Filling the Regulatory Gap: Potential Role of Institutional Review Boards in Promoting Consideration of Sex as a Biological Variable

Abstract

Consideration of sex differences in biomedical research is crucial to ensure the safety and effectiveness of drugs and devices for both sexes and to improve the rigor and reproducibility of scientific discoveries. Historically, women were underrepresented in clinical research and sex differences typically were not considered. The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have played a role in improving the representation of women in clinical trials and in encouraging the consideration of sex differences. As it is not appropriate for all studies to be reviewed by the FDA nor do all studies have NIH funding, this results in a regulatory gap. We propose that local institutional review boards (IRBs) and institutional animal care and use committees (IACUCs) provide greater oversight by encouraging researchers to consider sex as a biological variable (SABV) during protocol review. In this perspective article, we review how FDA and NIH policies have fostered change and highlight how IRBs and IACUCs could encourage investigators to consider SABV.