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

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


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Vaccines / administration & dosage
  • Adolescent
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / methods
  • Comprehension*
  • Consent Forms*
  • Female
  • Hepatitis B Vaccines / administration & dosage
  • Humans
  • Informed Consent By Minors / ethics
  • Informed Consent By Minors / standards*
  • Male
  • Patient Selection / ethics*
  • Research Design
  • Surveys and Questionnaires
  • United States
  • Vaccination* / adverse effects
  • Vaccination* / ethics
  • Young Adult


  • AIDS Vaccines
  • Hepatitis B Vaccines