NIH R01: The Intersection of Sex and Gender Influences on Health and Disease

Funding Opportunity Number: RFA-OD-22-028

Deadline: November 22, 2024

Research Objectives and Scope

This announcement solicits research to target gaps in knowledge regarding the influence and intersection of sex and gender on disease conditions to improve our understanding of the factors and mechanisms underlying sex differences in health. The primary objectives of this announcement include: (1) research applications that examine sex and gender factors and their intersection in understanding health and disease; and (2) research that addresses one of the five objectives from Strategic Goal 1 of the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research.

To be responsive to this FOA, applications must address each of the following three variables, and their intersection, in the context of advancing a better understanding of health and disease and as relevant to the current research investigation:

(1) Sex-based variables: including but are not limited to anatomical and physiological traits that include external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones, evaluation of sex as a biological variable; sex-based comparisons on conditions in females and males; or biomarkers.

(2) Gender-based variables: Including but not limited to social, environmental, cultural, and behavioral factors including gender identity, as an element of a person’s individual identity; or gender expression.

(3) One of the five objectives from Strategic Goal 1 of the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research.

The strategic plan for Goal 1 has the following objectives:

1.1 Discover basic biological differences between females and males. Studying female and male cells, organs, and biological systems is necessary to improve our understanding of the mechanisms by which sex influences health and disease.

1.2 Investigate the influence of sex and gender on disease prevention, presentation, management, and outcomes. Sex and gender factors and their intersection influence the course of many diseases, including risk and protective factors, presentation, treatment, and recovery

1.3 Identify the immediate, mid-, and long-term effects of exposures on health and disease outcomes. Various types of exposures affect disease risk across different timescales, ranging from an immediate outcome at the time of exposure to a delayed outcome that becomes evident at a later stage in life.

1.4 Promote research that explores the influence of sex and gender on the connection between the mind and body, and its impact on health and disease.

1.5 Expand research on female-specific conditions and diseases, including reproductive stages, and maternal and gynecologic health. Maternal health is critically important to the health of a woman during pregnancy and throughout her life-course, and for the health of her children. Because the maternal mortality rate in U.S. women is on the rise (GBD 2015 Maternal Mortality Collaborators, 2016, particularly in women of color, investigation of disparities in mortality and morbidity related to pregnancy is needed.

In addition, applications submitted in response to this FOA are encouraged to consider:

Health Disparities: Women are disproportionately affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment. Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, culture, education, sexual orientation, gender expression or identity, , access to care, and quality of care. .

Life-course/Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age. Women’s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and the frail elderly. Each of these factors may influence health, disease, lifestyle, treatment choices, and response to therapy.

For more detailed information, please see the opportunity webpage.