Toward Sex Inclusivity: Perspectives on Sex as a Biological Variable
J Womens Health (Larchmt). 2025 Jul 7.
Authors: Mulles SM, Aziz DZ, Binion CC, Pai N, Maragos SL, Flattum ME, Kowalczyk M, Volerman A, Woodruff TK, Kibbe MR.
Abstract:
Purpose: The National Institutes of Health (NIH) policy on sex as a biological variable (SABV) was implemented in 2016 to encourage researchers to consider both sexes within their study design. However, there continues to be ongoing debate regarding the utility of this initiative. This study aimed to evaluate opinions of the SABV policy among study section members and how these varied by self-reported sex. Method: An 18-question survey was sent via email in 2023 to 20,803 study section members who participated in a review session from May 15 to July 15 in 2020, 2021, 2022, or 2023. Survey questions were based on a previously published study surveying study section members from 2016 to 2017 to allow for comparison of results. Results: A total of 3,699 individuals responded to the survey (17.7%). Among respondents, 52.1% self-identified as male, and 69.8% conduct basic/translational research. Fewer respondents received resources to learn about the policy in 2020-2023 compared to 2016-2017 (n = 2,147, 58.0% versus n = 848, 73.0%, p < 0.001). More respondents in 2020-2023 felt that considering SABV would improve the rigor and reproducibility of NIH-funded research compared to 2016-2017 (n = 2,630, 71.1% versus n = 654, 56.3%, p < 0.001). However, only 2,358 (63.7%) respondents felt it was important for all NIH-funded research to consider SABV within experimental design, similar to 2016-2017 (n = 766, 66.0%, p = 0.2). Fewer male respondents compared to female respondents felt considering SABV would improve rigor and reproducibility (n = 1,325, 68.8% versus n = 1,285, 74.6%, p < 0.001), and fewer male compared to female respondents felt it was important for all NIH-funded research to consider SABV within their experimental design (n = 1171, 60.9% versus n = 1170, 67.9%, p < 0.001). Conclusions: Since the implementation of the SABV policy, diverse perspectives continue to exist among study section members. Continued efforts are required in order to understand how sex can be incorporated into research for the benefit of all people.
doi: 10.1089/jwh.2024.1009. Epub ahead of print. PMID: 40621992.