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Clinical trials in France:
new rules for the protection of subjects

The ethical issues related to clinical trials are not just confined to participants’ informed consent.

The French law concerning clinical trials was revised in 2004, following an EU Directive. Among the changes made is a revision of the notion of mandatory informed consent of participants, to allow research, in urgent cases, on minors and those who are "incapable" of giving informed consent. A database of trials must be set up, which should be accessible to patients’ associations and healthcare users. Biomedical research will henceforth be subject to prior authorisation from the public authorities and Committees for the Protection of Persons.

With competition between countries to attract investment from the pharmaceuticals industry intensifying, the government and the Committees for the Protection of Persons must be strict with regard to the quality of the research projects submitted to them. The ethical dimension of a trial is not confined to guaranteeing participants’ informed consent. It also includes the scientific relevance of the trial and the transparency of its results.

It is regrettable that French members of parliament did not seize all the opportunities offered by the EU Directive to give Committees for the Protection of Persons a scientific function. But these Committees retain appreciable room for manoeuvre, which they should make full use of, in the interest of protecting the public.

©Prescrire December 2005

Source: "Essais cliniques : de nouvelles règles pour la protection des personnes" Rev Prescrire 2005 ; 25 (267) : 858-863.

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