By Fadwa Dabbah
In the past, scientists often used only male subjects for experiments (females were under-represented) and applied the findings to both sexes. This caused unintended harm to females and economic loss. It has now become of great importance to emphasize considerations in integrating sex as a biological variable in all research, and especially that funded by funding organizations such as the National Institutes of Health (NIH). This is also reflected in the recently revised editorial policies of prominent scientific journals 1.
Sex and gender are not synonymous. Scientists are now avoiding using these terms interchangeably as there is a risk of harming patients if the difference is not clearly understood. Sex relates to the biology of living creatures: the gametes, chromosomes, sex hormones, anatomy, physiology, and reproductive organs, while gender relates to societal roles, self-gender representation, reproductive behaviors, and expectations that vary with time and place, historically and geographically (the ways by which individuals and communities interpret and express masculinity and femininity). Sex and gender affect each other, as gender is rooted in biology and can influence biological outcomes 1–4.
Classification problems of female/male are an issue in several countries. For example, in England, the legally recorded sex data in administrative documents is captured by what is recorded at birth or is based on a gender recognition certificate. In Scotland, recorded sex at birth could be changed administratively by a person’s choice, resulting in relevant information about biological sex becoming unavailable to healthcare practitioners and researchers 2. Integrating gender analysis and highlighting distinctions separately by sex and gender in biomedical research should include explicit definitions of each when planning the research, applying for funding, and reporting. Ambiguous data recordings that conflate sex and gender carry a risk of erroneous research findings, lead to research gaps on transgender, intersex, and other gender minority populations, and lower the quality of medical findings 4.
According to the AMA Style Manual for authors and editors, if demographics of human participants are presented in clinical research reports, the term ‘gender’ or ‘sex’ used should be indicated and defined by the method used to assess this distinction (eg, self-report, investigator-observed, metadata in a database). For authors of biomedical publications, when the term ‘sex’ is based on self-report, it will be incorrect only in a very small percentage of individuals who are not 46XX or 46XY, and conducting detailed genetic testing to determine the genetic make-up of all participants is not generally feasible in research studies 5.
For equity of research on gender and sex terms, a guideline on Sex and Gender Equity in Research (SAGER) was produced, and many journals over the past few years mandate following SAGER guidelines. These guidelines include a comprehensive procedure for reporting sex and gender information in study design, data analyses, results, and interpretation of findings. We encourage each researcher to use the SAGER guidelines to integrate the assessment of sex and gender into all manuscripts as an integral part of the editorial process 6.
- Lee SK. Sex is an important biological variable in biomedical research. BMB Rep. 2018;51(4):167-173. doi:10.5483/BMBRep.2018.51.4.034
- Bewley S, McCartney M, Meads C, Rogers A. Sex, gender, and medical data. BMJ. 2021;372:n735. doi:10.1136/bmj.n735
- Vaidakis N. Conceptual controversies regarding the terms gender and sex. Psychiatr Psychiatr. 2020;31(3):271-274. doi:10.22365/jpsych.2020.313.271
- Gonzales G, Ehrenfeld JM. Sex is not gender and why it matters for population health. Br J Anaesth. 2018;120(5):1130-1131. doi:10.1016/j.bja.2018.01.030
- Editors TJN. AMA Manual of Style: A Guide for Authors and Editors. New Edition. Oxford University Press
- Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and gender equity in research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016;1(1):2. doi:10.1186/s41073-016-0007-6