[The Jardé law, a real simplification of research in France?]

The Jardé law was voted in 2012 and its implementing decrees were published in November 2016. The delay between the vote and the decrees highlights the difficulties encountered. This law concerns all research, interventional and otherwise, involving the human person. Each research study must receive the approval of a randomly assigned ethics committee or Committee for the Protection of Persons. The approach here is based on risk in three types of study: interventional studies, studies with minimal risk and intervention, and non-interventional studies (observational studies). The main changes are: simplified informed consent for pediatric studies and possible enrolment for people not affiliated with a social health care system in non-interventional research. The law provides clarification for changes in the purpose of biological collections. For vigilance, the notions of "new facts" and "urgent security measures" have emerged. Although this law appears to be an advancement, some concerns still need to be clarified. The main problem arises from the foreseeable extension of the delay to implement research. Medical research is a competition where time is valuable. Colleagues working on cosmetics research have already anticipated these difficulties. On February 8, 2017, the decrees of the Jardé law were suspended for cosmetics studies. Will the Jardé law be suspended for all French clinical research?