Challenges in Arranging to Waive Parental Consent in HIV Prevention Studies of Adolescent Men Who have Sex with Men: The Case of HPTN 078

ABSTRACT

Including adolescent men who have sex with men (AMSM) in HIV prevention and treatment studies without parental permission is vital, but has often faced barriers. We examine the case of recent Institutional Review Boards (IRB) reviews of an HIV treatment and prevention study that requested waiving parental permission at four United States sites, but received different responses from each institution. IRBs varied in whether and how they weighed parental rights against AMSMs’ rights and individual and social benefits, and potential harms (e.g., if a parent disapproves of the adolescents’ sexual behavior). One IRB “tabled” the decision to receive advice from the university Office of General Counsel (OGC), despite state laws allowing minors to consent to HIV testing and treatment without parental permission. Another IRB consulted the university’s Chief Compliance Officer (CCO), which thought the waiver was inconsistent with state law, which discusses “venereal disease,” but not HIV. University attorneys may have competing priorities, however, and thus interpret relevant laws differently. This case raises critical concerns, highlighting needs for advocates for AMSM, researchers, IRBs and others at institutional, governmental, and community levels to educate policymakers, public health departments, IRB chairs, members, and staff, OGCs and CCOs about these issues.

KEYWORDS:

• Adolescent men who have sex with men (AMSM)
• homosexuality
• adolescents
• consent
• HIV
• IRBs
• public health

Acknowledgments

The authors would like to thank Theresa Gamble, PhD, Julian Dormitzer, RN BSN; Chris Root, BA, Kelly Lowensen, RN, MSN, ACRN and D. Scott Batey, PhD for their contributions to this manuscript, and Lundyn C Davis, Sayantanee Das, Jiseop Kim, Amanda Shen, Gabriella Smith, and especially Patricia Contino for their assistance with the preparation of this manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The HIV Prevention Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068619, UM1AI068613, UM1AI1068617), with co-funding from the National Institute of Mental Health, and the National Institute on Drug Abuse.