PT  - JOURNAL ARTICLE
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
TI  - Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception
AID  - 10.1136/jme.2007.023473
DP  - 2008 Sep 01
TA  - Journal of Medical Ethics
PG  - e16--e16
VI  - 34
IP  - 9
4099  - http://jme.bmj.com/content/34/9/e16.short
4100  - http://jme.bmj.com/content/34/9/e16.full
SO  - J Med Ethics2008 Sep 01; 34
AB  - 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.