1. Databanks and biobanks created through health research: Should their content be anonymized? A reflection… Emmanuelle Lévesque, LL.M., lawyer Research Associate, Centre de recherche en droit public, Université de Montréal STIRRHS - Seminar on Transdisciplinarity June 1-3 2006

2. Distinguishing Databank and Biobank Biobank: collection of biological material Databank: collection of data

3. Distinguishing Anonymization and Coding link between data/sample and the identity of the subject is deleted Data are separated from personal identifiers through use of a code # 1234 Coding Anonymization

4. Various interests at play Advancement of science Population Researchers Research participants And money...

5. A.Protection of confidentiality B.Duration of conservation C.Return of results D.Withdrawal from participating Outline Coding: Values, principles, rights promoted Anonymization: Values, principles, rights promoted

6. Anonymization: Maximum Protection Coding: Limited Protection Protection varies depending on the rules around access to the coding key Promotes: Privacy Professional secrecy Right to confidentiality Promotes: Protection of Health: offers a means of prevention through recontact Advancement of knowledge: obtains missing information and validates results A. Protecting Confidentiality

7. Anonymization: Duration of conservation often longer Sometimes held for an intedeterminate duration (to perpetuity) B. Duration of conservation Coding: Duration of conservation often shorter Generally duration of determinate length Promotes: Optimal use of research resources Promotes: Reasonable evaluation of consequences Confidentiality: shorter duration minimizes risk

8. Anonymization: Returning information is impossible C.Returning Results Coding: Returning information is possible Promotes: Privacy, confidentiality, professionnel secrecy Protects against discrimination (insurance/employment) Promotes: Protection of health (prevention) Informed reproductive choices Family health Autonomy

9. Anonymization: Withdrawal is impossible D. Withdrawal from Participating Coding: Withdrawal is usually possible Withdrawal process can be more or less complex Promotes: Privacy, confidentiality, professionnal secrecy Advancement of knowledge: stability of the sample size Promotes: Participant autonomy Control of a detached body part Right to withdraw consent

10. Conclusion Contradicting rights, values, interests… No universal solution: the solution must be adapted to the issues at play “The protection of the rights of people whose samples and data are in the biobanks, with respect to autonomy, confidentiality and protection of privacy, needs to be assured at the same time as allowing and encouraging research.” (CE-European experts group, 2004)