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To improve the outcomes of research and medicine, government-based international research funding agencies have implemented various types of policies and mechanisms with respect to sex as a biological variable and gender as a sociocultural factor. After the 1990s, the US National Institutes of Health (NIH), the Canadian Institutes of Health Research (CIHR), and the European Commission (EC) began requesting that applicants address sex and gender considerations in grant proposals, and offering resources to help the scientific community integrate sex and gender into biomedical research. Although it is too early to analyze data on the success of all of the policies and mechanisms implemented, here we review the use both of carrots (incentives) and sticks (requirements) developed to motivate researchers and the entire scientific research enterprise to consider sex and gender influences on health and in science. The NIH focused on sex as a biological variable (SABV) aligned with an initiative to enhance reproducibility through rigor and transparency; CIHR instituted a sex- and gender-based analysis (SGBA) policy; and the EC required the integration of the "gender dimension," which incorporates sex, gender, and intersectional analysis into research and innovation. Other global efforts are briefly summarized. Although we are still learning what works, we share lessons learned to improve the integration of sex and gender considerations into research. In conjunction with refining and expanding the policies of funding agencies and mechanisms, private funders/philanthropic groups, editors of peer-reviewed journals, academic institutions, professional organizations, ethics boards, health care systems, and industry also need to make concerted efforts to integrate sex and gender into research, and we all must bridge across silos to promote systemwide solutions throughout the biomedical enterprise. For example, policies that encourage researchers to disaggregate data by sex and gender, the development of tools to better measure gender effects, or policies similar to SABV and/or SGBA adopted by private funders would accelerate progress. Uptake, accountability for, and a critical appraisal of sex and gender throughout the biomedical enterprise will be crucial to achieving the goal of relevant, reproducible, replicable, and responsible science that will lead to better evidence-based, personalized care for all, but especially for women., (Published by Oxford University Press on behalf of the Endocrine Society 2021.)

A little over 5 years ago, the U.S. National Institutes of Health (NIH) announced the intention to develop policies to require applicants to report plans to balance male and female cells and animals in preclinical investigations. Soon thereafter, the NIH issued a request for information from the scientific community and consulted with various stakeholders. The feedback received was considered during development of policy requiring the consideration of sex as a biological variable (SABV) in NIH-funded research on vertebrate animals and humans, which went into effect for applications due on or after January 25, 2016. We identified NIH programs related to SABV and reviewed SABV-relevant scientific literature. We find that the application of SABV throughout the research process can serve as a guiding principle to improve the value of biomedical science. The NIH is engaged in ongoing efforts to develop resources to help investigators consider SABV in their research. We also provide an update on lessons learned, highlight ways that different disciplines consider SABV, and describe the opportunities for scientific discovery that applying SABV offers. We call on NIH's various stakeholders to redouble their efforts to integrate SABV throughout the biomedical research enterprise. Sex- and gender-aware investigations are critical to the conduct of rigorous and transparent science and the advancement of personalized medicine. This kind of research achieves its greatest potential when sex and gender considerations are integrated into the biomedical research enterprise in an end-to-end manner, from basic and preclinical investigations, through translational and clinical research, to improved health care delivery.

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 was implemented as it has become increasingly clear that male/female differences extend well beyond reproductive and hormonal issues. 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]., (Published by Elsevier Inc.)

One of the most compelling features of dry eye disease (DED) is that it occurs more frequently in women than men. In fact, the female sex is a significant risk factor for the development of DED. This sex-related difference in DED prevalence is attributed in large part to the effects of sex steroids (e.g. androgens, estrogens), hypothalamic-pituitary hormones, glucocorticoids, insulin, insulin-like growth factor 1 and thyroid hormones, as well as to the sex chromosome complement, sex-specific autosomal factors and epigenetics (e.g. microRNAs). In addition to sex, gender also appears to be a risk factor for DED. "Gender" and "sex" are words that are often used interchangeably, but they have distinct meanings. "Gender" refers to a person's self-representation as a man or woman, whereas "sex" distinguishes males and females based on their biological characteristics. Both gender and sex affect DED risk, presentation of the disease, immune responses, pain, care-seeking behaviors, service utilization, and myriad other facets of eye health. Overall, sex, gender and hormones play a major role in the regulation of ocular surface and adnexal tissues, and in the difference in DED prevalence between women and men. The purpose of this Subcommittee report is to review and critique the nature of this role, as well as to recommend areas for future research to advance our understanding of the interrelationships between sex, gender, hormones and DED., (Copyright © 2017 Elsevier Inc. All rights reserved.)

A Commentary highlighting the progress that sex-based data and research have made in neuroscience and the complexities that research has revealed thus far. Basic and preclinical neuroscientific research that considers sex as a biological variable will continue to build on the foundation of knowledge that has been started by multiple predecessors. The expansion of knowledge in preclinical neuroscience that integrates the study of both sexes will have a significant role in informing clinical trial design. We applaud the efforts of the editors and authors who have contributed to this issue. Published 2016. This article is a U.S. Government work and is in the public domain in the USA., Competing Interests: The authors have no conflict of interest to declare., (Published 2016. This article is a U.S. Government work and is in the public domain in the USA.)