THE ETHICS OF CLINICAL-TRIALS - THE DILEMMA OF INFORMED CONSENT

The usual randomized clinical trials are now confronted by evolving legal, ethical and sociocultural factors, accelerated by the AIDS epidemic. In every case in which a new product is tested in a disease for which no therapy is clearly effective, the informed consent of the patient is required. This consent, however, does not conform to the wishes of the patient to choose his/her own treatment. It is becoming clear that physicians and statisticians must both take into consideration the wishes of the patient and safeguard the crucial distinction between research and current therapy. In France, the Huriet Law proposes for the first time, a legal framework for clinical trials, introducing the concept of specialized and authorised teams working under the supervision of local ethical committees. It is evident that economic considerations will influence the applications of this law.