TY - JOUR T1 - Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception JF - Journal of Medical Ethics JO - J Med Ethics SP - e16 LP - e16 DO - 10.1136/jme.2007.023473 VL - 34 IS - 9 AU - I S Durand-Zaleski AU - C Alberti AU - P Durieux AU - X Duval AU - S Gottot AU - Ph Ravaud AU - S Gainotti AU - C Vincent-Genod AU - D Moreau AU - P Amiel Y1 - 2008/09/01 UR - http://jme.bmj.com/content/34/9/e16.abstract N2 - 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 (parent studies).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 (69–97%), 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. ER -