Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations An ORWH FY19 Administrative Supplement (Admin Supp Clinical Trial Optional) | PA 19 205

Frequently Asked Questions (FAQs) - NIH ORWH Administrative Supplement (PA-19-205)

What is PA-19-205 in plain terms?

PA-19-205 is an NIH Office of Research on Women's Health (ORWH) administrative supplement opportunity. It provides extra funding for one year to expand the scope of an already active NIH parent grant, specifically to strengthen research on women's health in U.S. populations that are understudied, underrepresented, and underreported (often described as U3 populations).

Is this funding for a brand-new, standalone research project?

No. This is an administrative supplement, not a new standalone award. The intent is to add targeted new activities (new aims, analyses, recruitment strategies, or methods) onto an existing, active NIH-funded parent grant.

What is the main purpose of the supplement?

The main purpose is to strengthen and accelerate research that addresses health disparities affecting women in NIH-designated health disparity populations in the United States, while explicitly incorporating sex and gender influences into the research design, measurement, analysis, and interpretation.

How long is the supplement period?

The supplement is designed to support a one-year targeted research expansion to the active NIH parent grant.

How much funding is available per award?

The opportunity lists an award ceiling of $140,000 for the administrative supplement.

What kinds of research activities can the supplement support?

The supplement can support research expansions such as adding new aims, conducting additional analyses, enhancing or expanding recruitment, or incorporating new methods that directly address women's health disparities and integrate sex and gender influences. The work may span preclinical, clinical, behavioral, and translational research.

Are clinical trials required?

No. Clinical trials are optional. Applicants may propose a clinical trial component if it fits the parent award and the scientific question, but a clinical trial is not required.

What is the scientific focus ORWH is emphasizing?

ORWH emphasizes research on how sex and gender interact with social determinants of health to shape human health and illness. The opportunity highlights the importance of treating sex and gender as central scientific variables rather than an afterthought.

Which social determinants of health are specifically mentioned?

The opportunity mentions social determinants such as race and ethnicity, socioeconomic status, education, health literacy, and related structural or contextual factors that influence risks, outcomes, access to care, and responses to interventions.

Do applications have to align with a specific NIH strategic plan?

Yes. Applications must align with the Trans-NIH Strategic Plan for Women's Health Research, "Advancing Science for the Health of Women," specifically Goals 1 and 2.

What does alignment with Goals 1 and 2 mean for a proposal?

Based on the description provided, alignment generally means the supplement aims should either: (1) advance rigorous, high-quality research directly relevant to women's health, or (2) develop and apply methods, approaches, or data resources that better account for sex and gender influences and thereby improve women's health research.

Is focusing on health disparity populations required?

Yes. A required element is that the proposed supplement project focuses on one or more NIH-designated health disparity populations.

Which NIH-designated health disparity populations are included?

The opportunity lists the following health disparity populations: Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities (SGM).

Does ORWH encourage intersectional approaches?

Yes. ORWH explicitly encourages intersectional approaches that combine populations or identities (for example, socioeconomically disadvantaged SGM women), recognizing that real-world patterns of unequal exposure, access, and outcomes can be missed when populations are studied in isolation.

Can the supplement focus on sex and gender influences in addition to social determinants?

Yes. The opportunity is geared toward studies that build sex and gender into the full research approach (design, measurement strategy, analysis plan, and interpretation), especially in contexts where social determinants and lived experience may change health risks, outcomes, access to care, or responses to interventions.

What types of organizations are eligible to apply?

Eligibility is described as broad across common NIH-eligible applicant types. The opportunity includes state, county, city, and special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities.

Are certain institution types specifically called out as eligible?

Yes. The opportunity explicitly mentions additional eligible categories, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and faith-based or community-based organizations. It also references eligible federal agencies, regional organizations, and U.S. territories or possessions.

Are foreign (non-U.S.) institutions eligible to apply?

No. The notice states that foreign institutions are not eligible to apply.

Can a U.S. organization include a non-U.S. component or foreign component in the project?

No. The opportunity states that non-U.S. components of U.S. organizations are not eligible and that foreign components (as defined by NIH policy) are not allowed. The work is intended to be fully domestic in scope and implementation.

What is the funding mechanism and general category of this opportunity?

The instrument is a grant and it is described as discretionary funding. It is also associated with multiple CFDA program numbers across NIH.

What is the application timing information provided?

The opportunity lists an original closing date of April 8, 2019, indicating it was a time-limited FY19 supplement call.

What makes this opportunity different from typical NIH research funding?

This opportunity is designed to leverage ongoing NIH-funded projects to produce near-term, concrete advances in women's health equity. Instead of funding a new project from scratch, it supports focused expansions to existing awards to better address sex and gender influences and health disparities among NIH-designated U.S. health disparity populations.

What is the expected emphasis regarding sex and gender in the research?

The emphasis is that sex and gender should be integrated throughout the study rather than added later. The opportunity highlights building sex and gender into the research design, measurement strategy, analysis plan, and interpretation, particularly in combination with social determinants of health.

What is ORWH ultimately trying to achieve with these supplements?

Based on the description, ORWH is aiming to strengthen the biomedical evidence base for women's health by ensuring that research includes populations in the United States that have historically been missing from studies, and by accelerating work that addresses disparities where sex, gender, and structural and social drivers of health intersect.