# Ethics of HIV-related research involving underage key populations in sub-Saharan Africa

> **NIH NIH R01** · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · 2022 · $793,572

## Abstract

Many youth who sell sex and adolescent men who have sex with men in sub-Saharan Africa are at high risk for
HIV and other adverse health outcomes. However, these youth are often excluded from studies conducted with
key populations in the region due to legal and ethical challenges. For example, the requirement to obtain
parental consent for the participation of minors in research is often not safe or practical for youth whose sexual
behaviors are stigmatized. This exclusion from research hinders the development and testing of interventions
tailored for underage key populations. This project's long-term objective is to identify legal and ethical barriers
to conducting HIV research with underage key populations in sub-Saharan Africa in order to inform strategies
for overcoming these barriers to implement such research where it is feasible and warranted. The specific aims
of this study are: (1) To examine the relationship between legal restrictions related to the participation of
minors under the age of 18 in research and the implementation of studies including underage key populations
(female sex workers and men who have sex with men) in 48 countries in sub-Saharan Africa. The content of
each country's ethical and regulatory guidance on research with minors will be analyzed, and a systematic
review of the literature on key populations in Africa will be conducted to determine where and what types of
research (e.g., observational or therapeutic) have been conducted with underage key populations. (2) To
assess through surveys the knowledge, attitudes and experiences of research ethics committee members and
institutional review board members (n=419) in sub-Saharan Africa regarding the review of studies that include
underage key populations as participants. We will analyze the country-level, committee-level, and individual-
level characteristics associated with willingness to consider approving research with underage key populations.
(3) To identify perceived obstacles to conducting research with underage key populations in Africa through
surveys of two groups of researchers who have conducted studies with key populations in Africa: those who
have a) included underage participants (n=50) and b) excluded underage participants (n=125). Deliberative
focus group discussions will also be conducted with researchers and research ethics committee members.
Findings will be disseminated to researchers, ethics committee members, and organizations representing
youth and key populations in Africa.

## Key facts

- **NIH application ID:** 10445571
- **Project number:** 1R01HD105684-01A1
- **Recipient organization:** RUTGERS BIOMEDICAL AND HEALTH SCIENCES
- **Principal Investigator:** Ashley Lynn Grosso
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $793,572
- **Award type:** 1
- **Project period:** 2022-09-20 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10445571

## Citation

> US National Institutes of Health, RePORTER application 10445571, Ethics of HIV-related research involving underage key populations in sub-Saharan Africa (1R01HD105684-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10445571. Licensed CC0.

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