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...
| Authors: | ; ; ; ; ; ; ; ; ; |
|---|---|
| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
| Journals Online & Print: | Drawer...
|
| Fernleihe: | Fernleihe für die Fachinformationsdienste |
| Published: |
BMJ Publ.
2008
|
| In: |
Journal of medical ethics
Year: 2008, Volume: 34, Issue: 9, Pages: 16 |
| Online Access: |
Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
MARC
| LEADER | 00000naa a22000002 4500 | ||
|---|---|---|---|
| 001 | 1816135666 | ||
| 003 | DE-627 | ||
| 005 | 20220908053456.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 220908s2008 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/jme.2007.023473 |2 doi | |
| 035 | |a (DE-627)1816135666 | ||
| 035 | |a (DE-599)KXP1816135666 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 1 |2 ssgn | ||
| 100 | 1 | |a Durand-Zaleski, I. S. |e VerfasserIn |4 aut | |
| 245 | 1 | 0 | |a Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception |
| 264 | 1 | |c 2008 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 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. | ||
| 601 | |a Therapeut | ||
| 700 | 1 | |a Alberti, C. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Durieux, P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Duval, X. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gottot, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ravaud, Ph |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gainotti, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Vincent-Genod, C. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Moreau, D. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Amiel, P. |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of medical ethics |d London : BMJ Publ., 1975 |g 34(2008), 9, Seite 16 |h Online-Ressource |w (DE-627)323607802 |w (DE-600)2026397-1 |w (DE-576)260773972 |x 1473-4257 |7 nnns |
| 773 | 1 | 8 | |g volume:34 |g year:2008 |g number:9 |g pages:16 |
| 856 | 4 | 0 | |u https://doi.org/10.1136/jme.2007.023473 |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u http://jme.bmj.com/content/34/9/e16.abstract |x Verlag |z lizenzpflichtig |3 Volltext |
| 935 | |a mteo | ||
| 951 | |a AR | ||
| ELC | |a 1 | ||
| ITA | |a 1 |t 1 | ||
| LOK | |0 000 xxxxxcx a22 zn 4500 | ||
| LOK | |0 001 4185589530 | ||
| LOK | |0 003 DE-627 | ||
| LOK | |0 004 1816135666 | ||
| LOK | |0 005 20220908053456 | ||
| LOK | |0 008 220908||||||||||||||||ger||||||| | ||
| LOK | |0 035 |a (DE-Tue135)IxTheo#2022-08-02#74F58B464C4B25F5FC5ABBC00772FCC55D14CEC0 | ||
| LOK | |0 040 |a DE-Tue135 |c DE-627 |d DE-Tue135 | ||
| LOK | |0 092 |o n | ||
| LOK | |0 852 |a DE-Tue135 | ||
| LOK | |0 852 1 |9 00 | ||
| LOK | |0 935 |a ixzs |a ixrk |a zota | ||
| OAS | |a 1 |b inherited from superior work | ||
| ORI | |a SA-MARC-ixtheoa001.raw | ||