[French version of The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, in a French law context].
Fiche publication
Date publication
mai 2023
Journal
Revue d'epidemiologie et de sante publique
Auteurs
Membres identifiés du Cancéropôle Est :
Dr FOURNEL Isabelle, Dr OMOROU Abdou Yacoubou
Tous les auteurs :
Bourmaud A, Fianu A, Kervan C, Verga-Gérard A, Fournel I, Dumas A, Mancini J, Alla F, Omorou A, Giraudeau B
Lien Pubmed
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".
Mots clés
Cluster randomized trial, Ethics, Informed Consent, consentement libre et éclairé, essais randomisés en clusters, Éthique
Référence
Rev Epidemiol Sante Publique. 2023 05 9;71(4):101847