Vanseymortier Marie, Thery Julien, Penel Nicolas
Centre Oscar-Lambret, direction de la recherche clinique et de l'innovation, 3, rue Combemale, 59020 Lille, France.
Centre Oscar-Lambret, direction de la recherche clinique et de l'innovation, 3, rue Combemale, 59020 Lille, France; Université Lille-Nord de France, faculté de médecine, place de Verdun, 59000 Lille, France.
Bull Cancer. 2019 Apr;106(4):389-394. doi: 10.1016/j.bulcan.2019.01.016. Epub 2019 Mar 15.
The regulatory framework of clinical research is necessary to ensure the protection of participants and to define the actors and their responsibilities. Although main principles have been set up in 1947 with the Nuremberg Code, this regulatory framework is relatively recent in Europe: development of national regulations in the years 1980-1990, first European Directive regarding clinical trials in 2001. In France, as 2006 was marked by the implementation of this first "Clinical trials Directive", the end of the year 2016 and the following months were marked by the enforcement of the Jardé law (previously modified in order to reinforce the regulatory requirements following the death of an healthy volunteer in a clinical trial). As clinical researches involve processing of personal data, the entry into force, on 25 May 2018, of the General Data Protection Regulation (GDPR) had also consequences on their implementation. Finally, regarding clinical trials on drugs, the "Clinical trials Regulation" repealing the Directive, voted in 2014, should come into force in the coming months.
临床研究的监管框架对于确保参与者的保护以及明确相关行为主体及其责任是必要的。尽管1947年制定了《纽伦堡法典》确立了主要原则，但该监管框架在欧洲相对较新：20世纪80至90年代各国法规得以发展，2001年出台了首部关于临床试验的欧洲指令。在法国，2006年以首部“临床试验指令”的实施为标志，而2016年底及随后几个月则以雅尔代法的实施为标志（此前该法已修订，以强化在一项临床试验中一名健康志愿者死亡后提出的监管要求）。由于临床研究涉及个人数据的处理，2018年5月25日生效的《通用数据保护条例》（GDPR）也对其实施产生了影响。最后，关于药物临床试验，2014年投票通过的废除该指令的“临床试验条例”应在未来几个月生效。
