Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research

Abstract

Purpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multi-site demonstration project and phase II safety study of HIV pre-exposure prophylaxis with 15-17 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 seventeen researchers at thirteen sites in twelve 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 7 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.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

“…Current interpretations of federal regulations that refuse to permit youth self-consent deprive SGMY their right to evidence-based interventions essential to their health and wellbeing (Fisher & Mustanski, 2014; Flicker & Guta, 2008; Gilbert et al, 2015; Mustanski, 2011). CDC recommendations for providing PrEP to HIV-risk populations underscore the urgent need for age- and population-targeted research to avoid the use of treatments tested in adult populations that may be ill-suited for SGMY (Center for Disease Control, 2014; Rudy et al, 2010).…”

“…This, in turn, can result in smaller, unrepresentative samples (Jelsma, Burgess, & Henley, 2012) that skew findings in ways that may limit the generalizability of findings to SGMY whose parents are nonaccepting. This, in fact, was the unfortunate situation faced by investigators in the Adolescent Trials Network (ATN 113) when the IRBs at six out of the thirteen testing sites refused to permit youth self-consent in a study on the use of PrEP among 15–17 year old YMSM and transgender women (Gilbert et al, 2015). …”

Facilitators and Barriers to Participation in PrEP HIV Prevention Trials Involving Transgender Male and Female Adolescents and Emerging Adults

“…Despite the fact that a majority of 14 – 17 year olds reported disclosure and at least some family acceptance, approximately half reported they would be unlikely to participate if guardian permission was required. Fear of being stigmatized, punished, or in some cases, victimized by their families if guardian permission results in disclosure of their sexual orientation or gender identity has been identified as a barrier to participation among lesbian, gay and bisexual youth (D'Amico & Julien, 2012; DiClemente, Sales, & Borek, 2010; Fisher et al, 2016; Gilbert et al, 2015; Macapagal, Coventry, Arbeit, Fisher, & Mustanksi, 2016; Mustanski, 2011; Mustanski et al, in press). …”

Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV

“…[9] Concerns about disclosure-related vulnerabilities prompted study organizers to allow minors to self-consent; parental permission was not required for enrollment. [9] Project PrEPare was the first biomedical HIV prevention study in the U.S. that allowed minors to autonomously consent for enrollment, where such consent was consistent with local statutes. [9, 10]…”

“…[9] Project PrEPare was the first biomedical HIV prevention study in the U.S. that allowed minors to autonomously consent for enrollment, where such consent was consistent with local statutes. [9, 10]…”