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. 2013 Jun;39(6):410-2.
doi: 10.1136/medethics-2012-101286. Epub 2013 Jan 24.

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

Sonia Lee  1 , 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
Collaborators, Affiliations

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

Sonia Lee et al. J Med Ethics. 2013 Jun.

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.

Keywords: Clinical trials; HIV Infection and AIDS; Informed Consent; Minors/Parental Consent.

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References

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