[Legislative and ethical aspects of drug experimental in children and adolescents].
Experimentation of drugs in children meets with ethical and legal difficulties. After studying historical development of drug trials regulation, the different ways to define the modalities of clinical trials (law, technical aspect, deontology, ethics) are described. The importance of the informed consent and its particularities when children are concerned are emphasized. Finally, it appears ethical and necessary to practice drug trials in children in order to obtain safe and efficient drugs and prescriptions in pediatrics.
Unité d'Evaluation et de Recherche sur les Thérapeutiques Médicamenteuses, CHS Saint-Jean-de-Dieu, Lyon, France.
B
B
Lachaux
J
J
Grison-Curinier
A
A
Lachaux
D000293:Adolescent; D000928:Antidepressive Agents / Q000627:therapeutic use; D002648:Child; D004358:Drug Therapy / Q000592:standards; D004992:Ethics, Medical; D005602:France; D006381:Helsinki Declaration / Q000266:history; D049673:History, 20th Century; D006805:Human Experimentation / Q000266:history; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007883:Legislation, Medical
D000928:Antidepressive Agents
Aspects législatifs et éthiques de l'expérimentation des médicaments chez l'enfant et l'adolescent.