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. 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. [4] 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.
Margaret Stratford Livingstone is the Takeda Professor of Neurobiology in the Department of Neurobiology at Harvard Medical School in the field of visual perception. She authored the book Vision and Art: The Biology of Seeing. She was elected a member of the American Academy of Arts and Sciences in 2015 and was elected to the National Academy of Sciences in 2020.
Behavioral neuroscience, also known as biological psychology, biopsychology, or psychobiology, is part of the broad, interdisciplinary field of neuroscience, with its primary focus being on the biological and neural substrates underlying human experiences and behaviors, as in our psychology. Derived from an earlier field known as physiological psychology, behavioral neuroscience applies the principles of biology to study the physiological, genetic, and developmental mechanisms of behavior in humans and other animals. Behavioral neuroscientists examine the biological bases of behavior through research that involves neuroanatomical substrates, environmental and genetic factors, effects of lesions and electrical stimulation, developmental processes, recording electrical activity, neurotransmitters, hormonal influences, chemical components, and the effects of drugs. Important topics of consideration for neuroscientific research in behavior include learning and memory, sensory processes, motivation and emotion, as well as genetic and molecular substrates concerning the biological bases of behavior. Subdivisions of behavioral neuroscience include the field of cognitive neuroscience, which emphasizes the biological processes underlying human cognition. Behavioral and cognitive neuroscience are both concerned with the neuronal and biological bases of psychology, with a particular emphasis on either cognition or behavior depending on the field.
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.
Rodents have been employed in biomedical experimentation from the 1650s. Currently, 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 patient's gender. 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 questions about 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.
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.
George Alexander Truskey is an American biomedical engineer noted for his research on transport phenomena in biological systems, cardiovascular tissue engineering, and cell adhesion to natural and synthetic surfaces.
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.
Catherine S. Woolley is an American neuroendocrinologist. Woolley holds the William Deering Chair in Biological Sciences in the Department of Neurobiology, Weinberg College of Arts & Sciences, at Northwestern University. She is also a member of the Women's Health Research Institute in the Feinberg School of Medicine at Northwestern University.
Janine Austin Clayton is an American ophthalmologist. She is the NIH associate director for research on women's health and director of the Office of Women's Health. Clayton was previously the deputy clinical director of the National Eye Institute.
Kent L. Thornburg is an American scientist, researcher and professor. He lives in Portland, Oregon and works at Oregon Health & Science University (OHSU), in the School of Medicine. He is the director for both the OHSU Center for Developmental Health and the Moore Institute for Nutrition & Wellness
Jeffrey S. Mogil, FCAHS, FRSC is a Canadian neuroscientist and the E.P. Taylor Professor of Pain Studies and Distinguished James McGill Professor at McGill University. He is known for his work in the genetics of pain, for being among the first scientists to demonstrate sex differences in pain perception, and for identifying previously unknown factors and confounds that affect the integrity of contemporary pain research. He has an h-index of 100.
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.
Carrie Wolinetz is the Principal and Chair of Lewis-Burke Associate's Health and Bioscience Innovation Policy Practice Group. She formerly served in the National Institutes of Health as Senior Advisor to the Office of the Director, Associate Director for Science Policy, and Chief of Staff to Francis Collins. She also led the inaugural Health and Sciences division in the White House Office of Science and Technology Policy.