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Notice of Special Interest (NOSI): Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations (Admin Supp Clinical Trial Optional)
Notice Number:
NOT-OD-24-032

Key Dates

Release Date:

December 4, 2023

First Available Due Date:
January 31, 2024
Expiration Date:
February 01, 2024

Related Announcements

  • January 4, 2024 - Notice of Participation of NIMH in NOT-OD-24-032 "Notice of Special Interest (NOSI): Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations (Admin Supp Clinical Trial Optional)". See Notice NOT-MH-24-145
  • December 21, 2023 - Notice of Participation of NIDCD in NOT-OD-24-032. See NOT-DC-24-014
  • September 7, 2022 - Notice of Special Interest (NOSI): Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations (Admin Supp Clinical Trial Optional). See NOT-OD-22-208
  • January 25, 2022 - NIDDK Encourages Research on Sex/Gender Differences, Sexual and Gender Minority-Related Research and Race/Ethnic Diversity. See NOT-DK-22-003
  • October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) PA-20-272

Issued by

Office of Research on Women's Health (ORWH)

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 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 of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

National Institute on Minority Health and Health Disparities ( NIMHD )

National Institute on Deafness and Other Communication Disorders ( NIDCD)

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.

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 highlighting health inequities among women in the United States who are understudied, underrepresented and underreported (U3) in biomedical research.

Key Definitions

NIH-designated health disparity populations: Racial and ethnic minority groups, persons with low socioeconomic status, underserved rural populations, sexual and gender minority groups, and persons with developmental and physical disabilities in the U.S.

Intersectionality/Intersectional Approach: 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. This intersectional approach captures a lens for analysis in the research, where multiple domains and the accompanying layered set of challenges are simultaneously considered alongside comprehensive interventions to address needs and promote health equity.

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

According to the U.S. Census Bureau, women account for over half of the U.S. population and are more likely to experience diminished opportunities for health and health-related quality of life due to gendered power dynamics. Further, women and girls belonging to certain populations - including, but not limited to, NIH-designated health disparities populations; persons experiencing homelessness, institutionalization, or incarceration; and immigrants bear a disproportionate burden of adverse social determinants of health (SDOH) amplifying health risk and disease prevalence and outcomes. Underrepresentation in data reporting and biomedical research additionally hinders unique opportunities to learn more about associations between social identity, cultural factors, and health.

The intersection of internal biological (e.g., hormonal function) and external social and structural forces (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. In 2014, ORWH published The Women of Color Health Data Book, 4th edition, which presented an intersectional picture of U.S. government-sourced, population-based health, and disease, and provided visibility to the health experiences of multiply marginalized populations of women. This publication highlighted the urgent need to improve understanding of the etiologies of health and health care inequities and the mechanisms that contribute to the downstream health effects in populations of women.

This NOSI encourages rigorous experimental designs, as well as the implementation of collaborative interdisciplinary research on the common causes and pathways of ill health and disease, differential risk, treatment outcomes, morbidity, and mortality across socioecological domains and levels of influence. 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, as well as experienced women’s health researchers with those with expertise in health disparities, are encouraged to strengthen and accelerate multidisciplinary research in this space.

Specific Areas of Research Interest

This notice will support projects investigating inequities in women and girls health and intervention studies to improve equity. Additionally, projects with an emphasis on those that integrate measures beyond the individual level and consider perspectives from multiple disciplines are of specific interest. A broad range of research topics studied at the preclinical, clinical, behavioral, and translational levels including proposals incorporating multilevel interventions, using community-engaged approaches, and focusing on one or more NIH-designated health disparities populations are encouraged.

Topics of interest include, but are not limited to:

  • Examination of structural factors that influence morbidity, mortality, and healthcare access, entry, and/or retention
    • Studies of health interventions that incorporate constructs and measurement of structural racism and/or discrimination
    • Studies exploring gender-sensitive training for providers to optimize outcomes and reduce gender-based health inequalities (e.g., gendered dynamics of public health crises)
  • Studies seeking to identify novel dissemination and implementation approaches to reach underserved, understudied, and underrepresented populations of women
  • Studies exploring the causes of differences in entry, utilization, and retention of primary and preventive health care services and treatment adherence among underserved and underrepresented populations of women (i.e., intersectional stigma)
  • Studies exploring geographic barriers to care-seeking behavior and outcomes of underserved, understudied, and underrepresented women
  • Studies exploring caretaking/caregiving responsibilities, gender discrimination, and structural barriers to healthcare utilization
  • Studies to accelerate research on technologies to overcome barriers and increase uptake of preventative interventions and effective therapeutics at the point of care (e.g., Federally Qualified Health Center (FQHC), community hospitals, Indian Health Service affiliated hospitals/health facilities)
  • Studies exploring chronic debilitating conditions and multimorbidity in underserved, understudied, and underrepresented populations of women (e.g., women affected by autoimmune and neurological conditions, mental health disorders, and female-specific conditions) and the impact of evidence-based care coordination models on outcomes and trajectories of multimorbidity
  • Studies exploring social and structural determinants of health inequities in maternal health and maternal morbidity and mortality
  • Studies exploring inequities in gynecologic cancer screening, treatment, and supportive care
  • Studies exploring Post-Acute Sequelae of SARS-CoV-2 (PASC) infection (long COVID), or long-term effects of COVID-19 among understudied, underrepresented, underreported populations of women
  • Studies exploring the effects of direct and indirect exposures to violence across the lifespan, including intimate partner violence and elder mistreatment, and abuse during pregnancy and its subsequent impact upon infants/children
  • Studies leveraging clinical research networks to accelerate novel testing, pharmacologic, and disease management approaches focused on female-specific diseases, menopause, musculoskeletal diseases, inflammation and immunity, and aging
  • Studies focused on Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD). Relevant areas of AD/ADRD research emphasis include, but are not limited to, those described in AD and ADRD Research Implementation Milestones framework.

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. An exception may be given for proposals studying SARS-CoV-2 or COVID-19; please contact the ORWH scientific contact for approval.
  • Only one U3 Administrative Supplement award per period of performance is permitted to a peer-reviewed NIH-funded grant. An exception may be given for applications proposing research focused on SARS-CoV-2 or COVID-19. 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, or 3 of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research, Advancing Science for the Health of Women.

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 2024

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.
  • Applications for this initiative must be submitted using the following opportunity:
    • PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
  • All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
    • Application Due Date(s) January 31, 2024, by 5:00 PM local time of applicant organization
    • For funding consideration, applicants must include NOT-OD-24-032 (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:

Damiya (Miya) Whitaker, Psy.D., M.A.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-8206
Email: [email protected]