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J Adolesc Health. 2015 Jul;57(1):113-9. doi: 10.1016/j.jadohealth.2015.03.017.

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

Author information

1
Children's Health Services Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana; Regenstrief Institute, Inc., Indianapolis, Indiana. Electronic address: amylewis@iu.edu.
2
Indiana University School of Nursing, Indianapolis, Indiana.
3
Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana.
4
Department of Psychiatry, Stroger Hospital of Cook County, Chicago, Illinois.
5
Department of Health and Human Services, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

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.

KEYWORDS:

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

PMID:
26095412
PMCID:
PMC4477274
DOI:
10.1016/j.jadohealth.2015.03.017
[Indexed for MEDLINE]
Free PMC Article

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