RESUMO
In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities.
Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Regulamentação Governamental , Segurança Computacional/legislação & jurisprudência , França , Humanos , Prontuários Médicos/legislação & jurisprudência , Prontuários Médicos/normas , Direitos do Paciente/legislação & jurisprudênciaRESUMO
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.