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

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 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". 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 protect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommendations are explained and detailed through concrete examples. CONCLUSION: 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.

[Primary care: A definition of the field to develop research]. / Les soins primaires : une définition du champ pour développer la recherche.

BACKGROUND: Research in the field of primary care has dramatically increased in France in recent years, especially since 2013 with the introduction of primary care as a thematic priority for research proposals launched by the Ministry of Health (Direction générale de l'offre de soins). MATERIAL AND METHODS: The RECaP (Research in Clinical Epidemiology and Public Health) network is a French research network supported by Inserm, which recently implemented a specific working group focusing on research in primary care, based on a multidisciplinary approach. Researchers from different specialties participate in this group. The first aim of the group was to reach a common definition of the perimeter and of the panel of healthcare professionals and structures potentially involved in the field of primary care. For this purpose, a selection of different data sets of sources defining primary care was analyzed by the group, each participant collecting a set of sources, from which a synthesis was made and discussed. RESULTS: A definition of primary care at different levels (international, European and French) was summarized. A special attention was given to the French context in order to adapt the perimeter to the characteristics of the French healthcare system, notably by illustrating the different key elements of the definition with the inclusion of primary care actors and the type of practice premises. CONCLUSION: In conclusion, this work illustrates the diversity of primary care in France and the potential offered for research purposes.