New French Decree Clarifies The Scope Of Biomedical Research

Author:Ms Maureen Bennett, Christian Fulda, Colleen Heisey, Elizabeth A. Robertson, Cristiana Spontoni, Armelle Sandrin-Deforge, Indradeep Bhattacharya, Michele R. Goodman, Marina E. Moreno, Elinor Pecsteen and Tamara Senikidze
Profession:Jones Day

French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research involving human subjects" (recherches impliquant la personne humaine or "RIPH"). The new decree defines the scope of RIPH as investigations organized and carried out on willing participants, in the context of developing biological or medical knowledge.

More specifically, RIPH may include investigations regarding: (i) functioning mechanisms of a human organism (whether normal or pathological); or (ii) the efficiency and safety of actions undertaken, or the use of products for the purposes of diagnostic, treatment, or prevention of a pathological state. Investigations regarding cosmetic products, even if carried out on normal or pathological human subjects, do not qualify as RIPH as long as the purpose of such research is to test the product's capability to clean, perfume, change the appearance of human bodies, correct body odors, and/or protect human bodies.

Additionally, research that includes only a satisfaction survey regarding cosmetic or food products, any other type of satisfaction survey among patients, or experimentations...

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