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Social Science & Medicine 75 (2012) 1604e1611

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Social Science & Medicine

journal homepage: www.elsevier .com/locate/socscimed

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

Kieran C. O’Doherty a,*, Alice K. Hawkins b, Michael M. Burgess b

aDepartment of Psychology, University of Guelph, Guelph, ON, Canada, N1G 2W1bUniversity of British Columbia, Canada

a r t i c l e i n f o

Article history:Available online 28 July 2012

Keywords:CanadaBritish ColumbiaBiobanksPublic deliberationBiospecimenConsentPrivacy

* Corresponding author. Tel.: þ1 519 824 4120x589E-mail addresses: kieran.odoherty@uoguelph.ca

exchange.ubc.ca (A.K. Hawkins), mburgess@exchange

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

a b s t r a c t

This paper reports on the design, implementation, and results of a structured public deliberation onhuman tissue biobanking conducted in Vancouver, Canada, in 2009. This study builds on previous workon the use of deliberative democratic principles and methods to engage publics on the social and ethicalimplications of human tissue biobanking. In a significant refinement of methods, we focus on providingpublic input to institutional practice and governance of biobanks using a tailored workbook structure toguide 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 guidanceimplied by our findings are generalisable for biobanking internationally. Recommendations from thedeliberative 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 potentialdonors. Notable findings include public support for research use of anonymised un-consented tissuesamples when these come from archived collections, but lack of support when they are collectedprospectively.

� 2012 Elsevier Ltd. All rights reserved.

Introduction

A biobank is an organised collection of biological tissue samplesused for health research. Biobanks range from large national bio-banks containing hundreds of thousands of specimens (population-based) used for research into numerous medical conditions, tohospital or disease-specific collections used to research particulardiseases (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 byimproving quality and access to biospecimens and enhancingstandardised collection and annotation procedures.

Biobanks present social, legal and ethical challenges, includinghow to apply informed consent; privacy protection; specimenownership; maintaining trust between donors and the biobank;sample and data access; return of results; commercialisation andbenefit sharing (Hawkins & O’Doherty, 2010). This paper focuses onfive particular areas in which there is uncertainty regarding

19; fax: þ1 519 837 8629.(K.C. O’Doherty), alicehaw@.ubc.ca (M.M. Burgess).

All rights reserved.

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

1. Collection of Biospecimens (including the acceptability ofusing leftover clinical specimens for research and collectingadditional specimens for research);

2. Initial contact/Introducing the Biobank (including appro-priate avenues for introducing the biobank to potential donorsand identifying potential donors);

3. Linking Samples to Personal Information (including impli-cations of anonymised versus identifiable samples; see Table 1for definitions of these terms);

4. Consent (including acceptability of ‘blanket consent’,‘community consent’, and appropriate times and places forobtaining consent);

5. Governance of Biospecimens and Associated Data (includingwho determines whether particular research on biobankcollections is acceptable).

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

Table 1Sample identifiability and consent.

Technical term Meaning assigned for deliberation Support forresearchassumingconsent?

Support forresearchassumingno consent?

IdentifiedBiospecimens

Biospecimens associatedwith information that allowsthe straightforward identificationof the individual who donatedthe specimen

Yes No

De-identifiedBiospecimens

Biospecimens are stripped ofidentifiers and assigned a codethat permits re-linking of sampleto information by the biobank.Samples are passed on toresearchers without identifyinginformation. Re-identificationmight be necessary to add newdata or seek consent for additionalresearch. Tissue samples are thusnot completely anonymised, butresearchers use them withoutidentification

Yes No

AnonymisedBiospecimens

Biospecimens are permanentlyand irreversibly stripped of anypersonal identifiers so that theycannot be re-linked to theoriginal donor

Yes Depends onwhethercollection isarchived orprospective

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ideals suggest appropriate public involvement in policy formation.There is ambiguity among research ethics boards (institutionalreview boards) in addressing the challenges presented by biobanks(Gibson et al., 2008). Informed public input can provide guidance inworking towards best practice guidelines.

Mechanisms to engage publics in addressing such areas ofcontroversy have been developed and applied in a number of areasof biotechnology (Irwin, 2001; Jasanoff, 2004) including biobanking(Godard, Marshall, & Laberge, 2007; McCarty et al., 2008; Rotimiet al., 2007). Such public involvement makes science moreaccountable and may counter potential loss of public trust (Foltz,1999). Public engagement may also lead to the emergence ofissues deemed important by the public that researchers and policymakers may otherwise overlook.

The purpose of this paper is to illustrate a novel method fordeveloping meaningful public input on ethically contentious issuesin institutional biobanking policy. This study builds on previouswork involving the use of deliberative democratic principles toinform ethical debates on biobanking (Burgess et al., 2008;O’Doherty&Burgess, 2009; Secko, Preto, Niemeyer, & Burgess, 2009;Walmsley, 2011). The current study illustrates methodologicalrefinements geared to facilitating links between deliberation outputwith actual policy uptake. We illustrate the use of a workbook toguidedeliberants througha structureddeliberationprocess aimedatdeveloping outcomes that are both politically legitimate and prac-tically relevant.Althoughour focus is theBCBioLibrary, thepaperhasimplications for debates in the broader biobanking context.

Public deliberations are large, complex projects and it is notfeasible to provide detailed analyses on every aspect of these eventsin a single paper. The purpose of this paper is to provide a compre-hensive outline of the methods and results of the BC BioLibraryDeliberation. Where relevant we provide references to other papersin which further details are provided on particular aspects of thestudy.

Theoretical background

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

decisions on what policy should entail. Guidelines underlyingdeliberation focus on respectful engagement, participants’ posi-tions being justified and challenged by others, and conclusions thatrepresent the deliberating groups’ efforts to find common ground(Gastil & Levine, 2005).

Certain features of deliberation differentiate it from other formsof conversation. While there is some disagreement on precisedefinitions, Hamlett (2003, p. 122) provides a useful description:

Such deliberations, ideally, do not reflect the position of anyparticular interest group but rather express a reasoned, informed,consensual judgment forged out of the initially disparate knowl-edge, values, and preferences of the participants, as these haveevolved through the deliberative experience itself.

Deliberative democratic principles offer certain advantagesover traditional social scientific methods in this context. First,typical methods generally require participants’ familiarity withthe subject matter. In purporting to measure public opinion mosttraditional survey methods implicitly assume individuals havepre-formed opinions that are relatively enduring and bounded,and thus ‘cognitively available’ and possible to report toresearchers. Although some qualitative approaches do not makethese assumptions, they generally also rely on familiarity with thetopic and are subject to the same limitations as survey methods.Even if it were possible to ‘tap into’ public opinion throughsurveys, most people are not familiar with biobanking. Measuringsubstantive public opinions is therefore scientifically problematic.Moreover, even if public awareness was sufficient, ‘top of thehead responses’ arguably do not provide desirable policy input.Deliberative democratic forums allow lay publics to developinformed opinions before collating their input for policy withoutbiasing them towards vested interests (MacKenzie & O’Doherty,2011). Second, we are not interested in simply reporting onvalues or preferences; rather, we seek to involve publics in thedebates and resolution of ethical and policy conundrums. Delib-erative democratic forums may achieve this by guiding partici-pants through a process of considering diverse points of view andformulating mutually acceptable solutions. If agreement cannotbe reached, articulation of persistent disagreements can bea valuable outcome. The purpose of deliberative democraticforums is thus not to document individuals’ opinions, but ratherto support the explicit construction of social norms whilerespecting individual and group variation. The approachdescribed here also identifies persistent disagreements to avoidpremature conclusions and identify disputes that require furtherattention.

Deliberative methods have received criticisms, both in generaland in the context of biobanks. Deliberation in the form of mini-publics has been criticised for legitimising the interests of elitessince lay publics may not have the opportunity or required socialcapital to participate in deliberation (Hibbing & Theiss-Morse,2002). Deliberation has also been criticised for potentially legiti-mising majority views and silencing or marginalising minoritiesthrough inappropriate emphasis on consensus (Young, 2000).Finally, public engagement on biobanks, in particular, has beencriticised for framing issues from the outset and not allowingpublics to have a genuine voice in governance (Petersen, 2007).Below we illustrate the incorporation of particular structural andprocedural elements in deliberation to guard against theseproblems.

Method

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

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Recruitment

Recruitment aimed to achieve a sample that represented thediversity of values, life experiences, and discursive styles of BritishColumbians, in a relatively small-scale event that allowed formeaningful 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 thatwould otherwise not be heard (i.e., in contrast to special interestgroups that are able to lobby and influence policy). To this end,a random demographically stratified sample of 25 was recruited. Asmall sample cannot be politically and statistically representative ofa provincial population and deliberants may not represent views ofothers in their demographic profile. However, it is possible to aimfor diversity and minimise selection bias and thereby maximise therange of views available. Drawing on the theoretical construct ofa mini-public (Goodin & Dryzek, 2006), even a small sample ofsufficiently diverse participants can add an important set ofperspectives to policymaking processes that would otherwise beignored.

5000 letters of invitation were sent to random householdsacross the province selected by postal code, resulting in 224 indi-viduals expressing interest. Demographic stratification was ach-ieved by selecting 25 individuals to fill age, gender and HealthRegion (to account for potential systematic variation healthcareexperiences) categories. Thresholds were used to achieve approx-imate proportional representation relative to Canadian censusstatistics. In addition, two groups (First Nations (the preferred termfor Native Canadians) and individuals with genetic/chronicdisabilities) were over represented relative to the general pop-ulation (minimum of two participants for each category). Bothgroups were seen as potentially subject to disproportionate effectsfrom biobanks. A total of 28 individuals were invited to account forattrition. Participants were compensated for travel expenses andtime ($100/day).

Random invitation (rather than open invitation) assisted inassembling a diverse sample not characterised primarily by indi-viduals with vested interests. Ensuring the presence of particularlyimportant minority voices on the topic was augmented byminimum recruitment filters for individuals from First Nations andthose with chronic disabilities.

Information materials

Providing information for public engagement on a controversialtopic is open to criticisms of undue framing to favour vestedinterests (Petersen, 2007). To guard against this, the BC BioLibraryDeliberation involved framing issues ‘for deliberation’ (Friedman,2007). Information provided was aimed at being unbiased, repre-sentative of the diversity of views on the topic, and presented ina range of modalities to account for different learning styles andincrease information uptake. Prior to the event, deliberantsreceived an information booklet about the purpose of biobanks,types of biobanks, and a range of diverse perspectives. Additionalinformation materials, including the booklet, event description andadditional reading, were provided on a publicly accessible website(http://www.biobanktalk.ca).

The first day of the event included five presentations selected torepresent a broad range of perspectives: 1) an introduction tobiobanks and the BC BioLibrary; 2) an overview of ethical issues; 3)a First Nation’s perspective on biobanks; 4) a perspective on geneticdiscrimination; and 5) a report from a participant in a previousbiobank deliberation. Information provision was an important stepin creating an environment enabling meaningful and legitimatedeliberation. A key purpose was to give participants the confidence

to talk with some authority on issues surrounding biobanks. Expertspeakers did not participate in deliberation as the involvement ofexperts in deliberation can cause lay voices to be marginalised(O’Doherty & Davidson, 2010). Since an explicit point of the delib-eration was to document lay publics’ views, exclusion of experts isan important element in the legitimacy of this deliberation.

Deliberation structure

The deliberation took place in Vancouver, Canada, over twoseparate weekends in March 2009 to allow participants additionaltime to reflect on the issues between sessions. The event was audiorecorded and transcribed.

Day 1 was geared towards information provision and an intro-duction to deliberation. Days 2 and 3were dedicated to deliberatingthe five topics for which the BioLibrary sought input. Day 4 involvedinteraction with a panel composed of senior BioLibrary staff anda ratification process of the previous days’ resolutions. The paneldiscussion enabled participants to question those who wouldimplement their recommendations, and allowed BioLibrary staff toclarify questions they might have. The ratification process involvedrevisiting each topic for a final opportunity to log changes ofopinion. Given that the five topics had to be presented in someorder, some issues were discussed with more information beingtaken into account than others. The final ratification process wasseen as essential to counteract potential order effects, and allowparticipants to take into account the final discussion with Bio-Library personnel. The entire deliberation process was gearedtowards ensuring that conclusions reported from the event werenot rushed, but fully formed and reflective, while acknowledgingthe development and changing of individual opinions. The tangibleoutcome was a large poster that summarised the results of thedeliberation.

Deliberation was guided by a workbook covering the five topicsoutlined above. Each section included an initial overview of thetopic, definitions of technical terms, any important existing rules orregulations, and short examples or cases that served to illustrateabstract principles and outline different perspectives on the issue.Finally, each topic included one to five questions for participants todeliberate (for the complete workbook see http://www.biobanktalk.ca).

The workbook was developed in collaboration with senior Bio-Library personnel. The issues included in the workbook were notbased on abstract ethical principles, but rather on actual BioLibrarypractices. The items included were the result of an analysis of thegovernance structure and ethics protocols of the BioLibrary for anyareas of ‘ethical ambiguity’ (i.e., those in which the most ethicallyappropriate policy or course of actionwas not immediately obviousand there was regulatory uncertainty). Constraining deliberation tothe issues in the workbook increased the policy relevance of thefinal recommendations, but reduced the scope for emergingthemes to arise. It is relevant to note that undue framing has beenthe subject of criticism of public engagement on biobanks(Petersen, 2007). It is therefore important to justify the particularframing of issues as they were presented to participants in thisparticular forum. A detailed discussion of how the workbook wasconstructed to balance policy relevance and emergent themes isprovided in O’Doherty and Hawkins (2010). In brief, the mainpoints of this discussion are that (1) the framing of issues wassensitive to the results of a prior public deliberation in which therewas no framing of issues (in particular, the emergent themes of theunframed deliberation were cross-referenced against, and used toguide the framing of, the topics and questions posed to participants,and examples of recommendations from the previous forum werepresented in the workbook); (2) participants were encouraged to

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reframe any of the issues presented in the workbook if this wasnecessary to best express the values they were attempting to enactin their recommendations; (3) participants were free to highlightany concerns whatsoever (including rejection of biobanks in prin-ciple); issues raised by participants that were not in the workbookwere noted on a ‘parking spot’ for later discussion.

Deliberations were conducted in the large group (all partici-pants) and three small groups. Small groups consisted of 8e9participants structured to maintain diversity within the group,and remained constant to build familiarity and comfort incommunicating with other groupmembers. Small and large groupshad a facilitator and note taker from the research team. For eachtopic, participants received an initial briefing in the large group,followed by detailed discussion and exploration of the topic in thesmall groups. Importantly, no decisions were reached in the smallgroup discussions. Deliberation with the aim of achieving grouprecommendations occurred in subsequent large group discussions.Significantly, no consensus was forced. If it became clear that therewas persistent disagreement on an issue, the clear articulation anddocumentation of all remaining positions was seen as a satisfactoryoutcome. Large group discussion on each issue was concluded witha final vote on the recommendation(s). The vote served twopurposes: 1) to provide closure to discussion on an issue and allowthe facilitator to move discussion forward; and 2) to ensure thatminority views were not missed and clearly documented.

Results

Public deliberations produce large amounts of data, which canbe analysed and reported in a number of ways. Care needs to betaken in how variation in expressed opinion is addressed in anal-ysis. Deliberants are actively encouraged to reconsider their posi-tions in light of new information and other perspectives, and maychange their opinions. Analyses therefore need to differentiatebetween individual opinions expressed in discussion, themesemerging from analyses of the entire deliberation, and collectivestatements ratified by the group. We term these collective state-ments ‘deliberative outputs’ (O’Doherty & Burgess, 2009). Incontrast to post hoc analyses of deliberation transcripts, delibera-tive outputs have additional political legitimacy because theyrepresent collective positions arrived at through democraticdeliberation, that are subsequently ratified as such. Additionalanalysis of deliberation transcripts can provide important insightsand reveal subtleties such as value trade-offs, rejected positions,and implicit values underlying certain positions. However, suchanalyses draw their legitimacy more from the soundness of socialscientific methods and epistemology, rather than the politicalmandate accorded to the deliberative forum. Here, we report theratified collective conclusions (i.e., the deliberative outputs) of theforum. For analysis of selected transcripts see O’Doherty, Ibrahim,Hawkins, Burgess, and Watson (2012).

The format of the results below follows the five topics discussedby the forum. The framing of workbook questions was itself subjectto deliberation and in some instances changed by collective deci-sion. We report on the final questions that participants collectivelyagreed to vote on, the collective conclusion, whether it was agreedupon unanimously, and qualifications raised by deliberants. Whenunanimous agreement was not achieved, we report the number ofparticipants supporting the statement and give particular attentionto the nature of the disagreement. There is some variation in thenumber of participants voting, owing to minor attrition, andtemporary absences of an individual due to illness.

1. Collection of Biospecimens for ResearchThis discussion dealt with underlying principles and values

surrounding collection of tissue for research, and whethercertain practices should be permitted. Consideration of thistopic occurred on an “in principle” level, with the explicitassumption that an acceptable formal consenting process wasin place.

1.1 Support for use of leftover biospecimens (Agree: 23Disagree: 0).Participants unanimously supported the use of biospecimens

for research purposes. Not every individual would participate inbiobank 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 bio-specimens leftover from clinical diagnosis, but with somedissent. Two individuals expressed concern about insufficientsample being left for future care for the donor or familymembers, and potential secondary uses particularly if theprivate sector was involved. The issue of insufficient specimenfor future clinical needs was also voiced by other participants,but they were generally satisfied that existing ethics protocolswould safeguard against this. Further concerns included:commercial use of specimens; that participants should haveknowledge of the specific research and researcher qualifica-tions; confidentiality protections; that there should be scopefor withdrawing consent; and a time limit to how long tissuescould be used.

1.3 Support for using additional blood samples (Agree: 22Disagree: 1).

Researchers may request additional blood from patientswhose blood is being drawn for clinical reasons. Participantswere informed about typical amounts of blood requestedrelative to blood donations (which are significantly larger).Support for allowing this kind of procedure (again assumingconsent) was very strong, with only one person objecting. Onestipulated condition of support was that potential donorsshould know what the blood would be used for, and that thisnot be for ‘nefarious’ purposes. The person objecting arguedleftover clinical samples could be used and that the extra blooddraw might be detrimental to the donor’s health.

1.4 Can routinely collected biospecimens in a pathologydepartment archive be considered for research? (Yes, withconditions: 22 No: 1).

Tissue collections exist in many pathology departments that,while originally collected for clinical purposes, could now beused for research. It may not be feasible to obtain informedconsent from the biospecimen donors (due to difficultiesrecontacting individuals). After deliberation, all but one partic-ipant gave support for theuseof suchbiospecimens for research,providing that anonymity could be assured. The person whodisagreed argued that as the biospecimens were collected forclinical reasons, it would be a violation to use them otherwise.

2. Initial Contact or Introducing the BiobankBefore informed consent occurs, biobanks must identify

potential donors and approach them for participation. Initiallyit was difficult for deliberants to distinguish the consentprocess from being identified and approached for participation.This distinction became clear over the course of deliberationand deliberants explicitly bracketed out the issue of consentfrom these considerations. Also, the original questions posed inthe workbook focused on evaluating the appropriateness ofdifferent types of introduction (e.g., during a hospital visit, pre-operatively, post-operatively, by a surgeon or an admittingclerk). Deliberants resisted this framing and collectivelyformulated the conditions of first contact they felt wereappropriate:

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2.1 Under what conditions is it acceptable to introduce the biobankto 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’scare and who introduces the concept of a biobank to the patient,and how the patient can:a) seek further information, ORb) give permission for the biobank to contact them.

(Agree: 21 Disagree: 2).Face to face introductions were strongly preferred.

Websites, documentaries and Public Service Announce-ments, posters and pamphlets are all acceptable. Unsolic-ited phone calls or junk mail were rejected, as they wereperceived as inefficient and unprofessional because peoplealready receive too much information in this format.The two participants who disagreed expressed that more

‘buy-in’ was required for disease-specific biobanks (asopposed to population based biobanks), as they mightwarrant additional privacy considerations. Those intro-ducing the study should have intimate knowledge of theresearch, and a close connection to the potential donor,rather than peripheral involvement in the patient’s care. Forfurther discussion and more detailed transcript analysis onthe issue of introduction between biobanks and potentialdonors see O’Doherty et al. (2012).

3. Linking Samples to Personal InformationA complex issue discussed was the acceptability of using

biospecimens for research given different levels of privacyprotection. Although the original framing of the question didnot include considerations of consent, participants felt thatthey could not discuss the acceptability of biospecimen usewith different privacy protection without considering whetherconsent had been obtained. The statements below take thisinto account.

3.1 Identified biospecimensSupportive 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 assuminginformed consent. Participants were also unanimous inrejecting the use of such specimens when consent had not beenobtained.Participants’ concerns regarding the use of identified speci-

mens included adequate privacy protections, in particular thatdonors’ involvement in research would not affect insurancerates; that no personal information would be disclosed inresearch publications; and that there would be no cross-agencyaccess (e.g., law enforcement).

3.2 De-identified biospecimensSupportive assuming informed consent (Agree: 23

Disagree: 0).Supportive using non consented tissue (Agree: 1 Disagree:

22).Participants were introduced to the practice of “de-identifi-

cation” (see Table 1). Support for using de-identified bio-specimens for research was unanimous (assuming consent). Asingle participant supported the use of de-identified tissue inthe absence of consent because she believed the researchersare “going to do everything possible to keep my identityconfidential.” Participants were concerned that because bio-specimens can be re-identified, close attention should be givento ensuring that storage methods were adequate to protect

privacy. There was also recognition that donors might confusebiospecimens being de-identified with being anonymised, sodonors should be aware of what ‘de-identification’ means.

3.3 Anonymized biospecimensSupportive assuming informed consent (Agree: 23

Disagree: 0).In the context of fully anonymised tissue samples, partici-

pants were unanimous in supporting their use in researchassuming consent from the tissue sources. The issue of non-consented anonymised tissue samples is considered below.

4. ConsentOwing to the complexity of issues surrounding informed

consent, the topic was discussed later in the deliberation, afterparticipants had the opportunity to consider the previouslyoutlined issues. However, concerns around consent cannot beseparated from many other ethical problems. For example,participants considered the role of informed consent duringdiscussions of privacy protection:

4.1 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 bio-specimens associated with information that identified theindividual. However, this sentiment was not unanimous withone person indicating that in public healthcare systems (suchas Canada’s) participation in health research through biobankscould be considered mandatory.

4.2 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 theperson who argued for mandatory biobank involvement,another person stated that de-identified biospecimens could beused without consent as they had sufficient trust in this level ofprivacy protection.

4.3 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 issuewas whether the anonymised biospecimens were archivedsamples or whether theywere being collected prospectively forresearch. This distinction was not made in the original framingof the question and was driven by participants’ observationthat it would be a waste of a research resource not to usepreviously collected clinical specimens; however, when it cameto biospecimens that had not yet been collected, there was ‘noexcuse’ for not having a consenting process for research at thetime of collection for clinical purposes.

Regarding anonymised tissue samples collected prospec-tively for future studies, most participants (16) stipulated thatconsent should be required while seven stated that consentshould not be required. These participants argued that consentwas not necessary owing to the protection offered byanonymity (this was termed “security through obscurity”). Notrequiring consent would facilitate health research (i.e., bydecreasing the financial and time costs of obtaining consent),thus providing societal benefits in the long term. This senti-ment was even stronger in consideration of the case of ano-nymised archived samples, with almost all participantsconcluding consent was not required. Only three participantsstated that consent was required and one person abstainedowing to insufficient information. The shift from considerationof samples from prospective collections versus archivedcollections was justified primarily on the grounds that not

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using these archived samples would be wasting an importantresource. The concerns of the few participants who insisted onrequiring informed consent even for archived anonymisedsamples included: researchers should have had the foresight toobtain consent at collection; the rights of former patientsshould be protected; and expediency should not be put beforeinformed consent.

4.4 Should different types of biospecimen be treated differently forconsent 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 oftissue being considered did not affect the ethical questions theywere discussing. This was put to an explicit vote, with partici-pants unanimously expressing the view that blood should notbe considered different from other tissue types.

4.5 What are the appropriate time(s) and place(s) for obtainingconsent?The original phrasing of this question in the workbook out-

lined different options for deliberants to consider. Theseincluded different locations (e.g., hospital, physician’s office,home) and times (before or after a procedure/operation) andhow appropriate each might be for obtaining consent. Delib-erants 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 followingconsiderations: (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 betreated 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 relationshipsbetween patient and research team.

4.6 Blanket consentThe literature regarding secondary research use of bio-

specimens 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 consentcannot be fully informed with regard to precise research use.Discussions about blanket consent featured prominently anda vote was called regarding the appropriateness of blanketconsent as an option for potential biobank donors to consider.Deliberants expressed strong support towards making allow-ance 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 impli-cations of sample storage in anonymised and de-identified (orother) conditions. The person who voted ‘yes, with reserva-tions’ questioned how truly informed such consent could be.Her concern centred on identifiability and privacy; she agreedwith blanket consent being an option in the case of anony-mised tissues.

4.7 Community permission and individual consentIndividual versus community rights is a particularly salient

issue when considering the social and ethical implications ofbiobanks. The issues were presented to deliberants not only inthe form of written materials based on academic literature, but

by a member of the research ethics board of the Nuu-Chah-Nulth tribe, who had been adversely affected by participatingin biobank research (Pullman & Arbour, 2009). The final ques-tions considered by deliberants reflect a more nuanced andexpanded treatment of the issues compared to the originalpresentation of questions in the workbook. In this discussion,community research refers to research that is conducted onindividuals from a defined community or group, for examplea particular First Nations group. In particular, the followingissues were considered:

4.7 A) Is it necessary to ask for community permission forcommunity research on a specific group, when there is anidentified community governance structure? Yes: 23 No: 0

4.7 B) Can individual consent be skipped if community represen-tatives approve of research within their community? Yes:0 No: 23

4.7 C) Can individuals participate in community-based researchwhencommunity representativesdonot approveof researchwithin their specific community? Yes: 19 No: 1 Abstained: 3The three participants who abstained explained that this

was too complicated an issue and that there were too manyfactors in the question.

4.7 D) Can individuals be approached for participation incommunity research when community representatives donot approve of research within their specific community?Yes: 2 No: 17 Abstain: 4In general, participants disagreed with this suggestion.

However, of those who stated that individuals could beapproached by researchers in such a scenario, oneexpressed that this depended on the situation. It wasargued that it would be acceptable for individualcommunity members to participate if there was potentialfor personal benefit and the research did not have a nega-tive impact on the community.

4.7 E) Can individuals from a specific community participate inresearch that is not focused on that community withoutcommunity permission? Yes: 22 No: 1Participants recognised that circumventing a commun-

ity’s political structures or leadership was potentiallyproblematic. Individuals may not be aware of risks to thewhole community, there may be political implications tosuch research, and the group as a whole may be put at risk.Several participants stated that they did not want to causeconflict within a community by being insensitive to estab-lished protocols, that discrimination should not result fromthe research, and that there should be respect for thecommunity in question. Finally, participants stipulated thatresearchers should take more responsibility in dissemi-nating research outcomes and explain the rationale of theirresearch carefully.

5. Governance of Biobanks and Associated DataTime constraints and the complexity of issues pertaining to

governance required discussion to be limited to considerationof two questions: which elements of governance are essentialcriteria to incorporate in biobanks, and who should be repre-sented in the governing structure of biobanks? In answer to thefirst question deliberants developed the following list ofessential criteria (5.1). A vote was taken on whether everyoneagreed that these should be the minimal elements to beincorporated 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 groupof individuals)

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� Transparency� Standardisation & efficiency� Appropriate compensation of members of the governing boardto 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 toincorporate 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 andvary 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 fora variety of professions to be represented, though deliberantsin this forum refrained from stipulating which professionsshould be represented.To the question, “Who should be represented in the gov-

erning structure?” deliberants phrased the following responseand voted on its status as reflecting their collective conclusion:[There should be] representation of multiple perspectives

including different professions and communities to reflectthe 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 detaileddiscussion of what this board would be doing before they couldagree to who should be represented.

Discussion

The BC BioLibrary Deliberation illustrates a mechanism forincorporating public values in the governance of an area charac-terised by ethical and regulatory uncertainty. This study offersmethodological innovations and refinements to previous work thatincrease the practical efficacy of public engagement work, whilemaintaining a process that is non-partisan and gives participantsa strong opportunity to shape the outcomes.

Manyof the issues surroundinghuman tissue biobanking are valuebased. This recognition is at the core of our rationale for why it isimportant to consult the public. However, technical complexitiesinherent to the topic require some knowledge about biobanks andrelevant contextual information. Social scientific methods aimed atmeasurementwouldbeeffectiveatproducingknowledgeaboutpublic‘top of the head’ responses, potentially generalisable to the broaderpopulation. However, attempting to incorporate such responses intobiobank governance in an uncritical manner is problematic, especiallygiven the genuine uncertainty in the case of biobanking.

The results of this deliberation offer collective responses thatshould be understood as tailored policy input, rather than publicopinion measurement. The ratified conclusions of deliberation pre-sented here incorporate in-depth discussion and sharing of views ofindividuals who were specifically chosen to reflect the range ofdiversity found in British Columbia. The final conclusions (whetherconsensus or clear articulation of disagreement) have a certainrobustness through having been produced through deliberation andtested against the multiple perspectives embodied by the diversityof the deliberants. In this context, the final votes of deliberants donot represent personal opinion, but rather a collective position onhow a socially implementable solution should look (e.g., “I may

never want to give blanket consent for my sample, but I think thatthe option of blanket consent should be made available to people”.)

The public deliberation design presented here involves severalelements which, we argue, facilitate the translation of public inputinto policy, when compared to previous work conducted on publicdeliberation on biobanks. One such element is the substantiveinvolvement of BioLibrary personnel in the deliberation process atthree important stages: 1) one BioLibrary member was presentthroughout the proceedings; two members helped introduce thefive discussion topics using physical aids to explain technicalissues; 2) the panel discussion on the final day; 3) the identificationof issues for which public input was sought. The latter is critical inensuring that BioLibrary personnel were in fact able to act onrecommendations emerging from the public deliberation, as issuesidentified for discussion could realistically be addressed by theBioLibrary as an institution.

The methodological innovation used to structure discussion onthese particular issues was the workbook described above. Whilethe workbook constrained the range of issues deliberants dis-cussed, it enabled results that were more directly relevant foruptake. This is evident in comparing the format of results of anearlier deliberation (the BC Biobank Deliberation conducted in2007) in which the results covered a wider range of issues(O’Doherty & Burgess, 2009), but their translation into policy wasless obvious. In comparison, the advantage of the workbook wasthat the issues discussed were those for which the biobankrequired input, and thus had the capacity to implement in a fairlydirect fashion (O’Doherty & Hawkins, 2010; O’Doherty et al., 2012).

The tension between predetermined structure versus open-ended deliberation reflects a fundamental trade-off that cannotbe resolved definitively. Rather, the particular issue, the context, thecurrent level of public discourse on the topic, and the precisepurpose of the public deliberation all contribute to considerationsof the level of structure that is appropriate in a given imple-mentation. In the case of biobanking, earlier public deliberationswere conducted in a context of virtually no public discourse andlittle academic knowledge of public responses to various ethicaland social implications of biobanks (Burgess et al., 2008). Arguably,a less structured approach allowing members of the public toidentify issues of most concern to themwas more appropriate thanconstraining deliberation from the start. However, given theknowledge gained from those earlier studies, and with the prospectof actually translating public norms into policy, a more structuredapproach is defensible.

We have argued that the present approach offers advantages forthe translation of results into policy compared to deliberations wepreviously conducted. A comprehensive empirical validation ofthese claims will not be possible for some time, given the ongoingevolution of governance protocols of the BC BioLibrary and otherbiobanks. Nevertheless, to date the outcomes of the public delib-eration 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 themost salient points of the deliberation, which we feel also haverelevance for the broader debate on the ELS (ethical, legal, social)issues of biobanking.

� Based on the considered input of this public forum, the use ofarchived samples and data in research without identification ofindividuals is generally supported. Deliberants support dona-tion of samples and data to biobanks based on consent thatdoes not specify particular uses and does not necessarilyrequire re-contacting people for informed consent to specificprojects. 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 tocontinue to use archived samples in research without consentto the specific use or general research use when samples areanonymised and/or it is not possible to re-contact individualsfor consent. Since it is reasonable to anticipate that archivedmaterial may be used in this manner, it is important to seekconsent for the use of new archived material for unspecifiedresearch from the present day forward.

� The use of identifiable archived materials for research must beauthorised by consent for that specific research. It is unac-ceptable to use previously archived material in research withidentifiers without informed consent.

� Initial contact to provide information to individuals about bio-banks and possible involvement should be presented bya healthcare provider with whom the individual has a relation-ship, or at least someone directly authorised by such a person.

� Research that identifies specific communities as a key researchpopulation requires community-level agreement. Individualmembers should be approached for consent to participatein research only following community-level agreement forthis type of research, and should not be approached in theabsence of community agreement. This supports recentguidelines regarding research involving indigenous and iden-tifiable communities (TCPS2, 2010). Research on a wide pop-ulation that does not single out specific communities for thepurpose of the research does not require community-levelagreement.

� Participants noted that public trust in biobanks is bestmaintainedby transparent, accountable and independent management bya widely representative body. The uses of archived and bankedmaterials should be described and easily available to publics,including those whose samples and information are used.Procedures for consent and protection of identifying materialsshould be explicit, and there should be penalties for violations.The governing body should avoid conflicts of interest. This couldbeachievedbyagoverningbodythat is representative ofdifferentprofessional and public perspectives.

These results further demonstrate the ability of informeddeliberative publics to provide input to institutional practice andgovernance of biobanks. The BC BioLibrary represents a localcontext, and the sample of deliberants was selected to representthe diversity of BC. Care thus needs to be taken in translating theseresults internationally. Nevertheless, the issues considered byparticipants reflect the conceptual challenges confronting bio-banking internationally. From an international perspective, theconclusions therefore provide an important data point amongothers to be considered for ethical guidance for biobanking whilethe methodological innovations demonstrate the possibility ofachieving public input and enhancing the trustworthiness of bio-banking governance.

Acknowledgements

We would like to thank members of both the Face-to-Faceresearch team and the BC BioLibrary for their efforts in makingthe BC BioLibrary Deliberation happen and their inputs into thispaper: Ania Mizgalewicz, Dan Badulescu, Emma Cohen, HollyLongstaff, Isaac Filate, Jacqui Brinkman, Janet Wilson-McManus,Jennifer Myers, Michael Mackenzie, Sara Giesz, and Shauna Nep.We also gratefully acknowledge funding for this project fromGenome BC, the PROOF Centre of Excellence, the BC BioLibrary, andCIHR. Most importantly, we would like to thank all the participantsat the BC BioLibrary Deliberation for sharing their views with usand for dedicating weekends of hard work to this project.

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