title: Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.
abstract: This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational, and voluntary self-consent. Sixty sexually active SGMY (ages 14-17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not "out" to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills every day, logistics, and post-trial access to PrEP. Results demonstrate youth's ability to self-consent to age- and population-appropriate procedures, and underscore the value of empirical studies for informing institutional review board (IRB) protections of SGMY research participants.
authors.affiliation: Fordham University, Bronx, NY, USA Fisher@fordham.edu.
authors.forename: Celia B
authors.initials: CB
authors.lastname: Fisher
authors.affiliation: Fordham University, Bronx, NY, USA.
authors.forename: Miriam R
authors.initials: MR
authors.lastname: Arbeit
authors.affiliation: Fordham University, Bronx, NY, USA.
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Dumont
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Macapagal
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Mustanski
mesh_terms: D000293:Adolescent; D041923:Adolescent Development; D001290:Attitude; D001727:Bisexuality; D003219:Confidentiality; D030881:Disclosure; D032984:Ethics, Research; D005260:Female; D017144:Focus Groups; D015658:HIV Infections / Q000517:prevention & control*; D006302:Health Services Research / Q000941:ethics*; D018451:Homosexuality, Male; D006801:Humans; D057828:Informed Consent By Minors / Q000941:ethics*; D008297:Male; D055118:Medication Adherence; D016743:Mental Competency; D065129:Pre-Exposure Prophylaxis; D012725:Sexual Behavior; D000072339:Sexual and Gender Minorities; D011795:Surveys and Questionnaires; D063106:Transgender Persons
keywords: HIV prevention; adolescent medicine; ethics; gender identity; informed consent by minors; pre-exposure prophylaxis; research; sexual orientation