Se connecter
Rechercher

Version française des recommandations de la déclaration d'Ottawa sur la conception et la conduite éthique d'essais randomisés en clusters, dans le contexte législatif français.

Auteurs : Bourmaud A1, Fianu A2, Kervan C3, Verga-Gérard A4, Fournel I5, Dumas A6, Mancini J7, Alla F8, Omorou A9, Giraudeau B10
Affiliations : 1Unité d'épidémiologie clinique, CIC-EC 1426, Hôpital Universitaire Robert Debré, AP-HP, Paris et Université Paris-Cité, Paris, France.2Inserm CIC1410, CHU Réunion, Saint-Pierre, France/CERPOP, Université de Toulouse, Inserm, UPS, Toulouse, France.3Equipe MeRISP, Inserm UMR U1219, Bordeaux Population Health Research Center (BPH), Université de Bordeaux, Bordeaux, France.
Voir plus >>
Date 2023 Août 09, Vol 71, Num 4, pp 101847Revue : Revue d'épidémiologie et de santé publiqueType de publication : résumé en anglais; article de périodique; DOI : 10.1016/j.respe.2023.101847
Résumé

There is growing evidence on the ethical challenges raised by cluster randomized trials. This specificity is not reflected in the legal texts regulating research, which creates difficulties for researchers implementing these experimental designs. The Ottawa Statement (Weijer et al. 2012) aims to provide detailed guidance on the ethical design, conduct and assessment of cluster trials. More broadly aims to help research stakeholders and decision-makers to make informed ethical decisions regarding the particularity of these experimental designs. It seems that this international statement, written in English, is not sufficiently accessible to all of the French professionals involved in health research. The aim of this article is to provide these professionals with a contextualized and illustrated French translation of the "Ottawa statement".. The "complex design" working group of the RECaP network (Research in Clinical Epidemiology and Public Health), carried out this work. A first version was discussed by the authors in several meetings. It was completed by contextual explanations and examples of French studies currently conducted by the authors. The final version was obtained by consensus and validated by the group.. This work reports 15 recommendations grouped into 7 key questions: How to justify cluster design? How to submit an article to an ethics committee? How to identify research participants? How and when to obtain informed consent? Who are the gatekeepers? How to assess benefits and harm? How to protect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommendations are explained and detailed through concrete examples.Without interfering with current French laws, this work provides a framework for the organization, conduct and ethical assessment of cluster randomized trials in France. In the present-day context, it is essential that all concerned groups can base their decisions on recommendations in line with the elementary principles of health research ethics.

Mot-clés auteurs
cluster randomized trial; ethics; informed consent; consentement libre et éclairé; essais randomisés en clusters; éthique;
 Source : MEDLINE©/Pubmed© U.S National Library of Medicine
Accès à l'article
  Accès à distance aux ressources électroniques :
Exporter
Citer cet article
Bourmaud A, Fianu A, Kervan C, Verga-Gérard A, Fournel I, Dumas A, Mancini J, Alla F, Omorou A, Giraudeau B. Version française des recommandations de la déclaration d'Ottawa sur la conception et la conduite éthique d'essais randomisés en clusters, dans le contexte législatif français. Rev Epidemiol Sante Publique. 2023 Août 09;71(4):101847.
Courriel(Nous ne répondons pas aux questions de santé personnelles).
Dernière date de mise à jour : 22/07/2023.


[Haut de page]

© CHU de Rouen. Toute utilisation partielle ou totale de ce document doit mentionner la source.