Incorporating Sex as a Biological Variable into Clinical and Translational Research Training

Abstract

Incorporating sex as a biological variable (SABV) into basic and medical research requires a deliberate plan that weaves concepts of basic genetics, cellular and molecular physiology, and pharmacology into translational medicine. An R4 approach (Right content to the Right learner at the Right time with the Right modality) allows for content to be available in a variety of formats that reinforces the concepts at staged levels of integration. Weaving SABV throughout the varied formats of the R4 approach within the Clinical and Translational Research Training Programs, into the mentoring and training of scholars in NIH Building Interdisciplinary Careers in Women's Health (BIRCWH), and into the Career Enhancement Core of the Specialized Centers of Research Excellence (SCORE) on sex differences through curriculum, case-based approach and journal clubs, and workshops ensures that learners grasp its fundamental relevancy to their own research and beyond. In addition, the collaborative work among the BIRCWH and SCORE programs brings collective expertise from centers around the United States to individual programs through development of best practices and materials. These collective efforts assure that the next generation of basic, clinical, and translational scientists will bring the dimension of SABV into their research and clinical practice.

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

“…These findings thus support the call for additional training of all scientists who use animals in their research on how to best implement the SABV policy into protocol design. 15 This study has limitations. There is no available database inclusive of all biomedical researchers in the animal research community, so the sample was drawn from a national list of U.S. scientists who use vertebrate animals in their research that was generated through web searches of public and private research institutions.…”

“…These findings thus support the call for additional training of all scientists who use animals in their research on how to best implement the SABV policy into protocol design. 15 …”

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

“…Implementation challenges are, therefore, a necessary component to improving research, which echoes what others have argued about the SABV policy and highlights the importance of curricular efforts to train researchers on how to incorporate SABV. 3,[17][18][19][20][21][22] Identification of sex differences early in the translational pipeline instead of during human clinical trials may ultimately save money and time. More importantly, the rigorous examination of potential sex differences may prevent women from experiencing disproportionately harmful adverse effects when drugs reach the market.…”

A review of the genomics of neonatal abstinence syndrome

“…While some studies have suggested that male sex is associated with worse NAS, others have not (Jansson et al, 2010;Unger et al, 2011;Charles et al, 2017). Sex is an important biological variable that contributes to the fundamental differences seen in many diseases and pharmacologic responses (Bartz et al, 2020;Kantarci et al, 2020;Zucker and Prendergast, 2020;Sharifi et al, 2021). An urgent need exists to incorporate sex in the evaluation and management of NAS.…”