Implementation of the NIH Sex-Inclusion Policy: Attitudes and Opinions of Study Section Members

J Womens Health (Larchmt). 2019 Jan;28(1):9-16. doi: 10.1089/jwh.2018.7396. Epub 2018 Dec 8.


Objective: On January 25th, 2016, the National Institutes of Health (NIH) implemented a policy requiring investigators to consider sex as a biological variable (SABV) within their grant submissions. We surveyed NIH study section members in 2016 and 2017 to determine their attitudes toward the policy and their perceptions regarding its implementation.

Materials and methods: Members of standing study sections and special emphasis panels who met in May, June, or July of 2016 and 2017, and had a publicly accessible e-mail address, were invited to participate in the survey (n = 4376 and n = 4710, respectively). The survey assessed participant demographics, knowledge and awareness of the SABV policy, and opinions regarding its utility and implementation.

Results: A combined total of 1161 study section members participated in the survey for a response rate of 10.2% in 2016 and 15.1% in 2017. Respondents thought it was important for NIH-funded research to consider SABV (63% vs. 68%, p = 0.141) and that it will improve rigor and reproducibility (54% vs. 58%, p = 0.208). In terms of implementation, respondents indicated that the percentage of grants, which have successfully addressed and incorporated the policy, has significantly increased over time (p < 0.0001 for all endpoints). However, open-ended comments revealed concern for federal research funding, the overuse of experimental animals, and uncertainty surrounding grant scoring, as it relates to the SABV policy.

Conclusions: In this study, we show improving attitudes toward the sex-inclusive policy at NIH and that a statistically significant number of grants are addressing sex as a biological variable appropriately in their submissions. These data suggest the policy is becoming more well accepted, and it is thus anticipated that the reproducibility of scientific reports will increase over time and new discoveries using sex as a biological variable are on the horizon.

Keywords: NIH; research policy; sex inclusion.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Biomedical Research*
  • Clinical Trials as Topic / methods*
  • Guidelines as Topic / standards*
  • Humans
  • Minority Groups
  • National Institutes of Health (U.S.)
  • Patient Selection*
  • Public Policy*
  • Sex Factors
  • United States