Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception
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 misconcepti...
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Format: | Electronic Article |
Language: | English |
Check availability: | HBZ Gateway |
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Published: |
BMJ Publ.
2008
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In: |
Journal of medical ethics
Year: 2008, Volume: 34, Issue: 9, Pages: 16 |
Online Access: |
Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
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245 | 1 | 0 | |a Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception |
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520 | |a 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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