Limitations of the Male/Female Binary for Studying the Influences of Sex‐ and Gender‐Related Factors on Health

Momentum has been building for several decades around the value of incorporating sex and gender considerations in biomedical, clinical, and health research more broadly. In that period, there has been a proliferation of guidelines, policies, definitions, methods, and conceptual frameworks for doing so, which is both constructive and challenging: the diversity of concepts and methods generates knowledge that highlights different aspects of the phenomena under study, but at the same time, it can create inconsistency and fragmentation around the operationalization and interpretation of research attending to sex and gender considerations in health. A male-female binary approach to examining how sex and gender influence health has predominated in many domains, and although this has value for helping to identify health disparities related to sex and gender, there are also some important limitations of an uncritical overreliance on male-female comparisons; three case studies from the biomedical literature are used to help illustrate some of these limitations. Ultimately, there is no single correct approach to addressing sex and gender in health research. I contend that the most crucial element is that researchers need to bring careful and critical attention to the incorporation of sex and gender considerations in ways that are appropriate for their research context and understand and articulate the limitations of their chosen approaches.