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At SWHR, we believe that one of the keys to closing the historical gap in women’ through innovative and diverse partnerships. To learn more, please contact our Development Department at development@swhr.org or 202-496-5001.
While the terms sex and gender are often used interchangeably in society, they have distinct definitions that apply in scientific research. Both sex and gender are variables that should be considered in scientific research, from the development and design of studies to the analysis and reporting of study results.
Sex is a multidimensional biological construct based on anatomy, physiology, genetics, and hormones. These components are sometimes referred to together as “sex traits.”*
Gender is broadly defined as a multidimensional construct that encompasses gender identity and expression, as well as social and cultural expectations about status, characteristics, and behavior as they are associated with certain sex traits. Understandings of gender vary throughout historical and cultural contexts.*
*Definitions pulled from the NIH Office of Research on Women’s Health
Women were actively excluded from participating in most clinical trials. Why? Because of the persistent idea that female hormonal cycles were too difficult to manage in experiments — including the fear of harming potential pregnancies — and that using only one sex would reduce variation in results. This exclusion of females in health research wasn’t just limited to humans. It extended to research on female animals, cells, and tissue. Researchers assumed that they could simply extrapolate their male-only study results to females, a dangerous precedent that overlooked fundamental differences between women and men.
Fortunately, thanks to advocacy by the Society for Women’s Health Research and other groups, Congress passed the National Institutes of Health Revitalization Act of 1993, mandating the inclusion of women and minorities in NIH-funded clinical trials. In the same year, the Food and Drug Administration changed its policies to require the inclusion of women in efficacy studies and in the analysis of data on sex differences.
Then, in 2016, the NIH implemented a new policy stating that sex as a biological variable should be factored into preclinical research and reporting in vertebrate animal and human studies. Today, all NIH-funded researchers must either include both female and male research subjects or explain why they do not.
Although researchers have been playing catch-up for the past couple of decades, this longtime bias put the health of women at risk and created a huge gap in knowledge about women’s health and the role that differences between women and men play in health and disease.
SWHR is addressing unmet needs and research gaps in women’s health created by this historical bias in research and medicine. Each day in our work, we are identifying clinical and research gaps; raising awareness of diseases, conditions, and life stages that differently, disproportionately, or exclusively affect women; and promoting policies that could positively shape health outcomes for women.
At SWHR, we believe that one of the keys to closing the historical gap in women’ through innovative and diverse partnerships. To learn more, please contact our Development Department at development@swhr.org or 202-496-5001.
Both sex and gender influence health across the lifespan, and SWHR strives to comprehensively address both sex and gender as they relate to women’s health. When citing research, SWHR uses terminology consistent with what is used in the cited study. As inclusive language practices continue to evolve in the scientific and medical communities, we will reassess our language as usage to promote accuracy and inclusivity. Please note that not all language will be updated retroactively.
SWHR acknowledges that there are valued groups of people that may benefit from our materials who do not identify as women. We encourage those who identify differently to engage with us and our content.