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AAMC Endorses Consideration of Sex as Biological Variable in Preclinical Research

October 10, 2014— The AAMC Oct. 9 submitted  comments in response to a National Institutes of Health (NIH) request for information (RFI) on “sex as a biological variable” in biomedical research relying on animal models and cell lines [see Washington Highlights, Sept. 12].

The letter notes, “It is imperative that the scientific establishment continue to think critically about its own research, its standards and processes, and the effectiveness with which it serves patients and the nation. Advancing our understanding of any sex-specific variability will undoubtedly result in the ability to create more effective health interventions in the future.”

In its request, NIH noted heightened concerns within the scientific community that preclinical research (e.g., involving animals or cell lines) has not routinely considered how the sex of various research models might influence experimental results or eventual conclusions, and thus could seriously limit the generalizability of results to humans or may miss important findings altogether. Many studies, for example, have relied exclusively on the use of male mice or rats. 

NIH sought scientists’ thoughts on what impediments exist for wider inclusion of sex variance in studies, how impediments or needs might differ across fields of research, and the extent to which this matter relates to more general concerns about the reproducibility of published results. 

The AAMC response endorses further action on this topic and compares the current situation to the longstanding practice in clinical research with human subjects. “The NIH has long incorporated important requirements leading to the consideration of sex differences in clinical research by the inclusion of both male and female subjects. These requirements were partly a result of legislation but also in response to growing awareness of the need for representative research models in order to facilitate generalizability across the population. The goals to extend this inclusion in clinical trials across the spectrum of biomedical research are in line with and build upon these prior policies.”


Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926

Anurupa Dev, Ph.D.
Lead Specialist, Science Policy
Telephone: 202-862-6048


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
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