[Ethical problems posed by protocols of studies of anti-arrhythmia agents]

Clinical trials of new drugs cannot be considered to be free of risk. Guide lines have been laid down to guarantee the objectivity and quality of the scientific study carried out by the clinical experts charged with the trial. The French Medical Code of Ethics and the recommendations on medical ethics of the World Health Association (Helsinki 1964; Tokyo 1975) aim to guarantee that all therapeutic clinical trials are useful in themselves, that the interests of the individual patient pass before those of society, and, finally, that all trials are carried out with the free and informed consent of patients. Sometimes the licitness of a therapeutic trial may be unclear, exceptions to the rule of informed consent may be necessary, and the nature of surveillance during the testing of potential risks may be difficult to determine. In these cases it is of the utmost value that the proposed trial be submitted to an ethical committee provided that its composition guarantees the competence of its opinions from the technical, ethical and judicial points of view.