Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.

I. S. Durand-Zaleski 1, 2, * Corinne Alberti 3 P. Durieux X. Duval S. Gottot Ph Ravaud 4 S. Gainotti C. Vincent-Genod D. Moreau Philippe Amiel 5
* Corresponding author
1 IMRB - Institut Mondor de Recherche Biomédicale
2 Service de santé publique [Mondor]
3 Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Hopital Robert Debre
4 Département d'épidémiologie, biostatistique et recherche clinique
5 URSHS - Unité de recherche en sciences humaines et sociales
Abstract : 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.
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Journal articles
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https://hal.archives-ouvertes.fr/hal-00850486
Contributor : Philippe Amiel <>
Submitted on : Tuesday, August 6, 2013 - 5:44:37 PM
Last modification on : Tuesday, February 26, 2019 - 10:12:36 AM

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I. S. Durand-Zaleski, Corinne Alberti, P. Durieux, X. Duval, S. Gottot, et al.. Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.. Journal of Medical Ethics, BMJ Publishing Group, 2008, 34 (9), pp.e16. ⟨10.1136/jme.2007.023473⟩. ⟨hal-00850486⟩

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