Abstract
BACKGROUND: Ethical safeguards are critical in HIV research involving minors, especially vulnerable groups such as men who have sex with men (MSM) under 18 years. This systematic review explores how informed assent and consent practices are reported, guided by the 2016 Council for International Organizations of Medical Sciences (CIOMS) guidelines. METHODS: A systematic review was conducted of peer-reviewed studies from 2010 to 2023 involving MSM under 18 years, using PubMed, Embase, and Scopus databases. Key ethical components were extracted and synthesized thematically. RESULTS: Of 410 articles screened, 65 met inclusion criteria. All included studies reported informed consent, but only 20% (n = 13) included informed assent. Most were conducted in high-income countries (64%), with no representation from low-income settings. Only 7% involved minors living with HIV. Quantitative methods were predominant (82%), and 20% used online platforms. Waivers of parental permission were reported in 27% of studies, while only 3% obtained parental permission. Four studies described tailored consent/assent approaches, such as simplified language, comprehension checks, and involvement of minor advocates. CONCLUSION: This review highlights inconsistencies in how informed assent is addressed in HIV research involving MSM minors. Only one in five studies described ethically appropriate, youth-tailored processes. Limited use of waivers and adapted assent procedures points to ongoing gaps in aligning research with ethical standards. Future studies should adopt clearer, age-appropriate consent practices, ensure transparent reporting, and strengthen researcher training in ethics involving vulnerable minors.