Paper Abstracts:
1. Introduction to the Ethical Judgments Project – Stephen W Smith, Birmingham Law School
33
This paper will present an introduction to the Ethical Judgments Project. It will explain the genesis of the
project and its methodology. This will include not only a discussion about how the project was set up but also
explain important aspects of the project, such as what is meant by ‘ethical validity’.
2. Being a judge on the Ethical Judgments Project – Richard Huxtable, University of Bristol
This paper will explore what it was like to act as a judge during the project. Huxtable will discuss the process
of preparing a ‘judgment’ and the range of constraints he placed upon himself in that role. He will further
discuss what he felt were the most challenging aspects of the project as well as what he found most
interesting and enlightening.
3. Writing a commentary on the Ethical Judgments Project – Sorcha Ui Chonnachtaigh, Keele
University
This paper will explore what it was like to act as a commentator on the judgments. Ui Chonnachtaigh will
explore the extent to which writing a commentary in this context was different from writing a case
commentary in other instances, such as for a journal article. She will further explore how the aims and
purpose of the project influenced how she approached the commentary that she wrote.
4. The Impact and importance of the Ethical Judgments Project – Clark Hobson, Birmingham Law
School (Early Career Researcher)
This paper will present some of the results of the project. Hobson will explore what the editors thought were
the aims and purposes of the project and how those were accomplished by the collection. He will further
explore the potential impact and importance of the project, not only to what we might understand about the
alternative ways that medical law might have progressed in England and Wales, but also what this might tell
us about judicial decision-making. Hobson will also reflect on the wider potential application of the project,
both within the jurisdiction of England and Wales, and elsewhere.
Ochil 1
S25: Humans, Animals and the Environment
Chair: Bruce Jennings
Center for Humans and Nature, Chicago, Illinois, USA
PN: 263
Population Engineering and Sustainable Development
1
2
2
Travis Rieder , Jake Earl , Colin Hickey
2
Johns Hopkins University, Baltimore, Maryland, USA, Georgetown University, Washington, DC, USA
1
Keywords – Population; Fertility; Migration; Climate Change; Development
Abstract
The prospect of dramatic global climate change seems to put the world’s worst-off citizens in a double-bind:
Facilitating economic development in the world’s poorest nations will foster opportunity and well-being for
many, but will also predictably increase per-capita carbon output. This will then increase the rate and severity
of dangerous climate change, which will disproportionately affect the worst-off. We propose a novel solution
to the double-bind faced by the world’s poor: population engineering, or policy interventions aimed at
changing the size and structure of human populations. Specifically, we argue on behalf of two types of
mutually reinforcing strategies: first, interventions to reduce fertility rates in both developing and developed
nations; and second, interventions to increase migration from developing nations to developed nations.
Fertility-reducing and immigration-promoting population engineering policies would work in tandem to break
the double-bind by (roughly speaking) making more room for the global poor in nations that are already
developed. This would provide immediate aid to those who immigrate while allowing developing nations to
pursue economic growth more rapidly and more sustainably. This population engineering approach aims to
satisfy the demands of economic justice in the face of climate change and other environmental problems. It
will also help to mitigate the economic problems caused by below-replacement fertility rates (e.g., in Japan)
34
by supporting and stabilizing labor markets. This, in turn, rebuts one of the strongest objections to mitigating
long-term environmental threats by reducing the size of the world’s human population.
PN: 557
Veterinary ‘Donation’: Ethical Implications of Applying Best Interests
Arguments in Animal Medicine
1
1
Vanessa Ashall , Pru Hobson-West
Centre for Applied Bioethics, School of Veterinary Medicine and Science, United Kingdom
1
Keywords – Donation; Veterinary; Best Interests; Decision Making; Family
Discipline(s) – Veterinary Ethics; Medical Ethics; Social Science (Interdisciplinary)
Abstract
In live human medical donations an individual’s sacrifice is often justified by benefits to society. However,
when consent cannot be obtained the donor’s best interests are usually given priority. The practice of
veterinary ‘donation’ is rapidly growing in the UK and internationally where healthy blood or tissue is removed
from one live animal to increase treatment options for others of that species. This extrapolation of clinical
techniques from human to non-human animals has not yet been accompanied by sufficient normative work
exploring the ethical justifications for such practices. Using an interdisciplinary approach this paper critically
evaluates the applicability of ‘best interests’ arguments made in the veterinary setting. Empirical data from
dog owners who offer their pets as blood donors to a canine blood bank is analysed to explore why the best
interests of donor animals might not always be given priority. Using sociological ideas related to interspecies
‘families’ we show that relational as well as individual benefits are anticipated, both from the act of canine
blood donation and its presumed outcomes. Furthermore, the analysis uncovers the role of guilt and
obligation in explaining veterinary donation decisions. Ultimately the data implies that the best interests of a
canine donor may be difficult to separate from the interests of the human ‘family’ on which it depends. We
argue that this raises significant normative questions concerning the validity of best interests justifications.
The significance of ‘family’ in our interviewees’ accounts suggests our findings could ultimately challenge
existing understandings of human donation decisions.
PN: 204
One Health, Culling and Tainted Goods
1
Chris Degeling , Jane Johnson
1
University of Sydney, Australia
1
Abstract
One Health is an approach to animal-borne infectious disease that aspires to optimize not only human health,
but also of non-human animals and the environment. Despite the widespread valorisation of One Health,
culling domestic animals and wildlife remains a key component of institutional responses to zoonoses. This
approach finds justification in the harm principle, whereby at times of heightened risk the protection of public
and common goods are given precedence over the interests of animals and owners. It has been proposed
that a reinvigorated account of universal goods can reconcile these aspirations by broadening interest
considerations to other species. Using the threats posed to human health and wellbeing by zoonotic
pathogens such as bovine tuberculosis and highly pathogenic avian influenza as case examples, we explore
how culling and other standard control measures for animal-borne infectious disease might be justified as
part of One Health approaches. Arguments based on notions of “the good” will fail to promote substantive
changes to responses to zoonotic risks because they naturalise the structures that drive emergence. We
make a case that moving the core concerns of One Health to include our shared dependencies and interests
with animal populations and ecosystems might require a re-wilding of the commons.
PN: 34
One Health – Whose Health is it Anyway?
1
Zohar Lederman
1
35
Keywords – One Health; Reverence for Life; Public Health Policy-Making; Canary Birds; Albert Schweitzer
Discipline(s) – Bioethics, Public Health Ethics
Abstract
The One Health (OH) approach is rapidly gaining traction in various professional and academic fora,
including the bioethical and philosophical literature. While OH is usually perceived as an umbrella term which
covers various topics, e.g. zoonotic diseases, comparative medicine, pet-assisted therapy etc., its overall
definition remains relatively stable. The definition usually consists of two components: 1) interdisciplinary
collaboration with the goal of 2) optimizing the health of humans, non-human animals, and ecosystems.
Absent the second component, OH is hardly of interest to bioethicists. However, it is exactly the second
component that is largely missing in current OH literature and (alleged) practice. In this paper, I will use a
normative analysis and first examine the justification for the second component: why should we optimize the
health of humans, animals and ecosystems? I will argue that, in addition to anthropocentric motives, we
should do so for biocentric motives, because life qua life is morally valuable. Specifically, I will raise from the
dead Albert Schweitzer’s theory of ‘Reverence for Life,’ and argue for its soundness and plausibility as a
secular theory. Next, using Schweitzer’s theory, I will critically examine commonly cited examples of a OH
approach, such as the past use of canary birds as sentinels for health risks to miners. The originality of the
paper lies in its attempt to systematically and critically address the ethics of a OH approach. While relatively
few bioethicists and philosophers have written about OH, painfully few discuss the ethical framework for OH
research and practice.
Ochil 2
S18: Trends in Bioethics
Chair: Keymanthri Moodley
Centre for Medical Ethics and Law, Stellenbosch University, South Africa
PN: 579
Capturing the Empirical Trends in Bioethics
1
Tenzin Wangmo
1
Institute for Biomedical Ethics, Basel, Switzerland
Keywords – Methodology; Empirical Turn; Bioethics; Global Bioethics
Abstract
More than a decade ago, the empirical turn in bioethics is said to have taken place with the increasing use of
qualitative and quantitative methodologies to help answer research questions. This evolution can be gauged
with the increasing number of empirical studies published in bioethics journals. The goals are twofold: (1)
Explore whether the empirical turn in bioethics is still occurring, and if so, which direction is it taking: is it
moving towards a true normative empirical analysis or a quasi-ethical research with empirical data or an
empirical study on an ethical topic? (2) Assess what the consequences of this turn are on the field? This
research takes the debate concerning the empirical turn of bioethics a step further as it is the first time that
data from bioethics researchers themselves are taken into consideration to evaluate the empirical turn in
bioethics.
PN: 390
The Role of Philosophy in the Contribution of Bioethics to Individuals,
Public Interests and Public Goods
1
Kristine Bærøe
1
University of Bergen, Norway
Keywords – Philosophy; Practical Reasoning; Real World Ethics; Taxonomy
Discipline(s) – Philosophy; Bioethics
36
Abstract
How relevant is philosophy for the 'real world bioethics' embedded in experiences and actions of individuals,
the shaping and protection of public interests and the distribution of public goods? While 'doing philosophical
bioethics' can be defined as a particular way of thinking that aims for conceptual clarity, logical consistency,
and argumentative rigorousness, will ethical reasoning involved in real world practice be subjected to different
constraints like feasibility, personal motivation and social power structures. Philosophical approaches
engaged in real world, ethical issues, run the risk of collapsing into practical thinking. The aim of this paper,
however, is to map out the particular ways philosophy can serve the real world, ethical practice on its own
terms. The mapping exercise is carried out by reflection and is based up on combining identified, generic
situations calling for philosophical, ethical reasoning with i) two possible levels of generality of the approach
(general or particular) and ii) two possible levels of idealization of the conditions describing the case
(idealized or real and complex). The emerging, comprehensive taxonomy of eleven, distinct ways philosophy
can have a role to play in bioethics represents a new, useful overview. It provides everyone working with
bioethics in the intersection between theory and practice with an analytical tool for self-reflection; it clarifies
the academic conditions involved in distinct kinds of bioethical work; and it may add nuanced distinctions to
discussions about the validity of different ways of 'doing ethics'.
PN: 367
From Medical Ethics to Media Ethics: The Bioethics Model of Spoiler
Etiquette
David Shaw1
1
Institute for Biomedical Ethics, University of Basel, Switzerland
Keywords – Narrative; Spoilers; Consent; Right Not to Know
Discipline(s) – Bioethics; Media Studies
Abstract
There is considerable public debate about the “ethics of spoilers”, focusing on how media and social media
coverage of films, TV series and books should handle revealing key plot details. This research explores
whether key concepts from bioethics could be useful in formulating rules of spoiler ethics. Bioethical concepts
are helpful in establishing which rules should apply to discussion of spoilers. In particular, the requirements of
informed consent suggest that spoiler warnings should always preface any revelation of potentially sensitive
plot points. Fully informing readers, listeners and viewers about the content of articles and posts will facilitate
autonomous decision-making about spoilers, and guarantee that the “right not to know” spoilers is respected.
This in turn will maximise happiness of media consumers, which might even result in health benefits.
PN: 179
Empirical bioethics as art: an exploration of empirical bioethics as a
creative response to ethics in post-modernity
1
1
Jonathan Ives , Bert Vanderhaegen
University of Bristol, United Kingdom
1
Keywords – Bioethics; Ethics as Art; Postmodern Ethics; Empirical Bioethics
Discipline(s) – Bioethics; Philosophy; Sociology
Abstract
‘Empirical Bioethics’ has developed over the last few decades into a field of study devoted to developing
interdisciplinary methodologies that combine empirical and normative analysis to produce conclusions that
are context sensitive and not dominated by abstract philosophy. There are, however, concerns about the
coherency of Empirical Bioethics. Some of these are tied to concerns about developing methodologies that
endorse a kind of moral relativism or particularism that makes making general normative claims, appealing to
and using general moral rules or moral foundations, impossible. This may threaten the power or usefulness of
ethics, reducing moral statements to situation specific opinion or personal judgement. This only becomes
problematic (as opposed to legitimate meta-ethical disagreement), if the methodological work in empirical
37
bioethics fails to engage with this challenge: and to date, with few exceptions, it has not been engaged with.
In this paper we attempt to make some headway by exploring empirical bioethics as a response to the
problems of doing ethics in post-modernity. We first outline a broad vision of the challenge from postmodernism to modern ethics, and then show how various methodologies in the empirical bioethics literature
can be framed as attempts to take post-modernity seriously but resist slipping into post-modern ethical
nihilism. By framing empirical bioethics as field that is (perhaps unconsciously) responding to the challenges
of post-modern ethics, by framing ethical reasoning as a creative/artistic process, the field may be able to
develop a coherency that it has so far lacked.
Ochil 3
S26: Devices
Chair: Fabiana Arzuaga
Ministry of Science, Technology and Productive Innovation, Government of Argentina, Buenos Aires,
Argentina
PN: 411
Regulating Enhancement Devices: The Contribution of Bioethics
1
Hannah Maslen
1
Keywords – Regulation; Public Policy; Public Interests; Enhancement; Defining Subjective Benefits
Discipline(s) – Ethics and Law
Abstract
In the last few years, a market for enhancement devices has emerged. This market includes devices such as
transcranial direct current stimulators. Such devices, unlike their counterparts sold for research and treatment
purposes, are not regulated under medical device legislation (such as the Medical Devices Directive in the
European Union). This is because the manufacturers of such devices do not make therapeutic claims in
relation to the purpose the their devices. Instead, they claim that using their devices can enhance the
cognitive capacities of the user, such as her memory or focus. These devices provide an example of a
broader challenge that enhancement products present for consumer product regulation. Simply treating them
in exactly the same way as if they were medical devices does not appear to be a satisfactory solution. In this
paper, I explain why this is the case. I argue that bioethics can make a critical contribution to thinking through
the amount of risk consumers should be allowed to take in pursuit of enhancement, as well as how the risks
and benefits of enhancement devices should be conceptualised and assessed for the purposes of regulation.
I argue that the approach that should be taken to for enhancement devices differs from the approach
standardly taken to assess the risks and benefits of devices sold for medical purposes. This is an on-going
issue facing policymakers around the world, which has not yet been resolved. This paper makes original
recommendations for regulatory policy on the basis of bioethical arguments.
PN: 624
Drug and Device Manufacturer Support for US Patient Advocacy
Organizations
1
Matthew McCoy
1
University of Pennsylvania, Philadelphia, Pennsylvania, USA
Keywords – Patient Advocacy; Conflict of Interests
Discipline(s) – Bioethics; Health Policy
Abstract
Conflicts of interest in the US health care sector have received increasing attention from scholars and policy
makers. To date, however, this attention has focused primarily on financial relationships between physicians
and drug and device manufacturers—as have laws like the Sunshine Act, which requires manufacturers
participating in US federal health care programs to report payments made to physicians and teaching
hospitals. Far less attention has been paid to relationships between manufacturers and patient advocacy
38
organizations (PAOs), despite the fact that these organizations play a significant role in shaping health policy.
While limited research suggests that manufacturer support of PAOs may be common, there have been few
systematic attempts to document the scope of this support or the extent to which it tends to be disclosed by
PAOs. In this context, our study seeks to answer three questions: what is the scope of financial support that
PAOs receive from manufactures; to what extent do PAOs publically disclose this support; and what, from the
perspective of PAO leaders, are the major barriers to greater levels of disclosure? To answer these
questions, we reviewed tax filings, annual reports, and websites of the 50 largest PAOs in the US and
surveyed leaders of many of these organizations. Our preliminary data show that a majority of these
organization receive financial and non-financial support from manufacturers. While some disclosure of this
support is common, disclosure practices are highly variable across organizations.
PN: 510
Ethical Issues in Mobile Health and Wearable Technology
1
Karola Kreitmair
Stanford University, Stanford, California, United States
1
Keywords – Wearables; Consent; Self-Tracking; Authenticity
Abstract
I present fundamental ethical issues implicated in the rapidly- advancing area of health care/medical
wearables and mobile health applications. Such technologies span a wide range from fitness trackers, to
ingestible sensors used to monitor compliance with medication regimens, to smart phone apps such as
Apple’s Health Kit can be integrated with EHRs. I identify four categories of usage profiles for these
technologies that generate somewhat different ethical considerations. I distinguish between clinical use
mediated by a physician, clinical use not mediated by a physician, research use, and use by employers or
other industrial actors (such as the military or hospitals). I outline four areas of ethical concern. (1) Privacy
and confidentiality: Both the inadvertent and purposeful dissemination of sensitive data concerning one’s
health is problematic and likely with this technology. (2) Consent: Since the market for these technologies is
not regulated and information is likely to be transmitted between HIPAA covered entities and non-HIPAA
compliant consumers, the risk of non-informed users is substantial. (3) Coercion and surveillance: In
particular when this technology is used by employers to monitor some aspect of employee health there is a
worrying possibility for coercion and surveillance. (4) Authentic living: Being continuously outfitted with
devices that monitor minute physical and/or mental processes may have adverse effects on the ability of the
user to live in a non-distracted way.
PN: 784
More Compassion in Compassionate Use of Medicinal Products – New
European Approach Needed
1
Katarzyna Miaskowska-Daszkiewicz
1
John Paul II Catholic University of Lublin, Lubin, Poland
Keywords – Compassionate Use; Access to New Therapy; Unauthorised Medicine; Patient Safety
Discipline(s) – Public Health; Ethics and Law
Abstract:
The idea of a “compassionate use” is an exception to the rule adopted in Art. 6 of EU Directive 2001/83/EC,
that no medicinal product may be marketed in a member state without the authorization granted by the
competent authorities of that member state in accordance with this Directive or with Regulation 726/2004.
The term “compassionate use” means the use of drugs even before their official marketing authorization. The
legal framework for this possibility provides Art. 83 of the EU Regulation 726/2004, pointing the subjective
and objective criteria of “compassionate use”. However, its implementation and coordination remain in the
competence of individual states. This means the functioning in the EU legal space of different regulations and
practices relating to various types of diseases and medicinal products. The purpose of the proposed
presentation is to analyze legal conditions of “compassinate use”, in particular in the perspective of equality of
access to treatment (regardless of the country of residence) and the right to the highest level of health
39
protection (Hristozov case). The question to be answered is whether there is a need to extend the criteria for
“compassionate use” (the model legislation in the US) and for more standarised approach across the EU.
40
THURSDAY 16TH JUNE 2016 11:45-13:15
Pentland Auditorium
S35: WHO and Wellcome Trust: Bioethics at the World Health
Organization
1
2
3
4
5
Abha Saxena , Stephen Kennedy , Yali Cong , Michael Selgelid , Christiane Woopen , Andreas Reis
1
2
3
4
5
6
Coordinator, Global Health Ethics, WHO; Liberia; China; Australia; Germany; WHO
6
Keywords – public policy; globalization; national bioethics committees; partnerships; networking
Disciplines – bioethics; public health; public policy
Abstract
Globalization means that public health issues are no longer contained by national borders. A public health
crisis in one country can quickly spread to its neighbors and impact the rest of the global community. In these
scenarios, ethical questions are of central importance. In order to provide a space in which leading ethicists,
health care workers, policy makers and patients from across the world can come together to provide practical
answers to the major moral and ethical questions that arise during times of global health crises. WHO teamed
up with the University of York with a generous funding from the Wellcome Trust, to create a regular seminar
series examining key issues in global bioethics, titled “Global Health Ethics Seminars” (GHES). Past
seminars have focused on topics as varied as epidemics, antimicrobial resistance, and healthy ageing. In the
th
5 seminar of this series, the organizers of this session wish to share with the participants of the IAB, the role
of the WHO in the field of bioethics. Why does WHO – a public health agency - need to engage with
bioethicists, what is its role, and how does it fulfill its mandate of developing ethical and evidence-based
policies? To understand the role and functions of an inter-governmental public health agency in the field of
bioethics, this panel discussion brings together various stakeholders and partners who work with the
Organization.
SidlawS56: Symposium: What is Enough? Sufficiency, Justice and
Health PN: 261
1
2
3
4
Carina Fourie , Annette Rid , Benedict Rumbold , Leonard Fleck
1
2
3
University of Washington, United States, King’s College, London, United Kingdom, University College
London, United Kingdom, 4Michigan State University, United States
Keywords – Health or health care justice; sufficiency; thresholds in health or health care; two tiered
Health systems; right to a decent minimum of care
Abstract
What is a just way of spending public resources for health and health care? One approach is to aim for each
person to have “enough” so that her health or healthcare does not fall under a critical level. This approach is
called sufficientarian. Sufficientarian approaches to distributive justice are intuitively appealing, but require
further analysis. What exactly is sufficiency? Why do we need it? What does it imply for the just distribution of
health or healthcare? Based on a forthcoming book (Oxford University Press 2016, eds. Carina Fourie and
Annette Rid), this symposium offers fresh perspectives on these critical questions. Debates about health or
healthcare justice typically revolve around the conflict between favouring equality or giving priority to the
worst off. This is surprising, since helping individuals to achieve “enough” health seems to be an intuitively
more appealing aim of health policy than, for example, helping them achieve equal health. The symposium
sheds new light on the undertheorized yet intuitively powerful sufficientarian approach. All papers are original
and have not been previously presented. Conclusion: once properly construed, sufficiency has considerable
potential as a principle of health or healthcare justice. However, sufficientarianism may need supplementation
with other distributive, aggregative or procedural principles.
41
Carina Fourie, University of Washington (Chair)
The Sufficiency View: A Primer
This paper provides a brief introduction to sufficientarianism in health or health care.It provides, first, an
overview of distinctions between sufficiency and other key distributive principles of justice, notably promoting
equality and giving priority to the worst off. Second, the paper details significant elements that sufficientarian
approaches to health or health care justice need to specify, for example justification for why achieving a
critical threshold of health is morally significant and guidance on where and how that threshold should be set.
The paper provides the necessary background for a fruitful discussion about sufficiency.
Annette Rid, King’s College London
Why are so many bioethicists (hidden) sufficientarians?
Sufficientarian approaches to health or healthcare justice—that is, those approaches that attribute moral
significance to achieving a critical threshold of health or healthcare—tend to have a bad reputation. In
particular, they are faulted for promoting a minimal morality, given that their primary goal is to achieve
“enough” health. Moreover, the idea of a critical threshold of health or healthcare is either considered vague
or, if the threshold is fleshed out more concretely, arbitrary. Yet many authors on justice and health are
arguably sufficientarians. This paper argues not only that sufficientarian ideas are widespread in bioethics,
but also that sufficiency is rightly embraced as distributive principle in health or healthcare justice. The
discussion highlights reasons for embracing sufficiency as well as ways of responding to key criticisms of
sufficientarian approaches to justice and health.
Benedict Rumbold, University College London (ECR)
Why Stop at a Decent Minimum?
Most developed economies claim to run a ‘comprehensive’ health care system. Indeed, many countries
(including Finland, Latvia and Lithuania) find it easier to describe the health system’s ‘benefits package’ in
terms of which treatments and services are excluded, rather than those that are included. At the same time,
however, much of the philosophical debate around what constitutes a just distribution of health care
resources has tended to focus on the notion of a ‘decent minimum’. The question therefore arises, why think
the demands of justice stop there? In this paper, I put forth qualified defence of this threshold, arguing that,
though its exact location may be arbitrary, we can identify a range of possible position at which the addition of
further health care resources goes beyond what justice demands.
Leonard Fleck, Michigan State University
The Insufficiency of the Sufficiency Principle in Healthcare
How much healthcare does a just and caring society owe its citizens? Sufficientarians respond that justice is
fairly and reasonably addressed if all citizens are guaranteed access to adequate or sufficient healthcare,
some threshold above which questions of healthcare justice become irrelevant or secondary. This paper
argues that sufficientarianism fails to provide us with a morally adequate perspective for addressing
contemporary complex problems of healthcare justice, especially in connection with healthcare rationing or
setting limits. Sufficientarianism is therefore equally “insufficient” as other approaches to health or health care
justice—such as egalitarianism and prioritarianism—all of which fail to address complex limit-setting problems
in the real world. Consequently, all these approaches have to rely upon fair processes of rational democratic
deliberation that supplement a pluralist conception of healthcare justice.
Fintry
S67: Symposium: The Ethics of Human ‘Artificial Gametes’ PN: 304
1
2
3
4
John B. Appleby , Daniela Cutas , César Palacios-González , Heidi Mertes
1
2
Centre of Medical Law and Ethics, King's College London, United Kingdom; Department of Historical,
3
Philosophical and Religious Studies, Umeå University, Sweden; Centre of Medical Law and Ethics, King's
4
College, London, United Kingdom; Bioethics Institute Ghent, Ghent University, Belgium
Keywords – Reproduction; Gamete; Embryo; Stem-cell; Parenthood
42
Abstract
Each year thousands of IVF patients in the UK and around the world use donated gametes or embryos as
part of their fertility treatment. However, the development of experimental in-vitro gametogenesis techniques
may allow patients to reproduce using in-vitro derived gametes (often known as ‘artificial gametes’). The
availability of these techniques may offer a number of possible benefits to prospective (‘infertile’) parents who
desire to have children who are genetically related to them. These benefits include an increase in the supply
of gametes for fertility treatment, retaining the possibility of having genetically related children after sterilizing
medical treatments carried out during childhood, and allowing same-sex couples to have children that they
are both genetically related to. The emergence of ‘artificial gamete’ technologies raises a number of important
ethical issues, which this symposium aims to address. Conclusion: this symposium reveals that important
ethical issues (e.g. safety and accessibility) surrounding the use of artificial gametes must be addressed
before they are made clinically available.
Is there an ethical obligation to require that the first human use of artificial gametes take place in a
clinical trial?
It is impossible to know if artificial gametes are safe for use in reproduction until offspring are created and
their welfare is observed, preferably as part of a clinical trial. I consider the ethical implications of requiring
the first use of artificial gametes to take place in a clinical trial. I discuss how requiring prospective parents to
enrol in a clinical trial (with the option of later opting out) would impact on the ethical interests of: 1) parents;
2) children; 3) families wishing to use these techniques in the future (and their offspring); 4) clinicians and
researchers involved; and 5) society. For example, how can society’s interest in ensuring such techniques
are safe for use in creating additional offspring be weighed against some parents’ autonomy and privacy
interests? I conclude by recommending that the first parents to use artificial gametes should be required to
enrol in a clinical trial.
In-vitro created gametes for solo reproduction: why (not)?
I discuss the ethics of aiming at achieving human reproduction with genetic material from only one person.
According to statements by a minority of scientists working towards generating gametes in-vitro, it may
become possible to use an individual’s non-reproductive cells to create complementary gametes to those that
the individual already has and to use these gametes to obtain an embryo. I review some reasons why people
might want to have children this way; thus, putting such an innovation into perspective. I conclude that,
although unprecedented, solo reproduction is not more revolutionary than other reproductive technologies
that are currently in use, such as in-vitro fertilisation. My claim is that there are at least as good reasons to
pursue research towards enabling solo reproduction, and eventually to introduce solo reproduction as an
option for fertility treatment, as there are to do so for other infertility related purposes.
How does in-vitro gametogenesis affect the same-sex marriage debate?
Recent breakthroughs in stem-cell research suggest that in-vitro gametogenesis could be achieved in the
near future, with both human embryonic stem-cells and induced pluripotent stem-cells. What seems
remarkable about this is that it is theoretically possible that eggs could be created from male cells and sperm
could be created from female cells. Here I discuss how in-vitro gametogenesis affects the same-sex marriage
debate. Specifically, I demonstrate that in-vitro gametogenesis significantly undermines the arguments
against same-sex marriage advanced by the ‘new natural lawyers’ (e.g. John Finnis). I do this by showing
that their arguments rest on a metaphysical distinction between the type of infertility that affects heterosexual
couples and that which affects same-sex ones. According to them, the infertility of heterosexual couples is
one of ‘privation’, while that of same-sex couples is one of ’negation’. This distinction does not hold once we
take in-vitro gametogenesis into account.
Is there a place for non-patient specific stem-cell derived gametes in medically assisted
reproduction?
While most ethicists concentrate on the issues involved with the derivation of gametes from induced
pluripotent stem-cells or stem-cells obtained after therapeutic cloning (so that they ‘match’ the patient), I will
consider the ethical issues involved in the technically more feasible option of deriving gametes from embryos
created through fertilization. I argue that although this technique does not establish full genetic parenthood,
there may be good reasons to pursue it nonetheless. More specifically, it provides a safer and more feasible
route towards mutual genetic parenthood for same-sex couples.
43
Kilsyth
S87: Arts and Ethics Performance: Expanded Hope PN: 222
2
Bas van der Kruk
2
Erasmus MC, University Medical Centre, Rotterdam, Netherlands; Utrecht University, Ethics Institute,,
Netherlands
1
Type of Work – Dance/Physical Theatre
Keywords – Hope; Investigational Drugs; Experimental Treatment; Expanded Access
Abstract
Patients who have exhausted regular treatment options and do not have time left to wait for new medications
to be approved are offered the option to gain pre-approval access to investigational drugs in the hope it will
have positive effects on their condition. However, since these drugs are still in an early phase of development
little is known about their safety and efficacy. The risk of severe adverse drug reactions is substantial, while
the chance of a beneficial outcome is minimal. Moreover, patients will often have to fund the access to – very
expensive – investigational drugs themselves.
The paper will explore what it means for patients to have this option and how it influences not only
themselves, but also the relationship they have with their doctors, family and friends. Hope can change lives.
In a medical setting hope can provide the perseverance to continue fighting, however, it can also delay the
acceptance of the position people find themselves in. Hope can both empower and make people vulnerable.
Yet, is there such a thing as false hope when we are talking of last chances? The paper exploring the
possible meaning of hope in relation to expanded access is part of a larger project that maps ethical and
societal issues of efforts to expand access to investigational drugs. More information on the project can be
found here: http://www.nwo.nl/en/research-and-results/cases/trade-in-last-chances.html. The piece will be a
hybrid of dance and physical theatre in which text from the paper is recited live. The aim is to create a piece
that is an abstract representation of the paper and its reoccurring themes. The piece should provide an
artistic exploration of the paper, which makes texts and words come alive. Ultimately, it should be the
embodiment of the multifaceted concept of hope in relation to patients and expanded access to
investigational medication.
https://www.youtube.com/watch?v=RQGQ-S_LBy4 (dance show reel)
https://www.youtube.com/watch?v=o0EbawHUiXM (dance and art video)
www.basvdk.com (the artist’s website)
Tinto
S58: Symposium: New Crossroads for Bioethics, Environment, and the
Brain Sciences: Environmental Neuroethics PN12
1
2
1
3
4
DJudy Illes , Laura Y. Cabrera , Ralph Matthews , Jonathan H. Marks , Hervé Chneiweiss
1
2
University of British Columbia, Vancouver, Canada; Michigan State University, East Lansing, U.S.A;
3
4
Pennsylvania State, University Park, U.S.A.; Université Pierre et Marie Curie and INSERM, Paris, France
Keywords – Environmental change; neurotoxins; brain and mental health; culture
Discipline(s) – Neuroethics
Abstract
The effects of environmental change have been studied from many different perspectives over the past
decades, but it was not until the 1970s that the discussion of the moral relationship of humankind with the
environment was formalized as an academic discipline. A few decades later, environmental health emerged
as a complementary discipline to focus on the assessment and regulation of environmental factors that
broadly affect human health. Less attention has been paid, however, to the ethical, social and legal
implications that environmental change holds for brain and mental health. In response, here we will (1)
discuss the ethical implications of anthropogenic environmental change for brain and mental health from
different professional perspectives and disciplines, and (2) explore frameworks, challenges, and priorities for
this crossroads in bioethics, environment, and brain sciences that we call Environmental Neuroethics. Our
44
view is that brain and mental health is a matter of public health and an issue of social justice. The
complicated development of the brain is uniquely sensitive to environmental changes, and the cumulative
impact that begins early in human development can last for a lifetime. Beyond neurological effects, these
changes also affect psychological well-being, including individual capacity to cope with normal stresses of
life, work productively, and make contributions to society.
Rethinking the Role of the Environment for Brain and Mental Health
Laura Cabrera, PhD, ECR, Michigan State University
Humans have altered their environments in pursuit of self-improvement and better opportunities since ancient
times, but the scope and impact of these changes are unprecedented today. While anthropogenic
environmental changes have improved standards of living and provided new ways of protecting human
health, they have also contributed to global climate change and increased health risks from exposure to
toxicants and stress. Environmental Neuroethics, opens a discussion specifically about the impact of
environmental change and exposures for brain and mental health, and aligns this with ethical considerations.
I will show how Environmental Neuroethics is a suitable approach to rethink the role of the environment for
brain and mental health and as a public good, to articulate duties for future generations to push the
boundaries between what we know and do not know regarding environmental exposures, and to build bridges
among disciplines that historically have not collaborated.
Environmental Neuroethics as a Cultural Process
Ralph Matthews, PhD, University of British Columbia
Environmental Neuroethics focuses on the neurological impacts of the changing environment such as
resource extraction, water deterioration, and global warming. Environmental Neuroethics assesses the
inequality of such impacts and the manner in which they are understood and perceived, particularly by those
most affected. This presentation will consider the roles played by culture, values and knowledge in such
assessments. This neuroethics perspective is, by definition, formulated in a context of cultural values.
However, in Environmental Neuroethics analysis, there are many competing cultural assessments related to
differing evaluations of environment, of risk and toxicity, and of differing knowledge systems. Environmental
Neuroethics also involves competing views on how ‘culture gets into our brain’ either as neurologically
predetermined or through social learning. Culture is at the core of Environmental Neuroethics and this paper
seeks to examine its role and articulate the ways in which cultural considerations are most appropriately
incorporated in an Environmental Neuroethics assessment.
Environmental Neuroethics, Epistemics, and Law
Jonathan H. Marks, BCL, MA, Pennsylvania State
The relationship between brain and environment raises a complex set of ethical and epistemic challenges.
First, the environment and the brain are both complex systems. So systemic ethical analysis is essential if we
are to comprehensively address the impact of human and industrial activity on both. This requires a rich set
of conceptual and analytical tools that address the environment as habitat; the social and psychological
dimensions of wellbeing (as well as physical health and cognitive function); and the cumulative and
synergistic effect of environmental toxins. Second, environmental science and neuroscience employ different
criteria for statistical significance. Scientists will need to justify the criteria they use to establish a relationship
between anthropogenic changes in the environment and the brain. Third, we need to promote research that
will help enrich our understanding of these issues, while making both legal and policy decisions in the face of
scientific uncertainty.
Environmental Neuroethics: Do Brain Matters Change from 3D for 2D?
Hervé Chneiweiss, MD, Université Pierre et Marie Curie and INSERM
We are witnessing a revolution because our brains dedicate more and more time to a 2D space. We spend 25 hours per day exposed to various displays and even more for professional uses. How does this new
environment modify our learning, our cognitive process, and even our moral sense? The screen environment
involves multiple windows, several tasks in parallel, always unfinished and temporary. The cognitive
development of children first concerns the recognition and counting of concrete objects, and then later
categorization and reasoning that allows adults to distinguish between ideas. Does 2D impact this cognitive
developmental scheme? It is not only a matter of neuroplasticity as already reported for the use of
smartphones. According to Dehaene’s theory, neuronal recycling requires reorienting of neurons to enrich our
brain with new skills. The cost-benefit of this phenomenon is the calculus that we will explore.
45
Moorfoot
S19: Public Health Ethics
Chair: Koenig, B
PN: 132
The Right to Autonomy, the Duty of Disclosure and Public Health
Considerations – The 2013 Polio Crisis in Israel as a Case Study
1
Nili Eyal
College of Management's Haim Stricks School of Law, Rishon Lezion, Israel
1
Keywords - Vaccinations; Individual right to autonomy; Public health considerations; Duty of disclosure; Polio
Discipline(s) – Law
Abstract
Research Problem
This presentation addresses the question of whether public health considerations provide a legal justification
for restricting the information on vaccinations that is provided to the public. This paper uses the 2013 Israeli
polio crisis as a case study. During this crisis, the Israeli Ministry of Health (IMH) faced a significant
communication challenge in terms of what information should be provided to parents regarding the decision
and the vaccine. The 2013 Israeli polio crisis therefore offers an opportunity to explore the research problem.
Findings
A. Although the information provided to the public was not directly misleading, informational manipulation was
used to increase vaccination rates.
B. Although extensive information was provided to the public, the primarily aim of this strategy was to achieve
a high level of public cooperation, i.e., not to allow parents to make an autonomous decision.
Methodology
The communication strategies used by the IMH were identified and analyzed. For this purpose, information
provided to the public by the IMH and its representatives between July 2013 and December 2013 was
collected. Data were collected from all communication channels (i.e., IMH official website and Facebook
page; Online news media; TV). Different methods of communication were examined (e.g., written information
and informational videos). The collected information was thoroughly reviewed by the researcher, and several
themes were identified. These themes provided the factual basis for the legal discussion.
Conclusion
Although the information that was provided to parents was wide in scope, and although parents were not
directly misled, the IMH’s communication strategy unconstitutionality infringed on parents’ right to make
autonomous decisions for their children and, as such, was not consistent with Israeli law.
Furthermore, I conclude that the existence of a “rational connection” between the practice of withholding
information from the public about vaccinations and public health is questionable.
PN: 240
Ethical issues in Public Health Surveillance: A Systematic Literature
Review
1
2
3
3
Corinna Klingler , Diego Silva , Christopher Schürmann , Daniel Strech
2
1
Institute of Ethics, History and Theory of Medicine at LMU Munich, Munich, Germany; Faculty of Health
3
Sciences at Simon Fraser University, Vancouver, Canada; Institute for History, Ethics and Philosophy of
Medicine at Hannover Medical School, Hannover, Germany
Keywords - public health ethics; public health surveillance; systematic literature review
Discipline(s) – public health ethics; health policy
Abstract
Research Problem and Findings: Public health surveillance is a crucial basis for effective public health
practice. Several ethical issues can arise that need to be considered by practitioners when running
46
surveillance systems. However, practitioners are largely left alone with the task of identifying and handling
ethical issues due to limited guidance or reference documents. The research project was therefore aimed at
giving a comprehensive overview of potential ethical issues as necessary information base for practitioners
and current WHO guideline development. Based on 83 included references we identified 86 ethical issues
that could be grouped under four major categories representing the different phases of surveillance: (a)
background, (b) design and implementation, (c) data collection, storage and analysis, (d) data use,
dissemination and sharing.
Methodology: We conducted a systematic literature review for ethical issues in public health surveillance.
We defined ethical issues based on principlism assuming that ethical issues exist when (a) a normative
principle is not adequately considered or (b) two or more principles are in conflict. We searched PubMed and
GoogleBooks for relevant literature. The data were analysed using qualitative content analysis adapted from
Schreier (2012).
Originality
This is a first attempt to derive a comprehensive overview and synthesis of ethical issues in surveillance. We
discuss its opportunities and limitations in the development of ethical guidance.
Conclusion
Systematic review methods allow presenting comprehensive and stakeholder-oriented overviews of ethical
issues as important information source. Systematic reviews can improve transparency and inform policy and
guideline development also for normative questions.
PN: 177
Healthful Environments: Public Goods, Public Health, and Individual
Welfare
1
Peter West-Oram
Christian-Albrechts-Universität zu Kiel, Germany
1
Keywords - Public Goods; Public Health; Global Justice; Human Rights; Global Health
Discipline(s) – Bioethics; Political Philosophy
Abstract
Research Problem and Findings
Delivering effective public health policy can sometimes appear to conflict with adequately respecting
individual rights to finite resources – undermining the concept of rights to health care by rendering the
guarantees they entail contingent rather than absolute. Conversely however, excessive deference to
individual entitlements can endanger public health generally, by weakening health promoting infrastructures.
In this paper, I argue that thinking about public and individual health in terms of a generalised welfarepromoting public good, rather than entitlements to specific goods or services, enables us to reason effectively
about theoretical questions about the nature and extent of individual rights and duties, and the preservation of
public health. I argue that acknowledging a ‘healthful environment’ as a ‘meta’ public good in this way
provides a highly effective method of reasoning about both (domestic and global) public health policy, and
individual rights and wellbeing. This paper will suggest a novel approach to resolving tensions between the
need to preserve public health, and to respect the rights of individuals. While the importance of health public
goods is increasingly acknowledged in the literature, my paper will offer an original suggestion of how this
importance might be used to create just, effective public health policy. Conclusion: I will show how
conceptualising healthful environments as ‘meta’ public goods can provide the heuristic and analytical tools
with which to assess the just extent of our entitlements to finite resources, while simultaneously offering a
framework upon which to construct just public health policy.
PN: 86
Overdiagnosis of Thyroid Cancer: Can Public Health Ethics Help?
1
2
2
Wendy Rogers , Wendy Craig , Vikki Entwistle
1
2
Macquarie University Research Centre for Agency, Values and Ethics, Sydney, Australia; Health Services
Research Unit, University of Aberdeen, Aberdeen, United Kingdom
Keywords – overdiagnosis; thyroid cancer; conflict of interests; paternalism; public health
Discipline(s) – Medical ethics; surgery; public health
47
Abstract
Thyroid cancer overdiagnosis involves identifying small indolent cancers. It occurs through screening or
incidentally while managing other disease. Despite the excellent prognosis, many patients receive extensive
treatment including thyroidectomy, radioactive iodine and thyroid hormone replacement, with potential harm
to individuals and waste of healthcare resources. As yet there is little ethical analysis of this issue. Our
detailed analysis investigates the harms from thyroid cancer overdiagnosis accruing to patients and
healthcare systems. We argue that a public health approach provides valuable direction in addressing the
problem. Although individualistic ethical analyses identify many relevant issues, such approaches, especially
when focused on personal choice/autonomy, cannot direct systemic actions to address overdiagnosis. We
propose that the nature and extent of thyroid cancer overdiagnosis amounts to a public health problem,
requiring population-level solutions, including rationalisation of interventions. While this may raise concerns,
including worries about medical paternalism, these must be balanced against: the lack of evidence to support
treatment of overdiagnosed cancers; the need for equity in scarce resource allocation and for effective
communication; the inappropriateness of expecting individual patients’ choices to correct systemic or
professional shortcomings; and a re-thinking of the notion that prevention is (always) better than cure,
especially when the ‘disease’ in question may not eventuate. Conclusion: to counter the harm of thyroid
cancer overdiagnosis, a population level approach rationalising investigations is justifiable and may be
effective.
Carrick 1
S74: 20 x 20 (A)
Chair: Goold, I
PN: 315
Deep Brain Stimulation Research and U.S. Law: How are Vulnerable
Patients Being Protected?
1
Tyler Gibb
Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, USA
1
Abstract
Beginning in the 1970s, after a public outcry against the procedures, psychosurgery has been very heavily
regulated. In fact, some states explicitly forbid surrogate decision-makers from consenting to psychosurgery
for incapable patients. The ethical rationale for these heightened regulations was based in the patient's
perceived vulnerability. Today, many of the regulations established to protect patients from psychosurgery
are being avoided in the context of DBS. It is still an open question whether DBS and psychosurgery should
be regulated in similar ways. This presentation will examine and expound on the legislative history of the
psychosurgery laws and regulations and proved the necessary context for addressing the question: should
DBS be regulated in a similar manner to other psychosurgeries, or is DBS sufficiently different from
psychosurgery to be excluded from the strict regulations that arose during the 1970s?
PN: 54
A Guide to the Ethically Sound Inclusion of Children in Clinical
Research
1
Krista Tromp
Erasmus Medical Center, Department of Medical Ethics and Philosophy, Rotterdam, Netherlands
1
The process of recruitment and informed consent in clinical research with children might be clear in theory, in
practice it is not. The question remains how to design this process of recruitment, information and consent to
include the perspective of minors and their parents. In this presentation I will give a practical guide to the
ethical sound inclusion of children in pediatric clinical research. This guide combines ethical theories,
perspectives from children and parents (collected during my PhD-research), and views from health care and
research professionals.
48
PN: 146
Public Interests, Public Goods and Persons, but the Legal Ones?
1
2
Hana Konecna , Karolina Novakova
2
University of South Bohemia, Ceske Budejovice, Czech Republic; Masaryk University, Brno, Czech
Republic
1
Keywords – Assisted reproduction; legal person; access; welfare of the child; thought experiment
Abstract
There is a continuous discussion in the field of medically assisted reproduction (MAR), who should have an
access to it. Because no one can be discriminated, it is essential to substantiate every single refusal of
access carefully. Currently, a criterion of „welfare of the child“ is being used most frequently. On a thought
experiment, we want to demonstrate that the criterion of “welfare of the child“, even in its strictest form, easily,
allows an access to MAR also for legal persons.
PN: 168
Defining Categories of Actionability for Secondary Findings in NextGeneration Sequencing
1
Celine Moret
1
Institute For Ethics, History, And The Humanities, University of Geneva, Switzerland
Next-generation sequencing allows the analysis of the whole genome and is increasingly used for the
diagnosis of genetic disorders. However, this technique is associated with a high likelihood of finding results
unrelated to the diagnostic question. The type of unexpected results that ought to be disclosed to patients is
debated. Actionability of findings is a commonly used yet vague criteria. We will propose a usable application
of actionability in clinical practice for genetic results of clear significance. We will then tackle the issue of
variants of unknown significance in actionable genes and the ethical appeal to autonomy to justify disclosure.
PN: 242
Duty in Dying
1, 2
Guy Schofield
1
2
Imperial College London, London, United Kingdom and St George's, University of London, London, United
Kingdom
Keywords – Death; Dying; Personal Responsibility; Autonomy
Discipline(s) – Medical Ethics
Abstract
The practice of end of life care is focused on doing everything possible to improve the quality of life of the
patient and their family. The needs of the primary patient and their family can sometimes significantly differ or
be contradictory. Very rarely some patients actively worsen their family’s experience of their death. Patients
are thought to have responsibilities towards their health and use of healthcare during other phases of their
illness. This paper argues that these responsibilities extend in their scope as patients approach the end of
their life particularly concerning the impact of healthcare decisions on others.
PN: 245
Human Enhancement: Approaches to Conceptualization and Common
Theoretical Framework
1, 2
Elena Grebenshchikova
Institute for Scientific Information on Social Sciences of Russian Academy of Science, Moscow, Russian
2
Federation; Pirogov Russian National Research Medical University, Moscow, Russian Federation
1
Keywords – Bioethics; human enhancement; moral enhancement
49
Abstract
The issue of human enhancement is one of the discussions in bioethics. The purpose of the presentation is to
explore various theoretical approaches to the human enhancement, to identify the criteria for categorization
and the possibility of a general theoretical framework. The presentation analyzes fairly new questions of
moral enhancement, and their position in the overall issue. Special attention is paid to the society's attitude
to human enhancement, which is defined by cultural, social and educational factors. This aspect is also
considered as a basis for categorization of human enhancement. The research was supported by grant RSF
15-18-30057.
PN: 31
Bioethics Teaching and the Narrative Arts
2
David Obree
2
Centre for Ethics in Medicine, University of Bristol, United Kingdom; Centre for Medical Education (Visiting
Tutor), University of Edinburgh, Scotland
1
Discipline(s) – Arts and ethics; working across disciplines
Keywords – Teaching; Ethics; Stories; TV; Cinema
Abstract
Practical ethics and the narrative arts (cinema, theatre, television, novels) share cause, effect and conflict
resolution as primary devices or goals. Character and motivation are important in the narrative arts and virtue
ethics. Can these reciprocal themes be utilised to teach bio and medical ethics? This pictorial presentation
explores the opportunities for using the arts in teaching. Examples from popular culture are suggested along
with the results of a preliminary study with undergraduate medical students.
PN: 332
Usefulness of collaborative theatre as a teaching tool of bioethics in a
postgraduate intensive care nursing programme: A Mexican Experience
1
Enrique Olivares-Durán
1
High Specialty Regional Hospital of El Bajio (HRAEB), León, Mexico
Abstract
Is it feasible to use theatrical activity as a successful teaching tool of bioethics in a postgraduate intensive
care nursing programme? In theory, constructivist teaching techniques can bring originality, freshness and
meaningful experiences to the learning process. Based on a paradigmatic clinical case of ethical dilemmas at
the end of life in a hospital setting, it was suggested to a group of nurses studying the specialty of intensive
care that they stage a play of collective creativity, respecting the key points of the historic case but adapting it
to reality, customs and practices of a hospital and in accordance with the Mexican laws. Said play had to
include: a legal action of the family, a pros and cons debate, and a properly argued final verdict from the
judge. Nursing students created an original theatre script based on the proposed clinical case, with dialogues
that intentionally involved elements of human drama and the legal-ethical conflict in decision-making at the
end of life in such case. It was their final course work. It was presented to the University academic authorities.
Then, they were invited to present the play before the Ethics Committee of a specialty hospital and, latter, at
the IX Latin-American and Caribbean Congress of Bioethics (Guanajuato, Mexico, 17-20 April 2013).
Conclusion: collaborative theatre is a powerful tool in teaching and diffusion of bioethics in postgraduate
intensive care nursing programmes.
PN: 466
'Lithium' - Using Poetry in Bioethics Pedagogy
1
Trevor Stammers
St Mary's University, London, United Kingdom
1
50
Keywords – Poetry; Education; Suicide; Depression; Autonomy
Discipline(s) – Bioethics education; Poetry
Abstract
Using Robin Robertson’s poem ‘Lithium’, I illustrate how I use poetry to enhance teaching bioethics. The
advantages of the use of poetry in bioethics will be outlined and ‘Lithium’ will be presented and the questions
used in small groups in classes to bring out the meaning of the poem will then be shared. I will demonstrate
how relevant clinical and bioethical themes in the poem can then be identified. These can then be discussed
in class in the context of the empathy aroused in students by their engagement with the poem.
Carrick 2
S8: Organ and Tissue Donation
Chair: Ganguli-Mitra, A
PN: 547
Pre-donation status of renal donors in India
1
Radha Malattiri
1
MIMS Academy, Kozhikode, India
Abstract
In India where the living donation drives the kidney transplant program, factors affecting decision making in
donors have not been studied adequately. Our prior study had shown that 84% of donors were patients'
immediate relatives with spouses and mothers forming the lion's share. Our aim is to study the kidney donors
prior to transplantation with respect to social and psychological factors that could influence the decision
making process.
A single centre, prospective study was conducted on 82 consecutive donors using standard and self made
questionnaires. Interview was conducted on the day prior to donation with informed consent. Women
constituted 83%(68/82) of donors, wives and mothers were in equal proportions. Among female donors
22/68(32%) had depression prior to donation. Compared to others including wives, mothers had significantly
more depression (48% vs 23%). Awareness towards health consequences and follow-up requirements were
reported only by 44%(36/82) of donors. Fifty- three of 82 donors(66%) and 54/68(79%) of female donors
were not financially independent. The educational qualification was below high school certification in
66%(54/82) of the donors. Thirty five of 82(43%) donors did not meet or discuss with a donor or donor family
the process of donation to understand the implications.
Our study shows increased depression among kidney donors especially women prior to donation. Majority of
donors did not have education beyond high school, were not financially independent and lacked awareness
about pre and post-donation health issues.
PN: 594
Transplants and the Advance Health Care Directives: the ethical and
legal challenges of organ and tissue donation
1
2
3
Sarah Rego Goiata , Bruno Torquato de Oliveira Naves , Diogo Luna Moureira , Maria da Fátima Freire Sá
2
1
Pontificia Universidade Católica De Minas Gerais, Belo Horizonte, Brazil, Pontificia Universidade Católica
3
De Minas Gerais, Belo Horizonte, Brazil, Pontificia Universidade Católica De Minas Gerais, Belo Horizonte,
4
Brazil, Pontificia Universidade Católica De Minas Gerais, Belo Horizonte, Brazil
4
Keywords - Informed consent; Organ donation; Living will; Bioethics; Biolaw
Discipline(s) - Public Health, Ethics and Law
Abstract
Drawing on a reflexive critical perspective it is evident that Brazil has improved substantially concerning the
legal surrogates on organ and tissue donation. However, information available to the general population is
51
still scarce and may represent a serious obstacle on enhancement of number of donors. Although Brazil has
the second largest transplant program in the world, getting consent from relatives is still a challenge.
Including personal preference on the advance health care directives is essential to enhance the number of
donors. Numerous factors are involved in the current reality of organ donation. Limited knowledge by the
common population and the uncertainty of the personal preference of a relative diagnosed with brain death
are the main reasons relatives refuse to sign an organ and tissue donation consent. This work is a critical
discourse analysis of the advance health care directives as surrogates to organ and tissue donation. After an
extensive review and profound analysis of the legislation in Brazil, we conclude that the advance health care
directives ensure the patients´ autonomy by expressing their will as to being a donor when they are no longer
capable of expressing themselves. This document may also ease the burden on relatives and medical staff
on making important decisions concerning medical treatment and organ donation. Considering our current
pluralist society, in which private autonomy and self-determination are mandatory, promoting a wider use of
this legal document should be encouraged as a tool to express individual preference as to being an organ or
tissue donor.
PN: 47
Organ Provision, Postmortem Gestation, and the Responsibilities of the
Recently Dead
1
Jamie Nelson
1
Michigan State University, East Lansing, United States
Keywords - Organ Procurement, Postmortem Pregnancy, Death
Abstract
To determine the implications of the willingness or obligation to provide transplant organs after death for
postmortem gestation. The presentation opens up a new line of discussion concerning the kinds of harms
and wrongs to which the dead are vulnerable. Conclusion: neither those women who volunteer as organ
donors, nor opt-out, nor routine retrieval theories, imply that anyone pregnant at brain death has “already
consented” nor “is obliged” to be used to continue gestation. Narrative: Both postmortem organ provision and
postmortem pregnancy, can be seen as putting tensions between the interests of individuals and those of
wider publics on display. In 1982 Veatch connected these topics in JAMA, arguing that there should be no
scruples about maintaining pregnant “brain dead” women on metabolism-supporting technology long enough
to allow birth, if they had previously volunteered to donate organs after death. It might seem similarly
plausible that, given the soundness of arguments either for presumed consent, or for assigning a positive
responsibility to provide organs, than a similar consent (or obligation) to continue postmortem gestation might
reasonably be inferred. I conclude that in none of these cases does the alleged inference hold. Pertinent
disanalogies are traced to gender, to families, and to the moral status of fetuses; an innovative account of
respect offenses to which the dead are vulnerable is outlined.
PN: 595
Is Donor Benefit Necessary For Justified Living Organ Donation?
1
Dr. Nicola Williams
Lancaster University, United Kingdom
1
Keywords – Donation ethics; Living organ donation; donor benefit; beneficence; non-maleficence
Abstract
For the majority of scholars concerned with the ethics of living organ donation, inflicting moderate harms on
the living to save/increase the life chances of others is held to be justifiable provided certain background
conditions are met. These conditions tend to include one, or more commonly, some combination of the
following requirements: living donation produces/is necessary to produce an all-things-considered benefit for
donors and recipients, retrieval is not liable to cause grave harm to the donor, and/or both donor and recipient
provide fully informed and valid consent. This paper critically examines the suggestion that alongside or
instead of certain of these requirements, key to justified living organ donation is that donors receive an allthings-considered benefit from donation. This view has traditionally been advanced in the rare cases where
52
incompetent persons have been proposed as potential donors. Some, however suggest its extension to all
cases of living organ donation, holding that the doctor’s role as patient advocate and his prima facie
obligation to do no harm means that organ retrieval from the living, regardless of capacity, can only be
justified where donor harm is outweighed by donor benefit. I suggest however, that although donor benefit is
nearly always a welcome result of an instance of living donation, given the numerous and often competing
roles of the doctor, as well as the importance of ensuring un-coerced consent and retaining a focus on
altruism and solidarity, donor benefit should not be viewed as a necessary requirement of justified living
organ donation.
Carrick 3
S27: Disease control
Chair: Pringle, J
PN: 543
Is There an Ethical Difference Between Withdrawing and Withholding
Donor Blood Safety Measures?
1
Koen Kramer
2
1
Sanquin Blood Supply Foundation, Amsterdam, Netherlands; Wageningen University, Wageningen,
Netherlands
Abstract
Blood services have since the 1980’s introduced numerous safety measures against the transmission of
dangerous infections through blood transfusion. Concern with the costs of donor blood safety is growing,
however, which raises the question whether expensive technologies that increase safety only marginally
should be discontinued. Withdrawing such measures would allow securing more health benefits by
reallocating resources to more cost-effective health care interventions, but is rare in practice and may raise
serious moral objections. This paper discusses whether discontinuing blood safety measures is any more
objectionable, ethically speaking, than deciding not to implement them. Its approach is to draw arguments
from the most advanced debate on withdrawing and withholding medical interventions, namely those on lifesustaining therapies, and to reinterpret these to fit the current issue. The first argument is that discontinuing
blood safety measures amounts to doing harm to patients and is therefore more objectionable than not
introducing such measures, which allows harm to occur. The second is that transfusion recipients are
historically entitled to the continued performance of blood safety measures that have been instituted by just
procedures. We consider neither argument persuasive. We argue that discontinuing blood safety measures is
more appropriately understood as allowing than as doing harm to transfusion recipients. When resources are
scarce, furthermore, historical entitlement to continued treatment does not extend to futile or disproportionate
interventions. We conclude that blood services should be just as – and sometimes even more – prepared to
withdraw as to withhold inefficient blood safety measures.
PN: 668
Zika Virus in Latin America and the Caribbean: What Are the Ethical
Issues?
1
Carla Saenz
1
Pan American Health Organization, Washington, United States
Keywords – Zika; epidemics; Latin America and the Caribbean; research; priority-setting
Discipline(s) – Bioethics; public health ethics
Abstract
There is currently a Zika virus disease outbreak in the Americas. Zika is spreading rapidly in Latin America
and the Caribbean. A mosquito-borne disease, Zika is asymptomatic in 4 out of 5 persons. Its symptoms are
mild fever, skin rash and conjunctivitis. There is no treatment or vaccine for Zika and diagnosis is difficult
because the virus can cross-react with other viruses such as dengue and yellow fever. Zika has been linked
to microcephaly in infants, which implies severe brain damage. In Brazil in 2015 there were 20 times more
53
cases of microcephaly than in 2014. Zika seems to be linked also to Guillain–Barré syndrome, a potentially
life-threatening condition in which one’s immune system attacks the nervous system, causing paralysis.
The goal of this presentation is to discuss the key ethical issues raised by the Zika outbreak, namely, (1)
decision-making at the clinical and political level in the context of very difficult risk-benefit assessments, (2)
conduction of research during an emergency, (3) communication of information to the general public, and (4)
priority-setting in the context of collapsed health system. The discussion of these four issues will take into
account the lessons that have been learned from the Ebola outbreak in West Africa.
PN: 162
Ethical Analysis of Public Goods in Infectious Disease Control
1
Euzebiusz Jamrozik
1
Monash University, Australia
Keywords – Public health ethics; public goods; infectious disease
Discipline(s) – Bioethics; public health ethics
Abstract
Infectious diseases are responsible for a large burden of death and disability at a global level and
disproportionately affect poor populations. Freedom from infectious disease (or control initiatives aimed at
reducing transmission) shares some features with classic public goods (‘non-rival’, ‘non-excludable’ and
frequently underprovided) and requires collective action. Yet the concept(s) of public goods and links with
theories of collective action have received limited philosophical attention in this context from within bioethics.
Multiple public goods are required for disease control e.g. clean air and water (in the sense of being free from
pathogens), herd immunity from vaccination, bed nets and vector interventions, knowledge (basic science
research, drug development, epidemiological surveillance data) and controlling antimicrobial resistance.
Some of these public goods extend to the entire global population (global public goods), or to future
generations.In this paper I argue that public goods in disease control are best understood as collective action
problems whose moral weight is at least partially determined by the magnitude of benefits and harms at
stake, and that there are frequently issues of justice in terms of the unequal distribution of these benefits and
harms. Conclusion: I show how this perspective improves on existing conceptual models and argue that
ethical analysis is useful in (i) deciding which goods to prioritise, (ii) determining obligations for the provision
of public goods for both international organisations and individuals, and (iii) in some cases, justifying coercion
in order to secure global public goods.
PN: 484
Why the Definition of ‘Disease’ is Relevant to Public Health
1
Taryn Knox
1
University of Otago, New Zealand
Keywords – Disease; public health
Abstract
It is permissible to aim public health initiatives at non-diseases. For example, it may be permissible to have a
programme aimed at the responsible use of contraceptives, even though fertility is not a disease. Additionally,
some public health initiatives targeting diseases are not permissible. For example, an initiative that
stigmatised (i.e. harmed) depressed people would be impermissible. This means that it is neither necessary
nor sufficient for a public health initiative to be permissible that it be aimed at disease. In turn, it could be
argued the definition of ‘disease’ is irrelevant to people in public health. However, public health initiatives are
often justified on the basis of the disease-status of some condition. I argue this justification should be
restricted to cases in which a genuine disease is the target of the initiative. In other words, it is not
permissible to justify a public health initiative for a non-disease, based on the false claim that the condition in
question is a disease. For example, while a public health programme aimed at managing ‘everyday’ stress
may be permissible, the programme cannot be justified on the claim that ‘everyday’ stress is a disease (i.e. a
mental illness). This means if we want to justify a public health initiative on the basis that it targets a disease,
54
then we need to know whether it is a disease or not. Hence, the definition of ‘disease’ matters to those in
public health.
Harris 1 & 2
S29: Genetics, genomics and risk
Chair: Árnason, V
PN: 430
No Risk, No Worries? An Empirical and Ethical Investigation into
Australians’ Attitudes Towards Personal Genomics
1
1
2
3
2
Ainsley Newson , Jacqueline Savard , Chriselle Hickerton , Bronwyn Terrill , Erin Turbitt , Sylvia Metcalfe
Centre for Values, Ethics and the Law in Medicine, University of Sydney, University of Sydney, Australia;
2
3
Murdoch Childrens Research Institute, Parkville, Australia; Garvan Institute of Medical Resarch,
Darlinghurst (Sydney), Australia
2
1
Keywords - Personal genomics; Next generation sequencing; Empirical data; Risk; Autonomy
Discipline(s) – Empirical Bioethics
Abstract
Personal genomic testing offers healthy individuals access to their genetic makeup for purposes that include
ancestry, paternity, sporting ability and health. Increasingly, these forms of testing have become readily
accessible to individuals in many countries, including Australia. Less is known, however, about views of such
testing among the public(s) who may utilize them. In this paper, we will report on initial findings from the first
multi-disciplinary, multi-phase study to explore Australians’ awareness and expectations of personal genomic
testing. GeniOz (Genomics: National Insights of Australians) involves focus groups, a quantitative survey and
semi-structured interviews; combined with ethical analysis of emergent themes. Here, we present and critique
data from GeniOz focus groups. Fifty-six members of the public participated in seven focus groups (stratified
by age) hosted over two months in 2015. Recordings were transcribed, the transcripts were coded and
themes generated for analysis. Analysis indicates there was an absence of engagement by participants with
concepts of risk. Participants appeared not to consider the consequences of seeking or receiving genomic
information directly from the marketplace, as opposed to mediated via a relevant professional. We will
undertake a normative reflection on how consumers accessing genetic information in the marketplace claim
to do so as an exercise of autonomy – challenging whether such asserted choices can in fact be autonomous
when risk does not seem to have been countenanced. In conclusion, a statement of how this status quo will
impact how genetic information is valued, accessed and used by consumers will be explored.
PN: 558
Epigenetic Justice
1
Hafez Ismaili M'hamdi
Erasmus MC, Rotterdam, Netherlands
1
Keywords – Justice; epigenetics; fair equality of opportunity; luck egalitarianism
Discipline(s) – Ethics; Political Philosophy
Abstract
Research in the fields of epigenetics is evolving the way of examining how social and environmental
exposures influence the way genes are expressed without changing the underlying DNA. Ample research
demonstrates how epigenetic modifications, triggered by environmental cues, play an important role in the
development of poor pregnancy outcomes and non-communicable diseases later in life. In addition to
increasing the understanding of the aetiology and development of these poor health outcomes, epigenetics
challenges the ways we think about justice and fairness. This challenge arises because following epigenetic
insights, the traditional distinction between states of affairs we are given and states of affairs we are
responsible for, which is crucial for determining the demands of justice, becomes blurred and indiscernible.
55
The consequences of epigenetics on the demands of justice will be demonstrated by evaluating Daniels’s
approach to justice and the luck egalitarian approach to justice. The former is uses Boorse’s account of
health and disease. This view of health as statistical normal functioning is incompatible with the epigenetic
insights. It will be argued that Daniels’s approach to justice stands to gain from adopting an epigenetic view of
health. The latter makes the crucial distinction between brute luck and option luck. Epigenetic insights make
clear that most aspects of non-communicable disease development aren’t beyond control. Consequently
people may be held responsible for their own poor health outcomes. Using Scanlon’s two accounts of
responsibility a more adequate view of epigenetics, responsibility and the demands of justice will be given.
PN: 160
Genetics Trade or Blood Narcissism
1
1
1
1
Laura Andrea Massaro , Graciela Martha Soifer , María Laura Ferrari , Adriana Ines Ruffa , Gricelda
1
Ethel Moreira
1
Bioeticar Asociación Civil, Buenos Aires, Argentina
Keywords - Cryopreservation; Autonomy; Sexual and Reproductive Rights; Maternity; Post-modernism
Discipline(s) - Global Bioethics
Abstract
Is cryopreservation of fertile women’s oocytes justifiable from an ethical stance? Cryopreserving oocytes, not
within a therapeutic plan, is a decision which has an impact on personal and family related plans. It’s closely
linked to the non transferrable rights as well as to the exercise of the sexual and reproductive ones. In
current times, when many women decide to prioritize the development of their careers, which involves
postponing motherhood, the option of having their oocytes cryopreserved may sound attractive.
Nevertheless, it’s worth questioning if said option may induce a decision-taking process which violates
freedom and autonomy, thus reinforcing the model which highlights that a mother is the one who gives birth
to a child. Conclusion: the paradox consists in the fact that the necessary autonomy for exercising one’s
sexual and reproductive rights is not such, given that said autonomy is affected by corporate interests, thus
generating an induced autonomy. Said autonomy is induced by an option which lacks enough information for
a reasoned decision to be made. Based on this, sons and daughters are turned into market products, used as
part of a utilitarian or vindication-type consumption, rather than into children taken as individuals.
PN: 712
Harms at Stake in Cancer Screening
1
Lynette Reid
1
Dalhousie University, Department of Bioethics, Halifax, Canada
Keywords - Public health ethics; screening; cancer prevention; medical harm
Discipline(s) – Philosophical analysis in public health ethics
Abstract
Our understanding of public goods is incomplete as long as we do not investigate public or population harms.
Screening programs have long been assessed with reference to Wilson and Jungner's 1968 WHO principles.
Recent re-assessments note that the desiderata do not include the requirement that benefits of screening
outweigh harms. Proposed reformulations include this requirement, as well as strengthened requirements for
program evaluation and oversight. I argue that this desideratum as posed is not yet capable of
operationalization: the concept of harm is too generic, and the nature of screening program implementation is
such that the data to address the question of the overall balance of harms and benefits is not available until
decades after implementation. The original Wilson & Jungner desiderata, by contrast, speak realistically to
the scientific and social situation in which the decision to screen actually takes place. I review the original
Wilson & Jungner desiderata for their implicit reference to specific kinds of harm in order to create a
taxonomy of harms, individual and public, at stake in cancer screening programs. This process generates
both standards screening programs should meet and mitigation strategies they should have in place for
unavoidable harms and possibilities of net harms. I then test these with reference to 1) how such mitigation
strategies would have avoided harms in past successes (cervical cancer screening), and 2) how such
56
standards help us diagnosis the fundamental challenges emerging in current troubled screening programs
(breast and prostate cancer screening).
Ochil 1
S52: Symposium: Developing a Framework for Genomic and Biobanking
Research in Africa PN: 336
1
2
3
4
Ciara Staunton , Paulina Tindana , Aminu Yakubu , Patricia Marshall
1
2
Centre for Medical Ethics and Law, Stellenbosch University, Cape Town, South Africa; Navrongo Health
3
4
Research Centre, Ghana Health, Navrongo, Ghana; Federal Ministry of Health, Abuja, Nigeria; Case
Western Reserve, Cleveland, Ohio, USA
Keywords – Genomics; Biobanking, regulation; Africa; H3Africa; community engagement
Discipline(s) – Ethics; Law; Public Health
Abstract
Genomic and biobanking research in Africa raises a unique set of ethical challenges partly due to the
confluence of medical research with traditional beliefs and cultures. The H3Africa project seeks to develop
research capacity for genomics and biobanking research on the African continent which includes identifying,
exploring and where possible addressing ethical challenges. The Ethics and Regulatory Issues Working
Group (WG) has to date held two ethics consultation meetings with over 100 members of over 40 research
ethics committees in 20 African countries involved in the review of H3Africa projects. During the second
meeting held in May 2015, there was a call to develop a framework to guide harmonisation of regulations
across Africa. With involvement from leading science organisations on the continent and National Research
Ethics Committees from across Africa, we developed a Framework for Best Practice for Genomics and
Biobanking Research in Africa. Its aim is to outline foundational principles and core elements that ought to be
considered and incorporated in the review and design of African genomics and biobanking research. This
symposium will present the framework and discuss the practical challenges involved in developing and
implementing such a framework in Africa including the current regulatory sphere for genomics and
biobanking. This symposium’s focus will be on the framework developed by the WG and the consultation
meetings and the panel discussion will provide an opportunity for final insights as the WG finalises its
framework for publication in late 2016. Target audience for this symposium would be anyone involved in
medical research in Africa, including genomics and biobanking research.
Dr Ciara Staunton: Challenges facing a harmonised framework for genomic and biobanking research
in Africa
At the heart of the H3Africa project is the creation of a pan-African network that will build up and develop
genomic and biobanking research in Africa. Yet developing a consortium such as H3Africa on a continent as
diverse as Africa is challenging. Collaboration is key to its success, but this can be hampered by differences
in regulatory frameworks that are heavily influenced by differences in culture and tradition. Regulatory
approaches range from restrictive that hinder the development of the science, to more permissive
approaches that encourage open science. The history of parachute research has also led to considerable
suspicion of international collaborations and unease in the sharing of samples across borders. Drawing on
the cultural, legal and ethical challenges facing the Consortium, this paper will argue that a continental
framework is a necessary step towards harmonisation of regulatory frameworks within Africa.
Paulina Tindana: Framework for Best Practice in Genomics and Biobanking Research in Africa:
development, content and stakeholder engagement
In this paper, we will discuss the development and content of a proposed Framework for Best Practice for
Genomics and Biobanking Research developed under the auspices of the H3Africa Working Group on Ethics,
with input from the African Academy of Sciences and National Research Ethics Committees from across
Africa. We will explore the purpose of the framework and describe the process of stakeholder engagement
that was followed in order to develop it. Subsequently, we will summarise the content of the framework and
solicit feedback and discussion about key items. Importantly, the Framework stresses the importance of
African ownership and leadership of scientific projects, the need for robust and authentic community
engagement to accompany such science, broad consent for future unspecified use of samples and
addressing the risk of stigma or group harm.
57
Aminu Yakubu: Towards implementation – next steps in finalising and distributing the framework
The growth of genomic and biobanking research has been matched by an explosion in international
statements and guidelines. The importance of this framework is that it is the first statement for Africa that also
incorporates the ethical, cultural and historical considerations that are unique to the continent.
Implementation of this framework will begin with adoption by the H3Africa Steering Committee so that it
becomes a leading guide for new scientific projects taking place under the H3Africa umbrella. The African
Academy of Sciences, through the Alliance for the Acceleration of Excellence (AESA) will be encouraged to
adopt this framework as well as the New Partnership of Africa’s Development (NEPAD) which has direct links
to the African Union and hence African governments. This paper will discuss the plan for implementation of
the framework so that it becomes the guide for developing genomic and biobanking regulations and
guidelines in Africa that will ultimately lead towards harmonisation across Africa.
Ochil 2
S36: Farr Institute Sponsored Symposium: Governance Interoperability
in Health Research Regulation PN: 138
Chair: Knoppers, B
Legal Interoperability: A Sine Qua Non for International Data Sharing
1
1
Adrian Thorogood , Bartha Knoppers
Centre of Genomics and Policy, McGill University, Montreal, Canada
1
Abstract
The successful translation of genomic discovery into improvements in human health hinges on the effective
and responsible sharing of genomic and health related data. The Global Alliance for Genomics and Health
(GA4GH) brings together over 375 leading healthcare, research, disease advocacy, life science, and
information technology organizations committed to establishing harmonized approaches to data sharing. The
Regulatory and Ethics Working Group (REWG) of the GA4GH specifically promotes the legal interoperability
of data. It has developed a Framework for Responsible Sharing of Genomic and Health-Related Data, which
aims to activate the human right of every citizen to benefit from the progress of science. This human rights
basis gives the Framework political and legal dimensions that reach beyond the moral appeals of bioethics.
Subsequent policies and initiatives of the REWG address a slew of emerging questions related to consent,
privacy, security, transparency and responsible data governance: What language is appropriate for consent
to broad data sharing? Can valuable legacy datasets be used even where consent is silent about
international data sharing? Should privacy safeguards always be strict, even where data is anonymized or of
low sensitivity? Is there a middle ground between open and controlled access? Can conditions of data access
be rendered machine readable, so as to enable automated data discovery? Can researchers be held
accountable for not sharing data where patients have consented to broad sharing? And how do patients and
the public feel about sharing their data for broad research purposes?
Sharing Data Across Sectors for the Public Good: Cultural, Sectoral and
Technical Barriers to interoperability
Leslie Stevens
Research Fellow Administrative Data Research Centre (ADRC) Scotland, Mason Institute University of
Edinburgh, School of Law, Scotland
Abstract
Interoperability refers to ‘…the ability of systems to work with other systems without extra effort.’ This talk will
consider the persistent cultural, sectoral and technical barriers to sharing data across sectors in the UK. In
context of findings from a funded workshop, we will explore the necessary factors to achieve both nontechnical and technical interoperability within data custodian organisations.
Time To Be a PRIG? Patient Relationship as the Driver for Information
Governance to Overcome Barriers and Enable Interoperability
58
Nathan Lea
University College London, United Kingdom
Abstract
As we anticipate the promises and meet the challenges of cross sectoral sharing of information, are we
overlooking an important foundation for realising the benefits and overcoming the barriers that we are
encountering? This talk focuses on understanding the expectations formed by patients and practitioners in
the confidential therapeutic relationship which is founded on trust. It emphasises the importance of being able
to understand the relationship in order to support interoperable working and guide the processes of
proportionate and supportive information governance as information is shared and reused beyond the
therapeutic context.
Patients’ Perspectives on Appropriate Flows of Information
Don Willison
University of Toronto, Canada
Abstract
The conduct of health research using data and biobanks is contingent on the good-will and trust of
those “data subjects” that the data and samples are being used appropriately. But what constitutes
“appropriate” use? In her framework of contextual integrity, Nissenbaum posits that the norms
which prescribe the flow of personal information include: (1) the context; (2) the types of information
in question; (3) the respective roles of the subject, the sender, and the recipient of the information;
and (4) the principles or constraints under which the information is transmitted from the sender to
the recipient. In this presentation, I examine empirical data on public attitudes regarding appropriate
conditions for use of their health information and biological samples, interpreted through
Nissenbaum’s framework. I consider the implications of the inclusion of information on the social
determinants of health and the value of patient and public involvement in data governance.
Ochil 3
S28: Relational Ethics
Chair: Kamuya, D
PN: 451
Ethics in Home Care: Need for New Paradigms
1
1
2
Ian Mitchell , Juliet Guichon , Rosemary McGinnis
2
1
University of Calgary, Calgary, Canada; Alberta Health Services, Calgary, Canada
Keywords – Homecare; Ethics paradigm; relational ethics
Discipline(s) – Homecare Ethics
Abstract
Health care ethics were developed in the 1980’s in response to developments in health care and changes in
the relationships between patients, families and health care practitioners. Ethics committees were largely
based in acute care facilities in Canada. Today much of health care is delivered in home care, long term care
and assisted living where ethical challenges are often radically different from those seen in acute care.
A Home Care Ethics Committee was set up in Calgary Health Region (Calgary, Canada, pop 1.100,000) in
2004. The Committee expanded to include transition services, seniors’ health outreach programs and rural
settings. The Committee engages in applied ethics education including annual committee education,
consultation training, provides support to staff experiencing moral distress, clinical consultation, policy review
and care pathway development. There have been > 300 consultations. Common reasons for ethics
consultations are:
x Living at risk
x Moral distress of staff
x Funding issues
59
x Misunderstandings and conflict at the interface between acute care and home/community care
x Duty of care especially when patient/client refuses care
x Difficult situations with family or significant others
x Boundary violations
The Committee’s accomplishments and challenges will be presented. Our experience has led us to question
if the principlism paradigm (autonomy, beneficence, non-maleficence and justice) is the most appropriate
guide to ethics in community/home care. Most consultations are based on relational concepts (relational
autonomy focusing on family context, domestic relations underlying disrespect, prejudice,etc) We encourage
the development of ethics services beyond Acute Care settings and welcome collaboration with those
engaged in such work in other countries.
PN: 692
The Complex Relational Ethics of Teamwork in Humanitarian Medical
Aid Projects
1
Matthew Hunt
1
McGill University, Montreal, Canada
Keywords – Ethics; disasters; humanitarian aid; non-governmental organizations; teamwork
Discipline(s) – Bioethics; disaster studies
Abstract
International humanitarian non-governmental organizations are key contributors to relief and reconstruction
efforts during crises, including in contexts of disaster, war or disease outbreak. Provision of care and
implementation of public health interventions in these settings raises a range of vexing ethical challenges. An
ethical issue that remains underexamined to date is the ethics of teamwork in humanitarian medical
organizations. Such teams are typically international and interdisciplinary, and gradients of power and
privilege (for example between expatriate and local staff) may be significant. Challenges may also arise
around different sets of professional expectations, moral commitments and cultural norms within teams. In
this presentation, I draw on secondary analysis of over 70 in-depth interviews with expatriate and national
health professionals and managers who participated in the response to humanitarian crises. These interviews
reveal a rich array of ethical questions related to teamwork in humanitarian aid. On conclusion: ethical
challenges of teamwork exist at many levels in humanitarian field projects ranging from how decisions are
made and who is involved in them, to who will be evacuated during an emergency. Critical analysis of these
features of humanitarian teamwork can help make these relational dynamics visible, and render them more
accessible for discussion and reflection.
PN: 781
Protecting Privacy and Enabling Public Benefits? Dynamic Consent and
Network Governance
1
Jane Kaye
HeLEX - Centre for Health, Law and Emerging Technologies, Oxford, United Kingdom
1
Keywords – Privacy; participant-centric; consent; biomedical research
Abstract
Innovations in technology, such as information communication technologies (ICT) are increasingly being used
in the research context. Software such as Dynamic Consent provide the means for individuals to
communicate with researchers, to give consent for research but also specify their privacy preferences. In this
talk, I will discuss the Dynamic Consent approach and how it may help to address some of the challenges of
recruitment, consent and retention of research participants in the rapidly changing environment of global
research networks. I will report on some of our empirical research findings with research participants as to
how they perceive their privacy interests and how these might be addressed using ICT. I will argue that the
60
use of patient-centric initiatives (PCIs) in research enables individual privacy interests to be addressed and in
doing so promotes the public interest in research.
PN: 467
The Development and Effectiveness of Clinical Trials Joint Ethics
Review Mechanism in Taiwan
1
Daniel Fu-Chang Tsai
1
Department & Research Institute of Medical Education and Bioethics, National Taiwan University College of
Medicine, Taipei City, Taiwan
Keywords - research ethics; ethics review; joint review mechanism; IRB
Discipline(s) – Research ethics
Abstract
Traditional model of ethics review for multi-center clinical trials is often criticized to be lack of efficiency and
wasting of resource due to repetitive reviews, which also lead to insufficient human subject protection. Joint
review mechanisms were hence developed and promoted by many countries for the purposes of enhancing
efficiency and quality in ethics review. In this presentation, the author will introduce models and progresses
of joint ethics review mechanisms in Taiwan including JIRB, NRPB-IRB and C-IRB. Since the setup of C-IRB
from July 2013 till now, 334 new protocols were reviewed and the averaged review time was 10.1 days for
each protocol. From May 2012 till now, 26 new protocols were reviewed by NRPB-IRB and the averaged
review time was 12.5 days. The satisfaction rate for the joint review mechanism by NRPB-IRB and c-IRB
were 100% and 92.9%. The author maintained that the development of joint ethics review mechanism is
necessary and beneficial. While improving efficiency and quality for ethics review, human subject protection
can be actualized and biomedical research promoted.
PN: 714
Are We Oppressed? Using Theatre of the Oppressed to Explore Black
Minority Ethnic (BME) Groups' Perceptions of Health and Services
1
Marisa De Andrade
1
Keywords - Theatre of the Oppressed; inequalities; Black Minority Ethnic (BME); health service
improvement; wellbeing
Discipline(s) - Health Policy [Arts & Ethics]
Abstract
Research Problems
Policymakers are acknowledging the need for health services to focus on service users’ experiences, needs
and aspirations. Community ‘empowerment’ and ‘engagement’, particularly with deprived and BME groups,
have subsequently become regulatory responses to tackling health inequalities and improving services.
However, engaging diverse communities can be complex and challenging. Why? Are services accessible and
culturally sensitive? How can arts-based methodologies be used as evidence to inform policy and practice
through co-production and bottom-up, asset-based approaches being advocated by policymakers to improve
health outcomes? I will explore these issues from the perspective of BME migrants in Glasgow (Slovakian,
Romanian, Polish and Pakistani community members) – some unemployed, living in disadvantaged areas,
suffering from mental health issues, addiction and social exclusion.
Methodology and Originality
Videos from an interactive knowledge exchange event using Theatre of the Oppressed – techniques
facilitating the transfer of experience and knowledge between “performers” (BME community members) and
“audience” (NHS practitioners, policymakers, third sector) by enabling them to step into, and change, the
theatrical action presented by diverse communities – will be shown.
Findings
There appears to be a disconnection between policy and practice; perceived tokenism; culturally specific
barriers to engagement; a desire for local champions and creative community initiatives.
61
Conclusion
There is limited evidence evaluating processes involved in asset-based initiatives and lack of mechanisms to
‘measure’ the effectiveness of asset-based working ‘softer’ outcomes against more tangible ‘harder’ health
performance targets. Developing rigorous frameworks for evidencing arts-based engagements is a priority.
Pentland Auditorium
Arts and Ethics: Poetry Session
S89: Nuffield Council on Bioethics: ‘(Un)natural Poetry’ PN: 301
Chair: Hugh Whittall, Director, Nuffield Council on Bioethics
1
2
3
4
Panellists: Catherine Joynson , Kayo Chingonyi , Anna Smajdor, Darian Meacham,
1
2
3
Programme Manager, Nuffield Council on Bioethics, Poet, Norwich Medical School, University of East
4
Anglia, Philosophy, University of the West of England
Type of Work – Poetry performance
Keywords – Naturalness; Nature; Public; Ideas; Morality
Abstract In 2015, the Nuffield Council on Bioethics undertook an exploration of different ideas about
naturalness and identified some of the ways that these feature in public discussions about the ethics of
science, technology, and medicine. As the project was primarily interested in the use of language, the Council
decided to enlist the help of poets to explore ideas about naturalness and to encourage a wider audience to
engage in the debate.There were two elements to the work. First, poet Kayo Chingonyi was commissioned to
help the Council think creatively about how words and language are used to express ideas about
naturalness. Kayo produced an initial piece of work in August 2015 and further works towards the conclusion
of the project in November. Second, a poetry competition was opened in September 2015. Poets from across
the UK were encouraged to think about what people mean when they describe something as natural or
unnatural. 152 entries were received. A judging panel selected a winner and two runners up. Kayo and the
competition winners performed their poems at an evening event in London on 30 November 2015 to an
audience of around 100 members of the public.
The Council is keen to give the delegates of the IAB2016 the opportunity to hear these poems performed.
This 1.00-1.5 hour event will be facilitated by Hugh Whittall, Director of the Nuffield Council, and will include a
short presentation by Catherine Joynson, Programme Manager at the Council, about the contribution of
poetry to the Council’s work. Kayo Chingonyi will then perform his work on naturalness in person (a total of
around 15 minutes’ performance), and videos will be shown of the three winners of the competition
performing their poems. Time will also be allocated during the event for a panel discussion, when the
audience will be encouraged to discuss ideas about naturalness and the intersection of poetry and ethics with
Kayo Chingonyi, representatives of the Nuffield Council and other invited guests.
The poems by Kayo Chingonyi and videos of him performing the poems can be found at:
http://nuffieldbioethics.org/project/naturalness/performance-poetry-collaboration/commissioned-poet-kayochingonyi-2/
The poems of the competition winners and videos of their performances can be found at:
http://nuffieldbioethics.org/project/naturalness/performance-poetry-collaboration/poetry-competition/
A blog post discussing the contribution of poetry to the Council’s work by Catherine Joynson can be found at:
http://nuffieldbioethics.org/blog/2015/12010/
The Council’s Analysis Paper ‘Ideas about naturalness in public and political debates about science,
technology and medicine’ can be downloaded at: http://nuffieldbioethics.org/project/naturalness/the-findings/
62
Pentland Auditorium
S50: Symposium: After Ebola: Challenges facing Infectious Diseases
Biobanking PN: 265
Calvin Wai Loon Ho1, Wayne Towers2, Ciara Staunton2, Dr Abha Saxena3, Katherine Littler4,
Paulina Tindana5, Keymanthri Moodley2, Alastair V Campbell1
1
Centre for Medical Ethics and Law, Faculty of Medicine and Health Sciences, Stellenbosch University, South
3
4
Africa, World Health Organization, Geneva, Switzerland, The Wellcome Trust, London, United Kingdom,
5
Navrongo Health Research Centre, Navrongo, Ghana
2
Abstract
The outbreak of Ebola in West Africa just slightly more than a year ago is unprecedented in scale, and has
generated a great number and variety of biological samples. Such samples constitute a precious, nonrenewable resource, and offer a unique opportunity to facilitate rapid expansion of our knowledge of the
Ebola virus and its pathogenesis, crucial to expedite the development of effective interventions with which to
control and prevent the disease in the future. As the current outbreak winds down, ethically appropriate
standards must be put in place to ensure that the immediate needs for preservation and storage of thousands
of biological samples taken from patients during the crisis are met, along with longer–term concerns with
advancement of therapeutic interventions and capacity building in the West African sub-region that has been
most affected by the outbreak. This symposium will explore a range of options for biobanking - from national,
through regional, to international models, including centralised and distributed physical sites, and concepts of
distributed, shared, and ‘virtual’ knowledge resources. In planning for biobanking, key challenges including
those related to infrastructure, trust and accountability will be considered, although the focus will be on
ethical, legal, and policy concerns. Finally, the symposium will consider ongoing work of the World Health
Organization in guidance development in biobanking, with a focus on Ebola. The significance of this guidance
to international pandemic responsiveness and its implications on building scientific, administrative, and
technological capacities in the West African sub-region will be critically evaluated.
Individual speaker abstracts
Re-Centring Social Justice in Biobanking
Dr Calvin Wai Loon Ho, JSD LLM MSc
As essential tools for translating biomedical research into practice, biobanks (and databanks) have become a
global phenomenon. Their importance as research infrastructure will grow with increasing emphasis on
precision medicine as a means to improve healthcare treatment pathways. Yet despite their prevalence and
the different governance systems that have been established to address ethical, legal and social concerns,
recent bio- (and data-) banking experiences continue to highlight formidable operational and equity issues.
This paper broadly discusses the trend towards greater diversification of bio- (and data-) banking
arrangements. It argues that such a developmental trajectory will deepen inequities in global health, given the
absence of a coherent approach to address capacity building concerns and equitable distribution of the
burdens and benefits of research. With a focus on the recent Ebola outbreak, this paper concludes with an
argument for a global ethical framework that re- centres social justice in constituting such repositories as
moral enterprises.
Dissemination of Both Primary and Incidental Findings in Research-driven Genomic Studies: Ethical
Implications for Large-scale Bio-banking of Samples
Dr Wayne Towers, PhD MSc BSc (Hons) PG Dip
The tools used to investigate viral diseases, like Ebola, have greatly improved with the advent of whole
genome/exome technologies. However, we are only now becoming aware of the ethical issues that arise from
their application. Dissemination of both primary and incidental findings obtained using these technologies is
ethically complex as there has to be a fine balance reached between producing clinically valid outcomes for
63
individual participants, and understanding the underlying pathogenesis of the disease to be better able to
treat it within the population, which may not be clinically actionable. Simultaneously, these communities are
extremely vulnerable and therefore any collection and dissemination strategies developed need to be
collaborative, transparent and ethically sound. This presentation outlines an ethical framework for handling
the issues that arise before, during and after the collection and investigation of bio-banked samples from
vulnerable communities affected by viral outbreaks such as Ebola using these technologies.
Perspectives on Developing Guidelines for a Localised Biobank
Dr Ciara Staunton, PhD LLM
Central to the success of any biobank is public trust in the biobank and its governance framework. In Africa
there are cultural beliefs attached to biological samples such as hair and blood that can impact a community’s
willingness to donate. To build and maintain this trust, the governance mechanisms must demonstrate an
understanding and respect of these beliefs and values. To achieve this, there must be early and ongoing
engagement with the community to assess their concerns and avoid potentially damaging harm to local
communities and their beliefs. This presentation discusses findings from empirical research conducted at a
public hospital in Cape Town, South Africa on developing a community
engagement guideline for a local biobank. Concerns about the use of blood and bodily fluids as well as the
role the community would like to have will be discussed. These findings can provide guidance in how the
communities affected by the Ebola outbreak may be engaged in the future use of their samples.
Guidance Development in Biobanking: WHO Perspective
Dr Abha Saxena, MD
The Ebola epidemic brought to the fore the need to share data and biological samples obtained during the
epidemic, not only to learn more about the epidemic itself, but also to be able to develop new diagnostics and
drugs for future epidemics. The countries from which the samples are obtained have a keen interest in this as
do the countries where the technology to store samples and to develop the diagnostics and therapeutics
exists. However, this means there must be consensus among various service providers as well as those
conducting research on the need for coordination, and cooperation on collecting and sharing data and
biological specimens, there must be trust, and there must be the acceptance of normative standards, and
establishment of governance structures that are acceptable to all stakeholders. How can we meet the
expectation of all stakeholders? WHO has the mandate to play the role of the honest broker and facilitate the
development of a global biobank that meets all the criteria above. This presentation will touch upon some of
the issues mentioned, and propose some solutions.
Sidlaw
S62: Symposium: What Does It Mean To Regulate in the Public Interest?
PN: 225
Chair: Sorbie, A
Annie Sorbie1, Leslie Stevens1, Mark Taylor2, David Townend,3 Alena Buyx4, Annette Rid5
1
2
3
University of Edinburgh, United Kingdom, University of Sheffield, United Kingdom, Professor of Law and
4
Legal Philosophy in Health, Medicine and Life Sciences, Maastricht University, Netherlands, University of
5
Kiel, Germany, King's College London, United Kingdom
Discipline(s) Law, bioethics, social science
Keywords Legitimacy, public interest, research, regulation, solidarity
Abstract
How can health research be regulated in the ‘public interest’? First, we have a challenge of definition. The
notion of ‘public interest’ is frequently used to justify research, as well as to constrain it. However, this
suggests a prior existence of ‘the public interest’ and of ‘a public’. The second challenge is one of scope. If it
is to be a useful guiding concept or principle in health research regulation, we must achieve some consensus
around its scope. This leads to the difficult task of trying to give effect to competing and conflicting values.
Does it have greater weight than concerns that traditionally relate to the participants’ interests? Thirdly, we
64
are faced with the challenge of implementation. Do we have regulatory tools that specifically address the
public interest, and if so, are such tools interoperable across research areas? There is little consensus in any
of the represented disciplines as to the notion of public interest, despite its appeal. This symposium will more
effectively integrate public interest within health research regulation in an ethically responsible manner.
Conclusion: The symposium will establish fruitful, cross-disciplinary avenues for achieving consensus around
the public interest’s definition, scope and implementation.
Paper Abstracts
Paper One: In pursuit of proportionality: regulating health research in the public interest
It is commonly said that health research regulation must strike the right balance between two competing
interests: 1) the public interest in promoting valuable research and 2) the individual interests of study
participants in not being exposed to excessive research risks and in exercising control. In this talk, I will argue
against the idea that the public interest in research and the individual interests of study participants are in
conflict. I propose instead that protecting the interests of research participants is an essential part of
regulating health research in the public interest; just as individuals have an interest in a strong public, so the
public has an interest in strong individuals. This implies that health research regulation in the public interest
needs to reflect a plurality of individual and collective interests. I close by suggesting that a proportionate
approach to regulating health research is best suited for this task.
Paper Two: Public interest and solidarity
When trying to determine what it means to regulate in the public interest, the concept of solidarity understood as enacted commitments to accept costs to assist others with whom a person or persons
recognise similarity in a relevant respect - is an obvious candidate for consideration. This talk will address
how the notions of public interest and solidarity interrelate in all three dimensions of definition, scope, and
implementation: it will examine whether solidarity can help determine what the relevant ‘public’ or ‘publics’ are
in a particular context, such as health research; whether and how the interests and rights of individuals can
be compatible with notions of public interest, for example in population-based health research; and what
solidarity-based governance of health research could look like in practice, for example in health database and
‘big data’ research.
Paper Three: A public interest mandate to support the use, sharing and linkage of administrative data
Administrative data refer to the vast range of information collected by public authorities in the course of their
routine operations. Considerable uncertainties remain as to the lawful and ethical basis for reuse of
administrative data for research, even where the public interest weighs heavily in favour of data use.
Research and experience tells us that despite focus on legal barriers, organisational-cultures of data
custodians pose the most obstacles to good governance. To move beyond the culture of caution, a cultural
paradigm shift is required in how public authorities value and act upon the data they hold. Adoption of a
public interest mandate will be considered as a means to refocus attention to the public nature of
administrative data. This reframes the issues from a public interest perspective and the public mandate of
government organisations to act accordingly, whereby the public interest is, defined and crafted by authorities
in each context.
Paper Four: Personal Responsibility and the Public Interest
Autonomy has an almost unassailable primacy in today’s bioethics; in the modern consumer society,
individual freedom is taken to offer individuals free, unfettered choice. Many constructions of privacy are
made within this paradigm. This can place the notion of the public interest at odds with expectations of
privacy; the public interest is seen as justifying a breach of or interference with a privacy right. However,
human rights and ethics requires an ‘other regarding’ construction of privacy. This is not simply a matter of
Utilitarianism. The Categorical Imperative and Politeness, for example, require such an attitude from the
individual. The impact of this interpretation will be considered in relation to definition, scope and
implementation. In particular, the questions of how the public interest is privacy, and active citizenship is
required in the face of bioethics dilemmas will be explored.
Paper Five: ‘Expect, Respect, and Accept’: a triple test for the proper protection of privacy and public
interest in the use of patient confidential data for public policy objectives?
The public interest is not something to be balanced against privacy. Nor the reverse. Each can place limits
upon the other but because each should be accounted for in a conception of the other. Recognising the
relationship between them is not to recognise the need for compromise. It is to recognise the need for
65
legitimacy. Unpacking this idea in the use of patient confidential data for public policy objectives (such as
health research) supports a claim that respect for both privacy and the public interest may be characterised
by: (1) patients being given reason to expect the use; (2) use respecting patient preferences; and (3) use
being for purposes that patients have reason to accept. As data flows increasingly shape society, and
reliance on ‘ask or anonymise’ is increasingly outmoded, the triple test of ‘expect’, ‘respect’, and ‘accept’ may
prove an important test to reciprocally protect, and constrain, legitimate invocations of both privacy and the
public interest in this context.
Fintry
S11: Reproductive Rights and Liberties
Chair: Widdows, H
PN: 40
Ethical Arguments for and Against Cross-border Commercial Surrogacy
1
Ruth Macklin
Albert Einstein College of Medicine, Bronx, United States
1
Keywords - Surrogacy, medically assisted reproduction, exploitation, commodification
Discipline(s) - Bioethics
Abstract
The research problem is to determine the ethical acceptability of cross-border reproductive health services, in
particular, that of surrogacy. Infertile couples--mostly from industrialized countries--travel mainly to
developing countries where the services of women who serve as surrogates are much cheaper than in the
United States, and not available at all in many European countries. A review of the bioethics, feminist, and
social science literature has identified numerous different arguments for why the practice is unethical and
should be prohibited. Some argue that it is a form of exploitation of poor women. Others contend that paying
poor women so much more money than they could otherwise earn coerces them into becoming surrogates.
Another criticism is that paid surrogacy is commodification of the human body, which degrades the women
serving as surrogates. The methodology involves examining each argument to identify its soundness. The
paucity of empirical evidence makes it impossible to determine whether the lives of surrogates (and possibly
also their own children) are improved as a result of being paid to bear a foreign couple’s genetic child. This
study takes a new approach by calling for empirical evidence on the benefits and harms of surrogacy
arrangements for both the surrogates themselves and the commissioning couple or individual. The
conclusion is an alternative to both prohibition and a laissez-faire approach: well-designed, properly enforced
regulation of surrogacy, respecting the rights and welfare of the surrogates instead of favoring the contracting
couple and the clinics that profit from cross-border reproductive services.
PN: 723
Who Decides? Consequences of the Public Policy Approach to Nonenforceability of Surrogacy Contracts
1
Debra Wilson
1
University of Canterbury New Zealand
Keywords – Surrogacy; Contracts for reproduction; Commodification; Exploitation; Autonomy
Discipline(s) – Law, public policy (individuals, public interests and public goods theme)
Abstract
In many countries surrogacy arrangements are described in law as being ‘not illegal, but not enforceable’.
This approach reflects a deliberate public policy decision that permitting enforcement of such arrangements
not only results in both the surrogate and the (future) child being treated as the subject matter of a contract
and therefore as commodities, but also allows and accepts the exploitation of the surrogate. It therefore
reflects a prioritisation of the interests of the public in limiting certain forms of medically assisted reproduction
over the autonomy of individuals to choose to enter into such agreements. This paper will discuss three
66
recent examples in which this prioritisation has resulted in an arguably unacceptable outcome, with the
intended parents using the non-enforceability of surrogacy arrangements to interfere with the surrogate’s
reproductive autonomy during the pregnancy. It will be argued that these cases provide strong evidence of an
unforeseeable consequence of the prioritisation of public interests over individual interests, and that a reprioritisation is required. While the public might have a legitimate interest in the regulation of medically
assisted reproduction, this interest should not be prioritised over the individual surrogate’s right to make
decisions relating to her own body during pregnancy.
PN: 184
Secrecy in Personal Relationships – Veracity and Donor Conception
1
2
3
4
Lucy Frith , Olga van den Akker , Eric Blyth , Marilyn Crawshaw
2
3
University of Liverpool, United Kingdom , Middlesex University, United Kingdom, University of
4
Huddersfield, United Kingdon, University of York, United Kingdom
1
Keywords - Disclosure, family practices, gamete donor conception, register, reproductive secrets, secrets,
UK DonorLink.
Discipline(s) – Bioethics, mixed-method survey research, moral philosophy
Abstract
This presentation considers the sharing, disclosure and exchange of information about being donor
conceived. There has been considerable debate over whether those who are donor conceived should be told
that they were conceived from donor gametes. This presentation contributes to this debate by considering the
ethics of secret keeping and the different moral status of certain ‘relationship relevant’ pieces of information.
This area has generally been approached by evaluating the effects of disclosure versus secrecy on family
functioning and welfare of the child. This presentation will refocus the debate to consider the ethics of secrecy
and trust in personal relationships. Drawing on data from a mixed-method survey undertaken with donorconceived adults registered with UK DonorLink (a voluntary DNA-linking register) the role of secrets in donor
conception will be explored. Drawing on Bok’s work on secrets, this paper will explore whether keeping
secrets about donor conception from donor conceived offspring is morally acceptable and in what
circumstances an individual’s control of their own information can be overridden. It considers whether there
are particular kinds of information that it is immoral to withhold, what kinds of information one has a moral
duty to share, what duties of veracity parents may have to their children and how this is balanced with
parental privacy. It will conclude that information about donor conception is something parents have a moral
duty to disclose to their donor conceived offspring.
PN: 141
Reproductive Liberty Through a Public Health Ethics Lens: From
Individual Rights to the Public Good of Procreating
1,2,3
Christian Munthe
2
Dept. of philosophy, linguistics and theory of science, University of Gothenburg , Sweden, Centre for
3
Antiobiotic Resistance Research (CARe), University of Gothenburg, Sweden, Centre for Ethics, Law and
Mental Health, University of Gothenburg, Sweden
1
Keywords - Public health ethics, reproduction, population, public good
Discipline(s) – Bioethics, philosophy, ethics, public health ethics, population ethics
Abstract
Reproductive bioethics has almost entirely proceeded within an individualist paradigm, where rights of parties
are set against each other or societal interests. This paper takes some steps to analyse what happens if the
ethical analysis of reproductive medicine and policy is instead approached based on public health ethical
assumptions. That is, the general issues are about how society should organise itself with regard to the
procreation of its population, and particular issues regarding, e.g., abortion, ART, contraception, pregnancy
care, prenatal testing, etc. are analysed from that standpoint. Albeit there has been some public health
ethical attention to sexual health issues, this way of approaching reproductive ethics has been ignored almost
entirely, with a handful of exceptions the last few years taking account of, e.g., public expenditure on ART
67
and environmental concerns linked to population policy. This presentation aims to sketch a preliminary
theoretical framework for a general theory of reproductive public health ethics, within which such and further
attempts may be placed and critically analysed, and to compare it to the traditional formats of reproductive
bioethics. Conclusion: general theory of reproductive public health ethics will view reproduction as a social
rather than biological process, taking place at a collective level, and its values will hence be public goods and
aggregates, while notions of individual rights will not be primary. This view also means that there is no basic
relevant distinction to be made between procreating a population through migration and through biological
reproduction.
Kilsyth
S88: Arts+Ethics Performance
PN: 112
Playing God: The Rock Opera - A New Tool for Bioethics Education and
Public Engagement
1,2,5
1,5
3
4
3
5
6
Tuija Takala , Matti Häyry , Rebecca Bennett , Tom Buller , Søren Holm , Corky Laing , Anna Smajdor
2
3
1
Aalto University, Helsinki, Finland, University of Helsinki Finland, University of Manchester , United
4
5
Kingdom, Illinois State University, Chicago, United States, Corky Laing and The Perfect Child / Polite
6
Bystander Productions, Helsinki and New York, Finland and USA, University of East Anglia, United Kingdom
Artists/contributiors
1,6
6
1,2,6
Introduction by the creators: Matti Häyry , Corky Laing & Tuija Takala
6
Rock Opera video: Performance by Corky Laing & The Perfct Child
1,2,6
1,6
3
4
3
Panel discussion: Takala (chair) , Matti Häyry , Rebecca Bennett , Tom Buller , Søren Holm and Anna
6
Smajdor
Reviews and description
“… silly, explosive, intellectual, and all around madness as we explore sociological issues, suicide, the
afterlife, the Gods, and so much more with the rock opera’s characters as they toy with human creation,
struggle with the human condition, and watch on as they reap what they’ve sown. Perfection.”
AJ Garcia, Shakefire.com
“As a musical performance, Playing God is a post-modern Tommy, a good old rock opera with a purpose.
Evocative melodies bring artistic life to the many bioethical debates spawned by modern medicine and
scientific advance. Mr. Laing has never been better on drums and as composer. His collaboration with
Professors Hayry and Takala led to music on a grand scale with meanings and melodies that left our
audience both thinking and humming about the human quest for perfection.”
Prof. Joseph J. Fins, Weill Cornell Medical College
Playing God: The Rock Opera tells the story of a fictional small town whose inhabitants have enjoyed the
benefits of gene technology for decades. Two of the creators of the opera are academic philosophers, and
the themes covered - designer babies, immortality treatments, saviour siblings, cloning and gene therapy emerge directly from their research. Through the music and the characters, the audience is invited to study
their own ethical convictions. Playing God does not give normative answers; rather it encourages, in an
open-ended way, people to think about parental choices, perfection, identity and what it means to be human
in a world with an increasing number of genetic interventions available.
More information: www.playinggodrocks.com
68
Tinto
S9: Donors
Chair: Leach Scully, J
PN: 207
The Limitations of Surrogate Decision-making in Bodily Material
Donation for Therapy or Research
1,2
Jakub Zawiła-Niedźwiecki
2
University of Warsaw, Institute of Philosophy, Warszawa, Poland, University of Warsaw, Centre for
Bioethics and Biolaw, Warszawa, Poland
1
Keywords - surrogate decision-making; competence;
Discipline(s) – philosophical bioethics
Abstract
Extant literature on competence or capacity to consent mostly deals with situations of two sorts: 1. consent of
patients in clinical ethics 2. consent of research subjects in research. Although existing normative frameworks
and empirical evaluation methods for these situations have their own faults the area of surrogate competence
that has been hardly explored. The purpose of my presentation is exploration of characteristics and limits of
competence of surrogate decision makers. As acting agents they are subject to all the limitations and biases
that any agent is subjected to when deciding for herself. Yet they are also subject to additional limitations in
proxy decision-making. By using results from other areas of philosophy and my own analyses I shall
characterise the types of limitations as regarding to:
1. Internal psychological characteristics of an acting agent.
2. Epistemic limitations of knowledge of other person’s goals, preferences and interests.
3. Normative characteristics of the stewardship duty of surrogate decision makers.
I would like to sketch implications of those limitations and characteristics of surrogate decision-making on
such practices as organ and tissue donation, post-mortem gamete retrieval, and research on incompetent
patients. I will also include a brief sketch of how assisted decision-making might help situations of persons by
lifting the limitations and biases of surrogate decision-making.
PN: 342
Should People with Dyslexia Be Allowed to Donate Gametes?
1
Stephen Wilkinson
1
Keywords - Donation, Gamete, Reproduction, Selection, Sperm
Discipline(s) – Philosophy & Bioethics
Abstract
In 2015, a London sperm bank’s policy of rejecting dyslexic donors generated media controversy. This paper
asks whether it is morally acceptable for clinics to ‘screen out’ dyslexic gamete donors. It begins by outlining
two possible bases for excluding of dyslexic donors: the child welfare justification and the consumer choice
justification. The child welfare justification claims that using non-dyslexic donors will create children with
higher levels of health and/or wellbeing and thus that the exclusion of dyslexic donors is a positive thing. The
consumer choice justification suggests that screening out dyslexic donors is permissible because most
recipients (if offered a choice) would prefer to use gametes from non-dyslexic donors. It then examines each
justification. Regarding the child welfare justification, I argue that while its overall structure is sound – i.e.
child welfare is, in principle, a reasonable basis for donor selection – it may not be applicable in this case. For
several important empirical and conceptual questions regarding the extent to which dyslexia can count as
heritable, and whether or not it can really be said to constitute disability of disease, cast doubt on the
applicability of the justification here. Regarding the consumer choice justification, I argue that such
69
considerations only fully engage when the choice on offer is not itself defective: e.g. it must not ‘pander to’
discriminatory or irrational attitudes and preferences. The overall conclusion is that, while we can imagine
contexts in which excluding dyslexic donors is defensible, such a policy will not be justified in most real-world
situations.
PN: 634
Gamete Donation and the Transfer of Responsibilities
1
Reuven Brandt
1
Keywords - Donor-conception, ARTs, responsibility, parenthood
Discipline(s) - Philosophy, Bioethics
Abstract
There is an ethical tension in how responsibilities towards children are ascribed in ‘traditional reproduction’
and how they are ascribed in donor-assisted reproduction. As manifest in the legal norms governing child
support, biological ties are often sufficient for the imposition of significant responsibilities towards children
when pregnancies are the result of sexual intercourse (consider child-maintenance obligations following
unintentional pregnancies). In donor-assisted reproduction however, this is not the case. One proposed
solution to this tension has been to argue that it is permissible for gamete providers to transfer their
responsibilities to intending parent(s). However, I argue that we should reject the view that procreative
responsibilities are transferrable. I do this by first showing that arguments in favour of the transferability of
responsibilities often ignore the distinction between the transfer and delegation of responsibility, and upon
reflection these arguments only support the delegation of responsibility. I then provide an argument against
the transferability of responsibilities in gamete provision cases. Conclusion: I conclude that gamete providers
cannot transfer their responsibilities, but that these responsibilities are not parental. I then suggest a possible
legal / regulatory solution to the ethical tensions raised by donor-assisted conception that recognizes
intending parent(s) as the child’s sole parent(s), while also recognizing the special ethical status of gamete
donors.
PN: 358
Conscientious Objection to Controlled Donation after Circulatory Death
1
1
Marina Gascon Abellan , Pablo De Lora Del Toro
2
1
Universidad de Castilla-La Mancha, Albacete, Spain, Universidad Autónoma de Madrid, Spain.
Keywords - Conscientious Objection / Controlled Donation after Circulatory Death / Limitation of Therapeutic
Efforts
Discipline(s) – Bioethics/ Philosophy/Legal Philosophy/ Medical Humanities
Abstract
Organ transplantation raises significant ethical and legal concerns. In the case of deceased organ donation,
those concerns are related to the extent to which the so-called “dead donor rule” –the idea that physicians do
not kill patients in order to procure organs for transplantation- is compromised when applying current
protocols for death determination. In the history of organ transplantation there is a long-standing controversy
on whether brain-dead patients are “really dead”, and some jurisdictions allow patients and families to morally
object to the application of the legally established neurological criterion of death. But controlled donation after
circulatory death (CDCD), as described in the protocol known as Maastricht-III, also prompts moral suspicion.
Death occurs here when a previous “decision not to resuscitate” subsequent to the “decision to remove lifesustaining measures” is taken. Thus, death is not “irreversible” which for many seems morally problematic. At
its core, morally objecting to CDCD boils down to objecting to the limitation of therapeutic efforts in such
cases. Methodologically, in this paper we will firstly argue: (1) that there is a right to morally object to legal
norms based on the freedom of conscience which also applies to the protocol Maastricht-III. On the basis of
this specific form of conscientious objection we will discuss (2) what are its scope and limits in order to
protect the public interests and goods involved in transplantation; (3) who are the bearers of such right; and
(4) whether health care institutions may also morally object to the practice of CDCD.
70
Moorfoot
S24: Health Research Resources
Chair: Montgomery, J
PN: 297
Rethinking Jurisdiction in Transnational Genomic Clouds
1
Heidi Beate Bentzen
1
University of Oslo, Norway
Keywords - Genome databases – Transnational – Jurisdiction – Solution
Abstract
Transnational clouds are increasingly considered the preferred storage and processing facility of choice for
genomic data sharing. This raises a range of legal questions, several of which have received much deserved
attention from academics, and others that have yet not been explored as thoroughly. The jurisdictional issues
related to genomic databases belong to the latter group. Traditionally, the territoriality principle has been
considered the primary basis of jurisdiction. These days, however, it is becoming increasingly difficult to draw
the line between territoriality and extraterritoriality, and neither the terms themselves nor the line drawing will
necessarily offer the needed guidance. A new model for handling jurisdictional matters that may arise in
transnational genomic cloud computing is proposed.The presentation is based on collaborative legal research
carried out by two academics from different countries. Legal dogmatic methodology was applied.
PN: 695
Rapid Data Sharing in Epidemics and Public Health Emergencies:
Beyond the Guidelines, Regulations and Frameworks
1
Sarah McNeill
Australian National University, Australia
1
Keywords - epidemics, data sharing, public health emergencies
Discipline(s) – Public Health Ethics
Abstract
The need for rapid data sharing in response to public health emergencies, namely epidemics, has been reiterated across much of the recent literature. While calls for regulatory frameworks to be revised with
reciprocal obligations for data sharing are justified in terms of ‘public goods’, scepticism remains about the
effectiveness of this approach. Alternative strategies include the development of a global data governance or
global ethics framework specific to this issue. From the bioethics perspective, the focus of concern in rapid
data sharing has been on the potential breech of individual patient confidentiality and of the rights of
individual researchers to retain data generated for use in academic publications. What remains to be
addressed is the practical mechanism by which data may be collected, cleansed and managed in low
resource settings. There are also clear ethical obligations for international organisations and well-resourced
nations to provide financial and practical support for this to be achieved. Part of this work must include better
systems to permit data reciprocity, given the current tendency for data flow away from low and middle income
countries (LMIC), where communicable disease burden is highest. These challenges will be discussed in
conjunction with an overview of developments in regulatory and ethical frameworks including the International
Health Regulations (2005) - presently under review by the WHO in response to the 2014 Ebola outbreak.
Concluding with an appeal to reconcile the ethical with the actual and a broadening of focus from the
individual patient and practitioner to the global community.
71
PN: 760
Health Research without Consent: Challenging the View that Research
Participation Should Always Be Voluntary
1
Angela Ballantyne
University of Otago, New Zealand
1
Keywords - research participation, consent, voluntariness, clinical records, social contract
Discipline(s) – Conference theme: Individuals, public interest and public goods
Abstract
I argue that patients have an ethical obligation to participate in medical research and that secondary use
research using clinical tissue samples and medical records is a low-risk way of fulfilling this obligation.
Research problem: Good medical practice relies on good evidence. Clinical data can provide a valuable
platform for generating evidence about the utility of medical treatment already in use. Yet, in many
jurisdictions, some form of patient consent is necessary to authorise access and use of clinical material for
.
research. Research ethics regulation arose in response to unethical clinician-driven research Public anger
and dismay over the breach of trust by clinicians in these studies led to regulation clearly separating clinical
practice from research and insistence that research participation must be voluntary. Consent procedures for
research are typically more demanding and more tightly regulated than consent procedures for equally
intrusive and risky clinical care. Originality and conclusion: Current debate about use of clinical material for
research tends to assume some form of consent is necessary (whether that is meta-, broad-, or specificconsent). Here I use a social contract approach to argue that citizens have an ethical obligation to participate
in research. Patients benefit from previous research with past generations. There is a reasonable prima facie
assumption that patients should contribute to current research, especially when research is low-risk and noninvasive. I will describe the social contract governing medicine and medical research, including the parties to,
and the content of, the contract and the normative force of the contract.
PN: 343
Governance of Global Health Research Consortia and Health Equity
1
2
Bridget Pratt , Adnan Hyder
2
Fellow, Johns Hopkins Berman Institute of Bioethics, Baltimore, USA, Johns Hopkins Berman Institute of
Bioethics, Baltimore, USA
1
Keywords - global justice; health equity; research consortia; governance; global health
Discipline(s) - International research ethics
Abstract
Global health research partnerships are increasingly taking the form of consortia that undertake programs of
research in low and middle-income countries (LMICs). These consortia typically aim to reduce health
disparities between and within countries. Governance has been identified as a key mechanism for
establishing and attaining health equity objectives, but there has been no conceptual exploration of how
consortia governance should be structured to advance such goals. This paper derives initial ethical guidance
on what is necessary for global health research consortia governance to promote health equity. A checklist
based on this guidance is proposed to assist consortia determine where their governance practices strongly
promote equity and where they may fall short. An account called shared health governance, which links
principles of global health justice to health governance, was applied to derive the proposed ethical guidance.
The main components of shared health governance are advancing the goals of health justice, shared
sovereignty, shared resources, shared responsibility, and mutual collective accountability. The proposed
guidance describes how global health research consortia might uphold each component of shared health
governance. Conclusion: connecting consortia governance to the reduction of health disparities entails ethical
requirements for the activities undertaken by consortia, the processes by which their priorities are set and
resources are allocated, and their monitoring and evaluation.
72
Carrick 1&2
S16: End of Life
Chair: Menon, S
PN: 106
Why the World Medical Association’s Resolution on Euthanasia is
wrong
1
Kevin Gary Behrens
1
Steve Biko Centre for Bioethics, Wits University, South Africa
Keywords - Euthanasia, WMA, Assisted Dying
Abstract
The WMA’s Resolution on Euthanasia condemns euthanasia and physician-assisted suicide as unethical and
calls on national medical associations and physicians not to engage in these practices, even where they are
legal. This is in stark contrast to the WMA’s Declaration on Therapeutic Abortion, which acknowledges that a
considerable diversity of views on the issue exists and requires physicians to adhere to the laws of their own
countries, while allowing for conscientious objection. In this paper I argue that the Resolution on Euthanasia
is wrong and that the WMA should treat the issue in a similar way to its approach to abortion, recognising the
diversity of views. I argue that the resolution unjustifiably stifles global debate on a highly contentious issue
that has serious implications for patients. Furthermore, it creates the false impression that there is general
agreement among physicians on the issue. It might also unduly influence lawmakers against reform – even
where the majority of public opinion supports euthanasia – due to a perception that the WMA is the
authoritative voice of the profession. The resolution is also open to the charge of ethical inconsistency, since
the withdrawal or withholding of life-sustaining treatment (on grounds of futility or of a scarcity of resources) is
routinely practice and regarded as ethical, even though it just as surely leads to the death of patients.
Method: Normative analysis of ethics statement of international body.
PN: 582
Public Attitudes Towards Assisted Dying at the End of Life in the USA
and UK
1
Gemma Clarke
University of Cambridge, United Kingdom
1
Keywords - Assisted-dying; end of life care; public attitudes; decision-making
Discipline(s) - Public Health
Abstract
Research problem: Decisions at the end of life are increasingly complex as patients are living longer, often
with multiple comorbidities, and limited decision-making capacity. Over recent years physician-assisted dying
(PAD) has been debated in many jurisdictions internationally.
Methodology: UK and USA public survey (N=2016) using a vignette series describing a person with
progressing neurological disease and decreasing decision-making capacity and swallowing ability.
Respondents were invited to choose a level of intervention for each scenario ranging from: 1) maintaining life
at all costs, including deprivation of liberty, 2) some invention with agreement, 3) no intervention, 4) measures
for ending life.
Originality: Evidence is limited as many surveys are based upon binary for/against measures. Our vignette
series explored PAD in a nuanced way.
Results: At each stage of deterioration, the proportion of respondents selecting measures for ending life
increased significantly from scenario 1 =4%, to scenario 6 =38%. Conversely, at the final scenario of endstage disease, 16% of respondents selected measures to maintain life at all costs. Group comparison of
respondents who selected measures to die peacefully (44%), and those who did not, revealed no significant
differences by country or gender. Older participants (t(1944)=5.68, p<0.001, Cohen’s d=0.26) and those with
73
personal experience ( 2(1, N=1898)= 20.79, p<0.001, phi=0.12) were more likely to select measures for
ending life.
Conclusions: Decision-making at the end of life is challenging, with no widespread consensus on
appropriate management. The marked heterogeneity of responses has important implications for public policy
and legal frameworks concerning assisted dying.
PN: 736
Medical End-of-life Decisions in Switzerland: Trends and Regional
Differences
1
3
2
3
3
Samia Hurst , Ueli Zellweger , Georg Bosshard , Margareta Schmid , Matthias Bopp
1
Institute for Ethics, History, and the Humanities, Geneva University Medical School, Geneva, Switzerland,
2
Clinic for Geriatric Medicine, Zurich University Hospital, and Center on Aging and Mobility, University of
3
Zurich and City Hospital Waid, Zurich, Switzerland, Epidemiology, Biostatistics and Prevention Institute,
University of Zurich, Zurich, Switzerland
Keywords - End-of–life decisions, Switzerland, suicide assistance, continuous deep sedation
Abstract
Research problem: The prevalence of medical end-of-life decisions (MELD) in the German-speaking region
of Switzerland was assessed in 2001. In 2013/14, we conducted the same study but included the German-,
French-, and Italian-speaking regions of the country.
Findings: From 8’963 mailed questionnaires, 3’173 (63.5%), 1’538 (51.9%), and 617 (61.7%) were returned.
Death was preceded by at least one end-of-life decision in 82.3%, 75%, and 74% of non-sudden, expected
deaths in German-, French-, and Italian-speaking regions respectively, with a significant increase from 2001
in the German-speaking region (74.7%). Forgoing life-prolonging treatment represented 35.2%, 20.6%, and
24.3% of all deaths. Intensified alleviation of symptoms represented 21.3%, 25.9%, and 24.3% of deaths.
Continuous deep sedation until death markedly increased from 4.7% of deaths in the German-speaking
region in 2001 to 17.5%, 17.5%, and 24.2% in 2013/14. Assisted suicide remained rare (1.8%, 1.5%, 0), but
increased from 2001 (0.05%) in the German-speaking region.
Methodology: Our study included a 21.3%, 41.1%, and 62.9% sample of deaths among residents aged one
year or older in the German-, French-, and Italian-speaking regions, respectively.
Originality: This is the first death certificate study allowing comparison of MELDs between Swiss language
regions.
Conclusions: Medical end-of-life decisions have become more frequent, and their prevalence varies
between the three Swiss language regions. There is a need for better support of palliative care and contextsensitive public awareness to improve these decisions and their context. Medical training should provide
doctors with more opportunities to learn how to deal with these issues.
PN: 128
Assisted Dying in New Zealand: Individual and Collective Interests at the
Very End of Life
Phillipa Malpas, University of Auckland, New Zealand
Keywords - Assisted dying, death, end of life
Discipline(s) – Medical ethics
Abstract
Research Problem and Findings: Although we understand we will all die, how we die sits at the heart of the
dying process. Following recent media coverage of a young woman dying of cancer, who wanted lawful
medical assistance to die, discussions of the legal options available at the end of life brought into sharp focus
the implications of physician assisted dying (PAD) in New Zealand.
Methodology: In this session I critically explore some of the findings from three qualitative studies we have
recently undertaken that explore the attitudes of older New Zealander’s towards (PAD). Although individuals
spoke of their concerns for self, overwhelmingly they spoke of their concerns for others as they contemplated
74
their own mortality and dying. Their concerns and interests were inextricably linked to those of their family
and community.
Originality: Whilst the prioritization of patient autonomy and patient centered care has become the dominant
paradigm in health care in many countries, viewing the dying process through a more collectivist lens
requires deeper engagement and critical analysis. With that focus in mind, the following questions will be
addressed: how do the attitudes of individuals towards physician assisted dying influence and shape
expectations of medical treatment and care at the end of life; and what can we learn from focusing beyond
the patient to others who are also involved in the dying process?
Conclusion: Such a focus will enrich our understanding of the experiences of those who have considered
their own mortality and dying within the context of physician assisted dying and how individual and collectivist
interests intersect.
Carrick 3
S48: Symposium: Adam Smith at the Bedside: The Influence of 'The
Theory of Moral Sentiments' in Clinical Bioethics Consultation PN: 738
1
2
3
Tyler Gibb , James Hynds , Kevin Dirksen
1
2
Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, United States, University
3
of California, Los Angeles (UCLA), United States, Providence Center for Health Care Ethics, Portland,
United States
Discipline(s): Clinical Bioethics, Moral Philosophy
Keywords: Medical Ethics, Clinical Bioethics, Adam Smith, Moral Philosophy, Clinical Ethics Consultation
Abstract
Adam Smith is famous for his contributions to economic theory. However, few are aware that his first
scholarly contributions were as a moral philosopher. Smith's treatise “The Theory of Moral Sentiments” is
rarely read today, but may prove to be as equally important as “Wealth of Nations.” In this panel, we will apply
the moral philosophy of Adam Smith articulated in the "Moral Sentiments" to clinical bioethics in three specific
ways: 1) to better understand the philosophical goals of clinical medicine; 2) to explore the nature of
friendship in the physician/patient relationship; and 3) to examine the character of the a virtuous physician.
These three areas of inquiry will be heavily informed by the experience of the panelists, professional clinical
ethicists practicing in the United States, and will offer insights those clinicians, both physicians, and ethicists,
in other countries may employ.
Panelist #1:
Whether there is an articulable philosophy of medicine is uncertain. Adam Smith, in the Theory of Moral
Sentiments, provides a novel avenue of understanding what, if anything, a goal of medicine might look like.
The first panellist will provide a brief overview of the major arguments about the nature of the philosophy of
medicine. This discussion will lay the foundation for a novel proposal for understanding the philosophy of
medicine, based upon Adam Smith's writings about goals and means in the Theory of Moral Sentiments,
specifically as it pertains to the clinical encounter.
Panelist #2:
Adam Smith specifically mentions many of the key principles often cited in medical ethics (e.g., beneficence,
social justice, respect for the person). However, he pays specific attention to the necessary and sufficient
conditions for, and the unique characteristics of friendship. This concept, as articulated by Adam Smith in The
Theory or Moral Sentiments, will be critically analysed and applied to the concept of physician-patient
relationship, which is based in a therapeutic alliance—a special form of friendship. The special nature of
friendship in the clinical encounter.
Panelist #3:
Adam Smith offers that the virtuous person is prudent, just, and benevolent. According to Smith, one’s selfish
affections promote prudence or the concern for the happiness of others. Prudence, in turn, promotes the
75
virtues of justice, which thereby restrains one from harming the happiness of others. Justice, in turn,
promotes the virtue of beneficence, which occasions the promotion of the happiness of others. (Smith, Part V:
"The Character of Virtue" in The Theory of the Moral Sentiments).
While recognizing that this Smith’s account of the virtues is based upon an anthropology which is culturally
and socially contextualized at the time of the Scottish Enlightenment, I will explore how his account may
complement a contemporary schema for tracking physician training in the U.S.-American context (cf.
Accreditation Council for Graduate Medical Education’s Core Competencies). Insofar as this represents a
dialogue partner with contemporary physician education, the applicability of Smith’s theory of the moral
sentiments in contemporary bioethics education will become apparent.
Harris 1 & 2
S39: Ibero-American Network: Mesa 2 (Session 2)
Coordinada por Casado, M
¿Qué hacer cuando un médico tiene problemas de salud que afecta su
desempeño clínico?
Claude Verges
Resumen: Al igual que cualquier persona, los médicos se enferman: cáncer, enfermedades inmunológicas,
HIV/SIDA, depresión o presentan trastornos de carácter que afectan su desempeño clínico. Esta situación
refleja dos problemas: el de la protección del médico contra infecciones en ambiente hospitalario, el de la
protección de los pacientes contra la acción de un médico con disminución de su capacidad de
razonamiento. Para las autoridades médicas estos problemas se traducen en un dilema bioético entre los
principios de confidencialidad y no-discriminación y los de protección, no-maleficencia y beneficencia. Las
leyes sanitarias obligan a la separación provisional o definitiva del médico enfermo con estatus de
pensionado. Sin embargo, la continuidad de sus funciones representa una necesidad emocional de los
médicos con enfermedades “físicas”; por otra parte los tratamientos psiquiátricos permiten una adecuada
funcionabilidad definitiva o periódica. Se presentan ejemplos de resolución de estos dilemas que intentaron
tomar en cuenta el interés de todas las partes, actuando caso por caso. La dificultad principal fue de
convencer a las autoridades administrativas de la viabilidad de las soluciones propuestas. Los comités de
bioética asistenciales tienen un rol importante para las recomendaciones sobre estas situaciones.
La liberalización de la información alimentaria: ¿problema de salud
pública o cuestión privada?
María José Plana Casado, Investigadora Predoctoral del Observatorio de Bioética y Derecho de la
Universidad de Barcelona y miembro del Grup de Recerca Consolidat no 2014-16 SGR 558 “Bioética,
Derecho y Sociedad” de la Generalitat de Cataluña
Palabras clave: información alimentaria; salud pública; divulgación científica; financiación privada de la
investigación; seguridad alimentaria.
Resumen: A diferencia de lo que ocurre con la mayoría de bienes consumibles, los productos alimenticios
son objeto de un complejo marco regulatorio que abarca tanto las características sanitarias del alimento
como la forma en la cual la industria proporciona información alimentaria a sus consumidores. La regulación
busca la veracidad de la información disponible para que la ciudadanía acceda a una alimentación saludable
como parte de la política pública de salud de los Estados. Así, se establece legalmente un listado de
menciones obligatorias, criterios científicos para determinar las propiedades saludables de los alimentos, o el
modo en el que se presenta la información en las comunicaciones comerciales. Sin embargo, es habitual
encontrar en la prensa generalista artículos que difunden información alimentaria que – por formar parte de
estudios científicos emitidos por centros de investigación y no por la industria- no queda sujeta a las
exigencias legales citadas. Esta “liberalización” de la información alimentaria es el resultado del
acercamiento entre la industria y la comunidad científica, manifestado en la creación de Cátedras
patrocinadas y la financiación privada de investigaciones relativas a las propiedades saludables de
determinados alimentos. Estos estudios no son sometidos al proceso de revisión por pares propio de la
76
divulgación científica especializada, si bien tienen un impacto en las creencias alimentarias de los
consumidores debido a su aparente neutralidad. En un contexto en el que el consumidor desconfía de los
operadores así como de las instituciones responsables del control de la seguridad alimentaria, confiando en
cambio en terceros “desinteresados” -entre los cuales destacan los centros de investigación-, es necesario
analizar el alcance de la relación entre operadores y comunidad científica, así como la transparencia de
dicha relación y las medidas públicas que garanticen que la connivencia entre estos no resulte en la
devaluación de la información alimentaria.
La sperimentazione sulle cellule staminali embrionali tra “ordine
pubblico” e interesse privato
Valeria Marzocco - Università degli Studi di Napoli Federico II ([email protected])
Silvia Zullo – Università di Bologna ([email protected])
Keywords: Persona; Embrione; brevettabilità del vivente; ordine pubblico; mercato
La decisione della Corte di giustizia Ue (dicembre 2014) di autorizzare la brevettabilità di cellule uovo umane
non fecondate, e quindi di ciò che può essere derivato da esse, ha per certi versi modificato l’orientamento
della stessa Corte che nella precedente sentenza sul tema (ottobre 2011) aveva bocciato una domanda di
brevetto relativa all’uso terapeutico di cellule staminali di embrioni umani . In Inghilterra, l’Autorità per la
fertilità e l’embriologia (Hfea) ha recentemente autorizzato il Francis Crick Institute ad avviare esperimenti di
manipolazione genetica su embrioni non destinati alla procreazione e che non potranno in alcun modo venire
impiantati.
Per un verso, la rideterminazione offerta nel 2014 dal Giudice di Lussemburgo è estremamente interessante
da considerare, nella prospettiva che viene offerta in tema di delimitazione tra soggettività morale
dell’embrione e materia biologica brevettabile, affidata, per il suo giudizio, ad un ruolo co-produttivo che
costituisce il giudice come soggetto chiamato a interpretare il dato scientifico secondo un modello dinamico.
Nel registro di una visione teleologica della natura umana e della qualificazione della soggettività
dell’embrione come parte di un processo in divenire, il meritevole di tutela si giustifica nel senso
dell’appartenenza finalistica a tale sviluppo che fa leva su di una determinazione non data in termini statici
(come nel caso del modello adottato dal legislatore spagnolo sia nel 2006, in materia di PMA, che nel 2007
con riguardo alla ricerca biomedica).
Per altro verso, ci si domanda se tali pronunce rispondano ad un percorso interpretativo sensibile a nuovi
interessi e criticità del mercato, oppure a pretese etiche per una riconcettualizzazione delle cellule staminali e
delle risorse genetiche umane in un’ottica di bene comune. In quest’ultimo caso, risulta problematico
conciliare le suddette pretese etiche con lo strumento giuridico della privativa brevettuale, non
particolarmente apprezzato dal punto di vista scientifico ed etico, specie in campo biomedico.
La reforma necesaria del Sistema Público de Salud en México
Dr. Jorge E. Linares Salgado, Programa Universitario de Bioética, UNAM, México
Palabras clave: sistemas de salud, justicia distributiva, interés público, responsabilidad social.
Resumen: De acuerdo con el último informe de la OCDE sobre el sistema público de salud en México
(OECD Reviews of Health Systems: Mexico 2016), éste se encuentra en un estado crítico, pues resulta
evidente que sus resultados son ineficientes y notoria su incapacidad para mejorar los indicadores más
importantes de salud en el país, como la mortalidad infantil, materna o la mortalidad en los casos de atención
de infartos en los hospitales, además de no poder controlar las enfermedades epidémicas: la diabetes y la
obesidad que padece un porcentaje muy alto de adultos y niños.
México necesita urgentemente reformar su sistema de salud para convertirlo en un sistema unificado,
homogéneo y de cobertura universal que pueda proveer a toda la población, sin distingo de su actividad y
sector laboral (público o privado), de la región o Estado en el que vive, en un sistema eficiente que utilice de
manera eficiente y racional el gasto público y que mejore sustantivamente la calidad de la atención sanitaria.
Esta es una responsabilidad del Estado y de la sociedad civil que resulta ya impostergable en vistas del
interés público armonizado con el interés particular de cada familia y ciudadano.
77
Como conclusión, el reto es enorme, dadas las dimensiones del país (más de 120 millones de habitantes,
cerca de la mitad en condición de pobreza), pero factible. Se discuten y analizan en esta ponencia los
modelos más exitosos de sistemas públicos de salud y las posibilidades para reformar el sistema mexicano
en un marco bioético de justicia distributiva y protección de derechos civiles fundamentales, al mismo tiempo
que su viabilidad económica y política.
Las esterilizaciones forzadas (AQVs) realizadas durante el gobierno de
Fujimori como eje central de la política de control de la natalidad y
reducción de la pobreza: ¿eliminación de la pobreza de la vida de las
mujeres campesinas o violación de sus derechos reproductivos?
Gisela Isabel Fernández
Palabras clave: anticoncepción quirúrgica voluntaria (AQV), derechos reproductivos, consentimiento
informado, vulnerabilidad, salud pública.
Resumen: La política de control de la natalidad llevada a cabo en el Perú durante el segundo gobierno de
Alberto Fujimori tuvo como eje central la implementación de la anticoncepción quirúrgica voluntaria (AQV),
mayoritariamente ligaduras de trompas y, en menor grado, vasectomías. Esta política se caracterizó por
estar dirigida a la población más pobre, mayoritariamente mujeres campesinas quechuahablantes.
Aunque estos casos han sido objeto de numerosas denuncias, hasta ahora no se ha realizado un análisis
desde los enfoques bioético y de género de manera conjunta. Ello se hará a través de la identificación de
dificultades que presenta la política pública de salud reproductiva en:
1. Su diseño: El eje central fue la reducción de la pobreza a través del control de la natalidad optándose por
priorizar métodos anticonceptivos que implicaban intervenciones quirúrgicas que se practicarían
desconociendo derechos reproductivos de la ciudadanía más pobre.
2. Su implementación: a. No incluyó el respeto por la autonomía de los usuarios pues las AQVs se
practicaron sin contar con su real consentimiento: no se brindó información suficiente y se forzó al personal
sanitario a practicar la mayor cantidad de AQVs imponiéndoseles cuotas obligatorias; b. Aunque la
vasectomía constituye una cirugía de menor costo y complejidad, se optó por preferir las ligaduras de
trompas; c. Debido a no contar con personal calificado o carecer de la cantidad necesaria de estos, algunas
veces se produjo mala praxis o negligencia médica.
3. La supervisión: Ni el aumento de las denuncias sobre la realización de AQVs sin consentimiento ni su
mala calidad, generó la implementación de un sistema de supervisión y monitoreo del servicio brindado.
En síntesis, la política pública llevada a cabo no incluyó un enfoque de derechos, ni respetó las diferencias
cultural y biológica; por el contrario, generó gran indefensión de derechos fundamentales seguida de total
impunidad.
Historia de la eutanasia en Colombia y la reconfiguración de lo
público/privado, ¿un reto para la bioética?
Eduardo Díaz, Profesor Asociado, Instituto de Bioética, Universidad Javeriana, Bogotá, Colombia
Palabras clave: Colombia, eutanasia, muerte digna, tanatoética, relaciones bioética/sociedad
Resumen: Colombia es uno de los pocos países en el mundo, y el único en Latinoamérica, en donde la
eutanasia puede ser realizada legalmente. En 1997, con la sentencia C-239 de 1997, la Corte Constitucional,
en un fallo polémico, despenalizó el homicidio por piedad y le pidió al Congreso de la República establecer
una ley que regulara la materia. Sin embargo, luego de dieciocho años esto no ha sido posible por el juego
político que se da en el legislativo. Esto llevó a una zona gris en la que médicos, instituciones de salud y
pacientes no tenían claridad sobre cómo actuar. Por esta razón, la Corte Constitucional emitió una nueva
sentencia en 2014 (T-970) en la que le ordenaba al Ministerio de Salud y la Protección Social proveer una
guía para que tanto las instituciones de salud como los pacientes supieran, ya fuera proveer o acceder al
procedimiento, hasta que finalmente el Congreso regule la materia. La guía expedida por el Ministerio en
78
2015 (Resolución 1216) fue recibida en medio de una fuerte polémica. La eutanasia es uno de los temas
clásicos de la bioética y viene siendo discutida en muchos países. Más allá del debate ético-filosófico, en
esta ponencia se adoptara un punto de vista histórico-crítico para, primero, poner en el contexto regional y
global el caso colombiano; segundo, analizar los aspectos políticos e ideológicos desatendidos en el debate,
particularmente las nuevas configuraciones de la relación individuo/sociedad e individuo/estado que se
revelan en dicho debate; y, tercero, señalar la importancia que tiene incluir en la bioética académica
perspectivas menos obsesionadas con la asepsia argumentativa y más abiertas al misterio del morir.
La investigación con datos masivos en la sociedad de mercado: ¿bien
público o negocio?
Dr Itziar de Lecuona
Palabras clave: investigación con datos masivos, comités de ética, biopolítica, priorización de los recursos,
bienes públicos.
Resumen: La investigación con datos masivos plantea nuevos retos a comités de ética en investigación,
gobiernos y ciudadanos. Las tensiones generadas en la sociedad de mercado -libertad de investigación y los
derechos de los participantes-, provienen ahora de la motivación de nuevos agentes de i+d+i por acceder al
sistema investigador, reino de la bioética: principios y reglas para evitar conflictos de intereses, objetivos
espurios y explotación de personas y datos personales de salud. Un nuevo nicho de mercado vinculado a la
investigación que los comités de ética deben identificar y afrontar, aportando soluciones creativas que los
han de situar en una posición clave en las instituciones donde se investiga y reivindicar su utilidad ante el
estado y ciudadanos. El trabajo aporta así propuestas. Se revisa la aportación de comités de ética en la
priorización de la investigación; el significado que adquiere que el estado les delegue aprobar o no proyectos
y sus metodologías y la relación con la sociedad y el ciudadano –proveedor del dato- que debería pivotar
sobre la transparencia, la confianza y la rendición de cuentas. La metodología parte del análisis de los
marcos normativos aplicables para luego concretar una casuística en la que se difuminan las fronteras entre
investigación y mercado y donde los usos no deseados de los datos personales de salud parecen no
advertirse y confundirse entre apps de salud, vestibles e internet de las cosas. El caso catalán servirá de
ejemplo como concreción del interés europeo por una economía guiada por el dato que potencia la
investigación e innovación con datos masivos para i.e. mejorar sistemas de salud y condiciones de vida. Así
será posible constatar la biopolítica de los datos masivos en tanto los comités no articulen mecanismos y
competencias que el trabajo propone.
Salus populi, principio de no lucro y deber cívico de donar sangre
Pol Cuadros
Palabras clave: Donación de sangre, salud pública, principio de no lucro, deber cívico.
Problemática: Desde 1985 la compraventa de sangre está prohibida en España. La DT2o de la ley de
trasplantes de 1979, y luego el artículo 21 del Convenio de Oviedo del Consejo de Europa, así lo exigían, al
establecer un principio de no lucro sobre el cuerpo humano y sus partes derivado del principio de la dignidad
humana. La Unión europea y la OMS recomiendan la donación no remunerada de sangre atendiendo a
criterios de salud pública y de seguridad, y a ello apela también la legislación española. Debido a la escasez
de sangre obtenida mediante donaciones altruistas, España importa sangre comprándola en el mercado
internacional. Ahora bien, ¿no rompe esta importación la observancia del principio de no lucro? Entendemos
que sí. Algunos dicen que no queda otra alternativa si se quieren satisfacer las necesidades sanitarias,
aunque con ello el principio de no lucro deba ceder.
Nosotros defendemos que no es necesario vulnerar este principio ético, el cual, en España, es además un
principio legal. Es posible que el principio de no lucro conviva con el de la tutela de la salud pública.
Creemos que ello es factible mediante el establecimiento de la obligación de donar sangre como un deber
cívico. Ello lograría satisfacer la necesidad de sangre, Salus populi suprema lex, y, a la vez, mantener de
forma exigente la prohibición de su compraventa. Las discusiones sobre esta cuestión giran en torno a los
aspectos técnicos, sin prestar demasiada atención al plano ético que subyace; por el contrario, esta
comunicación se centrará en el análisis de las cuestiones éticas. Conclusión: Una alternativa a la
compraventa de sangre que permite satisfacer tanto el principio de no lucro como las necesidades sanitarias.
79
Ochil 1&2
S10: Enhancement
Chair: McCarthy, M
PN: 290
The Edge Of Human? The Problem with the Posthuman as the ‘Beyond’
1
David Lawrence
1
University of Manchester, United Kingdom
Keywords - Enhancement, Posthuman, Humanity, Embodiment, Moral Value
Discipline(s) - Bioethics/ Philosophy
Abstract
This paper asks whether enhancement can truly lead to something beyond humanity, or whether it is, itself,
an inherently human act.The ‘posthuman’ is an uncertain proposition. What, exactly, would one be? Many
commentators suggest it to be an endpoint for the use of enhancement technologies, yet few choose to
codify the term outright; which frequently leads to a fatal- and unnecessary- confusion. Characterising the
term, particularly its more novel uses, is therefore a valuable enterprise.The abuse of the term ‘Human’,
especially in the context of the enhancement debate and the myriad meanings ascribed to it, could give
‘posthuman’ very different slants depending on one’s assumptions. There are perhaps three main senses in
which the term ‘human’ is employed- the biological, the moral, and the self-idealising. In the first of these,
‘human’ is often conflated with Homo sapiens, and used interchangeably to denote species; in the second,
‘human’ (or ‘humanity’) generally refers to a community of beings which qualify as having a certain moral
value; and the third, the self-idealising sense, is more descriptive; a label denoting the qualities that make us
who we are as beings, or ‘what matters about those who matter’. So, what might enhancement make us? A
novel species or genus of hominid? Or, perhaps, a morally more valuable being than a regular human? Of
course, there’s a third option: that a posthuman is a being which embodies our self-ideal more successfully
than we do ourselves- one “more human than human”. Which to choose?
PN: 522
Human Enhancement and Public Health
1
Alex McKeown
University of Bristol, London, United Kingdom
1
Keywords - Human Enhancement; Public Health; Health Policy, Prevention; Ethics
Discipline(s) – Public Health, Ethics and Law
Abstract
Rose’s pithy defence of (public) health is ‘it is better to be healthy than to be ill or dead. This is the beginning
and the end of the only real argument for preventive medicine’. Such straightforward beliefs are implicit in
public health’s raison d’etre, but this simplicity is more apparent than real. If health is good, would it be better
to be healthier, even if one is healthy? Would everyone be better off enhanced? I investigate the implicit,
unexplored continuity between enhancement and public health to better understand what role (if any) the
former has in the latter. Determining desirable enhancement at population level is complex, and measures
such as QALYs / DALYs may be sub-optimal. Interest proliferates in individual enhancement use for
technologically transcending ‘normal’ functioning, but this is not necessarily population-optimal. For example,
in public health, improving quality of life and wellbeing – via better housing, cohesive communities, improved
urban environments – rather than biomedically prolonging life or biotechnologically upgrading it, may be a
more sustainable approach to enhancing population health. Conclusion: since public health aims at improving
both normal and ill-health, 'appropriateness' is not limited by the therapy / enhancement distinction and the
nominally remedial boundaries of practice that it implies. I provide the first framework for understanding
enhancement and public health.
80
PN: 636
Could Moral Enhancement be Medically Indicated?
1
Sarah Carter
1
University Of Manchester, United Kingdom
Abstract:
This presentation explores the position that moral enhancement interventions could be medically indicated
(and so considered therapeutic) in cases where they provide a remedy for a lack of empathy, when such a
deficit is considered pathological. In order to argue this claim, the question as to whether a deficit of empathy
could be considered to be pathological is examined, taking into account the difficulty of defining illness and
disorder generally, and especially in the case of mental health. Following this, Psychopathy and a
fictionalised mental disorder (Moral Deficiency Disorder) are explored with a view to consider moral
enhancement techniques as possible treatments for both conditions. At this juncture, having asserted and
defended the position that moral enhancement interventions could, under certain circumstances, be
considered medically indicated, this presentation then goes on to briefly explore some of the consequences
of this assertion. First, it is acknowledged that this broadening of diagnostic criteria in light of new
interventions could fall foul of claims of medicalisation. It is then briefly noted that considering moral
enhancement technologies to be akin to therapies in certain circumstances could lead to ethical and legal
consequences and questions, such as those regarding regulation, access, and even consent.
PN: 686
Cognitive Enhancement in Children: Of Child Geniuses and Disability
1
Jenny Krutzinna
University of Manchester, United Kingdom
1
Keywords - Cognitive Enhancement; Welfare of the Child; Social; Model of Disability; Giftedness Studies;
Child Development
Discipline(s) - Public Health, Ethics and Law
Abstract
Despite the welfare of the child being the ‘paramount consideration’, it appears that the law is currently not
objective in its application to children. There is an undeniable link between healthy child development and
education, with the latter greatly impacting on mental health and general well-being. Drawing on the example
of the differential treatment of gifted children in an educational context, I argue that the legal framework with
regard to learning disabilities and cognitive impairments operates contrary to the proclaimed goal of
protecting and promoting the welfare of the child. This, I argue, constitutes unjustified discrimination,
especially since there is a case to be made that highly cognitively able children could be considered disabled
under a social model of disability. Whilst the group of affected children is small at present, developments in
cognitive enhancement technologies mean that many more children might in the future be discriminated
against. In addition, since the most promising cognitive enhancement interventions involve genetic
technologies, such as preimplantation genetic diagnosis, authorisation from the Human Fertilisation and
Embryology Authority will likely be required. This means the state will be acting as a facilitator in ‘creating’
cognitively enhanced children, and as a result shares in the responsibility for such children and their
particular welfare needs. Given the current treatment of gifted children in our educational and welfare system
and the similarities to cognitively enhanced children, it is time to start regulating for the future.
81
FRIDAY 17TH JUNE 2016 09:00-10:30
Pentland Auditorium
S43: Symposium: WHO TB Ethics Guidance Document – The Next
Iteration PN: 589
1
1
1
2,4
3
Diego Silva, Ernesto Jaramillo , Andreas Reis , Michele Loi , Verina Wild , Patrik Hummel
2
World Health Organization, Geneva, Switzerland, Ludwig-Maximilians-University, Munich, Germany,
3
4
University of St Andrews, St Andrews, Scotland, Institute for Biomedical Ethics and History of Medicine,
University of Zurich, Zurich, Switzerland.
1
Discipline(s) Philosophy; applied ethics; policy
Keywords Tuberculosis; migration; isolation; public health; infectious diseases
Format/Methodology Mixed methods (philosophical and policy discussion)
Abstract
In 2010, the World Health Organization (WHO) published its Guidance on Ethics of Tuberculosis Prevention,
Care and Control to help guide health care workers, policy makers, patients, and civil society on a wide range
of challenges related to tuberculosis (TB). The document is an important reference point for informed ethical
policy-making, clinical and public health practice. Last year, the WHO adopted the End TB Strategy, which
puts forth the goal of ending the global TB epidemic by 2035. Specifically, the End TB Strategy states that TB
deaths shall be reduced by 95%, new cases shall be cut by 90%, and no family shall be burdened with
catastrophic expenses. One of the core principles of the strategy is the protection and promotion of human
rights, ethics and equity. Since the publication of the 2010 TB ethics guidance document, new challenges
have emerged or gained more attention. Coupled with the ambitious goals of the End TB Strategy, the WHO
has decided to update its ethics guidance document. The presentations in this symposium encompass four of
the more challenging topics to be addressed in the new WHO guidance document: migrants and displaced
populations; treatment when recommended regimens are non-feasible; treatment of latent TB infection; and
involuntary isolation. The goal of this symposium is to present the global bioethics community with an
opportunity to provide important input for the next iteration of the WHO’s TB ethics guidance document.
Migrants and Displaced Populations
Migrants and displaced populations face particular challenges, and some are at increased risk of poverty and
discrimination. Even though international law provides a right to health for all, migrants often experience
difficulties in accessing healthy living conditions or quality healthcare. Their mobility can affect transmission
patterns and adherence to treatment, and the risk for multidrug-resistant TB (MDR-TB) increases. Moreover,
health checks are often a necessary requirement to enter a country, even for asylum processes; this can
motivate migrants to not fully disclose their health status or use irregular migration routes. Migrants
experience repatriation, which often complicates treatment. Therefore, there are unique challenges, often
ethical and political in nature, in preventing, diagnosing, and treating TB in migrant populations. Addressing
these issues is critical as the numbers of migrants and refugees is constantly rising.
Treatment When Recommended Regimens are Non-Feasible
TB represents a significant burden of disease worldwide, and MDR-TB a major threat to the progress
achieved in recent years. In order to prevent the worsening of drug resistance and to increase chances of
cure, recommended regimens for MDR-TB treatment consists of at least four effective drugs plus
pyrazinamide for a period of at least 18 months.
However, situations arise in which this standard of treatment is impossible. These pose a serious ethical
dilemma to National TB-programs, as well as to treating physicians, i.e. deciding whether to provide suboptimal therapy or refrain from treating the patient entirely, ultimately choosing between the best interests of
the patient and the public health. While the goal of temporarily alleviating symptoms or extending life
expectancy is laudable, we argue that providing sub-optimal therapy is only ethically defensible when applied
82
under very strict conditions, as otherwise resistance might develop, which can threaten important public
health goals.
Treatment of Latent Tuberculosis Infection
Which ethical principles should guide the treatment of persons with latent TB infection (LTBI)? Her body is
infected with Mycobacterium tuberculosis, which causes no illness and does not make the person contagious.
Yet, if the person is exposed to special risks the likelihood of developing actual TB increases. As a person at
risk of developing TB, the subject also potentially places other persons at risk. Diagnoses for LTBI can be
uncertain in some cases and carries costs that may be significant. Finally, the side-effects of treatment can
be fatal, with risk of harm being far from negligible. These features of LTBI render the ethics of treatment
especially complex and challenging and quite distinctive from other diseases. A one-size-fits-all ethical
answer is impossible because the risk of progression to actual TB is different for persons in different groups
(e.g. HIV-positive persons are more likely to convert than HIV-negative persons).
Involuntary Isolation
A patient with untreated TB poses a risk of infecting other persons and must remain in isolation. Whenever
all measures to enable adherence to treatment have been exhausted and a TB patient still ignores public
health orders to remain in isolation, involuntary isolation is justified. As such, the conditions that justify
involuntary isolation require careful consideration. Moreover, we ought to consider the ethical residue of
involuntary isolation, namely what the state and global community owes said individuals (e.g., provide basic
life necessities) and acknowledging the social and political realities that lead to involuntary isolation in the first
instance (e.g., a lack of job security that may motivate someone to break isolation orders to provide for their
families). This presentation will not only address the procedural conditions that ought to be met to justify
involuntary isolation, but will also speak to the point of context and the rights of TB patients.
Sidlaw
S57: Symposium: In It Together? The Role of Solidarity in Promoting
Public Interests in Biomedicine and Public Health PN: 462
1
2
1
Alena Buyx , Bruce Jennings , Pete West-Oram , Angus Dawson and Marcel Verwij (joint
3,4
5
presenters) , Barbara Koenig
2
1
Department for Biomedical Ethics, University of Kiel, Arnold-Heller-Str. 3, Haus 18, Kiel, Germany, Center
3
for Biomedical Ethics and Society, Vanderbilt University, Nashville, USA, Centre for Values, Ethics & the Law
4
in Medicine, University of Sydney, Sydney, Australia, Department of Social Sciences, Subdepartment
5
Communication, Philosophy, and Technology, Wageningen University, Wageningen, Netherlands, Institute
for Health Aging, University of San Francisco, San Francisco, USA.
Discipline(s) Public Health Ethics, Bioethics
Keywords Solidarity, Public Health, Health inequalities, Public Interest
Format/Methodology Symposium, four talks plus discussion
Abstract
Solidarity is increasingly prominent in bioethical discourse. This is partly due to the recognition that many of
the current political, societal, economic and environmental problems require policy strategies that
acknowledge and utilise the existence of complex relationships between even distant people, and that
demand cooperation and collaboration. This panel, bringing together leading scholars on solidarity in public
health and bioethics, examines if, and how, solidarity can help in this endeavour. Speakers explore the
analytic value and characteristics of solidarity and what sets it apart from terms such as justice; what
normative claims can be derived from solidarity; and what difference it can make in practice and policy
making. Areas of application include health inequalities, screening programs, and non-communicable
disease.The role solidarity can play in guiding theory, practice and policy in biomedicine and public health
has so far not been sufficiently explored. The symposium examines original ideas regarding the
conceptualisation and practical application of solidarity in these fields. Conclusion: current and emerging
crises require strategies that transcend national, political and social boundaries. They necessitate the
development of new theoretical frameworks which acknowledge and facilitate collaborative responses. This
symposium explores whether, and if so, how, solidarity can offer solutions in this respect.
83
Solidarity as Interdependence: Recognition and Response
This paper locates the discourse and practice of solidarity in the context of what can be called the “imperative
of interdependence” in contemporary political economies, which grows out of technological and ecological
change, and increasingly permeates everyday life. The imperative of interdependence provokes a political
and normative legitimation crisis because current normative systems (individualistic and agonistic) and
institutional structures (competitive and growth oriented) lack the capacity to recognize and accommodate
themselves to it. Solidarity offers an analytic, normative, and practical resource in this situation. Analytically,
solidarity provides a distinctive link between other norms, such as equality, justice, and liberty. Substantively,
solidarity reinforces membership and mutuality as democratic and constitutional values. Practically, the
concrete individual and organized group practices of solidarity in the lifeworld nurtures forms of selfunderstanding and individual and group interrelationships that strengthen democratic agency and support for
more egalitarian and adequate health and social programs.
ECR Paper: Just Effective Public Health Policy: From Self-Interest to Solidarity via Public Goods"
It has been argued that there are self-interested reasons for the citizens of wealthy countries to ensure that
all persons, even those beyond the traditional boundaries of their community, have access to health services
which protect against infectious disease. This is because many effective responses to infectious disease,
such as herd immunity, qualify as public goods, and can only be delivered and enjoyed collectively. Thus, for
the wealthy to benefit from protections offered by these services, the same protections must be extended to
all persons. However, health policy based on self-interest alone cannot motivate responses to noncommunicable diseases or injuries, potentially preventing many from accessing needed care. In this paper, I
argue that self-interest about infectious disease control can be the first step towards general solidarity in
health, and that thinking solidaristically about health has practical value in enabling us to achieve more just,
and more effective, global health
systems.
Evaluating health inequalities from the perspective of solidarity
Ethical discussions about health inequalities often start with the question which inequalities must be
considered as unjust or unfair. In our paper we argue that health inequalities should not solely be judged from
a perspective of justice, and we explore how solidarity offers a different, and broader basis for moral concern.
Justice perspectives seem to face at least two limitations. They focus on here and now and
therefore struggle with distribution of goods across generations. Moreover, the focus on distribution of
benefits and burdens of policies too easily considers investments to tackle health inequalities as costs in a
negative sense. Solidarity presents a normative perspective that sees the efforts of all (including better-off)
groups to fight and prevent health inequalities (now and in the future) not as a cost but as a quality of a good
society.
Achieving Solidarity through Deliberative Public Engagement: An Approach to Governance of StateMandated Newborn Screening in California
Newborn screening programs (NBS) are designed to achieve a broad public good. All newborns are
screened at birth for several rare conditions; in California residual blood spots are routinely stored for quality
improvement, clinical follow up, and research. Few people are aware of NBS programs; fewer still understand
when and how samples are banked for research. Sequencing technologies create further complexity,
dramatically expending the number of disorders to be included in a screening panel. How should such public
resources be governed? How should individual parental control be balanced with the public health goals of
NBS programs? This paper describes the theoretical and conceptual choices involved in designing and
implementing a deliberative public engagement in California in 2016. We present the recommendations
developed by a diverse group of Californians and presented to the state’s Department of Public Health. Our
paper demonstrates how solidarity can be enacted in actual public health practice.
Fintry
S65: Symposium: Children's Participation in Clinical Studies PN: 331
1
2
1
3,4
1
Leonardo DeCastro , Katharine Wright , Markus Labude , Daniel Fu-Chang Tsai , Victor Cole
2
Centre for Biomedical Ethics, National University of Singapore, Singapore, Singapore, Nuffield Council on
3
Bioethics, London, UK, Research Institute of Medical Education and Bioethics, National Taiwan University
1
84
4
College of Medicine, Taipei, Taiwan Center for Biomedical Ethics, National Taiwan University, Taipei,
Taiwan
Discipline(s) Philosophy and Medicine
Keywords Clinical Studies, Research, Vulnerability, Children, Minors
Format/Methodology Panel presentation and open discussion
Abstract
The idea of involving children in biomedical research is often met with expressions of fear about risks that
they have to assume. Yet there is also a realization that practices relating to the treatment of minors have to
be scientifically validated, a process that mostly requires their direct participation. Tension between the
opposing considerations suggests that there is a continuing need to explore innovative approaches to the
involvement of children in biomedical studies. In this symposium, we explore approaches that entail greater
participation of children in understanding the significance and value of clinical trials, the roles and
responsibilities that children can assume, and the protection that they may deserve to have throughout the
research process. We challenge the ways in which relationships in clinical studies have been understood. We
interrogate the notion of vulnerability that has been largely presumed to be a characteristic of minors. We
examine the role of a child participant who consents rather than merely assents. We explore the child’s
capacity for altruistic commitment to research participation, taking into account variable levels of children’s
maturity and the possible tensions with parental concerns. The originality of the symposium topic lies in its
exploration of innovative approaches to framing the involvement of children in clinical studies and the paper
authors’ willingness to question widely held presumptions about the vulnerability, exploitation, maturity and
responsibility of this type of research participant. The presentations are going to be given in the context of the
following themes: Public Health, Ethics and Law and Global Bioethics. Panel membership consists of a
combination of established bioethicists and early career researchers as indicated in the short bios after each
abstract.
Children and clinical research: ethical issues
1
Katharine Wright
Much has been written as to what constitutes ‘ethical practice’ in clinical research – but generally from the
starting point of research with competent adult participants. In May 2015 the Nuffield Council on Bioethics
published the report Children and clinical research: ethical issues, which starts from a consideration of
children and young people, of what makes their situation (ethically) different, and of their lived experiences of
participation in research.
This report offers a critical analysis of issues arising specifically in clinical research involving children,
including assumptions about vulnerability, the role of children themselves in decision-making, and the role of
parents and others in promoting children’s welfare. These issues are considered from a UK as well as an
international perspective. In writing this report, the Nuffield Council on Bioethics sought input from young
people, parents and professionals concerned with clinical research, including through school workshops and
collaboration with Young Person’s Advisory Groups across the UK, community engagement in Kenya and
networks of research professionals working in low and middle income countries from South East Asia to Latin
America.
Drawing on the conclusions of the report, this talk will present an ethical approach to children’s involvement in
research and set out our recommendations to help tackle some key challenges for those concerned with the
health and healthcare of children and young people.
1
Katharine Wright is Assistant Director of the Nuffield Council on Bioethics, who led the Council's project on
ethical issues arising from the involvement of children in clinical research. Her background is in health policy,
law and ethics: before taking up her current post, she spent 9 years at the UK House of Commons, briefing
MPs of all political parties on health issues, and then four years in the NHS, monitoring the effect of the
Human Rights Act on health law in England. During this time she was also seconded to the English
Department of Health to work on patient consent. Her work at the Nuffield Council has included consideration
of ethical issues arising in dementia; the donation of bodily material for treatment or research; and the sharing
of information in the context of donor conception.
85
Adolescent attitudes towards participation in clinical trials: A report on a bioethical outreach initiative
in Singapore
2
Victor M. Cole
This paper reports on a bioethical outreach project aimed at introducing Singaporean secondary school
students to ethical considerations related to children’s participation in both beneficial and nonbeneficial
clinical trials. In an extended role play activity, students aged 13 to 16 took on the perspectives of either
potential research participants or ethics committee members. Of particular note was the unwillingness
expressed by many students to participate in nonbeneficial clinical trials for fear of unknown health
consequences. In the Singapore context that requires the dual consent of parent and child for participation in
such studies, this attitude, if widespread, could pose a significant obstacle to the progress of pediatric
biomedical research. The paper will make recommendations for a follow-up empirical study of adolescent
attitudes towards research participation and will anticipate some ethical concerns that might arise in relation
to any attempt to inculcate altruistic attitudes for the sake of bolstering research participation.
2
Victor Cole is a Research Fellow with the Centre for Biomedical Ethics, Yong Loo Lin School of Medicine,
National University of Singapore. He trained in Education at Oxford University and obtained his doctorate in
Bioethics from Monash University. His current research interests lie in the ethics of clinical trials, the ethics of
human enhancement, and the relationship between moral theory and bioethical practice.
Dual Consent and the protection of children in biomedical research
3
Leonardo D. de Castro
Calling the attention of minors to the possibility of altruistic biomedical research participation can be expected
to have the effect of encouraging them to participate. Engaging minors directly assumes their readiness to
understand the nature, benefits and risks of research involvement and thus their readiness to provide
consent. How different is giving consent from “merely” assenting? This presentation seeks to clarify the
difference and asks if the shift from assent to consent is truly an improvement that provides greater protection
for minors as they participate in human biomedical research. It proceeds to examine if the shift really is
intended to provide greater protection for minors being recruited for biomedical research or to provide a
mechanism that enables research that could potentially benefit future minors while exposing current research
participants to risks that are otherwise avoidable.
3
Leonardo D. de Castro is Senior Research Fellow at the Centre for Biomedical Ethics, Yong Loo Lin School
of Medicine, National University of Singapore, where he chairs the Capacity Development Programme in
Ethics in Research. He is also Editor-in-Chief of the Asian Bioethics Review.
Justifying Pediatric Research: a Public Reason Perspective
4
Markus Labude
This paper discusses how we may justify a public policy of permitting the enrollment of children in biomedical
research, when such research does not offer them any potential for clinical benefit. As point of departure, I
take David Wendler’s recent justification for such non-beneficial pediatric research. Wendler holds that,
despite the absence of clinical benefit, participation in research often makes a child’s life go better because
the act of participation adds value to the child’s life. As an ethical basis for public policy an account like
Wendler’s appears, however, problematic. It violates constraints set by Public Reason because it relies on a
comprehensive conception of the good life. This paper suggests how to reconceptualize Wendler’s approach
in response to this concern. Instead of trying to justify the general permissibility of enrolling children in nonbeneficial pediatric research, Wendler’s account is better understood as explaining how enrollment may be a
good thing according to a particular conception of the good life. Further, since a regime governed by Public
Reason may not, without good reason, prevent individuals from living according to their conception of the
good, it may not bar children’s enrollment in non-beneficial research that comes with no more than minimal
risk.
4
Markus Labude is a Research Associate at the Centre for Biomedical Ethics at the National University of
Singapore. He is a graduate of Yale University’s doctoral program in philosophy. Markus’s current key
research interests include philosophy & public policy, research regulation, legal philosophy and the
methodology of ethics and political philosophy.
Children’s participation in Clinical trials: Legal and Ethical Reflection in Taiwan
5
Daniel Fu-Chang Tsai
Article 79 of the Taiwan Medical Care Act, as amended in 2003, states: “When conducting human research,
86
medical care institutions shall … first obtain a written consent from the research subjects. The subjects of
human research must be adults with disposing capacity.” This provision does not apply to human research
that is apparently beneficial to the health of specific populations or patients with a special disease.
“Where a research subject referred to in the preceding paragraph is a person with limited disposing capacity,
the consents of both the subject and his/her legal representative are required; where the research subject is a
person with no disposing capacity, the consent of his/her legal representative is required.” Therefore, children
between 7 and 20 years old must give consent or assent for participating in clinical trials together with their
parents’ according to the law in Taiwan. This presentation will address the legal requirement and practice of
children’s participation in clinical trials in Taiwan. The author’s research on how strongly parents feel about
deciding for their children regarding certain genetic testing decisions is an important reference concerning
children’s decisions for research participation will also be presented and discussed.
5
Daniel Fu-Chang Tsai MD, PhD is Professor, Department & Research Institute of Medical Education and
Bioethics, National Taiwan University College of Medicine; Attending Physician, Department of Medical
Research, National Taiwan University Hospital; Director, Center for Biomedical Ethics, National Taiwan
University.
Kilsyth
S46: Symposium: Ethical Considerations of Health Databases and
Biobanks: The Open Policy-making Process of the World Medical
Association PN: 37
1
2
Co-Chairs: Jon Snaedal , Ramin Parsa
1
2
Chair of the WMA Working Group, German Medical Association and Chair of the WMA Work Group on the
latest revision of the Helsinki Declaration (2013)
Panellists: Otmar Kloiber, Urban Wiesing, Ames Dhai, Jon Snaedal [affiliations below]
Abstract
Introduction:
Data from individual patients are increasingly collected into databases, not only for research but also for
quality assurance, administrative purposes, surveillance of diseases and many other reasons. The World
Medical Association (WMA) adopted a policy on ethical considerations on Health Databases in 2002, now
being revised and broadened.
Revision process:
The WMA introduced an open consultation on a revised policy on health databases and biobanks. Almost 90
partners responded and provided many valuable comments. These comments are now being processed and
discussed by the 106 National Associations of the WMA and in meetings in Europe and Asia. The policy will
form the ethical cornerstone of physicians in the world regarding handling data and material.
Main issues:
Some of major issues:
¾ Is it possible to make totally anonymised data? Are these data subject to the same ethical principles
as identifiable data?
¾ Is it ethically acceptable to ask for broad consent for later use of data, not known at the outset?
¾ Should individuals have the right to opt out, ask for deletion or corrections?
¾ Should the same ethical principles apply to genetic information as for other health information?
¾ Which rules should apply when biological material is used by others than those collecting them?
Conclusion:
The huge interest of so many partners on how health data of individuals as well as their biological material is
handled shows the importance of ethically acceptable principles. The aim of the WMA isto provide a sound
ethical platform.
Individual papers
Informed Consent, Health Databases and Biobanks: On the Problems of Passing an International
87
Declaration
Prof. Urban Wiesing, Tübingen, Germany
The presentation explains the different ethical options of informed consent regarding health databases and
biobanks currently discussed in the scientific community. Then the procedures of passing an international
declaration will be analyzed. The difference between a moral and a political decision will be highlighted. A list
of potential issues to be mentioned in an international declaration on health data bases and biobanks
regarding informed consent will be presented. Criteria for a selection among these issues will be discussed.
Finally the current draft version of the WMA Declaration on Ethical Considerations regarding Health
Databases and Biobanks will be explained."
Special Considerations on Human Material and Data in Biobanks
Professor Ames Dhai – University of the Witwatersrand, Johannesburg, South Africa.
While biobanking practice is of substantial importance in modern biomedical research, it raises several ethical
and legal concerns including issues of consent, control, unanticipated findings, privacy, benefit sharing,
unplanned closure and differing national positions resulting in a bottleneck between classical research ethics
paradigms and the wider societal goals of biobank research. The concept of biobanking is not new. What is
new is the extensive reliance on the use of an intersection of disciplines and generating knowledge across
disciplines with networking at national and international levels at a scale not seen before. Deep moral
significance is attached to the donation of body parts, tissues and organs. Biobanks evoke the notion that
property which is shared by all humanity must bear in mind population and individual considerations.
Common risks are usually social and dignitary. Social risks include stigmatization and discrimination, are
frequently group-based and implicate both research participants and non-participants. Exploitation, biopiracy
and disregard of benefit sharing are additional concerns from the developing world. Public consultation and
involvement are very necessary to the success of biobanking. Ongoing dialogue between the public,
researchers and biobank managers is essential. Biobank closure, sale, bankruptcy, end of funding and
transfer of materials to other entities have not been explored adequately as yet. Biobanks need to develop
plans for appropriate transfer, disposition and destruction of HBMs and data in the event of unexpected
discontinuation, such as if its funding was terminated, or if it no longer served a scientific valuable purpose.
National and international laws and policy guidelines will need to be amended or enacted to ensure that rights
are protected in the world of networks and extensive computerised processing of personal and health data.
The main issues of concern in a WMA policy on Health Databases
Otmar Kloiber, Secretary General of the WMA
With the increased use of databases and biobanks in medicine and healthcare to generate knowledge,
established instruments of subject protection have increasing limitations. The most important instrument for
the protection of personal autonomy and dignity in medical treatment and research is probably informed
consent. This has been supplemented with the introduction of an ethical review to improve the protection of
research subjects.However, due to the nature of their often unforeseeable scenarios of use, databases and
biobanks are not suitable for the classic application of informed consent and ethical review, and are therefore
only partially covered by existing policies such as the Declaration of Helsinki. In addition, health databases
and biobanks have a high appeal for commercial and administrative use. This can easily be classified as
research and must therefore be subject to the same ethical principles in order to maintain protection. Thus a
new model for an effective consent and review mechanism has to be put in place in order to protect those
who have given their health data or specimens to databases and biobanks.
World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving
Human Subjects. http://www.wma.net/en/30publications/10policies/b3/index.html
Tinto
S21: Discrimination/Policy
Chair: Choudhuri, L
PN: 65
An Ethical Defence of Sugar Tax Policies
1
Carwyn Hooper
St George's, University of London , London, United Kingdom
1
88
Keywords - Justice; Tax; Responsibility; Public Health; Global Health
Discipline(s) – Political Philosophy; Bioethics
Abstract
An increasing number of countries are imposing taxes on products that are likely to cause significant harm to
human health if they are consumed in excess. Tobacco and alcohol have long been taxed, but a number of
jurisdictions around the world are currently implementing taxes on sugar. Most public health experts defend
sugar taxes on the basis of utilitarian reasoning. In this paper I will introduce the concept of a sugar tax,
explain why they are in vogue, and briefly allude to the evidence of their effectiveness. I will then explore how
different normative theories of ethics and distributive justice can be used to defend such taxes. In particular, I
will argue that luck egalitarianism provides the most normatively robust rationale for implementing sugar
taxes. Sugar taxes are a relatively new tool in public health policy. There is a large health economic literature
about their effectiveness, but very little has been published about the ethical permissibility of such taxes. This
paper seeks to fill that lacuna by drawing, in particular, on the luck egalitarian literature. There are a number
of sound normative reasons why sugar taxes ought to be implemented. Luck egalitarianism offers the most
persuasive defence of such taxes.
PN: 447
Exacerbating Inequalities? Health Policy & the Behavioural Sciences
1
2
Muireann Quigley , Kathryn MacKay
2
1
Newcastle University, United Kingdom, University of Birmingham, United Kingdom
Keywords - Behavioural science; Law & policy; Social determinants of health; Inequality & (social) justice
Discipline(s) – Ethics & law, (public) health, behavioural sciences
Abstract
There have been calls for some time for a new approach to public health both in the UK and beyond. This is
consequent on the recognition and acceptance that health problems often have a complex and multi-faceted
aetiology. A range of social and other factors influence individual health outcomes. These include early health
status, educational attainment, employment and working conditions, and income level. Separately, there have
been recent policy moves towards utilising insights from behavioural research to help people make decisions
which are better for their health. The relationship between behavioural (public) health policy and the social
(and other) determinants of health has not hitherto been explored. In this paper I begin to examine this,
aiming to make explicit connections (or lack therein) between the two literatures. In so doing the analytical
focus is on two potential problems with the use of the behavioural sciences in (public) health policy: (1)
whether recent behavioural (public) health policy is, to a certain extent, blind to the social (and other)
determinants of health, and (2) whether such policies may perpetuate and/or exacerbate health inequalities
and social injustices. I conclude that the (potential) applications of the behavioural sciences in health policy
have mainly targeted the usual public health culprits (smoking, diet, alcohol intake, etc.). I suggest that
without adequate consideration of the wider social and other contexts of health, this could have equality and
justice implications. Moreover, this may be compounded by assumptions and practices which are built into
some behavioural sciences methodologies.
PN: 251
Liberation Justice: Beyond Principles and Rights
1
Michael McCarthy
Loyola University Chicago, Chicago, United States
1
Keywords - Principles, Rights, Research Ethics, Liberation Ethics, Justice
Discipline(s) - Research ethics, philosophy, global bioethics
Abstract
Given the rapid internationalization and globalization of the practice of biomedical research, there are serious
limitations to a principle or a rights-based approach to justice within the ethics of research practices and
89
priorities. An ethics of liberation (Ellacuría and Dussel) allows for a greater focus on the experiences and
needs of those who suffer injustice and whose needs go unrepresented in research agenda. This
presentation reflects briefly on the traditional use of rights and principles in research ethics, and argues that a
liberationist concept of justice proves more beneficial when analyzing the injustices within the practice of
biomedical research. Liberation philosophy has been used by Paul Farmer to address issues of health care
access, but this presentation makes a unique argument to its pertinence in the area of biomedical research.
Liberationist justice in biomedical research begins with the experience of those whose health needs go
under-researched and who suffer injustice due to social arrangements that limit the participation of individuals
and communities. Injustices related to research stem from issues of race, ethnicity, sex, geography,
education, and/or socioeconomic status. Beginning with stories of injustice experienced by the majority
creates an epistemological shift in which the needs of the vulnerable become the lens for establishing justresearch priorities and practices. The move to a liberationist focus incorporates principles and rights that
protect individual interest of research subjects, but establishes a framework for just-research that begins from
the health needs of vulnerable and marginalized populations.
PN: 524
Ethical Issues in Denial of Marriage Based on Couple’s Genotype
1,2
1,2
Euzebus Ezugwu , Felix Chukwuneke
2
University of Nigeria, Enugu Campus, Enugu state, Nigeria, University of Nigeria Teaching Hospital, IttukuOzalla, Nigeria
1
Keywords - Ethics, informed choice, marriage denial, church, Nigeria
Discipline(s) - Global bioethics
Abstract
In Nigeria as in many African culture, marriage is officially contracted by the payment of the bride price to the
bride’s family by the bridegroom. In Iboland, once this is done, culturally the couple are pronounced as
married. However with the advent of Christianity, couples are mandatorily expected to wed in the church.
Couples who failed to wed even after the completing the traditional marriage rite are seen as committing sin
and are condemned. Currently most churches in Nigeria compulsorily conduct haemoglobin electrophoresis
to determine the couple’s genotype. When both of them are found to have AS genotpe, the church
discourages them from marrying because they are at risk of having a child with sickle cell anaemia( SCA). In
some church denomination, the couple are denied wedding. SCA cause recurrent severe bone pain and even
death of the affected child. This paper explores the ethical challenges involved in such a denial. Does the
church have the right to deny wedding two adults who have the capacity to make an informed decision and
choice? Does the couple’s right to decide freely who to marry be allowed to cause a lifelong pain for their
offspring? Should couples be denied marriage based on the probability that their child may inherit SCA from
them? Are all marriages contracted purposely for child bearing? It is hoped that exploring the moral and
ethical implication of such a denial will help to raise the ethical consciousness and awareness of our people
and our society.
Moorfoot
S69: Symposium: New Perspectives on Ectogenesis PN: 355
4
2
2
3
Tuija Takala , Iain Brassington , Laura O'Donovan , Frida Simonstein
2
3
University of East Anglia, United Kingdom, Manchester University, United Kingdom, Yezreel Valley College,
4
Israel, Aalto University, Finland
1
Discipline(s): Bioethics
Keywords: Ectogenesis, justice, parenthood, reproduction
Symposium Description:
Shulamith Firestone argued that women cannot overcome the injustices of ‘sex class’ without ectogenesis
(gestation outside the womb). This symposium re-evaluates Firestone’s argument four decades after its first
publication. Firstly, we address the failure of society in general to respond adequately to Firestone’s
arguments, despite the fact that there are several avenues to ectogenesis that are currently feasible. We
consider where the moral obligations usually associated with gestation would fall in a world where
90
ectogenesis is practised, and examine the specifically legal questions that are likely to arise from the
development of ectogenesis. Finally, we address the fact that a number of arguments currently being made in
favour of genetic enhancement incorporate a silent assumption that all or most pregnancies will be
technologically assisted. Our approach is original in several ways. We consider that in the current sociopolitical and medical environment, the burdens experienced by pregnant women are significantly greater than
at the time when Firestone was writing in the 1970s. Secondly, we regard ectogenesis as being not just
possible but probable, given the trajectory of innovations in neonatal care and increasing ability to sustain
embryos in vitro.
Ectogenesis as a requirement of gender justice
Tuija Takala
Within Gender studies and in many other academic disciplines, the simplistic dichotomy between men and
women has been long refuted. In the real world, however, gender roles are still extraordinarily powerful. Even
in the more enlightened circles, women’s destiny is pre-shaped by the expectation that they will become
mothers. Women cannot blame only men for the hardships they face; they (I refuse to write “we”) are
confining themselves to specified roles. I will argue that the continuing lack of equality between the sexes
arises from the assumption that women (and only women) can bear and rear children. My claim is that
women, collectively and individually, should welcome the possibility of gestating the embryo and foetus
outside the womb. In this paper I will show how having the option of ectogenesis is in the interests of all
females and that if and when ectogenesis becomes a safe option it will finally make true equality between
humans possible.
Mother, gestator, technician
Iain Brassington
Of the arguments defending abortion rights, the one that focusses on women’s bodily integrity is one of the
most powerful: even if the foetus has some moral value, we can argue that it is insufficient to trump its
mother’s right to end her pregnancy should she choose. Similarly, it is the mother who puts in the
overwhelming majority of the procreative labour, which she presumably has some kind of right to withdraw.
Conversely, should she choose to remain pregnant, it is she who will have to discharge any putative
responsibilities to the foetus. Qua gestator, the woman is hugely important. The possibility of ectogenesis
overturns this. A gestation tank has no self-determination; it is a technician who puts in the labour and
discharges the duties. I hope here to begin to unpick some moral aspects of the technician’s quasi-maternal
role.
Ectogenesis: the legal challenges
Laura O’Donovan
The prospect of ectogenesis brings with it a host of legal implications that force us to re-evaluate the
prospective roles of mother, father and the state, and their respective interests in the foetus. English law
currently holds that motherhood is determined by gestation; but the possibility that a foetus may be gestated
external to the human body renders uncertain the identity of the legal mother. Even if separation between the
role of the artificial womb, the commissioning parent(s) and that of the technician is possible, ectogenesis
raises further legal questions concerning the status of the embryo and the legality of abortion. In order to
accommodate this technology, the laws regulating ARTS, the provision of parenthood and abortion will
require comprehensive reform. It would seem that ectogenesis does not solve questions concerning
reproductive rights: instead it serves to further complicate them.
Genetic enhancement and the artificial womb
Frida Simonstein
Editing the germ-line to improve future people's health may concord with public health goals, improve the
health of individuals and communities, and thus it may be considered a public good. However, enhancing
future generations will require IVF, raising the question of whether all women would have to conceive with
IVF. Remarkably, the necessary involvement of women in an enhancing scenario has been overlooked.
However, the present discourse about moral obligations to future generations seem to imply that women
could be required, morally, if not legally, to reproduce with IVF. Enhancing future generations will be
gendered; unless ectogenesis is developed. This requires a wider perspective - of both women and men - on
the issues involved. Certainly there is an urgent need for open discussion about the merits and risks of
human genome modification; but this debate must include the necessary role of women in this scenario.
91
Carrick 1&2
S6: Research in Resource-limited Contexts
Chair: Sina, B
PN: 540
Conducting Scientific Research in Low-resourced Laboratories: Ethical
Considerations in Research
1
Louise Bezuidenhout
University of Exeter, St Germans Road, Exeter, United Kingdom
1
Keywords - Life sciences, laboratory practices, low/middle-income countries, low-resourced research
environments
Discipline(s) - Empirical ethics
Abstract
Stimulating scientific research in low/middle-income countries (LMICs) is vital for addressing current global
inequalities. There has been a considerable increase in research funding in these countries, however the
historical legacy of academic research in these regions together with persistent infrastructural and
governance issues continue to challenge efforts to build capacity. Recognizing the penetrance and impact of
such issues is vital for future capacity building initiatives. Moreover, it is important that these issues of
persistent resource deprivation be considered from many perspectives. This talk considers these issues in
relation to the physical environment of laboratories. Despite the increasing amount of project-specific
funding, many LMIC laboratories continue to be resource scarce. Current funding structures often preclude
infrastructure upgrades, the purchase of non-specialized equipment, and the ability to harness technical and
maintenance expertise. This creates a host of challenges for scientists working in these environments –
including how they work in the laboratories, what work can be conducted, and how research is disseminated.
In 2016 a survey was issued to scientists in southern and eastern Africa to determine exactly what such
issues were seen as significant barriers to effective research. This presentation discusses the findings of the
survey and draws attention to the considerable ethical issues that arise from these data. In particular, the
presentation questions the fitness of current approaches to research inequality amelioration and questions
the philosophical positions driving current initiatives. The presentation concludes with some suggestions on
increasing the efficiency of research capacity building initiatives in LMICs.
PN: 566
Research Ethics Development in a Limited Resource Setting: A Case
Study for Uganda Research
1
1
1
Joseph Ochieng , Erisa Mwaka , Betty Kwagala , Nelson Sewankambo
Makerere University, Kampala, Uganda
1
1
Abstract
The globalization of clinical research in the last two decades has led to a significant increase in the volume of
clinical trials in developing countries. Uganda is the third largest destination for clinical trials in Africa. For
research to proceed ethically, there is need for adequate capacity to facilitate its efficient regulation.
Historically, regulation of research in Uganda started in 1970 by the National Research Council (NRC). In
1990 the NRC was transformed into the Uganda National Council for Science and Technology with a broader
mandate to coordinate all national research and development programs. However, for regulation of research
to meet global standards, there was need for capacity development in the field of research ethics including
human resources, infrastructure and finances. We are reporting trends in research ethics development in the
Ugandan setting. A number of achievements have been made including; formulation of a law that gave rise to
the National council for science and technology; formulation of National guidelines in 1997 and their
revisions; implementation of training programs in research ethics and bioethics; conducting annual research
ethics conferences; Establishment of Research Ethics Committees and their accreditation; research site
monitoring for compliance with regulations; and creation of a forum for chair persons of research ethics
92
committees. Conclusion: there are supportive laws and a number of programs have been initiated that
promote discussion, dialogue and ethical conduct of research.
PN: 377
Complex Ethical Challenges Arising When Recruiting Participants into
Research in Low and Middle Income Settings
1
Susan Bull
1
University of Oxford, Nuffield Department of Population Health, University of Oxford, United Kingdom
Keywords - Consent, research, research ethics, recruitment
Discipline(s) - Research ethics, bioethics
Abstract
Health research aimed at addressing the needs of populations in low and middle income settings remains a
high priority. The normative importance and practical achievement of valid informed consent to research
participation, particularly in low income settings, has been one of the most discussed topics in bioethics. It is
widely accepted that, exceptions notwithstanding, the obtaining of valid consent to research participation is a
benchmark of ethical practice and there is much national, regional, and international guidance on how this is
to be achieved. Despite this, valid consent to research participation in low income settings has resisted being
transformed into a primarily practical challenge: it continues to be highly productive of complex, irreducibly
normative difficulty. Social science literature continues to demonstrate that interesting and complex
unresolved issues arise in practice when engaging with and recruiting research participants. This
presentation reports on the results of a novel systematic literature review with a broader focus than existing
published reviews. This review was designed to identify the range and conceptualisation of ethical issues
associated with consent processes for research in empirical, theoretical and policy literatures. In addition to
mapping identified issues, it examines published research on why specific complex ethical issues are morally
challenging to resolve, and reviews accounts of practice, recommendations, and debates about best
practices. The presentation concludes by outlining the implications of the review findings for policy
development, capacity building activities and setting empirical ethics research priorities.
PN: 474
Ethical Guidance Challenges in Research Involving Pre-collected, Active
Public Health Data in Resource-limited Countries
1,2
1
3
2
1
Evelyn Anane-Sarpong , Tenzin Wangmo , Osman Sankoh , Marcel Tanner , Bernice S. Elger
2
Institute for Biomedical Ethics, University of Basel, Basel, Switzerland, Swiss Tropical and Public Health
3
Institute, University of Basel, Basel, Switzerland, International Network for the Demographic Evaluation of
Populations and their Health, Accra, Ghana
1
Keywords - Ethical guidance, Public health research, Public health ethics, Surveillance data, Resourcelimited countries
Discipline(s) – Public health ethics (Theme: Public heath, ethics and law)
Abstract
Existing ethics guidelines, influential bioethics literature and policies on ethical research generally focus on
real-time data collection from humans. They enforce individual rights and liberties thereby lowering need for
aggregate protections. While dependable, emerging public health research paradigms like research using
pre-collected surveillance data (RUPD) raise application challenges. Unlike traditional research, RUPD is
population-based, aligned to public health activities, reliant on pre-collected, traceable and potentially
personalisable data, and requires no further participant contact to proceed. These characteristics alter the
dynamics of research ethics applications and protections significantly enough to hypothesize that in resource
limited countries where ethical frameworks and regulatory oversight may be at developmental stages, RUPD
may operate in some form of an ethical vacuum. We set out to explore and analyze RUPD challenges in
relation to ethical guidance and applicable policies on best practices. We then analysed field experiences of
bioethical-contact in resource-limited countries, and expectations of what the bioethics community could
contribute to RUPD to build a theoretical case for appropriating identified justificatory principles for RUPD
93
ethics. We reflected and comment on four important principles that are challenging to apply in RUPD: respect
for participants, social value, risk minimization, and independent review. We argue for a framework founded
on these principles as a minimum base for RUPD ethics and proffer ways of practicalizing them within the
core surveillance activities. We conclude that compliance with this framework, rather than waiving
challenging principles deemed impractical to optimize science, will help optimize RUPD ethics and bioethics
for resource-limited countries.
Harris 1 & 2
S71: ECR Session : Publishing
1
2
3
Panellists: Heather Widdows, Dominic Wilkinson, Graeme Laurie
2
3
1
University of Birmingham, United Kingdom, University of Oxford, United Kingdom, University of Edinburgh,
United Kingdom
Writing is the bread and butter of academic life, and yet this can often be a particularly challenging aspect of
‘what we do’. This session is designed to offer some helpful, practical advice on various aspects of the writing
process and publication. Panel members will discuss the following topics in particular: approaches to writing
journal articles; constructively dealing with rejection; transforming doctrinal work into monographs; and
handling perspectives from journal editors on having work reviewed, as well as acting as a constructive peer
reviewer. A particularly helpful topic will explore the challenge of planning publications, and knowing when to
say ‘no’: something which does not come easily to many of us!
Ochil 1&2
S17: (Neuro) Interventions
Chair, Illes, J
PN: 614
Neurointerventions to Prevent Crime and the Problem of Unjustified
Incarceration Practices
1
1
Katrien Devolder , Thomas Douglas
1
University of Oxford, Suite 8, Littlegate House, St Ebbes Street, Oxford, United Kingdom
Keywords - Neuroethics, chemical castration, autonomy, coercion, complicity
Discipline(s) – Medical ethics, Neuroethics
Abstract
Neurointerventions are increasingly used to prevent criminal recidivism. One example is the chemical
castration (CC) of sex offenders. There is an increased interest in offering CC to sex offenders as an
alternative to continued incarceration, though many object to this on the ground that the offender’s consent to
undergo it would be coerced and therefore invalid. We have argued elsewhere that, even if valid consent
cannot be obtained, it is permissible to offer CC as an alternative to continued incarceration if this will
expectably increase the offender’s autonomy, and if the incarceration is justified. Call this ‘the argument from
autonomy.’ However, intuitively, the argument from autonomy is problematic if the incarceration, or its
imposition, is unjustified. We consider whether it is possible to vindicate this intuition, and investigate the
implications for the ethics of offering CC to sex. We investigate three potential explanations for why the
unjustified initial restriction in the offender’s autonomy may pose a problem for the argument from autonomy:
(i) it counsels replacing compulsion with coercion, (ii) it commits the proponent of the argument to a
hypocritical position, and (iii) it ignores the fact that those who make the offer thereby become complicit in
maintaining unjustified incarceration practices. We conclude that (i) only the appeal to complicity may
succeed in establishing that offering the choice between CC and unjustified incarceration is dispreferable to
simply imposing unjustified incarceration, and (ii) even this argument will fail in many cases, especially when
the offerer is an individual psychiatrist.
94
PN: 239
Three Varieties of Mental Interference: A Guide for Assessing
Neurointerventions and Nudges
1
Dr Thomas Douglas
1
University of Oxford, Brasenose College, United Kingdom
Abstract
There has been considerable recent debate on the ethics of using nudge techniques to achieve public health
objectives. In parallel, there is a developing discussion of the ethics of neurocorrectives—direct brain
interventions used to promote rehabilitation in criminal offenders and thereby protect the public from crime.
I argue that there is a common theme to these discussions: both assess interventions that are morally
troubling chiefly because of the way in which they interfere with human minds. Bublitz and Merkel have
recently argued that such mental (as opposed to bodily) interference has been unduly neglected in legal and
moral philosophy. I agree. This paper begins to correct this neglect by offering a taxonomy for assessing the
moral status of mental interferences, thereby advancing practical debates regarding both neurocorrectives
and public health nudges. The taxonomy I offer distinguishes (1) rational interference, which influences a
person's mind by engaging rational processes such as conscious deliberation, from (2) arational interference,
which bypasses rational processes. It then further distinguishes (2a) forms of arational influence which alter
mental states that would otherwise have been rationally produced from (2b) forms which alter states that
would in any case have been arationally produced. I argue that interferences of type (1) are typically (though
not always) morally unproblematic and that interferences of type (2a) are typically more morally problematic
than interferences of type (2b). I then draw out some preliminary lessons from the foregoing analysis for
debates on public health nudges and neurocorrectives.
PN: 684
Anti-libidinal Interventions, Human Rights, and the Medicalisation of
Deviance
1
Lisa Forsberg
1
Keywords - Anti-libidinal interventions; Human rights; Consent; Inhuman and degrading treatment;
Medicalisation
Discipline(s) – Ethics and Law
Abstract
Research problem and findings
In some jurisdictions, antilibidinal interventions (ALIs), sometimes termed ‘chemical castration’, are used to
reduce testosterone levels in male sex offenders. Some commentators have suggested that the use of ALIs
might infringe the rights enshrined in the European Convention of Human Rights (ECHR).
This paper examines whether ALI use in sex offenders infringes Articles 3 and 8 of the ECHR, which protect
individuals from state infliction of inhuman or degrading treatment and state interference with private and
family life interests respectively. I argue that while ALIs may interfere with protected Convention interests,
they are unlikely to violate an individual’s human rights insofar as their use can be construed as medically
necessary (i.e., medicalised), and that, indeed, whether ALIs can be medicalised matters more than whether
they are administered with or without consent. I argue in addition that, morally speaking, we might have
reason to worry about the delegation of decision-making to the medical profession that medicalisation of
interventions such as ALIs entails, and the power that the medical profession has to expand the scope of
medicalised behaviour. That ALIs do not violate human rights, therefore, should not be the end of the story.
This issue is important since ALIs are used in many jurisdictions at present, with other jurisdictions
considering their use. In addition, the argument also has implications for the use of other crime-preventing
interventions, and the medicalisation of deviant behaviour more generally. Conclusion:.the important issue
here is not whether ALI use violates human rights, but whether they are medicalised, and the role therein for
physicians’ judgements about which behaviours are appropriately fall within the domain of medicine.
95
PN: 288
Problems of Control: Testing the Impact of Alcohol Dependence on
Capacities for Personal and Criminal Responsibility
1
Jillian Craigie
1
King's College London, United Kingdom
Keywords - Legal capacity, rationality, responsibility, mental health, alcohol dependence
Discipline(s) – Mental health ethics/law
Abstract
Problems of self-control pose difficult questions both in law concerning personal decisions and law
concerning criminal acts. In both contexts, psychopathologies associated with impaired self-control raise
questions about the appropriateness of assigning legal capacity: Should the person retain the right to refuse
treatment? Should they be held fully responsible for a criminal act? One central issue that has arisen in both
contexts concerns whether problems of volition are adequately accounted for in so-called ‘rationality’ tests.
In this talk I will focus on the current approach in England and Wales to questions of impaired control in
alcohol dependence, considered in relation to law concerning anorexia nervosa. The analysis reveals a
recent alignment of the approach to understanding problems of control in alcoholism in the test for diminished
responsibility, with the approach to understanding the problems of control in anorexia found in legal
judgments concerning refusal of treatment. This will be used to reflect on the fairness of the current approach
to these questions of legal capacity; as well as the broader question about the adequacy of rationality tests.
Ochil 3
S31: Vulnerability, Treatment and Relationships
Chair: Taylor-Alexander, S
PN: 187
All Life's a Maze: Bioethical Issues in Daniel Keyes' Flowers for
Algernon
1
Michael Campbell
1
Chinese University of Hong Kong, Hong Kong.
Keywords - Research Ethics; Literature; Bioethics
Discipline(s) - Philosophy, Literary Criticism
Abstract
In this paper I discuss Daniel Keyes' work Flowers for Algernon, paying particular attention to the bioethical
issues raised by the novel in its depiction of the lives of its twin protagonists, Charlie and Algernon, and their
treatment at the hands of the medical establishment. Flowers for Algernon depicts a developmentally
challenged individual, Charlie, who is given an experimental therapy which dramatically improves his
intelligence but with unforeseen side-effects. A central narrative arc is Charlie's changing relationships with
the clinicians who administer the treatment; he gains, and then gradually loses, a sense of fellowship with
them, finally concluding that he has more in common with the hyper-intelligent mouse subject, Algernon, than
with the researchers. Keyes' work can be read as an extended criticism of the supposition that human life can
be understood through the methods of the 'life sciences'. Alternatively, from a Marxist perspective, Charlie's
progress can be seen as an instance of the dawning of class-consciousness, and hence as a critique of the
bourgeois aspects of the medical sciences. I elaborate and reconcile these two readings, showing how the
deficiencies in the researchers' understanding of Charlie stem from a source which is at once political and
conceptual. I suggest that the urge to treat Charlie and Algernon as objects fit for systematic study represents
a value-laden privileging of one kind of understanding over others. As such, the work as a whole dramatises
and applies the Platonic belief in the fundamental interdependence of moral, political and epistemological
issues. As well as helping to illuminate issues of perennial concern in research ethics, the paper will address,
96
inter alia, broader methodological issues to do with the relationship between literature and philosophical
ethics.
PN: 75
Empirical-ethical Reflection on Collective Representation of Autism and
Dementia Patients and their Representatives
1
1
Karin Jongsma , Silke Schicktanz
1
University Medical Centre Göttingen, Göttingen, Germany
Keywords - Patient organisations, representation, decision-making, ethics, health policy
Discipline(s) – medical ethics, health policy
Abstract
Patient organisations (POs) have increasingly been included in national health care decision-making over the
last decades. The idea that patients should have a say in health policy is political-ethically legitimated as they
are the ones directly affected by the decisions. Certain patients, who have conditions that impair their
capacities to conduct self-representation, are represented by two different types of POs: organizations FOR
patients (mainly established by patient’s relatives-caregivers or professionals) and organizations OF patients
(composed of those patients themselves). A practical example can be found in POs in the field of dementia
and autism. The views of these two different forms of representation sometimes conflict with each other, for
example in terms of the desirability to find a cure and the types of care necessary for the disease. This raises
the question whose interests should be represented by POs and how conflicting views should be dealt with in
health policy. In an empirical-ethical approach, we will develop a theoretical framework for reflecting on the
ethics of representation and collective autonomy by conducting interviews with patient representatives of
Dementia and Autism POs. The debate concerning the involvement of POs in health care policy has
focussed mostly on procedures for patient involvement and on evidence of democratizing health care
decisions, but only little attention been paid to legitimacy questions who these POs should and actually do
represent. Conclusion: Our analysis of representation in POs indicates a variety of forms of representation
and decision-making. This variety will be critically reflected upon, regarding the underlying concepts of
representation as well as on the underlying assumptions of what it means to be affected.
PN: 21
The Indispensability of Labels to a Theory of Bioethical Vulnerability
1
Adrian Kwek
1
SIM University, Singapore, Singapore
Keywords - Vulnerability, labels, reflective equilibrium, principles
Abstract
Recent literature on vulnerability in bioethics converges on one point: Reducing vulnerability to a list of labels
is ill-advised because vulnerability is sensitive to context but categorising via labels is not. In my presentation,
I argue that labels are indispensable to a theory of vulnerability precisely because of the context-sensitivity of
vulnerability in bioethics. My argument begins with a critical evaluation of two influential accounts of
vulnerability – F. Luna’s and S. Hurst’s – together with A. Wrigley’s attempt to eliminate the concept of
vulnerability from bioethics. This critical evaluation yields two desiderata for vulnerability in bioethics: a) It has
to provide guidance for judgments in novel cases; b) It has to provide guidance for changes in core principles.
I then introduce two senses of the term ‘label’ that has surfaced in the literature. The first sense takes labels
as naming categories that are identified by principles. The second sense takes labels as naming categories
that inform our judgments about particular cases. I call these two senses ‘principled label’ and ‘heuristic label’
respectively. I argue that heuristic labels have been neglected as an important guide to judgments about
principles. Finally, I invoke the familiar idea of reflective equilibrium. I use it to show how judgments of
vulnerability can be context-sensitive with respect to both particular principles and cases, and how a) and b)
can be satisfied. I argue that principles and heuristic labels are the more stable positions in our bioethical
reasoning, without which the process of reflective equilibrium cannot get started.
97
PN: 602
The Ethics of Incentivized Breast Cancer Screening and the Duty to
Think
1
Harald Schmidt
Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States
1
Keywords - breast screening; screening; personal responsibility for health; behavioural economics;
population health
Abstract
Breast screening raises some of the most thorny ethical issues in person-centric and community-centric
health initiatives and public health law and policy. At the population level, breast screening clearly saves
lives. The more women get screened, the more lives are saved. Problem: While some women will experience
direct benefit at the individual level, a far larger number of women also experiences harms. For example, the
US Preventive Service Task Force’s recently updated guidelines estimate that screening 1,000 women age
50+ biennially for 20 years will avert 7 breast cancer deaths. But there will also be 953 false positive findings
with associated worry and anxiety, and 146 unnecessary biopsies. In addition, there will be 19 overdiagnosed tumors, meaning that women will go on to have needless partial or full breast removal, and
chemo- or radiation therapy. In view of these data, what is the right policy response?
Methods, findings:
Combining a systematic review and conceptual analysis, I describe and critically discuss international policy
approaches ranging from leaving the screening decision to the individual doctor-patient consultation, to
national invitation systems with/without default appointments, to commonly used financial or other rewarding
incentives for getting mammograms, to penalties for not getting screened.
Conclusion:
It is argued that the ethically most defensible policy is to offer financial rewards for using evidence-based
decision aids on mammograms. While clearly not uncontroversial, arguments based in the ethics of personal
responsibility for health, behavioral economics, clinical medicine and public health are identified that can
provide robust support.
98
FRIDAY 17TH JUNE 2016 11:00-12:30
Pentland Auditorium
S83: Symposium: Closing the Ethics Gap: WHO Guidance on Public
Health Surveillance PN: 794
Chair: Ronald Bayer, PhD, Center for the History and Ethics of Public Health, Mailman School of Public
Health, Columbia University, USA
1
2
3
4
Calvin Wai Loon Ho , Andreas Reis , Amy Fairchild , Angus Dawson
1
2
3
4
World Health Organization, Geneva, Switzerland, Columbia University, United States, University of
Sydney, Australia
Discipline(s) Ethics, Public Health, Law
Keywords Public Health Surveillance; Public Good; Data Collection; Public Health Reporting; Data-Sharing
Abstract
Surveillance is one of the most fundamental activities of public health, involving diverse practices in areas
such as non-communicable disease registers, outbreak investigations, infectious disease, health systems
research, and digital surveillance. Public health surveillance (PHS) raises multiple ethical issues, and in 2014,
the World Health Organization (WHO) launched a project to develop ethics guidelines for PHS. These
guidelines are intended to establish a general ethical framework that is intended to be applied by
governments, public health agencies and practitioners when designing public health surveillance policies and
practices. In explicating the key components of these guidelines, this symposium will:
(1)
(2)
(3)
(4)
(5)
Provide an overview of the modalities of PHS and the ethical issues that could arise, including
those that have been identified in the literature;
Identify ethics gaps in existing regulatory frameworks, including the International Health
Regulation;
Explicate the key ethical values, these being (i) prioritising public health as public good, (ii) equity
and justice, (iii) respect for persons, and (iv) accountability and good governance;
Broadly explain the application of these guidelines in PHS, with focus on ethical challenges that
arise at the point of data collection; use and storage; and dissemination; and
Seek the views of the IAB community before the guidelines are officially formalised.
These guidelines represent an important stride forward in articulating a set of animating values and
procedural principles that, while beginning from the premise that public health has an affirmative duty to
conduct surveillance, recognise that it must be subjected to ethical limits.
Guidance Development in Public Health Surveillance: WHO Perspective
Dr Andreas Reis, MD MSc
The WHO Guidelines on Ethics and Public Health Surveillance close a crucial gap, as so far there are only
national guidance documents and international guidelines on specific diseases. While research with human
subjects is well regulated globally, the same is not true for surveillance activities, although they can entail
similar risks to participants. At the same time, in order to achieve the Sustainable Development Goals,
countries have an obligation to establish and strengthen public health surveillance and reporting systems.
The challenge will be to implement these guidelines in countries, and in particular to promote mechanisms of
ethical oversight for surveillance activities.
Amy Fairchild: The New Norm: Public Health Ethics and the Mandate for Surveillance
Professor Amy Fairchild, PhD, MPH
This presentation places work of the surveillance group into historical context. It considers the ways in which
research ethics guidelines have recognized but failed to address the particular challenge of public health
99
surveillance. The AIDS epidemic provided a focal point in which bioethics, human rights, and an emergent
ethics of public health offered different—sometimes complementary, sometimes conflicting—perspectives on
the limits of and duties to conduct surveillance. While, in practice, ethical pluralism will necessarily
characterize the discussions that must take place in diverse social and political contexts, public health ethics,
with the priority it places on the health of on populations, provides a strong affirmative duty to undertake
surveillance. The analysis concludes that while the ethical oversight that has been developed for research is
not appropriate for public health, nations bear responsibility for ensuring that ongoing, systematic ethical
scrutiny of surveillance systems is the norm moving forward.
Angus Dawson: Statements, Text and Values in the Public Health Surveillance Guidelines
Professor Angus Dawson, PhD
This presentation discusses the different issues that needed to be considered and balanced in the
construction of the guidelines. The reasons for adopting the structure of a set of short, clear and focused
statements (with separate explanatory and justificatory text) will be outlined and discussed. Possible
alternative structures were considered but rejected. The key ethical values as used in the text will be
presented and a couple of examples will be used to illustrate how they are relevant to justifying the different
guidelines.
Calvin WL Ho: Patching the Justice Gap in Public Health Surveillance
Dr Calvin WL Ho, JSD LLM MSc
With focus on the principle of justice, this presentation highlights an important aspect of the WHO guidelines
as not being limited in focus to health outcomes, but are more broadly concerned with enabling a health
system to advance the general wellbeing of its population by improving health, especially for the worst off.
Specifically, these guidelines provide a framework to help key stakeholders (and policy makers in particular)
determine which inequalities are the most morally important to render visible for public health attention and
action. In applying the framework, this presentation illustrates how health inequalities can help inform
judgements about justice and public health, especially in explicating systematic patterns of profound
disadvantage for some groups to achieve sufficiency of well-being. The presentation also illustrates how
moral priorities may change as patterns of social and systematic arrangements vary in different settings, as
well as over time.
Sidlaw
S 41: Symposium: Ethics in Evidence Generation and Research During
Humanitarian Responses to Public Health Crises PN: 628
John Pringle1, Matthew Hunt1, Donal O'Mathuna2, Lisa Eckenwiler3
1
2
3
McGill University, Montreal, Canada, Dublin City University, Dublin, Ireland, George Mason University,
Fairfax, United States
Disciplines: Bioethics, public health ethics, humanitarian ethics, disaster research ethics
Format/Methodology: Interactive symposium
Abstract
This symposium examines key ethical issues pertaining to knowledge acquisition during humanitarian
responses to public health crises. Ethical challenges surrounding knowledge acquisition in public health
crises are profound, contestable, and largely unresolved. Given evolving global health threats such as climate
change, economic disparity, war, epidemics, and mass migration, public health crises will continue to be a
defining feature of the coming decades. The issues are complex and intersectional, and warrant careful and
sustained scrutiny which this symposium aims to foster.Evidence generation and research during
humanitarian responses to public health crises are crucial and yet their integration compounds ethical
challenges. The four papers tackle substantive and normative challenges, collectively illustrating the role for
bioethics in public health crises.
Individual Abstract papers
Matthew Hunt:
Research conducted during disasters is crucial for improving future relief interventions. Such research,
however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster
100
research also poses challenges for research ethics committees, in part due to the rapid turnaround needed to
initiate research after an acute disaster event. Drawing on interviews with research ethics committee
members, I will examine key features that need to be accounted for in the review of disaster research. I will
also discuss adaptations of standard REC procedures that aim to balance the need for timely review of
urgent protocols while ensuring that ethics review of disaster research is diligent and thorough.
Dónal O'Mathuna:
Research during humanitarian crises raises complex ethical challenges. Involving children in research is
challenging at the best of times and more so during humanitarian crises. However, children are increasingly
recognised as being resilient and having voices that should be heard despite their heightened vulnerabilities.
Evidence is needed to ensure that children’s needs and perspectives are understood properly and responded
to effectively. This presentation will argue that involving children in evidence generation and research projects
can be justified ethically, and generates responsibilities to address the ethical challenges of such activities,
including: consideration of power relationships that impact children, especially across different cultures and in
conflict settings; addressing difficulties with informed consent, especially around controversial topics;
separating humanitarian aid from research participation, and; examining whether children should serve as
translators in research. The complexities of each will be noted briefly, and those involving power relationships
examined in more detail.
Lisa Eckenwiler:
This presentation will examine the epistemic challenges to demonstrating responsiveness, an ethical principle
and practice we have called for to help govern disaster research. Concerns for investigators are noted briefly
but here the emphasis is on institutional and structural features of research and its ethical oversight that can
undermine appreciation for morally relevant features of research in such settings that can serve to create or
perpetuate or deepen vulnerabilities. Innovations like pre-approved protocols, for example, trade off rapid
deployment of research for knowledge of the specific details of scenarios. Too, the asymmetry between
researchers and their ethics committees and disaster-affected populations in many cases, and the pervasive
absence of meaningful local review, can threaten understanding of what is at stake ethically and in turn,
responsiveness. Specific reforms are suggested.
John Pringle:
Public health crises are dynamic and unpredictable. Appropriate humanitarian responses require rapid needs
assessments to inform planning and operations. Rapid needs assessments involve the collection of health
data through qualitative and quantitative survey methods. Surveys are used to measure morbidity, mortality,
and vaccination coverage, but also more complex indicators like traumatization and deprivation. Such
surveys are considered routine and are typically exempt from research ethics review on the grounds that they
are not research but part of routine operations. To clarify the distinction, exemption criteria have been
proposed. However, despite established exemption criteria, the line between research and non-research
remains often blurred. Drawing from a disaster research ethics scoping review, this presentation provides
examples of where this blurring occurs and discusses ethically salient distinctions between routine data
collection and research. The presentation reframes the issue by putting onus on ethically sound data
collection.
Fintry
S 42: Symposium: Ethical Challenges in the Quest to Cure HIV PN: 746
1,2
2,3,4
5
2,3
Stuart Rennie , Adam Gilbertson , Prof. Keymanthri Moodley , Dr. Allison Mathews
2
1
Center for Bioethics, University of North Carolina-Chapel Hill , Chapel Hill, United States, Department of
3
Social Medicine, University of North Carolina, Chapel Hill, United States, Institute for Global Health and
4
Infectious Diseases, University of North Carolina, Chapel Hill, United States, School of Anthropology and
5
Museum Ethnography, University of Oxford, Oxford, United Kingdom, Center for Medical Ethics and Law,
University of Stellenbosch, Cape Town, South Africa
Discipline(s) Philosophy, anthropology
Keywords HIV cure, community engagement, informed consent, standard of care, risks and benefits
Format/Methodology Chaired series of presentations followed by discussion with audience
101
Abstract
Biomedical research has become increasingly focused on finding ways to control HIV that are superior to
results currently achieved with antiretroviral treatment. The ultimate goal of this research is characterized as
the search for a HIV ‘cure’ or HIV ‘remission’. Research approaches currently being explored include
experimental use of stem cell transplants, gene editing, immune-based therapeutics, and novel anti-latency
agents. This symposium offers results and works-in-progress from a global collaborative project on the ethical
and social implications of innovative HIV cure research. Chaired by Professor Jing-Bao Nie (University of
Otago, New Zealand), our session will present conceptual and data-driven work on interrelated ethical
challenges in HIV cure research. After a brief introduction on HIV cure research, four presentations will be
followed by an audience question-and-answer session. Our aim is to present key ethical challenges in this
emerging and important biomedical research domain, and explore directions for future social science
research and ethical analysis. The overarching theme tying together the four presentations is: how to conduct
ethically responsible research towards a highly desired goal (‘HIV cure’) in a context where effective
treatment already exists, and amid rapid scientific change, hope, rumour, uncertainty, and relative lack of
public awareness?
The ethics of interrupting HIV treatment to study HIV cure interventions
Some HIV cure research protocols have an ethically controversial design, namely analytic treatment
interruption (ATI): HIV-positive patients stop anti-retroviral therapy for researchers to test the effects of a
study intervention(s) over time. Given that antiretroviral therapy is current standard of care for HIV-positive
patients, and some data exists on the negative health effects of interrupted HIV treatment, how can ATI be
ethically justified? In this presentation, we analyse four areas of ethical concern: the scientific value of ATIs;
equipoise and standard of care; the risk/benefit relationship; and informed consent. Some strategies aiming
to meet these concerns will be presented, critically evaluated, and areas of future ethics research related to
these concerns will be identified. Current HIV cure research, particularly studies that involve ATIs, are being
conducted in a context of rapid scientific change, hope, uncertainty, and relative lack of public awareness.
Greater community engagement and media attention to this relatively new field may mitigate, or exacerbate,
ethical concerns surrounding these trials.
Unanticipated benefits of HIV cure research: participant perspectives and the responsible conduct of
research
Interventions in early-phase cure trials involve substantial and often unknown risks, but no direct health
benefits for participants. Researchers emphasize this lack of benefits in order to discourage therapeutic
misconception. We explored whether and what social or psychological ‘side’ benefits exist for participants –
benefits rarely discussed during informed consent procedures – and their significance for the responsible
conduct of research. In-depth, semi-structured interviews were conducted with 15 HIV cure-related research
participants in Chapel Hill, USA. Interviews were transcribed, coded, and analysed to identify themes related
to participants’ experiences and perceptions of benefits. The majority of HIV cure participants experienced
psychological/emotional benefits, and/or those related to increased HIV knowledge, positive behavioural
changes, and access to improved standard of care. Conclusion: subjective, contingent, ‘side’ benefits are
often more significant for participants than material incentives. This should be taken into account by research
ethics committees when assessing HIV cure-related research.
Informed consent for HIV cure trials in South Africa: anticipated challenges
Consent processes for clinical research in resource-depleted settings have raised controversy for decades. In
recent times, concerns have escalated with increasing complexity of scientific research. Consent for HIV
prevention and treatment research was facilitated via widespread awareness campaigns in South Africa.
However, the science of HIV cure strategies is extremely complex and awareness levels regarding cure are
much lower. Use of terminology has the potential to generate confusion, curative misconception and
subsequently false expectations, so discussing remission at this early stage may be more prudent. The
possibility of treatment interruption during cure trials is perceived as a major barrier to participation and this
could lead to recruitment challenges. Given these constraints, it is important that consent processes are
preceded by widespread community engagement and that additional tools such as educational videos are
included as part of the consent process.
Doing the good thing right: challenges in implementing community engagement in biomedical HIV
cure research
102
Responsible HIV cure research will require significant community engagement, but power imbalances
between stakeholders affect its implementation. We consider the ethics of implementing community
engagement activities for biomedical HIV cure research. We use good participatory guidelines (GPP) and
community-based participatory research principles to examine the ethical strengths and weaknesses of
community advisory boards (CABs) and research literacy curricula (RLC). A logic model was developed to
situate community engagement within biomedical HIV research. CABs allow community members to shape
the design and implementation of research protocols, but power imbalances persist due to researcher control
over CAB funding, decision-making, and possession of greater scientific knowledge. RLC about HIV
biomedical research are often inaccessible. Our logic model incorporates ethical considerations, community
engagement activities, and desired outcomes. Conclusion: researchers should integrate alternative
community engagement activities to counteract the weaknesses of standard approaches. We provide
alternative examples to increase the capacity of HIV community engagement efforts.
Kilsyth
S90: Arts+Ethics: Films
PN: 788
Hazel
1
Jacqueline Donachie
1
Northumbria University/ Glasgow Museums, Glasgow, United Kingdom
Type of Work Short Film – 8 minutes (plus presentation, 12 minutes)
Keywords: Genetics, Inheritance, Beauty, Loss, Ageing
Space Requirements Cinema or Auditorium
Technical Requirements Screen, projector (HD), with sound
Abstract
Hazel is a new short film by artist Jacqueline Donachie. Based on a series of interviews made with five
women who have myotonic dystrophy, an inherited neuromuscular disorder, and their unaffected siblings,
the short film Hazel reflects on the sisters attitudes to the ongoing affects of DM on their physical and
emotional wellbeing, whilst also looking at the wider symptoms of ageing and reproduction. Recruitment of
participants to take part in the interviews was facilitated via the UK Myotonic Dystrophy Patient Registry
based at the John Walton Muscular Dystrophy Research Centre , Newcastle University, and funded by the
AHRC and Northumbria University.
The work proposes to explore the extent to which art practice can challenge representations of experience in
the fields of genetics, social science and contemporary art whilst offering a reflection on portraiture; an
outcome of the piece has been to understand the importance of this in ‘classifying’ genetic conditions, and
has offered a subtle portrait of myself and my own sister, who is now very badly affected by the condition.
The film recently won first prize at the AHRC Anniversary Research and Film Awards (2015) in the category
‘Best Doctoral Film Since 1998’, and has been presented at international scientific conferences in
Washington DC and Paris. It is the final outcome of a doctoral study looking at the influence of collaborative
creative practice in the field of biomedical research and practice, following over 10 years of highly acclaimed
research in the field, much of which was funded by the Wellcome Trust.
My research has been directly involved in several key themes outlined, involving interdisciplinary working
practice, engagement with both biomedical and clinical researchers and the vulnerable groups on whom their
research is focused; recruitment for a creative study via a clinical network, and public engagement, via its
exhibition in national museum spaces.
x working across disciplines
x body ethics and art
x public engagement
x the arts and ethics
103
The film is presented as a single screen film work, 8 minutes in length, with an introductory performance
presentation by the artist of approximately 12 minutes.
PN: 556
I have a Dream: A World without HIV
1,2
1
1
4
1
Melany Hendricks , Ciara Staunton , Malcolm Roubaix , Gill Black , Dianno Baaitjies , Theresa
3
1
Russouw , Keymanthri Moodley
2
3
1
University of Stellenbosch, Paarl, South Africa, Stikland Hospital , Brackenfell, South Africa, University of
4
Pretoria, Pretoria, South Africa, Sustainable Livelihoods Foundation, Cape Town, South Africa
Keywords - Ethics; HIV; Educational; Video; Community engagement
Abstract
South Africa’s journey with HIV has been long and difficult. The most arduous part of this journey was the
‘lost decade’ of governmental AIDS denialism, calculated to have cost at least 300,000 lives. Despite
progress made, there are still 400,000 new infections each year. Cure research started globally. South Africa
with its history in HIV research and high prevalence rates is likely to become involved. The need for early
and sustained community engagement to address misconceptions and introduce “cure speak” is well
documented. Although challenges with cure research resonate with HIV researchers, cure research raises
unique issues, especially in a culturally diverse society. Public discussion in South Africa on cure research is
limited and research done in the Western Cape exposed ignorance of HIV cure research. To address this, a
14 minute educational video for patients in waiting rooms at HIV clinics throughout South Africa was
developed. This paper describes ethical challenges in developing this educational video, hoping that lessons
learned will assist others to develop and document engagement activities. Ethical challenges explored in this
paper includes the difficulty in conceptualizing cure which is compounded by Africa’s history of false HIV
“cures”, potentially impacting the public understanding of cure; the challenge of engagement with a culturally
diverse community and ensuring that the end product remains relevant across the different cultural and racial
boundaries. The production of this video called for the continuous balancing of hope versus unrealistic
expectation and balancing accessibility of scientific concepts to lay people against paternalism.
Link to video: https://www.youtube.com/watch?v=oNfw9n5nBtU
Tinto
S60: Symposium: Ethical issues in efforts to expand access to
investigational drugs PN: 475
1
2
3
1
Eline Bunnik , Annette Rid A , Mark Sheehan M , Nikki Aarts
Postdoctoral Researcher, Erasmus MC, Rotterdam, Netherlands, Senior Lecturer in Bioethics and Society,
2
3
King’s College, London, United Kingdom, Oxford Biomedical Research Centre Ethics Fellow, Ethox Centre,
University of Oxford, Oxford, United Kingdom.
1
Discipline(s) Medical ethics, Parmacoepidemiology, Responsible Innovation
Keywords: investigational drugs, compassionate use, expanded access programs, right to try
ethical issues
Abstract
Efforts to expand access to investigational drugs for patients with unmet medical needs are ongoing on the
level of legislation and regulation, such as the Right-to-Try movement in the USA and adaptive pathways for
marketing authorization at the EMA, but are now also driven by patient advocacy organizations and
commercial entities such as the Amsterdam-based company myTomorrows. In anticipation of globally rising
demands from patients, bioethicists need to think through the implications of more widespread use of
unapproved drugs through expanded access pathways. Is it ethical to expand and/or facilitate access to
investigational drugs, and if yes, under what conditions? The demand for early access to investigational
drugs is likely to intensify in the near future. Stakeholders stand in urgent need of an ethical framework for
dealing with larger-scale requests for expanded access from patients with unmet medical needs. With this
104
symposium, we aim to raise awareness of the ethical issues in compassionate use, to inform the audience
about recent efforts to expand patient access to investigational drugs with the accompanying newly arising
ethical issues, and to outline key ethical principles and research priorities.
Presentation 1:
While in the USA, the ethical debate on expanded access is well underway with the Right-to-Try movement
and the Johnson & Johnson advisory committee, in Europe and elsewhere, the ethical debate is just getting
started. Recent efforts to help patients get pre-approval access to investigational drugs build on existing
regulatory pathways for ‘named patient’ or ‘compassionate use’ programs, and aim at making these programs
more easily available for more patients with unmet medical needs, e.g. through information provision,
services and drug distribution. Expanded access, however, was never intended for widespread use. This
presentation explains what expanded access is and how it works, and highlights current barriers to expanded
access, including lack of awareness and/or willingness among physicians and pharmaceutical companies,
regulatory difficulties, dearth of reimbursement options. It also explains how recent efforts seek to overcome
these barriers and displace essential characteristics of expanded access, giving rise to novel ethical issues.
Presentation 2:
Though patients may have a ‘right to try’, expanded access to investigational drugs is conditional on
cooperation by treating physicians, who must prescribe the drug and shoulder the responsibility. We are
conducting a multidisciplinary study in which empirical data are gathered based on surveys, interviews and
focus groups with physicians and patients in the Netherlands, Turkey and the USA. Physicians are expected
to determine whether a patient qualifies for expanded access based on formal criteria (e.g. seriousness
and/or life-threatening condition, no standard treatment options), but might also use additional criteria, such
as required effort, financial considerations, and their estimations of benefit/risk, to decide on eligibility. Little is
known about the interests and preferences of patients with unmet medical needs: do patients prefer freedom
to choose or should they instead be protected against ‘false hope’? In this talk, I will present preliminary
results on physicians’ and patients’ views on expanded access.
Presentation 3:
Mark Sheehan, Ethox Centre, University of Oxford
This talk will begin by considering the ethical issues associated with access to investigational products. It will
present a framework for research ethics and examine the ways in which expanded or early access to
investigational products can be thought of as falling under this framework. The second part of the talk will
locate the general ethical question of expanded access within the context of a distinction between ethics and
law. In this context it will consider the ethical justification for regulating access and possible rationales for
adjusting the stringency of this regulation. The talk will conclude by suggesting that so long as the context of
expanded access is understood to be clearly a research context, rather than a clinical one, the ethical issues
associated with expanded access will be limited to familiar research ethics issues.
Moorfoot
S59: The Ethics of Complex Bodily Exchange PN:293
Chair: Annelien L. Bredenoord, Associate Professor, Biomedical Ethics, UMC Utrecht, Netherlands
1
2
3
Alastair V Campbell , Kristin Zeiler , Sarah Boers
2
1
Professor in Medical Ethics at NUS School of Medicine, Singapore, Associate Professor Ethics, Swedish
3
Collegium of Advance Studies at Uppsala University and Linköping University, Sweden, PhD candidate,
UMC Utrecht, Netherlands.
Discipline(s) Bioethics, Philosophy, Social sciences
Keywords Bodily material, Exchange, Ethics, Organoids, Embodiment
Abstract
Recent advances in biotechnology result in an increased scope of the processing, use, and exchange of
bodily material. Stem cells, for instance, can be used for individual interests, like personalized medicine.
105
Simultaneously, they can be distributed globally, and used for multiple aims by multiple stakeholders. The
traditional bioethical debate on the exchange of bodily material is dominated by proponents of either a gift or
a market approach. This dichotomy, however, is challenged by a complex network of bodily exchange and
use. The aim of this symposium is twofold. First, we aim to examine new conceptual approaches towards
complex bodily exchange. Second, we aim to apply a combined theoretical approach to a novel stem cell
technology: organoids.
Alastair V. Campbell ‘Biobanks, Altruism, and Trust’
Abstract
Biobanks, like the UK Biobank, are collections of biological material, linked to phenotypical data, that can be
used for a broad scope of future use. In biobanking, the interests of the individual have to be weighed against
public and commercial interests. Traditionally, the bioethical debate on the exchange of bodily material has
revolved around the gift versus property paradigm. However, this dichotomous debate falls short in assessing
how the altruism and trust, that is exhibited by participants of the UK Biobank, for example, can be honoured.
The aim of this presentation is to examine theoretical and practical approaches that are apt for ensuring that
such altruism and trust are safeguarded. Three measures seem to be essential components that must be
incorporated into any governance regime for biobanks: (1) genuine participation and partnership; (2)
independent scrutiny; and (3) public openness and accountability.
Kristin Zeiler ‘The Benefit of the Theoretical Lens of Sharing in Donation Ethics’
Abstract
Two ethical frameworks have dominated organ donation discussions for long: that of property rights and that
of gift-giving. Recently, however, there has been a rise in the number of philosophical analyses of the
meaning of giving, and, in sociological and anthropological work, on the gift metaphor. Four frameworks for
thinking about bodily exchanges in medicine can be distinguished: those of property rights, heroic gift-giving,
sacrifice, and gift-giving as aporia. These frameworks represent different ways of making sense of donations,
draw on different conceptions of the relations between self and other, address different ethical issues, and
seem inapt to make sense of reciprocity and relational interdependence in donation. This presentation argues
for an alternative framework of giving-through-sharing, that allows us to make sense of the multiple
relationalities and temporally extended character that bodily exchanges can imply, and explicate the potential
and limits of the gift metaphor in the context of donation.
Sarah N. Boers ‘Organoids as hybrids: ethical implications for the mode of exchange’
Abstract
Organoid technology can serve a broad scope of clinical, scientific and commercial aims, such as
personalized medicine, drug development and regenerative medicine. Organoids, which are threedimensional immortal cell lines, can be banked for unlimited time. The technology involves ‘complex bodily
exchange’, characterized by multiplicity, i.e. multiple types of donors, stakeholders, modes of distribution, and
applications. Traditionally, the exchange debate in bioethics is framed in terms of giving or selling, and based
on a dichotomous understanding of body parts as either subject or object. Organoid technology escapes
these dichotomous approaches. In this presentation we ask, what is the moral status of organoids and what
ethical implications does this have for the donor’s entitlements and the appropriate mode of exchange? We
propose to regard organoids to be hybrids, and argue for evaluating the moral justification of the mode of
exchange on a context-specific basis.
Carrick 1
S13: Consent
Chair: Hooper, C
PN: 101
Right to Know? Making Sense and Contextualising of Informed Consent
in Human Subject Protection: A Chinese Perspective
Haihong Zhang
106
1
1
Peking University, Beijing, China
Keywords - Rights, Face-to-face Group, Privacy, Strangers with Authority, Vulnerable
Discipline(s) – Research Ethics, Global Bioethics
Abstract
Informed consent, as one of the most precious legacy of Nuremberg Code, is accepted world-widely as one
of the most significant strategies that can help protecting the rights and welfare of human subject. Nearly all
the international and national guidelines, regulations reached their consensus to adopt this requirement.
However, it varies a lot in social, economic and cultural context regarding to the real world issues.
After a pilot empirical study carried out by observing real-life informed consent process and interviewing
subjects, investigators, IRB members in China, two research team members conducted data coding
independently to make sure the interpersonal validity of data analysis. We found that, informed consent,
which derived from the basic idea of individual right and respect for people, may sometimes overturned by
local customs or other pitfalls that unpredictable at the first sense. Deeply rooted in Chinese culture, people
always identify themselves in families/groups, in other words, different interpersonal relationships, rather than
individual. The Chinses society, used to be a face-to-face group, now undergoing a dramatic changing
process of urbanization and modernization. Investigators, particularly in the context of clinical research, are
“strangers with authorities”. Besides, the long history of absence of individual right and privacy makes
Chinese subject even more vulnerable to give voluntary informed consent. It is an alerting that informed
consent, though widely accepted, should never be adopted with oversimplification as a fit-for-all strategy for
human subject protection. On the contrary, it should be updated, contextualised and tailored with integration
of local context and cultural traditions.
PN: 650
From Competence to Resilience – Untwining Limitations of Vulnerability
on Informed Consent in the Context of Global Research Bioethics
1
Nabeel Mangadan-Konath , Consultant in Public Health and Bioethics
1
Public Health and Bioethics Consultant, UC Ward, PO Chovva, India
Keywords - Medical Research, Clinical Trials, Vulnerability, Resilience, Global Bioethics
Discipline(s) - Bioethics, Medical Research
Abstract
Vulnerability as a concept in deliberations related to research ethics seems to be viewed through a very
narrow lens. Hence, the predominant guidelines, regulations, key publications and often research ethics
reviews tend to focus the discussions towards pre-categorized groups called “vulnerable populations” or
“vulnerable categories” of research participants rather than the different types of vulnerabilities of individual
participants. On one hand, several research participants with vulnerabilities tend to miss out from research
ethics radars since they do not belong to these pre-categorized groups. Secondly, just because a participant
belongs to a particular group, we tend to overprotect them – for example, women, children, elderly, etc. While
the former situation can lead to the argument that every research participant is vulnerable, the latter situation
denies the benefits of research from some groups in the name of their protection. Both these arguments defy
the usefulness of this important concept. I propose to overcome this paradox by moving focus away from
“vulnerable populations” and concentrating on the resilience of individuals within communities vis-a-vis
potential “vulnerability factors”. This is explained using a conceptual model of informed consent, which shows
how prospective participants decide to participate or not based on their relative perceptions of risk and
benefit.Conclusion: different vulnerability factors of an individual can have varying degrees of push-pull
effects on the risk-benefit perception threshold of this decision making model. Using this model, I
conceptually demonstrate how an assessment of ‘Resilience’ and wherever possible its building and
reinforcement - as opposed to the mere individualistic and superficial reliance on ‘Competence’ – is to be
incorporated into the research enterprises and research ethics review mechanisms. This would be essential
in addressing vulnerabilities of research participants in the context of Global Research Bioethics.
107
PN: 287
The Informed Consent Doctrine and Patients Excluded from Public
Health Screening Programs
1
Maya Peled-Raz
1
University of Haifa, Israel
Keywords - Public health policy, public health screening, informed consent, common practice, right to know
Discipline(s) – Public health law, torts law
Abstract
The referral of an individual to a screening test – such as mammography, embryonic ultrasound or pap-smear
– may in many cases rely not on the individual's specific medical condition, but on a systemic policy decision,
concerned with the well-being of the community as a whole, and weighing not only the interests of the
specific patient but also general interests, amongst which - the statistical effectiveness of the tool.
When a patient is excluded from the screening process, on public health grounds, and the test/tool is
furthermore not recommended for him for any specific ailment, the question arises – whether he should still
be informed about the existence the screening tool – allowing him to choose to undergo the screening
nevertheless. I will argue here, that care-takers may in some cases bear information dispersal duties towards
a patient, who's "excluded" from public-health driven screening programs, but that those duties do not derive
from the Informed consent doctrine, but stems from the general reasonable standard of care, expected of the
care-taker under general torts caution standard. The importance of this distinction, between the Informed
Consent doctrine as opposed to the information dispersal duties required by general torts law, lies in the
fundamental difference between the standards of care required under the two doctrines in Israel – the general
torts' standard of care observes the behaviour of the "reasonable care-taker", and relies on common medical
practice, while the Informed Consent doctrine applies the much more demanding "reasonable patient"
standard, while rejecting the common practice criteria.
PN: 18
Is It Worse To Compel Than To Coerce?
1
Jonathan Pugh
1
Uehiro Centre for Practical Ethics, University of Oxford, United Kingdom
Keywords - Consent, Autonomy, Public Health, Coercion, Compulsion
Abstract
A central tenet of medical ethics holds that it is permissible to perform a medical intervention on a competent
individual only if that individual has given informed consent to that intervention. However, in the context of
public health, it is sometimes claimed that this ‘consent requirement’ may be outweighed. In this paper, I shall
assume that it may sometimes be justifiable to violate the consent requirement in the interests of public
health. The neglected question that I shall consider is whether there is a moral difference between the
different ways in which we might carry out interventions that violate the consent requirement. More
specifically, I shall consider whether it is morally worse to compel an individual to undergo a medical
intervention by subjecting them to irresistible physical force, than it is to coerce them into doing so by
threatening them with severe sanctions for non-compliance. I shall provide an original discussion of this
question, which has been widely overlooked in the medical ethics literature, but which also has important
implications for public health policy. By providing a novel philosophical analysis of both compulsion and
coercion, and their implications for autonomy and rational agency, I argue for the surprising conclusion that
although coercion might involve the same sorts of wrongs as compulsion, it also incorporates further wrongs
that compulsion does not. Accordingly, when it is justifiable to override the consent requirement, compelling a
competent individual to undergo a medical intervention might be morally preferable to coercing them into
undergoing that intervention.
108
Carrick 2
S12: Reproduction and the embryo
Chair: Salas Ibarra, S
PN: 550
Seeing, Feeling, Doing: Mandatory ultrasound laws and the role of
emotion in abortion ethics
1
Catherine Mills
Monash University, Wellington Road, Clayton, Australia
1
Keywords - Ultrasound laws; Abortion; Empathy; Moral status of the fetus
Discipline(s) – Philosophy, Bioethics
Abstract
In recent years, a number of US states have adopted laws that require pregnant women to have an
ultrasound examination, and be shown images of their fetus, prior to undergoing a pregnancy termination.
While there is a growing critical literature on such laws, there has been little attempt in bioethics or philosophy
to unpack one of the basic presumptions of them: that seeing one’s fetus changes the ways in which one
might act in regards to it, including in terms of the (ethical) decision about whether to allow it to live or not.
However, this presumption raises significant questions about the relation between visibility, emotion and
ethics that feminist bioethicists would do well to analyze. I address these questions to yield insight into the
role of emotion tin ethics, which seems to underlie mandatory ultrasound laws. First, I consider the theory of
maternal bonding and its use in these attempts to limit access to abortion. Second, I elaborate notions of
maternal bonding in terms of recent philosophy of empathy, with particular reference to comments by moral
sentimentalist, Michael Slote, on the relevance of empathy to the ethics of abortion. I argue that while it is not
technically possible to empathize with a fetus, ultrasound laws nevertheless seek to elicit this empathic
relation, while simultaneously suppressing empathy with pregnant women. The approach I develop ultimately
gives rise to a new account of the politics of emotion in relation to abortion – not in terms of grief and shame,
but in those of a critical analysis of the (variable) mobilization of empathy and care.
PN: 227
On Abortion, Right and Duty: A Feminist Analysis of Conscientious
Objection to Abortion in a Nordic Welfare State
1
Tiia Sudenkaarne
University of Turku, Turku, Finland
1
Keywords - Abortion; Feminist Bioethics; Human Rights; Medical Ethics; Welfare State
Discipline(s) – Applied Ethics
Abstract
The legal right for medical professionals not having to participate in (non-life threatening) terminations for
reasons of conscience, i.e. conscientious objection to abortion, is a commonly stipulated medical
professionals’ right in Europe. I suggest it is not a coincidence that out of the five European countries
currently not granting that right, three are Nordic welfare states: Sweden, Iceland and Finland whose
parliament only recently rejected by landslide a citizens’ initiative for the right for conscientious objection to
abortion to be protected by law. Yet there remains a consensus that abortion should be legal. Whose right
and whose duty is abortion anyway? By using the method of reflective equilibrium, I analyze six arguments I
have identified to be universally used for defending medical professionals’ right to conscientiously object
abortion, and refuse them all as ethically unsustainable. The most urgent dilemma is that they are in fact not
arguments for conscientious objection but arguments against abortion per se. I wish to offer a feminist
account on reverence of life in the public health context. I also discuss the effects abortion law has on
women’s (basic) rights and citizenship. On the latter note, I wish to inquire does the Nordic welfare state
model/sociodemocratic ideology have something unique to offer in terms of public interest and public goods.
109
PN: 154
Editing, Selecting, and Creating Embryos: Does the Legal Status of
Different Reproductive Technologies Track Ethical Differences?
1
Christopher Gyngell
1
Keywords - Gene editing, embryo selection, reproductive ethics, selective fertilization, genetic enhancement
Discipline(s) – Ethics and law
Abstract
In the near future, there will be at least three distinct ways in which parents can use biotechnologies to alter
the genetic makeup of their future children. 1) Parents could select between embryos based on their genetic
makeup, using technologies like preimplantation genetic diagnosis (PGD). 2) Parents could edit the DNA
sequences of existing embryos, using gene editing techniques like CRISPR. 3) Parents could create embryos
with a specific genetic makeup, by performing genetic tests on gametes and using technologies like
23andMe’s ‘Gamete Donor Selection Based on Genetic Calculations’ to selectively combine particular
gametes. These three methods have very different legal status’s. In general, embryo selection is legal for
some purposes, gene editing is illegal for any purpose, and embryo creation through selective fertilization is
not covered by exiting laws. In this presentation, I examine whether the legal differences between selection,
editing, and creation technologies track ethical differences– i.e when creating a child with a particular genetic
makeup, is there a moral difference between using embryo selection, gene editing, or gamete testing and
selective fertilisation to achieve this outcome? I look at the possible ethical differences between the use of
these technologies for a number of different purposes, including to avoid disease, to deliberately cause
disease, and to target non-disease traits.
PN: 156
The Embryo As Object of Regard
1
1
Jenni Millbank , Isabel Karpin
1
University Technology Sydney (UTS), Ultimo, NSW,,Australia,
Abstract
Australian ethics guidelines and assisted reproductive technology (ART) legislation directly, but obliquely,
engage with the entity of the human embryo. While ostensibly governing specific IVF treatment and research
practices, these rules, through prohibiting certain kinds of embryos and certain kinds of uses, also generate
the embryo as a legal and discursive entity with far broader impact. Many of these documents instruct us that
disembodied embryos are not mere tissue, they are “widely regarded” as unique objects of serious moral
consideration. The embryo, by virtue of its uniqueness and orientation toward future development, commands
“respect”. The woman whose desire for a child or children created this embryo, and who inhabits the body to
whom it may one day be returned, is an omission or at best an afterthought in this framework. This paper
engages in an historical analysis of how this situation came about in the Australian context, arguing that the
institutional structure of foundational ethics bodies with a mandated mix of scientific and religious
representation, dominated by men and absent the participation of women patients, has created the embryo
as an object of ideological compromise: not mere cells and not life but as a poorly bounded and endlessly
contested something-in-between. The paper asks what, if anything, can be done to reorient law and policy
toward the concerns, needs and desires of women who generate embryos.
110
Carrick 3
S20: Public Interests
Chair: McCoy, M
PN: 581
Protecting Public Health or Commercial Interests? When a
Government's Lack of Transparency Threatens Public Interests
1,2
1
1
Jean-Christophe Bélisle Pipon , Louise Ringuette , Victoria Doudenkova , Pr. Bryn Williams-Jones
2
1
Université De Montréal, Montréal, Canada, Institut de recherche en santé publique de l'Université de
Montréal, Montréal, Canada
1,2
Keywords - Access to information, Public Health, Transparency, Vaccines
Abstract
Vaccines undoubtedly provide important benefits for public health in their protection against a variety of
infectious diseases, and so they are now a key component of public health interventions. But vaccines are
not without risk, and once approved the population must be informed about all the benefits (i.e., individual
and public health) and risks (i.e., individual, social or financial costs) of a vaccine, both to ensure individual
informed consent to be vaccinated, and as a means of public transparency and accountability. With these
considerations in mind, we examined the documentation available for the target population of a publiclyfunded vaccination campaign against the serogroup B meningococcus (MSB) initiated in May 2014 in a northeastern region of Québec in Canada. When assessing the information regarding the cost of the vaccine (and
of the intervention), we realized that such information was not accessible. This presentation is showing our
efforts to get access to the cost of the MSB vaccine and discussing the ethical implications of a lack of
government transparency (whereas such information is available, for example, in the UK). This MSB
vaccination campaign is a perfect example of how government transparency, regarding health matters, is
somewhat still very weak. It is in the public interest that information about the choice of vaccines be
transparent (e.g., benefits, risks, cost-effectiveness), so that individuals can make informed decisions about
whether to participate in a particular vaccination campaign, and so they can hold their government
accountable for decisions that it makes in the public interest.
PN: 789
Public Interests as Furthering Citizenship
1
Evert-Ben van Veen
MedLawconsult, Den Haag, Netherlands
1
Keywords - Public interests, GDPR, rights, citizenship
Discipline(s) - Individuals, Public Interests and Public Goods, or Public Health, Ethics and Law
Abstract
The concept of ‘public interests’ seem rather new to the bioethics discourse. In public health ethics ‘public
interests’ obviously plays a key role, yet there is substantial discussion as to what constitutes public health
and hence public interests (Coggan, 2012), just as in political philosophy in general (Held 1970, but still valid
today as it seems to me). Lawyers have worked with the concept for a long time. ’Public interests’ is used in
various legislative documents, such as the European Convention on Human Rights or the EU Treaties to
legitimate an exception to the general rules stated in these documents. The coming EU General Data
Protection Regulation (GDPR) even uses the phrase ‘public interests’ 73 times as one the elements to
legitimate an exception to most of all the informed consent principle. Yet, as always context matters. In public
economic law ‘public interests’ are meant to curtail the principles of the free market. In the GDPR public
interests seems to trump individual privacy rights. I will discuss how the various approaches can be combined
by following formula: public interests are what furthers citizenship. This does not beg the question as the
broad lines as to what constitutes citizenship in Western society are much less contested. Which certainly
does not mean that the conditions for such citizenship are always met. These conditions require quite a lot
111
from the state and from the citizens themselves. Citizenship is not an essentially contested concept but is
very fragile.
PN: 711
The Myriad Gene Patent Cases and Controversy: Balancing Public and
Private interests in the patentability of health-related inventions
1
Aisling McMahon
Newcastle Law School, United Kingdom
1
Keywords - Patents; Myriad; Gene; Access; Health benefits
Abstract
This paper will examine recent Myriad cases involving the patentability of genes in the US and Australia,
comparing these to the situation in the Europe. In doing so, it highlights the difficulties which have been faced
in applying traditional patentability criteria in the context of biotechnology and related inventions. Intellectual
property rights (IPRS) such as patents have a two-fold effect in this context. On the one hand IPRs are often
lauded as necessary to facilitate and encourage innovation in such fields. On the other hand, there are clear
limitations on access for both the public and other researchers to inventions subject to patent, albeit for the
limited period of patent duration. Such restrictions are particularly problematic when they relate to upstream
inventions or technologies, and have proven deeply controversial in the context of gene patents. This paper
will argue that whilst recent cases represent a rowing back on the patent protections which could previously
have been sought in this context, however, there remains much uncertainty as to the effect of this litigation
and particularly on the likely effect on patents over related diagnostics. It argues that the patent system needs
to take greater account of public interest arguments in constructing and applying patentability criteria, and
particularly in relation to inventions/technologies with health benefits. In this vein, it will argue that provisions
such as the morality provisions in the EU context should be used to limit patents on upstream technologies
where restrictions may have consequences for the broader public health.
PN: 198
'In the Public Interest': Dovetailing Two Individual End-of-Life Choices End of Life/Public Interest
1
Jeffrey Kirby
1
Dalhousie University Faculty of Medicine, Halifax, Canada
Keywords - Donation after assisted death; ethically-problematic; public trust; individual choice; comparativeconceptual analysis
Discipline(s) – Bioethics; Philosophy; Medicine
Abstract
Although controlled organ donation after assisted death (cDAD) has been implemented in Belgium and the
Netherlands, this practice has not been widely-adopted in other international jurisdictions with legalized
assisted dying. Critiques of cDAD include potential engenderment of a (individual-based) ‘duty to die’ and
speculation that public-trust in organ donation/transplantation practices as-a-whole could be degraded. The
topic is approached through a comparative-conceptual analysis of cDAD and another organ donation practice
that has achieved acceptance in many international jurisdictions: controlled organ donation after circulatory
death (cDCDD). The comparative analysis incorporates a dynamic exploration of the known, ethicallyproblematic dimensions of cDCDD. These include: compromised autonomy and suboptimal consent, the
irreversibility objection, and uncertainty about whether cDCDD donors are ‘actually dead’ and/or capable of
sensory experience during organ procurement. Conclusion: the outcomes suggest that cDAD is less ethicallyproblematic than the accepted practice of cDCDD. Because of the possibility of, and requirement for, fullyinformed, direct consent, cDAD better respects and actualizes the autonomy interests of potential donors
than does cDCDD. A claim that the cessation of the donor’s circulatory function is irreversible in the cDAD
context can be supported, given that prior implementation of voluntary euthanasia precludes
autoresuscitation and successful cardiopulmonary resuscitation efforts. As the donor is either ‘actually dead’
112
or deeply-anesthetized during the relevant surgical time frame, there is no potential for the donor to
experience negative sensation during organ procurement. Further, the counterintuitive conclusion is
supported by a variety of identified, pragmatic advantages of cDAD over cDCDD.
Harris 1 & 2
S72: ECR Session: Funding, Policy and Careers
1
2
3
4
Panellists: Hugh Whittall, Ilina Singh, Dan O’Connor, Nils Hoppe
2
3
1
Director, Nuffield Council on Bioethics, University of Oxford, United Kingdom, Head of Medical Humanities,
4
Wellcome Trust, Leibniz University,Hannover, Germany
This masterclass is designed to cover a range of increasingly important issues within academia. For example,
panel members will offer their perspectives on funding with a special focus on writing funding grants, as well
as funder perspectives on reviewing funding applications. On careers, we will consider important aspects of
career progression, starting out, juggling commitments, working in a team, and leading teams. Panel
members will share with us what has worked and what has not worked in their own careers. We will also
consider experiences of influencing policy and practice, a topic that is becoming an increasingly important
responsibility for academics. Panel members will share their experiences of working with policy makers,
translating and communicating academic work in a policy-friendly way, strategies, challenges and benefits of
successfully influencing and responding to policy matters in bioethics. Further we will hear from policy makers
about their own experiences of working with academics.
Ochil 1&2
S33: Resources and Accountability
Chair: Hayry, M
PN: 173
Resource-based Thresholds for Futility in Neonatal Intensive Care
1
1
Dominic Wilkinson , Julian Savulescu
2
University of Oxford, United Kingdom, John Radcliffe Hospital, Oxford, United Kingdom
1
Keywords – Futility, Intensive Care, Resource Allocation
Discipline(s) – Medical ethics
Abstract
In neonatal intensive care, disputes sometimes arise between families and clinicians over potentially
beneficial life-prolonging treatment for a newborn infant. Parents strongly desire the treatment, yet health
professionals judge that it would be futile. While professional guidelines support the concept of ‘medical
futility’, there is no guidance on how to determine whether or when treatment would be futile. In this paper, we
explore the application of cost-effectiveness thresholds (CET), used elsewhere in public health systems, to
the determination of resource-based futility in newborn intensive care. We outline briefly the concept of futility,
and of cost-effectiveness assessment. We then draw on CET to explore sequentially a series of clinical
questions. When is a patient’s chance of survival too low to provide expensive life-support? How long is too
long to provide intensive life-prolonging medical treatment? What level of quality of life is too low for lifesaving surgery to be provided? This paper represents the first attempt to evaluate distributive justice based
determination of futility in intensive care. It builds on careful analysis of existing empirical evidence as well as
ethical argument. We identify and address major counterarguments to the use of cost-effectiveness in
deriving futility thresholds for intensive care. Conclusions: our analysis identifies key normative questions for
resource-based treatment limitation decisions as well as key empirical data necessary to inform such
decisions.
113
PN: 574
Exploring Accountability Relationships and Ethical Issues Surrounding
the Provision of Complementary and Alternative Medicines in the NHS in
Scotland
1
2
Kevin Smith , Louise Crawford
2
1
Abertay University, Dundee, United Kingdom, Robert Gordon University, Aberdeen, United Kingdom
Keywords - Complementary & Alternative Medicine (CAM); Science-Based Medicine; Accountability; Public
Funding
Discipline(s) - Public Health Ethics
Abstract
Complementary & Alternative Medicine (CAM) encompasses a mixture of non-mainstream therapies,
including acupuncture, chiropractic, herbalism and homeopathy. The House of Lords Science and
Technology Select Committee investigated CAM in 2000 and recommended that more research was
necessary to determine efficacy before public expenditure on particular CAM modalities could be justified.
This committee was reconvened in 2010 to specifically consider homeopathy, and concluded that public
expenditure on this form of CAM was not justified. Despite such negative conclusions, the NHS has
continued to fund various forms of CAM including. However, accountability information about the amount of
public funding committed and the efficacy of CAM to contribute to social health and wellbeing is not widely
available. Recent Freedom of Information requests evidence that CAM public funding is substantially higher
(per head) in Scotland compared with the rest of the UK. Ultimately, costs are incurred by the NHS at the
point of consultation where CAM is recommended or prescribed, or subsequently where a CAM therapy has
not worked necessitating reversion to mainstream medicine. Thus, the promotion of CAM by healthcare
professionals during patient consultations serves as an important driver of costs; the extent to which this
occurs within the NHS in Scotland needs to be ascertained. An appreciation of the accountability and ethical
issues surrounding public funding of CAM in Scotland is important in respect of the health and wellbeing of
the individual patient and the Scottish population as a whole.
PN: 454
Fair Inclusion of Research Participants: Methodological Challenges
1
1
1
1
Rieke Van der Graaf , Rolf Groenwold , Martijn Oudijk , Indira van der Zande , Johannes van Delden
University Medical Center Utrecht, Netherlands
1
1
Keywords - Fair inclusion, subgroups, pregnant women, research methodology, research ethics
Discipline(s) – Research ethics, epidemiology and gynaecology
Abstract
For historical and ethical reasons certain subgroups have been excluded from research activities, such as
children, mentally incapacitated persons, women and pregnant women. At the same time, it is increasingly
acknowledged that a lack of evidence may also harm these subgroups. Therefore, some argue that
underrepresented groups should be given priority in research and that their exclusion must be justified.
However, having to justify exclusion may be methodologically challenging. For instance, heterogeneous
subgroups do not always contribute to socially valuable knowledge that may eventually benefit these
subgroups. We will conceptually analyze fair inclusion, both from a scientific/methodological and ethical
perspective. Accordingly, we will use case studies in which women and pregnant women have been in- and
excluded and evaluate whether their in- or exclusion from research was fair. We argue that in order to yield
socially valuable health knowledge for subgroups it may sometimes be necessary to set up different trials, or
to deliberately exclude these groups. Moreover, if it is unknown whether intervention effects differ between
subgroups, the inclusion of these subgroups should be substantial and proportional. Conclusion; Some
ethical guidelines seem to have gone from the one extreme into the other: from justifying inclusion to
justifying exclusion. In order to fairly include subpopulations a sole focus on justice as priority is not sufficient,
methodological aspects should be taken into account as well.
114
PN: 637
A PrioritarianCritique of the Treatment-enhancement Distinction
1
Alexandre Erler
American College of Thessaloniki, Thessaloniki, Greece
1
Keywords - Enhancement, justice, proper bounds of medicine, resource allocation, therapy
Discipline(s) - Medical ethics, bioethics
Abstract
Many people believe that the treatment-enhancement distinction (TED) has significant normative force. They
hold that enhancements are by their very nature ethically problematic, or at least that they are morally less
important than treatments, which tend to benefit people who are worse off than those who seek
enhancements. Authors like Norman Daniels thus argue that enhancements shouldn’t usually be included in
medical insurance packages. In response, some enhancement supporters have denied that treatments can
be meaningfully distinguished from enhancements. This paper takes a different approach and argues that
even if we accept the meaningfulness of the TED and its prioritarian starting point, its normative significance
has been overstated. Indeed, its proponents neglect the indirect social benefits and non-positional goods that
enhancements can bring about. For instance, it is in principle possible to biomedically enhance doctors and
scientists so as to serve the interests of the sick and disabled. Furthermore, on certain definitions of
enhancement, we have already done so through the development of medical technology. When costeffective, such interventions have significant claims on public resources, and whether or not they should be
funded by medical insurance is an administrative rather than an ethical issue. I conclude that their own ethical
commitments require supporters of the TED to endorse many more types of enhancement than they typically
recognize, and that the distinction’s force largely relies on the contingent fact that some of today’s
enhancements are not safe and effective enough, rather than on an essential moral difference between
treatments and enhancements.
Ochil 3
S32: Perspectives on bioethics
Chair: Garcia, A
PN: 135
‘Participatory Ethics’: The Relevance of Epistemic Justice for Applied
Bioethics
1
Silke Schicktanz
University Medical Center Goettingen, Göttingen, Germany
1
Keywords - Political ethics, mixed judgements, epistemic participation, marginalized perspectives, patients
Discipline(s) – bioethics
Abstract
This paper starts with the critical discussion of the legitimacy of the inclusion of the perspectives provided by
patients or related advocacy groups in public, political and scientific debates. These considerations are
located between the empirical analysis of the increasing impact of patient advocacy and the critical
assessment of that impact: Is there too much or too little impact? Are the positions one-sided, balanced,
arbitrary, or justified? I will defend the ethical legitimacy by criticizing the existing epistemic injustices of
public-political debates concerning medicine or biotechnology. By relying on the philosopher Miranda Fricker’
approach of epistemic injustice I will identify unfair exclusion and one-sided advantages given to particular
discourse participants. Epistemic injustice occurs when statements by members of particular groups are
systematically neglected or discredited by a more powerful part of society. Moreover, I will explore three
related aspects: (a) scepticism towards expertocracy, b) the normative relevance of ‘being affected’, and (c)
epistemic justice and analyse their meta-ethical and practical relationship. Finally, I suggest that bioethical
approaches - especially in an empirical-ethical setting – can contribute to more epistemic justice in the
political-public discourse by taking a more critical stance towards existing power relations framing current
115
discourses. However, a critical perspective on patients’ particular perspective is needed. The argumentation
developed above serves as a general framework for the analysis of existing power relations and discursive
strategies for combating epistemic injustice, but it provides a basis for more scrutiny regarding the question
of who should be involved.
PN: 70
Edinburgh and the Foundations of Modern Medical Ethics
2
Robert Baker
1
Bioethics Program of Clarkson University & Icahn School of Medicine at Mount Sinai, Schenectady, USA
KeyWords - Edinburgh Medical College, John Gregory, History of Medical Ethics, Medical Oaths, Scottish
Enlightenment
Abstract
The 2016 World Congress of Bioethics is meeting in the city where modern medical ethics was invented by
the faculty of the Edinburgh Medical College some two-hundred-and-fifty years ago. Seeking a safe haven
from religious fervor and a competitive advantage against more established rivals the faculty expounded a
non-religious medical morality according to which empathic physicians trained in the empirical foundations of
medical science would use their knowledge to mitigate patients’ pain and suffering and tend to their emotional
needs. Documentation of this new morality first surfaces in a version of the Hippocratic Oath that replaced a
mandatory sponsio academica (academic loyalty oath) in the 1730s. John Gregory elaborated on this new
conception of medical morality in annual lectures commencing in 1767-1768. His student, the New Yorker
Samuel Bard, exported Gregory’s vision of medical morality to American medical students in a 1769 lecture,
as did his Philadelphian classmate Benjamin Rush twenty years later. In 1803 another of Bard’s classmates,
Thomas Percival of Manchester, England, dubbed the new medical morality “medical ethics”; and, in 1829,
another Edinburgh alumnus, Michael Ryan, became the earliest known “professor of medical ethics.” This
presentation explores the factors favoring Edinburgh’s development of the ideal of empathic scientific
physicians arguing that in their quest for competitive advantage the Edinburgh faculty adopted English as a
language of instruction, emphasized the scientific basis of medical practice, tolerated religious diversity, and
drew upon the moral philosophy of the Scottish Enlightenment then evolving in the salons and coffee houses
of Edinburgh.
PN: 487
Superhumains.ch: Artistic Perspectives on Human Enhancement
1
Johann Roduit
Center for Medical Humanities, University of Zurich, Zurich, Switzerland
1
Keywords - Human enhancement; Art; Bio-art; Emerging technologies; Democratization of science
Discipline(s) – Bioethics; Arts
Abstract
In this presentation, I will outline results from the science-communication project superhumains.ch. The goal
of the project was to educate, inform and dialogue with teenagers about ethical issues regarding the use of
emerging technologies on humans, while encouraging a discussion between art, science and ethics. Specific
concerns regarding the ethics of human enhancement have been raised from the participants of
superhumains.ch. First, they have shown worries that social pressure to use human enhancement might
threaten their autonomy. Second, they have been concerned that human enhancement might be
dehumanizing. And, finally, they have questioned whether enhancement might have too many negative side
effects to be worthwhile. Those concerns regarding coercion, human authenticity/nature, and safety have
already been raised in the debate by so-called bioconservatives, but have often been strongly refuted. I
defend here that these concerns need to be taken into consideration seriously in the debate, nonetheless.
The debate itself should be re-framed in order to include lay people’s concerns and arguments. This would
enable a democratic process that would encourage broader reflections on human enhancement. This is
important because moral decisions regarding human enhancement should not be limited to academics only.
116
PN: 52
Towards an Appreciative Ethics of Care
1,2,3
2
Antonio Sandu , Ana Frunza
2
1
Stefan cel Mare University of Suceava, Romania, Suceava, Romania, LUMEN Research Center in Social
3
and Humanistic Sciences, Iasi, Romania, Iasi, Romania, Romanian Unit - UNESCO Chair in Bioethics, Cluj,
Romania, Cluj, Romania
Keywords - Appreciative Ethics, Ethics of Care, social constructionism, moral agency
Discipline(s) - ethics, bioethics, applied ethics, sociology
Abstract
Research Problem: Ethics of care is a theoretical model centered on the interdependence of the actors
involved in providing care. The ethics of care takes into account the fact that some communities or individuals
are more vulnerable than others, thus requiring additional attention. This paper focuses on constructing a
new ethical framework with regard to chronic care, starting from the Ethics of Care model and adding to it a
constructionist dimension derived from the appreciative paradigm (Appreciative Inquiry).The appreciative
vision proposes a paradigm shift in social change starting from the replacement of the problem-centered
approach with one centered on the successful elements which can represent the premises for the creative
transformation of the system. We will construct a framework of principles with regard to the Appreciative
Ethics of Care. Conclusion: In our view, Appreciative Ethics of Care should be based on the value of cocreation and co-care in the care process. The process of care cannot be understood unilaterally as being
paternalistic, but rather as an appreciative reconstruction, based on the elements of maximum value for
everybody involved in the process of care. The moral agent, understood within the appreciative paradigm,
builds his autonomy in the very care context. Being a model based on an assessment of strengths, any
appreciative ethic is clearly an ethic of virtue.
117
FRIDAY 17TH JUNE 2016 14:15-15:45
Pentland Auditorium
S40: Symposium: Ethics and Regulation of Global Beauty Practices and
Procedures PN: 87
Chair: Hugh Whittall
1
2
3
4
Panellists: McHale JV, Whittall H, Widdows H, Wright K, Marway H
1
5
2
3
University of Birmingham, United Kingdom, Director of the Nuffield Council on Bioethics, University of
4
5
Birmingham, United Kingdom, Assistant Director, Nuffield Council on Bioethics, University of Birmingham,
United Kingdom
Discipline(s) Philosophy, ethics, law, public policy
Keywords Global ethics, beauty, regulation, choice
Abstract
Symposium Description
We will consider the under-explored topic of beauty in the context of global health. Beauty practices and
procedures are rarely considered to be primary issues either in discussions of global ethics and justice or in
practical concerns of bioethicists and medical practitioners (recognised by the current Nuffield Council
Working Party). This symposium is drawn from the Beauty Demands Project, which brings together
academics from across disciplines (from bioethics to sociology) with practitioners and artists to consider the
‘Changing Requirements of Beauty’. Core issues raised by the network include; normalisation, body
dissatisfaction, expectation, efficacy and safety of such procedures. There is little existing law and ethics
scholarship on beauty procedures and practices. What there is it largely focuses upon the ethics and
regulation of particular practices at single jurisdictional level. Beauty Demands perspective is original in that it
is multidisciplinary and connects theory to practice, and seeks to consider beauty practices and their
implications for health and well-being as a whole and globally. Taken together the papers highlight the need
to move beyond case-by-case models (which focus on particular practices alone or individual choice).
Dramatic increases in the use of such procedures and in the expectations to conform mean that this is an
issue which merits public debate and engagement by practitioners and policy-makers alike.
The Ethical Implications of an Emerging Global Beauty Ideal
Heather Widdows
I argue that current trends in beauty procedures, practices and preferences suggest that there is an emerging
global beauty ideal. This ideal is more dominant and demanding (it applies to more types of women – and
increasingly men – and more is demand to attain ‘normal’). What is ‘normal’ becomes harder to achieve and
there is increasing pressure to go beyond normal. This is not trivial (for individuals or communally given the
costs of beauty). As the beauty ideal becomes global it is increasingly difficult to argue that difference
provides resources for resistance, making ‘opting out’ of the demands of beauty harder for individuals and
increasingly political (as can be seen, for example, in the trends in body hair removal). To recognise and
address the demands of beauty we need to look communally and at practices, rather than focus only on
individual choice.
The Global Regulation of Beauty Practices: A futile Endeavour?
Jean McHale
In the past access to beauty procedures was largely a matter for individual jurisdictions. However increasingly
beauty has become a global business. Patients are travelling to other jurisdictions for treatment. Beauty
products are being distributed across a global market. Concerns around the safety of such procedures has
led to calls for regulation of products and practices and those who administer them. Alongside this in some
contexts there is a debate as to whether certain procedures should be totally prohibited, This paper asks
118
given the nature of the global market is regulation ultimately futile or is there a real prospect of a global
solution?
Individual Preferences, Global Contexts, and Racialised Beauty Practices
Herjeet Marway
At first glance, decisions to beautify, modify or enhance the body may be taken to be individual expressions
of preference. Of course, preference formation occurs in contexts, such that these expressions at least
implicitly encompass a host of social/political/economic factors. In this paper, I examine the substance of
beauty preferences in order to reveal potentially ethically concerning features, focusing particularly on
racialized underpinnings of beauty practices. I illustrate with the case of skin-lightening using one example
each from the global north and the global south, and I draw out differences and highlight similarities, before I
underscore the ethical problems relating to race in both. This analysis will lead me to conclude that there are
ethical reasons to resist certain beauty practices on the grounds of racism despite these being expressed
preferences. Such obligations of resistance though will vary according to the agent involved.
The Role of Policy Makers
Katharine Wright
Policy concern with cosmetic procedures has primarily focused to date on standard setting and safety, with a
series of reports over the past decade arguing for greater levels of regulation in these domains. However, this
approach leaves unchallenged a number of important underlying ethical questions, examination of which is
needed for coherent policy formulation. Can we draw clear distinguishing lines between everyday beauty
routines, ‘cosmetic procedures’, and therapeutic procedures (and if not, how can we regulate meaningfully)?
Are those undertaking procedures consumers, or patients, neither or both – and what does this
consumer/patient distinction mean for the responsibility of professionals providing procedures? Are there any
procedures that are ethically unacceptable in all circumstances (and if so, on what basis?). Are there any
groups of people who should be ‘protected’ from procedures? And, perversely, might statutory regulation
simply add to the sense that procedures are routine and risk-free?
Sidlaw
S68: Symposium: Nasty, Brutish and Rude: On Assholes, Politeness,
Ethics and Good Manners PN: 231
1
Professor Inez De Beaufort et al.
Erasmus MC, Rotterdam, Netherlands
1
Discipline(s) Bioethics, Philosophy
Keywords Manners, Politeness, Virtues, Education and Integrity
Format/Methodology Presentations and panel debate
Abstract
Etiquette and good manners have often been distinguished from morality, the first supposedly being
superficial, innocuous and fashion-prone, whereas morality is about what really matters in human interaction.
According to many both in the popular media as well as in scientific areas there is an increase in rudeness, a
growing popularity of asshole-behaviour and a corresponding decline of politeness in many spheres of life.
Such behaviour can be annoying and may even lead to undermining the integrity of certain spheres or of the
whole social fabric of societies. Some spheres of life are considered particularly sensitive to rude behaviour,
e.g. public transport, the internet, sports. But in the field of bioethics itself, of science, and health care there
are differing views on what are good manners, and on the differences and similarities between required
virtues and good practices. In this symposium we will go into some conceptual issues: what are the
similarities and distinctions between morality and good manners; some normative issues: is politeness a
much needed virtue or sometimes a vice. We will discuss what can and ought to be done in terms of
education of children and in professional contexts, in setting examples, blaming and shaming, rules and
regulations and legal measures.
119
Images of Rudeness
The theme will be introduced by a selection of images in film clips from fictional and from real life stories,
illustrating the different kinds of rudeness and the different spheres.
Conceptual Issues: Do Manners Matter?
Confrontations with rude behaviour in daily life are annoying or worse for many people, e.g. being pushed,
confronted with litter, attacked on the internet, can be scary or humiliating; a revival of good manners and
virtues (civility, politeness) stemming from respect for others is brought forward as an answer. Some argue
that good manners are just a thin layer camouflaging our uncivil nature. Others hold that good manners are
essential to any social cohesion. In order to participate in that debate it is important to go into questions such
as: what are good manners, what can be seen as asshole-behaviour, is the line between criminal behaviour
and ‘simple’ rude behaviour a thin one? What is the moral problem? This will be illustrated with examples and
explanations from different ‘offenses’ within different spheres of life, e.g. relating to anonymity, competition,
an increasing narcissistic mentality etc.
Professional Rudeness in Bioethics
In philosophy in general, and bioethics more specifically a certain kind of professional rudeness occurs.
Those on 'the other side of the debate' are sometimes treated dismissively. Instead of merely claiming that
their arguments are bad (in the technical sense of being invalid or unsound), they are personally attacked as
being dim-witted or morally bad. In this presentation some examples of these practices will be provided, all
from prominent bioethicists, followed by an analysis when such rudeness is appropriate (if ever).
Good Manners in Science
Research integrity is currently high on the academic and public agenda. Intense debates are taking place on
how to foster responsible research practices. As a PhD student or scientist in your early career, you need to
learn ‘the rules of the game’ quickly. But how do you learn those ‘rules’? And from who do you learn your
‘good manners’ when it comes to scientific integrity? What if you don’t have any good examples at your
department? What if the practices your supervisors or other colleagues refer to as ‘good manners’ conflict
with your ideas of responsible research practices? For example, is it a case of good manners that you ‘thank’
your colleague for the help with data collection by offering him/her an authorship? In this presentation I will
tell you my story as a PhD student learning the ‘good manners’ of science, and, with permission, some
stories of my colleague-PhDs.
Politeness as a Vice and Rudeness as a Virtue in Health Care
This presentation examines politeness as a virtue and rudeness as a vice in various health care contexts. In
particular, it explores how politeness can be a disguise for unethical behaviour and how behaviour ordinarily
regarded as rude can be indicative of virtuous character under some circumstances. The presentation also
highlights the relationship of virtues and vices to particular roles that people have to play. What counts as
virtuous behavior in the context of a particular role may be seen as vicious; what counts as vicious behavior
in the context of a given role may be regarded as virtuous. Behaviour regarded as virtuous may contribute to
human flourishing under some circumstances but become an impediment to human flourishing under other
circumstances. Examples of health care scenarios will be discussed to highlight these points and to generate
conclusions and recommendations pertaining to health care settings.
Fake it Until You Make It
Is moral education condensable to the slogan ‘fake it until you make it’? For Aristotle the firsts steps to
becoming a virtuous person consist of imitating virtue or as Kant puts it in his Über Pädagogik “For when men
play these roles, virtues are gradually established”. Since virtues aren’t inborn, they have to be learned
through imitation. This imitation of virtue, that is, politeness can be seen as moral scaffolding. Still, politeness
does not necessarily lead to good moral behaviour, not will all who fake it make it. There are countless
examples in fiction and real-life of polite yet ruthless figures of evil. Nevertheless, in this presentation the idea
of ‘faking it’ in moral education will be defended.
120
Fintry
S63: Global Bioethics, Human Rights and Religions PN: 241
Alberto Garcia, John Lunstroth, Chris Durante, Joseph Tham [affiliations below]
Discipline(s) Comparative religions, Religious ethics, Bioethics, Human Rights
Keywords: Global Bioethics, Human Rights, Comparative Religion, Multiculturalism, Dialogue
Abstract
Global bioethics faces many challenges today. While there is a need to have a universal outlook and
methodology that can be shared across different cultures and religious sensitivities, it is not easy to
accommodate the diversity of ethical outlooks found in them. The 2005 UNESCO Declaration on Bioethics
and Human Rights sought to maintain this delicate balance of universality and diversity through the human
rights discourse. Nonetheless, many groups are not totally comfortable with this language which is seen as a
foreign or western imposition since the Declaration has not fully engaged religio-cultural traditions of the
world with their ethical expressions. This symposium wishes to address these complex issues from several
original perspectives. The main paper will discuss the Convergence of Human Rights and Duties among
different religious traditions as a way towards a Global Bioethics. Another paper argues contrarily that the
Declaration, while succeeding as moral statement, is so watered down by political inputs that its references to
human rights are trumped by its commitments to sovereignty and oligarchy and is therefore unusable as
universal positive norm. A third paper looks at the problem from the perspective of natural law, as a possible
bridge between religio-cultural plurality and universal claims. The last paper proposes a methodology of
dialogue among diverse ethical positions that is both respectful of the religio-cultural differences without
yielding to moral pluralism. We conclude that while tension exists between human rights and cultural
diversity, dialogue is possible and religious input can be of value to bioethics.
Convergence of Human Rights and Duties: Towards a Global Bioethics
Prof. Alberto Garcia JD, Director. UNESCO Chair in Bioethics and Human Rights. Rome, Italy
Global bioethics is an emerging concept. In 2005 the UNESCO Universal Declaration on Bioethics and
Human Rights was passed by the acclamation of 193 states. In spite of that, some critics argue that ethical
relativism is so deeply engrained it prevents the emergence of substantive universal norms, permitting only
procedural approaches to shared norms. We question that conclusion. An examination of the notions of
rights, duties and dignity in the major religious traditions suggests that there may be paths, through those
concepts, to substantive normative convergence. If rights and duties are seen as a unitary thing then their
ideological functions will not play such a prominent role in divisiveness among the traditions, but the unified
concept(s) could encourage convergence towards norms acceptable to all traditions.
How Contradictions in the Ius Gentium are Reflected in the UNESCO Approach to Bioethics
John Lunstroth, JD
The UNESCO Declaration on Bioethics and Human Rights (2005) purports to be soft international law. It
seeks to achieve that status procedurally, through member state consent, and substantively, by numerous
references to ius gentium, especially human rights. The ius gentium though consists of several competing
normative systems each of which strives to dominate the others. In practice the dominant organizing principle
or Aristotelian order (constitution) of the international community is oligarchy. Roughly accommodated within
it are several other complex normative orders: science; human rights; humanitarianism; public health;
development; and constitutionalism (sovereignty). The positive law of human rights is split at the highest level
between the liberalism of the ICCPR and the socialism of the ICESCR. It is thus imprudent to seek soft law
status for bioethical norms by wholesale reference to human rights. UNESCO should recognize bioethical
norms as subsidiary, and seek to anchor them in specific international rights, e.g. freedom of conscience.
Dialogue Despite Diversity: Sharing Norms When Our Moralities Differ
Chris Durante, PhD, Fellow, UNESCO Chair in Bioethics & Human Rights, Visiting Assistant
Professor, Religious Studies, Manhattan College
This paper lays the foundations of a bioethical methodology intended to cope with the issues of moral
diversity and religio-cultural pluralism without losing site of the fact that bioethics emerged out of the need for
shared moral guidelines and rigorous ethical analysis of novel medical technologies. The method being
121
proposed involves a discursive process that is able to quest for consensus while simultaneously maintaining
a respect for, and making possible the accommodation of, incommensurable moral and ontological
differences amongst religious traditions and philosophical systems and, is intended to contribute new insights
into the processes of bioethical inquiry, deliberation and policy formation. Begotten from a diverse array of
perspectives, the positions produced by this method have the potential to be more adequately representative
of our multicultural and religiously diverse society and hence, can help produce bioethical policies that protect
persons from potential harms without overriding their freedom of belief.
Natural Law and Global Bioethics
Fr. Joseph Tham, MD, PhD, Dean, School of Bioethics, Pontificio Ateneo Regina Apostolorum, Rome,
Italy
This paper looks at the challenges of ethical behaviors in a global village. Medical tourism, organ trafficking,
and gender selective abortions are seen as violations of universal human rights by international standards.
Nonetheless, others have questioned whether human rights might not be neo-colonialism in disguise. The
natural law tradition analyzed in The Search for Universal Ethics: A New Look at Natural Law seeks to
address the perennial problem of universality and particularism in ethics. It proposes rationality as the
common ground for human rights and dignity, thus avoiding the simple solution of consensus ethics, without
conflating multicultural and multi-religious settings with ethical relativism. The paper will also address the
question of the incommensurability of ethical traditions raised by Alasdair MacIntyre. While shunning cultural
relativism, he recommends mutual understanding of rival moral traditions through in-depth rational debates
and encounters in order to arrive at the most valid moral system.
Kilsyth
S91: Arts and Ethics Youth Session: Nuffield Council on Bioethics
Deliberative Workshop on Cosmetic Procedures
Harvey, K
Abstract
Why do people have cosmetic procedures? Does having a cosmetic procedure change more than how a
person looks? How is society affected by the growing demand for cosmetic procedures?
The Nuffield Council on Bioethics will undertake a closed deliberative workshop with invited S5 and S6
students from across Edinburgh and Lothian to discuss these questions, and to contribute to the Council’s
work on cosmetic procedures: ethical issues.
Tinto
S61: Symposium: Consent for secondary use of clinical data for
research PN: 353
1
2
4
3
Angela Ballantyne , Søren Holm , Kirstin Borgerson , James Wilson
2
Department of Primary Health Care and General Practice, University of Otago, New Zealand, Centre for
3
Social Ethics and Policy, School of Law, University of Manchester, United Kingdom, Department of
4
Philosophy, University College London, United Kingdom, Department of Philosophy, Dalhousie University,
Canada
1
Discipline(s) Research ethics
Keywords Medical research, consent, evidence, clinical records, health information
Abstract
Research is vital to progress in healthcare; and research requires data. One potentially valuable and underutilized source of data is patients’ clinical information. Open access to clinical material for research has
potential high social value in terms of big data analytics, reproducibility of research results, comparative
effectiveness studies of existing health treatments, and the capacity to develop effective ‘learning healthcare
systems’. Yet clinical records are not routinely used for research. Many jurisdictions hold that information
collected for clinical purposes cannot be used for research without patient consent. Further, the established
ethical separation between research and clinical practice inhibits the movement of data from one context to
122
another. The presentations challenge many of the underlying assumptions in existing debates about consent
in secondary research: for example, the established split between research and clinical practice; that patients
‘own’ and should control access to their personal health information; and the dichotomy between no-consent
and specific consent.
Paper 1: Research and practice are increasingly integrated in medicine. Activities characteristic of integration
include research conducted on data collected from electronic patient records and comparative effectiveness
studies. How should bioethicists, who tend to endorse a strict research-practice distinction, adapt in response
to this shift toward integrated “learning health care systems”? As some scholars have recognized, these
recent developments provide bioethicists with an opportunity to develop an integrated ethical framework. In
this presentation I will argue that any such framework should attend less to the goals of activities (for
instance, generalizable knowledge or individual patient care) and more to the aspects of those activities that
give rise to ethical concern (such as the potential for harm). Making this shift has the potential to lead to
better practices of informed consent in clinical practice, while simultaneously tempering the tendency of
bioethicists to fixate on informed consent during the prospective review of clinical research.
Paper 2: In discussions about the secondary research use of clinical data it is often explicitly stated that the
options that need to be considered in relation to consent is no consent, broad consent or specific consent;
and it is often implicitly assumed that the solution we need will apply the same consent regime either across
the board for a particular type of data, or for all ‘participants’ whose data are used in a particular research
project. The paper will argue that both the explicit statement about consent options and the implicit
assumptions are unwarranted and that we can construct consent systems that allow individuals a more
nuanced control over the use of their clinical data and samples. It will present the outlines of such a ‘metaconsent’ system and advocate for a consent system that allows individuals to exercise choice in relation to
consent options according to their own preferences.
Paper 3: A number of legal regimes (e.g. England’s section 251 of the NHS Act 2006), have a mechanism
that allows research involving health identifiable information to proceed without consent for a large population
on grounds of the impracticability of gaining consent, even though the same research project would require
the consent of all participants were the number of participants significantly smaller. This paper examines the
cogency of the reasoning involved in such decisions, arguing that it seems difficult to justify on the
assumption that in usual circumstances individuals have a right that their identifiable health information not be
used without their consent. If using someone's identifiable information without their consent would violate
their rights if they were a member of a small group, why should it stop being a violation of that person's rights
if the group they are in becomes sufficiently large?
Paper 4: In this paper I challenge the implicit assumption that patients ‘own’ their health information and
should therefore control access and use. I propose instead that clinical data is co-constructed through a
collaborative process involving the patient, the clinician, medical technology and the health system. Patients
rely on the health system to extract, interpret, process, classify and store health information. No patients, not
even those who are medically qualified, construct single-handed their own medical history, create radiology
images, test blood samples or conduct gene sequencing. Nor do patients store or manage the resulting data.
It may therefore be more accurate to conceive of clinical data as a social resource, at least in cases where
these are generated and sustained via public funds. When clinical data is created in a publically funded
environment it is plausible that both the state and the individual should have rights to access and use it.
Moorfoot
S49: Symposium: How Climate Change Compounds Social Injustice PN:
769
1,2
3,4
5,6
7,8,9
Cheryl Macpherson , Angus Dawson , James Dwyer , Bruce Jennings
1
2
St George's University School of Medicine, Bioethics Dept, St Georges, Grenada, Windward Islands
3
Research and Education Foundation (WINDREF), St Georges, Grenada, Centre of Values, Ethics and the
4
Law in Medicine (VELiM), University of Sydney, Australia, School of Public Health, University of Sydney,
5
Australia, Center for Bioethics and Humanities, Upstate Medical University, Syracuse NY, United States,
123
6
7
Department of Public Health, Upstate Medical University, Syracuse, United States, Center for Humans and
8
9
Nature, Chicago, United States, School of Public Health, Yale University, United States, School of
Medicine, Vanderbilt University, United States.
Discipline(s) Bioethics and Public Health
Keywords Climate change, health, vulnerability, justice, responsibility
Abstract
Because people are producing more greenhouse gases than the natural world can absorb and recycle, the
climate is changing. Climate change has been called the biggest public health threat of this century. It
contributes to public health problems including: heat waves, rising sea levels, natural disasters, infectious
diseases, malnutrition, water shortages, and environmental refugees. We are not all equally vulnerable to the
related health risks. Vulnerability depends on the generation to which one belongs, the geography of where
they live, the social position they inhabit, and on the wealth and governance of the society in which they live.
About 11% of the world’s population produces about half of all global emissions; their socioeconomic status
and resources render them more able to protect themselves against the harms than those who produce fewer
emissions. Such differences in emissions, vulnerability, and power raise deep issues about justice. And
issues of justice raise questions about responsibility to address injustices.
The Symposium Chair is Cheryl Macpherson, Professor and Chair of the Bioethics Department at St.
George’s University in Grenada; and editor of Bioethical Insights into Values and Policy: Climate Change and
Health (a 2016 volume in Springer’s Public Health Ethics Series). She will offer a 3-4 minute introduction to
the Symposium and its speakers by framing causes and impacts of climate change as ethical dilemmas that
manifest differently in different contexts, and calling for more attention to these dilemmas in practical and
scholarly bioethics.
The first speaker is Angus Dawson, Director of the Centre of Values, Ethics and the Law in Medicine
(VELiM), School of Public Health, at the University of Sydney, Australia; and joint editor of the journal Public
Health Ethics. His presentation will focus on the public health impacts of climate change on low- and
moderate-income countries of India and Pakistan in light of geographical and climatic characteristics of the
region; regional socioeconomic consequences; related vulnerabilities and adaptations; and ethical issues that
these considerations raise in and beyond this region. It draws from his co-authored chapter in Macpherson’s
book on impacts and ethics of climate change in countries of South Asia.
The second speaker is Euzebiusz Jamrozik, a practising clinician in Melbourne and a doctoral student at the
Monash Centre for Human Bioethics. He will discuss the increasingly recognised mechanism by which
climate change exacerbates global injustice in health outcomes: an increase in infectious disease driven by
warmer temperatures, changing weather patterns, and effects on vectors. He will argue that there is a strong
ethical case for wealthy countries to act in order to mitigate these harms and this injustice among vulnerable
populations, and discuss urgent priorities in this area of public health policy. His presentation draws from his
co-authored chapter in Macpherson’s book which tabulates and discusses infectious and zoonotic disease
burdens around the world, and uses this evidence to substantiate concerns about justice and explain why
infectious disease and climate change should concern bioethicists.
The third speaker is James Dwyer, a faculty member in the Center for Bioethics and Humanities and the
Department of Public Health at Upstate Medical University in the United States; and coordinator of the
environmental bioethics network of the IAB. He will discuss a crucial ethical question: How should we
respond to climate change? He will frame the question by outlining injustices associated with climate
change, the issue of people’s responsibility to address these injustices, and how responsibility and
responsiveness might differ with how people are situated. He proposes that social, political, and ethical
changes are called for, and asks whether many people, especially in countries with high emissions, need to
change the way they live: the technologies that they use, the social practices and institutions they participate
in, and the habits and virtues that they embody. He also draws from his contribution to Macpherson’s book.
The fourth and final speaker is Bruce Jennings, Director of Bioethics at the Center for Humans and Nature;
Senior Advisor and Fellow at The Hastings Center; and a faculty member the Yale University School of Public
Health and the Vanderbilt University School of Medicine. Building on the roles of equity and justice discussed
124
above, he will consider how understandings of liberty and autonomy will be altered in the context of
responses to climate change and argue that changing to more sustainable, interdependent modes of living
will not undermine individual autonomy but enhance it. Liberty and autonomy will find more explicit
connection with equity, justice, and solidarity in the process. He will emphasize the centrality of links between
health and climate change to practical and scholarly bioethics, and provoke audience engagement in
dialogue about the need for related work in bioethics.
Carrick 1
S75: 20 X 20 Session (B)
PN: 250
The Proactionary Principle in Environmental Ethics
1
Esteban Rossi
Universidad Javeriana, Bogota, Colombia
1
Discipline(s): Environmental ethics, ecology, resource management.
Keywords: Environmentalism, human ingenuity, risk, innovation, technology.
Abstract
Environmental ethics seeks to identify principles to guide human-environment relations. Some of these
principles, e.g. the balance of nature, were theoretically productive but either conflicted with scientific
understanding of ecological processes, or were empirically inapplicable. Using the energy-conservation
trade-off as an example, this study examines the application of the proactionary principle in environmental
ethics. As proposed by Max Moore, the proactionary principle is based on the need to protect people’s
freedom to experiment and innovate, coupled with a thorough reconceptualization of risk. Findings suggest
that the proactionary principle has much to contribute to both the philosophical and the empirical aspects of
environmental debates.
PN: 255
The Role of Ethical Analysis in Developing Neglected Tropical Disease
Policy
1
2
Ana Iltis , Kirstin Matthews
2
1
Wake Forest University, Winston-Salem, United States, Rice University, Houston, United States
Discipline(s) Bioethics, public policy, health professionals, biomedical research
Keywords Neglected tropical diseases, infectious diseases, global health
Abstract
‘Neglected tropical diseases’ (NTDs) are a group of parasitic, viral and bacterial diseases that cause serious
illnesses affecting more than one billion people globally. Many countries with high NTD burden lack the
resources for research, development, and delivery of interventions to prevent or treat NTDs. There has been
much emphasis on promoting policy development in wealthy countries to combat NTDs. This presentation
highlights some of the central ethical issues pertaining to NTD policy development and argues that ethical
considerations should be included in the policy development process. Failure to do so risks development of
feeble, ineffective, or unsustainable policy.
PN: 256
Different Understandings and Interpretations of Research Ethics and
Integrity among Biologists and Physicists around the World
1
1
Kirstin Matthews , Elaine Howard Ecklund , Steven Lewis
Rice University, Houston, United States
1
1
125
Discipline(s): Responsible conduct of research scholars, research ethicists, scientists, bioethicists, public
policy scholars
Keywords research ethics, international ethics, research integrity
Abstract
This presentation will highlight research findings from an international survey and interview project on the
social factors impacting scientists and their work. Approximately 20,000 physicists and biologists were
surveyed and more than 600 follow-up interviews were conducted in 8 different countries and regions—US,
UK, India, Italy, France, Taiwan, Hong Kong, Turkey. We will compare and contrast findings on the religiosity
of scientists, their perspectives on ethical difficulties in their work, and their perception of a science and
religion conflict. The results will help elucidate national and disciplinary similarities and differences with the
goal of improving communications and appreciation of ethical standards between national contexts.
PN: 49
Practices of Zambian Investigators and Research Ethics Committees
(RECs) Regarding Monetary and Non-monetary Goods Offered to Study
Subjects in Zambia
1
2
2
2
2
Chrispin Mweemba , Adnan Hyder , Nancy Kass , Joe Ali , Kristina Hallez
2
1
University of Zambia, P.O Box 50110, Lusaka, Zambia, Johns Hopkins Bloomberg School of Public Health,
Baltimore, USA
Discipline(s) Health Economics, Bioethics
Keywords Incentive, Inducement, Reimbursement, Compensation, Ethics
Abstract
Offering incentives to study participants is a common practices in research. It remains unclear, however, how
investigators decide on whether, and to what degree to offer these incentives, especially in developing
economies where research is limited. Debates are ongoing on whether incentives can cause participants to
join studies that they would otherwise not join. This study aims at understanding factors that Zambian
investigators and Research Ethics Committees (RECs) consider when deciding whether, the type and
quantity of incentive to offer participants. REC chairpersons and a sample of local investigators will be
interviewed using a cross-sectional study design.
PN: 538
Assent for Pediatric Research: What Information Should Be Disclosed?
1,2
Vilius Dranseika
2
Department of Logic and History of Philosophy, Vilnius University, Vilnius, Lithuania, REMEDY, Research
Ethics in Medicine Study Group, Jagiellonian University Medical College, Krakow, Poland
1
Discipline(s) Research Ethics
Keywords Assent, Disclosure, Pediatric Research, Autonomy, Decision-making
Abstract
According to international regulations as well as national regulations in a number of countries, children
participating in biomedical research should be involved in decision-making concerning their research
participation. There are, however, no detailed discussions in the literature on how precisely should the
content of disclosure be determined.
In this presentation, I claim that the issue of the content of disclosure should be seen in the light of
justifications of involving children in decision-making concerning their participation in research, such as
children’s rights, respect for a child’s developing autonomy, and the best interests of the child.
126
PN: 638
A Learned Society Founded in the Digital Era: ELSI2.0 is Responding to
Challenges Faced by ELSI Researchers, and Providing New
Opportunities
1
1
2
Sarah Coy ,Jane Kaye , ELSI2.0 Steering Committee
2
1
University of Oxford, United Kingdom , ELSI 2.0 Collaboratory, HeLEX – Centre for Health, Law and
Emerging Technologies, University of Oxford, United Kingdom
Discipline(s): ELSI
Keywords: ELSI, ESR, Collaboration, Networking, International
Abstract
In 1990 as part of the Human Genome Project the USA committed to support academic scholarship into the
ethical, legal and social implications (ELSI) of genetics and genomics, bringing together expertise from social
science, philosophy, law and ethics. 15 years on we reflect on progress that has been made internationally to
support ELSI research, and discuss challenges faced by those striving to establish themselves in this
emerging field. We discuss how the ELSI2.0 Collaboratory is using online resources to stimulate and support
international collaboration, connect disparate academics and offer new opportunities for researchers to
discuss their work.
PN: 659
Global Clinical Trials: Surveying the Community Landscape
1
Morven Shearer
1
University of St Andrews, United Kingdom
Discipline(s) Global Bioethics
Keywords global; trials; community; engagement; benefit-sharing
Abstract
When considering the ethics around global clinical trials the focus is often on the interaction and engagement
with the local community and participants. Taking a broader view, there are a number of other groups that
could also be characterised as ‘communities’ in clinical trials research – who are they and how do they
interact? Focussing on a large TB drug trial in Africa our scoping study seeks to identify and characterise the
distinct communities and map the relationships between them, the drivers, responsibilities and expectations.
A good understanding of this landscape will benefit future trial design, coordination and conduct.
PN: 785
Protecting Human Subjects in the New Research Regime
1
Lisa Rasmussen
1
University of North Carolina, United States
Discipline(s)Philosophy, Research Ethics
Keywords: Citizen Science, corporate research; human subject protection
Abstract
The current approach to human research subject protection assumes a certain picture of such research that
no longer holds. Research is increasingly being conducted by private corporations, patient groups not
affiliated with conventional institutions, “citizen scientists,” and private citizens. The field of bioethics must
consider alternative protections for human subjects in this new research regime. I outline the problem and
explore alternative protections, including minor alterations to the current system; hybrid public/private
approaches; discipline-based oversight; and purely private solutions. My conclusions are that the new
regime will require a granular approach, and that this will vary from country to country.
127
Carrick 2
S5: Research and Communities
Chair: Haimes, E
PN: 350
Neuroethics, Neuroscience, and Non-Human Primates
Tom Buller, Illinois State University, United States
Abstract
Discussions between science and ethics about the mentality and moral status of nonhuman primates NHP
often stall on account of the fact that the properties that ethics presents as evidence of NHP mentality and
moral status, namely consciousness and sentience, are not observable “scientifically respectable” properties.
In order to further discussion between science and ethics it seems, therefore, that we need to identify
properties that would satisfy both domains. Within neuroethics there has been considerable discussion
regarding the identification of neurological factors that influence moral decision-making, free will, and the
identification of consciousness and other mental states though neuroimaging. All of these factors are
regarded as scientifically respectable and have been understood to have normative conclusions, and all of
them apply to some degree to non-human primates.
PN: 234
‘Paid to Endure’: On Paid Research Participation, Passivity, and the
Goods of Work
1
Erik Malmqvist
Linköping University, Sweden
1
Keywords - clinical research; distributive justice; ethics; payment; work
Discipline(s) - Philosophy
Abstract
The increasing globalization of clinical research and its growing reliance of paid developing world volunteers
who depend on trials for their livelihood underscore the need to scrutinize the widespread practice of paying
research participants. Previous ethical analyses of this practice have primarily focused on concerns about
“undue inducement” and exploitation. However, these concerns are not specific to the research setting but
apply to many regular occupations as well. And like in these occupations, they can be accommodated by
different regulatory measures. Thus, these concerns do not speak against paying research participants, but
rather in favor of conceiving and regulating paid participation as a form of work. This presentation explores
another concern about paying research subjects that remains comparably neglected. Elliott and Abadie have
noticed that unlike other workers, subjects are not paid to produce or achieve anything, but rather to have
unpleasant and potentially degrading things done to them. They are “paid to endure”. I discuss how morally
weighty this concern is, whether it is specific to the research setting, to what extent it can be accommodated
by regulatory measures, and whether it ultimately undermines the conception of research participation as
work. To answer these questions, I draw on recent analyses in political philosophy on the goods and bads of
work as objects of distributive justice. Thus, my presentation contributes to the ongoing shift from an
individual to an institutional/structural focus in research ethics.
PN: 41
Developing an Integrative Concept of Vulnerability in Human Subjects
Research
1,2
1,2,3
Dearbhail Bracken-Roche , Eric Racine
2
1
Neuroethics Research Unit, Institut de recherches cliniques de Montréal, Canada, McGill University,
3
Canada, Université de Montréal, Canada
Keywords - Vulnerability, research ethics, literature review, concept analysis
128
Discipline(s) – Bioethics, neuroethics
Abstract
In the context of human subjects research, it is commonly accepted that some subjects are more vulnerable
than others and that there exists a moral obligation to pay special attention to and provide
additional protections for these subjects. However, the central protective role vulnerability is intended to play
in research is undermined by the fluidity with which the concept is used and the lack of explanation or
agreement between research guidelines about what vulnerability is. This research seeks to (1) review the
range of definitions provided in the literature, and (2) propose an integrative concept of vulnerability, drawing
on the existing literature. We conducted a database search to identify literature addressing the conceptual
definition of vulnerability in research ethics, including peer-reviewed literature, book chapters, and grey
literature. Articles were analysed for conceptual definitions of vulnerability or vulnerable subjects, and we
identified any concepts used to explicate these terms. Inspired by a previous method used to integrate a
large body of literature (Makoul and Clayman 2005), we propose a definition of vulnerability that synthesizes
and integrates the key conceptual elements identified through our analysis.
PN: 425
Gendered Negotiations for Research Participation in Community-based
Studies: Implications for Ethics and Health Research in Kenya
1,2
Dorcas M. Kamuya
2
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya, The Ethox Centre, Nuffield Department of
Population Health, University of Oxford, United Kingdom
1
Abstract
There is a growing literature documenting the complex realities of consent processes in the field, and the
negotiations and ethical dilemmas involved. Much has also been written about how gender and power shape
household decision making processes. However, these bodies of literature have rarely been brought together
to inform research practice in low-income settings. In this paper, we analyse data from a large study
conducted on the Kenyan Coast to explore how gender and power relations within households and
communities and between field workers and communities shape consent processes and interactions, and
consider the implications for health systems research. Across diverse forms of household, significant
consultation was observed on whether or not to participate in research. Although male members and
household heads are typically described as household decision makers in our setting, including for research,
in practice decision-making processes are often far more nuanced, with many women using their agency to
control, albeit subtly, the decisions made. Where decisions are made without adequate consultation of
women, many find strategies to exercise their choice, in ways that safeguard important relationships within
households in the longer term. The gender of field staff who typically conduct research activities in the field,
including consent processes, can influence household decision-making processes. It is essential that frontline
field staff conducting community-based health research, and their supervisors are aware of the realities and
implications of complex processes at household level, and that they develop appropriate approaches that
support ethical practice.
Carrick 3
S30: Treatment and care
Chair: Mitchell, C
PN: 482
The Learning Healthcare System: Dissolving the Distinction Between
Research and Care to Solve the Evidence Base Problem in Paediatrics
1
Martine Charlotte De Vries
1
Leiden University Medical Center; Department of Medical Ethics and Health Law, Leiden, Netherlands
129
Keywords - Learning Healthcare Systems; Paediatrics; Evidence Based Medicine; Research-care
distinction; Oversight policies
Discipline(s) – Research ethics; Paediatrics
Abstract
Much of paediatric care lacks evidence-based support. Up to 70% of daily prescribed treatments have not
been adequately tested in children, sometimes resulting in ineffective or even harmful treatments being given
and beneficial treatments being withheld. Worldwide, paediatricians called for action to overcome this
evidence-base problem. Solutions were sought in expanding the current research regulations to make more
(risky) research possible, especially in phase 1-2 trials. EU law, for example, now accepts more than minimal
risk in non-therapeutic research. I will argue, however, that this does not solve the evidence-base problem.
Current regulations are based on a sharp distinction between research and care. Accepting more research
risks upholds the potential under-regulation of innovative (non-research) projects and usual care practices,
and gives no incentives to study current (unproven) practice. The present oversight system also
overregulates risk-free evaluation research (e.g. comparative effectiveness research), although of crucial
importance for assessing everyday treatments. For this research, current review and consent requirements
overburden researchers and patients. I will subsequently argue that the idea of a Learning Healthcare
System (LHS) can truly overcome the evidence-base problem. LHS promotes review and consent that, rather
than being based on a distinction between research and practice, is commensurate with risk and burden in
both realms. Focus is on continuous evaluation of daily care through research. The societal goal of a just and
high-quality paediatric healthcare system is not met by intensifying high-risk research on rare diseases, but
can only be achieved by making continuous learning the moral mindset.
PN: 729
MUPS – Medically Unexplained Physical Symptoms – How Physician
and Patient Narratives Construct Meaning when Confronted by
Uncertain Diagnoses
1
Chloe Atkins , Keith Brownell
1
University of Calgary, Canada
Keywords - Hermeneutic Research, Diagnosis, MUPS, doctor-patient relations, Feminist Bioethics
Discipline(s) - Qualitative health research, bioethics, medical sociology
Abstract
Medically Unexplained Physical Symptoms can prove to be the bane of the patient and physician. Our study,
financed by a Canada Institute of Health Research Ethics Catalyst Grant: “Best Ethical Practices in Managing
Uncertainty in Medical Diagnosis: An Investigation of Ethical Principles Applied to Decision-making”, takes a
phenomenological approach to patient and practitioner experiences of uncertain diagnoses. We conducted
open-ended interviews in 2 large Canadian cities (Calgary and Vancouver) both with MUPS patients and,
with specialist and family physicians. After reviewing our data, we reached thematic ‘saturation’ at both sites
and in both populations. Our interviews reveal that patients loathe being diagnosed with “stress-related”
illness and, physicians dislike attributing illness to psychological causes. Both patients and practitioners can
feel as though they are antagonists in dealing with uncertain symptoms.. Yet, both populations acknowledge
that a good therapeutic relationship between doctor and patient is key to symptom management. Given the
thematic predominance of communication and trust between a MUPS patient and MD, we propose a rubric
that may help both clinician and layperson navigate MUPS more successfully. In doing so, we try to address
concerns about medication, psychological and, other interventions. Conclusion: overall themes of good
relations and strong communication emerge from this qualitative, experiential study. It is an example of the
manner in which ‘the arts” (through personal narrative) and the social sciences (through qualitative research
methodologies) can contribute to the understanding and treatment of illness. In sum, we distill meaning out
of experience. As such, we propose a tentative rubric in approaching MUPS. Further, we recognize that
more research in pediatric populations as well as with other health professions will also be key to the ethical
management of uncertain diagnoses in the future.
130
PN: 312
Preparing for the Future by Looking at the Past: The Biopolitical
Fragmentation of Terri Schiavo
1
Tyler Gibb
Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, USA
1
Abstract
It has been over a decade since Terri Schiavo died. The drama the unfolded on television screens and
across the media between her husband, Michael Schiavo, and her parents, Robert and Mary Schindler,
captivated millions of people all over the globe. Fifteen years before her death, Terri collapsed in her
apartment after suffering a cardiac arrest. She suffered devastating anoxic brain injury, which left her in a
condition known as the persistent vegetative state. Over time, her husband and parents, who were initially
unified in a commitment to get her the best treatment available, slowly drifted in different directions regarding
how they believe she would be wanted to be treated as her prognosis became more certain. The dispute
between them eventually entered the court system and captured the attention of the national international
media. Despite hundreds of newspaper and magazine articles, blog post, academic articles, books and
countless hours of television and radio coverage of what has become known as the Terri Schiavo case,
several important questions remain unanswered. Why did this case, which is widely regarded as the most
intensely media-saturated end-of-life bioethics case is history, hit the public spotlight? In a country where
similar end-of-life decisions are made on a daily basis, what was unique about this case that propelled it into
the national and international consciousness? Was the Schiavo case merely an anomaly, or does it represent
something more fundamentally problematic about medicine, the law, and our society? In this paper, using the
Schiavo case as an analytical lens, I offer ways to address these important questions. I argue that the
development and notoriety of the Schaivo case is due to a fundamental societal shift—what I describe as
biopolitical fragmentation. By reinterpreting the biopolitical theory of modern philosophy since Foucault, I
argue that the radical fragmentation seen in the Schiavo case is understandable as symptomatic of a societal
shot in how the human body, understood in its broadest sense, is fragmented through the institutions of law,
medicine, and society. This presentation will highlight how this analysis illuminates a few specific fragments in
the Schiavo case—the persistent vegetative state, and the role of popular media. By looking carefully at the
Schiavo case, future cases that challenge the foundation of societal assumptions about good and bad in the
delivery of health care can be better anticipated and meaningfully engaged.
PN: 183
The Role of the Profession in End-Life Decisions Between Patient’s
Autonomy and State Regulations
1
Eduardo Rivera-Lopez
Conicet, Buenos Aires, Argentina
1
Keywords: medically assisted death; medical profession; special duties; state regulation
Discipline(s): bioethics
Abstract
The discussion on medically assisted death (active euthanasia and assisted suicide) (MAD) has mostly been
carried out at two levels: the purely moral and the ethical-legal one. From the first perspective, the question is
about the moral justification of the act of killing (or assisting the death of) a terminally ill patient. From the
second, the question is whether such kind of act should (or should not) be legally allowed. The role of the
medical profession and its ethical duties as collective agent has been less discussed in connection to MAD,
except to argue against legalization with arguments such as that professional ethics, since Hippocrates,
prohibits doctors to kill, that the medical profession is not in the business of killing, and similar ones. My
purpose in this paper is to argue that, in many cases of terminally ill patients, there are ethical reasons to
legalize MAD, which are based on professional duties toward those patients. I want to explore the idea that
medicine (as an institutional agent) bears a specific kind of responsibility for harms related to medical
treatment. Once medical treatment has exhausted its capacity to cure, doctors are (at least in many cases)
not entitled to just “withdraw” from a patient’s life and reaffirm the sacred principle of not killing. Terminally ill
patients have a right to MAD against doctors, not only because their condition is, all things considered,
harmful for them, but also because it is medicine that, to some extent, has contributed (even if not
131
intentionally) to place them in this particular and unfortunate situation. MAD may, at least in many cases, be
the only way to stop an ongoing harm for which the medical profession bears a kind of “moral strict liability”.
Harris 1 & 2
S23: Balancing Interests
Chair: Townend, D
PN: 379
Balance Between Individual Rights versus Societal Needs in Expanded
Access
1
1
1
Nikkie Aarts , Eline M. Bunnik , Suzanne van de Vathorst
1
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC - University Medical Center
Rotterdam, Netherlands
Keywords - Clinical trials, expanded access, ethical issues, drug development
Discipline(s) – Medical ethics, pharmacology
Abstract
Unapproved [investigational] drugs can be prescribed by physicians through expanded access programmes
for seriously ill patients without standard options. Expanded access is a treatment option, and not an
experiment in a research setting. Concerns have been raised that expanded access will direct resources (i.e.
funds and manpower) and eligible patients away from clinical research. As a consequence, expanded access
may undermine research that benefits society. However, individual pleas from mortally ill patients often
receive a lot of support and put pressure on drug developers to provide an investigational drug. Recent
initiatives to facilitate access to investigational drugs will increase demand from patients. How can
pharmaceutical companies ensure that marketing authorization of drugs will not be hampered or slowed
down by expanded access? One possibility is to collect observational real-world data on quality of life and
outcome measures in expanded access programmes. The data can be used to evaluate what will happen in
a “real” patient population, and to accelerate HTA decisions on reimbursement. However, opponents raise
issues such as the limited scientific value of the data, the extra burden on physicians and patients, and the
possibility that patients are exploited. I will discuss whether data collection in expanded access can serve
both the needs of seriously ill patients and of society as a whole.
PN: 415
Caring for the Ageing Mind: Balancing Individual Responsibilities and
Collective Benefits of Healthy Cognitive Ageing
1
Cynthia Forlini
The University of Queensland Centre for Clinical Research, Royal Brisbane and Women’s Hospital, Australia
1
Keywords - neuroethics, cognitive ageing, brain health, public health, policy
Discipline(s) – Neuroethics, public health
Abstract
As the world’s population ages, governments and non-governmental organizations in developed countries are
promoting cognitive health to reduce the rate of age-related cognitive decline and sustain economic
productivity in an ageing workforce. Recommendations from the Productivity Commission (Australia),
Dementia Australia, Government Office for Science (UK), Presidential Commission for the Study of Bioethical
Issues (USA), Institute of Medicine (USA), among others, are encouraging mental, physical, and social
activities, to maintain cognitive health in later life. Prioritizing cognitive health is a beneficial strategy on
economic and public health levels. However, it is unclear whether these economic motivations and prevention
strategies resonate with the ageing population on individual and social levels. In this presentation, I address
these individual and social interests. First, I demonstrate that the policy and popular messages about healthy
cognitive ageing imply an individual responsibility to care for the ageing brain. Second, I argue that this
132
approach to healthy cognitive ageing is challenged by social factors including: (1) the influence of socioeconomic factors on lifestyle, (2) the role of stigma in the marketplace for products related to healthy
cognitive ageing and (3) the emphasis of economic benefits over the individual benefits. This analysis of
policy recommendations for healthy cognitive ageing will help to understand the expectations and pressures
that ageing individuals face as they grow older in a society that values productivity. I propose that policies can
balance the interests of society and ageing individuals if stakeholder preferences and perspectives are
examined and incorporated into recommendations for healthy cognitive ageing.
PN: 136
When Bioethics Meets Law: Judging the Best Interests of Minimally
Conscious Patients
1
1
Giles Birchley , Richard Huxtable
University of Bristol, United Kingdom
1
Keywords - Law; judges; bioethics; best interests; welfare; minimally conscious state
Discipline(s) – Bioethics; law; applied ethics
Abstract
The “best interests” standard offers an insight into the cross-pollination of law and bioethics, yet the extent to
which the respective understandings coincide is under-explored. While the standard is familiar internationally,
our Wellcome Trust-funded research focuses on English law, where best interests guides judgments about
the (non-)treatment of incapacitated patients. Our findings offer insight into judges’ (explicit and implicit)
engagement with bioethical debates. Focusing on (non-)treatment decisions for patients in a minimally
conscious state (MCS) we examine whether, or to what extent, bioethical understandings of best interests are
echoed in legal judgments. By analysing the bioethics literature and legal judgments, we detail: the
(bio)ethical values associated with the standard in these decisions; and the values captured and the
weighting(s) acquired in judges’ uses of the standard. Given its ambiguities, the MCS diagnosis invites
debate about the mobilisation of values within the best interests standard. Analyses of (and judgments within)
medical law tend to emphasise respect for autonomy, while this presentation looks beyond that value to the
patient’s welfare, more broadly. Existing bioethical studies, meanwhile, tend to concentrate on the values of
patient proxies and healthcare professionals, but not on legal officials (like judges). By analysing the values
that are brought into play in legal judgments about best interests in MCS we explore judges’ engagement with
bioethics. This deepens our understanding of best interests in particular cases, and informs a broader
narrative about the best interests standard across a range of bioethically-charged cases.
PN: 43
Sex Selection and a Parent’s Right to an Open Future
1
Tamara Browne
Australian National University, Australia
1
Abstract
It has been argued that assumptions about gender impede a child’s right to an open future by foreclosing
certain opportunities which could have been available if the parent were not so encumbered by unfounded
assumptions or biases. Yet parents also have a right to an open future unencumbered by unfounded
assumptions about gender which constrain what they believe is possible in parenting a boy or a girl. As
shown by studies of the reasons parents give for wishing to select the sex of their child, what ultimately
motivates parents to undergo sex selection is an assumption that a child of a certain sex will conform to the
gender roles, norms and stereotypes typically associated with that sex. While the potential impact of such
assumptions on a child’s autonomy has previously been raised, the literature has overlooked the impact of
these assumptions on another aspect of parental autonomy – the perceived freedom to have the sort of
childrearing experience one desires. I present the reasons why parents prefer to have a child of a particular
sex and how gender essentialism underlies these reasons. Given the scientific evidence thus far, it appears
that gender essentialism is unjustified and unduly restricts expectations regarding the nature of, and
possibilities for, parenting a child of either sex. Parents seeking sex selection therefore fail to realise that their
wishes could potentially be fulfilled by a child of either sex if they are willing to transgress social norms and
133
prejudice. A parent’s right to an open future is thus undermined by the gender essentialism inherent in, and
reinforced by, sex selection.
Ochil 1&2
S22: Economic Interests
Chair: Schmidt, H
PN: 16
Setting Specific Marketing Requirements for Emerging Medicinal
Products and Medical Devices Incorporating Nanomaterials: Promoting
Patient Safety or Hindering Development and Trade?
1
Samvel Varvastian
1
Mykolas Romeris University, Vilnius, Lithuania
Keywords - Nanomedicine, medicinal products, medical devices, patient safety, marketing requirements
Discipline(s) – Law, Bioethics
Abstract
The main challenge posed by the emerging field of nanomedicine is the high level of scientific uncertainty
surrounding the application of nanoparticles in medicinal products and medical devices. Although there is no
data explicitly showing the unacceptable level of risk to patients, some studies have suggested that certain
nanoparticles may show acute toxicity. Unfortunately, the toxicological effect of nanoparticles does not
always fit into the current risk assessment framework as many existing safety standards are simply
insufficient. Therefore, a question may well be addressed whether the marketing of nanomedicinal products
should be subjected to specific legal scrutiny to enhance patient protection. The presentation uses a complex
interdisciplinary approach by considering the existing state-of-the-art of nanomedicinal products and
assessing it through the lens of law and bioethics..The different approaches adopted by institutions and
scholars have deterred legislators from developing a clear regulatory strategy, thus specific provisions on the
marketing of medicinal products and medical devices containing nanoparticles are still universally lacking.
Eventually, this may compromise patient safety and cause the entire field to be stigmatised.
PN: 561
Private Profits for the Public Good: Is There a Fair Price for Medical
Products of Human Origin?
1
Dominique Martin
1
The University of Melbourne, Australia
Keywords - Commodification; blood donation; organ and tissue donation; market ethics; health equity
Discipline(s) – Bioethics; applied ethics
Abstract
There is widespread international consensus among policy makers and health authorities that medical
products of human origin (MPHO) such as blood, tissue, and organs for transplantation should not be bought
and sold, but that manufacturers and professionals are entitled to recover the costs associated with
processing and distributing these “exceptional” health products. Yet in practice many such products are
exchanged within lucrative domestic and international markets. This poses two key dilemmas: (i) What
constitutes a “fair” price for MPHO? (ii) Does commodification of MPHO within the broader economy of
healthcare goods and services justify the payment of donors of the biological materials used to create them? I
address here the first question, arguing that it must be answered prior to the second. The notion of a “fair”
price for MPHO has been previously considered in the context of donor payments, but not for MPHO as such.
I draw on the World Health Organization’s explication of reasonable cost recovery in the context of human
cells, tissues and organs, to develop a practical framework for distinguishing between “reasonable” and
134
“undue” prices for MPHO. This framework and its normative implications are then analysed using principles of
justice. It will be argued that the distinction between “reasonable cost recovery” and “undue profit” in
economies of MPHO can best be made at the principled level. Irrespective of the exchange price associated
with specific products, the profits that may be accrued in MPHO markets may be unjust in the context of
unpaid public donation systems.
PN: 147
Medical Crowdfunding by Canadians
1
Jeremy Snyder
1
Simon Fraser University, Canada
Keywords - Medical Crowdfunding; Canada; Equity; Privacy; Justice
Discipline(s) – Philosophy; Bioethics
Abstract
One common form of crowdfunding is for expenses related to medical care. Canadians are presently using
medical crowdfunding campaigns in order to address their medical and related need. While medical
crowdfunding campaigns are generating increased media attention. Little is known about why Canadians with
medical problems use medical crowdfunding campaigns, what benefits they receive from these campaigns, to
what degree their fundraising and other goals are met through these campaigns, and what obstacles or other
problems they face when using these websites. In this talk, I present findings from medical crowdfunding
campaigns by Canadians with a focus on ethical issues raised by these campaigns. We thematically
analyzed the content of crowdfunding campaigns with the aim of improving our understanding of why
Canadians initiate these campaigns, including demographic information about the intended beneficiaries of
these campaigns; what resources and dollar amounts are being targeted; how successful campaigns are in
meeting these goals; what language is used to motivate giving; what positive and negative references are
made to the provision of health care in Canada; and what expectations are expressed for medical outcomes
resulting from to the funds raised in the campaign. Conclusions: ethical dimensions of medical crowdfunding
campaigns by Canadians have not previously been explored. We conclude that they raise a host of ethical
concerns, including fraud and misinformation, fairness among users, perpetuating systemic injustice,
inefficient use of resources, loss of privacy, and shifting health care’s valuation.
PN: 402
Fairness, Ethics, and Policies of Using Genetic Information in Life
Insurance Risk Classification
1
Anya Prince
Center for Genomics and Society, Chapel Hill, United States
1
Keywords - Genetic discrimination, life insurance, actuarial justification, international policy, public health
Discipline(s) – Law, Bioethics
Abstract
There is ongoing debate over life insurer use of genetic information between advocates for equal access to
insurance and advocates for economic stability in the insurance industry, with both sides employing moral
terms of fairness. Relevant policy discussions tend to focus on whether life insurers should use genetic
information, but have not often explored when and how information can currently be used. These potential
uses raise ethical and legal considerations beyond the overarching normative question. For example, if a
woman has a BRCA1 mutation, is it just for an insurer to assign a higher risk category or should they
consider available preventive modalities that lower her risk of breast cancer to below the general population?
I conducted a review of literature addressing economic and social fairness and life insurer use of genetic
information. Next, I applied five established features relevant for evaluating the accuracy and fairness of risk
classification systems (separation, reliability, incentive value, homogeneity, and admissibility) to different
types of genetic information. This highlighted the tensions and compatibility between scientific evidence and
economic and social fairness. In addition to these results, I will present examples of country policies limiting
life insurer use of genetic information. Conclusion: use of genetic information by life insurers is often a
lightening rod issue pitting values of social and economic fairness against one another. By examining the
135
legal requirements of fair risk classification systems, this presentation deepens the debate surrounding just
and ethical insurer use of genetic information.
Ochil 3
S64: Symposium: Global Geroethics: Rowe & Kahns’s Successful
Ageing Model PN: 598
1
2
3
1
Hans-Joerg Ehni , Maartje Schermer , Sridhar Venkatapuram , Selma Kadi
1
2
Institute for Ethics and History of Medicine, University of Tuebingen, Germany, Dept. Medical Ethics and
3
Philosophy, Erasmus MC, University of Rotterdam, Netherlands, Global Health & Social Justice, King's
College London, United Kingdom
Discipline(s) Global Bioethics, Moral & Political Philosophy, Gerontology
Keywords Successful Ageing, Geroethics, Capabilities Approach, health equity, older people
Abstract
Throughout human history only a small percentage of human beings born lived to the age of 60 or more.
Now, it is likely that most human beings will live past 60 in rich, middle and low income countries. In many
countries, a growing proportion of society living longer combined with decreasing birth rates is leading to
significant demographic changes often described as ‘population ageing’ (PA). PA can be understood to be an
important human achievement as individuals and societies worldwide value living a full life span as well as
living longer, all other things being equal. Yet, PA also presents challenges in multiple domains, including
ethics. Bioethicists have previously considered healthcare rationing and the elderly. But there has been little
ethical work on ageing from the perspective of individual wellbeing over the life course, older people and
social/health inequalities, global inequalities and ageing, ageing and sustainability, et cetera.To motivate the
nascent area of ‘geroethics’, this symposium brings together experts in gerontology ethics, health justice,
global ageing policies, and the ‘successful ageing’ model.
Speaker 1 (Ehni): Introduction to the Concept of “Successful Ageing” and its Ethical Aspects
“Successful ageing” as put forward by Rowe and Kahn is contrasted against “normal ageing”. It is
characterized by three main components: low probability of disease and disability, high cognitive and physical
functional capacity, and active engagement with life. Ageing better than “normally” is possible for individuals if
they pursue particular strategies regarding their health behaviour, nutrition, physical activities etc. The
concept has become highly influential in gerontology and in policy making especially in the USA, but it also
has met important criticism. However, although its shortcomings seem obvious from an ethical or bioethical
perspective, there has been no corresponding critical reflection. Some of the possible major criticisms include
a lack of a normative foundation of the choice for the criteria of “successful ageing”, neglect of individual,
neglect of cultural difference and of global ageing, overstatement of individual responsibility for health
outcomes and a neglect of social determinants of health.
Speaker 2 (Schermer): Concepts of Successful Ageing and Cultural Difference
The starting point of Rowe and Kahn’s conceptual distinction between usual and successful aging, was the
recognition that previous research had neglected the substantial heterogeneity among non-diseases elderly
people, “both within cultures and between cultures” (Rowe & Kahn 1987, 143). However, recent critiques on
models of successful aging point towards the neglect of differences in income, class, gender, race, ethnicity
and culture, and claim that lay people’s views of successful aging (their values and attitudes) are
incorporated insufficiently. Critics also point to the cultural bias of successful aging “with its implied sense of
individual accomplishment that is incompatible with the cultural understandings of life and aging held by many
people across the world with diverse cultural backgrounds.” In my paper I will discuss why this is not only a
conceptual, but also an ethical problem.
Speaker 3 (Venkatapuram): Theory of the Good Life and “Successful Ageing”
The WHO World Report on Ageing and Health released in 2015 included in it a definition of healthy ageing
that relied heavily on the capabilities approach. The implications are that the WHO not only seeks a
conception of wellbeing of older persons in terms of capabilities but also the ethical or justice claims of older
136
persons to capabilities worldwide. This paper compares and contrasts the capabilities approach to ageing
and Rowe & Kahns’s successful ageing model. While there is likely to be large overlap, the differences may
be more illuminating for both sides. In particular, the paper will explore whether the universalism that is so
often assumed in biomedical models holds when confronted with facts of life in poor countries. And second,
whether the capabilities approach conceptions of minimum wellbeing/health have neglected the unique needs
and issues of older persons.
Speaker 4 (Kadi): Successful Ageing and Global Ageing Policies
The paper discusses models for ageing well promoted in global ageing policies, analysing documents from
the WHO (Active Aging, 2002; World Report on Ageing, 2015), United Nations (Vienna International Plan of
Action on Ageing, 1983; Political Declaration and Madrid International Plan of Action on Ageing, 2002),
European Commission (Healthy Ageing: a Challenge for Europe, 2007) and OECD (Policies for Healthy
Ageing: an Overview, 2009). It contextualizes the successful ageing model in a discussion of its rivals,
namely active and healthy ageing. Whereas policies for healthy ageing differ from those for successful
ageing, active and successful ageing approaches are closer. Compared to successful ageing, active and
healthy ageing have been much more important for global ageing policy. If the successful ageing model is
thought of as a possible model to be used for policy on the global level, this highlights several of its
shortcomings, such as the emphasis on lifestyle change, the definition of good life in later life and the neglect
of social inequalities and global inequities.
137
2016
Edinburgh
138

Carrick 2

Transcription

Similar documents

Ethics

..J New York-Presbyterian

Summary - Institute of Business Ethics

Napp Code of Ethics

Good Value Judgement - Malaysian Institute of Accountants

Here - Rotary Club of Harrisonburg

fantome windjammer

it is much more difficult to cheat or steal when you know the boss isn

Weaving a Moral Ecology

Speaker Profiles - Keck Graduate Institute