title: [Biomedical research in France: what has changed since 2004].
abstract: The public health law passed in 2004 is the implementation into French law of the European Clinical Trial directive 2001/20/EC on the implementation of good clinical practice in conducting clinical trials on medicinal products for human use. This law goes further than the European directive since it reconsiders all the components related to all fields of biomedical research. It has (i) standardized communication with the authorities (French Drug Agency/French Health Authority and the Ethics Committee); (ii) reinforced protection to participants in clinical trials and modified the information delivered to participants and how their informed consent is obtained; (iii) added risk-benefit assessment; and (iv) increased transparency for the public.
authors.affiliation: Clirophtha, La Gaude, France.
authors.forename: N
authors.initials: N
authors.lastname: Clerget-Chossat
authors.forename: T
authors.initials: T
authors.lastname: Caillaud
authors.forename: P-P
authors.initials: PP
authors.lastname: Elena
mesh_terms: D035843:Biomedical Research / Q000266:history / Q000639:trends*; D004992:Ethics, Medical; D005602:France; D049674:History, 21st Century; D006801:Humans; D011634:Public Health / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends