La protection de la personne dans la recherche biomédicale
Institution:
Rennes 1Disciplines:
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Abstract EN:
Experimentation on man to improve the health of individuals is not the only issue for research workers. Other interests can put into question the safety of the subjects and lead to abuses. Legislators passed the amended law no 88-1138 of the 30 december 1988 concerning the protection of persons taking part in biomedical research. Thus, there is a need to evaluate the real safety measures for subjects undergoing research experimantation. This evaluation is carried out during the setting up of the experimentation (part i). This means that there are legal procedures to be carried out between the partners concerning the research protocol. The partners must respect the legislative provisions which are to be directly integrated into the contracts that are made. By defining their respective obligations the partners include other practical measures aimed at avoiding any accident which could involve their responsibility. The experimentation contract must also take into account this safety requirement. The protection of volunteers is studied during the execution of the experimentation (part ii). Consultative committees for the protection of persons in biomedical research, administrative controls and a national record for individuals taking part in trials without any personal gain have been set up with the aim of encouraging the partners to increase their vigilance. As well, in the hypothesis of non respect of the "huriet-serusclat" law, the penal and civil responsabilities of the research workers come into play. In the case of damages the promotors of the research are required to compensate the subjects for the trial risks.
Abstract FR:
L'experimentation sur l'homme destinee a ameliorer la sante des individus ne constitue pas l'unique enjeu des chercheurs. D'autres interets peuvent remettre en cause la securite des sujets en generant des abus. Le legislateur a alors institue la loi no 88-1138 du 20 decembre 1988 modifiee relative a la protection des personnes se pretant a des recherches biomedicales. Aussi, convient-il de mesurer la securite effective accordee aux sujets d'experiences. Cette evaluation se fait au regard de la mise en place de l'experimentation (partie i). Ainsi, autour d'un protocole de recherche, plusieurs relations juridiques se nouent entre les partenaires de l'essai. Ces derniers doivent respecter les dispositions legislatives qu'ils integrent directement dans les contrats qu'ils concluent. En definissant leurs obligations respectives, ils inserent d'autres mesures pratiques destinees a eviter tout accident susceptible d'engager leur responsabilite. Le contrat d'experimentation doit aussi tenir compte de cet imperatif de securite. La protection des volontaires est etudiee lors de la mise en oeuvre de l'experimentation (partie ii). Des comites consultatifs de protection des personnes dans la recherche biomedicale, des controles administratifs et un fichier national pour les individus se pretant a des essais sans benefice individuel direct ont ete institues dans l'objectif d'inciter les partenaires des essais a redoubler de vigilance. De meme, dans l'hypothese du non respect de la loi "huriet-serusclat", les responsabilites penale et civile des chercheurs sont susceptibles d'etre engagees. En cas de dommage, les promoteurs sont tenus d'indemniser les sujets des risques de l'essai.