Quel cadre réglementaire en France pour réaliser une recherche qualitative ?

Qualitative methods, in the field of medicine, are concerned with what subjects say about what they are experiencing. These methods seek to describe, understand and explore an observed phenomenon and to capture a person’s lived experience. The French regulatory framework for research: The so-called Jardé law published in 2012 has been discussed for more than 5 years. Since the Health Modernization Law of 2016, the French regulatory framework is in line with the European Medicines Regulation of 2014. Two categories of research co-exist: those involving the Human Person (RIPH) examined by a ethic committee, and as opposed to “non-RIPH” research examined by the HDH/CESREES/CNIL. RIPHs are type 1 (interventional), or 2 (weakly interventional), or 3 (non-interventional). All research must also comply with the Data Protection Regulations (GDPR). Regulatory Framework for Qualitative Health Research: Comprising essentially interviews with the protagonists of the experience or phenomenon being studied, they are closer to an observation than to a weak intervention, they are rather part of the RIPH 3 framework with MR003. Careful attention must be taken when writing patient information notices. DOI : 10.4267/2042/70739 R ec h er ch e q u al it at iv e