[The Committee for the Protection of Human Subjects in biomedical research, crossroads of misunderstandings]

Abstract

The conditions for carrying out clinical experiments involved numerous and serious breaches of Hippocratic morality and of the rights of people subjected to research situations. The World Medical Association has recommended the prior intervention of an independent committee "for advice and guidance" to the medical researcher. This recommendation has been taken into consideration by the competent authorities of industrially developed countries, which have incorporated structures of this type into their legislation, each having their own dispositions in this domain. In this regard, European regulations leave each member state free of their organisation. Since 1988, French legislation has set up specialised committees, whose missions have changed over time. However, the interpretations that are made by most medical researchers of the nature and roles of this institution are characterised by significant misconceptions, misunderstandings and errors in view of what arises from a legal analysis. In contrast with that the name of "ethics committee" suggests, the Committees for the Protection of Participants (CPP) do not have to comment on the ethics of the trials, but must ascertain that the sponsors and investigators organise their research protocol in compliance with the law, both with regard to the rights of the participants and the obligations incumbent on them. While it is possible for the CPPs to give an opinion on the relevance of the research, this opinion does not make them either expert committees or scientific committees. The aim of this work is to re-establish an interpretation of the role of Committees for the Protection of human subjects that conforms to the law.

Keywords: Comité de protection des personnes; Droit; Ethics; Institutional review board; Law; Éthique.