You likely saw the recent Nature policy article, in which NIH Director Francis Collins and NIH Office of Research on Women’s Health Director Janine Clayton discussed ways that NIH is addressing sex differences in research. As our understanding of science evolves, so do our policies that govern research. This commentary cites several studies that highlight the need to further consider sex differences in preclinical research and describes how NIH will enact new policies to expand the consideration of sex differences in research studies using animal models and cells. The article generated quite a buzz in the community, and I wanted to take this opportunity to explain the roll out of our implementation plan.
As you saw in the article, we stated that we will begin phasing in policies over the course of the next fiscal year (which begins October 1st), requiring grantees to address inclusion of both sexes in preclinical research. Under current policy, applicants proposing work in vertebrate animals must justify the use of animals in their experimental design, describe why they are using a particular species, and include the number and sex of the animals. For the immediate future, applicants should continue reporting this information. Over the next year, we will issue Guide notices that will explain what new information should be included in applications and progress reports to address sex differences and the timing of these new requirements. Additionally, we will be developing guidelines for reviewers as they consider the information about the sex of animals in their evaluation of applications.
This is an important step towards strengthening our understanding of sex differences—and more broadly—towards improving the overall rigor of NIH-supported research. Earlier this year, in this blog and in a Nature commentary by Francis Collins and NIH Deputy Director Larry Tabak, we discussed how NIH is working to enhance the reproducibility of biomedical research. In addition to considering sex differences, rigorous research studies must address critical experimental design elements, such as blinding, randomization, and sample-size calculations. As you know, NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. We will only truly improve public health if we have confidence in the fundamental knowledge that serves as the basis for developing clinical treatments and interventions.