Two deliberative forums involving members of the public from across the province. Participants were tasked with considering the ethical and social implications of biobanking and to formulate recommendations for policymakers.
Problems and Purpose
Biobanks have been hailed as revolutionising health research. Time Magazine featured biobanks as one of 10 Ideas Changing the World Right Now. In particular, biobank-based research is an important means for further understanding the multifactorial nature of genetic and environmental factors in causing common diseases. Researchers hope that the genomic knowledge gleaned from such biobanks will enable a better understanding of the role of genetics in disease as well as lead to a more personalized approach to medicine with safer and more effective drug use by permitting individualized therapy (i.e. pharmacogenomics). Biobanks can be disease based (smaller collections of samples obtained from individuals with a specific disease) or population based (larger scale collections obtained from individuals with and without a variety of diseases).
While biobanks offer great promise to health care research, they have sparked significant controversy due to the ethical, legal, and social implications surrounding utilization of samples and data. These issues include: informed consent, ownership, confidentiality, secondary use of samples and data over time, return of results and data sharing, trust, access to samples, and potential commercialization. Such issues present significant challenges for research ethics boards, many of whom are unsure how to deal with such issues resulting in a lack of consistency in committees’ decisions regarding biobanking.
Given these concerns with biobanking and the fact that there is no general agreement as to how best to resolve them, there is an evident need for public engagement on the issue. The purpose of the deliberative forums held in BC, therefore, was to create a mechanism by which meaningful public input could be obtained to inform policy on biobanking. Another purpose, particularly for the BC Biobank Deliberation held in 2007, was to present a proof of principle that it is possible to achieve meaningful and informed policy input on a topic involving complex biotechnology from a randomly selected sample of members of the public.
Background History and Context
In April and May of 2007, a research group at the University of British Columbia implemented the BC Biobank Deliberation. The project was motivated by an observation that although there was an active debate on the social and ethical implications of biobanks, this debate was dominated by experts from the fields of law, bioethics, and medical research. At best, the debate was complemented by certain stakeholder groups, such as disability advocates. What was missing from the debate was a voice from the general public. Although there is little or no awareness of biobanking in the general public, citizens are potentially affected by biobanking policy in a number of ways. For example, patients in hospitals may have tissue removed for clinical reasons (diagnosis or removal of diseased tissue), which may then be used for health research; also large biobanks are often expensive provincial or national projects, and investing in them requires decisions regarding the allocation of public resources. However, difficulties in securing input from the general public include i) that there is little or no public awareness of biobanking and ii) deciding who, precisely, should be invited to a deliberative forum. The BC Biobank Deliberation was the first attempt to address these challenges, and involved a random demographically stratified sample of 25 British Columbians deliberating and making recommendations on the subject.
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. The results of that forum were used by the Mayo Clinic to inform the ethical protocols and governance of their own biobank that was being planned at the time. In Western Australia (WA) the Office of Population Health Genomics (OPHG), an office within the Department of Health, was tasked with developing a position statement on biobanking. OPHG 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 the citizens of Western Australia to inform their policy.
One of the characteristics of the deliberation structure of the BC Biobank Deliberation (as well as the Mayo and Western Australian instantiations) 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. These criticisms highlighted a failing in public engagements that are too narrowly focused to allow citizens to have any meaningful opportunity to question underlying principles of such projects as large scale biobanks. Deliberation in the BC Biobank Deliberation was designed to allow for in-depth consideration of issues of concern that emerged from participants' deliberation itself. As a consequence, however, the results of these deliberations are relatively high level, and translation into detailed policy is a non-trivial task.
To address these and other challenges, the UBC research team conducted a second deliberative forum, the BC Biolibrary Deliberation, in April 2009. This project was conducted in collaboration with the BC Biolibrary, a publicly funded organisation that acts as an umbrella across several biobanks to facilitate appropriate access to biospecimens for researchers. Whereas the 2007 Biobank Deliberation aimed to document underlying public values to guide biobanking policy, the 2009 Biolibrary Deliberation aimed to provide more detailed public advice, targeted towards the ethical protocols and governance structures to be adopted by the BC Biolibrary.
Organizing, Supporting, and Funding Entities
The 2007 BC Biobank Deliberation was funded primarily by a Genome Canada grant (Principal Investigators: Michael Burgess, Peter Danielson). The 2009 BC Biolibrary Deliberation was funded primarily by a Genome BC grant (Principal Investigators: Kieran O’Doherty, Peter Watson). Both events had additional support from several other public funding sources (CIHR, BC Biolibrary, BC Cancer Agency Tumor Tissue Repository, The James Hogg iCAPTURE Centre, St. Paul’s Hospital, Canadian Biotechnology Secretariat, Canadian Tumor Repository Network, PROOF Centre of Excellence).
Neither BC forum had an official mandate to influence policy, though a commitment was made by the BC Biolibrary to take into account the results of the 2007 event in their governance. This commitment was formalised when the BC Biolibrary became a collaborator in the implementation of the 2009 event geared more specifically towards informing the ethical protocols and operating procedures of the Biolibrary. The Mayo and WA instantiations of the deliberative forum represent interesting contrasts in mandate. Whereas the BC deliberations were implemented by an independent academic group, the Mayo deliberation was implemented by an institution to inform its own policies, and the WA deliberation was implemented by a government office to inform state policy.
Participant Recruitment and Selection
The aim of recruitment in both the 2007 and 2009 deliberative events was to engage a group of citizens that reflected the diversity of the province of British Columbia. To achieve this, recruitment aimed to engage a random demographically stratified sample of 25 individuals from across the province of British Columbia. In both events participants were recruited to fill stratification for ethnicity, religion, occupational group, and sex on the basis of the 2001 Canadian Census for BC. In addition, at least 2 participants were recruited from each of BC’s 5 health regions. Recruiting from the 5 health regions was deemed to enhance the diversity of experience with health care, and an effort was made to extend the diversity of the sample to include participants that might have been excluded had recruitment relied only on random sampling (i.e., First Nations, disability community, specific religious perspectives).
One notable difference between the two events was that the 2007 Biobank Deliberation used random-digit dialling, whereas the 2009 Biolibrary Deliberation involved mailing invitations to random households, with a second stage of random selection to fill demographic stratifications from respondents to the mail-out. In the 2007 event 21 participants completed the entire event, in the 2009 event it was 23.
Methods and Tools Used
Deliberation during both the 2007 and 2009 events were conducted in small (7-9 individuals) and large groups. The first event structured group dialogue around the 'Future Workshop' methodology which allows participants to freely consider future scenarios. Conversely, the second event used 'Thematic Dialogue Tables' to structure small group deliberation which restricts participants' discussion to one of several topics or themes (in this case, five topics based on ‘areas of ethical ambiguity’ were pre-selected for discussion). Deliberations during both events were facilitated. As well, both events included an informational session where participants heard from and questioned experts and stakeholders.
What Went On: Process, Interaction, and Participation
Both deliberations were conducted using several core design elements. These included inviting participants to the forum for four days of deliberation over two non-contiguous weekends. The first day was dedicated primarily to informing participants about the topic and introducing them to the idea and practice of deliberation. Information on the topic was provided through an information booklet written specifically for the event, 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. In all this, an effort was made to present information from different perspectives on the subject. For instance, expert and stakeholder speakers included a scientist involved in several biobanks, an indigenous person who was the chair of an ethics board of a tribe that had experience with unethical conduct on the part of scientists, a disabilities advocate, a privacy lawyer, and an ethicist. Deliberation in both events was conducted in small (7-9 individuals) and large groups. Beyond this, the two events differed in structure and outcomes.
In the 2007 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 Biolibrary Deliberation, participants’ discussed five specific topics that were decided by the hosts of the deliberation and presented in the form of a workbook. These topics were: Collection of Biospecimens, Initial contact/ Introducing the Biobank, Linking Samples to Personal Information, Consent, Governance of Biospecimens and Associated Data. The five topics were chosen based on ‘areas of ethical ambiguity’ that were identified in the context of attempting to establish ethically sustainable protocols, standard operating procedures, and governance structures for the specific case of the BC Biolibrary. A further difference between the two deliberative forums was thus that the first one was implicitly more focused on population based biobanks, whereas the second was focused specifically on disease based biobanks, usually associated with tissue samples collected by pathology departments of hospitals.
One of the key features of both forums is that while deliberation aimed at consensus, facilitators were instructed not to gloss over any disagreements. Rather, if disagreements in basic values persisted in spite of deliberation, these disagreements were to be clearly articulated and documented.
Influence, Outcomes, and Effects
In line with the different structures of the two deliberations, the results took very different forms. The outcomes of the 2007 BC Biobank Deliberation took the form of recommendations from the group across a large range of issues including the purpose and anticipated outcomes of biobanks; governance; funding; standardisation of procedures to facilitate research output; privacy, security, and access to research samples; participation and implications for donors; consent; issues of ownership and benefit sharing; public engagement. Across these issues, particular recommendations achieved different levels of agreement and disagreement. Notably, however, three recommendations achieved consensus across the entire group of deliberants:
- Support for the existence of biobanks in general, and developing a biobank in BC, specifically.
- Recommendation that biobanks should have a governing body that is independent of both funders and researchers.
- Recommendation that standardization was needed to enhance efficient research use and privacy.
The 2009 Biolibrary Deliberation achieved more specific recommendations on the particular topics presented for deliberation (see above). In both deliberations, the final outcomes (whether reflective of consensus or some degree of disagreement) were fed back to deliberants for ratification.
The BC deliberations on biobanking have had several effects and influence, some of which were not anticipated at the outset. The most immediate effect was an influence on the practices of the BC Biolibrary who had made an a priori commitment to public engagement in establishing their organisation. In addition, members of the research team conducting the deliberations sit on various ethics or advisory boards and incorporate findings from the deliberations through their role in the regulation of biobanking practice. An interesting influence to emerge from the deliberations is uptake of the methods of public engagement, as opposed to the actual substance of the views of the deliberants. This makes sense, since the BC deliberations explicitly sought to give voice to the values of the citizens and residents of British Columbia. To achieve similar political legitimacy in other jurisdictions (i.e., Olmstead County, Minnesota, and Western Australia) thus required the implementation of similar forums using local participants. Finally, an unexpected outcome of the deliberations was that participants of the forums have since been recruited to act as community advisors on biobank boards or advisories. Because participants of these forums 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.
Analysis and Lesson Learned
By virtue of being academic projects, data emerging from the deliberations have been analysed along several dimensions. These include exploration of the deliberations for particular substantive issues (e.g., informed consent to participate in biobanks; public views on privacy implications) as well as analyses of process related issues (e.g., reliance of deliberants on media coverage of biobanks; reliance of deliberants on information presented by expert and stakeholder speakers). Other analyses have focussed on interpreting data emerging from the deliberations in the context of ongoing debates in the academic literature on such issues as how individuals draw on different aspects of their identity to warrant claims in deliberation, and the discursive logics that can be seen to operate in deliberation.
A criticism that can be levelled at the 2007 Biobank Deliberation is that there was a design flaw in the way the final session of the deliberation was handled. 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, and that they subsequently presented to the large group. The purpose of the final session of the deliberative event was to integrate the recommendations of the three separate groups into one coherent set of results. This attempt was only partially successful as only a small proportion of the issues that were discussed over the course of the event in the small groups was able to be covered in this final large group discussion. This failure was a result of more than simply insufficient time to address all issues discussed in the small groups. Many participants expressed frustration at having to revisit arguments they had covered in detail in their small groups. In many instances, deliberation in the final large group discussion faltered over misunderstandings, and confusion and disagreement regarding different meanings attached to terminology (e.g., standardisation).
A further purpose of the 2009 Biolibrary Deliberation was thus to refine the deliberative design to overcome this problem. This was successfully achieved by limiting discussions in the small groups to an exchange of views only, without facilitators guiding deliberations towards group consensus. The small group discussions thus served to help people to explore and articulate their own views on a particular aspect of biobanking, and to expose 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 consideration 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.
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