Notice of Special Interest (NOSI): Research on the Health of Women of Underrepresented, Underserved, and Underreported (U3) Populations (Admin Supp Clinical Trial Optional)
Notice Number:
NOT-OD-24-179

Key Dates

Release Date:

October 11, 2024

First Available Due Date:
January 22, 2025
Expiration Date:
January 23, 2026

Related Announcements

  • NOT-DC-25-012 - Notice of Participation in NOT-OD-24-179, "Notice of Special Interest (NOSI): Research on the Health of Women of Underrepresented, Underserved, and Underreported (U3) Populations (Admin Supp Clinical Trial Optional)".
  • November 15, 2024 - Notice of Participation of the National Institute of Nursing Research (NINR) in NOT-OD-24-179, "Notice of Special Interest (NOSI): Research on the Health of Women of Underrepresented, Underserved, and Underreported (U3) Populations". See Notice NOT-NR-25-004
  • December 4, 2023 - Notice of Special Interest (NOSI): Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations (Admin Supp Clinical Trial Optional) (NOT-OD-24-032)
  • October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272 

Issued by

Office of Research on Women's Health (ORWH)

Office of AIDS Research (OAR)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD) November 18, 2024 - Participation added (NOT-DC-25-012)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Nursing Research (NINR), November 15, 2024 - Participation added (NOT-NR-25-004)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Tribal Health Research Office (THRO)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Sexual and Gender Minority Research Office (SGMRO)

Purpose

The Office of Research on Women’s Health (ORWH) announces the availability of administrative supplements to support research to address health disparities among women in the United States who are underrepresented, underserved, and underreported (U3) in biomedical research. 


Key Definitions

  • NIH Populations with Health Disparities: Racial and ethnic minority groups, people with lower socioeconomic status, underserved rural populations, sexual and gender minority (SGM) groups, and people with disabilities. 
  • Intersectionality: Intersectionality describes how individuals’ multiple, social identities (e.g., gender, racial group, class, sexual orientation, and disability status) intersect to shape position in society, overall lived experience, and health.  
  • Social determinants of health: Conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning and quality-of-life outcomes and risks. 


Background

The intersection of internal biological (e.g., hormonal function) and external social and structural factors (e.g., social determinants of health) plays a complex role in the health status, disease presentation, treatment responses, and health-related quality of life of women across the life course. Health care inequities in the U.S. are particularly evident in the disproportionate burden of disease and adverse health outcomes experienced by women belonging to NIH populations with health disparities. Underrepresentation in data reporting and biomedical research additionally hinders unique opportunities to learn more about associations between social identity, cultural factors, and health. In 2024, ORWH published the “Health of Women of U3 Populations Data Book,” presenting current information on how socially determined categories and environments, systems, and policies intersect, resulting in different health outcomes for U3 women and communities in the United States. The nationally representative population-based health and disease statistics on the health experiences of multiply marginalized populations of women described in this publication highlight the importance of considering intersectionality in research on the health of women. 


This NOSI encourages rigorous, collaborative, interdisciplinary research on the differential risk, treatment outcomes, and morbidity experienced by populations of women who are underrepresented, underserved, and underreported in biomedical research across the lifespan. Thoughtful incorporation of intersectionality and culturally and contextually relevant approaches into research by applying the NIMHD Minority Health and Health Disparities Research Framework to meet group- and population-level needs is encouraged. Partnership between early career and independent investigators is encouraged to strengthen and accelerate multidisciplinary research in this space. 


Specific Areas of Research Interest

This notice will support projects investigating inequities in women’s health and intervention studies to improve health and related outcomes in populations of women from NIH-designated health disparities. Projects with an emphasis on measures beyond the individual level and consider perspectives from multiple disciplines are of specific interest. A broad range of research topics across preclinical, clinical, behavioral, and translational levels and including proposals incorporating multilevel interventions and community-engaged approaches are encouraged. The proposed research must address at least one objective from the strategic goals 1, 2, 4 or 5 of the NIH-Wide Strategic Plan for Research on the Health of Women 2024-2028


Topics of interest include, but are not limited to:

  • Studies evaluating interventions to reduce health disparities among women from U3 populations
  • Studies to improve our understanding of how social determinants of health and other factors (e.g., immigration status, English proficiency) influence health disparities experienced by women
  • Studies exploring the etiologies underlying health disparities in prevention, treatment or outcomes from female-specific or gynecologic conditions (e.g., menopause, menstrual mood disorders, PCOS, endometrial cancer)
  • Studies exploring the etiologies underlying health disparities in prevention, treatment or outcomes from diseases that disproportionately affect women (e.g., autoimmune disorders, mental health diseases)
  • Studies exploring etiologies underlying health disparities in prevention, treatment or outcomes from diseases that present and progress differently in women (e.g., cardiovascular disease, metabolic conditions, substance use disorders). 
  • Studies seeking to identify novel dissemination, outreach, and implementation approaches by which research findings can reach populations of U3 women
  • Studies exploring the causes of differences in entry, utilization, and retention of primary and preventive health care services and treatment adherence among populations of U3 women 
  • Studies exploring geographic and structural barriers to care-seeking behavior and outcomes of U3 women
  • Studies exploring caretaking/caregiving responsibilities, gender discrimination, and other structural barriers to healthcare utilization for U3 women
  • Studies to accelerate research on technologies to overcome barriers and increase uptake of preventative interventions and effective therapeutics at the point of care for women from underserved communities (e.g., Federally Qualified Health Center (FQHC), community hospitals, Indian Health Service affiliated hospitals/health facilities)
  • Studies exploring chronic conditions and/or multimorbidity in U3 women 
  • Studies exploring social and structural determinants of health in maternal health and maternal morbidity and mortality for U3 women
  • Studies exploring the effects of direct and indirect exposures to violence and trauma across the lifespan, including intimate partner violence among U3 women 


Eligibility

  • Only PDs/PIs of an active DP1, DP2, DP4, DP5, K01, K08, K23, K76, K99/R00, P01, P20, P30, P40, P41, P50, P51, P60, P2C, PM1, R01, R03, R15, R21, R24, R25, R33, R34, R35, R37, R41/R42, R43/R44, R41, R42, R43, R44, R61, RF1, RC4, RM1, S06, S11, U01, U10, U19, U2C, U24, U42, U44, U54, U56, UC2, UL1, UM1, UM2, UG1, UG3/UH3, UH2/UH3, UH2, or UP5 award from NIH are eligible to apply.
  • Only electronically submitted applications will be accepted.


PDs/PIs of the above-mentioned activity codes must also fulfill on each of the following requirements, otherwise, their applications will be deemed non-responsive to this NOSI.

  • The parent peer-reviewed NIH-funded grant must have at least 16 months of active grant support remaining from the due date. No-cost extension is not an eligibility criterion.
  • The proposed research must be within the scope of the parent award to meet increased costs that are within the scope of the approved award, but were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted.
  • Only one U3 Administrative Supplement award per period of performance is permitted to a peer-reviewed NIH-funded grant. Prior approval from the ORWH scientific contact is required to submit more than one application.
  • The proposed research must address at least one objective from the strategic goals 1, 2, 4 or 5 of the NIH-Wide Strategic Plan for Research on the Health of Women 2024-2028.


Foreign Institutions:

  • Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
  • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
  • Foreign components, as defined in the NIH Grants Policy Statement, are allowed.


Budget

  • ORWH intends to commit at least $1 million annually for this program.
  • The application budget should not exceed $140,000 in direct costs. Applicable F&A (indirect) costs can also be requested.
  • The application budget is limited to one year only.
  • Supplements may provide support above the dollar limits of the funding opportunity announcement of the parent grant award.
  • Earliest start date – August 2025
     

Scientific Review Process

  • The NIH program staff will conduct administrative reviews of the application submissions; the most meritorious applications will receive funding consideration pending the availability of funds.
  • Continuous Submission is not permitted. In other words, no late applications will be accepted.


Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

  • PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)


All instructions in the How to Apply - Application Guide and PA-20-272 must be followed, with the following additions:

  • Application Due Date(s) – January 22, 2025, and January 22, 2026, by 5:00 PM local time of applicant organization
  • For funding consideration, applicants must include “NOT-OD-24-179” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
  • The Research Strategy section of the NOSI is limited to 6 pages.
  • It is strongly recommended that the applicant contact both the program officer at the Institute supporting the parent award and the ORWH scientific contact to confirm, ahead of time, that the supplement falls within the scope of the parent award.
  • To facilitate efficient processing, applicants are strongly encouraged to notify the program contact at the IC supporting the parent award that supplement application has been submitted in response to this funding opportunity.
     

Inquiries

Please direct all inquiries to:

Sarah M Temkin, MD
Office of Research on Women’s Health (ORWH)
Telephone: 301-402-1770
Email: [email protected]