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[Required procedure for nominal data files processing in biomedical research].

C Chambon-Savanovitch1, C Dubray, E Albuisson

  • 1Laboratoire Environnement et Santé Publique, Faculté de Pharmacie, B.P. 38, 63001 Clermont-Ferrand cedex. E-mail:.

Revue D'Epidemiologie Et De Sante Publique
|February 15, 2002
PubMed
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This summary is machine-generated.

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French laws govern biomedical research data. This research requires patient data protection, adhering to specific procedures and obtaining authorization from data processing committees like CCTIRS and CNIL.

Area of Science:

  • Biomedical research regulations
  • Health data privacy laws
  • French data protection legislation

Background:

  • Biomedical research in France involving nominal data must comply with specific legal frameworks.
  • Two key French laws, enacted in 1988 and 1978/1994, govern patient data in research.
  • These laws establish rules for nominal data files and individual rights.

Purpose of the Study:

  • To outline the legal obligations for conducting biomedical research with nominal data in France.
  • To describe the general and simplified procedures required for compliance.
  • To highlight the necessity of obtaining authorization from relevant committees.

Main Methods:

  • Review of French legislation pertaining to patient data in biomedical research.

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  • Description of the information and authorization procedures required.
  • Identification of relevant consultative committees (CCTIRS and CNIL).

    • Main Results:

    • Biomedical research using nominal data requires adherence to strict French data protection laws.
    • Specific procedures, including information and authorization, are mandatory.
    • Compliance involves engagement with the Comité Consultatif sur le Traitement de l'Information en Recherche Biomédicale (CCTIRS) and the Commission Nationale Informatique et Libertés (CNIL).

    Conclusions:

    • Researchers must navigate complex legal requirements for handling patient data in French biomedical studies.
    • Understanding and implementing the described procedures is crucial for legal compliance.
    • Authorization from CCTIRS and CNIL is a critical step in the research process.