Public Regulation of Tumor Banks

224 Pages·2018·3.632 MB·English

by  Xavier Bioy

Xavier Bioy Editor
Public
Regulation of
Tumor Banks
Establishment, Heritage Status,
Development and Sharing of Human
Biological Samples
Public Regulation of Tumor Banks
Xavier Bioy
Editor
Public Regulation of Tumor
Banks
Establishment, Heritage Status, Development
and Sharing of Human Biological Samples
Editor
XavierBioy
Toulouse1CapitoleUniversity
Toulouse,France
ISBN978-3-319-90562-4 ISBN978-3-319-90563-1 (eBook)
https://doi.org/10.1007/978-3-319-90563-1
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Foreword
Theresearch,anaccountofwhichwewillgetoverthisbook,isdesignedtoanalyze
how theessential resource for researchthat are human biological elements, mainly
tumor tissues, and the personal data associated with them are developed. The
treatment and study of cancer requires us to collect and store diseased tissue and
thusconstitutecollectionsthatwillbeusefultothepatienthimself,andthenpossibly
toresearch.Foraboutadecade, thesecollectionshavebeensubjecttoalegislative
frameworkthatprotectsdifferentinterestsbutalsodefinesthemeansofacommon
standardofconservationandcirculation.Fromthebeginning,structuredcollections
oftumors,ortumorbanks,havefiguredprominentlyamongbiobanks.Ifwereferto
the definition of the INCA, “tumor banks are located in health facilities, where
biological samples are recorded, cryopreserved, then according to specific, legally
defined conditions and structures, are made available to doctors and scientists for
clinicaltestsorresearchstudies”.
In the field of cancer research, they occupy a crucial place in translational
research, i.e. research which attempts to use the technical and scientific advances
formedicalcareasquicklyaspossible.Makingsamplesandpersonalpatients’data
availabletoresearchersisavitallinkfortheprogressofcareprotocols,inparticular
asitenablesustotestbiomarkersforpreventionanddiagnosis.
Thatiswhythetopicofthisresearchandthisconferencefocusesonstudying,in
humanandsocialsciences,theformidablequestionofthe“development”ofcollec-
tions and, concretely their regulation or their governance. Basically, how can be
decided nowadays and how could be decided in the future the constitution, the
funding,theallocationofresourcestoaparticularresearchprogram?
The interests at stake are still incorrectly identified but there are already a great
numberofthemandyourconferencewillenablethisidentification.Theinterestsof
researchers come first but they are already diverse, depending on the purposes of
research, but also on the integrated nature or not of the collection to the research
program.
Buttheinterestsofpublicandprivatefundersarenolessreal.TheINCAaswell
assometeachinghospitalshavethusperceivedtheimportanceofapublicpolicyfor
v
vi Foreword
these collections, but the health insurance, which funds much of the process, has
only done so to a lesser extent. The Inserm has implemented for several years an
extensiveprogramofstructuringwhichisbeyondthescopeofoncology,butwhich
integratesit.Healthplayersarereallyreceptivetoresearchlikeyoursaroundthenew
job of biobanker, which tends to move away from the only organ or pathology
expertise.
The essential contribution of this research resides in the legal, economic and
socialstudyofbiobanksinoncology.Indeed,althoughtherearesomelegislativeor
regulatoryelements,theyarefarfromcoveringalltheimportantorspecificaspects.
Inparticular,theelementsofapublicpolicyofdevelopmentarestill pending.The
doctors and engineers here will insist on quality requirements and technical stan-
dards,butthereisalso,asyouknow,theissueofthecollectionsuse.
Therearemanywaystohelpwiththecreationoftheseresourcesandwithmaking
them available for research. All these ways require a clarification of roles and
jurisdictions. I have seen that the book will lead to reflect on the constitution of
public or private “patrimonies” and to clarify the legal status of the contracts that
securethecirculationofcollections.Itisbothnecessaryanddifficultforlawyersto
analyze these aspects precisely and they should do so along with doctors and with
themanagersofthesecollectionstoassesspracticesandguidethem.
It is also remarkable that this research has created a group that includes econo-
mists,inaprestigiouseconomicsschoolwhichalreadyanalyzeshealtheconomics.
A fine apprehension of costs and of the market around biobanks, and specifically
tumorbanks,seemsindispensabletoknowwherepublicauthoritiescanhelp.
Iseethatthebookmakesroomforasociologicalperspective.Itisagreatthing
becauseyoucannotignoretherepresentationsthatsocietyconveyswhenitcomesto
cancerandresearch,thehumanbody,and“humanresources”.
It seems to me that this book raises the right questions. Those questions are
considered from the outset to define the legal and economic nature of collections
which interest researchers. I guess it is a challenge in itself to name what already
exists.
Next,youwillgettothecoreoftheissue,frommypointofview:whydevelop
collectionsandofferbroadaccesstothem?Especiallythroughthesoundframework
ofEuropeanrelationsandinternationalcooperationactivities?Theissueofnetwork-
ingiscentraltoallresearch,butthisisespeciallytrueforcancerwhichrequiresthe
collectionofahugeamountofinformationonitsdeterminingfactors.
Finally, the reader can provide what scientists expect: leads and answers on the
legal and political means of this development and of this regulation to benefit the
greater good. The book intends to carefully consider ways towards a pooling of
resources/knowledge. This issue of ‘pooling’, regarding health, should not worry
anyone.Ofcourse,thecostofnewtherapiesissuchthatdrugproducinglaboratories
must protect their work and their resources. But it is also politically important to
encourage, as much as possible, collectors to share their resources for an optimum
collectivedistribution,intheinterestofall.
Finally, I am very pleased to see that the Toulouse site has also seized the
opportunityofthepresenceofOncopole.Indeed, the2003 project, whichhasnow
Foreword vii
been completed, combining public and private research with all types of care
structures, will have an influence. Researchers from other structures, such as
Université Toulouse 1 Capitole, will now work with them more, because cancer is
alsoamatterforhumansciences.Toulousebecomesyearafteryearakeylocationof
thefightagainstthedisease.
DeputySecretaryGeneralofthe PhilippeDouste-Blazy
UnitedNations,NewYork,NY,USA
Contents
PartI TumorBanksortheValorizationofaComplexObject
1 IsPuttingCancerinBanksaPatrimonyToBeDeveloped?. . . . . . 3
XavierBioy
2 BiologicalSamplesandTheirSamplingDegrees. . . . . . . . . . . . . . . 9
ThibautCoussens-Barre
3 PersonalDataProtectioninTumorBanks. . . . . . . . . . . . . . . . . . . 19
EmilieDebaets
4 ThePoliciesofTumorBiobankers:MainStrategiesand
anExampleofthePoliciesAdoptedbytheNiceHospital
Biobank,France. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
PaulHofman
5 TheConceptofBiologicalSamplesCollection. . . . . . . . . . . . . . . . . 41
AnneBrouchetandSophiePeries
6 DoesTumorBankRegulationPromotetheValorization
ofTumorCollections?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
AnnaPigeon
7 EconomicModelingandValorizationofBiobanks. . . . . . . . . . . . . 63
CatherineBobtcheffandCaroleHaritchabalet
8 SocializingTumors:FromtheConservationofTumorsinBanks
toTheirOntologicalVariations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
FabienMilanovic
PartII TheIssuesRelatedtoTumorCollectionsValorization
9 TheValorizationofTumorCollections:ReconcilingtheInterests
oftheDifferentActors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
EmmanuelleRial-Sebbag
ix
x Contents
10 TheDevelopmentofTumorCollections:TheInterestofthe
EuropeanUnion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
NathalieDeGrove-Valdeyron
PartIII TheMeansforTumorCollectionsValorization
11 AcademicValorizationofBiobanks. . . . . . . . . . . . . . . . . . . . . . . . . 113
Anne-MarieDuguet,LaurenceMabile,andAnneCambon-Thomsen
12 CommercializationThroughtheUseofPrivateLawContracts. . . . 127
LaurentIzac
13 TheGovernanceFrameworkofNorthAmericanBiobanks:
ARapidlyEvolvingPolicyPatchwork. . . . . . . . . . . . . . . . . . . . . . . 141
YannJolyandMiriamPinkesz
14 BiobankExpertiseandtheResearchUnit-BiobankRelationship. . . 165
CatherineBobtcheffandCaroleHaritchabalet
15 Extra-PatrimonialityforthePatient. . . . . . . . . . . . . . . . . . . . . . . . 175
SophieParicard
16 TheMomentofPatrimonialization. . . . . . . . . . . . . . . . . . . . . . . . . 183
Marie-XavièreCatto
17 ThePatrimonialSpecificitiesofPublicPersons. . . . . . . . . . . . . . . . 201
BenoîtSchmaltzandPierreÉgéa
18 BiologicalSampleCollectionintheEraofGenomicMedicine:
ANewExampleofaPublicCommons?. . . . . . . . . . . . . . . . . . . . . 211
ChristineNoivilleandFlorenceBellivier
List of Abbreviations
BRIF BioresourceResearchImpactFactor
CAD Collecteuranalyseurdesdonnées(Dataanalyzercollector)
CCQ CivilCodeofQuébec
CNRS Centrenationaldelarecherchescientifique(France) ScientificResearch
NationalCenter
CPP Comité de protection des personnes (France) Committee for the
ProtectionofPersons
CPPP Contractualpublic-privatepartnerships
CRB Centersofbiologicalresources
CSP Codedelasantépublique(France)Publichealthcode
EPIC EuropeanProspectiveInvestigationintoCancerandNutrition
ERIC Europeanresearchinfrastructureconsortium)intheareaofbiobanksand
Biomolecularresources,«ERIC-BBMRI
ELSI TheEthical,LegalandSocialIssuesService
ESFRI Europeanstrategyforumforresearchinfrastructures
FAO FoodandAgricultureOrganization
GeCIP GenomicsEnglandClinicalInterpretationPartnership
HIPAA HealthInsurancePortabilityandAccountabilityAct(1996)US
hSERN HumanSampleExchangeRegulationNavigator
IBiSA Biology,Health,andAgronomyInfrastructure
IGAS GeneralInspectorateofSocialAffairs(France)
INCa Frenchnationalcancerinstitute
Inserm Institutnationaldelasantéetdelarecherchemédicale(France)National
InstituteofHealthandMedicalResearch
IRB Institutionalreviewboard
JTIs JointTechnologyInitiative
MTA MaterialTransferAgreement
mBRCs Microbiologicalresourcecenters
OMC Worldorganizationoftrade
xi