ORWH was established in September 1990 in response to congressional, scientific, and advocacy concerns that a lack of systemic and consistent inclusion of women in NIH-supported clinical research could result in clinical decisions being made about health care for women based solely on findings from studies of men—without any evidence that they were applicable to women. ORWH is part of the Office of the Director of NIH, and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH—and throughout the scientific community.

The establishment of the Office heralded earnest efforts by NIH to develop a research agenda addressing gaps in scientific knowledge about women's health across the lifespan and to increase the number of scientists pursuing investigations with a scientific design that would reveal sex/gender differences in outcomes. These aims were articulated in the first ORWH agenda-setting report, Report of the National Institutes of Health: Opportunities for Research on Women's Health (commonly referred to as the Hunt Valley report).

In 1997, ORWH undertook a second systematic program of collaborative planning and convened a series of public hearings and scientific workshops that culminated in the publication of the Agenda for Research on Women's Health for the 21st Century. That agenda expanded the vision for NIH, going "beyond Hunt Valley" to highlight the importance of promoting interdisciplinary, collaborative research; studying and addressing the health differences and needs of all populations of women; and increasing the diversity of the biomedical workforce.

Accomplishments

Thirty years after the establishment of ORWH, significant progress has been achieved in four benchmark areas: (1) policies have been developed and implemented to ensure the inclusion of women in NIH clinical research; (2) women's health and sex differences research has increased; (3) new programs have been implemented to prepare researchers to conduct women's health research; and (4) there has been new focus on interdisciplinary career development and sex/gender differences research across the research continuum. Consequently, reports on sex/gender-related factors in health and disease and analysis of clinical trials by sex of participants have steadily increased in the scientific literature.

Over the years, the biennial reports of the Advisory Committee on Research on Women's Health, in collaboration with the NIH Coordinating Committee on Research on Women's Health, attest to the attention and greater appreciation that has developed for women's health and sex/gender differences research in the design of studies and the translation of findings into clinical practice. The growth of NIH-funded women's health research addressing the expanded concept of women's health across the lifespan—including more than just the reproductive years while continuing to explore understudied areas of reproductive health and the menopausal transition—has been impressive. Additionally, increasing numbers of investigator-initiated women's health research in areas such as cardiovascular disease and stroke, musculoskeletal and immune disorders, and mental health and substance abuse, among many others, reflect enormous progress.

As a result of the increased attention to women's health research funded by the NIH Institutes and Centers, women's health scientists, providers, and advocates have gained a strong sense of their capacity to effect change. Research on women's health has become a tangible reality.

Furthermore, women's health, sex differences, and interdisciplinary women's health research have become distinct research career paths in multiple fields, a testament to the success of two ORWH signature programs: Building Interdisciplinary Research Careers in Women's Health (BIRCWH), established in 1999, and the interdisciplinary Specialized Centers of Research Excellence (SCORE) on Sex Differences, established in 2002.