1. Big Biobanks: Three Major Governance Challenges Roger Brownsword Centre for Technology, Ethics, Law & Society (TELOS), Dickson Poon School of Law, King’s College London and Chair EGC (UK Biobank)

2. Overview 1. Big biobanks 2. Informed consent, broad consent, and variation of rules 3. The responsibility to give feedback (return incidental findings) 4. The role of the public interest

3. 1. Big Biobanks UK Biobank has 500,000 participants Collection of samples and data is open to access by researchers (academic as well as commercial) worldwide Participants give ‘broad consent’ to access and use for ‘health related’ research by bona fide researchers Access adjudicated by UKB not by the EGC

4. Access figures to 31.12.2013 Submitted Registrations: 841 Approved Registrations: 692 Submitted Preliminary Applications: 115 Submitted Main Applications: 56 Projects Underway: 40

5. Approved registrations in 2013

6. Approved registrations by type in 2013

7. Submitted main applications by location in 2013

8. Submitted main applications by institute type in 2013

9. 2. Challenge #1: Informed consent, broad consent, and variation of rules The consent given by participants needs to be free and informed. How can it be informed when the particular research purposes are not specified? The consent is informed ‘in the relevant sense’. The authorisation given is broad (but still informed).

10. Consent being ‘informed’ in the relevant sense Consent by a right-holder authorising an act that would otherwise infringe a right: being ‘informed’ means that right-holder understands the nature of the authorising act. Consent by a person to a scheme of rules: being ‘informed’ means that the person understands that, if consent is given, the scheme is binding. In both cases, the purposes authorised may be narrowly or broadly specified. If the scope of the authorisation is unclear, it will be subject to interpretation.

11. The basis of the relationship between researchers and participants Tortious: consent authorises act that would otherwise be tortious (or even criminal) Contractual: consent is to package of terms and conditions Associational: consent is to scheme of governance

12. 3. Challenge #2: The responsibility to give feedback (return incidental findings) Clarifying ‘no feedback’ Some evidence that participants would want to have, and might expect to have, feedback where it would be beneficial. But, on what basis would a participant have a ‘reasonable expectation’?

13. Basis of reasonable expectation By reference to background law (esp of tort); but do researchers have a duty to look out for signs of pathology, or to inform participants? Where researchers voluntarily assume this responsibility. By reference to general practice. By appealing to the ‘reciprocal’ nature of the relationship.

14. Ethically 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 (Washington, December 2013): ‘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.’

15. A Right to Know? Suppose that researchers, who are conducting genetic analysis on biobanked materials, identify a particular mutation for breast cancer in a sample provided by an identifiable participant. Does the participant have a right to be informed? And, as a corollary, do participants have a right not to know? What is the scope and weight of the right? Do researchers owe feedback responsibilities also to non-participant third parties (such as relatives of the participant)? Would a right to be informed imply a right that researchers actively ‘look out for’ potentially clinically significant findings?

16. 4. Challenge #3: The Public Interest Two kinds of appeals to the public interest: To block access (even though this would be consistent with the participants’ consent) To permit access (even though this is not consistent with the participants’ consent) Focus on latter kind of appeal. Positive

17. Three test cases Linkage or merger of biobanks with overlapping pools of participants To identify victims of disaster To assist with detection of crime (case of Anna Lindh)

18. Rank-ordering reasons for and against access To protect essential infrastructure To protect respect for fundamental values To protect or serve the public interest To respect the biobank’s private scheme of governance.

19. Concluding remarks Big Biobanks, coupled with the proliferation of genetic sequencing, seem to have an important place in future health-related research initiatives. For those Big Biobanks that are yet to be set up, there are many challenges but there is also an opportunity to be smart by writing ‘constitutions’ that, while doing full justice to the interests of participants, articulate flexible and fair procedures for responding to a constantly changing backcloth of new technological and social developments.