The Office of Research on Women’s Health (ORWH) was the first Public Health Service office dedicated specifically to promoting women’s health. ORWH was established on September 10, 1990, by then–Acting Director of the National Institutes of Health (NIH) William F. Raub, Ph.D., in response to concerns about the lack of the inclusion of appropriate numbers of women in clinical research.
In 1993, Congress passed the NIH Revitalization Act, which, among other things, established ORWH in statute. The Director of ORWH is mandated by the act to:
- Advise the NIH Director and staff on issues related to women’s health research;
- Strengthen and enhance research related to diseases, disorders, and conditions that affect women;
- Ensure that research conducted and supported by NIH adequately addresses women’s health;
- Ensure that women are appropriately represented in biomedical and biobehavioral research supported by NIH;
- Develop opportunities and support for the recruitment, retention, re-entry, and advancement of women in biomedical careers; and
- Support research on women’s health issues.
Additionally, the act created two committees that advise the ORWH Director on topics related to women’s health research. The Advisory Committee on Research on Women’s Health (ACRWH) comprises leading non-Federal experts in many fields and provides the ORWH Director with recommendations from an external perspective. The Coordinating Committee on Research on Women’s Health (CCRWH) is a group of NIH Institute, Center, and Office (ICO) directors or their designees who can offer suggestions based on internal knowledge of NIH and its processes.
With the passage of the NIH Revitalization Act in 1993, Congress also enshrined into law the policy of inclusion of women and minorities in NIH-supported clinical research, which ORWH plays a key role in enforcing and refining. This led NIH, in 1994, to revise its inclusion policy to comply with the statutory language. The NIH Revitalization Act essentially reinforced certain existing NIH policies, stating that NIH should ensure:
- That women and minorities and their subpopulations are included in all clinical research;
- That women and minorities and their subpopulations are included in Phase III clinical trials in a way that allows for valid analysis to be performed;
- That cost is not allowed as an acceptable reason for excluding these groups; and
- That it initiates programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies
21st Century Cures Act
In 2016, Congress passed the 21st Century Cures Act, which introduced many significant changes associated with ORWH’s role in the promotion of the health of women across NIH. First, the act requires that CCRWH members, who serve as liaisons between ORWH and the ICOs, be either directors or their senior-level staff designees. The act also requires NIH Institute and Center (IC) directors to consult annually with the ORWH Director about their objectives to ensure that they are taking women into account and are focused on reducing women’s health disparities. Lastly, the strategic plans issued by the individual ICs, required at least every 6 years, must document these same priorities.
Inclusion Across the Lifespan
Another major policy set forth in the 21st Century Cures Act is the Inclusion Across the Lifespan policy, which applies to all grant applications and contract solicitations submitted on or after January 25, 2019. This policy has expanded previous policies for the inclusion of women, minorities, and children in clinical research to include individuals of all ages; states that justifications for exclusion criteria based on age must have valid ethical or scientific reasons; and requires that participants’ ages at enrollment be provided in progress reports. The 21st Century Cures Act also requires that applicable Phase III clinical trials report their results in ClinicalTrials.gov by sex/gender and by race and ethnicity.
Sex as a Biological Variable
NIH and ORWH implemented the Policy on Sex as a Biological Variable (SABV) in 2016. The SABV policy requires applicants for NIH grants for vertebrate animal and human studies to explain how they would factor sex as a biological variable into their studies or to provide scientific justification for a single-sex study.
The implementation of these policies serves as a major milestone in achieving the goals of ORWH, as they ensure that women, people of all ages, and members of underserved racial and ethnic groups are appropriately represented in clinical research and ensure that the treatments studied would be effective for these populations.
The NIH vision is that sex and gender influences are integrated throughout the biomedical research enterprise; that every woman receives evidence-based disease prevention and treatment tailored to her circumstances, needs, and goals; and that women in scientific careers reach their full potential. ORWH is continuing to work toward these aims by building on our past successes and forging an increasingly transdisciplinary path for the next generation of women’s health and sex/gender researchers.