New French Human Experimentation Act

Abstract

Dealing with the question whether or under which conditions non-therapeutical research on human beings should be permitted, the article follows one of the main features of French bioethics discussions in the last years. After a long period of hesitation and preliminary reports of the Comité Consultatif National d'Ethique pour le Sciences de la vie et de la santé (CCNE), the Council of State of the French Parliament finally engaged in legislative action on this issue. For the first time it recognized the legitimacy of non-therapeutical research and stated the conditions under which it should be conducted. The recent development of French public discussion on human experimentation is analysed in consideration of its social and historical context. Thus, there is given insight into a graduai change of traditional medicai ethics in France. The new legislation reflects an increasing emphasis on self-determination of the person, due to the stimulation of public debates by CCNE, which gradually is replacing the traditional attitude of paternalism and secrecy in French medical practice. One of the major innovations is the enforccment of reviewing procedures. The research protocols have to be reviewed by "comités consultatifs de protection des personnes dans la recherche biomedicale", but stili no firm predictions can be made as to whether these review boards will really serve as a democratic control.