The Society for Women’s Health Research (SWHR®) is the thought leader in research on biological differences in disease and is dedicated to improving women’s health through science, advocacy, and education.

SWHR advocates for greater public and private funding for women’s health research and the study of biological differences that affect the prevention, diagnosis and treatment of disease; encourages the appropriate inclusion of women and minorities in medical research studies; promotes the analysis of research data for sex and ethnic differences; and informs women, health care providers, and policy makers about contemporary women’s health issues through media outreach and periodic briefings, conferences and special events.

As a result of SWHR’s work, women are now included in medical research and clinical trials; scientists are researching the ways in which health conditions and diseases affect men and women differently and why. Through its use of evidence-based research and multi-pronged policy and public education efforts, as well as the involvement of health care providers and policy makers dedicated to improving women’s health, women’s health is now a national priority.


SWHR is the brain-child of Florence Haseltine, MD, PhD, who also coined the term “sex-based biology,” referring to the study of sex differences in health and disease. When Dr. Haseltine began working at the National Institutes of Health (NIH), she was told that her “role was to champion the field of obstetrics and gynecology,” which at the time were under-represented in research. In 1985, NIH lacked sufficient in-house expertise and funding for academic scientists. When her friend, Rosa DeLauro, developed ovarian cancer, Dr. Haseltine seized the opportunity to promote the need for more research into conditions affecting women.

In the spring of 1989, Dr. Haseltine gathered friends and colleagues from medical and scientific organizations across the country to address this critical issue. They congregated at the American College of Obstetricians and Gynecologists (ACOG) and agreed on the need not only for more gynecological research at NIH but also for research regarding women’s health in general. This meeting gave rise to SWHR.

SWHR guaranteed a dedicated leadership group of healthcare providers and others concerned with research and health care equality to provide a diverse range of perspectives. Physicians and researchers specializing in many fields, as well as nurses, lawyers, and public policy advocates interested in women’s health were included at the initial ACOG gathering, and later the first SWHR Board. SWHR opened its official headquarters in Washington, D.C. in 1993, hired a professional staff and selected Phyllis Greenberger, MSW, as the first Executive Director.

In the 1990’s, due to biases in biomedical research, the health of American women was at risk. SWHR’s all-volunteer first Board of Directors made it their priority to confront this injustice. They worked with the Congressional Caucus for Women’s Issues, its Executive Director- Leslie Primer, and Congressman Henry Waxman (D-CA) to persuade the Government Accounting Office (GAO; now the Government Accountability Office) to address the issue. They wanted GAO to evaluate NIH’s policies and practices regarding the inclusion of women and minorities in clinical trials.

The audit was successfully released at an NIH reauthorization hearing in June 1990. The NIH policy of 1986, which encouraged the inclusion of women in clinical trials, had been poorly communicated within NIH and the research community at large. Additionally, the policy was inconsistent across Institutes and only applied to extramural research (research conducted outside NIH). The GAO report concluded that there was “…no readily accessible source of data on the demographics of NIH study populations.” This made it impossible to determine if NIH were enforcing its own policy.


SWHR’s first policy efforts were addressed to Congress to change policies and regulations within the federal agencies. Within months of the June 1990 GAO audit, NIH published guidelines that required women to be included in clinical research, and established the Office of Research in Women’s Health. When NIH failed to complete these guidelines, SWHR fought for the 1993 NIH Revitalization Act, codified the requirements and mandated analyzation by sex for Phase III clinical trial results. This act also permanently established NIH’s Office of Research on Women’s Health (ORWH). In 2010, the passage of the Patient Protection and Affordable Care Act (H.R. 3590), which included the Women’s Health Office Act (WHOA) as a provision, secured offices of women’s health in other federal health agencies, among other things.

Right after the GAO audit, SWHR asked GAO to examine the inclusion of women in clinical trials used by FDA to evaluate drugs for market approval. The resulting 1993 report found that while women were sometimes included in drug trials, they were significantly underrepresented. And even when women were included, data were not analyzed to determine if women’s responses to drugs differed from men. Additionally the report revealed that insufficient numbers of women were included in pre-approval clinical trials of drugs. It concluded by recommending the FDA should ensure that drug companies consistently include “sufficient numbers of women in drug testing to identify gender-related differences in drug response and that such sex differences are explored and studied.”

Later in 1993, the FDA reversed its 1977 guidelines and published a new “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” that encouraged the inclusion of women in Phase I and II (safety and dosing) studies and required their inclusion in efficacy studies. The guideline also required analysis of data on sex differences, as well as those based on race and ethnicity.

Despite both its GAO and FDA victories, SWHR recognized that scientists still needed to be convinced of these important biological differences in order to properly design studies.

In 1996, SWHR began a six-year campaign to secure funding for an Institute of Medicine, or IOM “Committee on Understanding the Biology of Sex and Gender Differences.” SWHR then submitted a proposal to IOM to validate the concept of sex differences.

In 1999, SWHR established the national Women’s Health Research Coalition (WHRC) in order to represent a broader spectrum of health researchers, health care providers and policymakers. It now comprises more than 600 advocates from a range of academic, medical, and scientific institutions, as well as health-related associations and organizations. SWHR reaches out to health care providers and researchers in every field to conduct Congressional Hill briefings each year. These briefings inform policy makers about contemporary women’s health issues and the need for increased funding for research in women’s health and the study of biological sex differences affecting the prevention, diagnosis, and treatment of disease.

At SWHR’s request in 2000, GAO was asked to audit NIH’s practices again. GAO issued a follow-up audit to its examination of practices at NIH, concluding that “NIH has made less progress in implementing the requirement that certain clinical trials be designed and carried out to permit valid analysis by sex, which could reveal whether interventions affect women and men differently.”

Then in 2001, SWHR-backed GAO audit on FDA records revealed that eight out of the last ten drugs withdrawn from the market caused adverse effects more often in women than men. Four of these drugs were more often prescribed to women than men, which explained the higher number of negative outcomes in women. The other four appeared to present a true sex difference in the incidence of adverse effects. The GAO report concluded that “The FDA has not effectively overseen the presentation and analysis of data related to sex differences in drug development.”


In 2001, IOM published a landmark report from this committee, , Exploring the Biological Contributions to Human Health: Does Sex Matter? And subsequently answering the question with a resounding, “yes.” This IOM report established that:
• “Every cell has a sex,”
• “Sex begins in the womb,” and
• “Sex affects behavior and perception…”

The report concluded that “There is now sufficient knowledge of the biological basis of sex differences to validate the scientific study of sex differences and to allow the generation of hypotheses with regard to health. . . Naturally occurring variations in sex differentiation can provide unique opportunities to obtain a better understanding of basic differences and similarities between and within the sexes.”

Following the release of the IOM report, Exploring the Biological Contributions to Human Health: Does Sex Matter?, SWHR sponsored regional Scientific Advisory Meetings (SAMs) to educate scientists and policy makers about the IOM report.

From 2000-2006, SWHR hosted innovative conferences on Sex and Gene Expression (SAGE),which explored how sex influences the expression of genetic information from embryonic development through adulthood. SAGE conferences assembled leading researchers as well as outstanding new researchers in biochemistry, genetics, and molecular, developmental, and cellular biology. After realizing their unique and invaluable work necessitated more than an annual conference, SAGE scientists worked with SWHR staff to found the Organization for the Study of Sex Differences (OSSD) in 2006. This scientific community promotes the field of sex and gender differences research.

Another product of the 2001 IOM report, Exploring the Biological Contributions to Human Health: Does Sex Matter?, was the establishment of SWHR’s Interdisciplinary Studies in Sex-differences (ISIS) Networks. The SWHR ISIS Networks promote scientific collaborations through interdisciplinary networks focusing on distinct areas. The first network, established in 2001 and concluded in 2007, concentrated on “Sex, Gender, Drugs, and the Brain.” This network also published Sex Differences in the Brain: From Genes to Behavior. Other networks address sex differences in metabolism, musculoskeletal health, and cardiovascular disease.

In May 2005, SWHR released the groundbreaking Crisp report, showing that NIH’s support of research on biological differences between women and men was lower than the growing evidence of the importance of sex differences warranted. It also suggested that the Institutes with the largest budgets supported the least research on sex differences. SWHR discussed this report with many NIH leaders and pushed for the necessary changes., several of the Institutes comprising NIH, including the National Institute on Drug Abuse, the National Institute for Mental Health, the National Institute for Environmental Health Sciences, the National Institute on Aging, and the National Institute for Dental and Craniofacial Research, have recognized the need for sex differences research and have installed programs to fund-related research largely because of SWHR.

Many of SWHR’s endeavors have proven successful. Increasingly, those who fund biomedical research have included sex as a biological variable. Researchers have found sex differences in every tissue and organ system. The field has advanced so much that in 2006, SWHR and the Medtronic Foundation established an annual Prize for Scientific Contributions to Women’s Health to recognize a female scientist or engineer for her contributions to women’s health. The prize is intended to encourage research on issues uniquely related to women’s health and mentorship of scientists considering sex differences research.


SWHR’s first major public educational effort was the “Woman Can Do” campaign, designed to educate and recruit more women to become involved in medical research. After the regulatory changes mandated women’s participation in research, SWHR learned that researchers had difficulty finding women to participate in research studies. In 2003, nearly 90 other organizations joined SWHR’s Alliance for Women in Clinical Research to educate women about medical research and ways they can participate. SWHR continues to advise researchers, research establishments, and FDA about ways to eliminate the barriers to recruiting and retaining women in research.

SWHR conducts many other consumer education campaigns on a variety of topics, has a press service distributing news on women’s health and the latest in relevant research to national media outlets, conducts periodic media briefings and roundtables, and holds workshops for clinicians. SWHR has published the first consumer book ever to discuss sex differences, entitled, The Savvy Woman Patient: How and Why Sex Differences Affect Your Health.

In addition to providing the latest research on conditions that affect women differently from men, SWHR also emphasizes the need for women to become advocates for themselves and their families. SWHR’s educational programs and written materials, as well as the SWHR website are great sources for women and their practitioners.

Looking Forward

In 2017 the Society for Women’s Health Research is looking ahead to challenges facing the country with healthcare and health reforms. We will continue to identify the gaps in health care and research that still exist, target those differences and close the gaps. SWHR strives to ensure that women’s health remains a high priority on the national agenda and that biological differences become more widely-recognized as vital to health care treatment options. Both the size of staff and roster of volunteer leaders have grown over time to assist in these efforts. Medical, nursing, and scientific experts from a wide range of disciplines have participated in SWHR’s science programs, educational outreach and advocacy efforts.

SWHR will continue to partner with the widest possible range of healthcare providers, policy makers, and scientists to gather evidence-based information and then communicate it as appropriate to Congress, the scientific research community, health care providers, health advocacy groups and the public.