Informed consent in biobank research: A deliberative approach to the debate

Abstract

As acknowledged in the literature, public consultation related to biobanks has been largely oriented to assuring and informing rather than seeking considered input. In April and May of 2007, the authors participated in running a deliberative public engagement event in British Columbia, Canada, which sought to enhance public input related to the governance of biobanks. The topic of the event was ‘Biobanking in British Columbia (BC)’ and at the event a random-digit dialed demographically stratified sample of 21 participants deliberated on what values and interests ought to be considered in the regulation and use of biobanks for health research. In this paper, we report results related to debate over the place of informed consent in biobank research. Drawing on a pre/post-survey and qualitative analysis of event transcripts, we show that participants indicated strong support for biobanks, for a general reduction in concern for withdrawal of samples, and placed a strong emphasis on the need for review of biobanks research that is independent of funders and researchers. In this context, there was persistent disagreement about when consent was required for new research activities.

Introduction

In recent decades, there has been a growth of scrutiny and bureaucracy intended to protect human subjects in research from harm and exploitation that has focused largely on the concept of informed consent as the key mechanism (McDonald, 2001). The underlying purpose of informed consent is to provide potential subjects with the opportunity to make free and informed choices about whether or not to participate (or to continue to participate) in a specified research study. There is a strong literature detailing the significant limitations of informed consent to promote voluntary participation in research and its inadequacy (Boulton and Parker, 2007, Burgess, 2007, Corrigan, 2003, Kent, 1996, McDonald, 2001, Miller and Boulton, 2007). While these arguments exceed the scope of this paper, they highlight that far from being an ethical panacea, the role of informed consent in the protection of human subjects is hotly debated and unclear.

Ethical claims over the role of informed consent have come to the fore in discussions around biobanking (Barr, 2006, Brekke and Sirnes, 2006, Cambon-Thomsen et al., 2007, Knoppers, 2005). Large population-based biobanks, which are repositories of blood and tissue samples that are often combined with medical and other personal information, are being developed and used for research in numerous countries such as Canada (www.cartagene.qc.ca), Iceland (www.decode.com) and Britain (www.ukbiobank.ac.uk). These biobanks are seen as a promising way to untangle the links between genetics and environmental factors and begin to understand the causes of common diseases, all with the hope of developing new treatments and preventions (Khoury, Millikan, Little, & Gwinn, 2004). The considerable hope for societal benefit from biobanks and the research they support brings into focus the tension between individual and societal interests, which while common to the research endeavour, gains new intensity in this context. Caulfield, Upshur, and Daar (2003) have observed that,

if we are to allow population genetic research to move forward, we need to recognize that adherence to this traditional model of informed consent is problematic. As the UK Human Genetics Commission recently concluded: “the difficulties involved in tracing and securing re-consent for different forms of medical research may make obtaining fresh consent impractical and would seriously limit the usefulness of large-scale population databases.”

This suggests that a loosening of current consent requirements is required before the potential benefits to human health promised by biobanks may be realized. However, there are also strong arguments for more stringent protection of subjects' and donors' interests, because of a concern (for example) that biobanks could support research that may erode privacy and confidentiality interests, be offensive to groups such as First Nations peoples, and enable discrimination (Arbour and Cook, 2006, Corrigan, 2006, Eriksson and Helgesson, 2005, Lee et al., 2001). Such arguments highlight the serious tension between individual interests and broader societal impacts, begging the question of how a balance might best be struck and whether and to what extent informed consent ought to play a role.

In this paper, we explore these questions through the deliberations of 21 British Columbians. After a brief review of consent in biobanking, we discuss our research team's recent public engagement event that sought deliberation on what values and interests ought to be considered in the regulation and use of biobanks for health research (Burgess, O'Doherty, & Secko, 2008). We discuss findings that draw on data collected through novel survey techniques and small and large group discussions. The resulting data is used to track changes in opinion over the course of the event and to illuminate the manner in which participants balanced the tension between the individual subject's interest and broader societal interests. We conclude by relating participant deliberations to ongoing debate over the place of informed consent in biobanking.