• Authors should use the terms sex and gender carefully in order to avoid confusing both terms.
• Where the subjects of research comprise organisms capable of differentiation by sex, the research should be designed and conducted in a way that can reveal sex-related differences in the results, even if these were not initially expected.
• Where subjects can also be differentiated by gender (shaped by social and cultural circumstances), the research should be conducted similarly at this additional level of distinction.
Recommendations per section of the article
Title and abstract
If only one sex is included in the study, or if the results of the study are to be applied to only one sex or gender, the title and the abstract should specify the sex of animals or any cells, tissues and other material derived from these and the sex and gender of human participants.
Authors should report, where relevant, whether sex and/or gender differences may be expected.
Authors should report how sex and gender were taken into account in the design of the study, whether they ensured adequate representation of males and females, and justify the reasons for any exclusion of males or females.
Where appropriate, data should be routinely presented disaggregated by sex and gender. Sex- and gender-based analyses should be reported regardless of positive or negative outcome. In clinical trials, data on withdrawals and dropouts should also be reported disaggregated by sex.
The potential implications of sex and gender on the study results and analyses should be discussed. If a sex and gender analysis was not conducted, the rationale should be given. Authors should further discuss the implications of the lack of such analysis on the interpretation of the results.