Controlled clinical trials in drug research: permission versus notification.
1. Controlled clinical trials by competent investigators in appropriate clinics or scientific institutions should be allowed upon notification of the health authority. 2. The notification should include the pharmacological and toxicological data, the name of the principal investigator and the institution he or she is working for. 3. In countries where there are no specific statutory provisions concerning clinical trials, the protocol should be approved by an ethics committee. In the case of a multicentre study, the approval of one committee should be sufficient. 4. Local law should provide the authorities with the power to stop or curtail the study if it appears to become dangerous.
D002986:Clinical Trials as Topic / Q000592:standards*; D004341:Drug Evaluation / Q000592:standards*; D028744:Ethics Committees, Research; D005060:Europe; D033161:Government Regulation; D006805:Human Experimentation; D038622:Internationality; D012926:Social Control, Formal; D014481:United States