Volume 64, Numéro 4, Juillet-Août 2009
|Page(s)||259 - 267|
|Section||Affaires réglementaires/Regulatory System|
|Publié en ligne||7 octobre 2009|
Collections of Human Biological Samples for Scientific Purposes. Why do Current Regulation Need to be Clarified and How?
Département de Pharmacologie médicale, Faculté de Médecine, Lille, France
2 Division Scientifique et Médicale, Pfizer France, Paris, France
3 Agence Française de Sécurité Sanitaire des Produits de Santé, Paris, France
4 Ministère de l'Enseignement Supérieur et de la Recherche, Paris, France
Accepted: 20 November 2008
The collection of human biological samples is of major importance for future research in France and Europe. In recent years, new regulatory procedures have been designed to monitor these activities; but they are somewhat complex and some clarifications are needed. The law needs also to be amended. The definition of biobanking activities should be clarified, and regulatory procedures, including consultation of the Ethics Committee, declarations to the Ministry of Research and the protection of personal data, should be simplified. It is also of great importance to correctly define the modalities in which Biobanks are granted their authorisations. The role of Ethics Committees regarding the evaluation of information and the consent procedures should also be clarified, particularly when samples from children are used, or when the samples are used for genetic analyses. As well as scientific and public health aspects, the storage of human biological samples may also have important economic consequences. It is hence crucial to adapt the procedure for submitting patents, particularly when several public or private partners are working together. The possible changes to both French and European laws planned in the next months would be an ideal time to introduce these changes.
Key words: collection of biological samples / biobanks / regulation / biomedical research
© Société Française de Pharmacologie et de Thérapeutique, 2009