French legal approach to clinical research

Abstract : Since 1988, France has been committed to drafting laws regulating clinical research. These laws must both reflect general legal standards relating to personal data protection and patient information and comply with EU regulations, which are supra-national norms. The 2012 legislation known as "Jardé law" came into force in 2016 and distinguishes between 3 different types of research involving human subjects: category 1:interventional research implying an intervention on the patient which is not justified by their usual treatment. Category 2: interventional research, which does not focus on medicinal products and only entails minimal risks and constraints. Category 3: non-interventional research implying one or multiple acts or proceedings devoid of listed risks. These studies require preliminary favourable opinions from the French Ethical Research Committees (CPP), who are appointed by the State, and must ensure the protection of personal data. For the other types of studies (retrospective data, practice surveys), French legislation only requires that the protection of personal data is ensured. However, it is highly recommended to submit these studies to an Institutional Review Board (IRB) in order to confirm that human subjects are not involved and to obtain an ethical opinion in the event of a scientific journal submission. These laws are constantly evolving in order to comply with the various international recommendations and European regulations, which are binding in France.
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https://hal.archives-ouvertes.fr/hal-02353979
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Submitted on : Thursday, November 7, 2019 - 3:22:41 PM
Last modification on : Friday, November 8, 2019 - 1:26:22 AM

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Elisabeth Toulouse, Christophe Masseguin, Brigitte Lafont, Gordon Mcgurk, Anna Harbonn, et al.. French legal approach to clinical research. Anaesthesia Critical Care & Pain Medicine, Elsevier Masson, 2018, 37 (6), pp.607-614. ⟨10.1016/j.accpm.2018.10.013⟩. ⟨hal-02353979⟩

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