Philippe Amiel

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators

Aujourd'hui, des malades atteints de pathologies graves pour lesquelles les alternatives therapeutiques sont limitees ou inexistantes reclament, non plus tant une protection contre les essais cliniques, qu'un droit d'y participer. Cette nouvelle revendication est le point de depart de la presente enquete, a la fois historique, juridique et sociologique, qui montre comment s'est formee, dans les normes et dans les pratiques, du XVIIIe au XXe siecle, la distinction entre l'animal de laboratoire et le sujet humain. Entre les cobayes et les hommes. La premiere partie de l'ouvrage decrit la formation, de part et d'autre du proces des medecins de Nuremberg, d'un consensus normatif international en reponse aux crises sanitaires, accidents et scandales qui emaillent l'histoire des essais medicaux sur l'etre humain. La seconde partie detaille la situation en France, l'emergence d'une legislation sur les recherches biomedicales, les paradoxes qui persistent dans la loi et les realites nouvelles, sociologiques et scientifiques, qu'elle doit affronter. L'ouvrage montre l'urgence d'un nouveau contrat social en matiere de recherche biomedicale, articulant respect de l'autonomie, equite d'acces et protection des personnes. Et il propose des solutions.