The science of sex and gender in human health: online courses to create a foundation for sex and gender accountability in biomedical research and treatment
Abstract:BackgroundSex and gender differences play a significant role in the course and outcome of conditions that affect specific organ systems in the human body. Research on differences in the effects of medical intervention has helped scientists develop a number of sex- and gender-specific guidelines on the treatment and management of these conditions. An online series of courses, “The Science of Sex and Gender in Human Health,” developed by the National Institutes of Health Office of Research on Women’s Health and … Show more
“…These courses have had good uptake and positive impact on a large number of participants. 36 The newest educational resource from ORWH and FDA's Office of Women's Health is called Bench-to-Bedside: Integrating Sex and Gender to Improve Human Health, 37 which is scheduled for release in 2020. This course contains modules that incorporate the application of SABV to various clinical topic areas, such as immunology, cardiovascular medicine, and pulmonology.…”
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.
“…These courses have had good uptake and positive impact on a large number of participants. 36 The newest educational resource from ORWH and FDA's Office of Women's Health is called Bench-to-Bedside: Integrating Sex and Gender to Improve Human Health, 37 which is scheduled for release in 2020. This course contains modules that incorporate the application of SABV to various clinical topic areas, such as immunology, cardiovascular medicine, and pulmonology.…”
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.
“…There are also testosterone-mediated dimorphism for mouse proximal tubules [ 35 , 36 ]. For these and other reasons, increasing emphasis is being placed on the importance of sex as a biological variable in pre-clinical [ 37 ] and clinical studies [ 38 ].…”
Renin expressing cells in the kidney’s juxta-glomeruluar compartment likely also serve as progenitors for adult glomerular cells in disease. Although these cells of renin lineage (CoRL) decrease in number with advancing kidney age, accompanied by less responsiveness to typical stimuli such as ACE-inhibition, mechanisms and the impact of sex as a biological variable with age are not known. Accordingly, labeled CoRL were sorted from individual young (2m) and aged (27m) male and female Ren1cCre|ZsGreen reporter mice, and their transcriptomic profiles analyzed by RNA seq. When both aged female and male mice were combined, there were 48 differentially expressed genes (DEG) compared to young mice. However, when compared to their young sex-matched mice, aged female and male mice had 159 and 503 DEGs respectively. In addition to marked differences in individual genes between aged female and male mice, gene ontology analysis showed major pathway differences by sex. The majority of DEGs in one sex did not significantly change or changed in the opposite direction in the other sex. These results show that in CoRL of advanced age, individual genes and gene ontologies change, but differ between female and male mice, highlighting sex related differences the aging process.
“…Several resources are available to help educators embed concepts of sex and gender into graduate and postgraduate curricula [ 27 , 28 ]. However, to our knowledge, the Institute of Gender and Health e-learning modules are the first to undergo rigorous testing for evaluating changes in knowledge and self-efficacy.…”
BackgroundTo describe the effectiveness of online learning to augment academic capacity to consider sex and gender in the conduct of basic science, clinical research, and population health studies.MethodThe analysis compares pre- and post-test scores from 1441 individuals who completed the Canadian Institutes of Health Research Institute of Gender and Health’s interactive e-learning modules between February 2016 and May 2017. The tests measured knowledge, self-efficacy, and self-reported intent to change behavior for three competencies: (1) the ability to appropriately define and distinguish between sex-related versus gender-related variables, (2) the application of methods for integrating sex and gender, and (3) the critical appraisal of sex and gender integration in the design, methods, and analysis plan of research proposals and publications.ResultsOf the 543 individuals who completed the basic science module, 62% demonstrated improved knowledge, and 86% increased self-efficacy across all competencies. Gains in knowledge and self-efficacy also occurred among 84% and 77% of completers of the human data collection module (n = 463) and among 73% and 82% of those who completed the secondary data analysis module (n = 435). In aggregate, 95% of participants reported an intent to change their behavior with respect to sex and gender in health research.ConclusionsInteractive online learning combined with feedback and self-assessment results in improved knowledge and self-efficacy for integrating sex and gender in health research.
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