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...

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Authors: Lee, Sonia (Author) ; Kapogiannis, G. (Author) ; Flynn, M. (Author) ; Rudy, J. (Author) ; Bethel, James (Author) ; Ahmad, Sushma (Author) ; Tucker, Diane (Author) ; Abdalian, Sue Ellen (Author) ; Hoffman, Dannie (Author) ; Wilson, M. (Author) ; Cunningham, K. (Author)
Format: Electronic Article
Language:English
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Published: BMJ Publ. 2013
In: Journal of medical ethics
Year: 2013, Volume: 39, Issue: 6, Pages: 410-412
Online Access: Presumably Free Access
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520 |a 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. 
700 1 |a Kapogiannis, G.  |e VerfasserIn  |4 aut 
700 1 |a Flynn, M.  |e VerfasserIn  |4 aut 
700 1 |a Rudy, J.  |e VerfasserIn  |4 aut 
700 1 |a Bethel, James  |e VerfasserIn  |4 aut 
700 1 |a Ahmad, Sushma  |e VerfasserIn  |4 aut 
700 1 |a Tucker, Diane  |e VerfasserIn  |4 aut 
700 1 |a Abdalian, Sue Ellen  |e VerfasserIn  |4 aut 
700 1 |a Hoffman, Dannie  |e VerfasserIn  |4 aut 
700 1 |a Wilson, M.  |e VerfasserIn  |4 aut 
700 1 |a Cunningham, K.  |e VerfasserIn  |4 aut 
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