Recommendation: Clarity of Sex and Gender Definitions


Authors should clearly define and distinguish between sex and gender in their research:

Sex refers to biological attributes (chromosomes, hormones, reproductive organs) and is generally categorized as female, male, or intersex.

Gender refers to socially constructed roles, behaviors, expressions, and identities of girls, women, boys, men, and gender diverse people.

These concepts are distinct but interrelated, and clarity in their use is essential for accurate interpretation and application of research findings. When either term is used, authors should clearly specify which construct they are referring to and justify their choice based on the research context.

Recommendation: Research Design and Methodology

Authors should:

• Design studies that enable detection and analysis of sex and gender differences and similarities

• Ensure adequate representation of diverse sexes and genders in study populations (unless scientifically justified otherwise)

• Include both sexes/genders in preclinical and clinical research

• Consider sex and gender in sampling strategies to ensure sufficient statistical power

• Use gender-sensitive data collection methods

• Select appropriate measures and instruments that are validated for diverse populations

• Document and report the sex and gender composition of study samples

Recommendation: Data Disaggregation and Sex/Gender-Based Analysis

Authors should:

• Disaggregate data by sex and gender in all analyses unless scientifically justified otherwise

• Perform sex and gender-based analysis (SGBA) to identify differences, similarities, and interactions

• Report both statistically significant and non-significant findings related to sex and gender

• Present disaggregated results in tables, figures, and text

• Analyze potential mechanisms underlying observed sex and gender differences

• Consider intersectionality – how sex and gender interact with other variables (age, race, ethnicity, socioeconomic status, etc.)

• Use appropriate statistical methods to test for sex and gender effects and interactions

Disaggregation and analysis are critical for revealing important patterns that may be masked in aggregated data.

Recommendation: Interpretation, Limitations, and Conclusions

Authors should:

• Interpret findings in the context of biological sex differences and gender-related social factors

• Discuss potential mechanisms underlying observed sex and gender differences or similarities

• Acknowledge limitations related to sex and gender aspects of the study:

– Sample composition and representativeness

– Measurement approaches

– Ability to distinguish sex from gender effects

– Generalizability to other populations

• Avoid over-generalization from single-sex/gender studies

• Consider alternative explanations for findings

• Discuss implications for different sexes and genders

• Provide recommendations for future research to address gaps

Thoughtful interpretation ensures that research findings are appropriately applied and translated into practice and policy.