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-22-208

Key Dates

Release Date:

September 7, 2022

First Available Due Date:
January 31, 2023
Expiration Date:
February 01, 2023

Related Announcements

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

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)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

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)

Sexual and Gender Minority Research Office (SGMRO)

National Cancer Institute (NCI)

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 Nutrition Research (ONR)

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. Robust studies exploring sex and gender influences and social determinants of health are needed to reduce inequities. The proposed research must address at least one objective from 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.

Background

Women account for over half of the U.S. population, according to the U.S. Census Bureau. Women and girls belonging to certain populations - including, but not limited to, NIH-designated health disparities populations; persons experiencing homelessness, institutionalization, or incarceration; persons having physical, intellectual, or sensory disabilities; and immigrants—bear a disproportionate burden of health risks, disease prevalence, and poorer health outcomes. Additionally, underrepresentation in data reporting and biomedical research hinders unique opportunities to learn more about associations between personal identity, sociocultural factors, and health.

There is a complex intersection of internal biological (e.g., hormonal function) and external social and structural forces (e.g., social determinants of health, experiences of trauma) that play a 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 consists of U.S. government-sourced, population-based health, and disease data. This publication highlights the urgent need to improve understanding of the etiologies of health and health care inequities among populations of women disadvantaged by social determinants of health (e.g., racism) and the mechanisms that contribute to the downstream health effects.

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, morbidity, and mortality, across socioecological domains and levels of influence. To help meet group- and population-level needs with culturally and contextually relevant approaches, this NOSI also encourages thoughtful incorporation of intersectionality into research by applying the NIMHD Minority Health and Health Disparities Research Framework. Lastly, the COVID-19 pandemic has magnified longstanding challenges and barriers. This NOSI will support work to address the challenges faced by women and girls with respect to gendered work, lower paid positions/economic instability, gender-based violence, and unsafe housing—including when they intersect with bias and discrimination associated with race, sexual orientation, disability, age, and socioeconomic status. To strengthen and accelerate multidisciplinary disparities research in women’s health, this opportunity encourages the partnership of junior and senior investigators, as well as experienced women’s health researchers, with those with expertise in health disparities.

Specific Areas of Research Interest

This NOSI will support projects highlighting common sources of inequities in women and girls’ health, with a specific emphasis on those that integrate measures beyond the individual level and consider perspectives from multiple disciplines. 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 systemic 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
  • Studies exploring chronic debilitating conditions and multimorbidity in specific communities of women (i.e., women affected by autoimmune and neurological conditions, mental health disorders, disorders of the uterus, and gynecologic and breast cancers) and the impact of evidence-based care coordination models on outcomes and trajectories of multimorbidity
  • 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 systemic barriers to healthcare utilization
  • 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 investigating the risk factors associated with COVID-19 disease prevalence among underserved and underrepresented populations of women (e.g., women frontline healthcare workers, women with low socioeconomic status, pregnant and lactating women, and women experiencing homelessness or having justice system involvement)
    • Studies exploring caretaking responsibilities and resilience in the context of the COVID-19 pandemic
    • 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 to accelerate research on technologies to overcome barriers and increase uptake of effective therapeutics and vaccines at the point of care (e.g., FQHCs, community hospitals, Indian Health Service affiliated hospitals/health facilities)
  • 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 where principles of computational modeling are employed to explore sex and/or gender differences and/or health disparities questions relevant to psychopathology, with an emphasis on models with the potential to lead to clinically useful applications/intervention insights for populations of women
  • Primary and secondary data analysis examining clinical differences among populations of understudied and underrepresented 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, RC4, RM1, S06, S11, U01, U10, U19, U2C, 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.

Note: Specific aims added to the parent grant per SARS-CoV-2/COVID-19 Competitive Revisions process are considered as part of the parent application and are eligible to apply for a supplement under this NOSI.

PDs/PIs of the activity mentioned above codes must also fulfill all 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 proposals studying SARS-CoV-2 or COVID-19. Please contact the ORWH scientific contact for approval.
  • 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 up to $2 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 – July/August 2023
     

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.

Application and Submission Information

  • The process for streamlined submissions using the eRA Commons cannot be used for this initiative.
  • 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, 2023, by 5:00 PM local time of applicant organization
    • For funding consideration, applicants must include NOT-OD-22-208(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: damiya.whitaker@nih.gov