Medical research is increasingly relying on biobanks, large repositories of human biological material and related health information. These can be best conceived as elaborate research infrastructures, which allow researchers, often brought together in international research consortia, to study in more detail the long-term interaction between genes, environment and life-style. Biobanks are an increasingly crucial research tool, but they also raise complex legal and governance issues, particularly related to privacy. A key challenge is the difficulty of adequately informing people who donate tissue samples and give access to personal data about the type of research that will be undertaken--often in the distant future--and what specific privacy risks are associated with it. There has been much debate about how traditional requirements of informed consent can be respected in the context of such open-ended information systems; whether informed consent should even be required; and how privacy protection can best be assured. Policy makers have taken various initiatives in this area. Genome Canada recently published, for example, a policy brief written by Timothy Caulfield and Bartha M. Knoppers to inform federal policy-makers of the various regulatory and policy options related to consent in the context of biobanks (http://www.genomecanada.ca/en/ge3ls/policy-portal/#coreAdvisory).
Lisa Austin and I have participated in some of these policy initiatives and we also added our voices to the academic debate. In two recently published co-authored chapters, we suggest that the discussion has focused too much on the question whether fully informed consent is possible when people donate biological material and give access to health information. Some of our colleagues have argued that the answer to this question is the introduction of a new form of open-ended informed consent, while others have rejected the importance of informed consent altogether. We argue that informed consent remains an important concept, but that it should be tightly connected to the issue of governance of research.
In a first chapter (an earlier version of which is available on SSRN at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1337695), published in a book edited by Jane Kaye and Mark Stranger, Principles and Practice in Biobank Governance (Farnhem: Ashgate, 2009), we first discuss how a variety of new developments make it increasingly hard to maintain that we can confidently assure the confidentiality of genetic information and detailed health information in the context of biomedical research. These developments include advances in genetic technology, particularly in the context of personalized genome scanning, the growth of health data sharing websites, the increasing regulatory requirements to publicize research data, and the development of large biobanks. We then analyze how the concept of fair information practices, embedded in many privacy statutes, already allows for some flexibility with respect to informed consent requirements in the context of medical research. These exceptions rely, however, heavily on the appropriate governance of health information privacy by research ethics boards. We point out that Canadian privacy statutes such as Ontario's Personal Health Information Privacy Act, inappropriately presume that there is currently a well-developed and coherent research ethics review system in place. The paper ends with an analysis of some key governance principles that ought to be respected to ensure appropriate privacy protection in the context of biobank research. These governance principles are widely accepted and integrated in various other governance systems. Yet, despite the explicit recognition of the importance of research ethics review in various statutory regimes and government policies, the REB governance system surrounding research fails in many Canadian provinces to respect these basic principles.
In the second chapter (available on SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1538512), which appeared in Pascal Borry and Kris Dierickx, eds., New Challenges for Biobanks: Ethics, Law and Governance (Antwerpen: Intersentia, 2009), we defend the position that even in the context of biobanks, it is possible to think of the role of informed consent in a highly principled manner, consistent with how consent is dealt with in tort law. Building on Neil C. Manson & Onora O'Neill's recent work on informed consent as a "waiver" we argue that the informed consent requirement can be met but only if there is a governance structure ensuring consistent information practices and policies across multiple research projects. We also suggest 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. We conclude by suggesting 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.
The chapters are among the key results of a research project that was funded by the Privacy Commission of Canada's Contributions Program and organized through the Faculty of Law's Centre for Innovation, Law and Policy. The research project also resulted in 2009 in an interdisciplinary workshop organized by Professors Lemmens and Austin, doctoral candidate Ubaka Ogbogu, and Senior Privacy Analyst Ruth Vale. The research group further included as researchers Stuart Hargreaves and Nisha Menon, graduate students of the Faculty of Law. Other results of the research project are still being finalized.
