Comprehension of a simplified assent form in a vaccine trial for adolescents
Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements...
| Authors: | ; ; ; ; ; ; ; ; ; ; |
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| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
| Journals Online & Print: | Drawer...
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| Fernleihe: | Fernleihe für die Fachinformationsdienste |
| Published: |
BMJ Publ.
2013
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| In: |
Journal of medical ethics
Year: 2013, Volume: 39, Issue: 6, Pages: 410-412 |
| Online Access: |
Presumably Free Access Volltext (JSTOR) Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
| Summary: | Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking. |
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| ISSN: | 1473-4257 |
| Contains: | Enthalten in: Journal of medical ethics
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| Persistent identifiers: | DOI: 10.1136/medethics-2012-101286 |