Lemaire François
92, rue d'Alésia, 75014 Paris, France.
Presse Med. 2019 Mar;48(3 Pt 1):238-242. doi: 10.1016/j.lpm.2019.01.006. Epub 2019 Mar 8.
The Jardé law has been voted in 2012 but was only enforced in November 2016, after the publication of its decree. Introduction of non-interventional researches in the scope of the "researches involving human beings" and random allocation of ethics committees are the main novelties of the new law. Global consent, which authorizes future researches on existing data without informing the study participant, has also been introduced. Submission of collections of biological samples and genetic studies on existing samples have been simplified. CNIL has revised the rules of data protection ("Reference Methodologies").
雅尔代法于2012年通过，但直到2016年11月其法令公布后才开始实施。将非介入性研究纳入“涉及人类的研究”范畴以及伦理委员会的随机分配是新法律的主要创新之处。还引入了全球同意，即允许在不告知研究参与者的情况下对现有数据进行未来研究。生物样本收集和对现有样本的基因研究的提交程序已得到简化。法国国家信息与自由委员会修订了数据保护规则（“参考方法”）。
