In 2001, the Institute of Medicine published a report titled Exploring the Biological Contributions to Human Health: Does Sex Matter?, which highlighted the fact women and men are characterized by both sex and gender. In this report, “sex” referred to being male or female based on reproductive organs and biological functions assigned by chromosomal complement. “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 are 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 SABV policy issued in June 2015 (NOT-OD-15-102, NOT-OD-15-103).
The sex/gender administrative supplements program supports 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 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 FY 2020 (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.
Since the inception of this program in FY 2013, ORWH has invested $38.87 million to support 383 investigators across many NIH ICOs to explore sex/gender influences in preclinical and clinical studies. To further advance this important but underappreciated area of research, ORWH has committed $1 million in funds for FY 2021.