title: Consent to medical research of vulnerable subjects from the French point of view: the example of consent in research in the case of Alzheimer disease.
abstract: The consent to research is the expression of autonomy. Some groups are vulnerable and cannot give free consent because their conditions limit their decision making or because they are unable to consent themselves (minor, incompetent adults). International standards and recommendations for medical research protect vulnerable subjects (article 17 of the Helsinki declaration, guidelines 9 and 13 of the CIOMS, article 17 of the Oviedo Convention). French Law protects mostly three categories of vulnerable people: minors, adults with a legal representative, and the people living in sanitary and social establishments. Specific protection is given as well to pregnant women, detainees and persons with psychiatric disorders in involuntary commitment. From the example of research with Alzheimer patients the authors show the original provisions of French legislation to involve in medical research incompetent patients with or without legal protection. Clinical research on Alzheimer's disease poses challenges as never before to research ethics. In fact, the development of the disease progressively reduces the patient's ability to make choices: the latter is no longer capable, but is not totally incapacitated. Several solutions are offered for a "proxy" consent or authorisation.
authors.affiliation: Inserm, Unité 1027 Toulouse, France.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Duguet
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Boyer-Beviere
mesh_terms: D000328:Adult; D000544:Alzheimer Disease; D005602:France; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006806:Human Rights / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D026684:Personal Autonomy; D035862:Vulnerable Populations