title: Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.
abstract: OBJECTIVE
  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.
authors.affiliation: 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.
authors.forename: Amy Lewis
authors.initials: AL
authors.lastname: Gilbert
authors.affiliation: Indiana University School of Nursing, Indianapolis, Indiana.
authors.forename: Amelia S
authors.initials: AS
authors.lastname: Knopf
authors.affiliation: Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: J Dennis
authors.initials: JD
authors.lastname: Fortenberry
authors.affiliation: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, Illinois.
authors.forename: Sybil G
authors.initials: SG
authors.lastname: Hosek
authors.affiliation: Department of Health and Human Services, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
authors.forename: Bill G
authors.initials: BG
authors.lastname: Kapogiannis
authors.affiliation: Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Zimet
mesh_terms: D000293:Adolescent; D035843:Biomedical Research; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D018451:Homosexuality, Male / Q000523:psychology*; D006801:Humans; D057828:Informed Consent By Minors / Q000941:ethics* / Q000331:legislation & jurisprudence*; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D065129:Pre-Exposure Prophylaxis / Q000941:ethics* / Q000331:legislation & jurisprudence*
keywords: Adolescent medicine; Ethics committee, research; HIV; Informed consent by minors; Jurisprudence; Preexposure prophylaxis