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      Training in the implementation of sex and gender research policies: an evaluation of publicly available online courses

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          Abstract

          Background

          Recently implemented research policies requiring the inclusion of females and males have created an urgent need for effective training in how to account for sex, and in some cases gender, in biomedical studies.

          Methods

          Here, we evaluated three sets of publicly available online training materials on this topic: (1) Integrating Sex & Gender in Health Research from the Canadian Institutes of Health Research (CIHR); (2) Sex as a Biological Variable: A Primer from the United States National Institutes of Health (NIH); and (3) The Sex and Gender Dimension in Biomedical Research, developed as part of “Leading Innovative measures to reach gender Balance in Research Activities” (LIBRA) from the European Commission. We reviewed each course with respect to their coverage of (1) What is required by the policy; (2) Rationale for the policy; (3) Handling of the concepts “sex” and “gender;” (4) Research design and analysis; and (5) Interpreting and reporting data.

          Results

          All three courses discussed the importance of including males and females to better generalize results, discover potential sex differences, and tailor treatments to men and women. The entangled nature of sex and gender, operationalization of sex, and potential downsides of focusing on sex more than other sources of variation were minimally discussed. Notably, all three courses explicitly endorsed invalid analytical approaches that produce bias toward false positive discoveries of difference.

          Conclusions

          Our analysis suggests a need for revised or new training materials that incorporate four major topics: precise operationalization of sex, potential risks of over-emphasis on sex as a category, recognition of gender and sex as complex and entangled, and rigorous study design and data analysis.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13293-024-00610-6.

          Abstract

          Recently implemented research policies requiring the inclusion of females and males have created an urgent need for effective training in how to account for sex, and in some cases gender, in biomedical studies. We evaluated three publicly available online trainings on this topic: (1) Integrating Sex & Gender in Health Research from the Canadian Institutes of Health Research; (2) Sex as a Biological Variable: A Primer from the United States National Institutes of Health; and (3) The Sex and Gender Dimension in Biomedical Research, developed as part of “Leading Innovative Measures to Reach Gender Balance in Research Activities (LIBRA)” from the European Commission. We reviewed each course with respect to their coverage of (1) What is required by the policy; (2) Rationale for the policy; (3) Handling of the concepts “sex” and “gender;” (4) Research design and analysis; and (5) Interpreting and reporting data. All three discussed the importance of including males and females to better generalize results, discover potential sex differences, and tailor treatments to men and women. The interconnectedness of sex and gender, how to operationalize sex, and potential downsides of focusing on sex more than other sources of variation were minimally discussed. Notably, all three courses explicitly endorsed invalid analytical approaches that lead to incorrect findings of differences. Our analysis suggests a need for revised or new training materials that cover four major topics: precise operationalization of sex, attention to potential risks of over-emphasizing sex, consideration of gender and sex as complex and intertwined, and rigorous study design and data analysis.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13293-024-00610-6.

          Highlights

          Three major online trainings on implementing sex and gender research policies from Canada, the United States, and the European Union covered much of the same content.

          A common theme among the trainings was the importance of including males and females to better generalize results, discover potential sex differences, and tailor treatments to men and women.

          Topics that were not substantially addressed in the trainings included the extent to which sex and gender are inextricably entangled, the operationalization of sex using concrete, measurable variables, and the potential risks of focusing on sex more than other sources of variation.

          All three courses explicitly endorsed invalid analytical approaches that produce bias toward false positive discoveries of difference.

          Key areas for improved or new materials are: precise operationalization of sex, attention to the downsides of over-emphasis on sex as a category, recognition of gender and sex as complex and entangled entities, and rigorous study design and data analysis.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13293-024-00610-6.

          Related collections

          Most cited references30

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          Beyond a catalogue of differences: a theoretical frame and good practice guidelines for researching sex/gender in human health.

          Extensive medical, public health, and social science research have focused on cataloguing male-female differences in human health. Unfortunately, much of this research unscientifically and unquestionably attributes these differences to biological causes--as exemplified in the Institute of Medicine's conclusion that "every cell has a sex." In this manuscript we theorize the entanglement of sex and gender in human health research and articulate good practice guidelines for assessing the role of biological processes--along with social and biosocial processes--in the production of non-reproductive health differences between and among men and women. There are two basic tenets underlying this project. The first is that sex itself is not a biological mechanism and the second is that "sex" and "gender" are entangled, and analyses should proceed by assuming that measures of sex are not pristine, but include effects of gender. Building from these tenets--and using cardiovascular disease as a consistent example--we articulate a process that scientists and researchers can use to seriously and systematically assess the role of biology and social environment in the production of health among men and women. We hope that this intervention will be one further step toward understanding the complexity and nuance of health outcomes, and that this increased knowledge can be used to improve human health. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            A 10-year follow-up study of sex inclusion in the biological sciences

            In 2016, to address the historical overrepresentation of male subjects in biomedical research, the US National Institutes of Health implemented a policy requiring investigators to consider sex as a biological variable. In order to assess the impact of this policy, we conducted a bibliometric analysis across nine biological disciplines for papers published in 34 journals in 2019, and compared our results with those of a similar study carried out by Beery and Zucker in 2009. There was a significant increase in the proportion of studies that included both sexes across all nine disciplines, but in eight of the disciplines there was no change in the proportion studies that included data analyzed by sex. The majority of studies failed to provide rationale for single-sex studies or the lack of sex-based analyses, and those that did relied on misconceptions surrounding the hormonal variability of females. Together, these data demonstrate that while sex-inclusive research practices are more commonplace, there are still gaps in analyses and reporting of data by sex in many biological disciplines.
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              Sex and Gender Differences Research Design for Basic, Clinical, and Population Studies: Essentials for Investigators

              Abstract A sex- and gender-informed perspective increases rigor, promotes discovery, and expands the relevance of biomedical research. In the current era of accountability to present data for males and females, thoughtful and deliberate methodology can improve study design and inference in sex and gender differences research. We address issues of motivation, subject selection, sample size, data collection, analysis, and interpretation, considering implications for basic, clinical, and population research. In particular, we focus on methods to test sex/gender differences as effect modification or interaction, and discuss why some inferences from sex-stratified data should be viewed with caution. Without careful methodology, the pursuit of sex difference research, despite a mandate from funding agencies, will result in a literature of contradiction. However, given the historic lack of attention to sex differences, the absence of evidence for sex differences is not necessarily evidence of the absence of sex differences. Thoughtfully conceived and conducted sex and gender differences research is needed to drive scientific and therapeutic discovery for all sexes and genders.
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                Author and article information

                Contributors
                dmaney@emory.edu
                Journal
                Biol Sex Differ
                Biol Sex Differ
                Biology of Sex Differences
                BioMed Central (London )
                2042-6410
                3 April 2024
                3 April 2024
                2024
                : 15
                : 32
                Affiliations
                [1 ]Rollins School of Public Health, Emory University, ( https://ror.org/03czfpz43) Atlanta, GA USA
                [2 ]Department of Psychology, Emory University, ( https://ror.org/03czfpz43) Atlanta, GA USA
                [3 ]Harvard-Radcliffe Institute, Cambridge, MA USA
                Author information
                http://orcid.org/0000-0002-1006-2358
                Article
                610
                10.1186/s13293-024-00610-6
                10988906
                38570790
                04c69579-4c76-40e4-8b97-97f7241907b9
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 16 December 2023
                : 26 March 2024
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000124, Office of Research on Women’s Health;
                Award ID: U54AG062334
                Funded by: FundRef http://dx.doi.org/10.13039/100006274, Radcliffe Institute for Advanced Study, Harvard University;
                Award ID: n/a
                Categories
                Research
                Custom metadata
                © Society for Women's Health Research and BioMed Central Ltd. 2024

                Human biology
                sabv,sgba,sex differences,gender differences
                Human biology
                sabv, sgba, sex differences, gender differences

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