1. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive

2. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Biobanks: Balancing Existing Norms and Emerging Needs Timothy Caulfield Health Law Institute An exploration of the justification for the emerging consent policies

3. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Biobanks BioBank/Cohort - a research platform Med info Lifestyle Socio Demo Public participants: donate DNA sample, etc. Cancer Asthma Infectious Exercise

4. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive A shifting norm? Pressures to move away from the autonomy driven consent model… Blanket/Broad/General Consent is a Deviation from the Accepted Standard. When it comes to biomedical research using biobanks, classical informed consent is abandoned in favour of general consent – a less strict standard (Elger and Caplan, 2006).

5. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Fundamental right? -SCC (Labaye) What is at stake… …research in biobanks … goes to the core of individual autonomy and fundamental rights. National Bioethics Commission (Greece) (2006). Confidentiality Protecting information Autonomy Control of info, self determination, not about risk… ????

6. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Autonomy and Research In part, the strength of autonomy in health law/research ethics is a reaction against the public worth of science argument

7. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Policy and Research If about autonomy (as a fundamental right) and if it applies to control of genetic and health information, what evidence is needed to override? At a minimum, the onus is on those who want to impinge on the right (cant be presumed) Autonomy New Consent Approach

8. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Recommendation 9: Blanket consent for future research is only permissible in circumstances where anonymity of future data can be guaranteed blanket future consent is only permissible where anonymity can be guaranteed, and there is no risk that unexpected results will filter back to the subjects concerned. If this guarantee is not possible, or if linking of data is necessary for the research, then specific consent to the specific research must be obtained.

9. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Public Perception Research A justification for a policy?

10. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Themes from the research People want control Trust important A minority dont want to contribute Sensitivity around genetic information If asked, re-consent an issue

11. 29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS CONFERENCE 29e Confrence internationale des commissaires à la protection de la vie prive Policy and Research If it is about autonomy as a fundamental concept, what is the role of perception evidence? Can a majority preference override a minority right? If yes, what rights and when? Reconcile emerging policies with existing norms…