In 2001, the Institute of Medicine published a report titled  Exploring the Biological Contributions to Human Health: Does Sex Matter?, which highlighted the fact that all individuals are characterized by both sex and gender. In this report, “sex” referred generally to categories of male or female based on reproductive organs and biological functions assigned by chromosomal complement.¹ “Gender” referred to socially defined and derived expectations and roles rooted in biology and shaped by the environment and experience. Sex and gender, as defined above, are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. Consideration of these variables is critical to the accurate interpretation and validation of research findings that affect various aspects of women’s health.

In 2013, ORWH initiated an NIH-wide program to catalyze exploratory research on sex/gender differences by providing administrative supplements to existing peer-reviewed NIH-funded grants. The administrative supplements provided one-year awards of approximately $100,000 to support research projects that fell within the scope of the original parent grant. The initiative advanced research on sex/gender influences that predated the NIH sex as a biological variable (SABV) policy issued in June 2015 (NOT-OD-15-102,  NOT-OD-15-103).

The sex and gender administrative supplements program, referred to as the “SAGE program,” supported three research approaches: (1) adding the opposite sex/gender (the addition of animal or human subjects, tissues, or cells of the sex opposite to those used in the parent grant, to allow sex/gender-based comparisons); (2) increasing sample size (the addition of more animal or human subjects, tissues, or cells to a sample which already includes both males and females, to increase the power of a study to analyze for a sex/gender difference); and (3) analyzing existing data (comparative analyses of extant samples/datasets/databases and/or data mining to investigate the role of sex/gender).  

• In Fiscal Year (FY) 2019 (Funding Opportunity Announcement:  PA-19-165), ORWH awarded 26 of 75 (34.67%) applications for a total of $3.8 million across 15 NIH Institutes, Centers, and Offices (ICOs).  
• In FY20 (Notice of Special Interest:  NOT-OD-20-049), ORWH awarded 14 of 30 (46.67%) applications for a total of $2.01 million across 10 ICOs.
• In FY23 (NOT-OD-22-030), ORWH awarded 10 out of 14 (71.43%) applications for a total of $2.05 million across 10 ICOs.  

Since the inception of this program in FY13 through its sunsetting in 2024, ORWH has invested $44.62 million to support 422 investigators across many NIH ICOs to explore sex and gender influences in preclinical and clinical studies. In 2024, the SAGE program was sunset because the consideration of sex has become more integrated in research design and analysis across NIH. ORWH continues to fund research on the influences of sex and gender in health and disease through other programs, such as the Specialized Centers of Research Excellence (SCORE) on Sex Differences program and the Intersection of Sex and Gender Influences on Health and Disease (R01).

For more information, view past program summaries here:  

• FY 2015 Program Summaries
• FY 2014 Program Summaries  
• FY 2013 Program Summaries   

¹ NIH usually categorizes sex as male or female, although variations do occur. These variations in sex characteristics are also known as intersex conditions. Intersex individuals are estimated to make up approximately 1.7% of the population, although some estimates may vary, depending on clinical definitions. Transgender individuals who may have undergone gender-affirming surgery may also have sex traits that do not conform to a single sex.