Comprehension of a simplified assent form in a vaccine trial for adolescents

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Journal of Medical Ethics
June 2013, Volume 39, Issue 6
http://jme.bmj.com/content/current

Brief report
Comprehension of a simplified assent form in a vaccine trial for adolescents
Sonia Lee, Bill G Kapogiannis, Patricia M Flynn, Bret J Rudy, James Bethel, Sushma Ahmad,    Diane Tucker, Sue Ellen Abdalian, Dannie Hoffman, Craig M Wilson, Coleen K  Cunningham,
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN

Abstract
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.

http://jme.bmj.com/content/39/6/410.abstract