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J Med Ethics. 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.

Author information

1
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal Pediatric Infectious Disease Branch, Bethesda, Maryland, USA. leesonia@mail.nih.gov

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

PMID:
23349510
PMCID:
PMC3655100
DOI:
10.1136/medethics-2012-101286
[Indexed for MEDLINE]
Free PMC Article
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