Gender discrimination isn’t just for people; it extends to animals and cell lines, too. Fortunately, male/female disparities among clinical research participants are discouraged, thanks to initiatives such as the NIH Revitalization Act, which has required the inclusion of women in NIH-funded clinical research since 1993. Today, women account for just over half of NIH-funded clinical research participants. Yet male/female disparities have persisted in preclinical studies, where male animals and cell lines predominate.
Gender disparities matter whether males are overrepresented in the clinic or the laboratory. Such disparities can obscure gender differences in disease susceptibility, disease progression, treatment efficacy, optimal dosing, and adverse drug reactions. They can also contribute to the problem of irreproducibility in research.
To avoid these problems, the NIH is developing policies to achieve a better male/female balance in preclinical studies. As indicated in a commentary published May 14 in Nature, the NIH “plans to address the issue of sex and gender inclusion across biomedical research multi-dimensionally—through program oversight, review, and policy, as well as through collaboration with stakeholders including publishers.”
The commentary was prepared by Janine Clayton, M.D., director of the institutes’ Office of Research on Women’s Health, and Francis S. Collins, M.D., Ph.D., the institute's director. According to Drs. Clayton and Collins, “The NIH is now developing policies that require applicants to report their plans for the 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. These policies will be rolled out in phases beginning in October 2014, with parallel changes in review activities and requirements.”
The authors recognize that various organizations have raised awareness of gender bias in preclinical studies and have taken steps to curb it. For example, the authors note, some journals now require authors to specify sex- and gender-related information. The NIH, however, will take on actions of greater scope. It will also proceed systematically. Besides disseminating training on gender-balanced experiment design for NIH staff, trainees, and grantees, the NIH will monitor compliance of sex and gender inclusion in preclinical research funded by the agency though data-mining techniques.