Case 10: Human tissue biobanking in B.C

Michael Burgess (UBC); Kieran O'Doherty (University of Guelph); David Secko
(Concordia U)

Introduction

Biobanks are large collections of human biological tissue that are used for research, but they may also contain varying amounts of other health-related data, including clinical, medical and personal health histories. Due to the sensitive nature of this material, there are ethical complications to the use of Biobanks for research. Researchers at the W. Maurice Young Centre for Applied Ethics, University of British Columbia, have conducted two deliberative forums on the topic of human tissue biobanking: The BC Biobank Deliberation (2007) and the BC BioLibrary Deliberation (2009). The events were funded by Genome Canada/BC, CIHR, the PROOF (Prevention of Organ Failure) Centre of Excellence, and the BC BioLibrary. In both cases, members of the public from across British Columbia were invited to participate in two weekends of deliberation that would inform policy and practice on biobanks. The task of the participants in these forums was to consider the ethical and social implications of biobanking and to formulate recommendations for policy makers.

Methods

Both deliberations were conducted using several core design elements and principles from deliberative democracy. Twenty-five demographically stratified participants from across British Columbia were randomly invited to the forums for four days of deliberation.¹ The first day of deliberation was primarily dedicated to informing participants about the topic and introducing them to the practice of deliberation. Information on the topic was provided through an information booklet written specifically for the event, along with additional key readings from the academic literature, presentations from speakers who were either experts or represented key stakeholder groups, and teaching aids such as a physical model representing biobanking processes.² Efforts were made to present a balanced and complete range of the available perspectives on the subject. Deliberation was conducted in small (7-9 individuals) and large (all participants) groups. While deliberation aimed at consensus, facilitators were instructed not to gloss over any disagreements. Rather, if disagreements persisted in spite of deliberation, they were to be clearly articulated and documented.

Beyond this, the two events differed in structure and outcomes. Whereas the 2007 Biobank Deliberation aimed to document underlying public values that could guide biobanking policy, the 2009 BioLibrary Deliberation intended to provide more detailed public advice that was targeted towards the ethical protocols and governance structures of the BC BioLibrary (a publicly funded organisation acting as an umbrella across several biobanks).³ In the 2007 BC Biobank Deliberation, participants' first deliberative task was to discuss their hopes and concerns about biobanking. Their second and more substantive task was to develop a conceptual design for a hypothetical biobank in BC. In the 2009 BC BioLibrary Deliberation, participants discussed five specific pre-determined topics: the collection of biospecimens; initial contact/ introducing the Biobank; linking samples to personal information; consent; and the governance of biospecimens and associated data.⁴ The five topics were chosen based on the particular needs of the BC BioLibrary for establishing ethically sustainable protocols, standard operating procedures, and governance structures.

In line with the different structures of the two deliberations, the results took different forms. The outcomes of the 2007 BC Biobank Deliberation were broad recommendations from the group across a large range of issues with different levels of agreement and disagreement.⁵ The 2009 BioLibrary Deliberation achieved more specific recommendations on the particular topics presented for deliberation.⁶ In both deliberations, the final outcomes (whether reflective of consensus or some degree of disagreement) were fed back to deliberants for ratification.

Outcomes and impact

The results, methods, and analyses of various aspects of the deliberations have been published in several peer-reviewed papers.⁷ Beyond the peer-reviewed literature, the most immediate effect of the deliberations was on the practices of the BC BioLibrary, which had made an a priori commitment to public engagement in establishing its organisation. Since the BioLibrary is a coordinating body for many biobanks in British Columbia, it is anticipated that its adopted practices will influence individual biobanks. Moreover, several senior members of the BC BioLibrary are involved in other biobanks across Canada, leaving open the possibility that effective governance mechanisms used in BC will be transferred to other parts of Canada. In addition, members of the research team sit on various ethics or advisory boards and incorporate the findings through their role in the regulation of biobanking practice.

An unexpected outcome of the deliberations was that participants of the forums have since been recruited to act as community members on biobank boards or advisories (a member of the 2007 Deliberation was invited to sit on the BioLibrary governance oversight committee, and one of the 2009 Deliberation participants now serves on a national ethics advisory committee). Since forum participants have been exposed to a diversity of views and perspectives on biobanking and its potential effects on the community, they have the unique quality of being able to represent a range of viewpoints on an issue about which there is relatively little public awareness.

The main influence of the deliberations to date, however, seems to be the uptake of the methods of public engagement. This makes sense, since the BC deliberations explicitly sought to give voice to the values of the citizens and residents of British Columbia. Achieving similar political legitimacy in other jurisdictions thus required the implementation of similar forums involving local participants. The design of the BC Biobank Deliberation was subsequently applied in two other contexts with only minor differences. The Mayo Clinic (Rochester, Minnesota) used the design to conduct a deliberative forum in late 2007 involving citizens of Olmstead County to inform the ethical protocols and governance of a Mayo Biobank. In Western Australia, the Office of Population Health Genomics (Department of Health) was tasked with developing a position statement on biobanking. The Office involved several stakeholder groups in the development of this document and also used the design of the BC Biobank Deliberation with minor amendments in 2008 to consult citizens of Western Australia to inform their policy.⁸

Lessons learned

One of the characteristics of the deliberation structure of the 2007 BC Biobank Deliberation was that discussion was relatively unstructured. This was a conscious decision in response to criticisms of public engagements conducted in the context of UK Biobank, which had argued that narrow framing of issues did not allow for meaningful consideration of public concerns. The BC Biobank Deliberation was designed to allow for in-depth consideration of issues that emerged from participants' discussions.

As a consequence, however, the results of these deliberations were very broad, making translation into policy difficult. For example, a recommendation of the forum focused on the importance of protecting donors' privacy while not making these restrictions so strict that they excessively impede research. The tension between privacy protection and research facilitation is well-recognised in the academic literature on biobanking, but beyond the observations that a public forum also recognised this dilemma, the recommendation does not provide specific input on how to navigate this issue. The design of the BC BioLibrary Deliberation conducted in April 2009 included changes to address these and other challenges.

A further problem identified in the 2007 Biobank Deliberation pertained to the concluding session of the deliberation. The deliberative event was structured in such a way that the participants were divided into three small groups, each of which came up with its own recommendations on issues they felt were most important. The purpose of the final session was to integrate the recommendations of the three separate groups into one coherent set of results. This was only partially successful because only a small proportion of the issues that were discussed in the small groups over the course of the event could be covered in this final discussion. This failure was a result of more than insufficient time. Many participants expressed frustration at having to revisit arguments that they had already covered in detail in their small groups. In many instances, deliberation in the final large group discussion faltered over misunderstandings, and confusion and disagreement arose regarding different meanings attached to terminology.⁹

The design of the 2009 BioLibrary Deliberation included refinements to successfully overcome this problem. In particular, discussions in the small groups were limited to an exchange of views only, without facilitators guiding deliberations towards group consensus. The small group discussions thus served to help people explore and articulate their own views on a particular aspect of biobanking, while also exposing them to the views of others in the group. The goal of reaching agreement on particular recommendations on biobanking policy was reserved exclusively for discussion in the large group. This strategy proved to be effective in that the considerations of the full complement of deliberants was brought to bear on all issues, and none of the participants expressed frustration at having to revisit particular arguments or discussions.

Date modified:

2013-11-18