{"id":1911,"date":"2017-11-06T11:05:55","date_gmt":"2017-11-06T10:05:55","guid":{"rendered":"http:\/\/www.universalmedica.com\/biomedical-research-reform-the-jarde-law\/"},"modified":"2021-06-25T12:43:18","modified_gmt":"2021-06-25T10:43:18","slug":"biomedical-research-reform-the-jarde-law","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/en\/biomedical-research-reform-the-jarde-law\/","title":{"rendered":"Biomedical research reform: the Jard\u00e9 law"},"content":{"rendered":"

The Jard\u00e9 law<\/a>, voted in March 2012, aims at giving a legal and statutory framework to clinical trials which involve people. Universal Medica summarizes for you the main points of the decree number 2017-884 of May 9th, 2017<\/a> which modifies certain arrangements.<\/p>\n

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Creation of 3 new categories<\/h2>\n

With the Jard\u00e9 law, the “Biomedical Research (called in French RBM)” changed of name to be now called “Research Implying Human Person (called in French RIPH)”. The RIPH is divided into 3 categories according to the intervention level of each person:<\/p>\n

CATEGORY 1: interventional researches which contain an unjustified intervention on a person by its usual coverage.<\/p>\n

CATEGORY 2: interventional researches at minimal risks which contain only minimal risks and constraints (list fixed by the Minister for Health and after notice of the ANSM director – ANSM stands for National Security Agency of Medicines and Health Products or in french l\u2019Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9). This category was formerly called “common care researches”.<\/p>\n

CATEGORY 3: non-interventional researches in which all acts are practiced and all products are used in a usual way, without additional or unusual procedure of diagnosis, treatment or supervision.<\/p>\n

The retrospective non-interventional research (concerning medical files, and not the people) does not enter the Jard\u00e9 law.<\/p>\n

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Statutory steps<\/h2>\n

1\/. Institutional review board (IRB)<\/h3>\n

All researches are presented to a IRB with random designation by drawing lots. The IRB becomes the only ethical authority for all RIPH with a request of compulsory favorable opinion for the 3 categories of researches.<\/p>\n

2\/. ANSM – National Security Agency of Medicines and Health Products<\/h3>\n

All RIPH are broadcasted in a public directory: n\u00b0 ID-RCB (presented to the ANSM). The ANSM authorization request is compulsory only for category 1 researches. For category 2 and 3 researches, it is necessary to send to the ASNM a copy of the favorable opinion of the IRB and the summary of the research.<\/p>\n

3\/. The Chair of the French data protection authority (CNIL – Commission Nationale de l\u2019Informatique et des Libert\u00e9s)<\/h3>\n

With the implementation of reference methodologies, declaration procedures to the CNIL are simplified in the realization of a conformity commitment with:<\/p>\n