Adolescent self-consent for biomedical human immunodeficiency virus prevention research

Amy Lewis Gilbert, Amy Knopf, J. Fortenberry, Sybil G. Hosek, Bill G. Kapogiannis, Gregory Zimet

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Purpose 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. Methods 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. Results 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. Conclusions 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.

Original languageEnglish
Pages (from-to)113-119
Number of pages7
JournalJournal of Adolescent Health
Volume57
Issue number1
DOIs
StatePublished - Jul 1 2015

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Adolescent Medicine
Clinical Protocols
HIV
Research Ethics Committees
Research
Research Personnel
Population
Information Storage and Retrieval
Interviews
Safety

Keywords

  • Adolescent medicine
  • Ethics committee, research
  • HIV
  • Informed consent by minors
  • Jurisprudence
  • Preexposure prophylaxis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Public Health, Environmental and Occupational Health

Cite this

Adolescent self-consent for biomedical human immunodeficiency virus prevention research. / Gilbert, Amy Lewis; Knopf, Amy; Fortenberry, J.; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory.

In: Journal of Adolescent Health, Vol. 57, No. 1, 01.07.2015, p. 113-119.

Research output: Contribution to journalArticle

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