Considering sex as a biological variable (SABV) in research: a primer for intramural investigators

Authors

• E Gorodetsky
• KJ Serrano
• VA Cargill

Abstract

The NIH policy on rigor and reproducibility (NOT 15-102; NOT 16-011) highlights the importance of sex as a biological variable (SABV) in research investigations. This poster presents the rationale for considering SABV in preclinical research as a primer for investigators. A systematic analysis of large databases revealed that sex/gender remains an independent and important biological variable that influences disease development and outcomes, even after controlling for age, comorbidities, scored risk factors, and ethnicity. Despite this, preclinical research often uses single-sex cells and/or animals to examine diseases that affect both men and women without evidenced-based justification. Moreover, when studies do use both sexes, results are often not disaggregated by sex. Thus, the consequences of such research include irreproducible data, inconsistent findings, and results that cannot be generalized to either men and/or women – leading to incomplete knowledge of the pathogenesis of disease despite a significant funding investment. The NIH policy expects that the sex of vertebrate animals and humans will be factored into research designs, analyses, and reporting. The SABV policy aims to promote transparency, enhance rigor and reproducibility. The policy does not require the use of specific methods, experiments to be powered to detect sex differences, or the doubling of sample sizes. The NIH Office of Research on Women's Health is committed to providing SABV resources to enhance rigor and reproducibility of biomedical research to promote the health of women and men.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021