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

TitleComprehension of a simplified assent form in a vaccine trial for adolescents.
Publication TypePublication
Year of Publication2013
AuthorsLee S, Kapogiannis BG, Flynn PM, Rudy BJ, Bethel J, Ahmad S, Tucker D, Abdalian SEllen, Hoffman D, Wilson CM, Cunningham CK
Corporate AuthorsAdolescent Medicine Trials Network for HIV/AIDS Interventions
JournalJ Med Ethics
Volume39
Issue6
Pagination410-2
Date Published2013 Jun
ISSN1473-4257
KeywordsAdolescent, AIDS Vaccines, Clinical Trials as Topic, Comprehension, Consent Forms, Female, Hepatitis B Vaccines, Humans, Informed Consent By Minors, Male, Patient Selection, Research Design, Surveys and Questionnaires, United States, Vaccination, Young Adult
Abstract

<p><b>INTRODUCTION: </b>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.</p><p><b>METHODS: </b>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.</p><p><b>RESULTS: </b>123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly.</p><p><b>CONCLUSIONS: </b>Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.</p>

DOI10.1136/medethics-2012-101286
Alternate JournalJ Med Ethics
PubMed ID23349510
PubMed Central IDPMC3655100
Grant ListM01RR00083-42 / RR / NCRR NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
U01 HD 040474 / HD / NICHD NIH HHS / United States
U01 HD040474 / HD / NICHD NIH HHS / United States
U01 HD040497 / HD / NICHD NIH HHS / United States
M01RR05096 / RR / NCRR NIH HHS / United States
Z99 HD999999 / / Intramural NIH HHS / United States
UM1 AI069415 / AI / NIAID NIH HHS / United States
M01 RR005096 / RR / NCRR NIH HHS / United States
M01 RR001271 / RR / NCRR NIH HHS / United States
M01RR01271 / RR / NCRR NIH HHS / United States
M01RR020359 / RR / NCRR NIH HHS / United States
U01 HD040499 / HD / NICHD NIH HHS / United States
U01 HD040470 / HD / NICHD NIH HHS / United States
M01 RR000083 / RR / NCRR NIH HHS / United States
M01 RR020359 / RR / NCRR NIH HHS / United States