Sex as a biological variable

[1] Enrolling both men and women in clinical trials can impact the application of results and permit the identification of factors that affect the course of disease and the outcome of treatment.

The policy came into effect in 2015 which specified that "SABV is frequently ignored in animal study designs and analyses, leading to an incomplete understanding of potential sex-based differences in basic biological function, disease processes, and treatment response.

NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies.

[4] Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex.

[6] In 2012, the American Physiological Society (APS) journals began requiring sex and gender to be reported in studies involving cells, tissues, animals, and humans.

[14][15] Including SABV in basic research and preclinical studies can reduce costs and time requirements to test sex differences in clinical trials.