TY - JOUR T1 - Comprehension of a simplified assent form in a vaccine trial for adolescents JF - Journal of Medical Ethics JO - J Med Ethics SP - 410 LP - 412 DO - 10.1136/medethics-2012-101286 VL - 39 IS - 6 AU - Sonia Lee AU - Bill G Kapogiannis AU - Patricia M Flynn AU - Bret J Rudy AU - James Bethel AU - Sushma Ahmad AU - Diane Tucker AU - Sue Ellen Abdalian AU - Dannie Hoffman AU - Craig M Wilson AU - Coleen K Cunningham AU - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Y1 - 2013/06/01 UR - http://jme.bmj.com/content/39/6/410.abstract N2 - 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. ER -