The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional) | RFA OD 19 029

Frequently Asked Questions (FAQs)

What is the title and opportunity number for this NIH funding opportunity?

The funding opportunity is titled "The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)" and the opportunity number is RFA-OD-19-029.

Which federal agency is sponsoring this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What is the main purpose of this FOA?

This FOA supports investigator-initiated R01 research projects that deepen understanding of how sex and gender, separately and together, shape health outcomes and disease processes. It specifically encourages studies that move beyond using sex or gender as simple demographic variables and instead explicitly test how biological sex and sociocultural gender factors interact.

What does the FOA mean by focusing on the "intersection" of sex and gender?

It means designing research that examines how biological sex-linked factors and sociocultural gender-related exposures jointly influence health and disease. The emphasis is on studying their combined and interacting effects on outcomes such as risk, resilience, diagnosis, treatment response, disease progression, and overall health outcomes.

What kinds of research questions are considered responsive to this opportunity?

Responsive projects are those that meaningfully advance knowledge about the roles of sex and gender (individually and in combination) in health and disease. The FOA highlights questions related to differences across populations and contexts when both sex-linked biology and gender-related exposures are considered, including impacts on risk, resilience, diagnosis, treatment response, progression, and outcomes.

Does the FOA require applicants to propose a clinical trial?

No. The FOA is "clinical trial optional," meaning clinical trials may be proposed but are not required. Applications may include clinical trials, observational cohort studies, mechanistic laboratory studies, or other approaches, as long as the project fits the R01 scope and addresses the FOA emphasis.

What research areas or methodologies does NIH allow under this FOA?

The FOA allows a wide range of research, including basic, translational, clinical, behavioral, and population-based research, provided the proposed work is rigorous, hypothesis-driven, and centered on sex and gender influences and their intersection in health and disease.

How does this FOA relate to the Trans-NIH Strategic Plan for Women's Health Research?

The FOA invites projects that align with and advance one of the five research priorities in the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research, "Advancing Science for the Health of Women." Applicants may focus directly on sex and gender intersection questions or frame the work to address a strategic priority for women's health research where sex and gender factors are relevant and scientifically important.

Who coordinates funding and oversight for this program within NIH?

Funding administration is coordinated through the NIH Office of Research on Women's Health (ORWH), in partnership with participating NIH Institutes and Centers. Funds are made available by ORWH and scientific partners across NIH.

What does it mean that this is a trans-NIH effort?

It signals NIH-wide interest in the topic area and cross-cutting involvement of multiple NIH Institutes and Centers. In practical terms, a broad range of diseases, body systems, and research approaches may be considered responsive, as long as the application clearly addresses the FOA emphasis on sex and gender influences and their intersection.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R01 research project grant mechanism and is described as supporting investigator-initiated R01 projects.

What type of grant is this categorized as?

The opportunity is categorized as a discretionary grant.

What CFDA numbers are associated with this FOA?

The FOA is associated with multiple CFDA numbers: 93.113, 93.121, 93.172, 93.213, 93.242, 93.273, 93.279, 93.313, 93.361, 93.855, and 93.866.

Which organizations are eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.

Are minority-serving institutions specifically mentioned as eligible applicants?

Yes. The FOA explicitly highlights eligibility for Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are faith-based and community-based organizations eligible to apply?

Yes. The FOA identifies faith-based or community-based organizations among eligible applicant categories.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA lists U.S. territories or possessions as eligible applicant categories.

Are federal agencies eligible to apply?

Yes. The FOA includes eligible federal agencies among the eligible applicant categories.

Can a foreign (non-U.S.) organization apply as the applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization under this FOA.

Can a non-domestic component of a U.S. organization apply as the applicant?

No. The FOA states that non-domestic components of U.S. organizations are not eligible to apply.

Are foreign components allowed in a project led by a U.S.-based applicant?

Yes. Foreign components, as defined under the NIH Grants Policy Statement, are allowed. This generally means a U.S.-based applicant may include certain foreign collaborations or elements when well-justified and compliant with NIH policy.

What is the original close date listed for this opportunity?

The original close date provided is 2021-11-26.

What is the creation date listed for this opportunity?

The creation date provided is 2019-09-27.

Does the listing provide an award ceiling or the expected number of awards?

No. The provided text does not specify an award ceiling or an expected number of awards.

What should applicants do if they need budget expectations or other detailed application requirements?

Because the provided listing does not include an award ceiling, expected number of awards, or detailed budgetary expectations, applicants would typically consult the full FOA or relevant NIH guidance for institute-specific interests and application requirements.

What is the broader goal of funding research at the intersection of sex and gender?

The broader goal described is to generate higher-quality evidence on how sex and gender influence health, with the long-term aim of improving prevention strategies, diagnostics, and interventions that work effectively across diverse groups by treating sex and gender as scientifically meaningful drivers of variation.

Is this opportunity limited to any specific disease area?

The provided information does not limit the opportunity to a single disease area. It emphasizes broad relevance across conditions, consistent with trans-NIH participation, as long as the project clearly addresses sex and gender influences and their intersection.

Does the FOA emphasize a particular style of study design?

Yes. The FOA emphasizes rigorous, hypothesis-driven research that explicitly tests how sex-linked biology and gender-related factors interact, rather than treating sex or gender as basic demographic covariates.