Privacy, Consent, and Governance

Abstract

Many discussions of health information privacy in relation to biobanks focus on the question of informed consent and, in particular, on why the future of biobanking likely requires the acceptance of some derogation from the traditional standard of informed consent to medical research. Following Neil C. Manson & Onora O’Neill’s recent work on informed consent as a “waiver,” we argue in this paper that the role of consent can be thought of in a narrower but still highly principled manner which is consistent with how consent is dealt with in tort law. Using this conception, we defend the position that the traditional standard of informed consent to participate in a biobank can be met but only where there is a governance structure ensuring consistent information practices and policies across multiple future research projects. We also argue that specific research uses of research samples and associated data in the biobank do not necessarily require informed consent but do require a governance structure that can regulate privacy risks such as the risk of re-identification. We thus distinguish consent at the outset of the collection and no-consent for future use, with both requiring a governance structure in order to protect the important interests at stake. In our conclusion we suggest that the legal and ethical debates regarding biobanking must shift from an obsession with consent and focus more closely on the elements of good governance in order to move away from compromises and back to the principled protection of research subjects.