[Drug evaluation in healthy volunteers. Legislative and ethical aspects].
Studies in healthy volunteers have been legalized since December 20th 1988 in France. The healthy volunteer is employed for a variety of studies in phases I and IV of drug development. This type of research can equally be called nontherapeutic in nature. Every experiment involving healthy volunteers should be approved by the Ethics Committee. Using volunteers within the department, company or other organisation, while offering advantages for the investigator should be prohibited as freedom of concept might not be safeguarded. As well, financial incentives may over-persuade individuals, including students, who have low incomes and promote the "professional volunteer". To avoid this problem, French law planned a national register. The potential benefits of such a disposition are still unknown. Having been given appropriate information concerning the drug trial, his obligations and rights, the healthy volunteer gives his written consent. Specific recommendations for nontherapeutic assessments of drug effects are given concerning prisoners, the mentally handicapped, women with a risk of frequency, children. Ethical considerations concerning research on a healthy population must go beyond the law recently promulgated in France.
Warot
D
D
Service de Pharmacologie Clinique, Hôpital la Pitié-Salpêtrière, Paris.
D004341:Drug Evaluation; D004992:Ethics, Medical; D005602:France; D006801:Humans; D007883:Legislation, Medical; D011619:Psychotropic Drugs
D011619:Psychotropic Drugs
Les essais de médicaments chez le volontaire sain. Quelques aspects législatifs et éthiques.