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

Opportunity Information: Apply for RFA OD 19 029

The NIH funding opportunity titled "The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)" (RFA-OD-19-029) supports investigator-initiated R01 research projects that deepen understanding of how sex and gender, separately and together, shape health outcomes and disease processes. The central aim is to move beyond treating sex or gender as simple demographic variables and instead encourage studies that explicitly test how biological sex and sociocultural gender factors interact to influence risk, resilience, diagnosis, treatment response, progression, and outcomes across conditions. The FOA also invites projects that align with and advance one of the five research priorities laid out in the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research, "Advancing Science for the Health of Women," meaning applicants can either focus directly on sex and gender intersection questions or frame their work to address a strategic priority for women's health research where those factors are relevant and scientifically important.

Mechanistically, the announcement is designed to stimulate rigorous, hypothesis-driven work that can clarify why health and disease patterns differ across populations and contexts when sex-linked biology and gender-related exposures are both considered. This can include basic, translational, clinical, behavioral, and population-based research, and the "clinical trial optional" designation means applicants may propose studies that include clinical trials, but they are not required to do so. In practice, this flexibility allows projects ranging from mechanistic lab studies to observational cohort research to interventional studies, as long as the proposed work meaningfully advances knowledge about the roles and intersection of sex and gender in health and disease and fits the R01 scope.

Funding administration is coordinated through the NIH Office of Research on Women's Health (ORWH) in partnership with participating NIH Institutes and Centers, using funds made available by ORWH and scientific partners across NIH. This matters for applicants because it signals a trans-NIH interest in the topic area and typically implies that a broad range of diseases, systems, and methodological approaches may be considered responsive, provided the proposal clearly addresses the FOA's emphasis on sex and gender influences and their intersection. The opportunity is categorized as a discretionary grant, using the R01 mechanism, and 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, 93.866), reflecting the cross-cutting involvement of different NIH components.

Eligibility is broad and includes many common U.S.-based applicant types: 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. The FOA explicitly highlights additional eligible applicant categories such as 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), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws clear boundaries around foreign participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, which generally means a U.S.-based applicant may include certain foreign collaborations or elements when well-justified and compliant with NIH policy.

Key administrative details provided include the opportunity number (RFA-OD-19-029), the sponsoring agency (National Institutes of Health), the original close date (2021-11-26), and the creation date (2019-09-27). The listing does not specify an award ceiling or expected number of awards in the provided text, so applicants would typically look to the full FOA or NIH guidance for any budgetary expectations, institute-specific interests, or application requirements. Overall, the program is best understood as an NIH-wide push to generate higher-quality evidence on sex and gender influences in health, encouraging researchers to design studies where sex and gender are treated as scientifically meaningful drivers of variation rather than afterthoughts, with the longer-term goal of improving prevention strategies, diagnostics, and interventions that work effectively across diverse groups.

• The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.213, 93.242, 93.273, 93.279, 93.313, 93.361, 93.855, 93.866.
• This funding opportunity was created on 2019-09-27.
• Applicants must submit their applications by 2021-11-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA OD 19 029

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