Sex as a biological variable (SABV) is a research policy recognizing sex as an important variable to consider when designing studies and assessing results. Research including SABV has strengthened the rigor and reproducibility of findings. Public research institutions including the European Commission, Canadian Institutes of Health Research, and the U.S. National Institutes of Health have instituted SABV policies. Editorial policies were established by various scientific journals recognizing the importance and requiring research to consider SABV.
In 1999, the Institute Of Medicine established a committee on understanding the biology of sex and gender differences. In 2001, they presented a report that sex is an important variable in designing studies and assessing results. The quality and generalizability of biomedical research depends on the consideration of key biological variables, such as sex. To improve the rigor and reproducibility of research findings, the European Commission, Canadian Institutes of Health Research, and the U.S. National Institutes of Health (NIH) established policies on sex as a biological variable (SABV). [1] Enrolling both men and women in clinical trials can impact the application of results and permit the identification of factors that affect the course of disease and the outcome of treatment. [2]
In 2003, the European Commission (EC) began influencing investigators to include sex and gender in their research methodologies. The Canadian Institutes of Health Research (CIHR) requires four approaches: sex and gender integration in research proposals, sex and gender expertise among research teams, sex and gender platform in large consortiums, and starting in September 2015, the completion of sex and gender online training programs. [1]
In May 2014, the NIH announced the formation of SABV policy. [4] The policy came into effect in 2015 which specified that "SABV is frequently ignored in animal study designs and analyses, leading to an incomplete understanding of potential sex-based differences in basic biological function, disease processes, and treatment response. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex." [2] [1] The review criteria should assess the extent to which the sex of participants has been incorporated into the research plan. [5]
In 2010, the National Centre for the Replacement, Refinement and Reduction of Animals in Research published the ARRIVE guidelines which promotes incorporating SABV in animal studies. [6] In 2012, the American Physiological Society (APS) journals began requiring sex and gender to be reported in studies involving cells, tissues, animals, and humans. [7] This APS editorial policy was not widely accepted by reviewers and researchers. [8]
The European Association of Science Editors established the gender policy committee (GPC) in 2012. The GPC published Sex and Gender Equity in Research (SAGER) guidelines in 2016. [9] In January 2017, the Journal of Neuroscience Research began requiring the consideration of SABV. [10] The December 2017 ICMJE recommendations encouraged the use of SABV by researchers. [1]
Research incorporating sex as a biological variable increases the rigor and reproducibility of results. [11] [12] After publishing the NIH published SABV policy, there were increases in the percentage of scientists understanding and recognizing its importance. [13] Some investigators were critical of the NIH SABV policy, saying it would increase cost and labor requirements. [14] [15] Including SABV in basic research and preclinical studies can reduce costs and time requirements to test sex differences in clinical trials. [16] [17]
Historically, there were concerns among researchers of the female reproductive system impacting findings in animal studies. [18] Other studies using mice models found that despite the estrous cycle, variability was the same among sexes. [19] Studies following SABV policies can identify potential hormonal variability in earlier phases of biomedical research. [20]
In 2020, the NIH Office on Women's Health and the Food and Drug Administration Office of Women's Health created an educational tool, Bench-to-Bedside: Integrating Sex and Gender to Improve Human Health. [21]
A model organism is a non-human species that is extensively studied to understand particular biological phenomena, with the expectation that discoveries made in the model organism will provide insight into the workings of other organisms. Model organisms are widely used to research human disease when human experimentation would be unfeasible or unethical. This strategy is made possible by the common descent of all living organisms, and the conservation of metabolic and developmental pathways and genetic material over the course of evolution.
Sex differences in medicine include sex-specific diseases or conditions which occur only in people of one sex due to underlying biological factors ; sex-related diseases, which are diseases that are more common to one sex ; and diseases which occur at similar rates in males and females but manifest differently according to sex.
Rat Park was a series of studies into drug addiction conducted in the late 1970s and published between 1978 and 1981 by Canadian psychologist Bruce K. Alexander and his colleagues at Simon Fraser University in British Columbia, Canada.
Medical research, also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
The Wistar Institute is an independent, nonprofit research institution in biomedical science with special focuses in oncology, immunology, infectious disease and vaccine research. Located on Spruce Street in Philadelphia’s University City neighborhood, Wistar was founded in 1892 as a nonprofit institution to focus on biomedical research and training.
Rodents are commonly used in animal testing, particularly mice and rats, but also guinea pigs, hamsters, gerbils and others. Mice are the most commonly used vertebrate species, due to their availability, size, low cost, ease of handling, and fast reproduction rate.
Emery Neal Brown is an American statistician, computational neuroscientist, and anesthesiologist. He is the Warren M. Zapol Professor of Anesthesia at Harvard Medical School and at Massachusetts General Hospital (MGH), and a practicing anesthesiologist at MGH. At MIT he is the Edward Hood Taplin Professor of Medical Engineering and professor of computational neuroscience, the associate director of the Institute for Medical Engineering and Science, and the Director of the Harvard–MIT Program in Health Sciences and Technology.
Gender-biased diagnosing is the idea that medical and psychological diagnosis are influenced by the gender of the patient. Several studies have found evidence of differential diagnosis for patients with similar ailments but of different sexes. Female patients face discrimination through the denial of treatment or miss-classification of diagnosis as a result of not being taken seriously due to stereotypes and gender bias. According to traditional medical studies, most of these medical studies were done on men thus overlooking many issues that were related to women's health. This topic alone sparked controversy and brought about question to the medical standard of our time. Popular media has illuminated the issue of gender bias in recent years. Research that was done on diseases that affected women more were less funded than those diseases that affected men and women equally.
Robert F. Murphy is Ray and Stephanie Lane Professor of Computational Biology Emeritus and Director of the M.S. Program in Automated Science at Carnegie Mellon University. Prior to his retirement in May 2021, he was the Ray and Stephanie Lane Professor of Computational Biology as well as Professor of Biological Sciences, Biomedical Engineering, and Machine Learning. He was founding Director of the Center for Bioimage Informatics at Carnegie Mellon and founded the Joint CMU-Pitt Ph.D. Program in Computational Biology. He also founded the Computational Biology Department at Carnegie Mellon University and served as its head from 2009 to 2020.
Rebecca M. Jordan-Young, is an American feminist scientist and gender studies scholar. Her research focuses on social medical science, sex, gender, sexuality, and epidemiology. She is an Associate Professor of Women’s, Gender, and Sexuality Studies at Barnard College.
Rochelle (Shelley) Buffenstein is an American comparative biologist currently working as Research Professor at the University of Illinois Chicago. Previously, she was a senior principal investigator at Calico Life Sciences, an Alphabet, Inc. funded research and development company investigating the biology that controls aging and lifespan where she used the extraordinarily long-lived cancer resistant naked mole-rat as an attractive counter-example to the inevitability of mammalian aging; for at ages greatly exceeding the expected maximum longevity for this mouse-sized rodent, they fail to exhibit meaningful changes in age-related risk of dying or physiological decline. As such these rodents likely provide the blueprint for how to stave off myriad adverse effects of aging and provide proof of concept that age-related health decline can be avoided in humans.
Carolyn M. Mazure is an American psychologist and the Norma Weinberg Spungen and Joan Lebson Bildner Professor of Psychiatry and Psychology at the Yale School of Medicine. She created and directs Women’s Health Research at Yale — Yale’s interdisciplinary research center on health and gender.
Gina Rippon is a British neurobiologist and feminist. She is a professor emeritus of cognitive neuroimaging at the Aston Brain Centre, Aston University, Birmingham. Rippon has also sat on the editorial board of the International Journal of Psychophysiology. In 2019, Rippon published her book, Gendered Brain: The New Neuroscience that Shatters the Myth of the Female Brain, which investigates the role of life experiences and biology in brain development.
Joni Wallis is a cognitive neurophysiologist and Professor in the Department of Psychology at the University of California, Berkeley.
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Arthur Palmer Arnold is an American biologist who specializes in sex differences in physiology and disease, genetics, neuroendocrinology, and behavior. He is Distinguished Professor of Integrative Biology & Physiology at the University of California, Los Angeles (UCLA). His research has included the discovery of large structural sex differences in the central nervous system, and he studies of how gonadal hormones and sex chromosome genes cause sex differences in numerous tissues. His research program has suggested revisions to concepts of mammalian sexual differentiation and forms a foundation for understanding sex difference in disease. Arnold was born in Philadelphia.
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