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Eur Ann Otorhinolaryngol Head Neck Dis. 2019 Apr;136(2):103-108. doi: 10.1016/j.anorl.2019.02.004. Epub 2019 Feb 23.

Regulatory aspects of prospective and retrospective clinical research in France in 2018.

Author information

1
Département de cancérologie cervico-faciale, Gustave-Roussy, 114, rue Edouard-Vaillant, 94800 Villejuif, France; GETTEC groupe d'étude des tumeurs de la tête et du cou, 94800 Villejuif, France. Electronic address: philippe.gorphe@gustaveroussy.fr.
2
Réglementaire et qualité, service de promotion des essais cliniques, direction de la recherche clinique, Gustave-Roussy, université Paris-Saclay, 94800 Villejuif, France.

Abstract

In France, the so-called "Jardé law" (named for its proposer) on human research, implemented since 2016, defines the regulatory and legal framework for "prospective" studies, formerly known as "biomedical research" or "common care". Three categories are distinguished: type 1 is at-risk drug or non-drug interventional research, type 2 is low-risk, low-burden interventional research, and type 3 is non-interventional research. The decrees of April 12, 2018 precisely define a list of research categories for types 2 and 3, thereby clarifying the regulatory procedures. The Sponsor registers the trial on the database of the National Drug Safety Agency (ANSM), or the European EudraCT database for drug studies, to obtain an identification number. Regulatory procedures are undertaken with the IRB and ANSM and then the Data Protection Commission (CNIL). Retrospective research on previously collected data (other than genetic) does not come under the Jardé law, and is governed by the 1978 data protection law, updated by the application decree of December 2016 and the law No. 2018-493 of June 20, 2018 on protection of personal data. This article presents a clarification of the key methodologic and regulatory steps.

KEYWORDS:

Clinical research; Prospective research; Retrospective research; “Jardé law”

PMID:
30803860
DOI:
10.1016/j.anorl.2019.02.004
[Indexed for MEDLINE]

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