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

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. 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. 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. 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. 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. 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.