BBMRI ELSI WORKSHOP REPORT · BBMRI ELSI WORKSHOP REPORT ... The main aim of this meeting was to...

ThismeetinghasreceivedfundingfromtheEuropeanUnion’sHorizonresearchandinnovationprogrammeundergrantagreementNo676550.

BBMRIELSIWORKSHOPREPORT

Sharingandaccesstodataandhumanbiospecimensforthebenefitofpatients–TowardsaBBMRI-ERICPolicy


BBMRIELSIWORKSHOPREPORT

Sharingandaccesstodataandhumanbiospecimensforthebenefitofpatients–TowardsaBBMRI-ERICPolicy:ELSIWorkshopSeptember08-09,2015Paris,

France

PreparedbyMatsG.Hansson,MoaKindstromDahlin,andHeidiCarmenHowardCentreforResearchEthicsandBioethics,UppsalaUniversity,Sweden

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TABLEOFCONTENTS

I -SHORTSUMMARYOFWORKSHOP 3

RATIONALANDMAINOBJECTIVES 3SUMMARYOFAGENDA 3DETAILEDPROGRAMME 4WORKSHOPDELIVERABLE: 4

II -POINTSTOCONSIDERFORTHEACCESSANDSHARINGOFHUMANDATAANDBIOSAMPLESINTHEBIOBANKINGCONTEXT 5

INTRODUCTION 5APHILOSOPHICALAPPROACHTOPOLICYISSUESREGARDINGREASONSWHYSHARINGOFDATAAND

BIOSAMPLESISIMPORTANT(B.SOLBERG) 6WHATNEEDSTOBEDONEFORBIOBANKSANDRESEARCHERSTODESERVETHETRUSTOFPATIENTSAND

RESEARCHERS? (G.MARTIN) 8THERELEVANTLEGALFRAMEWORKFORSHARINGINBIOBANK(J.REICHEL) 9INTELLECTUALPROPERTYRIGHTSINBIOBANKING:WHATTOCONSIDER(I.HUYS) 10THEIMPORTANCEOFCONSENTINSHARINGBIOLOGICALSAMPLESANDDATA(R.JAHNS) 12THE IMPORTANCEOFADEQUATELY RECOGNIZING THOSEWHOORGANIZEANDMAINTAIN BIOBANKS (A.CAMBON-THOMSEN,H.C.HOWARD) 15

III -CONCLUSIONANDFUTURESTEPS 16

REFERENCES 17

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I-ShortSummaryofWorkshop

RationalandmainobjectivesThere is a growing international recognition that greater access to, and sharingofresearchdata andbio-specimen collections couldhelp to optimize their long-termvalue and exploit their potential for health-related discoveries. Currently, theincreasingvalueofdataandbio-specimencollectionsdoesnotcorrespondwithanequalincreaseindata/sample-sharinganddata/sampleaccess.Ideally,dataandbio-specimenswouldbemadewidelyavailableinanethicallyresponsiblemannertoaninclusivegroupofresearcherswhocouldmakesounduseofthem.However,thereare logistical, legalandethicalchallengestowidespreadaccess.Moreover, there isoften resistanceby institutions and individualswho fear that theywill not receiverecognitionfortheirinvestmentinbuildingcollections.Sincethesharingofdataandsamples is, in some instances, an essential and/or greatly facilitating element tomaking novel biomedical discoveries, we must further consider how to furthersupportsharingatall levels (regional,national, international).Furthermore, fromapatientperspective,ifsharingcouldleadtoausefuldiscovery,patientsmayfeelthatit is a moral imperative for researchers to share samples and data. Indeed, thediscussionaroundsharingandincreaseaccessisoftenheldamongaselectgroupofstakeholders(oftenacademics)therebypotentiallyignoringthevalues,andagendasofpertinentstakeholders.Thediscussionaroundaccessandsharingshouldbehadwith a wide range of stakeholders and different values and needs should beconsidered.

The main aim of this meeting was to discuss the ethical, legal and social issuessurroundingincreasedaccessandsharingofbiomedicalsamplesanddata,includingthe barriers and potential solutions. In doing so, we also achieved two otherimportantgoalstothefunctioningofBBMRI-ERICELSIgroup:i)membersofdifferentnational nodeswere able tomeet, often for the first time; and ii)memberswerepresented with the basic information surrounding the ethical, legal and socialimplications of sharing data and samples, thus bringing everyone to the sameinformationallevel.Bothofthesesub-goalswillfacilitatefutureworkintheBBMRI-ERICELSIgroup.

SummaryofAgendaBroadthemesaddressedduringthismeetingincludedwere:

1- Sharingandaccessingeneral2 -HumanRights3 -Philosophicalaspectsofsharing4 -Crossbordersharingandlegalaspects5 -InformationalandInformedconsentneeds6-Intellectualproperty7-Alternatewaystoproviderecognitiontobiobanks/stakeholdersthatshare8-PatientandPublicperspectiveofsharing9- Transparencyandpublicengagement

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10-GovernanceStructures11-Codesofpractice

Numberofpresentations:14plusconclusion

DetailedProgrammeTuesday8September

09.00MeetingwiththeBBMRI-ERICCommonserviceELSI-Team(thatis:allELSIpeoplewhoarefunded/secondedforBBMRI-ERIC)

12.00 Lunch13.00 Introductiontoworkshoponsharingandaccess–Jan-EricLitton13.10 HumanRightsandprinciplesforstewardshipsettingthestage–MatsHansson13.40 Philosophical underpinnings for sharing –Berge Solberg14.10 Generaldiscussion14.30 Coffee

15.00SharingbiospecimensandhealthdataacrossbordersinEU–JaneReichelandOlga Tzortzatou

15.40 Generaldiscussion

16.00Information and consent procedures needed for sharing – Emmanuelle Rial-Sebbag, France

16.30Respect for intellectualpropertyacrossborders–TomSoutherington,Finland,Gauthier Chassan, France

17.00Recognitionofintellectualinvestments–BRIFandAuthorship–AnneCambonThomsen, France andHeidiHoward, Sweden

17.30 Generaldiscussion19.30 Dinner

Wednesday9September

09.00 Sharing policies from the perspective of patient and public trust – Gillian Martin,Malta

09.30 Providingtransparencyofuse: theexampleofEstoniaBiobank–TBA10.00 Coffee

10.30

Examples of governance structures/code of practices:TheGlobalAllianceCode for responsible sharing–EdwardDove,GlobalAlliance forGenomicHealthRD-ConnectCodeofPractice–MatsHanssonICGC–AnneCambon-Thomsen

11.30 ConclusionstowardsBBMRI-ERICpolicyonsharingandaccess13.00 Closing, Lunch

WorkshopDeliverable:-Workshopreport-compiledbyHeidiCarmenHoward,MoaKindstromDahlin,andMatsG.Hansson,withcontributionsfromBergeSolber,GillianMartin,JaneReichel,IsabelleHuys,RolandJahns,andAnneCambon-Thomsen.

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II - PointstoConsiderfortheaccessandsharingofhumandataandbiosamplesinthebiobankingcontext

Introduction

Whilebiobankingmayappeartosome(externaltotheactivities)asahomogeneousendeavorwherethefundamentalpurpose(s),composition,configuration,operationsandactivitiesareallverysimilarand/orharmonizedbetweendifferentbiobanks,thisiscurrentlynotthecase.Eventhemaindefinitionofbiobanksmaydiffersignificantly[1][2].Moresurprisinglyperhaps,isthefactthattheactivityofsharingsamplesanddata between biobanks and researchers – the seemingly “raison d’être” of theseinstitutions – is still not optimal, and in many cases is hindered by a number ofchallengesandbarriersofdifferentnature(forreviewseeColledgeetal.2013,[3]).

Thegoal of theBBMRIworkshop inPariswas to reflect anddiscuss regarding theethical, legalandsocialaspectssurroundingthesharingofsamplesanddatainthebiobanking context in order to shed light on the endeavor and help find ways tobetter conceptualize the activity as well as realize it in practice. Anchored in thepresentationsanddiscussionsheldover thedayof theworkshop, six internationalscholarswithdifferentareasofexpertisefromdifferentnationalBBMRInodeswereaskedtoelaboratefurtheronthemesthatareparticularlysalienttothediscussionaroundtheaccessto,andsharingofhumandataandbiospecimens.(Table1)

Table1Name, country, specialty Subject Berge Solberg, Norway Abackground, includingpolicy issues,specifictowhyphilosophy sharing is importantGillianMartin,Malta WhatneedstobedoneforbiobanksandresearcherstoSociology and anthropology deserve the trustofpatientsandparticipantsJane Reichel, Sweden DescribetherelevantlegalframeworkinwhichBBMRI-law ERIC is situated/isworking.Roland Jahns, Germany Information and consent procedures for sharing samplesCardiology, Biobank Director and data.

IsabelleHuys,Belgium Whatdoweneedtopayattentionto/haveestablishedPharmacy and intellectual property withrespecttoIPRandhowshoulditbedone?AnneCambon-Thomsen,France What is important toconsiderwith respect to intellectualImmunology and Bioethics and resource investmentby researchersandbiobanksandand howtheycanbe recognized.Heidi CarmenHoward, Sweden Genetics and Bioethics

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Aphilosophicalapproachtopolicyissuesregardingreasonswhysharingofdataandbiosamplesisimportant(B.Solberg)

Itisclearthatsharingcanbenefitscience.Therearemanyreasonsforthis,includingthat we get can achieve greater goals faster if we share than if we don’t share.Sharing,however,goesdeeperthanthis.Fromthephilosophyandthesociologyofscienceweknowthatsharingcouldberegardedasatypeofcorefeatureofscience.Karl Popper and later Robert Merton would come close to talk about sharing asexpressing the ethos of science. [4] Popper’s idea of an open science in an opensociety where scientists work together to try to falsify their own hypotheses,presupposessomeformofsharing.Merton’snorm“communism”refersexplicitlytothepointthatinscienceweshouldshareeverythingwitheveryone.[5]Andhisnorm“universalism”referstothefactthatscienceisauniversalenterprisewhichinvolvescollaboration. He describes Science as not being a local enterprise for localresearchersbelongingtoacertaincultureorreligion.Furthermore,hespecifiesthatScience is a universal enterprise where particularities such as class, nationality,gender,ethnicity,etc.,shouldberegardedasirrelevant.[5]

Particularly in the field of genetics and genomics, the Human Genome Project(https://www.genome.gov/12011238) highlighted a new dimension of sharing. Inaddition to the fact that sharing and collaboration was fundamental in order toreachthegoalofthisambitiousprojectinthetimeoutlined,therewasalsoastrongbelief by some that the human genome represented a type of knowledge that inparticular shouldbecollectivelyownedandcollectivelyaccessible. In linewith, forinstance, developments likeWikipedia, the information from the Human GenomeProject was understood by some as a “knowledge commons” (albeit for experts),wheretheideaofsharingisintimatelyconnectedtotheimportantvaluesofhumandignity,democracyandaccessto(partsof)thescience.Thefearthatprivateinterestshouldclaimownershiptothehumangenome,hasbeencentraltotheregulationofgenomicsinmanycountries,leadingforinstance,torecentcourtdecisionsintheUSthatnaturallyoccurringDNAisnoteligibleforapatent.

In addition to these more integral reasons for sharing in genetics/genomics andbiobankresearch,therearealsoamanymorepracticalreasonsforsharing.TheUKDataArchive,(http://www.data-archive.ac.uk)whichacquires,curatesandprovidesaccess to theUK's largest collectionof socialandeconomicdata,has for instance,mentionedtenreasonsfordatasharing.Whattheyallhaveincommonisthattheyfocusonthepositiveandconstructiveconsequencesdatasharingwillhaveforscienceand society. Increased transparency and accountability, increased visibility ofresearch, increased collaboration between data users and data providers andincreasedscientificinquiry,areonlysomeofthereasons.Whilethisisadatabankofinformationfromthesocialsciencesandhumanities,theseimpactsareclearlyalsothosedesiredinbiomedicalresearch.

Indeed,thelistofpositivereasonstosharecanbemadeverylong.Theethicalfocusthenperhapsshouldnotbesomuchonwhetherthereareanyethicalreasonsfor

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sharing,butrather theopposite:Arethereanyethical reasons fornotsharing?Anobvious answer to this question concerns the respect for participant autonomy,confidentialityandprivacy.Sharingdatamightberegardedasaprivacy threat.Ontheotherhand,dataprotection isanessentialpartofall research.Goodtechnicalsolutions have been suggested as to how to protect privacy in research for years,and there seem to be no reason to believe that we would be less able to findtechnicalsolutionsforfuturechallenges.Alessobviousconcern,butmaybeamoreimportant one, is how data sharing might impact on the ties between biobankresearchinstitutionsandindividualdonorsandparticipants.

Biobank research, internationally, in termsofoverall functioningandgoals, canbevery similar, and clearly illustrate some of the content of Mertons concept of“universalism”. On theotherhand,almost allbiobanksallover theworldarealsofundamentally local intheirnature,andtheyseemtohighlightthe localabovetheuniversal.Veryoftenbiobanksorbiobank-infrastructureshavenamesthatrefertoaparticular nation, like the UK Biobank, the Danish national biobank, the EstonianBiobank or Biobank Norway. Theymay also refer to a certain city or a particularregionwhereacohortstudyhastakenplace,liketheTromsøstudy,TheFraminghamheart study, the HUNT Biobank, the Guangzhou Biobank , etc. This means thatbiobanks collect their samples and their data in a context of local and nationalentities. The research institution might be local, the researchers are local, theinformation ismediatedthroughthe localnewspaperandtheethicsreviewwillbeperformedbythelocalresearchethicscommittee.Thislocalframingofbiobanksispartlyintentionalbecauseamongpeopleandparticipantsitcanhelpensuretrust.Inaddition it can also create pride and thereby increase the participation rates incohortstudies.

Biobank research then might appear to ordinary participants as being of a localnature.Butit’struenatureisuniversal.Thiscancreateatensionbetweenthelocalcontextwherehumanbiologicalsamplesarecollectedandlateruseofsamplesanddatainauniversalistscontext.JaneKayehasformulatedthetensioninthisway:“Datasharinghasthepotentialtoseverthetiesbetweentheresearcherresponsiblefor participant enrollment and the individual participants in an original study. Theonwardsharingofdataraisesquestionsaboutwhoisaccountablenotonlytoresearch ethics committees approving new research but also to the researchparticipantsforthesecondaryusesofdatainotherstudies.”[6]

Inordertohelpeasethistension,researchparticipantsmustbeinformedaboutthevalue of sharing data and/or samples. Theymust be informed about the value ofthinking globally in science, even though they may have acted locally. The localcontext in which so many biobanks are situated, should not be downplayed.However,localbelonging, localtrustandeventuallyalsolocalpride,mightgohandinhandwith internationaldata sharing. In fact, it shouldbepossible tobuild localtrustandpridebyhighlightingthelocalcontributiontoauniversalistscience.

Theethicalreasonstobevigilantaboutsharingareimportanttoaddress,however,theycannotbe,inandofthemselves,reasonstonotshare.Thebenefitsofsharing

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mustbeweighedagainstthepotentialharms.Therearemanyfundamentalreasonsfor internationaldatasharing.However,allthereasonsfordatasharingcannotbeconsideredascommonsense fornon-expertpublics.Amajor focus in theyears tocome should be to inform different publics, including patients and researchparticipants about the value of data sharing. With the proper safeguardingprocedures in place, data sharing should not be considered as something dubiousamongthepublic.Datasharingcancontribute to thecommongood,andcouldbeclaimedtobeatrueexpressionoftheethosofscience.

Whatneedstobedoneforbiobanksandresearcherstodeservethetrustofpatientsandresearchers? (G.Martin)

Onewaytoviewpersonswhodonatetime,samplesandinformationtoBiobanksisasparticipants.Theyparticipateinthecreationofsciencebydonatingtheseitems.In some cases (ie: rare diseases) they can also be viewed as active collaboratorswithintheresearchprocess–oneinwhichtheyareoftenemotionallyandrationallyinvested.Inthecaseofchronicorrarediseases,itenablesotherwisedisenfranchisedindividualstoparticipateactivelyinthedrivetoimprovetheirownandpotentially,their kin’s situation. In the case of the general public, it allows the enactment ofaltruisticdonation,drivenbyasenseofempathy,and,incontextswithstrongpublichealthsystems,asenseof‘payback’orfairreturnwithinthenormofreciprocity.

This typeof involvementor sharingbyparticipants,donorsor collaborators, is thebedrockofabiobank’sexistence.Thereare,however,potentialhazardsentrenchedintheactionofsharing intimate,personaldata -principally thepotentialbreachofdatasecuritywhichmayleadtostigmaanddiscrimination.Otherkeyareasofconcernhighlighted by Hawkins and O’doherty’s (2010) include the unknown andunforeseeableconsequencesofbiobanks;concernsassociatedwithvestedinterestsoftheresearchersrelatedtoprestigeandprofit;thepotentialmisuseofdata,resultsand technology , and the potential sharing and use of research data for unethicalpurposesunrelatedtotheoriginalbiobankdonation. [7]Theremaybeaconsciousutility/risktradeoffatthecoreoftheindividual’sdecisiontodonateandconsenttoshare data and bio-tissue, and ultimately trust is an essential factor in taking thatstep.

Biobank donation is complex because the relationship of trust the participant haswith the biobanker isthen conjugated down through the network of researcherswithwhomdataand tissuesare shared.Trustofactualorpotentialparticipants isimplicitly rooted in a common denominator of ethical standards and functioningthroughout the researchernetwork,anda clearaudit trail of accountability to thegoverningethicscommittee.

Thekeytobuildingtrustworthinessisdevelopingasystemofgovernancebasedonaccountability, transparency and control which accommodates and protects theneedsandrightsofthemultipleplayersintheprocess:participants,researchersandpolitical/privatesponsors.Ofparticular importance isthatthegoverningbody

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shouldbewidely representativeof stakeholders, includingpatientsand layexpertsonissuessuchasethnicityandculture.

Trustworthiness hinges on robust and transparent policies aimed at protectingprivacy and anonymity of donors, anchoredonto a brief, simple language consentdocumentwhichishonestaboutmakinganypotentialbreachesclear.

Participants’ trust in the biobank governance systemwould benefit if attention ispaid to the senseofactivecollaboration thatdrives their initialwish todonate. IntheidealsituationBiobanksshouldpotentiateempowermentofparticipantsbygivingthem access to updates on research process, sharing of sample and results,andgiving participants option to stop their samples being used for research theyconsiderunethicalorundesirable.Theuseofdynamicconsent [8] isan interestingoption, however one that hinges on two assumptions: that there is adequate ITtechnology and IT literacy, and that individuals trust this technology to maintainsecurityandconfidentiality.

The idea that the bio-sample and personal data may be commodifed and sharedwithcommercialentitiesmay leadtodistrustandresentment.Emphasisshouldbemadeon the fact that the key step to achieving tangible healthbenefits from theresearchprocess is often the involvementofprofit drivenpharmaceutical industryand,thathealthandwealthbenefitsarenotnecessarilyzerosumideals.

Trust is rooted in transparency. ‘Biobanks should be where the public is’ –educationalcampaignsfocusedonpotentialsocialbenefitsofbiobankparticipation,andclearemphasisontherightsandprivilegesofparticipants,havebeenshowntovalorise the action of donation and augment response. [9] Care should be taken,however not to offer unrealistic promises of feedback, and to work within thelimitationsofavailable/accessibletechnology.

Therelevantlegalframeworkforsharinginbiobank(J.Reichel)The European research infrastructures consortia, ERICs, are internationalorganisationssetupbytheEuropeanCommissionontheapplicationofatleastthreeEUMemberStates,accordingtoprocedureslaiddownintheERICregulation.Article15of theERICregulation lists the legalacts relevant tothesetting-upand internalfunctioningofanERIC:

• EU law, in particular the ERIC regulation, and the decisions taken by theCommissiontoestablishtheERIC,

• thelawoftheStatewheretheERIChasitsstatutoryseat,• thestatutesoftheERICandtheirimplementingrules.

ThelawapplicabletotheactualactivitiescarriedoutbytheERICwillinthefirsthandbethelawofthecountrywheretheERIChasitsseat,whichinthecaseofBBMRI-ERIC is Austrian law. However, BBMRI-ERIC is a distributed ERIC,with activities inseveralstatesandtherefore, it is the lawof the landwheretheactivity isactually

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conducted that will be applicable to these activities. This issue is not clearly laiddownintheERICregulation itself,but inparagraph21ofthepreamble it isstatedthatiftheERIChasaplaceofoperationinanotherstate,thelawofthatlatterstateshouldapplyinrespectofspecificmattersdefinedbythestatutesoftheERIC.

Further, incaseswhere theresearch is fundedvia theEUresearchbudget, theEUdemands that the values and principles of EU law be respected. According to theHorizon2020-regulation,alltheresearchandinnovationactivitiescarriedoutistocomply with ethical principles and relevant national, Union and internationallegislation,includingtheCharterofFundamentalRightsoftheEuropeanUnionandthe European Convention on Human Rights and its Supplementary Protocols. Thelegalframeworkforcross-borderbiobankingwithintheEUmustthereforeabidebybothEUlawandthelawsofthelandofallparticipatingstates.

The BBMRI-ERIC does not in itself have any mandate to change the regulatoryframeworkapplicabletotheresearchconducted.Itcannotenactactsthatsupersedetheapplicable lawofthecollaboratingstates,norreplacethedecisionsofnationalsupervisory bodies such as ethical review boards. However, the BBMRI-ERIC mayenact soft law tools such as charters, standards and guidelines that can provideconsiderablesupport for researchersconductingcross-border research.Theroleofsoft law and the use of self-regulation within the research policy area havetraditionallybeenoutspokenandistoalargeextentaccepted.Thesesoftlawtoolscangiveguidancetoresearcheronhowtoachieveahigh levelof legalandethicalcompliance,inaccordancetothelegalframeworkapplicabletotheBBMRI-ERICandHorizon2020-projects.Onthebasisof theirpersuasiveauthority, rather than legalforce,theymayfurtherprovideguidancealsotonationalethicalreviewboardsandtherebyactasbridgesbetweennationaljurisdictions.IfallpartnerswithintheBBMRI-ERIC take common standards into account already from the stageof drafting newresearchproject,futurecollaborationcanbecomemorecoherentalreadyfrom thestart. In the long run, BBMRI-ERIC might be able to contribute to a bottoms-upharmonization of a bioethical framework for the EU. A precondition for this,however,isthattheframeworkisdraftedwithconsiderationoftheroleandfunctionof legally binding frameworks of the Member States concerned. If not, aBBMRI-ERIC framework for legal andethical issues could insteadadd to thecomplexityofanalreadyfragmentedlegalframework.

IntellectualPropertyRightsinBiobanking:whattoconsider(I.Huys)The(legal)roleofbiobankswithintheBBMRI-ERICnetworkinthe(pharmaceutical)scientificinnovationprocesscouldbemanifold,fromcollectororproviderofhumanbiological material (HBM) and data or creator of integrated databases up to co-developer of innovative therapies. To keep upwith the desired ethical, legal, andsocialaswell as innovation requirementsandexcel inquality,biobankswithin theBBMRI-ERIC network need to make substantial investments in the creation,organization and maintenance of collections of HBM and data stored in theirbiobanks.Thismayresult insubstantiveamountsofresearchandnewinnovations.IntellectualPropertyRights(IPRs)aredesignedastoolstoprotectinnovations.

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Article 19 of the European ‘Commission Implementing Decision of 22 November2013 on setting up the BBMRI-ERIC as a European Research InfrastructureConsortium’indicatesthat‘BBMRI-ERICmayclaimappropriateIPRsavailablewithinapplicablenationaland international jurisdictionsover tools,data,productsoranyother results developed or generated by BBMRI-ERICwhile carrying out theWorkProgramme.’

TypesofIPRsrelevantforbiobanksaremainlycopyrights,suigenerisdatabaserights,trademarks, patent rights and trade secrets. Copyrights could beheld onsoftwareandcodingsystemsdevelopedtocollectandanalyzesamplesanddata,as well asthe text and/or structure of health questionnaires. Copyright could protect themanner in which samples and data is selected and structured, or protocols,standardoperatingproceduresorevaluationframeworks(e.g.BioresourceResearchImpact Factor (BRIF) parameters), or software to store, process and conductautomaticsearchesinthecollectionofHBManddata. Onecouldholdcopyright inrelation to the appearance or design of databases of samples and data or to thewebsitethatprovidesaccesstothecollectionofsamplesand/ordata(e.g.CatalogueofEuropeanBiobanks).Copyrightcouldfinallybeobtainedinrelationtopublicationsthatresultfromtheuseofsamplesand/ordatausedintheframeworkofaresearchproject. The particular arrangements or compilation of samples and data in adatabase (e.g. to guarantee quality) could be the object of sui generis databaseprotection (e.g. MIABIS , Minimum Information About Biobank data Sharing as astandard).

Abiobankcouldapplyforatrademarkregistrationinrelationtothename, logoorslogan of the biobank – such as the UK Biobank or the BBMRI-ERIC logo –, itsproductsorservices,orthedatabaseorsoftwareitdeveloped.Tradesecretscouldbe held on the (systematic) approach chosen to collect, store, label, process andtrackHBManddataor thealgorithmused toanalysedata.Patent rightsmightbeobtained in relation to innovative technology or equipment developed for theimprovedcollection,labelling,processing,storage,trackingandretrievalofHBManddata (e.g. in the Common Services for Biological Resources) , as well as for dataanalysisandpresentations.TheuseofHBManddataintheframeworkofaresearchprojectcouldresult inpatentable inventionsfurtherdownstream.However,patentrights will, in principle, not be granted in relation to the data resulting from theresearchproject, as such.Onlypersons thatmadeanessential contribution to theinventionareconsideredasinventors.

Asidefromthefactthat IPRsmaybeclaimedon inventionsorothercreations,theexerciseofsuchIPRsneedsparticularattention.AcarefullydevisedIPRpolicycouldconstituteaneffectivetooltoenhancetheacknowledgementandprotectionoftheinterestsofthebiobank,whilerespectinginterestsofotherstakeholders.

First,biobankscouldsetconditionsforaccesstoanduseofcollectionsofHBManddata.

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Second, any IPR policy must balance the needs to facilitate access to scientificadvancementsandtoensuretheacknowledgmentandprotectionoftheinterestsofbiobanksandotherstakeholders.Theinvolvementofallstakeholders(e.g.facilitatedviatheCommonServiceStakeholderForum)inthedevelopmentofpoliciesonIPRsmaycreatetransparencyandopenthedoor forcontinuousdialogueswithdonors,applicants,fundersandbiobanks.

Third,IPRpolicieswouldincludeprovisionsonupstreamIPRsheldbyresearchersonresearchresultsaccruingfromuseofHBManddatafrom(publiclyfunded)biobanks.Suchpolicy could prohibit users fromobtaining IPRs onprimaryHBManddata orupstreamdatadirectlyderived fromthecollectionofHBManddata.Aproper IPRpolicy should, however, contain sufficient incentives to stimulate innovation.Researchers shouldmaintain the possibility to obtain IPRs on downstream clinicalapplicationsorproducts,suchasdiagnostictests,therapiesandmedicinesthatarisefromusingthecollectionofHBManddata.

Theimportanceofconsentinsharingbiologicalsamplesanddata(R.Jahns)A growing number of biobanks, both in Europe and world-wide, collect humanbiological materials and related health and personal information for use inbiomedicalresearch.Theyrepresentimportantresourcesforadvancementinhealthresearch, including basic research, and medical research (e.g. personalized orstratifiedmedicine, diagnostics and treatment development). To foster biomedicalresearch, particularly for rare diseases, where so few samples exist, the researchcommunitymustdevelopinternationallyacceptedandapplicablestrategiesinorderto facilitate sharing (and access to) data and human bio-specimen across borders.The BBMRI-Common Service ELSI group aims to facilitate, support and guide suchendeavorsinanethicallyresponsiblemanner.

Indeed,oneimportantfactorthatneedstobeaddressedinthiscontextisindividuallevelconsentofparticipantsdonatingsamplesandphenotypicinformation.Currentpractices and procedures for consent for the future use of samples and data inbiobankingvarywidely, includingopt-in,andopt-outapproaches.Additionally, theamount and type of information provided to individuals regarding the types ofresearchusesmayalsodifferagreatdeal.Thesetypesofconsent includeblanket,broad, limited,specific,andtieredconsent.[10]BroadconsenthasbeendefinedbyGrady and colleagues (2015) as “as consent for an unspecified range of futureresearchsubjecttoafewcontentand/orprocessrestrictions.Broadconsentislessspecific than consent for each use, butmore narrow than open-ended permissionwithoutanylimitations(i.e.,“blanket”consent).”[11]Accordingtosomeauthors,inordertofacilitatesharingandaccessofhumanbiologicalmaterialsandrelateddata,a “broad consent” (i.e. as broad as possible, while keeping within ethicallyacceptable limits, seebelow) shouldgenerally be aimed for. Thiswould allowbio-specimensanddatatobemadewidelyavailable“tothemostinclusiveandethicallyresponsibleresearchcommunity”.[12,13]However,potentialrisksofdiscriminatingvulnerable patient groups because of health-related data sharing must beconsideredwhenstrivingforbroadconsent.

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Arecentworkshopregroupinginternational(includingEuropean)expertsinresearchethics,organizedbytheNIHDepartmentofBioethics,arguedthatbroadconsentisethicallyacceptableas longasparticipantsareprovidedwithsufficient informationtomake a reasonably informeddecision and that additional safeguards are put inplace. [11] They“concludedwithaproposal forbroad initialconsentcoupledwithoversightand,whenfeasible,ongoingprovisionof informationtodonors.”([11]p.34) Similarly, in 2015 the WMA published a draft “Declaration on EthicalConsiderations regarding Health Databases and Biobanks” considering a broadconsenttobeethicallyacceptableifindividualsare“informedaboutthepurposeoftheHealthDatabaseorBiobank,thenatureofthedataormaterialtobecollected,andaboutwhowillhaveaccesstotheHealthDatabaseorBiobank.Thedonorsmustalso be informed about the governance arrangements and themeans thatwill beused to protect the privacy of their information.” [14] This exemplifies a crucialfactorinthediscussionaboutconsentforbiobankingresearch,andmorespecificallyabouttheacceptabilityoftheuseofbroadconsent:differentgroupsmaybeusingthe same term “broad consent” but the conditions attached to its respective usemayrenderitsmeaningdifferent,atleasttosomeextent(seebelow).Itisimportanttokeep trackof suchdifferencesandsupplemental conditionsandnot to take forgrantedthatallusesoftheterm“broadconsent”are,inpractice,synonymous.(seealsoBioMedBridges,http://www.biomedbridges.eu/deliverables/52-0)

Indeed,thenotionsrelatedto“broadconsent”areincreasinglybeingconsideredtobe the most helpful notions for maximizing the research value of human bio-specimen/data frombiobanks. Broad consent and its associated consent-types aregaining groundwithin the EU in caseswhere the scope of the biobank cannot belimited to research into specificdiseases. Importantly, it is generallyaccepted thatbroadconsentrequiresawell-definedethicaland legal framework;nonetheless, insomeEUmember states it is not yet the prevailing view, perhaps due, in part, todiffering values about the concept and/or understanding about the terminology.Becauseof itsbreathandtheunpredictabilityofresearchpurposes,broadtypesofconsent are evidently not themost informative forms of consent for participants.Therefore, it is recommended thatanyknown future researchpurposes shouldbeexplainedtothedonorsaspreciselyaspossible;alternatively,thegeneralaimofthebiobankincludingthepotentialbiomedicalfieldsofresearchshouldbeindicatedinaclearandtransparentmanner(thatiseasilyandpubliclyaccessible,e.g.abiobank’shomepage).[15]

Beyondthetypeofconsent, there isconsensusthatanyconsent forthecollection(andcross-bordersharing/use)ofhumanbiologicalmaterialsandrelatedhealthandpersonal information, should include simple and transparent information aboutstorage, utilization, andprocessing of the data/samples.Of course, thesemust beoutlinedinatransparentmanneralwaysrespectingthecurrentlyapplicablenationalandinternationalethicalandlegalframework.

Furthermore, constant technical developments challenge the concept of (privacy-protecting) “anonymisation” of bio-specimen, which may contain genomicsequences. This is especially a concern aswhole genome sequencing is becoming

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more affordable and accessible to a wide range of researchers. Detailed geneticdata,especiallywholegenomesequencedata,isuniquetoonepersonand,assuch,thegeneral riskof re-identificationshouldbeexplainedtodonors.Thus, currently,evenwithbroad consent, anyopen-accessorpublicationof the full genomeof anindividualrequiresaspecific,unambiguousconsent.[15]

While information and consent documents do not replace the face-to-facediscussionbetweenclinician/researcher,biobankanddonor,theyareanimportantcomponent of the consent procedure and its documentation, not least legally.Empirical studies have shown that consent forms are often incomprehensive,incomprehensible or impractical, and fail to meet donors’ needs. [6] Therefore,appropriate (broad) consent documentsmust explain the breadth of consent andother elements of the framework for future research such as, for example, cross-border sharing and use of bio-specimen and/or data, property rights,(commercialuse if applicable), and data protection, employing a simple and comprehensiblelanguage.Moreover,amaximumdegreeofharmonizationofconsentformsusedforhuman biobanks is essential for cooperation and networking at the European (atleast between BBMRI member states) as well as for other internationalcollaborations.[16]

It is also pertinent that as amechanism of compensation or adjustment, patientsand/or study-participants who are asked under the principles of a broad consentwhethertheyarewillingtodonatebiologicalmaterialsandrelateddataformedicalresearchshouldbeexplicitly informedabouttheirrighttorefuseorwithdrawtheirconsentatanytimewithoutanyfearofdetriment.

Dependentonthescopeoftherespectivebiobank/collectionthebio-specimenthatare stored and may be used for broad medical research purposes should be (A)eithertissuesand/orbodyfluidsthathavebeencollectedfordiagnostic/therapeuticpurposeswhichareno longer requiredand,otherwise,wouldbedestroyed,or (B)bodyfluidsthatareadd-oncollectedforbroadbiomedicalutilizationintheframeofdiagnostic/therapeutic procedures (in that case the exact type and quantity ofblood/urine/othersamplesmustbedescribedindetails).[17]Relateddatacollectedunder theprinciplesof abroad consentmay comprise selected information aboutthe donor, in particular,medical/ health data but also additional datawhich thenmustbespecifiedintheinformationsheet(e.g.geneticdata,life-styledata).[17],Finally, in the context of sharing biomaterials and related data it is stronglyrecommended that the biobank itself does not host any identifying data and thatsuch data are hosted by the institution (clinic/physician) in which thedata/biomaterialwasgained. Suchconditionsaregenerallypreferred,because thesubject-identifying data are then protected by medical secrecy and criminalproceduralaccessprohibition.Ifanyotherprocedureisplanned,thismustbeclearlystatedinthedonor-informationsheet.

Incidental findingsregardingundetectedhealthrisksordiseasesof thedonorraisethequestionofwhether there is anobligation to inform thedonor.On theother

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hand,any‘rightnottoknow’mustberespected.Thisconflictcannotcompletelyberesolved but should, at least, be duly managed through implementing an explicitdeclarationexplainingwhatwillhappenregardingthefeedbackofincidentalfindingstothesampledonor.[15]

Theimportanceofadequatelyrecognizingthosewhoorganizeandmaintainbiobanks(A.Cambon-Thomsen,H.C.Howard)

A great deal of biomedical science such as epidemiology, clinical trials, biomarkerresearch and genetics, is currently reliant, to some extent, on samples and datacollected and assembled in biobanks. These biobanksinclude the biological andphenotypicinformationfromalargecollectionofpersons.Asmentionedabove,theincreaseaccessto,andsharingofthisinformationcangreatlyhelpmakebiomedicaldiscoveries. However, there are a wide variety of obstacles to wide and efficientsharingor access to samples anddata.[3]Oneobstacle to sharingbiosamples anddata has been identified as the recognition of researchers and clinicians whodeveloped the bioresource.[18] That is to say that researchers and even thoseorganizingbiobanksmaybereluctanttosharetheircollectedsamplesanddatadueto fear that their contribution to establishing, collecting and maintaining theseresources will not be (adequately) recognized. The concept of the BioresourceResearch Impact Factor (BRIF) was developed in order to directly address thisproblem.

Theconceptofa(BRIF)wasfirstproposedin2003(albeititwasoriginallyreferredtoasthe“biobankimpactfactor”(BIF))[18]andhassincebeenfurtherdevelopedonitswaytobecomingaconcretetool foruse.AsrecentlydescribedbyMabileetal.(2013)

“The BRIF initiative was set up to construct an adequate framework andprovide a set of tools that will allow an objectivemeasure of the actual researchutilizationofbioresourcesasasignificantcomponentforestablishingtheirreliabilityandsustainability.”[19]

It will be loosely modeled on the concept and functioning of the journal impactfactor.Therational is that if thestakeholderswhohavesetup,maintainedand/orcontributed to bioresources are properly recognized and acknowledged for theircontributiontoresearch(discoveries),theywillbemoreapttosharetheirsamplesanddatawithotherresearchers.Mabileandco-authorsexplainthatthisBRIFwouldallow for and support a virtuous cycle to occur: the higher the quality of thebioresource(s), themore frequentthe solicitationsshould be;more solicitationsmeansmore chances for sharingand themorebioresourceswouldbe shared, themoreone’simpactwouldincrease,“andthemoreoneisinclinedtoshare.”[19]

An internationalworkinggroup includingexperts from22countries (primarily fromEuropeandNorthAmerica)wasdevelopedtoaddressfiveparticularlysalientareasrelativetotheBRIF[19]:

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i) “digital identifiers”addresshow to identifyuniquely and inapersistentway, different bioresources. track, quantify the contribution for andacknowledge

ii) “Parameters” address the issues surrounding identifying and weighingparameters to be used in metrics aiming at measuring the use ofbioresources and at producing indicators of their impact. Basically thisaddressesthetopicofhowtomeasuretheutility ofabioresource.

iii) “Sharing policies” addresses the policies for access and sharing ofbioresourceswhichcanplayahugeroleinsupportingorhinderingwidersharing.

iv) “Journal editors” includes analysing the role(s) played by journalguidelinesandpoliciesforresourcecitingandreferencingandproducingaguidelineforcitinginastandardwayinarticlesthebioresourcesusedinresearch. The next step is to foster the implementation of such aguideline.

v) “Dissemination” addresses the needs for outreach and for raisingawareness of the BRIF concept and current efforts. For the BRIF tobecomeaconcreteframeworkandforitstoolstobeuseful,stakeholders,mustbeawareofitsexistenceandmustcontributetoitsdevelopment.

FormoreinformationontheBRIF,pleaseseeMabileetal.2013[19]andBravoetal.2015[20].

III -ConclusionandFutureSteps-Theworkshopandthisreporthavehighlightedtheimportanceofthesharingof,and

accesstobiomaterialsanddata.Theyhavealsoaddressedthebarrierstomorewide-spread,efficientandethicallyacceptablesharing(e.g.adequaterecognition,issueswith(broad)consent)aswellasaspectsthatareparticularlysalienttotheactivities and context of sharing in biobanking research (e.g. the trust ofparticipants,intellectualproperty,andtheEUlegalcontext).

-AddressingtheissuesofsharingandaccesstobiomaterialsanddataisanimportantactivityfortheBBMRIELSIgroup.

-Future steps could include the consideration of reviewing and mapping outexisting current documents that address these issues (e.g. from OECD 2009guidelinesonHumanBiobanksandGeneticResearchDatabanks,GlobalAlliance2014 Framework for Responsible Sharing, International Cancer GenomeConsortium(ICGC)Goals,Structure,PoliciesandGuidelines,ConsortiumPoliciesandGuidelines,InternationalCharterofprinciplesforsharingbio-specimensanddata(RDConnect).

-Shouldthesedocumentsstillhavegapsand/ordonotaddressfullyareasimportanttoBBMRI,afollowingstepcouldthenbetodevelopasetofrecommendationsonbiomaterialanddatasharingandaccess.

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References1. Cambon-Thomsen, A., The social and ethical issues of post-genomic human

biobanks.NatRevGenet,2004.5(11):p.866-73.2. Fransson,M.N.,etal.,Towardacommonlanguageforbiobanking.EurJHum

Genet,2015.23(1):p.22-8.3. Colledge,F.,B.Elger,andH.C.Howard,Areviewofthebarrierstosharingin

biobanking.BiopreservBiobank,2013.11(6):p.339-46.4. Popper,K.,Theopensocietyanditsenemies.1945,2012,London:Routledge.5. Merton, R.K., The sociology of science. 1973, Chicago: The University of

ChicagoPress.6. Kaye, J.,TheTensionBetweenDataSharingandtheProtectionofPrivacy in

Genomics Research.Annual Review of Genomics and Human Genetics, Vol13,2012.13:p.415-431.

7. Hawkins,A.K.andK.O'Doherty,Biobankgovernance:a lesson intrust.NewGeneticsandSociety,2010.29(3):p.311-327.

8. Kaye, J.,etal.,Dynamicconsent:apatient interface for twenty-firstcenturyresearchnetworks.EuropeanJournalofHumanGenetics,2015.23(2):p.141-146.

9. Leitsalu, L.a.A., A., Providing transparency of use: the example of EstonianBiobank,inBBMRIELSIPArisMeetingSept.2015.2015.

10. Edwards, T., et al., Biobanks containing clinical specimens: definingcharacteristics,policies,andpractices.ClinBiochem,2014.47(4-5):p.245-51.

11. Grady, C., et al., Broad Consent for Research With Biological Samples:WorkshopConclusions.AmJBioeth,2015.15(9):p.34-42.

12. Mascalzoni, D., et al., International Charter of principles for sharing bio-specimensanddata.EurJHumGenet,2015.23(6):p.721-8.

13. Sariyar, M., et al., Sharing and Reuse of Sensitive Data and Samples:Supporting Researchers in Identifying Ethical and Legal Requirements.BiopreservBiobank,2015.13(4):p.263-70.

14. (WMA), W.M.A., Declaration on ethical considerations regarding healthdatabasesandbiobanks.AdraftfromtheWGintendedforopenconsultationafteracceptanceoftheExecutiveCommitteeoftheWMA.2015.

15. BioMedBridges,Template: Information Sheet and Consent Form (Version 2.081014)2014.

16. Strech, D.e.a.,A broad consent template for biobank research. Results andexplanationofanevidenceandconsensus-baseddevelopmentprocess.EJHG,submitted.

17. Committees, W.P.o.t.G.M.E., Text template for the donation, storage, andutilization of biological materials as well as the collection, processing, andusageofrelateddatainbiobanks..2015.

18. Cambon-Thomsen,A.,Assessingthe impactofbiobanks.NatGenet,2003.34(1):p.25-6.

19. Mabile, L., et al., Quantifying the use of bioresources for promoting theirsharinginscientificresearch.Gigascience,2013.2(1):p.7.

20. Bravo, E., et al., Developing a guideline to standardize the citation ofbioresourcesinjournalarticles(CoBRA).BMCMed,2015.13:p.33.

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