The Office of Research on Women's Health (ORWH) announces the availability of administrative supplements to support research highlighting health disparities among women in the US who are underrepresented, understudied, and underreported (U3) in biomedical research. 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."

Background

NIH encourages and supports biomedical research that serves the entirety of the population of women in the US. However, there is a disproportionate burden of disease that exists in a significant subpopulation of women, including racial and ethnic minorities, immigrants, those living in poverty, and those in both rural and urban areas. These subpopulations are diverse and are not mutually exclusive. Women and girls in these subpopulations bear a disproportionate burden of health risks and conditions compared to the general US population but are often underrepresented and understudied in clinical and biomedical research and underreported in surveillance data. Similarly, women with physical, intellectual, and developmental, and sensory disabilities also are often underrepresented in biomedical research. When women are not well represented in clinical research subsequent interventions may not be relevant to the health of women https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425923/

Understudied and underreported subpopulations represent an increasing percentage of the US population and bear a disproportionate burden of health risk, poorer health, and disease prevalence. In 2014 ORWH published "The Women of Color Health Data Book, 4th edition" (https://orwh.od.nih.gov/sites/orwh/files/docs/WoC-Databook-FINAL.pdf), which consists of US Government sourced, population-based health and disease data which highlights these health disparities. Additionally, women in a sexual minority (including but not limited to transgender and intersex women) are often underrepresented in biomedical research as well as in data reporting, failing unique opportunities to learn more about not only the differences among men and women, but also the effects of the hormonal milieu that differs from that expected based upon biologic sex alone.

The health of women is affected by a multitude of factors acting across the life course. The complex intersection of these internal (e.g., genetics) and external (e.g., social determinates) factors play a crucial role in the health status, disease presentations, and treatment responses of women as well as the effects of diseases and conditions on women's quality of life. Thus, consideration of a multidimensional framework (Schweinhart and Clayton, 2018) is needed to improve the quality of women's lives, reduce their disease burden across the life course, and address health disparities for populations of women at most considerable risk for certain diseases.

Interdisciplinary research initiatives integrating perspectives from multiple disciplines as well as researchers with diverse skills, knowledge, and experiences are crucial to capturing the complex interplay of various factors affecting the health of all women. Therefore, this NOSI encourages research on emerging topics that include collaborations across a range of disciplines including but not limited to economics, medical anthropology, psychology, sociology, and demography to address areas in the fuller context of women's lives and the underlying common root causes of poorer health outcomes.

Specific Areas of Research Interest

The NOSI will support projects that highlight common sources of disparities in women's health. The common pathways for the manifestations of ill health and disease, differential risk, risk exposure, resilience, morbidity, and mortality at the individual, community, and national levels are areas of particular research interest. This NOSI provides the following descriptions for the applicants to consider:

• Primary and secondary data analysis and reporting of sex -and gender-based data, race and ethnicity data, and their intersection in clinical research, including subgroup analyses of existing data to examine clinical differences among women of diverse racial and ethnic backgrounds, women in sexual and gender minority, women with physical, intellectual and developmental, and/or sensory disabilities.
• Identify evidence-based methods and intervention for reaching out to women and girls who are under-represented in the proposed study and describe why selected methodology is appropriate for the project.
• Develop new and effective statistical methods, and sampling techniques in small study sample to include understudied and underreported sub-population groups of women, if applicable.
• Identify the process of novel dissemination and implementation approaches currently or previously implemented in the field or identified in the scientific literature.
  Areas of scientific interest include but are not limited to the study of subjects of U3 populations, and the comparison of their outcomes in the following general areas:

• Sensitivity and specificity of biomarkers, screening, diagnosis of disease risk, prognosis, or benefit of treatment.
• The effect of violence, including intimate partner violence across the lifespan, including elder abuse, abuse during pregnancy, and its subsequent impact upon the infant/child.
• Evidence-based interventions to improve outcomes in women who have experienced gender-based violence.
• The role of limited access to health care on care-seeking behavior and outcomes in geographically isolated populations of understudied and underrepresented women.
• Factors contributing to disparities in reproductive health and/or gynecologic conditions, and their impact on risk factors, diagnosis, treatments, and health outcomes.
• Maternal morbidity and mortality including the effect of maternal morbidities on health conditions throughout a women’s life course.
• Chronic diseases that demonstrate health disparities in specific communities of women.
• Exposure assessments and disease outcomes in understudied women.
• Disparities in economic hardship (e.g., low socioeconomic status) and its effect on the risk of disease (e.g., epigenetic), disease development (e.g., lack of safe open spaces for activity and the development of obesity; mental and physical consequences of early genital trauma), premature aging, and increased morbidity or mortality.
  Interdisciplinary and transdisciplinary areas of scientific interest include but are not limited to:

• Studies that explore the intersections of social determinants such as education, socioeconomic status, culture, built environment on health outcomes, and risk for poor health outcomes in diverse populations of women; women are suffering from intellectual and developmental disabilities.
• Studies that will fill out the gap focusing on inclusion of critical subpopulation of women who do not reside in households, e.g., homeless, institutionalized, or incarcerated, to ensure these gaps in surveillance addressed through a research program.
• Studies that encompass our understanding of the mutable causes of disparities in HIV risk, presentation for care, care engagement, linkage to care, and treatment adherence for female, transgender, or intersex individuals across the lifespan.
• Studies that foster our understanding of the influence alone or in a combination of exogenous factors such as stigma, racism, classicism, residential segregation, historical trauma (as examples) on risk for disease, disease progression, health care engagement, and retention, disease morbidity and mortality.

Eligibility

Only PDs/PIs of an active P01, P20, P30, P50, P60, P2C, S06, U10, U19, U2C, U54, UC2, UM2, R01, R15, R21, R24, R25, R33, R34, R35, RC4, S11, U01, UM1, UP5 award from NIH are eligible to apply. The PDs/PIs are encouraged to apply electronically.

PDs/PIs of the activity, as mentioned above, must also fulfill all the following mandatory requirements; otherwise, their applications will not be responsive for this NOSI.

• There should 16 months remaining in the project period of the parent grant. The no-cost extension is not eligible.
• Only one U3 Admin. Supp. Award permitted to a peer-reviewed NIH funded grant in one grant cycle.
• 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 US Organizations are not eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Budget

• $2,000,000 is expected to be available annually for funding this program.
• The budget should not exceed $140,000 direct costs for the administrative supplement per year. In addition to the direct cost, applicable F&A (indirect) cost 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 2020 and July/August 2021

Scientific Review Process

NIH program staff will conduct administrative reviews of submitted applications and will support the most meritorious applications submitted for consideration, pending availability of funds.

Scope of Support

Administrative supplements can be used to meet increased costs that are within the scope of the approved award, but that were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted. Applicants should propose research that, if successful, would contribute to a greater understanding of the health and wellbeing of underrepresented, understudied, unreported women in the US population.

IC-Specific Considerations

It is strongly recommended that the applicant contact their respective program officers at the Institute supporting the parent award to confirm ahead of time that the supplement falls within the scope of the parent award.

Application and Submission Information

PA-18-591 - 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-18-591 must be followed, with the following additions:

• Application Due Date(s) January 28, 2020, January 21, 2021, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-OD-20-048 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.
• Requests must be for one year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• 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.

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOSI to facilitate efficient processing of the application.