[Ethical and legal problems of medical responsibility in drug trials (author's transl)]

Trials of new drugs are not without risk. Standards have been laid down ensuring the objectivity and quality of the scientific studies of investigators involved in the clinical trial. Article 19 of the French Medical Code of Ethics and the recommendations on medical ethics formulated by the World Medical Association (Helsinki, 1964; and Tokyo, 1975) are designed to ensure that clinical trials on human subjects are of benefit to the subjects themselves, that the interests of the individual are placed before those of society, and, finally, that the trials are conducted with the informed consent of the subjects. In the case of injury sustained by a subject as a result of a clinical trial, the question arises as to the legal liability of the investigator. Possible grounds for malpractice include absence of licitness of the trial, lack of informed consent and negligence or irresponsibility in the conduct of the trial. In certain cases it is difficult to determine the licitness of a clinical trial; exceptions to the rule of informed consent may appear necessary; and it is sometimes difficult to ensure adequate control and evaluation of potential risks of a trial. Hence the need to submit such cases to an ethical committee, provided its members are so chosen as to guarantee the technical and legal competence of its pronouncements.