Paper Title
Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research
Keywords
- adolescent medicine
- self-consent
- biomedical research
- hiv prevention
- preexposure prophylaxis
- high-risk adolescents
- institutional review boards
- ethics in research
- informed consent by minors
- research ethics
- jurisprudence
- adolescent health
- hiv research
- clinical trials
- youth participation
- risk reduction
- public health policy
- irb approval
- ethical challenges
- legal considerations
- research implementation
- biomedical ethics
- human subjects research
- adolescent risk behavior
- health disparities
- multisite studies
- decision-making processes
- health policy
- regulatory standards
- youth autonomy
Article Type
Original Article
Journal
Research Impact Tools
Publication Info
Volume: 57 | Issue: 1 | Pages: 113–119
Published On
July, 2015
Downloads
FULL PDF
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.
View more »