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Christine NOIVILLE CNRS / Paris 1 University

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Biobanks for research. Ethical and regulatory aspects in human biological samples collections in France. Christine NOIVILLE CNRS / Paris 1 University. Introduction. Biobanking: its significance in modern medical research

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Biobanks for research. Ethical and regulatory aspects in human biological samples collections in France

Christine NOIVILLE

CNRS / Paris 1 University

  • Biobanking: its significance in modern medical research

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

Pathology oriented biobanks / populational biobanks

  • Biobanking in France

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

special rules for control (declaration/authorization ; ethical review Board)

bioethics principles (29 july 1994 law amended 6 august 2004: consent, gratuity, « non-patrimoniality »)

introduction 2
Introduction (2)
  • Main ethical issues

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

Protecting donors (I)

Sharing the content and benefits of biobanks (II)

i protecting donors
I. Protecting donors


  • General principles :
    • informed consent always needed, either express (clinical trial -Opt in) or tacit (healthcare – Opt out)
    • No blanket consent: opposition right to new research programs
    • Consent withdrawal
  • Remaining issues :
    • Balance between donors’ protection and research needs
    • right to know / not to know about the results of the research
  • General rules :
    • Biobanks must be declared or autorized (research with health data) by CNIL (national authority protecting privacy and personal data)
    • Identifying data must be encoded (exceptions, e.g. peculiarity of the research)
    • Commercial exploitation of identifying data is forbidden (13 august 2004 law on health insurance) ; transfer to employers or insurers (article L. 110-4 public health code / 4 march 2002 law) ; criminal sanctions (articles 226-13 et 226-14 criminal code)
  • Remaining issues :
    • can courts and police authorities access samples and data for public security reasons ?
    • profiling whole groups of people
ii sharing the content and benefits of biobanks
II. Sharing the content and benefits of biobanks

Access to biological samples

  • a source of unique biological samples and a powerful tool for research
  • Public hospitals (APHP) / Health Research Institute (INSERM) conflict
  • Collection value : necessity to recognize each protagonist’s added value (doctors, researchers, facilities hosting collections, firms…)
  • Property rights : limits of exclusive property as regards access imperative
  • CCNE’s advice n°77 : invent a new legal concept that guaranties access
Sharing benefits with donors ?
  • Donors’ right to get a return if a product is developed with their samples ?
  • US: John Moore case; France: donors have no property rights on their samples
  • Benefit sharing should be conceived in a collective and non financial manner.
  • Donors contribute to science altruistically // biobanks increasingly involve researchers, biotech firms and pharma companies which aim to profit by these donations.
  • Resources must be exploited in a way that favors donors’ interests.
  • Rules have been adopted in order to protect donors’ interests (patent rules preventing too large monopolies blocking research ; rules guarantying patients’ access to important patented medicines).

Biobanking activities may proceed only if :

  • Rights and obligations of all stakeholders (donors, researchers, facilities, industry…) are clearly addressed and regulated
  • They remain in line with french ethical values (consent, altruism) and with their very original aim (research, public health improvement).