P3G$MODEL$FRAMEWORK$FOR$BIOBANK$GOVERNANCE$(2013)$

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1 P3GMODELFRAMEWORKFORBIOBANKGOVERNANCE(2013) ArianeMallette,AnneMarieTassé&BarthaMariaKnoppers I. BACKGROUND Inordertofurtheritsmissiontolead,catalyzeandcoordinateinternationaleffortstooptimize theuseofbiobanks,thepublicpopulationprojectingenomicsandsociety(p 3 G)hasupdated the 2008 model framework for biobank governance. 1 The proposed governance framework incorporates an analysis of the last five years of legislation, policies and literature that have influencedandshapedthegovernanceofbiobanks,andreflectsthep 3 G svisionofglobalaccess toresearchtools.moreover,thepracticesofcurrentp 3 Gmemberswerereassessed,including their governance mechanisms and changes in policy since 2008 ( It is our hope that this model framework will provideausefultoolforthenextgenerationofpopulationbiobanks. II. INTRODUCTION There is voluminous literature on the need for a new model of governance for modern biobanks. Today, the extent of sample and data sharing required for biobank research is unprecedented, 2 raising ethical and regulatory challenges. 3 Nevertheless, biobanks are beginning to provide access for research, even while their procedures and tools continue to generate ethical and legal uncertainty. 4 Moreover, established concepts of research ethics [are] stretchedtotheirlimits bythefloodofinformationcreatedbyrecentadvances. 5 Thus, existingnorms,bothethicalandlegal,inadequatelyregulatebiobanking. 6 This criticism stems from the national regulation of biobanks, which creates heterogeneous systems across countries and a lack of standardized biospecimens and data, inhibiting 1 SusanWallace,KarineBédard&BarthaMKnoppers, Buildingamodelframeworkforthegovernanceof biobanks (2008),online:P3G< 2 PaulRBurtonetal, Sizematters:justhowbigisBIG?Quantifyingrealisticsamplesizerequirementsforhuman genomeepidemiology (2009)38InternationalJournalofEpidemiology StephanieMFullertonetal, MeetingtheGovernanceChallengesofNextPGenerationBiorepositoryResearch (2010)2:15ScienceTranslationalMedicine15. 4 HerbertGottweis&GeorgLauss, BiobankgovernanceinthepostPgenomicage (2010)7:2PersonalizedMedicine 187at JeantineELunshofetal, Fromgeneticprivacytoopenconsent (2008)9:5NatureReviewsGenetics406at KieranCO Dohertyetal, Fromconsenttoinstitutions:Designingadaptivegovernanceforgenomicbiobanks (2011)73:3SocialScienceandMedicine367at367;JaneKaye, Fromsinglebiobanktointernationalnetworks: developingepgovernance (2011)130:3HumanGenetics377. 1

2 transnationalsharingandcollaboration. 7 Theresultislegalfragmentationduetothemultiplicity of normative sources and local practices. 8 These variable and occasionally inconsistent norms havecreatedapatchworkofregulation. 9 Forexample,inEurope,astudyofthevariouslevelsof biobank governance revealed that several models of policy are used, depending on the legal systems in which they operate. 10 Similarly, in SubPSaharan Africa, the regional variability of biobanking guidelines was considered to be an obstacle to collaboration and success of biobankinginitiativesinafrica. 11 Similarly,researchethicsboardsareculturallyandregionally variable,whichfurtherhindersinternationalcollaborationandresultsinduplicativeefforts. 12 Whiletheregulationofbiobanksisregionallyvariable,researchisincreasinglyglobalinnature, requiring research governance mechanisms that are also global in nature. 13 The present challenge for a biobank is to ensure compliance with all applicable norms. 14 Thus, the main 7 HaidanChen," GoverningInternationalBiobankCollaboration:ACaseStudyofChinaKadoorieBiobank (2013) 18:3ScienceTechnologySociety321"at322;MartinAsslaber&KurtZatloukal, Biobanks:transnational,European andglobalnetworks (2007)6:3BriefingsinFunctionalGenomics193;GoranHallsman&JimmieBVaught, Best PracticesforEstablishingaBiobank (2011)675MethodsinBiobankingMethodsinMolecularBiology241;Office ofbiorepositoriesandbiospecimenresearchetal, NCIBestPracticesforBiospecimenResources (2011)online: NationalCancerInstitute< Practices]. 8 GideonParchomovsky&MichaelMattioli, QuasiPPatientsandSemiPPatentsinBiobanking ingiovannipascuzzi, UmbertoIzzo&MatteoMacilotti,eds,Comparative"Issues"in"the"Governance"of"Research"Biobanks:"Property," Privacy,"IP"and"the"Role"of"Technology(Heidelberg:Springer,2013)251at JeanVMcHale, Accountability,GovernanceandBiobanks:TheEthicsandGovernanceCommitteeasGuardianor ToothlessTiger? (2011)19:3HealthCareAnalysis231;SusanMCGibbons, RegulatingBiobanks:ATwelvePPoint TypologicalTool (2009)17:3MedicalLawReview313at314;Gottweis&Lauss,supra"note4at18;Herbert Gottweis&GeorgLauss, Biobankgovernance:heterogeneousmodesoforderinganddemocratization (2012)3:2 61;EuropeanCommission, BiobanksforEurope:AChallengeforGovernancePReportoftheExpertGroupon DealingwithEthicalandRegulatoryChallengesofInternationalBiobankResearch (Luxembourg:EuropeanUnion, 2012). 10 EmmanuelleRialPSebbag&AnneCambonPThomsen, TheEmergenceofBiobanksintheLegalLandscape: TowardsaNewModelofGovernance (2012)39:1JournalofLawandSociety113at CiaraStaunton&KeymanthriMoodley, ChallengesinbiobankgovernanceinSubPSaharanAfrica (2013)14:35 BMCMedicalEthics. 12 JaneKaye, BiobankNetworksPWhataretheGovernanceChallenges injanekaye&markstranger,eds, Principles"and"Practice"in"Biobank"governance"(Burlington:AshgatePublishingCompany2009)201"at208; EuropeanCommission,supra"note9;BarthaMariaKnoppers,Ma nhzawati&emilyskirby, SamplingPopulations ofhumansacrosstheworld:elsiissues (2012)13AnnualReviewofGenomicsandHumanGenetics395at Kaye,supra"note6;JaneKayeetal, Ethical,LegalandSocialIssuesArisingFromtheUseofGWASinMedical Research,LiteratureReviewfortheWellcomeTrust,(2009)online:CentreforHealth,LawandEmerging Technologies< documents/wtconsultancy_for_website_publication_ p1.pdf>;europeancommission,supra"note9. 14 TheOrganisationforEconomicCoPoperationandDevelopment(OECD), CreationandGovernanceofHuman GeneticResearchDatabases (2006),online:OECD <

3 problem with existing governance mechanisms is their national and parochial nature. 15 Other challenges include developing standards, oversight mechanisms, participant interest and articulatingthemainrolesandresponsibilitiesoftheactorsinvolved. 16 Governanceplaysacrucialroleinaddressingthesocialandethicalchallengesofbiobanking. 17 It remains pivotal to maintaining public support and financing, and ensuring the security and protectionofparticipants,respectforculturalperspectivesandtheavailabilityofbiospecimens and data for research. 18 Moreover, proper governance is key to the success of a biobank. 19 Nonetheless, few efforts have defined what constitutes a proper governance framework in practice. 20 Without a proper governance framework, population biobanks may unduly add multiple layers of oversight, limiting their ability to conduct research and their overall utility. Various theoretical approaches to governance have been advanced, considering the changing nature of postpgenomic medical research and the growing need for global research networks, notablyepgovernance,reflexivegovernanceandanticipatorygovernance. 21 III.THEORETICALAPPROACHESTOGOVERNANCE Numeroustheoreticalapproacheshelptoconceptualizethechallengesfacedbybiobankswhen settingtheirgovernancestructures. EPgovernance, or digital governance, is based on a digital global governance system whereby existing mechanisms and committees continue to exist, but do not always come into play. 22 This approach hinges on rethinking the conceptual basis of research governance and using informationtechnology(it)moreefficientlyasamechanismforgovernance. 23 Accordingly,we should move away from paperpbased systems and think in terms of data flow and research portals that enable sharing and access. 24 Secondly, we should move away from the one researcher,oneproject,onejurisdiction model 25 totherecognitionofresearchnetworks.it can be used to direct and allow research proposals based on ELSI appropriate behaviors, Kaye,supra"note12;Kaye,supra"note6at EuropeanCommission,supra"note9. 17 AliceKHawkins&KieranCO Doherty, Biobankgovernance:alessonintrust (2010)29:3NewGeneticsand Society311at Ibidat317;Staunton&Moodley,supra"note Gottweis&Lauss,supra"note9. 20 Hawkins&O Doherty,supra"note17;O Dohertyetal,supra"note6. 21 Kaye,supra"note6at379;Parchomovsky&Mattioli,supra"note8;Gibbons,supra"note9at314&345;Gottweis &Lauss,supra"note4at187;O Dohertyetal,ibid"367;EuropeanCommission,supra"note9. 22 Kaye,supra"note6at Ibidat Ibid. 25 Ibid"at Ibid. 3

4 rather than having to incessantly rely on an oversight committee. Instead, there would be a triage of research proposals and expert review based on the principle of do no harm. 27 This global system does not dismiss the principles and mechanisms that have evolved over time; rather, it combines them in an efficient way whereby certain mechanisms need not be triggered,resultinginasystemoftriage,digitalgovernanceandexpertreviewconsistentwith currentfoundationalethicalprinciples. A second theoretical approach is reflexive governance, intended to adapt to the existing challengesgenerallyfacedbybiobanks. 28 Reflexivegovernanceispremisedontheprinciplesof integrity of purpose, 29 proportionality of action and reflexivity of approach, whereby mechanismsaredevelopedtopermitbiobankstooperatedespiteuncertaintyandtoadaptwith timetoensure goodgovernance,definedas: 1. designingpininteroperabilitywithrespecttoscientificandgovernanceapproaches, 2. designingpoutapproachesthatarerestrictiveofsharing,cooperation,flexibilityand mutuality, 3. establishingpoliciesandprocedurestopromoteactivelytheuseoftheresourcein keepingwithitsoriginalpurpose, 4. ensuringthelongevityofthebiobankthroughcarefullymanagedaccesspoliciesand arrangementsandstewardshipoftheresource,and 5. ensuringthatgovernancepoliciesandmechanismsremainfitfortheirpurposeover time. 30 Reflexivegovernance mustoperateintandemwiththedevelopmentofscientificendeavor 31 while encouraging cooperation and compliance, and it is dependent on those governed and those governing being receptive, responsive and open. Legal regulation is therefore not necessary. Similarly, anticipatory governance is another theoretical approach that acknowledges the uncertainty surrounding technological and scientific innovation. 32 Anticipatory governance considers human values and stakeholders, constituting a form of shared/participatory 27 Ibid. 28 GraemeLaurie, Reflexivegovernanceinbiobanking:onthevalueofpolicyledapproachesandtheneedto recognisethelimitsoflaw (2011)130:3HumanGenetics347at DefinedbyLaurieas [focusing]onthe[trust]relationshipbetweenthosewithresponsibilityforthebiobankand thosewhohavecontributedtoitormightexpecttobenefitfromit,whichcouldincludesocietyatlarge,ibid"at Ibid." 31 Ibid"at Vural Ozdemir et al, Beyond ELSIs: Where to from Here? From Regulating to Anticipating and Shaping the InnovationTrajectoryinPersonalizedMedicine inyuipwingflam&larisahcavallari,eds,pharmacogenomics:" Challenges"and"Opportunities"in"Therapeutic"Implementation(NewYork:Elsevier,2013)405at413. 4

5 governance, extended peer review and social embedding 33 of innovations, going beyond expertopinion.otherkeyfeaturesofanticipatorygovernanceinclude: o earlyupstreamengagement; o notionof coproduction ofknowledgebysocietyandscience; o anticipatesfuturedevelopmentsandissueswiththegoalofadapting;and o considerationofexpertopinionandpublicengagement. 34 These theoretical approaches help conceptualize the challenges faced by biobanks and set commonstandards,buttheyofferlimitedguidanceintermsofconcretesteps,mechanismsand measuresthatshouldbeadoptedbybiobankstoattainthesestandards.therefore,weadopta practicalapproachtogovernance,settingoutcoreelementstobiobankgovernance.webuild on the recommendations and the generic model for biobank governance advanced in 2008, incorporating public perception as a key element in governance, as well as these new approaches.thispaperwilloutlinetheprinciplesandproceduresthatinformthecreationand implementation of governance mechanisms (core elements) used by biobanks. These mechanismsareeitherexternalorinternaltothebiobankandmayvarythroughoutthelifecycle ofthebiobank. 35 IV.GOVERNANCEMECHANISMSANDTHELIFECYCLEOFABIOBANK Thelifecycleofabiobankcanbedividedintothreestages:1)Conceptualizationanddesignof thebiobank(before);2)buildingthebiobank(during);and3)usingthebiobank(after)(figure 1). 36 Sincetheneedsofthebiobankdifferfrominceptiontotheoperationalphase,governance needsandmechanismsvaryduringeachofthesestages.whiletheelaborationofagovernance frameworkisnotaonepsizepfitspallapproach,certaingovernancemechanismscutacrossstages of the biobank s lifecycle, as with ethics approval for example, while other events are single occurrences,likethecreationofcommittees. 1. Before:ConceptualizingandDesigningtheBiobank The before period is the first stage in the lifecycle of a biobank and includes the planning, design and creation phase. A majority of the governance mechanisms usedin this stage are external ones that the biobank must consider or respond to. For example, key regulatory concernsmustbeaddressed,includingenrolment,consent,proprietaryinterestsandprivacy. 37 Moreover, an ordering process must be undertaken, including the creation of protocols, data 33 Ibid. 34 Ibid"at Gibbons,supra"note9at239;Wallce,Bédard&Knoppers,supra"note1. 36 Ibid." 37 Parchomovsky&Mattioli,supra"note8. 5

6 warehousesanddatabases. 38 Veryearlyintheprocess,theremustbediscussionswithfunders, an examination of applicable laws and regulations and public engagement. 39 As plans are consolidated, formal applications must be made to funders and ethics committees for approval During:BuildingtheBiobank Once a design/plan has been created, the second step, the during phase, is building the biobank. The design is implemented, participants are recruited, samples are collected and bankingbegins.thegovernancefocusshiftstothecreationofinternalmechanismstomanage the development and operations of the resource, such as the establishment of an executive committee,andscientificandethicscommittees. 3. After:UsingtheBiobank Thethirdstepisthe after stage,wherethesamplesanddataarebankedanditistimefor researcherstoaccessthebankandproceedtoanalysis.thebiobankhasbecomeoperational. Atthisstage,adata/sampleaccesspolicyandintellectualpropertypolicieswillhavetobe createdandputinplace.methodsforcommunicatingtheresearchresultsderivedfrombiobank andforencouragingpublicinputwillalsohavetobeconsidered. BEFORE PPublicengagement PLegislaton PFunderrequirements PScientficpeerreview PEthicsreview DURING PExecutveCommivee PScientficOversightCommivee PEthicsOversightCommivee PSamplehandling PDatamanagement PPartcipantengagement AFTER PData&sample access PIPProcedures PPublicaton PPublicoutreach Figure1.Governancemechanismsandthelifecycleofabiobank V. GOVERNANCEMECHANISMS&FRAMEWORKS Throughout this lifecycle, governance frameworks regulate the processes and interactions between the various actors involved and include agreements, procedures, guidelines, laws, conventions,policies,socialnormsandinstitutionsthatdefinedecisionpmaking,accountability 38 Gottweis&Lauss,supra"note9at Wallace,Bédard&Knoppers,supra"note1. 40 Ibid." 6

7 and power. 41 Biobanking is at the intersection of multiple disciplines, actors, activities and issues, including medicine, science,as well as public and private interests. This intersection raisesnumerousquestionsthatmustbeansweredtodeterminetheproperformofgovernance for a biobank, specifically, what should be the level of regulatory response? Who are the decisionpmakers? What is the extent of their role? How should responsibilities be shared between the various actors? What types of measures should be favored (incentives or restrictions)? 42 Thegovernanceofbiobanksisalsoaboutregulatingtherelationshipsbetween citizens,society,researchersandbiobanks. 43 Thesecomplexseriesofinteractionsareregulated byexternalandinternalmechanisms(figure2). 44 Figure2.Interactionsbetweensocietyandbiobankgovernancemechanisms Thegovernanceofbiobanksisdynamic,meaningadequategovernancemustbetailoredtothe specific context of the biobank. Different biobanks will require varying forms and degrees of oversight and regulation. 45 Nevertheless, the goal remains to create a system, capable of 41 MarcHufty, InvestigatingPolicyProcesses:TheGovernanceAnalyticalFramework(GAF) inuwiesmann&h Hurni, eds, Research" for" Sustainable" Development:" Foundations," Experiences," and" Perspectives (Geographica Bernensia,2011)403at405;JohnGraham,BruceAmos&TimPlumptre, PolicyBriefNo.15:PrinciplesforGood Governance in the 21 st Century (2003), online: Institute on Governance < content/uploads/2012/12/2003_august_policybrief15.pdf>. 42 RialPSebbag&CambonPThomsen,supra"note10at114& Gottweis&Lauss,supra"note4. 44 EuropeanCommission,supra"note9;Wallace,Bédard&Knoppers,supra"note1at3. 45 TheoPapaioannou, Democraticgovernanceofgenomics:thecaseofUKBiobank (2012)31:2NewGenetics Society111at129P131;Hawkins&O Doherty,supra"note17;Gibbons,supra"note9at339;CanadianInstitutesof 7

8 adaptingovertime,fortheefficientuseofsamplesanddatafortheadvancementofscience, respectingtheconfinesoflawandethicsandtherightsofpersons. 46 While this paper by no means intends to resolve the lively debate 47 on the governance of biobanks,andwhiletheliteratureisfarfromreachingaconsensusonthematter, 48 ageneric model governance framework is proposed (Figure3), taking into account the external and internalgovernancemechanismsillustratedaboveandexplainedbelow(figure2). 49 Figure3.Proposedmodelofbiobankgovernanceframework HealthResearchetal, TriPCouncilPolicyStatement:EthicalConductforResearchInvolvingHumans (2010)online: GovernmentofCanada< commentsonarticle12);janekaye&markstranger,eds,principles"and"practice"in"biobank"governance" (Burlington:AshgatePublishingCompany2009);"O Dohertyetal,supra"note6at InternationalSocietyforBiologicalandEnvironmentalRepositories(ISBER), 2012BestPracticesforRepositories: Collection,Storage,Retrieval,andDistributionofBiologicalMaterialsforResearch,3 rd ed,(2012)10:2 BiopreservationandBiobankingat259;RialPSebbag&CambonPThomsen,supra"note McHale,supra"note9at AlexanderMCapronetal, EthicalNormsandtheInternationalGovernanceofGeneticDatabasesandBiobanks: FindingsfromanInternationalStudy (2009)19:2KennedyInstituteofEthicsJournal101at KarineBédardetal, PotentialConflictsinGovernanceMechanismsUsedinPopulationBiobanks injanekaye& MarkStranger,eds,Principles"and"Practice"in"Biobank"governance"(Burlington:AshgatePublishingCompany2009) 217at220. 8

9 1.ExternalGovernanceMechanisms External governance mechanisms are those over which biobanks have no control. These mechanisms include binding and, in some cases, even nonpbinding sources of obligations and cangenerallybegroupedintosixcategories(figure4). Figure4.Externalgovernancemechanisms a) PublicPerception Abiobankcannotoperatewithoutsocialacceptance.Publicperceptionisnowseenasacrucial considerationinthegovernanceofabiobank. 50 Transparencyandaccountabilityofthebiobank ensurepositivepublicperception,enhancingthelegitimacyandtrustinthebiobank. 51 b) SocioXculturalNorms&Values SocioPculturalnormsandvaluesalsoimpacttheexistenceandconductofbiobanksandareby definition culturally variable. 52 Biobanks must conform to such norms and values, to ensure social acceptance and public participation. Examples include trust, respect for privacy, reciprocityandsolidarity,aswellasnotionsofownership. c) Legislation&Regulations 50 Hawkins&O Doherty,supra"note17;RialPSebbag&CambonPThomsen,supra"note Hawkins&O Doherty,ibid;KieranCO Doherty,AliceKHawkins&MichaelMBurgess, Involvingcitizensinthe ethicsofbiobankresearch:informinginstitutionalpolicythroughstructuredpublicdeliberation (2012)75:9Social Science&Medicine RialPSebbag&CambonPThomsen,supra"note10at127. 9

10 Withinlegalsourcesofgovernance,therearetwoapproachestobiobanking:specificorgeneral legislation.certaincountries 53 havelegislativelycreatedandregulatedbiobanking,whileothers have relied on existing general legislation (e.g." data protection, privacy, research involving humansubjects)orevenprofessionalselfpregulation. 54 Therefore,whilenotnecessarilyspecific tobiobanking,allcountrieshaveinplaceregulations,beitlegislation,professionalguidelinesor othertechnicalorethicsnorms,thatmustbetakenintoaccountintheoperationandoversight of a biobank. In short, external governance mechanisms include various legal, ethical and culturalnorms,inadditiontooverarchinginternationalorintergovernmentalethicalguidelines andcodesofconduct. 55 Moreover,numeroussetsofstandards,qualityassurancemechanisms andbestpracticeshavebeencreatedtoguidetheoperationofbiobanks.adhesionisgenerally voluntary. 56 d) Funders Requirements Fundersfallwithinmanycategoriesandtheircontributioncanbepublic,privateorcharitable. Fundershavetheirownguidelinesandrequirementsthatgranteesandresearchersmustfollow, asnonpcompliancemayjeopardizetheresearchproject.moreover,anindirectformofauthority thatgovernancefunderspossessisanabilitytodirectthepathofsciencebyallocatingmoney toareasofinteresttothem(e.g."fundingallocatedtoaparticulardiseaseortechnology).their most important influence in the context of biobanking is to require open access to such biorepositories. 57 e) ScientificPeerReview Thecreationofabiobankmustreceiveapprovalfromascientificpeerreviewcommittee.Thisis oftenpartofthefundingprocess,wherethereviewisorganizedbythefunderandiscrucialto thisformof infrastructurescience Spainforexampleenactedthe2007LawonBiomedicalResearchwhichregulatesbiobanking.SeeLaw"14/2007" of"july"3,"on"biomedical"researchatarticle1(e)andchapter4. 54 OECD,supra"note14;Bédardetal,supra"note49;Gottweis&Lauss,supra"note9. 55 OECD, OECDGuidelinesonHumanBiobanksandGeneticResearchDatabases (2009),online:OECD< Association(WMA),Declaration"of"Helsinki:"Ethical"Principles"for"Medical"Research"Involving"Human"Subjects (1964),online:WMA< 56 Seee.g."ISBER,supra"note46;NCIBestPractices,supra"note7;EuroBioBank,online: < 57 SabrinaFortinetal, AccessArrangements forbiobanks:afinelinebetweenfacilitatingandhindering Collaboration (2011)14:2PublicHealthGenomics104at PaulNSchofieldetal, SustainingtheDataandBioresourceCommons (2010)330:6004Science

11 f) EthicsandPrivacyReview Similarly, like all research, the creation of a biobank must receive ethics approval. Thus,an ethics committee (e.g. REB, IRB, REC, etc.) must approve the overall plan for the biobank, including its consent materials, recruitment plans, as well as privacy, communication and securitymeasures.asplanschange,additionalreviewmayberequired. 2.InternalGovernanceMechanisms Internalmechanismsarecreatedbythebiobankitselftomeetarequirementorfulfillitsrole, andregulateforexampleitsmandate,operationandfinancing. 59 These mechanisms can largely be grouped into six core categories, found within most operational biobanks: a) Public Engagement Committee; b) Biobank Steering Committee; c) Scientific Advisory Committee, d) Ethics Oversight Committee; e) Laboratory BioPsafety Committee;andf)DataAccessCommittee(Figure5). 60 There may also be other types of committees, e.g. looking at epidemiology, information and technology (IT) and data security. 61 These oversight committees have specific roles and functions, with varied expertise. 62 We propose a model framework for the governance of biobanksbasedonthesix(6)coreelementsoutlinedabove. Figure5.Internalgovernancemechanisms 59 Bédardetal,supra"note Ibidat220;SeeUKBiobank,online:< < < 61 SeeGenerationScotland,UKBiobank,CARTaGENEandBBMRIforvariousorganizationalstructures,ibid." 62 OECD,supra"note14;OECDGuidelines,supra"note55;NCIBestPractices,supra"note7. 11

12 a) PublicEngagementCommittee Public engagement committees help researchers gauge the public s acceptance or concerns withthebiobank,enablingresearcherstodesigntheirstudiesaccordingly. 63 Thisinputfosters legitimacy and sustainability to the resource. 64 While public engagement encapsulates public perception, the latter may not necessarily be actively sought out by the biobank and may remainanexternalgovernancemechanism. Evenpriortorecruitment,publicengagementcantakevariousformsdependingonthecontext andcultureofthetargetedcountryorpopulation,includingforums,citizenconferences,town hall meetings, surveys and committees. There is a need for both the launching and ongoing publicsupportandengagementforthepropergovernanceofpopulationbiobanks. 65 Thereby moreinclusiveapproachestogovernancearerequired. 66 b) BiobankSteeringCommittee The Biobank Steering Committee manages the dayptopday scientific and management operationsofthebiobank,includinginformingthepublicaboutitsgoalsandactivities,seeking theinputofsocietyandparticipants,andmodifyingitsplansaccordingly. c) ScientificAdvisory/OversightCommittee Scientificadvisory/oversightcommitteesgiveadviceonthescientificaspectofthebiobank. 67 Memberscanincludeexpertssuchasgeneticists,epidemiologists,ethicistsandbiostatisticians, oftenfromothercountries. 68 Indeed,itisequallyimportantthatanindependentInternational ScientificAdvisoryCommitteeprovideadviceonthescienceandgovernanceofthebiobank. d) EthicsAdvisory/OversightCommittee Ethicsadvisory/oversightcommitteesprovideadviceonthelegal,ethicalandsocialaspectsof biobanking activities, overseeing the ethical conduct of the biobank (e.g." data protection 63 SeeforexampleGenerationScotland spublicconsultationprogramdividedinvariousstagesandaimedat exploringthepublic sopiniononarangeofissuestiedtotheuseofgeneticsinhealthcare,online: < 64 O Doherty,Hawkins&Burgess,supra"note OECD,supra"note14;EdwardSDove,YannJoly&BarthaMKnoppers, Powertothepeople:awikiPgovernance modelforbiobanks (2012)13GenomeBiology Gottweis&Lauss,supra"note9;RialPSebbag&CambonPThomsen,supra"note RialPSebbage&CambonPThomsen,ibid. 68 SeeforexampleCARTaGENE sinternationalscientificadvisoryboard,online: < 12

13 questions, consent issues, legal questions). Members may include lawyers, ethicists, social scientists and representatives of the population. The Ethics Oversight Committee is a key oversightbodycommontomostjurisdictions,actingasagatepkeeper,decidingwhetherornot aresearchprotocolcanproceed. 69 Dependingonthelegislationanddatasecuritymechanisms inplace,theapprovaloftheethicscommitteemayberequiredforaccesstodataandsamples. Moreover,thecommitteemaybeinternaltothebiobank,orbeexternalandindependent. 70 e) SampleandDataStorage/LaboratoryPracticesCommittee Sample and data storage committees oversee the quality control, quality assurance and data protection policies used when handling and storing samples, data from participants (e.g. questionnaires, body measurements, etc.) and derived data. 71 A Laboratory BioPSafety Committeeshouldalsobeconstitutedtooverseethehandlingofsamples(i.e.,"requirementsfor collection,storage,labeling,etc.). f) Data/SampleAccessCommittee Data/sample access committees oversee the processes allowing researchers to gain access to the biobank s samples and data. 72 Specifically, a Data/Sample Access Committee creates guidelines for access and reviews access requests made by researchers. It can be internal or externalandindependentfromthebiobank.accesspoliciesvary,butaregenerallybasedona notion of proportionality, balancing the needs of researchers with the potential benefits and riskstoparticipantsandsociety,reflectingthebiobank sconcernsandpriorities FinalRemarks While no onepsizepfitspall, the following should be sought in order to create an adequate governanceframework: Scientific"Aspects" Theresearchconductedwilladvancescienceandbenefitsocietyinthefuture. Thebiobank sproceduresandactivitieswillreceiveindependentscientificreview. Researchers seeking access to the biobank will undergo scientific review of their 69 Kaye,supra"note6at SeeforexampletheUKBiobankEthicsandGovernanceCouncil,online:< RialPSebbag&CambonPThomsen,supra"note10;OECDGuidelines,supra"note52;Kaye,supra"note6;Fullertonet al,supra"note3. 71 SeeforexampleUKBiobankSampleHandlingandStorageSubPgroupdiscussedinPaulElliott&TimCPeakman, TheUKBiobanksamplehandlingandstorageprotocolforthecollection,processingandarchivingofhumanblood andurine (2008)37:2InternationalJournalofEpidemiology OECD,supra"note14;OECDGuidelines,supra"note Fortinetal,supra"note57at

14 researchproposalatsomelevel. Ethical"Aspects" The confidentiality of personal information will be protected and consent will be obtainedfromparticipants. 74 The biobank s procedures and activities will receive regular and independent ethics review. Allrequestsforaccesstothebiobankwillbereviewedatsomelevel. The biobank will comply with all relevant legislation, guidelines and norms, further ensuringtheprotectionofparticipants fundamentalrights. Legal"Aspects" Thebiobankwillcomplywithallrelevantlegislation. Thebiobankwilladdresstheownershiporcustodianshipofthebiologicalmaterials. 75 Thebiobankwilladdressresearchers obligationsanditsownobligations. 76 Expertise" There will be expert representation on all governance and oversight committees as required(i.e.,epidemiologists,bioinformatics,sociologists,geneticists ). Communications"&"Reporting"Aspects"" Participants will be kept informed of the research conducted using their samples and data. Researchersgainingaccesstothebiobankwillhavereportingobligations,notablyhaving toreporttheirgeneralresearchresultstothebiobankforpublicdissemination. Participants will be able to register their comments, queries and complaints, with the assurancethatanycomplaintwillbeaddressedbythebiobank. The 2012 recommendations on biobank governance of the European Commission are also noteworthy and reflect many of the mechanisms, principles and theoretical approaches previouslydiscussed: " Develop a consistent, coherent legal framework that protects participants fundamentalrights(privacy,dataprotection,useofhumantissue); " Better coordination and collaboration between national oversight bodies and mutual recognition of decisionpmaking to eliminate unnecessary duplication of oversightandcompliancerequirements; " Sustainablegovernancemechanismstoinvolveandengagethepublictoensure continualparticipation,trustandsupport; " Sustainable governance mechanisms for creating a relationship of reciprocity betweenbiobanksandsociety; 74 Fullertonetal,"supra"note3;"Capronetal,supra"note Capronetal,ibid."" 76 Ibid."" 14

15 " New emerging governance bodies should be integrated into existing systems to developametapgovernanceforbiobanking; " Biobanks need to be embedded in the public healthcare structure as valuable resourceforclinicalcare,personalizedmedicineandtranslationalresearch; " GreaterinvestmentindevelopmentofePgovernancetoolstofacilitatesharing; " Useofweb2.0technologiestoinvolvepatients,participantsandthepublicinthe governanceofbiobankstoensuretrust;and " Newaccreditationsystemstoreward/acknowledgeeffortsofscientistswhobuild biobanks. 77 VI. CONCLUSION Therecentfocusintheliteraturehasbeenoncreatingnetworkstofacilitateglobalresearchand international collaboration. It is therefore important to move beyond the unipjurisdictional model of governance in existence. There is also a need for mutual recognition, requiring new strategies to regulate the relationships between citizens, societies and biobanks and avoid duplicationofeffort. 78 Thereexistsnosingleidealgovernanceframework.Rather,governancemustbetailoredtothe needsofthebiobankandbecapableofadaptingovertime.theidentifiedsixcoreelementscan be found in most operational biobanks and can be adapted to the existing challenges of biobanking. Considering these elements, minimally, biobanks can follow general principles of goodpracticebycreatingagovernancestructurethatrespondstotheneedsandexpectations ofparticipantsandtherequirementsimposedonthem.moreover,whiletherehasbeenacall for harmonization of biobanking practices and policies, this feat is not currently possible considering cultural and legislative variations, and differences in organizational structures and funding. 79 Thus, we must continue to consider all external mechanisms when creating and adopting internal mechanisms of governance, and keep in mind that the purpose of a governancestructureistofacilitate,nothinder,scientificprogress. Acknowledgements WethankAdrianThorogood,CentreofGenomicsandPolicy,McGillUniversity,forhisreviewandcommentson draftsofthisdocumentandsylvieouellette,p3g,forherhelpinformattingthefigures. 77 EuropeanCommission,supra"note9 78 Gottweis&Lauss,supra"note4at187;EuropeanCommission,supra"note9. 79 OECD,supra"note14. 15

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