1. Protecting Participants in a Global Research Community Dr. Jane Kaye University of Oxford, UK

2. Technological Advances Open Access Policies Building of Resources New Scientific Questions

4. SACHPR Washington DC - 20 th October 2010 How do these trends test the basic principles of medical research?

5. SACHPR Washington DC - 20 th October 2010 1. Informed Consent  Unhealthy obsession with consent forms o Designed for physical harm and ‘one project’ research o Is required at the beginning of the research process o Difficult to inform research participants at the time of collection of all the research uses and who will use it o Part of the ‘tick box’ procedural requirements  Focus is on individuals rather than the concerns of families, groups and populations

6. SACHPR Washington DC - 20 th October 2010 Broad Consent?  Used in biobanking but contentious  Consent for a broad range of purposes  Asking individuals to give a one-off consent for the use of their medical information, which will be used for many years building up profiles of individuals  Effectively is ‘consent for governance’ as hard decisions will be delegated to research ethics committees or advisory boards

7. SACHPR Washington DC - 20 th October 2010 2. Withdrawal  Research participants should be able to withdraw from research at any time  Withdrawal cannot be promised when data and samples are shared widely o Computer datasets containing personal information must be continually archived o It is difficult to claw back minute segments of sequence spread over a global network o Data used in multiple research projects

8. SACHPR Washington DC - 20 th October 2010 3. Social Contract  Research participation has been based on altruism and an appeal to solidarity  In return, participants have been promised: o Anonyminity o Confidentiality of personal information  Procedures and practice have been developed on the basis of this implicit agreement

9. SACHPR Washington DC - 20 th October 2010 The Challenges  We can no longer promise the confidentiality of personal information (Lunshof et al 2008) – DNA is a unique identifier (Homer et al 2008) – Data can be replicated indefinitely – Data is shared globally and can be linked to other datasets – Genome sequence is becoming more accessible to people other than researchers  Yet participants are still expected to be altruistic and to hold to their side of the bargain

10. SACHPR Washington DC - 20 th October 2010 4. New Dilemmas -Feedback  If it is increasingly difficult to make information anonymous  Increased amount of information on individuals also increases the likelihood of identifying serious treatable conditions and incidental findings  Is there an obligation to feedback? o Should secondary and tertiary researchers be held responsible?

11. SACHPR Washington DC - 20 th October 2010 So what should we do?

12. SACHPR Washington DC - 20 th October 2010

13. SACHPR Washington DC - 20 th October 2010 New Forms of Governance  Development of IT ‘participant-centric’ approaches  Opportunity for people to have greater control over the use of their information if they so desire  Other bodies no longer stand in the shoes of participants  Less reliance on research ethics committees and their perception of the concerns of participants  Makes re-consent for studies easier  Based on participants as partners in the research process and enabling an on-going dialogue  Potential to deal with issues of feedback

14. SACHPR Washington DC - 20 th October 2010 Issues  What are the boundaries of this control?  All types of research?  Can it be instituted at the global level?  Still need oversight of the proposals that are put to participants  Relies on participants being computer-literate  Does not address the issues of families, groups or populations

15. SACHPR Washington DC - 20 th October 2010 In conclusion  Implement IT mechanisms to give research participants greater involvement in research  Requires a change in attitude as participants must be seen as partners in the research process  Potential to develop new ways of carrying out research  Potential to enable the translation of results

16. SACHPR Washington DC - 20 th October 2010 Acknowledgements  EnCoRe Project www.encore.org  HeLEX –Centre for Health, Law and Emerging Technologies http://www.publichealth.ox.ac.uk/helex/  Making Connections Group

17. SACHPR Washington DC - 20 th October 2010 2010 Publications  Curren L., Boddington P., Gowans H., Hawkins N., Kanellopoulou N., Kaye J., Melham K., (2010) Identifiability, Genomics and UK Data Protection Law European Journal of Health Law Vol 17, 4: 329-344  Curren L. & Kaye J., (2010) ‘Revoking consent: a 'blind spot' in data protection law?’ Computer Law and Security Review Vol 26:3, 273-283  Curren L. & Kaye J., (2010) ‘Data subjects’ rights — are they inadequate?’ Privacy & Data Protection Journal Vol. 10 :5.  Kaye J., Boddington P., de Vries J., Hawkins N., Melham K., (2010) Ethical Implications of the Use of Whole Genome Methods in Medical Research European Journal of Human Genetics 18: 398-403  Heeney C., de Vries J., Hawkins N., Boddington P., Kaye J. Assessing the Privacy Risks of Data Sharing in Genomics Public Health Genomics (DOI:10.1159/000294150) Published Online: March 29, 2010

18. SACHPR Washington DC - 20 th October 2010