Evaluating the National Institutes of Health's Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research

Abstract

Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH's 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal research as well as human studies. However, questions remain regarding how researchers and members of research oversight committees perceive the value and need of the SABV policy. Materials and Methods: Based on 62 interviews with animal researchers and oversight personnel, we analyze what the animal research community knows about the policy and sees as the benefits and challenges of implementation. Results: We found that the 62 interviewees disagreed about the need for the policy, with some being supportive and others questioning whether the policy is based on science or is politically motivated. There were also tensions in how interviewees conceptualized the challenges to and resources needed for implementing the SABV policy. For instance, while some thought implementation would require a significant increase in numbers of animals used for each study, others explicitly rejected this claim. Conclusions: We conclude by discussing the practical and social implications of our findings about the views of members of the animal research community regarding the SABV policy.

Biomedical Researchers' Perceptions of the NIH's Sex as a Biological Variable Policy for Animal Research: Results from a U.S. National Survey

“…Potential explanations for this researcher subset include diverse funding sources for individual research portfolios or the fact that some studies meet allowable exemptions for the NIH's SABV policy—a limitation of the policy that some biomedical researchers criticize. 11 Another interpretation of this finding is that a lack of buy in about the importance of the SABV policy among some researchers leads them to not always analyze their findings by sex. Supporting this explanation is that survey respondents who thought sex-based analysis was not important or was more important in human trials were less likely to analyze their own data by sex compared with respondents who thought that analyzing by sex was equally important for human and animal studies as well as those who thought SABV would improve translation.…”

“…10 In addition, qualitative interviews with scientists who use animals in their research and Institutional Animal Care and Use Committee (IACUC) members revealed that levels of support for the SABV policy varied among animal research community members. 11 Departments of 1 Social Medicine and 2 Public Policy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.…”

“… 10 In addition, qualitative interviews with scientists who use animals in their research and Institutional Animal Care and Use Committee (IACUC) members revealed that levels of support for the SABV policy varied among animal research community members. 11 Importantly, that study indicated that independently of their level of support for the policy, researchers and IACUC members identified challenges to the policy's implementation, particularly regarding the lack of funding to support the inclusion of two sexes in research studies. Findings such as these raise questions about the extent to which U.S. biomedical researchers have integrated SABV into their work as well as how they perceive the importance of NIH's policy for advancing biomedical research.…”

Harnessing the Power of Sex Differences: What a Difference Ten Years Did Not Make

“…Thus, it is possible that researchers believe that the addition of both sexes without thorough analyses is enough to satisfy the initiatives. Another outcome of the qualitative analyses, that perhaps should not come as a surprise, is that some researchers do not appreciate mandates 56 . One could argue that the mandates do not go far enough and are limited to a few agencies in the EU, Canada, and the US.…”

Advancing research in pregnancy during COVID-19: Missed opportunities and momentum in the US

“…Although the 1993 National Institutes of Health (NIH) National Revitalization Act mandated inclusion of women and minorities in clinical research, many preclinical trials continued to rely on exclusively male animal models for years after; not until 2016 did the NIH begin requiring analysis of sex as a biological variable, with uneven results. 2 Even with progress toward fair inclusion of women broadly, one population still faces significant outstanding evidence gaps: pregnant people.…”