Tuesday, July 1, 2025 7/1/2025

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

Award Number: R01HD105684
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	450 CLARKSON AVE	BROOKLYN	NY	11203	KINGS	USA	Child Health and Human Development Extramural Research	002	3	11/14/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$597,196
2025	2023	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	001	2	11/14/2024	NON-COMPETING CONTINUATION	-$295,120
2025	2022	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	000	1	11/14/2024	NEW	-$302,076
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $658,052 )
2024	2024	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	450 CLARKSON AVE	BROOKLYN	NY	11203	KINGS	USA	Child Health and Human Development Extramural Research	003	4	8/31/2024	NON-COMPETING CONTINUATION	$658,052
2024	2023	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	001	2	6/18/2024	NON-COMPETING CONTINUATION	-$467,673
2024	2023	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	450 CLARKSON AVE	BROOKLYN	NY	11203	KINGS	USA	Child Health and Human Development Extramural Research	002	3	6/18/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$467,673
2024	2023	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	000	2	5/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $658,052

Issue Date FY: 2023 ( Subtotal = $762,793 )
2023	2023	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	001	2	8/18/2023	NON-COMPETING CONTINUATION	$762,793
2023	2023	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	002	2	9/6/2023	NON-COMPETING CONTINUATION	$0
2023	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	000	1	10/22/2022	NEW	$0
														Subtotal = $762,793

Issue Date FY: 2022 ( Subtotal = $793,572 )
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	000	1	9/20/2022	NEW	$793,572
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Child Health and Human Development Extramural Research	001	1	9/22/2022	NEW	$0
														Subtotal = $793,572

Grand Total All Awards = $2,214,417

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

Award Number: R01HD105684

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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