The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)

The NIH is offering funding through the R01 Research Project Grant mechanism for studies focused on the intersection of sex and gender influences on health and disease. This funding opportunity invites applications that explore sex and gender factors in health research, as well as projects that address specific objectives from the Trans-NIH Strategic Plan for Women’s Health Research, particularly in enhancing understanding of the role of sex and gender in various health conditions. Participating NIH Institutes and Centers will provide funding through the Office of Research on Women’s Health (ORWH) to support successful proposals in line with this mission. The primary goal of this initiative is to address gaps in understanding how sex and gender intersect to influence health outcomes, including disease prevalence, management, and treatment responses. Eligible research includes examining sex-based biological factors (such as genetics or hormone influence) alongside gender-based social and cultural influences. Research under this grant may also address any of the five specific objectives of Strategic Goal 1, including understanding biological sex differences, effects of exposures over time, and impacts on maternal and gynecologic health. These areas of focus align with a broader NIH commitment to integrate sex and gender as critical variables in health research. Funding availability for this grant program depends on NIH budget appropriations, with approximately $3 million estimated for up to seven awards per receipt date. Applicants may request a maximum of $350,000 per year for up to four years. Applications are open to a range of eligible entities, including higher education institutions, nonprofits, for-profit organizations, and government bodies. Non-U.S. institutions cannot apply directly, though foreign components within U.S.-based projects are allowed. Applications must comply with NIH submission protocols, including SAM, Grants.gov, and eRA Commons registrations. Proposals should follow the SF424 (R&R) Application Guide, emphasizing the incorporation of sex and gender variables, strategic plan objectives, and a detailed Data Management and Sharing Plan. Letters of intent are requested 30 days prior to the deadline, though not required. Due dates for application submission are set for November 22 annually through 2024, with reviews concluding in March and anticipated funding start dates in July of each cycle. NIH will evaluate applications through scientific peer review based on significance, innovation, research strategy, and investigator qualifications, with a separate review for clinical trials where applicable. Proposals that address public health challenges related to sex and gender in health, especially within underserved populations, may have strategic priority. Following peer review, proposals will undergo a secondary review by an NIH Advisory Council. Applicants are encouraged to consult with program staff at ORWH for guidance and to ensure compliance with NIH policies on data sharing, use of human subjects, and inclusion across diverse populations.