Sex as a Biological Variable: A 5-Year Progress Report and Call to Action

Area of Science:

• Biomedical Science
• Health Research
• Sex Differences in Biology

Background:

• The U.S. National Institutes of Health (NIH) initiated policies requiring the consideration of sex as a biological variable (SABV) in preclinical research.
• Feedback from stakeholders informed the development of policies mandating SABV consideration in NIH-funded research on animals and humans, effective January 25, 2016.

Purpose of the Study:

• To review NIH programs and scientific literature related to SABV.
• To assess the impact and application of SABV in biomedical research.
• To provide an update on lessons learned and opportunities for scientific discovery through SABV integration.

Main Methods:

• Identification of NIH programs focused on SABV.
• Review of scientific literature relevant to SABV.
• Analysis of how different disciplines incorporate SABV.

Main Results:

• The application of SABV across the research process improves the value of biomedical science.
• NIH is developing resources to support investigators in considering SABV.
• Opportunities for scientific discovery arise from applying SABV.

Conclusions:

• Integrating SABV throughout the biomedical research enterprise is crucial for rigorous and transparent science.
• Sex- and gender-aware investigations are critical for advancing personalized medicine.
• End-to-end integration of SABV, from basic research to healthcare delivery, maximizes research potential.