July 19, 2023

Guidelines on Sex- and Gender-Based Analyses

For research involving or pertaining to humans, animals, or eukaryotic cells, investigators should integrate sex- and gender-based analyses into their research design according to funder/sponsor requirements and best practices within the field.

Authors should address the sex and/or gender dimensions of their research in their article. In cases where they cannot, they should discuss this as a limitation to the generalization of their research. It is important to emphasize that authors must explicitly state which definitions of sex and/or gender they are applying to enhance the accuracy, rigor, and reproducibility of their research and avoid ambiguity or conflation of the terms and constructs to which they refer.

Sex generally refers to a set of biological attributes associated with physical and physiological characteristics (e.g., chromosomal genotype, hormone levels, internal and external anatomy).

A binary categorization of sex (male/female) is often assigned at birth ("sex assigned at birth"), most often based solely on the visible external anatomy of a newborn.

Gender generally refers to socially constructed roles, behaviors, and identities of women, men, and people with diverse genders that occur within a historical and cultural context and can vary between societies and over time. Gender influences how individuals perceive themselves and others, how they behave and interact, and how power is distributed in society.

Sex and gender are often incorrectly portrayed as binary (female/male or woman/man) and immutable, while these constructs actually exist along a spectrum and include additional sex categorizations and gender identities, such as individuals who are intersex/have differences in sexual development or identify as non-binary. Moreover, the terms "sex" and "gender" can be ambiguous—therefore, it is important for authors to define how they are used.

In addition to this definitional guidance and related guidelines, the terms "sex" and "gender" may remain ambiguous. Therefore, it is crucial for authors to clarify how these terms are applied in their research.

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