Listening to Our Stakeholders On Considering Sex as a Biological Variable

By Dr. Janine A. Clayton
 

One year ago, NIH announced a plan to adopt a new policy requiring a deliberate approach to the consideration of sex as a biological variable (SABV) in preclinical research. (Read the article, co-authored by Janine Clayton and NIH Director Francis Collins, here .) Since that moment, we have been working diligently and collaboratively inside and outside NIH to craft meaningful policy that promotes the best science.

One of the most important first steps we took was to issue a Request for Information (RFI): Consideration of Sex as a Biological Variable in Biomedical Research(NOT-OD-14-128) to gather input from the research community and other interested stakeholders with the following questions:

• Does considering SABV affect the reproducibility, rigor, and/or generalizability of research findings?
• What are the areas of science or phases of research that might benefit from consideration of SABV?
• What are the main impediments of considering SABV?
• How can NIH facilitate considering SABV?

What we learned from this outreach was gratifying (see more details here  (PDF - 780.8KB)). The vast majority of respondents agreed that consideration of sex as a biological variable is an issue affecting the reproducibility, rigor, and/or generalizability of research findings. We also learned that despite overwhelming agreement that SABV is good science, scientists and other stakeholders are concerned about practical matters. In an era of biomedical fiscal austerity, researchers are worried about cost as well as constraints on methodological and experimental design. As such, more than half of the people we heard from suggested that NIH could offer tangible resources to help with SABV policy implementation.

The NIH Office of Research on Women's Health and the NIH Office of Extramural Research have taken into account input from scientists and the public in developing SABV policy, and we understand the need for more information about studying both sexes. Above all, our goal is to fund research that takes into account essential biological variables — of which sex is a very important one. Our unwavering goal is to support the best science that underpins health advances for women and for men.

We are working hard to develop SABV training resources and scientific tools such as courses, workshops, and online resources to help applicants, reviewers, and NIH program staff to be prepared for the forthcoming policy. Stay tuned!