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Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses

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Ethics and Governance of Biomedical Research

Part of the book series: Research Ethics Forum ((REFF,volume 4))

Abstract

The development of “Big Biobanks” (population-wide biobanks that are established as a resource to be curated for access and use by the research community) is relatively new, and it is taking place at a time when the possibility of undertaking quite detailed genotyping and sequencing is assuming much greater prominence. Although there is much to debate concerning such biobanks, there is broad agreement that their good governance and legitimacy hinges on two fundamental conditions: first, that the interests of the participants are respected; and, secondly, that the activities are compatible with the public interest. Given this context, three of the many governance challenges faced by Big Biobanks will be discussed. First, there is question of whether individual “informed consent” can continue to function where hundreds of thousands of participants are involved and where the particular research purposes and projects to be pursued are not specified in advance. Secondly, there is the hot topic of the moment, namely whether biobanks have any responsibility to return individual clinically-significant findings to participants who, because of the longitudinal nature of such research, remain identifiable. Thirdly, there is the question of how the public interest is to be understood and applied: in which circumstances will access be denied as contrary to the public interest (even if the application is otherwise consistent with the consent given by participants) and, conversely, in which circumstances will access be granted for reasons of the public interest notwithstanding that the application is inconsistent with the consent given by participants?

This paper is a revised version of a talk that was first given at a workshop on “Consenting to Biobank Research” held at the University of Hannover in August 2013, and then of a lecture given at the University of Hong Kong in February 2014. I am grateful for comments made by participants at those events; but, of course, the usual disclaimers apply. I should make it absolutely clear that this paper is written in my personal capacity and not as Chair of the Ethics and Governance Council of UK Biobank (2011–2015).

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Notes

  1. 1.

    For discussion of the consent options, and then advocacy of a model of “intermediate consent”, see Forgó et al. 2010.

  2. 2.

    In order to avoid any doubt about the legality of broad consent, Finland recently enacted a Biobank Act (Act 688/2012) that makes it clear that a participant may consent to a broad range of purposes; see Soini 2013. According to Joanna Stjernschantz Forsberg and Sirpa Soini, the authorisation may “include research into health-promoting activities, causes of disease, and disease prevention and treatment, as well as research and development projects that serve healthcare”; see Forsberg and Soini 2014. However, compare the restrictive Lifegene decision in Sweden (FN 3).

  3. 3.

    There is also a potential difficulty for researchers if the informational rights recognised in relation to the processing of personal data build in a “specific purposes” limitation. In principle, a rights-holder might give an informed consent allowing researchers to process the data for broad purposes; but, in practice, there would need to be very explicit signalling of such an authorisation. So, for example, in a case involving the biobank Lifegene, the Director of Sweden’s Data Inspection Agency has ruled that the gathering of personal information for “future research” is in breach of the Personal Data Act. The problem is that Lifegene’s expressed research purposes are too general to satisfy section 9c of the Act, which provides that the collection and processing of personal information must be for “specific, explicitly stated and justified purposes […].” I am indebted to Adrienne Hunt for drawing my attention to this case and to Søren Holm for translating and summarising the case. See: http://ethicsblog.crb.uu.se/2011/12/20/the-swedish-data-inspection-board-stops-large-biobank/. Accessed 14 Feb 2015.

    Of course, this is now all subject to the fate of the European Commission’s proposed General Data Protection Regulation: see EC 2012b.

  4. 4.

    Compare the way in which clinical care slides into research in the early clauses of the current version of the WMA Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects (WMA 2013).

  5. 5.

    In the English law of contract, an independent requirement of an “intention to create legal [contractual] relations” was introduced by the Court of Appeal in Balfour v Balfour [1919] 2 K.B. 571. This requirement translates into a rebuttable presumption that domestic and social agreements are not backed by the requisite intention and thus should not be treated as legally enforceable contracts; by contrast, the presumption is that business agreements are backed by an intention to create legal relations and are enforceable. It is not clear how an otherwise contractual relationship between researchers and participants would be classified; but, my guess is that the presumption would be that the parties do not intend to create a legally enforceable agreement.

  6. 6.

    Article IVc of the Ethics and Governance Framework of UK Biobank (2007) provides for revision in the following somewhat general terms:

    The Board of Directors, the Ethics and Governance Council, the Funders and other interested parties (including participants and members of the wider public) may propose amendments or revisions of the Framework. In particular, the Ethics and Governance Council will advise on outstanding issues, and may propose adjustments in response to new developments. Adoption of any amendment or revision will rest with the Board of Directors.

  7. 7.

    Compare Article 3.4 of the PGP-UK consent form (PGP-UK 2014). This provides that proposed revisions to the terms and conditions have to be first reviewed and approved by the relevant research ethics committee. Then, each participant will be asked to sign up to the revisions. Those who sign up will continue as participants; those who do not will have their accounts deactivated until such time as they review and sign up to the revisions.

  8. 8.

    Compare the Presidential Commission for the Study of Bioethical Issues, Anticipate and Communicate—Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (PCSBI 2013, 3):

    The current challenge for public policy and professional ethics is to identify through thoughtful deliberation specific criteria that practitioners can use to determine when it is ethically permissible or obligatory for clinicians, researchers, or DTC companies to disclose and not to disclose incidental findings to patients, participants, or consumers.

  9. 9.

    The Presidential Commission (PCSBI 2013, 4) identifies “four ethical principles to be particularly applicable to the ethical assessment of incidental and secondary findings: respect for persons, beneficence, justice and fairness, and intellectual freedom and responsibility.” Compare the criteria proposed by Kaye et al. 2014. (But, nb, the authors’ caution that their approach does not translate straightforwardly to large population-based biobanks.)

  10. 10.

    In this light, we should note the Presidential Commission’s remarks about the need for more empirical research concerning the impact of giving feedback and the attitudes of participants towards the return of findings (see, e.g., PCSBI 2013, 7, rec 3).

  11. 11.

    For the view that “raw personal data” should be accessible to individual participants, see Lunshof et al. 2014.

  12. 12.

    In English law, the rules of the biobank might be likened to those of a private club and, as such, not judicially reviewable (notwithstanding the “public” dimensions of a big biobank). Compare, e.g., R v Disciplinary Committee of the Jockey Club, ex parte Aga Khan [1993] 2 All ER 833.

  13. 13.

    For my conception of a “community of rights”, see e.g. Brownsword 2008; and, for a related analysis about the ordering of a community, see Brownsword 2013a.

  14. 14.

    Formally, this was achieved by the introduction of Part VIa into the Privacy Act, 1988; see Reidenberg et al. 2013, 11–14.

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Brownsword, R. (2016). Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses. In: Strech, D., Mertz, M. (eds) Ethics and Governance of Biomedical Research. Research Ethics Forum, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-28731-7_14

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