[Evaluation of decision-making by CCPPRBs].
OBJECTIVE
The aim of this study was to analyse the way in which 19 committees for the protection of people participating in biomedical research (CCPPRBs) develop their opinions and to determine whether the legitimacy of the decisions taken is based on detailed discussion by the various members of the committee.


METHODS
An independent evaluator visited 19 CCPPRBs and attended two sessions at each centre. He investigated the functioning of the CCPPRBs both theoretically and in practice during the sessions, using a standardised data collection grid.


RESULTS
The ethics of discussion are difficult to implement in these committees for four reasons: (i) a lack of training of the members; (ii) comments during sessions are rare (15% of all comments); (iii) too many dossiers are dealt with per session, resulting in some dossiers not being discussed in session; and (iv) there are too few nonscientific members, with the scientific members and the president playing a predominant role in the debates.
Fauriel
Isabelle
I
Laboratoire d'Ethique Médicale, de Droit de la Santé et de Santé Publique, Faculté de Médecine Necker, Paris, France.
Moutel
Grégoire
G
Duchange
Nathalie
N
François
Irène
I
Hervé
Christian
C
D035843:Biomedical Research / Q000592:standards*; D003657:Decision Making; D005602:France; D006801:Humans