Office of Research on Women’s Health (ORWH)
Answering Questions on Considering Males and Females in Preclinical Research
Posted June 27, 2014
Since announcing in Nature that NIH will require a deliberate approach in considering sex in preclinical research, we have heard from nearly every sector of the biomedical research community on this upcoming policy change.
Many researchers have expressed that it’s about time to go beyond one size fits all science, and that this change will be an important step toward delivering the kind of rigorous and relevant science that drives the medical advances we need.
We’ve also heard from members of our community who have questions and concerns about how this upcoming policy will affect their work. We know that addressing sex influences in cell and animal studies is a change in the way many scientists conduct their research, and we understand that such change cannot be accomplished in one step. We want to make sure that stakeholders in the research community are informed about the importance of studying the influence of sex, and that scientists understand how to maximize preclinical research experimental design, analysis, and reporting to produce findings for males and females that can guide clinical studies for men and women. To help answer some immediate questions, please review our Q and A guide.
This is a meaningful change that we are working to apply in a meaningful way. We recognize that this requires new approaches that will affect the research community. We look forward to engaging the scientific community in the coming months in this important conversation so that together we can make NIH-funded science even stronger.
Janine Austin Clayton, M.D.
Director, Office of Research on Women’s Health
Associate Director for Research on Women’s Health, NIH
Department of Health and Human Services
- NIH Director’s Statement: NIH Takes Steps to Address Sex Differences in Preclinical Research
- Rock Talk: More on Addressing Sex Differences in Pre-clinical Studies
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.
Dr. Clayton and ORWH in the News
- In a Nature Comment published on May 14, 2014, Dr. Francis Collins and Dr. Janine Clayton outlined NIH steps to address sex differences in preclinical research. This news was covered widely in the media. (May 2014)
- Labs Are Told to Start Including a Neglected Variable: Females , New York Times
- Medical research still short on inclusion of women , USA Today
- Needed: More Females in Animal and Cell Studies , Science magazine
- U.S. health agency to erase sex bias in biomedical studies , The Washington Post, The Chicago Tribune (Reuters)
- Mostly Male, Nature podcast , Nature
- More »