Policy: NIH to balance sex in cell and animal studies
By Janine A. Clayton & Francis S. Collins
Originally published at Nature.com
More than two decades ago, the US National Institutes of Health (NIH) established the Office of Research on Women's Health (ORWH). At that time, the Congressional Caucus for Women's Issues, women's health advocacy groups and NIH scientists and leaders agreed that excluding women from clinical research was bad for women and bad for science. In 1993, the NIH Revitalization Act required the inclusion of women in NIH-funded clinical research.
Today, just over half of NIH-funded clinical-research participants are women. We know much more about the role of sex and gender in medicine, such as that low-dose aspirin has different preventive effects in women and men, and that drugs such as zolpidem, used to treat insomnia, require different dosing in women and men.
There has not been a corresponding revolution in experimental design and analyses in cell and animal research — despite multiple calls to action. Publications often continue to neglect sex-based considerations and analyses in preclinical studies. Reviewers, for the most part, are not attuned to this failure. The over-reliance on male animals and cells in preclinical research obscures key sex differences that could guide clinical studies. And it might be harmful: women experience higher rates of adverse drug reactions than men do. Furthermore, inadequate inclusion of female cells and animals in experiments and inadequate analysis of data by sex may well contribute to the troubling rise of irreproducibility in preclinical biomedical research, which the NIH is now actively working to address.
The NIH plans to address the issue of sex and gender inclusion across biomedical research multi-dimensionally — through programme oversight, review and policy, as well as through collaboration with stakeholders including publishers. This move is essential, potentially very powerful and need not be difficult or costly.
NIH, Gender inclusion, Study guidelines, Francis Collins
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