[French regulation of medical research].

Authors :: Michaud M
Michaud Peyrot C
Source :: La Revue de medecine interne [Rev Med Interne] 2020 Feb; Vol. 41 (2), pp. 98-105. Date of Electronic Publication: 2019 Dec 31.
Publication Year :: 2020
Abstract: In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities.<br /> (Copyright © 2019 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier Masson SAS. All rights reserved.)