Deliberative Legitimacy and the Governance of Biobanks

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Deliberative Legitimacy and the Governance of
Biobanks

• Susan Dodds
• University of Wollongong
• Rachel A Ankeny
• Universtiy of Adelaide

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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

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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), Françoise Baylis and Jocelyn Downie
  (Dalhousie University)

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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

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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

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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 states role as provider of welfare services,
  
• as protector of citizens individual rights,
• as defender of a common way or shared set of
  values.

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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)

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Participation

• Role of participation in establishing legitimacy
  of policy is to avoid pre-judging policy
  processes and outcomes in areas where
• We dont know enough about who is affected
• We arent 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

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

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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 publicAll 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)

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Constraints on Deliberation

• We arent in ideal speech situations
• None of us are perfectly rational
• Significant ethical, political, and social
  disagreements exist
• We arent skilled in the culture of deliberation
  and public reasoning

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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)

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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.

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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)

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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

• Health data
• Genetic records pedigree, family medical history
• Environmental exposure
• Medical history including linking of records
  across services
• Concurrent medical records
• Research records

• Bioinformatics data linkage
• Complex data comparisons make vast array of data
  useable for analysis, research
• Comparisons among data sets, samples
• Tracking across time, groups

• Biobanks may be
• Retrospective
• Prospective
• Both

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• 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--gtprospective

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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

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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

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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

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Big-Picture Bioethics Policy-Making and Liberal
Democracy

• For further information
• ARC Discovery Project Big Picture Bioethics
  website
• www.uow.edu.au/arts/research/bigpicturebioethics
• sdodds_at_uow.edu.au