Janine Austin Clayton

Abstract
Sex as a biological variable (SABV) is a key part of the new National Institutes of Health (NIH) initiative to enhance reproducibility through rigor and transparency. The SABV policy requires researchers to factor sex into the design, analysis, and reporting of vertebrate animal and human studies. The policy has implemented as it has been increasingly clear that male/female differences extend well beyond reproductive and hormonal issues. Implementation of the policy is also meant... Show more

Abstract
Sex as a biological variable (SABV) is a key part of the new National Institutes of Health (NIH) initiative to enhance reproducibility through rigor and transparency. The SABV policy requires researchers to factor sex into the design, analysis, and reporting of vertebrate animal and human studies. The policy has implemented as it has been increasingly clear that male/female differences extend well beyond reproductive and hormonal issues. End of
Translation Implementation of the policy is also meant to address inattention to sex influences in biomedical research. Sex affects: cell physiology, metabolism, and many other biological functions; symptoms and manifestations of disease; and responses to treatment. For example, sex has profound influences in neuroscience, from circuitry to physiology to pain perception. Extending beyond the robust efforts of NIH to ensure that women are included in clinical trials, the SABV policy also includes rigorous preclinical experimental designs that inform clinical research. Additionally, the NIH has engaged journal editors and publishers to facilitate reproducibility by addressing rigor and promoting transparency through scientifically appropriate sex-specific study results reporting. The Sex And Gender Equity in Research (SAGER) guidelines were developed to assist researchers and journal editors in reporting sex and gender information in publications [1]. Show less

While women have been well represented in medical school and biomedical doctoral degree programs, they do not comprise half of academic medicine faculty positions. Furthermore, there is a significant paucity of women in academic medicine leadership positions, as evidenced by the fact that only 16% of dean positions at United States Medical schools are filled by women. In this commentary, the authors review the state of women in academic medicine and argue that increased representation of women… Show more

While women have been well represented in medical school and biomedical doctoral degree programs, they do not comprise half of academic medicine faculty positions. Furthermore, there is a significant paucity of women in academic medicine leadership positions, as evidenced by the fact that only 16% of dean positions at United States Medical schools are filled by women. In this commentary, the authors review the state of women in academic medicine and argue that increased representation of women in the academic workforce will lead to economic gains, increased scientific discovery, and improvements to women's health. Show less

Abstract
In May 2014, the U.S. National Institutes of Health (NIH) announced that it will ensure that investigators account for sex as a biological variable (SABV) in NIH-funded preclinical research as part of the agency's rigor and transparency initiative. Herein, I describe in more detail the rationale behind the SABV policy component and provide additional detail about policy goals. In short, studying both sexes is a guiding principle in biomedical research that will expand knowledge… Show more

Abstract
In May 2014, the U.S. National Institutes of Health (NIH) announced that it will ensure that investigators account for sex as a biological variable (SABV) in NIH-funded preclinical research as part of the agency's rigor and transparency initiative. Herein, I describe in more detail the rationale behind the SABV policy component and provide additional detail about policy goals. In short, studying both sexes is a guiding principle in biomedical research that will expand knowledge toward turning discovery into health. NIH expects that considering SABV in preclinical research will help to build a knowledge base that better informs the design of clinical research and trials in humans. Integrating the practice of studying both sexes in preclinical research will, over time, expand our currently incomplete knowledge base that plays a critical role in informing the development of sex- and gender-appropriate medical care for women and men. Show less

Janine A. Clayton and Francis S. Collins unveil policies to ensure that preclinical research funded by the US National Institutes of Health considers females and males.

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… Show more

Janine A. Clayton and Francis S. Collins unveil policies to ensure that preclinical research funded by the US National Institutes of Health considers females and males.

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 action1. Publications often continue to neglect sex-based considerations and analyses in preclinical studies2,3. 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 do4. 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 address5,6.

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. Show less