Biobanks for research.
This presentation is the property of its rightful owner.
Sponsored Links
1 / 8

Christine NOIVILLE CNRS / Paris 1 University PowerPoint PPT Presentation


  • 88 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

Christine NOIVILLE CNRS / Paris 1 University

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Christine noiville cnrs paris 1 university

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

Christine NOIVILLE

CNRS / Paris 1 University


Introduction

Introduction

  • 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

Consent

  • 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


Christine noiville cnrs paris 1 university

Confidentiality

  • 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


Christine noiville cnrs paris 1 university

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).


Conclusion

Conclusion

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).


  • Login