[Research ethics: French regulations and applications in radiation oncology].

Éthique de la recherche : réglementations françaises et applications en oncologie radiothérapie.
Comité de protection des personnes Committee for Protection of Persons Ethics Human beings Oncologie radiothérapie Personne humaine Radiation oncology Recherche Research Éthique

Journal

Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique
ISSN: 1769-6658
Titre abrégé: Cancer Radiother
Pays: France
ID NLM: 9711272

Informations de publication

Date de publication:
Jul 2020
Historique:
received: 29 11 2019
revised: 31 01 2020
accepted: 24 02 2020
pubmed: 6 6 2020
medline: 26 6 2020
entrez: 6 6 2020
Statut: ppublish

Résumé

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients' information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.

Identifiants

pubmed: 32499188
pii: S1278-3218(20)30121-9
doi: 10.1016/j.canrad.2020.02.012
pii:
doi:

Types de publication

Journal Article

Langues

fre

Sous-ensembles de citation

IM

Pagination

306-315

Informations de copyright

Copyright © 2020 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.

Auteurs

T Haaser (T)

Service d'oncologie radiothérapie, hôpital Haut-Lévêque, centre hospitalier universitaire de Bordeaux, avenue Magellan, 33600 Pessac, France; EA 4574 « Sciences, philosophie, humanités », université de Bordeaux-université Bordeaux-Montaigne, domaine universitaire, 33607 Pessac, France; Service de pharmacologie médicale, comité de protection des personnes Sud-Ouest et outre-mer III, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, 33076 Bordeaux, France. Electronic address: thibaud.haaser@chu-bordeaux.fr.

D Berdaï (D)

Service de pharmacologie médicale, comité de protection des personnes Sud-Ouest et outre-mer III, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, 33076 Bordeaux, France; Faculté de pharmacie, université de Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France.

R Trouette (R)

Service d'oncologie radiothérapie, hôpital Haut-Lévêque, centre hospitalier universitaire de Bordeaux, avenue Magellan, 33600 Pessac, France.

C Dupin (C)

Service d'oncologie radiothérapie, hôpital Haut-Lévêque, centre hospitalier universitaire de Bordeaux, avenue Magellan, 33600 Pessac, France.

S Marty (S)

Centre de coordination de cancérologie, hôpital Saint-André, centre hospitalier universitaire de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Unité de recherche en soins et en sciences humaines, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, 33076 Bordeaux, France.

B L'Azou (B)

Faculté de pharmacie, université de Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France.

V Berger (V)

Unité de recherche en soins et en sciences humaines, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, 33076 Bordeaux, France.

M-C Saux (MC)

Service de pharmacologie médicale, comité de protection des personnes Sud-Ouest et outre-mer III, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, 33076 Bordeaux, France; Faculté de pharmacie, université de Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France.

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Classifications MeSH