Opinion: Research community needs to better appreciate the value of sex-based research

Twenty-five years ago, the National Institutes of Health (NIH) Revitalization Act of 1993 mandated the inclusion of women in clinical research (1), following decades of misconceptions surrounding women’s health and reversing previous guidelines preventing women of childbearing age from participating in early-stage research (2). Many of us held tight to the belief that this requirement would usher in a new era of discovery where consideration of the female sex would become routine experimental practice both in the clinical and basic sciences. Yet today, 25 years later, women remain underrepresented as research subjects in the design and development of novel therapeutics and technologies (3⇓⇓–6). Moreover, when women are included in NIH-funded clinical research, there is often no attempt to desegregate or analyze data by sex or gender, hindering reproducibility and limiting the potential for sex-specific discoveries and our knowledge about the influences of sex or gender on health and disease (7). Our survey results suggest many study section members do not think sex is an important part of experimental design, sentiments that likely extend to the broader research community. Image credit: David Cutler (artist). Survey data we’ve collected imply a further problem. Our results suggest that nearly one-third of NIH study section members do not think it is important to consider biological sex as part of experimental design. This indicates that, although in the minority, the “gate-keepers” of federal funding do not recognize the importance of sex-based research, and these sentiments likely extend to the broader research community. To fully understand the implications of sex and gender, it’s important to outline their difference. Sex is a biological attribute of cells or organisms, defined by genetics, physiology, anatomy, and the hormonal milieu. In the context of clinical studies, male physiology differs from female physiology not only in … [↵][1]1To whom correspondence should be addressed. Email: tkw{at}northwestern.edu. [1]: #xref-corresp-1-1