Ethics of randomised clinical trials.

Up to now there are no generally accepted ethical guidelines for controlled studies. The issue is hardly discussed in the Helsinki Declaration even in its last version. The reason might be that in many of these studies it is difficult to determine whether to classify them as 'mere patient-care' or as research. If they are to be considered as mere patient-care, the doctor is under the obligation to answer for his action to the medical authorities involved, but if they are to be characterised as research experiment they have, in accordance with the Helsinki Declaration, also to be scrutinised by an independent ethical committee. The original version of this Declaration (I964)that in its essential features has been adopted in most countries, at least in Europe-addressed itself directly to the clinical investigator, who it was assumed would himself make the necessary ethical deliberations. Under these circumstances it was immaterial whether a measure was designated as patient-care or as research. With the very setting up of ethical committees and with the very introduction of scrutiny in the new version of the Declaration, the question has emerged in a partly new light. Even in its new version the Declaration is formulated as if it were directed towards individual doctors engaged in practical clinical work. Thus, the Declaration prescribes that a doctor among other things must have the right to utilise a new method if he considers that he can thereby help his patient. A medical measure of this kind need not have anything to do with research, but even in such a situation a doctor may need to be able to fall back on generally accepted principles of action. An ethical evaluation presupposes knowledge of the ethical issues involved. We doctors have to study these issues with the same interest and dedication as we use in the study of pure medical procedures. Our ambition must be to guide the evolution even in this field and not to lose the initiative to lead-as I see it-other groups with less qualification for this delicate task. To this end, the Swedish Society of Medical Sciences has established a Commission on medical ethics. The function of this Commission is to give advice and to formulate general statements concerning medical ethics when asked to do so, but also to act on its own initiative. The Commission is composed of ten members, five society members, including doctors from various specialities, one member from the State Medical Research Council and four laymen elected by various public bodies. It is primarily as chairman of this Commission that I have been confronted for the past ten years with many of the difficult ethical considerations facing medicine today. The State Research Council has in cooperation with this Commission tried to direct the control of medical research in Sweden. Ethical committees have been active since the end of the I960s at the six medical schools in the country.