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Office of Research on Women’s Health (ORWH)

Director’s Page

Photo of Janine Austin Clayton, M.D., Director, ORWH, and Associate Director for Research on Women's Health, NIH

Janine Austin Clayton, M.D.

Listening to Our Stakeholders On Considering Sex as a Biological Variable

Posted May 20, 2015

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). 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!

Janine Austin Clayton, M.D.
Associate Director for Research on Women’s Health, NIH
Director, Office of Research on Women’s Health

Sally J. Rockey, Ph.D.
NIH Deputy Director for Extramural Research
Director, Office of Extramural Research

Recent Director’s Articles

Toward More Individualized Medicine: Introducing the Women of Color Health Data Book, Fourth Edition
Reprinted from the October 2014 issue of the Journal of Women’s Health. Written by Janine A. Clayton, M.D., Claudette E. Brooks, M.D., and Susan G. Kornstein, M.D.

Back to Basics: New Publishing Guidelines to Enhance Reproducibility and Relevance
Back in 1958, the prominent British statistician Sir David Cox summarized five requirements for “good” experimental design.

More Director’s Articles »

Additional Information

About the ORWH Director

Janine Austin Clayton, M.D., was appointed Director for the NIH Office of Research on Women’s Health (ORWH) and Associate Director for NIH Research on Women’s Health by NIH Director Francis S. Collins, M.D., Ph.D., on September 4, 2012.

Read the full bio »

Dr. Clayton and ORWH in the News

This page last reviewed on May 21, 2015

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