Biomedical research has a history of excluding females as research subjects, which threatens rigor, reproducibility, and inclusivity. In 2016, to redress this bias, the U.S. National Institutes of Health (NIH) implemented a policy requiring the consideration of sex as a biological variable (SABV) in all studies involving vertebrate animals, including humans. Unless strongly justified, females and males must be included in all studies and results reported disaggregated by sex. Recent evidence indicates, however, that misunderstandings of the policy and other significant barriers impede its implementation. To shed light on those barriers at our home institution, we conducted a study funded by the Emory University Specialized Center of Research Excellence on Sex Differences (SCORE). In semistructured interviews of Emory principal investigators in the biological sciences, we noted their knowledge of what the policy entails and why it was implemented, their attitudes toward it, and the extent to which it has or has not changed their research practices. Although attitudes toward SABV were generally positive, most researchers face challenges with respect to its implementation. We suggest interventions that can be mounted at the level of home institutions, such as raising awareness of locally available core facilities, to help address these challenges. More training is needed on what the policy asks of researchers, how sex is defined, the nonhormonal ways that sex differences can manifest, and best practices for statistical analysis of sex-based data. Home institutions may also want to explore ways to lessen the stress associated with rollout of SABV policy.
Keywords: NIH policy; preclinical research; sex as a biological variable; sex-inclusive research.