Document Detail


Comprehension of a simplified assent form in a vaccine trial for adolescents.
MedLine Citation:
PMID:  23349510     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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;
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.     Date:  2013-01-24
Journal Detail:
Title:  Journal of medical ethics     Volume:  39     ISSN:  1473-4257     ISO Abbreviation:  J Med Ethics     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-05-21     Completed Date:  2013-08-12     Revised Date:  2013-12-25    
Medline Journal Info:
Nlm Unique ID:  7513619     Medline TA:  J Med Ethics     Country:  England    
Other Details:
Languages:  eng     Pagination:  410-2     Citation Subset:  E; IM    
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MeSH Terms
Descriptor/Qualifier:
AIDS Vaccines / administration & dosage
Adolescent
Clinical Trials as Topic / ethics*,  methods
Comprehension*
Consent Forms*
Female
Hepatitis B Vaccines / administration & dosage
Humans
Informed Consent By Minors / ethics,  standards*
Male
Patient Selection / ethics*
Questionnaires
Research Design
United States
Vaccination* / adverse effects,  ethics
Young Adult
Grant Support
ID/Acronym/Agency:
M01RR00083-42/RR/NCRR NIH HHS; M01RR01271/RR/NCRR NIH HHS; M01RR020359/RR/NCRR NIH HHS; M01RR05096/RR/NCRR NIH HHS; U01 HD 040474/HD/NICHD NIH HHS; U01 HD040474/HD/NICHD NIH HHS; U01 HD040533/HD/NICHD NIH HHS; U01 HD040533/HD/NICHD NIH HHS; Z99 HD999999/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
0/AIDS Vaccines; 0/Hepatitis B Vaccines
Investigator
Investigator/Affiliation:
C Wilson / ; C Partlow / ; J Korelitz / ; B Driver / ; Lawrence J D'Angelo / ; Connie Trexler / ; Rita Hagler / ; Amy Klamberg / ; John H Stroger / ; Ruth M Rothstein / ; Jaime Martinez / ; Lisa Henry-Reid / ; Kelly Bojan / ; Rachel Jackson / ; Donna Futterman / ; Elizabeth Enriquez-Bruce / ; Maria Campos / ; Pat Flynn / ; Sarah Stender / ; Kristen Branum / ; Mary Dillard / ; Tina Culley / ; Carla McKinley / ; Thomas Wride / ; Ellen Abdalian / ; Alyne Baker / ; Trina Jeanjacques / ; Leslie Kozina / ; Barbara Moscicki / ; Lisa D Irish / ; J B Molaghan / ; Ligia Peralta / ; Leonel Flores / ; Reshma S Gorle / ; Irma L Febo / ; Hazel T Ayala-Flores / ; Anne T F Gomez / ; Patricia Emmanuel / ; Jorge Lujan-Zilbermann / ; Diane M Straub / ; Silvia Callejas / ; Priscilla C Julian / ; Amayvis Rebolledo /
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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