Involving citizens in the ethics of biobank research: Informing institutional policy through structured public deliberation

Social Science & Medicine 75 (2012) 1604e1611

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Involving citizens in the ethics of biobank research: Informing institutional policy through structured public deliberation Kieran C. O’Doherty a, *, Alice K. Hawkins b, Michael M. Burgess b a b

Department of Psychology, University of Guelph, Guelph, ON, Canada, N1G 2W1 University of British Columbia, Canada

a r t i c l e i n f o

a b s t r a c t

Article history: Available online 28 July 2012

This paper reports on the design, implementation, and results of a structured public deliberation on human tissue biobanking conducted in Vancouver, Canada, in 2009. This study builds on previous work on the use of deliberative democratic principles and methods to engage publics on the social and ethical implications of human tissue biobanking. In a significant refinement of methods, we focus on providing public input to institutional practice and governance of biobanks using a tailored workbook structure to guide participants’ discussion. Our focus is on the local context and practices of a particular institution, the BC BioLibrary. However, elements of both the methodological innovations and the ethical guidance implied by our findings are generalisable for biobanking internationally. Recommendations from the deliberative forum include issues of informed consent, privacy protections, collection of biospecimens, governance of biobanks, and how to manage the process of introduction between biobanks and potential donors. Notable findings include public support for research use of anonymised un-consented tissue samples when these come from archived collections, but lack of support when they are collected prospectively. Ó 2012 Elsevier Ltd. All rights reserved.

Keywords: Canada British Columbia Biobanks Public deliberation Biospecimen Consent Privacy

Introduction

appropriate ethical protocols. These issues also emerged as areas in which the BC BioLibrary sought informed public input:

A biobank is an organised collection of biological tissue samples used for health research. Biobanks range from large national biobanks containing hundreds of thousands of specimens (populationbased) used for research into numerous medical conditions, to hospital or disease-specific collections used to research particular diseases (Watson et al., 2009). This paper focuses on the latter; specifically the BC BioLibrary (http://www.bcbiolibrary.ca/), a network that complements existing disease-based biobanks by improving quality and access to biospecimens and enhancing standardised collection and annotation procedures. Biobanks present social, legal and ethical challenges, including how to apply informed consent; privacy protection; specimen ownership; maintaining trust between donors and the biobank; sample and data access; return of results; commercialisation and benefit sharing (Hawkins & O’Doherty, 2010). This paper focuses on five particular areas in which there is uncertainty regarding

1. Collection of Biospecimens (including the acceptability of using leftover clinical specimens for research and collecting additional specimens for research); 2. Initial contact/Introducing the Biobank (including appropriate avenues for introducing the biobank to potential donors and identifying potential donors); 3. Linking Samples to Personal Information (including implications of anonymised versus identifiable samples; see Table 1 for definitions of these terms); 4. Consent (including acceptability of ‘blanket consent’, ‘community consent’, and appropriate times and places for obtaining consent); 5. Governance of Biospecimens and Associated Data (including who determines whether particular research on biobank collections is acceptable).

* Corresponding author. Tel.: þ1 519 824 4120x58919; fax: þ1 519 837 8629. E-mail addresses: [email protected] (K.C. O’Doherty), alicehaw@ exchange.ubc.ca (A.K. Hawkins), [email protected] (M.M. Burgess).

While ethical and other expert analyses are required to address these challenges, legitimate and sustainable solutions also require meaningful and informed public input (Burgess, O’Doherty, & Secko, 2008). Particularly for publicly funded biobanks whose existence requires the trust and participation of publics, democratic

0277-9536/$ e see front matter Ó 2012 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.socscimed.2012.06.026

K.C. O’Doherty et al. / Social Science & Medicine 75 (2012) 1604e1611 Table 1 Sample identifiability and consent. Technical term

Meaning assigned for deliberation Support for research assuming consent?

Identified Biospecimens associated Yes Biospecimens with information that allows the straightforward identification of the individual who donated the specimen De-identified Biospecimens are stripped of Yes Biospecimens identifiers and assigned a code that permits re-linking of sample to information by the biobank. Samples are passed on to researchers without identifying information. Re-identification might be necessary to add new data or seek consent for additional research. Tissue samples are thus not completely anonymised, but researchers use them without identification Anonymised Biospecimens are permanently Yes Biospecimens and irreversibly stripped of any personal identifiers so that they cannot be re-linked to the original donor

Support for research assuming no consent? No

No

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decisions on what policy should entail. Guidelines underlying deliberation focus on respectful engagement, participants’ positions being justified and challenged by others, and conclusions that represent the deliberating groups’ efforts to find common ground (Gastil & Levine, 2005). Certain features of deliberation differentiate it from other forms of conversation. While there is some disagreement on precise definitions, Hamlett (2003, p. 122) provides a useful description: Such deliberations, ideally, do not reflect the position of any particular interest group but rather express a reasoned, informed, consensual judgment forged out of the initially disparate knowledge, values, and preferences of the participants, as these have evolved through the deliberative experience itself.

ideals suggest appropriate public involvement in policy formation. There is ambiguity among research ethics boards (institutional review boards) in addressing the challenges presented by biobanks (Gibson et al., 2008). Informed public input can provide guidance in working towards best practice guidelines. Mechanisms to engage publics in addressing such areas of controversy have been developed and applied in a number of areas of biotechnology (Irwin, 2001; Jasanoff, 2004) including biobanking (Godard, Marshall, & Laberge, 2007; McCarty et al., 2008; Rotimi et al., 2007). Such public involvement makes science more accountable and may counter potential loss of public trust (Foltz, 1999). Public engagement may also lead to the emergence of issues deemed important by the public that researchers and policy makers may otherwise overlook. The purpose of this paper is to illustrate a novel method for developing meaningful public input on ethically contentious issues in institutional biobanking policy. This study builds on previous work involving the use of deliberative democratic principles to inform ethical debates on biobanking (Burgess et al., 2008; O’Doherty & Burgess, 2009; Secko, Preto, Niemeyer, & Burgess, 2009; Walmsley, 2011). The current study illustrates methodological refinements geared to facilitating links between deliberation output with actual policy uptake. We illustrate the use of a workbook to guide deliberants through a structured deliberation process aimed at developing outcomes that are both politically legitimate and practically relevant. Although our focus is the BC BioLibrary, the paper has implications for debates in the broader biobanking context. Public deliberations are large, complex projects and it is not feasible to provide detailed analyses on every aspect of these events in a single paper. The purpose of this paper is to provide a comprehensive outline of the methods and results of the BC BioLibrary Deliberation. Where relevant we provide references to other papers in which further details are provided on particular aspects of the study.

Deliberative democratic principles offer certain advantages over traditional social scientific methods in this context. First, typical methods generally require participants’ familiarity with the subject matter. In purporting to measure public opinion most traditional survey methods implicitly assume individuals have pre-formed opinions that are relatively enduring and bounded, and thus ‘cognitively available’ and possible to report to researchers. Although some qualitative approaches do not make these assumptions, they generally also rely on familiarity with the topic and are subject to the same limitations as survey methods. Even if it were possible to ‘tap into’ public opinion through surveys, most people are not familiar with biobanking. Measuring substantive public opinions is therefore scientifically problematic. Moreover, even if public awareness was sufficient, ‘top of the head responses’ arguably do not provide desirable policy input. Deliberative democratic forums allow lay publics to develop informed opinions before collating their input for policy without biasing them towards vested interests (MacKenzie & O’Doherty, 2011). Second, we are not interested in simply reporting on values or preferences; rather, we seek to involve publics in the debates and resolution of ethical and policy conundrums. Deliberative democratic forums may achieve this by guiding participants through a process of considering diverse points of view and formulating mutually acceptable solutions. If agreement cannot be reached, articulation of persistent disagreements can be a valuable outcome. The purpose of deliberative democratic forums is thus not to document individuals’ opinions, but rather to support the explicit construction of social norms while respecting individual and group variation. The approach described here also identifies persistent disagreements to avoid premature conclusions and identify disputes that require further attention. Deliberative methods have received criticisms, both in general and in the context of biobanks. Deliberation in the form of minipublics has been criticised for legitimising the interests of elites since lay publics may not have the opportunity or required social capital to participate in deliberation (Hibbing & Theiss-Morse, 2002). Deliberation has also been criticised for potentially legitimising majority views and silencing or marginalising minorities through inappropriate emphasis on consensus (Young, 2000). Finally, public engagement on biobanks, in particular, has been criticised for framing issues from the outset and not allowing publics to have a genuine voice in governance (Petersen, 2007). Below we illustrate the incorporation of particular structural and procedural elements in deliberation to guard against these problems.

Theoretical background

Method

Deliberative democracy involves giving citizens the opportunity to learn about a topic, engage in debate, and come to collective

Ethics approval for this study was obtained from the University of British Columbia Research Ethics Board.

Depends on whether collection is archived or prospective

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Recruitment Recruitment aimed to achieve a sample that represented the diversity of values, life experiences, and discursive styles of British Columbians, in a relatively small-scale event that allowed for meaningful deliberation on a limited budget (Longstaff & Burgess, 2010). A further aim was to address perceived democratic deficits (Burgess & Tansey, 2008) by giving voice to individuals/groups that would otherwise not be heard (i.e., in contrast to special interest groups that are able to lobby and influence policy). To this end, a random demographically stratified sample of 25 was recruited. A small sample cannot be politically and statistically representative of a provincial population and deliberants may not represent views of others in their demographic profile. However, it is possible to aim for diversity and minimise selection bias and thereby maximise the range of views available. Drawing on the theoretical construct of a mini-public (Goodin & Dryzek, 2006), even a small sample of sufficiently diverse participants can add an important set of perspectives to policymaking processes that would otherwise be ignored. 5000 letters of invitation were sent to random households across the province selected by postal code, resulting in 224 individuals expressing interest. Demographic stratification was achieved by selecting 25 individuals to fill age, gender and Health Region (to account for potential systematic variation healthcare experiences) categories. Thresholds were used to achieve approximate proportional representation relative to Canadian census statistics. In addition, two groups (First Nations (the preferred term for Native Canadians) and individuals with genetic/chronic disabilities) were over represented relative to the general population (minimum of two participants for each category). Both groups were seen as potentially subject to disproportionate effects from biobanks. A total of 28 individuals were invited to account for attrition. Participants were compensated for travel expenses and time ($100/day). Random invitation (rather than open invitation) assisted in assembling a diverse sample not characterised primarily by individuals with vested interests. Ensuring the presence of particularly important minority voices on the topic was augmented by minimum recruitment filters for individuals from First Nations and those with chronic disabilities. Information materials Providing information for public engagement on a controversial topic is open to criticisms of undue framing to favour vested interests (Petersen, 2007). To guard against this, the BC BioLibrary Deliberation involved framing issues ‘for deliberation’ (Friedman, 2007). Information provided was aimed at being unbiased, representative of the diversity of views on the topic, and presented in a range of modalities to account for different learning styles and increase information uptake. Prior to the event, deliberants received an information booklet about the purpose of biobanks, types of biobanks, and a range of diverse perspectives. Additional information materials, including the booklet, event description and additional reading, were provided on a publicly accessible website (http://www.biobanktalk.ca). The first day of the event included five presentations selected to represent a broad range of perspectives: 1) an introduction to biobanks and the BC BioLibrary; 2) an overview of ethical issues; 3) a First Nation’s perspective on biobanks; 4) a perspective on genetic discrimination; and 5) a report from a participant in a previous biobank deliberation. Information provision was an important step in creating an environment enabling meaningful and legitimate deliberation. A key purpose was to give participants the confidence

to talk with some authority on issues surrounding biobanks. Expert speakers did not participate in deliberation as the involvement of experts in deliberation can cause lay voices to be marginalised (O’Doherty & Davidson, 2010). Since an explicit point of the deliberation was to document lay publics’ views, exclusion of experts is an important element in the legitimacy of this deliberation. Deliberation structure The deliberation took place in Vancouver, Canada, over two separate weekends in March 2009 to allow participants additional time to reflect on the issues between sessions. The event was audio recorded and transcribed. Day 1 was geared towards information provision and an introduction to deliberation. Days 2 and 3 were dedicated to deliberating the five topics for which the BioLibrary sought input. Day 4 involved interaction with a panel composed of senior BioLibrary staff and a ratification process of the previous days’ resolutions. The panel discussion enabled participants to question those who would implement their recommendations, and allowed BioLibrary staff to clarify questions they might have. The ratification process involved revisiting each topic for a final opportunity to log changes of opinion. Given that the five topics had to be presented in some order, some issues were discussed with more information being taken into account than others. The final ratification process was seen as essential to counteract potential order effects, and allow participants to take into account the final discussion with BioLibrary personnel. The entire deliberation process was geared towards ensuring that conclusions reported from the event were not rushed, but fully formed and reflective, while acknowledging the development and changing of individual opinions. The tangible outcome was a large poster that summarised the results of the deliberation. Deliberation was guided by a workbook covering the five topics outlined above. Each section included an initial overview of the topic, definitions of technical terms, any important existing rules or regulations, and short examples or cases that served to illustrate abstract principles and outline different perspectives on the issue. Finally, each topic included one to five questions for participants to deliberate (for the complete workbook see http://www. biobanktalk.ca). The workbook was developed in collaboration with senior BioLibrary personnel. The issues included in the workbook were not based on abstract ethical principles, but rather on actual BioLibrary practices. The items included were the result of an analysis of the governance structure and ethics protocols of the BioLibrary for any areas of ‘ethical ambiguity’ (i.e., those in which the most ethically appropriate policy or course of action was not immediately obvious and there was regulatory uncertainty). Constraining deliberation to the issues in the workbook increased the policy relevance of the final recommendations, but reduced the scope for emerging themes to arise. It is relevant to note that undue framing has been the subject of criticism of public engagement on biobanks (Petersen, 2007). It is therefore important to justify the particular framing of issues as they were presented to participants in this particular forum. A detailed discussion of how the workbook was constructed to balance policy relevance and emergent themes is provided in O’Doherty and Hawkins (2010). In brief, the main points of this discussion are that (1) the framing of issues was sensitive to the results of a prior public deliberation in which there was no framing of issues (in particular, the emergent themes of the unframed deliberation were cross-referenced against, and used to guide the framing of, the topics and questions posed to participants, and examples of recommendations from the previous forum were presented in the workbook); (2) participants were encouraged to

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reframe any of the issues presented in the workbook if this was necessary to best express the values they were attempting to enact in their recommendations; (3) participants were free to highlight any concerns whatsoever (including rejection of biobanks in principle); issues raised by participants that were not in the workbook were noted on a ‘parking spot’ for later discussion. Deliberations were conducted in the large group (all participants) and three small groups. Small groups consisted of 8e9 participants structured to maintain diversity within the group, and remained constant to build familiarity and comfort in communicating with other group members. Small and large groups had a facilitator and note taker from the research team. For each topic, participants received an initial briefing in the large group, followed by detailed discussion and exploration of the topic in the small groups. Importantly, no decisions were reached in the small group discussions. Deliberation with the aim of achieving group recommendations occurred in subsequent large group discussions. Significantly, no consensus was forced. If it became clear that there was persistent disagreement on an issue, the clear articulation and documentation of all remaining positions was seen as a satisfactory outcome. Large group discussion on each issue was concluded with a final vote on the recommendation(s). The vote served two purposes: 1) to provide closure to discussion on an issue and allow the facilitator to move discussion forward; and 2) to ensure that minority views were not missed and clearly documented. Results Public deliberations produce large amounts of data, which can be analysed and reported in a number of ways. Care needs to be taken in how variation in expressed opinion is addressed in analysis. Deliberants are actively encouraged to reconsider their positions in light of new information and other perspectives, and may change their opinions. Analyses therefore need to differentiate between individual opinions expressed in discussion, themes emerging from analyses of the entire deliberation, and collective statements ratified by the group. We term these collective statements ‘deliberative outputs’ (O’Doherty & Burgess, 2009). In contrast to post hoc analyses of deliberation transcripts, deliberative outputs have additional political legitimacy because they represent collective positions arrived at through democratic deliberation, that are subsequently ratified as such. Additional analysis of deliberation transcripts can provide important insights and reveal subtleties such as value trade-offs, rejected positions, and implicit values underlying certain positions. However, such analyses draw their legitimacy more from the soundness of social scientific methods and epistemology, rather than the political mandate accorded to the deliberative forum. Here, we report the ratified collective conclusions (i.e., the deliberative outputs) of the forum. For analysis of selected transcripts see O’Doherty, Ibrahim, Hawkins, Burgess, and Watson (2012). The format of the results below follows the five topics discussed by the forum. The framing of workbook questions was itself subject to deliberation and in some instances changed by collective decision. We report on the final questions that participants collectively agreed to vote on, the collective conclusion, whether it was agreed upon unanimously, and qualifications raised by deliberants. When unanimous agreement was not achieved, we report the number of participants supporting the statement and give particular attention to the nature of the disagreement. There is some variation in the number of participants voting, owing to minor attrition, and temporary absences of an individual due to illness. 1. Collection of Biospecimens for Research This discussion dealt with underlying principles and values

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surrounding collection of tissue for research, and whether certain practices should be permitted. Consideration of this topic occurred on an “in principle” level, with the explicit assumption that an acceptable formal consenting process was in place. 1.1 Support for use of leftover biospecimens (Agree: 23 Disagree: 0). Participants unanimously supported the use of biospecimens for research purposes. Not every individual would participate in biobank research, but supported it as a societal activity. 1.2 Support for use of leftovers from clinical diagnosis (Agree: 21 Disagree: 2). Support was still strong for the more specific issue of biospecimens leftover from clinical diagnosis, but with some dissent. Two individuals expressed concern about insufficient sample being left for future care for the donor or family members, and potential secondary uses particularly if the private sector was involved. The issue of insufficient specimen for future clinical needs was also voiced by other participants, but they were generally satisfied that existing ethics protocols would safeguard against this. Further concerns included: commercial use of specimens; that participants should have knowledge of the specific research and researcher qualifications; confidentiality protections; that there should be scope for withdrawing consent; and a time limit to how long tissues could be used. 1.3 Support for using additional blood samples (Agree: 22 Disagree: 1). Researchers may request additional blood from patients whose blood is being drawn for clinical reasons. Participants were informed about typical amounts of blood requested relative to blood donations (which are significantly larger). Support for allowing this kind of procedure (again assuming consent) was very strong, with only one person objecting. One stipulated condition of support was that potential donors should know what the blood would be used for, and that this not be for ‘nefarious’ purposes. The person objecting argued leftover clinical samples could be used and that the extra blood draw might be detrimental to the donor’s health. 1.4 Can routinely collected biospecimens in a pathology department archive be considered for research? (Yes, with conditions: 22 No: 1). Tissue collections exist in many pathology departments that, while originally collected for clinical purposes, could now be used for research. It may not be feasible to obtain informed consent from the biospecimen donors (due to difficulties recontacting individuals). After deliberation, all but one participant gave support for the use of such biospecimens for research, providing that anonymity could be assured. The person who disagreed argued that as the biospecimens were collected for clinical reasons, it would be a violation to use them otherwise. 2. Initial Contact or Introducing the Biobank Before informed consent occurs, biobanks must identify potential donors and approach them for participation. Initially it was difficult for deliberants to distinguish the consent process from being identified and approached for participation. This distinction became clear over the course of deliberation and deliberants explicitly bracketed out the issue of consent from these considerations. Also, the original questions posed in the workbook focused on evaluating the appropriateness of different types of introduction (e.g., during a hospital visit, preoperatively, post-operatively, by a surgeon or an admitting clerk). Deliberants resisted this framing and collectively formulated the conditions of first contact they felt were appropriate:

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2.1 Under what conditions is it acceptable to introduce the biobank to a potential donor (if at all)? Face to face, by a known medical professional or other member of the healthcare team who is already involved in the patient’s care and who introduces the concept of a biobank to the patient, and how the patient can: a) seek further information, OR b) give permission for the biobank to contact them. (Agree: 21 Disagree: 2). Face to face introductions were strongly preferred. Websites, documentaries and Public Service Announcements, posters and pamphlets are all acceptable. Unsolicited phone calls or junk mail were rejected, as they were perceived as inefficient and unprofessional because people already receive too much information in this format. The two participants who disagreed expressed that more ‘buy-in’ was required for disease-specific biobanks (as opposed to population based biobanks), as they might warrant additional privacy considerations. Those introducing the study should have intimate knowledge of the research, and a close connection to the potential donor, rather than peripheral involvement in the patient’s care. For further discussion and more detailed transcript analysis on the issue of introduction between biobanks and potential donors see O’Doherty et al. (2012). 3. Linking Samples to Personal Information A complex issue discussed was the acceptability of using biospecimens for research given different levels of privacy protection. Although the original framing of the question did not include considerations of consent, participants felt that they could not discuss the acceptability of biospecimen use with different privacy protection without considering whether consent had been obtained. The statements below take this into account. 3.1 Identified biospecimens Supportive assuming informed consent (Agree: 23 Disagree: 0). Supportive using non consented tissue (Agree: 0 Disagree: 23). Participants were unanimous in their support for making identified biospecimens available for research assuming informed consent. Participants were also unanimous in rejecting the use of such specimens when consent had not been obtained. Participants’ concerns regarding the use of identified specimens included adequate privacy protections, in particular that donors’ involvement in research would not affect insurance rates; that no personal information would be disclosed in research publications; and that there would be no cross-agency access (e.g., law enforcement). 3.2 De-identified biospecimens Supportive assuming informed consent (Agree: 23 Disagree: 0). Supportive using non consented tissue (Agree: 1 Disagree: 22). Participants were introduced to the practice of “de-identification” (see Table 1). Support for using de-identified biospecimens for research was unanimous (assuming consent). A single participant supported the use of de-identified tissue in the absence of consent because she believed the researchers are “going to do everything possible to keep my identity confidential.” Participants were concerned that because biospecimens can be re-identified, close attention should be given to ensuring that storage methods were adequate to protect

3.3

4.

4.1

4.2

4.3

privacy. There was also recognition that donors might confuse biospecimens being de-identified with being anonymised, so donors should be aware of what ‘de-identification’ means. Anonymized biospecimens Supportive assuming informed consent (Agree: 23 Disagree: 0). In the context of fully anonymised tissue samples, participants were unanimous in supporting their use in research assuming consent from the tissue sources. The issue of nonconsented anonymised tissue samples is considered below. Consent Owing to the complexity of issues surrounding informed consent, the topic was discussed later in the deliberation, after participants had the opportunity to consider the previously outlined issues. However, concerns around consent cannot be separated from many other ethical problems. For example, participants considered the role of informed consent during discussions of privacy protection: Should consent be required for identified samples? Yes: 23 No: 1. In line with the discussion on privacy, participants felt strongly that consent was required for research use of biospecimens associated with information that identified the individual. However, this sentiment was not unanimous with one person indicating that in public healthcare systems (such as Canada’s) participation in health research through biobanks could be considered mandatory. Should consent be required for de-identified samples? Yes: 21 No: 2. For de-identified biospecimens most participants stipulated that consent should be required. However, in addition to the person who argued for mandatory biobank involvement, another person stated that de-identified biospecimens could be used without consent as they had sufficient trust in this level of privacy protection. Should consent be required for anonymised samples? Collected prospectively: Yes: 16 No: 7. Archived samples: Yes: 3 No: 19 Abstain: 1. Participants disagreed as to whether consent was required for the use of anonymised biospecimens. A significant issue was whether the anonymised biospecimens were archived samples or whether they were being collected prospectively for research. This distinction was not made in the original framing of the question and was driven by participants’ observation that it would be a waste of a research resource not to use previously collected clinical specimens; however, when it came to biospecimens that had not yet been collected, there was ‘no excuse’ for not having a consenting process for research at the time of collection for clinical purposes. Regarding anonymised tissue samples collected prospectively for future studies, most participants (16) stipulated that consent should be required while seven stated that consent should not be required. These participants argued that consent was not necessary owing to the protection offered by anonymity (this was termed “security through obscurity”). Not requiring consent would facilitate health research (i.e., by decreasing the financial and time costs of obtaining consent), thus providing societal benefits in the long term. This sentiment was even stronger in consideration of the case of anonymised archived samples, with almost all participants concluding consent was not required. Only three participants stated that consent was required and one person abstained owing to insufficient information. The shift from consideration of samples from prospective collections versus archived collections was justified primarily on the grounds that not

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using these archived samples would be wasting an important resource. The concerns of the few participants who insisted on requiring informed consent even for archived anonymised samples included: researchers should have had the foresight to obtain consent at collection; the rights of former patients should be protected; and expediency should not be put before informed consent. 4.4 Should different types of biospecimen be treated differently for consent purposes? No difference between blood and tissue: Agree: 23 Disagree: 0. BioLibrary personnel questioned whether there may be a need to differentiate between different types of tissue (e.g., blood, urine, tumours). All participants agreed that the type of tissue being considered did not affect the ethical questions they were discussing. This was put to an explicit vote, with participants unanimously expressing the view that blood should not be considered different from other tissue types. 4.5 What are the appropriate time(s) and place(s) for obtaining consent? The original phrasing of this question in the workbook outlined different options for deliberants to consider. These included different locations (e.g., hospital, physician’s office, home) and times (before or after a procedure/operation) and how appropriate each might be for obtaining consent. Deliberants resisted this framing and instead agreed that: ‘How’ consent is obtained is of primary importance, and ‘when’ it is obtained should be subject to the following considerations: (Agree: 23 Disagree: 0)  The person should not be in pain, have a clear state of mind, and be able to make a decision.  The patient’s clinical needs must be first, the patient should be treated with respect, and must understand the research (i.e., the nature of the biobank).  The consent process should foster societal trust in biobanking. Such trust is beneficial to research in the long run.  The consent process should foster positive relationships between patient and research team. 4.6 Blanket consent The literature regarding secondary research use of biospecimens suggests the possibility for researchers to obtain ‘blanket’ consent (Hansson, Dillner, Bartram, Carlson, & Helgesson, 2006; McGuire, Caulfield, & Cho, 2008; Rothstein, 2005). The obvious ethical objection is that such consent cannot be fully informed with regard to precise research use. Discussions about blanket consent featured prominently and a vote was called regarding the appropriateness of blanket consent as an option for potential biobank donors to consider. Deliberants expressed strong support towards making allowance for this option: Should blanket consent be an option? Yes: 22 Yes (but with reservation): 1. Deliberants articulated the caveat that potential donors must be aware of implications of blanket consent, as well as implications of sample storage in anonymised and de-identified (or other) conditions. The person who voted ‘yes, with reservations’ questioned how truly informed such consent could be. Her concern centred on identifiability and privacy; she agreed with blanket consent being an option in the case of anonymised tissues. 4.7 Community permission and individual consent Individual versus community rights is a particularly salient issue when considering the social and ethical implications of biobanks. The issues were presented to deliberants not only in the form of written materials based on academic literature, but

4.7

4.7

4.7

4.7

4.7

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by a member of the research ethics board of the Nuu-ChahNulth tribe, who had been adversely affected by participating in biobank research (Pullman & Arbour, 2009). The final questions considered by deliberants reflect a more nuanced and expanded treatment of the issues compared to the original presentation of questions in the workbook. In this discussion, community research refers to research that is conducted on individuals from a defined community or group, for example a particular First Nations group. In particular, the following issues were considered: A) Is it necessary to ask for community permission for community research on a specific group, when there is an identified community governance structure? Yes: 23 No: 0 B) Can individual consent be skipped if community representatives approve of research within their community? Yes: 0 No: 23 C) Can individuals participate in community-based research when community representatives do not approve of research within their specific community? Yes: 19 No: 1 Abstained: 3 The three participants who abstained explained that this was too complicated an issue and that there were too many factors in the question. D) Can individuals be approached for participation in community research when community representatives do not approve of research within their specific community? Yes: 2 No: 17 Abstain: 4 In general, participants disagreed with this suggestion. However, of those who stated that individuals could be approached by researchers in such a scenario, one expressed that this depended on the situation. It was argued that it would be acceptable for individual community members to participate if there was potential for personal benefit and the research did not have a negative impact on the community. E) Can individuals from a specific community participate in research that is not focused on that community without community permission? Yes: 22 No: 1 Participants recognised that circumventing a community’s political structures or leadership was potentially problematic. Individuals may not be aware of risks to the whole community, there may be political implications to such research, and the group as a whole may be put at risk. Several participants stated that they did not want to cause conflict within a community by being insensitive to established protocols, that discrimination should not result from the research, and that there should be respect for the community in question. Finally, participants stipulated that researchers should take more responsibility in disseminating research outcomes and explain the rationale of their research carefully.

5. Governance of Biobanks and Associated Data Time constraints and the complexity of issues pertaining to governance required discussion to be limited to consideration of two questions: which elements of governance are essential criteria to incorporate in biobanks, and who should be represented in the governing structure of biobanks? In answer to the first question deliberants developed the following list of essential criteria (5.1). A vote was taken on whether everyone agreed that these should be the minimal elements to be incorporated into the structure of biobanking governance. 5.1 Which elements of governance are essential?  Governance should be independent from undue influence (e.g., conflicts of interest, pressure from an individual or group of individuals)

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 Transparency  Standardisation & efficiency  Appropriate compensation of members of the governing board to encourage participation  Fairness to donors & researchers  Protection of donors  Assessment of research to ensure it is ethical  Accountability Do you agree that these are the minimal elements to incorporate in biobank governance? Agree: 22 Abstain: 1. The participant who abstained expressed that ethical assessment was not necessary; he also deemed the term ‘ethical’ inappropriate as ethical norms change over time and vary across different social contexts. 5.2 Who should be represented on the governing structure? This question was posed to deliberants explicitly because it was spontaneously introduced by participants in a previous, less structured public deliberation on biobanks (O’Doherty & Burgess, 2009). In both deliberations participants called for a variety of professions to be represented, though deliberants in this forum refrained from stipulating which professions should be represented. To the question, “Who should be represented in the governing structure?” deliberants phrased the following response and voted on its status as reflecting their collective conclusion: [There should be] representation of multiple perspectives including different professions and communities to reflect the elements of governance mentioned previously. Agree: 21 Disagree: 2. The participants who disagreed were not convinced of the need for a governing board, and required more detailed discussion of what this board would be doing before they could agree to who should be represented. Discussion The BC BioLibrary Deliberation illustrates a mechanism for incorporating public values in the governance of an area characterised by ethical and regulatory uncertainty. This study offers methodological innovations and refinements to previous work that increase the practical efficacy of public engagement work, while maintaining a process that is non-partisan and gives participants a strong opportunity to shape the outcomes. Many of the issues surrounding human tissue biobanking are value based. This recognition is at the core of our rationale for why it is important to consult the public. However, technical complexities inherent to the topic require some knowledge about biobanks and relevant contextual information. Social scientific methods aimed at measurement would be effective at producing knowledge about public ‘top of the head’ responses, potentially generalisable to the broader population. However, attempting to incorporate such responses into biobank governance in an uncritical manner is problematic, especially given the genuine uncertainty in the case of biobanking. The results of this deliberation offer collective responses that should be understood as tailored policy input, rather than public opinion measurement. The ratified conclusions of deliberation presented here incorporate in-depth discussion and sharing of views of individuals who were specifically chosen to reflect the range of diversity found in British Columbia. The final conclusions (whether consensus or clear articulation of disagreement) have a certain robustness through having been produced through deliberation and tested against the multiple perspectives embodied by the diversity of the deliberants. In this context, the final votes of deliberants do not represent personal opinion, but rather a collective position on how a socially implementable solution should look (e.g., “I may

never want to give blanket consent for my sample, but I think that the option of blanket consent should be made available to people”.) The public deliberation design presented here involves several elements which, we argue, facilitate the translation of public input into policy, when compared to previous work conducted on public deliberation on biobanks. One such element is the substantive involvement of BioLibrary personnel in the deliberation process at three important stages: 1) one BioLibrary member was present throughout the proceedings; two members helped introduce the five discussion topics using physical aids to explain technical issues; 2) the panel discussion on the final day; 3) the identification of issues for which public input was sought. The latter is critical in ensuring that BioLibrary personnel were in fact able to act on recommendations emerging from the public deliberation, as issues identified for discussion could realistically be addressed by the BioLibrary as an institution. The methodological innovation used to structure discussion on these particular issues was the workbook described above. While the workbook constrained the range of issues deliberants discussed, it enabled results that were more directly relevant for uptake. This is evident in comparing the format of results of an earlier deliberation (the BC Biobank Deliberation conducted in 2007) in which the results covered a wider range of issues (O’Doherty & Burgess, 2009), but their translation into policy was less obvious. In comparison, the advantage of the workbook was that the issues discussed were those for which the biobank required input, and thus had the capacity to implement in a fairly direct fashion (O’Doherty & Hawkins, 2010; O’Doherty et al., 2012). The tension between predetermined structure versus openended deliberation reflects a fundamental trade-off that cannot be resolved definitively. Rather, the particular issue, the context, the current level of public discourse on the topic, and the precise purpose of the public deliberation all contribute to considerations of the level of structure that is appropriate in a given implementation. In the case of biobanking, earlier public deliberations were conducted in a context of virtually no public discourse and little academic knowledge of public responses to various ethical and social implications of biobanks (Burgess et al., 2008). Arguably, a less structured approach allowing members of the public to identify issues of most concern to them was more appropriate than constraining deliberation from the start. However, given the knowledge gained from those earlier studies, and with the prospect of actually translating public norms into policy, a more structured approach is defensible. We have argued that the present approach offers advantages for the translation of results into policy compared to deliberations we previously conducted. A comprehensive empirical validation of these claims will not be possible for some time, given the ongoing evolution of governance protocols of the BC BioLibrary and other biobanks. Nevertheless, to date the outcomes of the public deliberation were indeed influential in changing policy on one issue, which is the introduction of potential donors to a biobank (O’Doherty et al., 2012). Given these considerations, we conclude with a summary of the most salient points of the deliberation, which we feel also have relevance for the broader debate on the ELS (ethical, legal, social) issues of biobanking.  Based on the considered input of this public forum, the use of archived samples and data in research without identification of individuals is generally supported. Deliberants support donation of samples and data to biobanks based on consent that does not specify particular uses and does not necessarily require re-contacting people for informed consent to specific projects. This extends to the collection of additional samples at

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the time of consent to storage in a biobank. It is appropriate to continue to use archived samples in research without consent to the specific use or general research use when samples are anonymised and/or it is not possible to re-contact individuals for consent. Since it is reasonable to anticipate that archived material may be used in this manner, it is important to seek consent for the use of new archived material for unspecified research from the present day forward. The use of identifiable archived materials for research must be authorised by consent for that specific research. It is unacceptable to use previously archived material in research with identifiers without informed consent. Initial contact to provide information to individuals about biobanks and possible involvement should be presented by a healthcare provider with whom the individual has a relationship, or at least someone directly authorised by such a person. Research that identifies specific communities as a key research population requires community-level agreement. Individual members should be approached for consent to participate in research only following community-level agreement for this type of research, and should not be approached in the absence of community agreement. This supports recent guidelines regarding research involving indigenous and identifiable communities (TCPS2, 2010). Research on a wide population that does not single out specific communities for the purpose of the research does not require community-level agreement. Participants noted that public trust in biobanks is best maintained by transparent, accountable and independent management by a widely representative body. The uses of archived and banked materials should be described and easily available to publics, including those whose samples and information are used. Procedures for consent and protection of identifying materials should be explicit, and there should be penalties for violations. The governing body should avoid conflicts of interest. This could be achieved by a governing body that is representative of different professional and public perspectives.

These results further demonstrate the ability of informed deliberative publics to provide input to institutional practice and governance of biobanks. The BC BioLibrary represents a local context, and the sample of deliberants was selected to represent the diversity of BC. Care thus needs to be taken in translating these results internationally. Nevertheless, the issues considered by participants reflect the conceptual challenges confronting biobanking internationally. From an international perspective, the conclusions therefore provide an important data point among others to be considered for ethical guidance for biobanking while the methodological innovations demonstrate the possibility of achieving public input and enhancing the trustworthiness of biobanking governance. Acknowledgements We would like to thank members of both the Face-to-Face research team and the BC BioLibrary for their efforts in making the BC BioLibrary Deliberation happen and their inputs into this paper: Ania Mizgalewicz, Dan Badulescu, Emma Cohen, Holly Longstaff, Isaac Filate, Jacqui Brinkman, Janet Wilson-McManus, Jennifer Myers, Michael Mackenzie, Sara Giesz, and Shauna Nep. We also gratefully acknowledge funding for this project from Genome BC, the PROOF Centre of Excellence, the BC BioLibrary, and CIHR. Most importantly, we would like to thank all the participants at the BC BioLibrary Deliberation for sharing their views with us and for dedicating weekends of hard work to this project.

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