NIH to Require Balanced Sex Representation in Animal and Cell Studies

On May 14, 2014 National Institutes of Health (NIH) Director Francis Collins and Office of Research on Women’s Health Director Janine Clayton announced that the agency plans to require investigators to “report their plans for the balance of male and female cells and animals in pre-clinical studies in all future applications.”[1] Citing an over-reliance on male cells and animals in pre-clinical research which can obscure sex differences that may be important in subsequent clinical trials, Collins and Clayton stated that the new policies would be phased in starting in October 2014. The NIH plans to issue detailed policy guidance and include training for investigators as part of the modules being developed to enhance overall scientific rigor. Parallel changes in the peer review process will also be implemented, and the agency will partner with scientific publishers to promote reporting of sex in research publications. Since 2012 APS journals have required “the reporting of the sex of experimental animals and material derived from experimental animals or humans, as well as the sex (or gender where appropriate) of humans used in studies published in their journals.”[2]