Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception
I. S. Durand-Zaleski, C. Alberti, P. Durieux, X. Duval, S. Gottot, P. Ravaud, S. Gainotti, C. Vincent-Genod, D. Moreau & P. Amiel
Journal of Medical Ethics 34 (9):e16-e16 (2008)
AbstractBackground: 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
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Informed Consent as an Ethical Requirement in Clinical Trials: An Old, but Still Unresolved Issue. An Observational Study to Evaluate Patient's Informed Consent Comprehension.Virginia Sanchini, Michele Reni, Giliola Calori, Elisabetta Riva & Massimo Reichlin - 2014 - Journal of Medical Ethics 40 (4):269-275.
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