Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

TitleAdolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.
Publication TypePublication
Year of Publication2015
AuthorsGilbert ALewis, Knopf AS, J Fortenberry D, Hosek SG, Kapogiannis BG, Zimet GD
JournalJ Adolesc Health
Volume57
Issue1
Pagination113-9
Date Published2015 Jul
ISSN1879-1972
KeywordsAdolescent, Biomedical Research, Ethics Committees, Research, Ethics, Research, Female, HIV Infections, Homosexuality, Male, Humans, Informed Consent By Minors, Interviews as Topic, Male, Middle Aged, Pre-Exposure Prophylaxis
Abstract

<p><b>PURPOSE: </b>The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations.</p><p><b>METHODS: </b>Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process.</p><p><b>RESULTS: </b>A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations.</p><p><b>CONCLUSIONS: </b>The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.</p>

DOI10.1016/j.jadohealth.2015.03.017
Alternate JournalJ Adolesc Health
PubMed ID26095412
PubMed Central IDPMC4477274
Grant ListU01 HD 040533 / HD / NICHD 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
2T32 NR007066 / NR / NINR NIH HHS / United States
T32 NR007066 / NR / NINR NIH HHS / United States
UL1 TR001082 / TR / NCATS NIH HHS / United States