in two general areas. Not only are biologic sex and gender insufficiently reported within research studies, but women are also underrepresented as basic and clinical researchers in academic medicine. While these issues may seem unrelated, addressing both will diversify knowledge and interdisciplinary research teams, as well as improve the value of the science produced and ultimately the quality of health care provided.
In 1986, the National Institutes of Health instituted a policy urging the inclusion of women as subjects in clinical trials. This policy became law when Congress passed the NIH Revitalization Act of 1993, which requires that NIH-supported clinical research include women and minorities as subjects “in approximately equal numbers of both sexes … unless different proportions are appropriate because of known prevalence, incidence, morbidity, mortality rates, or expected intervention effect.” Women of childbearing potential cannot be routinely excluded without a strong scientific rationale.
Dr. Stacie Geller
Despite these initiatives, evidence suggests that sex/gender is still not sufficiently considered as a biologic variable in federally funded research, and studies oftentimes fail to account for the cultural and societal influences of gender in health outcomes. Women comprise more than half of clinical trial participants, yet 75% of federally funded studies published in 2009 failed to report any outcomes by sex/gender. Recent events, such as the Food and Drug Administration’s updated Ambien dosage recommendation for men versus women, demonstrate the harmful effects of failing to account for sex as a biologic variable.
In recognition of the slow progress, the NIH required that research grants submitted after Jan. 25, 2016, address biologic sex within their research design and added reviewer criteria related to consideration of biologic sex in the research proposal. Ensuring enhanced inclusion, analysis, and reporting of sex and gender goes beyond NIH policy to include NIH enforcement of its own policies. In addition, journal editors should add review criteria related to sex and gender, and researchers themselves should examine potential sex/gender differences in their research.
Abby Koch
The NIH and ORWH have implemented various programs to diversify the sciences; however, change has been less than desired. Studies indicate that females have lower publication rates throughout their careers, and are less likely to receive an R01 than men, despite reporting equal likelihood of applying for R01 awards. Additionally, the intraorganizational and network reach of female scientists is smaller than that of men, hindering opportunities for collaboration and publication. Even in the instance of equally qualified men and women conducting comparable work, investigators find differential pay between male and female researchers, as well as differential promotion to leadership positions. These factors, both in part caused by and exacerbated by unconscious or implicit interpersonal and institutional biases, lead to higher female attrition within the sciences and academia.
Addressing disparities and promoting greater inclusion includes unmasking unconscious bias and putting greater efforts toward mentoring and leadership initiatives for women. Only by partnering efforts to increase inclusion of sex/gender within research design with efforts to diversify the biomedical workforce can we adequately consider the role of sex and gender in biomedical research.
Dr. Geller is the G. William Arends Professor of Obstetrics and Gynecology at the University of Illinois College of Medicine, and the Director of the UIC Center for Research on Women and Gender. Ms. Koch is a senior research specialist at the Center for Research on Women and Gender. They reported having no financial disclosures.