[Required procedure for nominal data files processing in biomedical research].
To date, biomedical research using nominal data files for the data collection, data acquisition or data processing has had to comply with 2 French laws (Law of December, 20, 1988, modified, relating to the protection of patients participating in biomedical research, and the Law of January, 6, 1978, completed by the Law of July 1, 1994 n degrees 94-548, chapter V bis). This later law dictates rules not only for the establishment of nominal data files, but also confer individual rights to filed persons. These regulations concern epidemiological research, clinical trials, drug watch studies and economic health research. In this note, we describe the obligations and specific general and simplified procedure required for conducting biomedical research. Included in the requirements are an information and authorization procedure with the local and national consultative committees on data processing in biomedical research (CCTIRS, Comité Consultatif sur le Traitement de l'Information en Recherche Biomédicale, and CNIL, Commission Nationale Informatique et Libertés).
Chambon-Savanovitch
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Laboratoire Environnement et Santé Publique, Faculté de Pharmacie, B.P. 38, 63001 Clermont-Ferrand cedex. E-mail:.
Dubray
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Albuisson
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Sauvant
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MP
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003625:Data Collection; D005602:France; D006801:Humans; D008499:Medical Records / Q000331:legislation & jurisprudence*; D012106:Research / Q000331:legislation & jurisprudence*