[New legislation about clinical research involving "usual care": reminder of recent problems].
OBJECTIVE
The regulatory framework of clinical research in France was recently modified substantially, in part to transpose into French law directive 2001/20/EC of the European Parliament and Council, which concerns only drug trials. The revision also covered research on "human beings" (Public Health L. 2004-806, 2006-450), on biological samples (revision of bioethics, L. 2004-800) and on data (the so-called CNIL act, L. 2004-801). The value of this set of texts (statutes, decrees, and regulations) is that it diversifies and clarifies the different forms of clinical research.


METHODS
This article describes the painful progression of important public health studies, most often with "academic" sponsors.


RESULTS
The 5 studies described here managed to overcome a variety of obstacles posed by the pre-2004 regulations.


CONCLUSIONS
To understand the new provisions, it is useful to recall the difficulties, imprecision and inaptness of the earlier regulations.
Lemaire
François
F
Service de réanimation médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Val-de-Marne, Créteil. francois.lemaire@hmn.ap-hop-paris.fr
Schortgen
Frédérique
F
Chastre
Jean
J
Fagon
Jean-Yves
JY
Brochard
Laurent
L
Lacherade
Jean-Claude
JC
Becquemin
Jean-Pierre
JP
Brun-Buisson
Christian
C
D001675:Bioethics; D002986:Clinical Trials as Topic / Q000145:classification / Q000941:ethics / Q000331:legislation & jurisprudence*; D005602:France; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D011634:Public Health; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence