Consideration of Sex as a Biological Variable in NIH-funded Research
Women now account for roughly half of all participants in National Institutes of Health (NIH)-supported clinical research, which is subject to NIH's Policy on the Inclusion of Women in Clinical Research. However, more often than not, basic and preclinical biomedical research has focused on male animals and cells. An over-reliance on male animals and cells may obscure understanding of key sex influences on health processes and outcomes.
Accounting for sex as a biological variable begins with the development of research questions and study design. It also includes data collection and analysis of results, as well as reporting of findings. Consideration of sex may be critical to the interpretation, validation, and generalizability of research findings. Adequate consideration of both sexes in experiments and disaggregation of data by sex allows for sex-based comparisons and may inform clinical interventions. Appropriate analysis and transparent reporting of data by sex may therefore enhance the rigor and applicability of preclinical biomedical research.