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Protection des personnes et droit à l’essai dans la recherche biomédicale en France. Étude jurisociologique
Thèses et HDR   Open Access

Protection des personnes et droit à l’essai dans la recherche biomédicale en France. Étude jurisociologique

Philippe Amiel
Doctoral, Université de Montpellier
12/09/2008

Résumé

Biomedical research Jurisociology Private Law Droit privé Recherches biomédicales Jurisociologie
This doctoral thesis is about the legal response to patients claim that they should be recog- nized a personal right to participate in clinical trials, not being dependent upon prior investigator invitation. The first part (“An Inconceivable Right”) investigates the international internormative genesis—from the doctors trial in Nuremberg (1946-1947)—of the legal framework of biomedical research. This framework appears to be structured by the idea of protecting potential victims against possible torturers abuses. A personal right to participate is hardly conceivable in this framework as is the claim to serve as guinea pig. The second part (“An Essential Right: the French Case”) investigates the legal framework in France and the reality of research practices. Legal analysis reveals that the French law on biomedical research (“Huriet Law”, 20 Oct. 1998 revised) has to be put in line with the “Kouchner Law” of 2002 (March 4) on patient’s rights : the first preserves paternalistic paradoxical provisions; the latter is anti-paternalist and pro- motes patient’s autonomy.In practice, as shown by empirical sociological studies—a part specially conducted for the purpose— eligible subjects are not systematically invited to participate in trials. Autonomy of potential subjects is not respected (they are deprived of their right to decide) nor is justice. In conclusion En conclusion, the insert- ing of a new article in the Public Health Code is proposed and a wording is suggested.This study aims at being a prototype for pragmatic jusrisociological studies by which sociological inquiry would be fully integrated to legal reasoning.

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