Biobank networks, medical research and the challenge of globalisation

Dr Lisa Dive1, Dr Edwina Light1, Miriam Wiersma1, Prof Ian Kerridge1, A/Prof Wendy Lipworth1

1University Of Sydney, University Of Sydney, Australia

Biobanks are increasingly being linked together into networks in order to maximise their capacity to identify causes of and treatments for disease, and there is great optimism about the potential of biobank networks to contribute to personalised and data-driven medicine. However, there are also ethical concerns about, among other things, risks to personal privacy and exploitation of vulnerable populations. These concerns are magnified and increase in complexity as biobanks network across international borders.

This workshop will centre around an interactive exercise. Groups of workshop participants will be assigned roles such as tissue donors, biobank researchers, and ethics committee members. From these perspectives they will work through a series of scenarios involving sample and data networking and sharing, to articulate the ethical considerations raised in the context of biobank networking practices.

This interactive exercise will be complemented by presenters briefly describing elements of a current NHMRC-funded research project analysing the ethical, legal and and social issues raised by biobank networks and the challenge of globalisation. A comprehensive study of the attitudes and practices of Australian biobanks has been conducted alongside a survey of the Australian public, to assess their attitudes to tissue and data sharing. This has been complemented by conceptual analysis demonstrating how theories of globalisation can be of practical benefit in helping researchers, institutions and regulators to understand and manage the ethical issues raised by the internationalisation and commodification of tissue. An ethical framework is being developed to articulate the underlying values and ethical principles relevant to evaluating global tissue governance, informed by a panel of legal and regulatory experts.

Following the interactive exercise, preliminary findings from the current research will be presented and discussed in relation to the outcomes of the workshop.

The below table indicates the proposed structure for a workshop:

Introductory presentations:

  • Australian biobanks: empirical study of policy and practice 5 min
  • Survey of general public 5 min
  • Conceptual / theoretical analysis 5 min
  • Legal and regulatory analysis 5 min

Biographies:

Lisa Dive has a background in analytic philosophy and professional experience in health policy, and is now a postdoctoral research fellow at Sydney Health Ethics. Her research explores the challenges that emerging medical technologies – such as genomics – pose for fundamental concepts in medical ethics. She currently has a particular focus on patient autonomy, examining how it comes under pressure in information-intensive areas of medicine, and the epistemic challenges that arise with increasing complexity of medical knowledge.

Edwina Light is a postdoctoral research fellow at Sydney Health Ethics at the University of Sydney. Her doctoral work examined the use of involuntary psychiatric treatment in community settings. Her ongoing research interests are focused on the intersections between ethics, policy and law, which include an emphasis on mental health ethics, health policy, and the use of qualitative methodologies.

Miriam Wiersma is a research assistant at Sydney Health Ethics at The University of Sydney. She is currently doing a Master of Philosophy at Sydney Health Ethics with a project entitled – The allure of biomedical innovation: what are the social and psychological drivers for doctors’ use of innovative treatments? Her areas of interest include power, status and stigma processes within the medical profession, conflicts of interest in biomedical research and clinical practice, as well as clinical practice innovation.

Doing bioethics: (How) should we engage with those we critique?

Jane Williams1, Christopher Mayes1, Wendy Lipworth1

1 Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25) University of Sydney, NSW 2006 Australia

Successful research is increasingly characterised as that which has ‘impact’, engages with stakeholders, and informs policy and practice. However policymakers can be slow to respond to evidence and practitioners can be hostile to recommendations. These problems may be greater for bioethicists as our work often adds further nuance to already complex issues and may involve critiques of those whose engagement is sought. At best, our work tends to be viewed as peripheral in the eyes of policymakers and practitioners and it can be difficult to even find a voice in “real world” debates. In this workshop, we will generate discussion about the challenges faced by bioethicists who want to both critique current practice and influence policy and practice. We will begin by describing our attempts to engage with the Assisted Reproductive Technology (ART) industry on our work in conflicts of interest (COI). Following recent media focus on perceived COI in ART in Australia, we wrote a paper which called for debate and set out clear parameters for deliberation. Response from reviewers was positive yet the paper remains unpublished, ostensibly because it lacks “primary source evidence”.  There was also acknowledgement of the controversial nature of the topic and potential to alienate their professional readers.

We will use this experience to prompt group discussion, asking:

  • Should bioethicists strive to engage with stakeholders and influence policy and practice? If so, how?
    • How can bioethics research most effectively find its voice?
    • How can different conceptions of evidence be negotiated?
  • More generally, what do concepts like ‘impact’, ‘significance’, ‘innovation’ ‘engagement’, and ‘translation’ mean in the context of bioethical scholarship?

We will ask audience members to reflect upon and share their own experiences of “doing bioethics” with a view to informing policy and practice.


Biographies

Ms Williams is a final year PhD student at the Centre for Values, Ethics, and the Law in Medicine (VELiM). She is working on the ethics of cancer screening, and conflicts of interest in medicine.

Dr Mayes is a post-doctoral researcher at VELiM. His areas of work include conflicts of interest in medicine, continental philosophy, and food ethics.

Dr Lipworth is a senior research fellow at VELiM. She works on conflicts of interest in medicine, the ethics of biobanking, and the ethics of drug development.

Ethical & legal implications of new law governing human biomedical research

Sumytra Menon1

1 Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore

The conduct of human biomedical research will enter a new phase as Singapore transitions from advisory guidelines to legal regulation. The Human Biomedical Research Act (HBRA) heralds a landmark change that will impact research institutions, institutional review boards, researchers and research subjects. The Singapore government has announced a “sunrise period” so the affected parties can prepare for compliance. The purpose of the HBRA is to protect research subjects and tissue donors, and to provide a legal foundation to facilitate research studies that meets high ethical standards. This talk will focus on consent, researchers responsibilities and incidental findings. It will address some of the ethical and legal implications on researchers and research subjects, and reflect on the repercussions of such regulation on the conduct of human biomedical research.


Biography

Sumytra Menon is a Senior Assistant Director at the Centre for Biomedical Ethics (CBmE), Yong Loo Lin School of Medicine, National University of Singapore. She is a lawyer by training and in conjunction with the National Ethics Capability Committee, is developing a national competency and accreditation framework for clinical ethics and research ethics training. She is also the Programme Director of the CENTRES project (Clinical Ethics Network + Research Ethics Support), which offers training programmes for clinical ethics committees, research ethics committees and transplant ethics committees.

Fair research and free riders: Do patients have an ethical obligation to provide health data for research?

Angela Ballantyne1,

1 Department of Primary Health Care and General Practice, University of Otago, Wellington New Zealand, angela.ballantyne@otago.ac.nz

Medical knowledge is a ‘public good’ because, according to accepted economic theory, it is “non-rivalrous” and “non-excludable”[1] – one individual can consume medical knowledge without reducing its availability to another individual; and individuals cannot be excluded from the benefits of medical knowledge.  Other public goods include national security, public spaces, and clean air.  Medical research is an essential mechanism for improving medical knowledge. Medical research requires human participants, as well as data and biological samples.[2] I argue that, within certain constraints, we all have an obligation to participate in medical research and that to fail to do so makes us free riders on the efforts of others – we enjoy the benefits of medical knowledge without contributing our fair share. Making our medical records and clinical samples available for research is a low risk mechanism for fulfilling the obligation to participate in the generation of medical knowledge.

H.L.A Hart’s famously proposed the ‘obligation to participate’- “If others are cooperating for mutual benefit and I benefit from their cooperation, then I have an obligation to do my share”.[3]  I draw on the philosophical work of Rawls[4], Arneson[5], Nozick[6]  and Jonas[7] to explore arguments in favour and in critique of this obligation.

My account has implications for the governance and management of big-data initiatives in health care[8], learning health systems[9],[10] and biobanks. The current majority view is that consent, in some form (specific, broad[11], meta[12] or dynamic[13]), is necessary or at least preferable, prior to providing access to patient data and tissue for research. I argue that consent may not be necessary if there is an obligation for patients to allow their clinical data and samples to be used in secondary use research[14].


[1] Samuelson P A. (1954) The Theory of Public Expenditure,  Review of Economics and Statistics 36: 386–389.

[2] Schaefer GO, Emanuel EJ, Wertheimer A. (2009) The obligation to participate in biomedical research. JAMA.302(1):67-72.

[3] Hart H.L.A. (1955) Are there any antural rights? Philosophpicla Review 64:175-191. P185.

[4] Rawls J (1971). A Theory of Justice. Oxford: Oxford University Press.

[5] Arneson RJ. (1982). The principle of fairness and free-rider problems. Ethics 92(4):616-633.

[6] Nozick R (1974). Anarchy, State and Utopia. New York, New York: Basic Books Inc.

[7] Jonas, H. 1969. Philosophical reflections on experimenting with human subjects. Daedalus 98(2): 219–247.

[8] The Nuffield Council on Bioethics. (2015) The collection, linking and use of data in biomedical research and health care: ethical issues. London, UK: The Nuffield Council on Bioethics.

[9] Johnson K, Grossmann C, Anau J, Greene S, Kimbel K, Larson E, Newton K. (2015) Integrating Research into Health Care Systems: Executives’ Views. Discussion paper. Washington, DC: Institute of Medicine. http://www.iom.edu/integratingresearch   

[10] Faden R, Beauchamp TL, Kass NE. (2011) Learning health care systems and justice. Hastings Cent Rep. 41(4):3.

[11] Steinsbekk KS, Kåre Myskja B, Solberg B. (2013) Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Genet.21(9):897-902.

[12] Ploug T, Holm S. (2015) Meta consent: a flexible and autonomous way of obtaining informed consent for secondary research. BMJ 350:h2146.

[13] Kaye J, Whitley EA, Lund D et al. (2015). Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet. 23(2):141-6.

[14] Secondary use research refers to the use in research of data contained in records collected for a purpose other than the research itself.


Biography

Dr. Angela Ballantyne is a Senior Lecturer in the Bioethics Department at the University of Otago and is President of the International Association of Bioethics. She received her PhD from from Monash University and since then has worked around the world most notably as a visiting scholar at Yale University and for the World Health Organisation.

 

Exploitation, coercion and domination – the conceptual tool we have been missing?

David Hunter, Associate Professor of Medical Ethics1

1 Flinders University, Bedford park Campus, Adelaide, South Australia, david.hunter@flinders.edu.au 

Exploitation is a commonly dismissed issue in the bioethics literature. This is because that literature focuses (unfortunately almost exclusively) on autonomy and threats to autonomy. Hence much of the discussion of exploitation has tried to explicate the wrongness of exploitation in terms of coercion. However it has been argued across an array of areas that the kinds of cases in which exploitation is supposed to be problematic involve offers which expand the options available to people – such as payments for kidney donors or research participants. It is argued that these offers cannot be coercive because they increase rather than decrease the options available. Elsewhere I have argued that the mainstream bioethics literature (with the notable exception of some feminist bioethicists) has neglected a significant challenge to the validity of informed consent – that of being in a situation of domination. Someone is dominated where someone can arbitrarily interfere in important matters in our lives, with minimal consequences for them. In this situation we shape our lives and choices to the desires of those who have power over us which invalidates consent. In this paper I explore whether domination provides the conceptual space to explain the wrongness of exploitation in a novel and illuminating fashion.


Biography

David Hunter is an Associate Professor of Medical Ethics in the Medical School at Flinders University, originally from New Zealand he has been previous located at University of Birmingham, Keele University, the University of Ulster and Massey University. A political philosopher by background his work focuses on the intersection of medical ethics and political philosophy. Primary areas of interest include, research ethics, resource allocation, public health ethics and the ethics of regulation of new technologies.

Collaborating with the enemy? An ethical exploration of industry partnerships in food studies research

Prof Rachel A. Ankeny1 and Dr Heather J. Bray2

1 School of Humanities, University of Adelaide, Adelaide 5005 SA, Australia, email: rachel.ankeny@adelaide.edu.au
2 School of Humanities, University of Adelaide, Adelaide 5005 SA, Australia, email: heather.bray@adelaide.edu.au

The increased emphasis on industry partnerships and funding for research in Australia and beyond given increasing neoliberal pressures in academia often pose critical dilemmas for researchers seeking to do robust scholarly research with the potential for practical impacts. In this paper, we explore the actual and potential intersections of food studies, food science, and the food industry (broadly construed to include large- and small-scale producers, processors, and retailers, among others) in order to assess not only the well-understood pragmatic risks of collaboration, but the less well-explored possible epistemic and other benefits of engagement across these domains. In particular we develop an argument in favour of collaboration under certain circumstances that permits more rigorous reflections on the hidden assumptions and biases often held by those outside of industry and thus support more rigorous research as well as generating more effective impacts on our broader food system. We frame these arguments against the backdrop of a series of case studies based on our own qualitative research projects and those of others, as well as the changing landscape of the food industry.


Biography

Rachel A. Ankeny’s research combines bioethics, food studies, and history and philosophy of science. She leads the Food Values Research Group at the University of Adelaide, where she is engaged in several competitively funded grant projects relating to food studies and to history and philosophy of the biological sciences.

“Without legal commitment”: Compensation for injured participants in clinical research in New Zealand

Joanna Manning1

1 Faculty of Law, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

Because of the extreme difficulty of proving sponsor and/or investigator negligence and a causal link between any such negligence and participant injury, there is a wide consensus that no fault compensation is best ethical response to injured research participants. New Zealand is fortunate to have a taxpayer funded no-fault compensation scheme for accidental injury, included medical injuries. While injured participants in publically-funded research have access to secure and appropriate compensation under the legislative regime, those injured in pharmaceutical sponsored trials do not, having been excluded from cover under it in 1992. Injured subjects must rely instead on compensation assessed in accordance with non-legally binding guidelines imported from the United Kingdom. As a result injured participants are vulnerable to being left uncompensated or undercompensated. Most participants are not aware of this unless and until they are injured and seek compensation, because information sheets do not inform them of the non-legally binding nature of the sponsor’s obligation. This inequitable treatment of injured subjects in industry trials is readily remediable by extending cover under the state no-fault regime to all injured research participants. Relieved of the responsibility for compensating injured subjects, various options for increasing financial incentives on sponsors to exercise care to prevent injuries in clinical research can be considered. Equivalent industry guidelines operate in respect of injuries in industry trials in Australia, where participants must rely principally on ethics committees to ensure that they are fully informed about the “without legal commitment” nature of compensation.


Biography

Joanna Manning is a Professor at the Faculty of Law, University of Auckland, where she teaches and has published widely on issues of health law, policy, and ethics; torts, including negligence; and accident compensation, particularly treatment injury and medical misadventure. She was the consumer representative on the Medical Practitioners Disciplinary Committee for approx 10 years, the lawyer member of the National Ethics Advisory Committee from 2005 to 2011 and the lawyer member of the Scientific Advisory Committee of the Heart Foundation NZ (2011-2014).

12

About the Association

The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

The AABHL seeks to foster a distinctive Australasian voice in bioethics, and provide opportunities for international engagement through its membership, journal and conferences.

Members come from all the contributing humanities, social science and science disciplines that make up contemporary bioethics.

Many members have cross-disciplinary interests and all seek to broaden the dialogues in which all members of the wider community ultimately have an interest.

The AABHL is a supportive, creative and challenging community that provides a rich source of continuing academic refreshment and renewal.

Conference Managers

Please contact the team at Conference Design with any questions regarding the conference.

Photo Credits: Tourism Tasmania, Sean Fennessy, Luke Tscharke, Jess Bonde, Richard Strong, Jason Charles Hill,

© 2015 - 2016 Conference Design Pty Ltd