French version of The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, in a French law context

Introduction. - 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 detai-led 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.Method. - . 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. Results. - . 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 pro-tect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommenda-tions are explained and detailed through concrete examples.Conclusion. - Without interfering with current French laws, this work provides a framework for the organiza-tion, 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.(c) 2023 The Author(s). Published by Elsevier Masson SAS. This is an open access article under the CC BY-NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Automated summary

This article discusses the ethical challenges posed by cluster randomized trials and highlights the lack of specific legal regulations, which poses difficulties for researchers. It aims to provide French professionals involved in health research with a contextualized and illustrated French translation of the Ottawa Statement. The article presents 15 recommendations specific to cluster trials and offers concrete examples to support their explanation and implementation.