Deliberative Legitimacy and the Governance of Biobanks

Slide 1:Deliberative Legitimacy and the Governance of Biobanks Susan Dodds University of Wollongong Rachel A Ankeny Universtiy of Adelaide

Slide 2:Outline of Paper What is �Big Picture Bioethics�? Legitimacy on �bioethics policy� in pluralistic democracies Roles of public participation Forms of public engagement Democratic deliberation and justification Biobanks, issues raised Privacy, consent, governance, trust Conclusion: Deliberation towards the best policy justification

Slide 3:What Is Big Picture Bioethics? Focuses on novel approaches to the ethical/political analysis of health policy-making Integrates diverse disciplinary perspectives, resulting in new bioethics methodologies Comparative analyses of policy-making processes and content (Australia and Canada) Co-investigators: Susan Dodds (University of Wollongong), Rachel Ankeny (University of Adelaide), Fran�oise Baylis and Jocelyn Downie (Dalhousie University) Disciplines include: political philosophy, bioethics, feminism, law, history and philosophy of scienceDisciplines include: political philosophy, bioethics, feminism, law, history and philosophy of science

Slide 4:Key Features of �Big Picture Bioethics� Exploration of the justification of policy processes that lead to regulation (or decisions not to regulate) Investigation of the conditions that contribute to the legitimacy of policy Sensitivity to the social and political context of policy debates Ethical focus on process, not just outcomes

Slide 5:Aim: a normative political philosophical approach to public policy-making Desiderata: Determinate (if not definitive) policy outcome Public justifiability of policy Recognition of the fact of ethical disagreement Relative legitimacy: Process viewed as open to concerns of all those affected Those affected and policy makers are able to articulate why the policy is thought to be justified

Slide 6:Ethical disagreement, �bioethics policy� and the demands of democracy Bioethics policy as a challenge to general theories of legitimacy of state institutions Not addressing structural legitimacy, but legitimacy of specific policy on contested issues: which humans are protected by the state; distribution and use of public resources; control over information relating to individuals; determining whether or not an entity is one that the state will treat as having moral significance, etc Source of government or regulatory interest defended by reference to: the state�s role as provider of welfare services, as protector of citizens� individual rights, as defender of a �common way� or shared set of values.

Slide 7:What Makes Policy Legitimate? Legitimacy is grounded in the processes of decision-making including: Recognised formal process (formal legitimacy) Determining who is affected and what is actually at stake for them, based on their input; not just relying on experts (participatory legitimacy) Articulating and testing claims directed toward a common end (deliberative legitimacy) Active participation by affected publics engaging in deliberative process towards common end; accurate record of process and outcome (internal legitimacy) Developing a policy recommendation which is justified by appeal to previous processes particularly deliberative input (justificatory legitimacy) Expert input is important, but contestable and not definitive and regulators can draw on actual rather than presumed public responses (informed) �Hard� decisions are open to argument (contestable) Citizens provide direct input (participatory) Regulators, oversight bodies need to be responsive to deliberative input (justificatory) Expert input is important, but contestable and not definitive and regulators can draw on actual rather than presumed public responses (informed) �Hard� decisions are open to argument (contestable) Citizens provide direct input (participatory) Regulators, oversight bodies need to be responsive to deliberative input (justificatory)

Slide 8:Participation Role of participation in establishing legitimacy of policy is to avoid pre-judging policy processes and outcomes in areas where We don�t know enough about who is affected We aren�t clear about the values that they hold Nor do we know how their values may be affected by various scientific and other developments Process of participation should allow genuine inclusion and contribution by all those who may be affected

Slide 9:Head, B. W. (2007) Community Engagement: Participation on WhoseTerms? AJPS 42 (3) 441-454: 445.

Slide 10:Deliberation and its Constraints Deliberative approaches emphasise the legitimation of policy that comes from the transformation of interests through processes of ��collective decision making by all those who will be affected by the decision or their representatives: this is the democratic part. Also�it includes decision making by means of arguments offered by and to participants who are committed to the values of rationality and impartiality: this is the deliberative part.� (Elster, 1998, 8)

Slide 11:Ideal Deliberative Democracy Processes of deliberation take place in argumentative form, that is, through the regulated exchange of information and reasons among parties who introduce and critically test proposals. Deliberations are inclusive and public�[A]ll of those who are possibly affected by the decisions have equal chances to enter and take part. Deliberations are free of any external coercion� Deliberations are free of any internal coercion that could detract from the equality of the participants. Each has an equal opportunity to be heard, to introduce topics, to make contributions, to suggest and criticize proposals�. (Habermas)

Slide 12:Constraints on Deliberation We aren�t in ideal speech situations None of us are perfectly rational Significant ethical, political, and social disagreements exist We aren�t skilled in the culture of deliberation and public reasoning

Slide 13:Justificatory Liberalism Duty to �explain to one another.. how the principles and policies they advocate and vote for can be supported by the political values of public reason� (Rawls) �The moral lodestar of liberalism is� the project of public justification.� Macedo �To respect another person as an end is to insist that coercive or political principles be just as justifiable to that person as they are to us. Equal respect involves treating all persons, to which such principles are to apply in this way� (Larmore)

Slide 14:Attributes of More Legitimate Policy Processes Direct input to find out what matters to the people affected by policy Promoting public understanding of science Inclusive engagement (attention to systematic disadvantage) Ensuring discursive participation (fora for engagement) Fostering conditions for respectful deliberation and public trust in process Providing reasons for policy decisions (contestable justification) Review over time to capture changes in values, etc.

Slide 15:Contested deliberation where legitimacy not realised? Some ethically contentious issues where the development of policy that meets a threshold level of legitimacy is impossible Discursive modus vivendi agreements (Ivison) discursive because they emerge from the constellation of discourses and registers present in the public sphere at any given time, and subject to at least some kind of �reflexive control� by competent actors; and modus vivendi because they are always provisional, open to contestation and by definition �incompletely theorized� (Ivison)

Slide 16:Biobanks Linked biological samples and/or health records from a large epidemiological cohort Biological samples Pathology samples collected for clinical purposes Samples collected for routine screening Samples donated for research Donation on death

Slide 17:Prospective Biobank: UK Biobank www.ukbiobank.ac.uk Recruiting adult volunteers to donate samples and consent to future use, recontacted into future, no personal feedback �UK Biobank will gather, store and protect a vast bank of medical data and material that will allow researchers to study in depth, in decades to come, how the complex interplay of genes, lifestyle and environment affects our risk of disease. It is the first time that such a project has been attempted in such fine detail on such a vast scale� Retrospective Menzies Research Centre, Tasmania Clusters of families with genetic conditions, extensive �family tree� based on public record and connected with pathology samples, genetic �pedigree�; retrospective-->prospective

Slide 18:Why link deliberative democracy and biobanks? Public health system-- public good Records/ samples Citizens� reliance on state to protect/control access to health information Social interest in responsible use of health data/ development of �evidence based� health policy Individual and collective impact of use/misuse Access to resources and profits Biobanks as re-shaping the scope of the public and nature of public goods

Slide 19:Potential concerns and possibilities in the governance of Biobanks Public trust (Stranger et al 2005)/ Public �Gene Angst� (Bovenberg 2005) Citizens value medical research, fear risk of loss of privacy, control; discrimination Confidence, trust in institutions charged with protecting use of information Relational approach to consent (Lippworth el al 2006) Community involvement in deciding research priorities, administration of banks Benefit sharing/ commodification (Dickenson 2004) Questioning assumption that research benefits will be shared equitably Exploring the implications of human genetic information, tissues, cell lines becoming market commodities Creation of biocapital (Sunder Rajan, 2006) Recognition of the symbiotic development of technological capacity and markets for biotechnology Public participation in shaping policy (Stranger et al 2005) / �ethicality� (Scott et al 2005) Citizen participation as developing confidence in the process Community input in articulating the symbolic and cultural significance of policy/practice

Slide 20:Deliberation and the governance of biobanks Deliberative democratic approach: policy based on argument and reason; citizens able to participate in the deliberation Expert input is important, but contestable and not definitive Regulators can draw on actual rather than presumed public responses �Hard� decisions are open to argument Citizens provide direct input Regulators, oversight bodies need to be responsive to deliberative input

Slide 21: For further information ARC Discovery Project �Big Picture Bioethics� website www.uow.edu.au/arts/research/bigpicturebioethics sdodds@uow.edu.au Big-Picture Bioethics Policy-Making and Liberal Democracy