NIH plans to balance sex in preclinical research

Updated May 20:  Sally Rockey has posted a follow-up note to the Nature article.


While inclusion of women in NIH-funded clinical studies has led to important discoveries like the need for different doses of medication for men and women, preclinical research lags behind. An article recently published in Nature by Janine Clayton, M.D., director of the Office of Research on Women’s Health at the NIH, and Francis Collins, M.D., Ph.D, director of the NIH, describes the NIH’s plans to balance sex differences in cell and animal studies.

According to the article, “The NIH is now developing policies that require applicants to report their plans for balance of male and female cells and animals in preclinical studies in all future applications, unless sex-specific inclusion is unwarranted, based on rigorously defined exceptions.” The NIH expects to begin rolling out these new policies in October 2014. The rollout will include training on experimental design and evaluation of sex differences.

We anticipate these policy changes will have broad impacts at OHSU. Stay tuned for updates.