P3G$MODEL$FRAMEWORK$FOR$BIOBANK$GOVERNANCE$(2013)$ …p3g2.org/wp-content/uploads/P3G-Model-Framework...!2...

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

Ariane'Mallette,'Anne'Marie'Tassé'&'Bartha'Maria'Knoppers'

$I.$$ BACKGROUND$$'In'order'to'further'its'mission'to'lead,'catalyze'and'coordinate'international'efforts'to'optimize'the'use'of'biobanks,'the'Public'Population'Project' in'Genomics'and'Society'(P3G)'has'updated'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'influenced'and'shaped'the'governance'of'biobanks,'and'reflects'the'P3G’s'vision'of'global'access'to'research'tools.'Moreover,'the'practices'of'current'P3G'members'were'reassessed,'including'their' governance' mechanisms' and' changes' in' policy' since' 2008'(www.p3g.org/resources/biobankPcatalogues).' It' is' our' hope' that' this' model' framework' will'provide'a'useful'tool'for'the'next'generation'of'population'biobanks.'''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]'‘stretched'to'their'limits’'by'the'flood'of'information'created'by'recent'advances”.5'Thus,'existing'norms,'both'ethical'and'legal,'inadequately'regulate'biobanking.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'Susan'Wallace,'Karine'Bédard'&'Bartha'M'Knoppers,'“Building'a'model'framework'for'the'governance'of'biobanks”'(2008),'online:'P3G''<http://www.p3gobservatory.org/repository/ethics.htm>.''2'Paul'R'Burton'et'al,'“Size'matters:'just'how'big'is'BIG?'Quantifying'realistic'sample'size'requirements'for'human'genome'epidemiology”'(2009)'38'International'Journal'of'Epidemiology'263.'3'Stephanie'M'Fullerton'et'al,'“Meeting'the'Governance'Challenges'of'NextPGeneration'Biorepository'Research”'(2010)'2:15'Science'Translational'Medicine'15.'4'Herbert'Gottweis'&'Georg'Lauss,'“Biobank'governance'in'the'postPgenomic'age”'(2010)'7:2'Personalized'Medicine'187'at'187.''5'Jeantine'E'Lunshof'et'al,'“From'genetic'privacy'to'open'consent”'(2008)'9:5'Nature'Reviews'Genetics'406'at'406.'6'Kieran'C'O’Doherty'et'al,'“From'consent'to'institutions:'Designing'adaptive'governance'for'genomic'biobanks”'(2011)'73:3'Social'Science'and'Medicine'367'at'367;'Jane'Kaye,'“From'single'biobank'to'international'networks:'developing'ePgovernance”'(2011)'130:3'Human'Genetics'377.'

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transnational'sharing'and'collaboration.7'The'result'is'legal'fragmentation'due'to'the'multiplicity'of' normative' sources' and' local' practices.8'These' variable' and'occasionally' inconsistent' norms'have'created'a'patchwork'of'regulation.9'For'example,'in'Europe,'a'study'of'the'various'levels'of'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'biobanking' initiatives' in'Africa.11'Similarly,' research'ethics'boards'are' culturally' and' regionally'variable,'which'further'hinders'international'collaboration'and'results'in'duplicative'efforts.12'''While'the'regulation'of'biobanks'is'regionally'variable,'research'is'increasingly'global'in'nature,'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'Haidan'Chen,"“Governing'International'Biobank'Collaboration:'A'Case'Study'of'China'Kadoorie'Biobank”'(2013)'18:3'Science'Technology'Society'321"at'322;'Martin'Asslaber'&'Kurt'Zatloukal,'“Biobanks:'transnational,'European'and'global'networks”'(2007)'6:3'Briefings'in'Functional'Genomics'193;'Goran'Hallsman'&'Jimmie'B'Vaught,'“Best'Practices'for'Establishing'a'Biobank”'(2011)'675'Methods'in'Biobanking'Methods'in'Molecular'Biology'241;'Office'of'Biorepositories'and'Biospecimen'Research'et'al,'“NCI'Best'Practices'for'Biospecimen'Resources”'(2011)'online:'National'Cancer'Institute'<!http://biospecimens.cancer.gov/bestpractices/2011PNCIBestPractices.pdf>'[NCI'Best'Practices].''''8'Gideon'Parchomovsky'&'Michael'Mattioli,'“QuasiPPatients'and'SemiPPatents'in'Biobanking”'in'Giovanni'Pascuzzi,'Umberto'Izzo'&'Matteo'Macilotti,'eds,'Comparative"Issues"in"the"Governance"of"Research"Biobanks:"Property,"Privacy,"IP"and"the"Role"of"Technology'(Heidelberg:'Springer,'2013)'251'at'253.''9'Jean'V'McHale,'“Accountability,'Governance'and'Biobanks:'The'Ethics'and'Governance'Committee'as'Guardian'or'Toothless'Tiger?”'(2011)'19:3'Health'Care'Analysis'231;'Susan'MC'Gibbons,'“Regulating'Biobanks:'A'TwelvePPoint'Typological'Tool”'(2009)'17:3'Medical'Law'Review'313'at'314;'Gottweis'&'Lauss,'supra"note'4'at'18;'Herbert'Gottweis'&'Georg'Lauss,'“Biobank'governance:'heterogeneous'modes'of'ordering'and'democratization”'(2012)'3:2'61;'European'Commission,'“Biobanks'for'Europe:'A'Challenge'for'GovernanceP'Report'of'the'Expert'Group'on'Dealing'with'Ethical'and'Regulatory'Challenges'of'International'Biobank'Research”'(Luxembourg:'European'Union,'2012).''10'Emmanuelle'RialPSebbag'&'Anne'CambonPThomsen,'“The'Emergence'of'Biobanks'in'the'Legal'Landscape:'Towards'a'New'Model'of'Governance”'(2012)'39:1'Journal'of'Law'and'Society'113'at'121.'11'Ciara'Staunton'&'Keymanthri'Moodley,'“Challenges'in'biobank'governance'in'SubPSaharan'Africa”'(2013)'14:35'BMC'Medical'Ethics.''''12Jane'Kaye,'“Biobank'NetworksP'What'are'the'Governance'Challenges”'in'Jane'Kaye'&'Mark'Stranger,'eds,'Principles"and"Practice"in"Biobank"governance"(Burlington:'Ashgate'Publishing'Company'2009)'201"at'208;'European'Commission,'supra"note'9;'Bartha'Maria'Knoppers,'Ma’n'H'Zawati'&'Emily'S'Kirby,'“Sampling'Populations'of'Humans'Across'the'World:'ELSI'Issues”'(2012)'13'Annual'Review'of'Genomics'and'Human'Genetics'395'at'406.'13'Kaye,'supra"note'6;'Jane'Kaye'et'al,'“Ethical,'Legal'and'Social'Issues'Arising'From'the'Use'of'GWAS'in'Medical'Research”,'Literature'Review'for'the'Wellcome'Trust,'(2009)'online:'Centre'for'Health,'Law'and'Emerging'Technologies''<http://www.publichealth.ox.ac.uk/helex/imagesPandPdocuments/WTConsultancy_for_website_publication_20091022P1.pdf>;'European'Commission,'supra"note'9.'14'The'Organisation'for'Economic'CoPoperation'and'Development'(OECD),'“'Creation'and'Governance'of'Human'Genetic'Research'Databases”'(2006),'online:'OECD'<http://www.oecd.org/health/biotech/creationandgovernanceofhumangeneticresearchdatabases.htm#TOC'>'at'30.'

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problem'with' existing' governance'mechanisms' is' their' national' and' parochial' nature.15'Other'challenges' include' developing' standards,' oversight' mechanisms,' participant' interest' and'articulating'the'main'roles'and'responsibilities'of'the'actors'involved.16'''Governance'plays'a'crucial'role'in'addressing'the'social'and'ethical'challenges'of'biobanking.17It'remains' pivotal' to' maintaining' public' support' and' financing,' and' ensuring' the' security' and'protection'of'participants,'respect'for'cultural'perspectives'and'the'availability'of'biospecimens'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,'notably'ePgovernance,'reflexive'governance'and'anticipatory'governance.21'''III.$THEORETICAL$APPROACHES$TO$GOVERNANCE$!Numerous'theoretical'approaches'help'to'conceptualize'the'challenges'faced'by'biobanks'when'setting'their'governance'structures.''''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'information'technology'(IT)'more'efficiently'as'a'mechanism'for'governance.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,'one'project,'one' jurisdiction’'model”25'to' the' recognition'of' research'networks.' IT'can' be' used' to' direct' and' allow' research' proposals' based' on' “ELSI' appropriate' behaviors”,26'

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!15'Kaye,'supra"note'12;'Kaye,'supra"note'6'at'379.'16'European'Commission,'supra"note'9.''17'Alice'K'Hawkins'&'Kieran'C'O’Doherty,'“Biobank'governance:'a'lesson'in'trust”'(2010)'29:3'New'Genetics'and'Society'311'at'312.'18'Ibid'at'317;'Staunton'&'Moodley,'supra"note'11.''19'Gottweis'&'Lauss,'supra"note'9.''20'Hawkins'&'O’Doherty,'supra"note'17;'O’Doherty'et'al,'supra"note'6.'21'Kaye,'supra"note'6'at'379;'Parchomovsky'&'Mattioli,'supra"note'8;'Gibbons,'supra"note'9'at'314'&'345;'Gottweis'&'Lauss,'supra"note'4'at'187;'O’Doherty'et'al,'ibid"367;'European'Commission,'supra"note'9.'22'Kaye,'supra"note'6'at'381.'23'Ibid'at'380.''24'Ibid.'25'Ibid"at'381.'26'Ibid.'

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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,'resulting'in'a'system'of'triage,'digital'governance'and'expert'review'consistent'with'current'foundational'ethical'principles.''A' second' theoretical' approach' is' reflexive' governance,' intended' to' adapt' to' the' existing'challenges'generally'faced'by'biobanks.28'Reflexive'governance'is'premised'on'the'principles'of'integrity' of' purpose, 29 proportionality' of' action' and' reflexivity' of' approach,' whereby'mechanisms'are'developed'to'permit'biobanks'to'operate'despite'uncertainty'and'to'adapt'with'time'to'ensure'“good'governance”,'defined'as:''

1. designingPin'interoperability'with'respect'to'scientific'and'governance'approaches,''2. designingPout'approaches' that'are'restrictive'of'sharing,'cooperation,' flexibility'and'

mutuality,''3. establishing'policies'and'procedures' to'promote'actively' the'use'of' the' resource' in'

keeping'with'its'original'purpose,''4. ensuring'the'longevity'of'the'biobank'through'carefully'managed'access'policies'and'

arrangements'and'stewardship'of'the'resource,'and'5. ensuring'that'governance'policies'and'mechanisms'remain'fit'for'their'purpose'over'

time.30''''Reflexive'governance'“must'operate'in'tandem'with'the'development'of'scientific'endeavor”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'Graeme'Laurie,'“Reflexive'governance'in'biobanking:'on'the'value'of'policy'led'approaches'and'the'need'to'recognise'the'limits'of'law”'(2011)'130:3'Human'Genetics'347'at'347.'29'Defined'by'Laurie'as'“[focusing]'on'the'[trust]'relationship'between'those'with'responsibility'for'the'biobank'and'those'who'have'contributed'to'it'or'might'expect'to'benefit'from'it,'which'could'include'society'at'large”,'ibid"at'349.'''30'Ibid."''31'Ibid"at'352.'32'Vural' Ozdemir' et' al,' “Beyond' ELSIs:'Where' to' from'Here?' From' “Regulating”' to' Anticipating' and' Shaping' the'Innovation'Trajectory' in'Personalized'Medicine”' in'YuiPWing'F'Lam'&'Larisa'H'Cavallari,'eds,'Pharmacogenomics:"Challenges"and"Opportunities"in"Therapeutic"Implementation'(New'York:'Elsevier,'2013)'405'at'413.''

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governance,' “‘extended' peer' review’' and' social' embedding”33'of' innovations,' going' beyond'expert'opinion.'''Other'key'features'of'anticipatory'governance'include:'

o early'upstream'engagement;''o notion'of'“coproduction”'of'knowledge'by'society'and'science;'o anticipates'future'developments'and'issues'with'the'goal'of'adapting;'and'o consideration'of'expert'opinion'and'public'engagement.34'

'These' theoretical' approaches' help' conceptualize' the' challenges' faced' by' biobanks' and' set'common'standards,'but'they'offer'limited'guidance'in'terms'of'concrete'steps,'mechanisms'and'measures'that'should'be'adopted'by'biobanks'to'attain'these'standards.'Therefore,'we'adopt'a'practical'approach'to'governance,'setting'out'core'elements'to'biobank'governance.'We'build'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.'This'paper'will'outline'the'principles'and'procedures'that'inform'the'creation'and'implementation' of' governance' mechanisms' (core' elements)' used' by' biobanks.' These'mechanisms'are'either'external'or'internal'to'the'biobank'and'may'vary'throughout'the'lifecycle'of'the'biobank.35''''IV.$GOVERNANCE$MECHANISMS$AND$THE$LIFECYCLE$OF$A$BIOBANK$'The'lifecycle'of'a'biobank'can'be'divided'into'three'stages:'1)'Conceptualization'and'design'of'the'biobank'(before);'2)'Building'the'biobank'(during);'and'3)'Using'the'biobank'(after)'(Figure'1).36'Since'the'needs'of'the'biobank'differ'from'inception'to'the'operational'phase,'governance'needs'and'mechanisms'vary'during'each'of'these'stages.'While'the'elaboration'of'a'governance'framework'is'not'a'onePsizePfitsPall'approach,'certain'governance'mechanisms'cut'across'stages'of' the' biobank’s' lifecycle,' as'with' ethics' approval' for' example,'while' other' events' are' single'occurrences,'like'the'creation'of'committees.''''

1. Before:!Conceptualizing!and!Designing!the!Biobank!!'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' used' in' this' stage' are'external' ones' that' the' biobank' must' consider' or' respond' to.' For' example,' key' regulatory'concerns'must'be'addressed,'including'enrolment,'consent,'proprietary'interests'and'privacy.37'Moreover,' an'ordering'process'must'be'undertaken,' including' the' creation'of'protocols,'data'

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!33'Ibid.'34'Ibid"at'414.'35'Gibbons,'supra"note'9'at'239;'Wallce,'Bédard'&'Knoppers,'supra"note'1.''36'Ibid."'37'Parchomovsky'&'Mattioli,'supra"note'8.'

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warehouses'and'databases.38'Very'early'in'the'process,'there'must'be'discussions'with'funders,'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.40'

'2. During:!Building!the!Biobank!

'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'banking'begins.'The'governance'focus'shifts'to'the'creation'of'internal'mechanisms'to'manage'the' development' and' operations' of' the' resource,' such' as' the' establishment' of' an' executive'committee,'and'scientific'and'ethics'committees.''

3. After:!Using!the!Biobank!'

The'third'step'is'the'“after”'stage,'where'the'samples'and'data'are'banked'and'it'is'time'for'researchers'to'access'the'bank'and'proceed'to'analysis.'The'biobank'has'become'operational.''At'this'stage,'a'data/sample'access'policy'and'intellectual'property'policies'will'have'to'be'created'and'put'in'place.'Methods'for'communicating'the'research'results'derived'from'biobank'and'for'encouraging'public'input'will'also'have'to'be'considered.''

'Figure$1.$Governance$mechanisms$and$the$lifecycle$of$a$biobank$

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V.$$ GOVERNANCE$MECHANISMS$&$FRAMEWORKS$'Throughout' this' lifecycle,' governance' frameworks' regulate' the' processes' and' interactions'between' the' various' actors' involved' and' include' agreements,' procedures,' guidelines,' laws,'conventions,'policies,'social'norms'and' institutions'that'define'decisionPmaking,'accountability'

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!38'Gottweis'&'Lauss,'supra"note'9'at'64.''39'Wallace,'Bédard'&'Knoppers,'supra"note'1.''40'Ibid."'

BEFORE$

P'Public'engagement'P'Legislaton'P'Funder'requirements'P'Scientfic'peer'review'P'Ethics'review'

DURING$

P'Executve'Commivee''P'Scientfic'Oversight'Commivee'P'Ethics'Oversight'Commivee'P'Sample'handling'P'Data'management'P'Partcipant'engagement''

AFTER$

P'Data'&'sample'access'P'IP'Procedures'P'Publicaton''P'Public'outreach'

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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'raises'numerous'questions'that'must'be'answered'to'determine'the'proper'form'of'governance'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'The'governance'of'biobanks' is'also'about'regulating'the'relationships'between'citizens,'society,'researchers'and'biobanks.43'These'complex'series'of'interactions'are'regulated'by'external'and'internal'mechanisms'(Figure'2).44'

'Figure$2.$Interactions$between$society$and$biobank$governance$mechanisms$

'The'governance'of'biobanks'is'dynamic,'meaning'adequate'governance'must'be'tailored'to'the'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'Marc'Hufty,' “Investigating'Policy'Processes:'The'Governance'Analytical'Framework' (GAF)”' in'U'Wiesmann'&'H'Hurni,' eds,' Research" for" Sustainable" Development:" Foundations," Experiences," and" Perspectives' (Geographica'Bernensia,'2011)'403'at'405;'John'Graham,'Bruce'Amos'&'Tim'Plumptre,'“Policy'Brief'No.'15:'Principles'for'Good'Governance' in' the' 21st' Century”' (2003),' online:' ' Institute' on' Governance' <http://iog.ca/wpPcontent/uploads/2012/12/2003_August_policybrief15.pdf>.'42'RialPSebbag'&'CambonPThomsen,'supra"note'10'at'114'&'119.'43'Gottweis'&'Lauss,'supra"note'4.''44'European'Commission,'supra"note'9;'Wallace,'Bédard'&'Knoppers,'supra"note'1'at'3.'45'Theo'Papaioannou,'“Democratic'governance'of'genomics:'the'case'of'UK'Biobank”'(2012)'31:2'New'Genetics'Society'111'at'129P131;'Hawkins'&'O’Doherty,'supra"note'17;'Gibbons,'supra"note'9'at'339;'Canadian'Institutes'of'

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adapting'over'time,'for'the'efficient'use'of'samples'and'data'for'the'advancement'of'science,'respecting'the'confines'of'law'and'ethics'and'the'rights'of'persons.46'''While' this' paper' by' no'means' intends' to' resolve' the' “lively' debate”47'on' the' governance' of'biobanks,'and'while' the' literature' is' far' from'reaching'a'consensus'on' the'matter,48'a'generic'model' governance' framework' is' proposed' (Figure' 3),' taking' into' account' the' external' and'internal'governance'mechanisms'illustrated'above'and'explained'below'(Figure'2).49''

'Figure$3.$Proposed$model$of$biobank$governance$framework$

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!Health'Research'et'al,'“TriPCouncil'Policy'Statement:'Ethical'Conduct'for'Research'Involving'Humans”'(2010)'online:'Government'of'Canada'<!http://www.ethics.gc.ca/eng/policyPpolitique/initiatives/tcps2Peptc2/Default/>'(see'comments'on'article'12);'Jane'Kaye'&'Mark'Stranger,'eds,'Principles"and"Practice"in"Biobank"governance"(Burlington:'Ashgate'Publishing'Company'2009);"O’Doherty'et'al,'supra"note'6'at'370.''46'International'Society'for'Biological'and'Environmental'Repositories'(ISBER),'“2012'Best'Practices'for'Repositories:'Collection,'Storage,'Retrieval,'and'Distribution'of'Biological'Materials'for'Research”,'3rd'ed,'(2012)'10:2'Biopreservation'and'Biobanking'at'259;'RialPSebbag'&'CambonPThomsen,'supra"note'10.''47'McHale,'supra"note'9'at'232.''48'Alexander'M'Capron'et'al,'“Ethical'Norms'and'the'International'Governance'of'Genetic'Databases'and'Biobanks:'Findings'from'an'International'Study”'(2009)'19:2'Kennedy'Institute'of'Ethics'Journal'101'at'101.''49'Karine'Bédard'et'al,'“Potential'Conflicts'in'Governance'Mechanisms'Used'in'Population'Biobanks”'in'Jane'Kaye'&'Mark'Stranger,'eds,'Principles"and"Practice"in"Biobank"governance"(Burlington:'Ashgate'Publishing'Company'2009)'217'at'220.'

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! 1.!External!Governance!Mechanisms!!'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'can'generally'be'grouped'into'six'categories'(Figure'4).''

$

$Figure$4.$External$governance$mechanisms$

'a) Public$Perception$'

'A'biobank'cannot'operate'without'social'acceptance.'Public'perception'is'now'seen'as'a'crucial'consideration'in'the'governance'of'a'biobank.50''Transparency'and'accountability'of'the'biobank''ensure'positive'public'perception,'enhancing'the'legitimacy'and'trust'in'the'biobank.51'''

b) SocioXcultural$Norms$&$Values$$$

SocioPcultural'norms'and'values'also'impact'the'existence'and'conduct'of'biobanks'and'are'by'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,'reciprocity'and'solidarity,'as'well'as'notions'of'ownership.'

$c) Legislation$&$Regulations$

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!50'Hawkins'&'O’Doherty,'supra"note'17;'RialPSebbag'&'CambonPThomsen,'supra"note'10.'51'Hawkins'&'O’Doherty,' ibid;'Kieran'C'O’Doherty,'Alice'K'Hawkins'&'Michael'M'Burgess,'“Involving'citizens'in'the'ethics'of'biobank'research:'Informing'institutional'policy'through'structured'public'deliberation”'(2012)'75:9'Social'Science'&'Medicine'1604.''52'RialPSebbag'&'CambonPThomsen,'supra"note'10'at'127.'

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'Within'legal'sources'of'governance,'there'are'two'approaches'to'biobanking:'specific'or'general'legislation.'Certain'countries53'have'legislatively'created'and'regulated'biobanking,'while'others'have' relied' on' existing' general' legislation' (e.g." data' protection,' privacy,' research' involving'human'subjects)'or'even'professional'selfPregulation.54'Therefore,'while'not'necessarily'specific'to'biobanking,'all'countries'have'in'place'regulations,'be'it'legislation,'professional'guidelines'or'other'technical'or'ethics'norms,'that'must'be'taken'into'account'in'the'operation'and'oversight'of' a' biobank.' In' short,' external' governance' mechanisms' include' various' legal,' ethical' and'cultural'norms,'in'addition'to'overarching'international'or'intergovernmental'ethical'guidelines'and'codes'of'conduct.55'Moreover,'numerous'sets'of'standards,'quality'assurance'mechanisms'and'best'practices'have'been'created'to'guide'the'operation'of'biobanks.'Adhesion'is'generally'voluntary.56'''

d) Funders’$Requirements$'Funders'fall'within'many'categories'and'their'contribution'can'be'public,'private'or'charitable.'Funders'have'their'own'guidelines'and'requirements'that'grantees'and'researchers'must'follow,'as'nonPcompliance'may'jeopardize'the'research'project.'Moreover,'an'indirect'form'of'authority'that'governance'funders'possess'is'an'ability'to'direct'the'path'of'science'by'allocating'money'to'areas'of'interest'to'them'(e.g."funding'allocated'to'a'particular'disease'or'technology).'Their'most' important' influence' in' the' context' of' biobanking' is' to' require' open' access' to' such'biorepositories.57''

e) Scientific$Peer$Review$'The'creation'of'a'biobank'must'receive'approval'from'a'scientific'peer'review'committee.'This'is'often'part'of'the'funding'process,'where'the'review'is'organized'by'the'funder'and'is'crucial'to'this'form'of'“infrastructure'science”.58'''

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!53'Spain'for'example'enacted'the'2007'Law'on'Biomedical'Research'which'regulates'biobanking.'See'Law"14/2007"of"July"3,"on"Biomedical"Research'at'article'1(e)'and'Chapter'4.''54'OECD,'supra"note'14;'Bédard'et'al,'supra"note'49;'Gottweis'&'Lauss,'supra"note'9.''55'OECD,'“OECD'Guidelines'on'Human'Biobanks'and'Genetic'Research'Databases”'(2009),'online:'OECD'<!http://www.oecd.org/sti/biotech/44054609.pdf>'at'article'1B'[OECD'Guidelines];'See'e.g.'World'Medical'Association'(WMA),'Declaration"of"Helsinki:"Ethical"Principles"for"Medical"Research"Involving"Human"Subjects'(1964),'online:'WMA'<!http://www.wma.net/en/30publications/10policies/b3/>.'56'See'e.g."ISBER,'supra"note'46;'NCI'Best'Practices,'supra"note'7;'EuroBioBank,'online:'!<http://www.eurobiobank.org>;'OECD'Guidelines,"ibid.'57'Sabrina'Fortin'et'al,'“’Access'Arrangements’'for'Biobanks:'A'Fine'Line'between'Facilitating'and'Hindering'Collaboration”'(2011)'14:2'Public'Health'Genomics'104'at'106.'58'Paul'N'Schofield'et'al,'“Sustaining'the'Data'and'Bioresource'Commons”'(2010)'330:6004'Science'592.'

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f) Ethics$and$Privacy$Review$'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'security'measures.'As'plans'change,'additional'review'may'be'required.'''! 2.!Internal!Governance!Mechanisms'''Internal'mechanisms'are'created'by'the'biobank'itself'to'meet'a'requirement'or'fulfill' its'role,'and'regulate'for'example'its'mandate,'operation'and'financing.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;'and'f)'Data'Access'Committee'(Figure'5).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'biobanks'based'on'the'six'(6)'core'elements'outlined'above.''

'$Figure$5.$Internal$governance$mechanisms$

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!59'Bédard'et'al,'supra"note'49.''60Ibid'at'220;'See'UK'Biobank,'online:'<http://www.ukbiobank.ac.uk;'Generation'Scotland,'online:'<http://www.generationscotland.org>;'CARTaGENE,'online:'<http://www.cartagene.qc.ca>;'BBMRI,'online:'<http://bbmri.eu>;'Canadian'Partnership'for'Tomorrow,'online:'<partnershipfortomorrow.ca>.'61'See'Generation'Scotland,'UK'Biobank,'CARTaGENE'and'BBMRI'for'various'organizational'structures,'ibid."''62'OECD,'supra"note'14;'OECD'Guidelines,'supra"note'55;'NCI'Best'Practices,'supra"note'7.'''

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a) Public$Engagement$Committee$'Public' engagement' committees' help' researchers' gauge' the' public’s' acceptance' or' concerns'with'the'biobank,'enabling'researchers' to'design'their'studies'accordingly.63'This' input' fosters'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'remain'an'external'governance'mechanism.''Even'prior'to'recruitment,'public'engagement'can'take'various'forms'depending'on'the'context'and'culture'of'the'targeted'country'or'population,'including'forums,'citizen'conferences,'town'hall'meetings,' surveys' and' committees.' There' is' a' need' for' both' the' launching' and' ongoing'public' support' and'engagement' for' the'proper' governance'of'population'biobanks.65'Thereby'more'inclusive'approaches'to'governance'are'required.66'''

b) Biobank$Steering$Committee$$'

The' Biobank' Steering' Committee' manages' the' dayPtoPday' scientific' and' management'operations'of'the'biobank,'including'informing'the'public'about'its'goals'and'activities,'seeking'the'input'of'society'and'participants,'and'modifying'its'plans'accordingly.''

c) Scientific$Advisory/Oversight$Committee$$'Scientific' advisory/oversight' committees' give' advice'on' the' scientific' aspect'of' the'biobank.67'Members'can'include'experts'such'as'geneticists,'epidemiologists,'ethicists'and'biostatisticians,'often'from'other'countries.68'Indeed,'it' is'equally'important'that'an'independent'International'Scientific'Advisory'Committee'provide'advice'on'the'science'and'governance'of'the'biobank.'''

d) Ethics$Advisory/Oversight$Committee$'Ethics'advisory/oversight'committees'provide'advice'on'the'legal,'ethical'and'social'aspects'of'biobanking' activities,' overseeing' the' ethical' conduct' of' the' biobank' (e.g." data' protection'

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!63'See'for'example'Generation'Scotland’s'Public'Consultation'Program'divided'in'various'stages'and'aimed'at'exploring'the'public’s'opinion'on'a'range'of'issues'tied'to'the'use'of'genetics'in'healthcare,'online:''<http://www.generationscotland.org/index.php?option=com_content&view=article&id=61&Itemid=126>.'64'O’Doherty,'Hawkins'&'Burgess,'supra"note'51.'65'OECD,'supra"note'14;'Edward'S'Dove,'Yann'Joly'&'Bartha'M'Knoppers,'“Power'to'the'people:'a'wikiPgovernance'model'for'biobanks”'(2012)'13'Genome'Biology'158.'66'Gottweis'&'Lauss,'supra"note'9;'RialPSebbag'&'CambonPThomsen,'supra"note'10.'''67'RialPSebbage'&'CambonPThomsen,'ibid.''68'See'for'example'CARTaGENE’s'International'Scientific'Advisory'Board,'online:''<http://cartagene.qc.ca/en/governance>.'

!!

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questions,' consent' issues,' legal' questions).' Members' may' include' lawyers,' ethicists,' social'scientists' and' representatives' of' the' population.' The' Ethics' Oversight' Committee' is' a' “key'oversight'body'common'to'most'jurisdictions”,'acting'as'a'gatePkeeper,'deciding'whether'or'not'a'research'protocol'can'proceed.69'Depending'on'the'legislation'and'data'security'mechanisms'in'place,'the'approval'of'the'Ethics'Committee'may'be'required'for'access'to'data'and'samples.'Moreover,'the'committee'may'be'internal'to'the'biobank,'or'be'external'and'independent.70'''

e) Sample$and$Data$Storage/Laboratory$Practices$Committee$$'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'Committee'should'also'be'constituted'to'oversee'the'handling'of'samples'(i.e.,"requirements'for'collection,'storage,'labeling,'etc.).''

f) Data/Sample$Access$Committee$'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'external'and'independent'from'the'biobank.'Access'policies'vary,'but'are'generally'based'on'a'notion' of' proportionality,' balancing' the' needs' of' researchers'with' the' potential' benefits' and'risks'to'participants'and'society,'reflecting'the'biobank’s'concerns'and'priorities.73'''

3. Final!Remarks!!While' no' onePsizePfitsPall,' the' following' should' be' sought' in' order' to' create' an' adequate'governance'framework:''Scientific"Aspects"

! The'research'conducted'will'advance'science'and'benefit'society'in'the'future.'! The'biobank’s'procedures'and'activities'will'receive'independent'scientific'review.''! Researchers' seeking' access' to' the' biobank' will' undergo' scientific' review' of' their'

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!69'Kaye,'supra"note'6'at'379.'70'See'for'example'the'UK'Biobank'Ethics'and'Governance'Council,'online:'<'http://www.egcukbiobank.org.uk>;'RialPSebbag'&'CambonPThomsen,'supra"note'10;'OECD'Guidelines,'supra"note'52;'Kaye,'supra"note'6;'Fullerton'et'al,'supra"note'3.''''71'See'for'example'UK'Biobank'Sample'Handling'and'Storage'SubPgroup'discussed'in'Paul'Elliott'&'Tim'C'Peakman,'“The'UK'Biobank'sample'handling'and'storage'protocol'for'the'collection,'processing'and'archiving'of'human'blood'and'urine”'(2008)'37:2'International'Journal'of'Epidemiology'234.'''72'OECD,'supra"note'14;'OECD'Guidelines,'supra"note'55.''73'Fortin'et'al,'supra"note'57'at'106.'

!!

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research'proposal'at'some'level.''Ethical"Aspects"

! The' confidentiality' of' personal' information' will' be' protected' and' consent' will' be'obtained'from'participants.74''

! The' biobank’s' procedures' and' activities' will' receive' regular' and' independent' ethics'review.''

! All'requests'for'access'to'the'biobank'will'be'reviewed'at'some'level.'! The' biobank' will' comply' with' all' relevant' legislation,' guidelines' and' norms,' further'

ensuring'the'protection'of'participants’'fundamental'rights.'Legal"Aspects"

! The'biobank'will'comply'with'all'relevant'legislation.'! The'biobank'will'address'the'ownership'or'custodianship'of'the'biological'materials.75'! The'biobank'will'address'researchers’'obligations'and'its'own'obligations.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.'

! Researchers'gaining'access'to'the'biobank'will'have'reporting'obligations,'notably'having'to'report'their'general'research'results'to'the'biobank'for'public'dissemination.''

! Participants'will' be' able' to' register' their' comments,' queries' and' complaints,'with' the'assurance'that'any'complaint'will'be'addressed'by'the'biobank.''

$The' 2012' recommendations' on' biobank' governance' of' the' European' Commission' are' also'noteworthy' and' reflect' many' of' the' mechanisms,' principles' and' theoretical' approaches'previously'discussed:'''

" Develop' a' consistent,' coherent' legal' framework' that' protects' participants’'fundamental'rights'(privacy,'data'protection,'use'of'human'tissue);''

" Better' coordination' and' collaboration' between' national' oversight' bodies' and'mutual' recognition' of' decisionPmaking' to' eliminate' unnecessary' duplication' of'oversight'and'compliance'requirements;''

" Sustainable'governance'mechanisms'to'involve'and'engage'the'public'to'ensure'continual'participation,'trust'and'support;'

" Sustainable' governance' mechanisms' for' creating' a' relationship' of' reciprocity'between'biobanks'and'society;'

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!74'Fullerton'et'al,"supra"note'3;"Capron'et'al,'supra"note'48.'75'Capron'et'al,'ibid.""76''Ibid.""

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" New'emerging'governance'bodies'should'be' integrated' into'existing'systems'to'develop'a'metaPgovernance'for'biobanking;'

" Biobanks' need' to' be' embedded' in' the' public' healthcare' structure' as' valuable'resource'for'clinical'care,'personalized'medicine'and'translational'research;'

" Greater'investment'in'development'of'ePgovernance'tools'to'facilitate'sharing;'" Use'of'web'2.0'technologies'to'involve'patients,'participants'and'the'public'in'the'

governance'of'biobanks'to'ensure'trust;'and'" New'accreditation'systems'to'reward/acknowledge'efforts'of'scientists'who'build'

biobanks.77'''VI.$$ CONCLUSION$'The'recent'focus'in'the'literature'has'been'on'creating'networks'to'facilitate'global'research'and'international' collaboration.' It' is' therefore' important' to' move' beyond' the' uniPjurisdictional'model'of'governance' in'existence.'There' is'also'a'need' for'mutual' recognition,' requiring'new'strategies' to' regulate' the' relationships' between' citizens,' societies' and' biobanks' and' avoid'duplication'of'effort.78'''There'exists'no'single'ideal'governance'framework.'Rather,'governance'must'be'tailored'to'the'needs'of'the'biobank'and'be'capable'of'adapting'over'time.'The'identified'six'core'elements'can'be' found' in' most' operational' biobanks' and' can' be' adapted' to' the' existing' challenges' of'biobanking.' Considering' these' elements,'minimally,' biobanks' can' follow' general' principles' of'good'practice'by'creating'a'governance'structure'that'responds'to'the'needs'and'expectations'of'participants'and'the'requirements'imposed'on'them.'Moreover,'while'there'has'been'a'call'for' harmonization' of' biobanking' practices' and' policies,' this' feat' is' not' currently' possible'considering'cultural'and' legislative'variations,'and'differences' in'organizational' structures'and'funding.79'' Thus,' we' must' continue' to' consider' all' external' mechanisms' when' creating' and'adopting' internal' mechanisms' of' governance,' and' keep' in' mind' that' the' purpose' of' a'governance'structure'is'to'facilitate,'not'hinder,'scientific'progress.'''Acknowledgements$$'We' thank'Adrian'Thorogood,'Centre'of'Genomics'and'Policy,'McGill'University,' for'his' review'and'comments'on'drafts'of'this'document'and'Sylvie'Ouellette,'P3G,'for'her'help'in'formatting'the'figures.''''''!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!77'European'Commission,'supra"note'9'78'Gottweis'&'Lauss,'supra"note'4'at'187;'European'Commission,'supra"note'9.''79'OECD,'supra"note'14.'

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BIBLIOGRAPHY$$

LEGISLATION''

Law"14/2007"of"July"3,"on"Biomedical"Research"(Spain).''$

INTERNATIONAL'MATERIALS''Additional"Protocol"to"the"Convention"on"Human"Rights"and"Biomedicine,"Concerning"Biomedical""

Research"(2005),"online:'Council'of'Europe'"<http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm>.''

'Convention"for"the"Protection"of"Human"Rights"and"Dignity"of"the"Human"Being"with"Regard"to""

the"Application"of"Biology"and"Medicine:"Convention"on"Human"Rights"and"Biomedicine"(1997),"online:'Council'of'Europe'<http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm>.'''

'Universal"Declaration"on"the"Human"Genome"and"Human"Rights"(1997),"online:'UNESCO''

<http://www.unesco.org/new/en/socialPandPhumanPsciences/themes/bioethics/humanPgenomePandPhumanPrights/>.'

'World'Medical'Association'(WMA).'Declaration"of"Helsinki:"Ethical"Principles"for"Medical""

Research"Involving"Human"Subjects'(1964),'online:'WMA'!<http://www.wma.net/en/30publications/10policies/b3/>.'

'SECONDARY'MATERIALS:'ARTICLES''

'Asslaber,'Martin'&'Kurt'Zatloukal.'“Biobanks:'Transnational'European'and'Global'Networks”''

(2007)'6:3'Briefings'in'Functional'Genomics'and'Proteomics'193.'''''Borugian,'Marilyn'J'et'al.'“The'Canadian'Partnership'for'Tomorrow'Project:'Building'a'PanP'

Canadian'Research'Platform'for'Disease'Prevention”'(2010)'182:11'CMAJ'1197.'''Burton,'Paul'R'et'al.'“Size'Matters:'Just'How'Big'is'BIG?'Quantifying'Realistic'Sample'Size''

Requirements' for' Human' Genome' Epidemiology”' (2009)' 38' International' Journal' of'Epidemiology'263.'

'Capron,'AM'et'al.'“Ethical'Norms'and'the'International'Governance'of'Genetic'Databases'and''

Biobanks:'Findings'from'an'International'Study”'(2009)'19:2'Kennedy'Institute'of'Ethics'Journal'101.''

'

!!

! 17

Chen,'Haidan.'“Governing'International'Biobank'Collaboration:'a'Case'Study'of'China'Kadoorie''Biobank”'(2013)'18:3'Science,'Technology'and'Society'321.'

'Cutter,'Anthony'Mark,'Sarah'Wilson'&'Ruth'Chadwick.'“Balancing'Powers:'Examining'Models'of''

Biobank'Governance”'(2004)'5:1'Journal'of'International'Biotechnology'Law'187.'''Dove,'Edward'S,'Yann'Joly,'&'Bartha'M'Knoppers.'“Power'to'the'People:'a'WikiPGovernance''

Model'for'Biobanks”'(2012)'13'Genome'Biology'158.'''Elliott,'Paul'&Tim'C'Peakman.'“The'UK'Biobank'Sample'Handling'and'Storage'Protocol'for'the''

Collection,'Processing'and'Archiving'of'Human'Blood'and'Urine”'(2008)'37'International'Journal'of'Epidemiology'234.'

'Fortin,'S'et'al.'“Access'Arrangements’'for'Biobanks:'A'Fine'Line'between'Facilitating'and''

Hindering'Collaboration”'(2011)'14'Public'Health'Genomics'104.''Fullerton,'Stephanie'M'et'al.'“Meeting'the'Governance'Challenges'of'NextPGeneration''

Biorepository'Research”'(2010)'2:15'Science'Translational'Medicine'15.'''Gibbons,'Susan'MC.'“Are'UK'Genetic'Databases'Governed'Adequately?'a'Comparative'Legal''

Analysis”'(2007)'27:2'Legal'Studies'312.'''Gibbons,'Susan'MC.'“Regulating'Biobanks:'a'TwelvePPoint'Typological'Tool”'(2009)'17'Medical''

Law'Review'313.'''Gibbons,'Susan'MC'et'al.'“Governing'Genetic'Databases:'Challenges'Facing'Research'Regulation''

and'Practice”'(2007)'34:2'Journal'of'Law'and'Society'163.''Gottweis,'Herbert'&'Georg'Lauss.'“Biobank'Governance'in'the'PostPGenomic'Age”'(2010)'7:2''

Personalized'Medicine'187.'''Gottweis,'Herbert'&'Georg'Lauss.'“Biobank'Governance:'Heterogeneous'Modes'of'Ordering'and''

Democratization”'(2012)'3'Journal'of'Community'Genetics'61.'''Gottweis,'Herbert'&'Kurt'Zatloukal.'“Biobank'Governance:'Trends'and'Perspectives”'(2007)'74''

Pathobiology"206.''Graham,'John,'Bruce'Amos,'&'Tim'Plumptre.'“Policy'Brief'No.'15:'Principles'for'Good''

Governance'in'the'21st'Century”'(2003),'online:''Institute'on'Governance'<http://iog.ca/wpPcontent/uploads/2012/12/2003_August_policybrief15.pdf>.''

'

!!

! 18

Hallmans,'Goran'&'Jimmie'B'Vaught.'“Best'Practices'for'Establishing'a'Biobank”'(2011)'675''Methods'in'Biobanking,'Methods'in'Molecular'Biology'241.'

'Hawkins,'Alice'K'&'Kieran'C'O’Doherty.'“Biobank'Governance:'a'Lesson'in'Trust”'(2010)'29:3''

New'Genetics'and'Society'311.''Hewitt,'Robert'&'Peter'Watson.'“Defining'Biobank”'(2013)'11:5'Biopreservation'and'Biobanking''

309.''International'Society'for'Biological'and'Environmental'Repositories'(ISBER).'“2012'Best'Practices''

for' Repositories:' Collection,' Storage,' Retrieval,' and'Distribution' of' Biological'Materials' for'Research”,'3rd'ed'(2012)'10:2'Biopreservation'and'Biobanking'81.''

'Kaye,'Jane.'“From'Single'Biobanks'to'International'Networks:'Developing'EPGovernance”'(2011)''

130'Human'Genetics"377.''Kaye,'Jane'et'al.'“Ethical,'Legal'and'Social'Issues'Arising'From'the'Use'of'GWAS'in'Medical''

Research”,'Literature'Review'for'the'Wellcome'Trust,'(2009)'online:'Centre'for'Health,'Law'and'Emerging'Technologies''<http://www.publichealth.ox.ac.uk/helex/imagesPandPdocuments/WTConsultancy_for_website_publication_20091022P1.pdf>'

'Kaye,'Jane'&'Susan'MC'Gibbons.'“Mapping'the'Regulatory'Space'for'Genetic'Databases'and''

Biobanks'in'England'and'Wales”'(2008)'9'Medical'Law'International'111.''Kent,'A.'“Biobanks:'Governance'Issues”'(Background'paper'delivered'at'the'meeting'on'the''

International'Working'Group'on'Ethics,'Governance'and'Public'Engagement,'San'Diego'CA,'October'2007).''

'Knoppers,'Bartha'Maria,'Ma’n'H'AbdulPRahman'&'Karine'Bédard.'“Genomic'Databases'and''

International'Collaboration”'(2007)'18:2'Kings'Law'Journal'291.''Knoppers,'Bartha'Maria'&'Thomas'J'Hudson.'“The'Art'and'Science'of'Biobanking”'(2011)'130''

Human'Genetics"329.''Knoppers,'Bartha'M,'Man'H'Zawati,'&'Emily'S'Kirby.'“Sampling'Populations'of'Humans'Across''

the'World:'ELSI'Issues”'(2012)'13:1'The'Annual'Review'of'Genomics'and'Human'Genetics'1P1.19.'"'

'Laurie,'Graeme.'“Reflexive'Governance'in'Biobanking:'on'the'Value'of'Policy'Led'Approaches''

and'the'Need'to'Recognise'the'Limits'of'Law”'(2011)'130'Human'Genetics'347.''''

!!

! 19

Lunshof,'JE'et'al.'“From'Genetic'Privacy'to'Open'Consent”'(2008)'9:5'Nature'Reviews'Genetics''406.'

'McHale,'Jean'V.'“Accountability,'Governance'and'Biobanks:'the'Ethics'and'Governance''

Committee'as'Guardian'or'as'Toothless'Tiger?”'(2011)'19'Health'Care'Analysis'231.''O’Doherty,'Kieran'C'&''Michael'M'Burgess.'“Public'Deliberation'to'Develop'Ethical'Norms'and''

Inform'Policy'for'Biobanks:'Lessons'Learnt'and'Challenges'Remaining”'(2013)'9:2'Research'Ethics'55.'

'O’Doherty,'Keiran'C'et'al.'“From'Consent'to'Institutions:'Designing'Adaptive'Governance'for''

Genomic'Biobanks”'(2011)'73'Social'Science'&'Medicine'367.'''

O’Doherty,'Kieran'C,'Alice'K'Hawkins'&'Michael'M'Burgess.'“Involving'Citizens'in'the'Ethics'of''Biobank'Research:'Informing'Institutional'Policy'through'Structured'Public'Deliberation”'(2012)'75'Social'Science'&'Medicine'1604.'''

'Papaioannou,'Theo.'“Democratic'governance'of'genomics:'the'case'of'UK'Biobank”'(2012)'31:2''

New'Genetics'Society'111.''Prainsack,'Barbara'&'Alena'Buyx.'“A'SolidarityPbased'Approach'to'the'Governance'of'Research''

Biobanks”'(2013)'21'Medical'Law'Review'71.''$RialPSebbag,'Emmanuelle'&'Anne'CambonPThomsen.'“The'Emergence'of'Biobanks'in'the'Legal''

Landscape:'Towards'a'New'Model'of'Governance”'(2012)'39:1'Journal'of'Law'and'Society'113.'

'Schofield,'Paul'N'et'al.'“Sustaining'the'Data'and'Bioresource'Commons”'(2010)'330'Science'592.'$Staunton,'Ciara'&'Keymanthri'Moodley.'“Challenges'in'Biobank'Governance'in'SubPSaharan''

Africa”'(2013)'14:35'BMC'Medical'Ethics'1.'''Wallace,'Susan,'Karine'Bédard'&'Bartha'M'Knoppers.'“Building'a'model'framework'for'the''

governance'of'biobanks”'(2008),'online:'P3G''<http://www.p3gobservatory.org/repository/ethics.htm>.'

'SECONDARY'MATERIAL:'MONOGRAPHS'

'Dierickx,'Kris'&'Pascal'Borry,'eds.'New"Challenges"for"Biobanks:"Ethics,"Law"and"Governance''

(Portland:'Intersentia,'2009).'''

!!

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European'Commission.'Biobanks"for"Europe:"A"Challenge"for"Governance["Report"of"the"Expert""Group"on"Dealing"with"Ethical"and"Regulatory"Challenges"of"International"Biobank"Research'(Luxembourg:'European'Union,'2012).''

' 'Hufty,'Marc.'“Investigating'Policy'Processes:'The'Governance'Analytical'Framework'(GAF)”'in'U''

Wiesmann'&'H'Hurni,'eds,'Research"for"Sustainable"Development:"Foundations,"Experiences,"and"Perspectives"(Bern:'NCCR'NorthPSouth/"Geographica'Bernensia,'2011).''

'Kaye,'Jane'&'Mark'Stranger,'eds.'Principles"and"Practice"in"Biobank"Governance"(Farnham:''

Ashgate,'2009).'""'Kickbusch,'Ilona'&'David'Gleicher.'Governance"for"Health"in"the"21st"Century'(Copenhagen:''

World'Health'Organization'Regional'Office'for'Europe,'2012)'''Ozdemir,'Vural'et'al.'“Beyond'ELSIs:'Where'to'from'Here?'From'“Regulating”'to'Anticipating'and''

Shaping' the' Innovation'Trajectory' in'Personalized'Medicine”' in'YuiPWing'F'Lam'&'Larisa'H'Cavallari,' eds,' Pharmacogenomics:" Challenges" and" Opportunities" in" Therapeutic"Implementation'(New'York:'Elsevier,'2013).''

'Pascuzzi,'Giovanni,'Umberto'Izzo'&'Matteo'Macilotti,'eds.'Comparative"Issues"in"the""

Governance"of"Research"Biobanks:"Property,"Privacy,"IP"and"the"Role"of"Technology'(Berlin:'Springer,'2013).'

''SECONDARY'MATERIAL:'WEBSITES''

'Alberta'Tomorrow'Project,'online:''<http://www.in4tomorrow.ca>.'''ALSPAC'(Avon'Longitudinal'Study'of'Parents'and'Children),'online:'

<http://www.bristol.ac.uk/alspac>.''''Biobanking'and'Biomolecular'Resources'Research'Infrastructure'(BBMRI),'online:''

<http://bbmri.eu>.''''CARTaGENE,'online:''<http://cartagene.qc.ca/fr/gouvernance>.'''CPTP'(Canadian'Partnership'for'Tomorrow'Project),'online:''

<http://www.partnershipagainstcancer.ca/priorities/2007P2012Pinitiatives/strategicPinitiativesP3/canadianPpartnershipPforPtomorrowPproject>.''

'EuroBioBank,'online:''<http://www.eurobiobank.org>.''

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UK'Biobank,'online:'<http://www.ukbiobank.ac.uk>.'''Generation'Scotland,'online:'<http://www.generationscotland.org>.'''Public'Population'Project'in'Genomics'and'Society'(P3G),'online:'<http://p3g.org>.'''

SECONDARY'MATERIAL:'OTHERS''

Canadian'Institutes'of'Health'Research,'Natural'Sciences'and'Engineering'Research'Council'of''Canada'&'Social'Sciences'and'Humanities'Research'Council'of'Canada.'TCPS2"(Tri[Council"Policy"Statement):"Ethical"Conduct"for"Research"Involving"Humans"(2010),'online:'Government'of'Canada'<'http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf>''

$Office'of'Biorepositories'and'Biospecimen'Research'et'al.'“NCI'Best'Practices'for'Biospecimen''

Resources”'(2011)'online:'National'Cancer'Institute'!<http://biospecimens.cancer.gov/bestpractices/2011PNCIBestPractices.pdf>.'

$The'Organisation'for'Economic'CoPoperation'and'Development'(OECD).'“Creation'and''

Governance'of'Human'Genetic'Research'Databases”'(2006),'online:'OECD'<http://www.oecd.org/health/biotech/creationandgovernanceofhumangeneticresearchdatabases.htm#TOC'>'at'30.'

'OECD.'“OECD'Guidelines'on'Human'Biobanks'and'Genetic'Research'Databases”'(2009),'online:''

OECD''''''<http://www.oecd.org/sti/biotech/44054609.pdf>.'$$