Biobanks for research. Biobanks for research. Ethical Ethical and regulatory aspects in and regulatory aspects in

human biological samples human biological samples collections in Francecollections in France

Christine NOIVILLE Christine NOIVILLE

CNRS / Paris 1 UniversityCNRS / Paris 1 University

IntroductionIntroduction

Biobanking: its significance in modern medical Biobanking: its significance in modern medical researchresearch

Collections of human biological samples (tissues, body fluids, DNA…) and Collections of human biological samples (tissues, body fluids, DNA…) and related data (clinical, biological, genealogical…)related data (clinical, biological, genealogical…)

Pathology oriented biobanks / populational biobanksPathology oriented biobanks / populational biobanks

Biobanking in FranceBiobanking in France

biobanks abound  : profusion of samples collections ; networks (Cancer National biobanks abound  : profusion of samples collections ; networks (Cancer National Institute, Eurobiobank…) Institute, Eurobiobank…)

special rules for control (declaration/authorization ; ethical review Board) special rules for control (declaration/authorization ; ethical review Board) bioethics principles (29 july 1994 law amended 6 august 2004: consent, bioethics principles (29 july 1994 law amended 6 august 2004: consent, gratuity, « non-patrimoniality ») gratuity, « non-patrimoniality »)

  

Introduction (2)Introduction (2)

Main ethical issues Main ethical issues      

CCNE / National Ethics Committee, advice n° 77CCNE / National Ethics Committee, advice n° 77 (20th March (20th March 2003)2003)

Protecting donors (I)Protecting donors (I)

Sharing the content and benefits of biobanks (II)Sharing the content and benefits of biobanks (II)

I. Protecting donorsI. Protecting donorsConsentConsent

General principles : General principles :

informed consent always needed, either express (clinical informed consent always needed, either express (clinical trial -trial -Opt inOpt in) or tacit (healthcare – ) or tacit (healthcare – Opt outOpt out))

No blanket consent: opposition right to new research No blanket consent: opposition right to new research programsprograms

Consent withdrawal Consent withdrawal    

Remaining issues : Remaining issues :

Balance between donors’ protection and research needs Balance between donors’ protection and research needs right to know / not to know about the results of the right to know / not to know about the results of the

research research

ConfidentialityConfidentiality   General rulesGeneral rules : :

Biobanks must be declared or autorized (research with health Biobanks must be declared or autorized (research with health data) by CNIL (national authority protecting privacy and data) by CNIL (national authority protecting privacy and personal data) personal data)

Identifying data must be encoded (exceptions, e.g. peculiarity Identifying data must be encoded (exceptions, e.g. peculiarity of the research)of the research)

Commercial exploitation of identifying data is forbidden (13 Commercial exploitation of identifying data is forbidden (13 august 2004 law on health insurance) ; transfer to employers august 2004 law on health insurance) ; transfer to employers or insurers (article L. 110-4 public health code / 4 march 2002 or insurers (article L. 110-4 public health code / 4 march 2002 law) ; criminal sanctions (articles 226-13 et 226-14 criminal law) ; criminal sanctions (articles 226-13 et 226-14 criminal code)code)

Remaining issues : Remaining issues :

can courts and police authorities access samples and data for can courts and police authorities access samples and data for public security reasons ? public security reasons ?

profiling whole groups of people profiling whole groups of people

II. II. Sharing the content and Sharing the content and benefits of biobanksbenefits of biobanks

Access to biological samplesAccess to biological samples   

a source of unique biological samples and a powerful tool for a source of unique biological samples and a powerful tool for research research

Public hospitals (APHP) / Health Research Institute (INSERM) conflictPublic hospitals (APHP) / Health Research Institute (INSERM) conflict

Collection value : necessity to recognize each protagonist’s added Collection value : necessity to recognize each protagonist’s added value (doctors, researchers, facilities hosting collections, firms…)value (doctors, researchers, facilities hosting collections, firms…)

Property rights : limits of exclusive property as regards access Property rights : limits of exclusive property as regards access imperativeimperative

CCNE’s advice n°77 : invent a new legal concept that guaranties CCNE’s advice n°77 : invent a new legal concept that guaranties access access

Sharing benefits with donors ?Sharing benefits with donors ?

Donors’ right to get a return if a product is developed with their Donors’ right to get a return if a product is developed with their samples ?samples ?

US: John Moore case; France: donors have no property rights on US: John Moore case; France: donors have no property rights on

their samplestheir samples

Benefit sharing should be conceived in a collective and non Benefit sharing should be conceived in a collective and non financial manner. financial manner.

Donors contribute to science Donors contribute to science altruistically // altruistically // biobanks increasingly biobanks increasingly involve researchers, biotech firms and pharma companies which involve researchers, biotech firms and pharma companies which aim to aim to profit profit by these donations. by these donations.

Resources must be exploited in a way that favors donors’ Resources must be exploited in a way that favors donors’ interests.interests.

Rules have been adopted in order to protect donors’ interests Rules have been adopted in order to protect donors’ interests (patent rules preventing too large monopolies blocking research ; (patent rules preventing too large monopolies blocking research ; rules guarantying patients’ access to important patented rules guarantying patients’ access to important patented medicines). medicines).

ConclusionConclusion

Biobanking activities may proceed only if :Biobanking activities may proceed only if :

Rights and obligations of all stakeholders Rights and obligations of all stakeholders (donors, researchers, facilities, industry…) are (donors, researchers, facilities, industry…) are clearly addressed and regulated clearly addressed and regulated

They remain in line with french ethical values They remain in line with french ethical values (consent, altruism) and with their very original (consent, altruism) and with their very original aim (research, public health improvement). aim (research, public health improvement).