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Author and Reviewer Guidelines for Evaluating Sex and Gender Analysis in Manuscripts
Editorial boards of peer-reviewed journals can require sophisticated sex and gender analysis when selecting papers for publication to ensure the quality of research. Implementation of such policies has been swift for health and medical journals. The Lancet, for example, adopted such guidelines in December 2016 followed quickly by the International Committee of Medical Journal Editors. While biomedical journals have moved rapidly, we are not aware of any engineering or computer science journals with such guidelines. Journals with policies on sex- and/or gender-specific reporting are listed below:
A number of journals have adopted the ARRIVE guidelines for animal research (2010), which state:
A number of journals have adopted the SAGER guidelines (reproduced at the bottom of this page) published in Research Integrity and Peer Review (2016), which state:
A number of journals have adopted the updated International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (2016), which state that authors should:
Provide details of the animals used, including species, strain, sex, developmental stage (e.g. mean or median age plus age range) and weight (e.g. mean or median weight plus weight range). NB: the ARRIVE guidelines ask authors simply to record sex but not to analyze by sex.
Journal
Policy
Journal of Studies on Alcohol and Drugs JSAD has endorsed the SAGER guidelines. If a study is insufficiently powered to identify sex differences, then this limitation and implications for future research should be discussed. Journal of the American College of Cardiology Author Instructions. Editorial by V. Miller, In Pursuit of Scientific Excellence: Sex Matters. American Heart Association/American Stroke Association Journals The AHA recommends the NIH Principles and Guidelines for Reporting Preclinical Research, which includes reporting the sex of animals used. The AHA recommends the STROBE guidelines for observational studies and the STARD guidelines for studies diagnostic accuracy, both of which include giving demographic characteristics of participants. Research Guidelines Journal of the American Medical Association "Reporting Sex/Gender: The term sex should be used when reporting biological factors and gender should be used when reporting gender identity or psychosocial/cultural factors. The methods used to obtain information on sex, gender, or both (e.g., self-reported, investigator observed or classified, or laboratory test) should be explained in the Methods section. If only one sex is reported, or included in the study, the reason the other sex is not reported or included should be explained in the Methods section, except for studies of diseases/disorders that only affect males (e.g., prostate disease) or females (e.g., ovarian disease).
The sex distribution of study participants or samples should be reported in the Results section, including for studies of humans, tissues, cells, or animals. Study results should disaggregate and report all outcome data by sex. (Journal of the American Medical Association Network).American Journal of Physiology (AJP) Authors must report sex of cells and animals (for vertebrates) and the sex and/or gender of human participants. Subscribes to ARRIVE guidelines for animal research. Experimental Details to Report in Your Manuscript American Journal of Preventative Medicine Signs on to EQUATOR network for improving transparency of health research. Has over 400 reporting guidelines, including ARRIVE (report sex in animals), STROBE, and STARD (reporting demographic characteristics of human subjects). Signs on to CONSORT standards for clinical trials (includes demographic data of participants). "RCTs must also include a statement confirming that there was no racial or gender bias in the selection of participants."
Author Instructions and Editorial PoliciesBritish Journal of Pharmacology (BJP) BJP “requires sex to be considered as an experimental variable for all experimental reporting.” See Sex: A Change to Our Guidelines to Authors to Ensure This is No Longer an Ignored Experimental Variable." BMJ Global Health We encourage the use of the Sex and Gender Equity in Research (SAGER) guidelines for reporting of sex and gender information in study design, data analyses, results and interpretation. This includes the correct use of the terms sex (when reporting biological factors) and gender (when reporting identity, psychosocial, or cultural factors) and separate reporting and interpretation of the data by sex and gender. If sex and/or gender information are not reported, this should be explained. See SAGER guidelines and Sex and gender reporting in global health: new editorial policies. BMJ author guidelines Canadian Medical Association Journal Endorses ICMJE recommendations: Submission Guildlines Cell Press "Experimental model and subject detail In cases where this is appropriate, the influence (or association) of sex, gender, or both on the results of the study must be reported.
For in vivo animal studies, reporting of the sex and age/developmental stage of the subjects is required. If there are technical or scientific reasons why sex/gender and age/developmental stage cannot be reported, a statement must be provided to disclose this and the reasons why….Also, please describe here how animals were allocated to experimental groups (e.g., littermates of the same sex were randomly assigned to experimental groups).
For human studies, the age/developmental stage, sex, and gender identity (if known) of the subjects must be provided. If there are technical or scientific reasons why the sex and/or gender of the subjects cannot be reported, a statement must be provided to disclose this and the reasons why.
For cell lines, primary cultures, microbe strains, and plants, please describe culture/growth conditions, including temperature. Sex of cells must also be reported. If this is not possible, a statement must be provided to disclose this and the reasons why. Please note here available information about cell authentication. As you may be aware, the practice of cell authentication is becoming more common, and while we understand that this is not yet a standard practice, please indicate whether your cell lines have been authenticated. If so, please describe how.
For studies that use organisms as source for materials used in experiments (e.g., crystallography, biochemistry, in vitro studies), please provide details on the source organism (e.g., strain, growth/husbandry conditions, sex, age, etc.).”
“Experimental model and subject details
For human studies: Is the sex, gender, and information about age provided here for all study participants, or is it indicated where they can be found? If not, is there a statement of why this data is unavailable?
For animal studies, is the sex, genotype, age/developmental stage, health status, involvement in previous procedures, and other parameters following ARRIVE guidelines specified? If not, is there a statement of why this data is unavailable?For studies that include both male and female subjects or tissue from both sexes, please provide an analysis of the influence (or association) of sex, gender, or both on the results of the study, or indicate in the Experimental Model and Subject Details section why such analyses were not performed. If these analyses were not performed but may be pertinent for the generalization of the results to both sexes, consider covering this topic in the Discussion section. Include negative results as well as results that show differences
For cell lines and primary cultures, is the sex reported? If not, is there a statement of why this data is unavailable? Is any available information on cell line authentication provided?”Clinical Orthopaedic and Related Research For clinical research, authors should include relevant demographic data of the study population, including age, gender/sex distribution, BMI. Reviewer Tools (See Instructions for Using Clinical Research Article Building Tool.) A 2014 editorial recommends the following, but notes that they are not a requirement of publishing in CORR®: “
• Design studies that are sufficiently powered to answer research questions both for males and females (or men and women) if the health condition being studied occurs in both sexes/genders.
• Provide sex- and/or gender-specific data where relevant in all clinical, basic science, and epidemiological studies.
• Analyze the influence (or association) of sex or gender on the results of the study, or indicate in the Patients and Methods section why such analyses were not performed, and consider this topic as a limitation to cover in the Discussion section. Readers need to know whether the results generalize to both sexes/genders.
• Indicate (if sex or gender analyses were performed post-hoc) that these analyses should be interpreted cautiously because they may be underpowered (leading to a false conclusion of no difference). If there are many such analyses, indicate that they may lead to spurious significance, and an erroneous conclusion of a sex- or gender-related difference.”
Endocrinology Reporting the Sex of Human Research Subjects
The sex of research subjects must be indicated.
• If both males and females were included in the study, the numbers of subjects from each sex must be indicated, and it must be indicated whether sex was considered a factor in the statistical analysis of the data.
• Likewise, the sex from which human primary cell cultures or human tissues were obtained must be indicated.
• The authors are also encouraged to include the sex of human cell lines.
• If research subjects, cells or tissues from both sexes were used without regard to sex, this should be indicated.
Reporting the Sex of Research Animals
• Where applicable, the strain and sex of animals used in research studies must be indicated.
• If both males and females were used, the numbers of animals from each sex must be indicated, and it must be indicated whether sex was considered a factor in the statistical analysis of the data.
• Likewise, the sex from which primary cell cultures or tissues were obtained must be indicated.
• The authors are also encouraged to include the sex of cell lines.
• If cells or tissues from both sexes were used without regard to sex, this should be indicated. Author guidelines. J. Blaustein, Animals Have a Sex, and so Should Titles and Methods Sections of Articles in Endocrinology.
European Journal of Neuroscience
"When using experimental animals, authors are instructed to specify their sex. Experimental Physiology and the Journal of Physiology
Endorses ARRIVE guidelines for animal experiments (report sex).
Authors should also state the sex of human participants. )Journal of the International AIDS Society "Submitting authors shall include data disaggregated by sex (and, whenever possible, by race) and provide an analysis of gender and racial differences. The authors should include the number and percentage of men, women and, if appropriate, transgender persons, who participated in the research study. Anatomical and physiological differences between men and women (height, weight, body fat-to-muscle ratios, cell counts, hormonal cycles, etc.), as well as social and cultural variables (socio-economic, education, access to care, etc.), should be taken into consideration in the presentation of data and/or analysis of the results. If statistically significant differences were found between men and women or between different racial or cultural groups in the effects of the studied intervention, the implications, if any, for clinical and/or public health should be adequately discussed. If the research study was specific to one sex/gender, the reasons for this should be clearly stated." Author Instructions. The Lancet "We encourage researchers to enroll women and ethnic groups into clinical trials of all phases, and to plan to analyze data by sex and by race. For all study types, we encourage correct use of the terms sex (when reporting biological factors) and gender (when reporting identity, psychosocial, or cultural factors). Where possible, report the sex and/or gender of study participants, and describe the methods used to determine sex and gender. Separate reporting of data by demographic variables, such as age and sex, facilitates pooling of data for subgroups across studies and should be routine, unless inappropriate. Discuss the influence or association of variables, such as sex and/or gender, on your findings, where appropriate, and the limitations of the data." The Lancet: Information for Authors. L. Schiebinger et al., Editorial Policies for Sex and Gender Analysis Journal of the Faculty of Medicine (Revista de la Facultad de Medicina Humana) The Journal of the Faculty of Medicine endorses the SAGER guidelines. Journal of Korean Medical Sciences Ensure correct use of the terms sex (when reporting biological factors) and gender (identity, psychosocial or cultural factors), and, unless inappropriate, report the sex or gender of study participants, the sex of animals or cells, and describe the methods used to determine sex or gender. If the study was done involving an exclusive population, for example in only one sex, authors should justify why, except in obvious cases (e.g., prostate cancer). Authors should define how they determined race or ethnicity and justify their relevance. Journal of the National Cancer Institute "Where appropriate, clinical and epidemiologic studies should be analyzed to see if there is an effect of sex or any of the major ethnic groups. If there is no effect, it should be so stated in Results" (Manuscript Preparation). Nature Studies involving animals and human research participants
Sex and other characteristics of animals that may influence results must be described. Sex and Gender in Research
We encourage our authors to follow the ‘Sex and Gender Equity in Research – SAGER – guidelines’ and to include sex and gender considerations where relevant. Authors should use the terms sex (biological attribute) and gender (shaped by social and cultural circumstances) carefully in order to avoid confusing both terms. Article titles and/or abstracts should indicate clearly what sex(es) the study applies to. Authors should also describe in the background, whether sex and/or gender differences may be expected; report how sex and/or gender were accounted for in the design of the study; provide disaggregated data by sex and/or gender, where appropriate; and discuss respective results. If a sex and/or gender analysis was not conducted, the rationale should be given in the Discussion. We suggest that our authors consult the full guidelines before submission. These guidelines apply to studies involving humans, vertebrate animal and cell lines. See: http://genderedinnovations.stanford.edu/sex-and-gender-analysis-policies-peer-reviewed-journals.htmlNature Cancer
Nature Communication
Nature Medicine
Nature MetabolismFrom June 2022 onwards, Nature Cancer, Nature Communications, Nature Medicine and Nature Metabolism will introduce a pilot actively encouraging authors to report on points (i)-(iii) below. We also urge responsible communication of research findings on sex and gender differences so as to avoid inadvertent perpetuation of harmful gender stereotypes.
i. Title and/or abstract should indicate when the findings apply to only one sex or gender
ii.describe in the Nature Portfolio Reporting Summary whether sex and gender were considered in the study design, whether sex and/or gender of participants was determined based on self-report or assigned (and methodology used).
iii. data should be reported disaggregated for sex and gender where this information has been collected and consent has been obtained for reporting and sharing individual-level data; disaggregated numbers for individual experiments must be provided in the source data as appropriate whereas overall numbers may be provided in the Nature Portfolio Reporting Summary. See: https://www.nature.com/nature-portfolio/editorial-policies/ethics-and-biosecurity Researchers who submit papers to a subset of Nature Portfolio journals (see list at go.nature.com/3mcu0zj) will be prompted to state whether and how sex and gender were considered in their study design, or to indicate that no sex and gender analyses were carried out, and clarify why. They should note in the title and/or abstract if findings apply to only one sex or gender. They will also be asked to provide data disaggregated by sex and gender where this information has been collected, and informed consent for reporting and sharing individual-level data has been obtained. The changes apply to studies with human participants, on other vertebrates or on cell lines, in which sex and gender is an appropriate consideration.Journal of Neuroscience Research
Addressing Sex as a Biological Variable:
The National Institutes of Health now mandates the inclusion of sex as a biological variable. To conform with this mandate, JNR has established new policy requiring all authors to ensure proper consideration of sex as a biological variable. These are as follows: 1. Any paper utilizing subjects (cells, animals, humans) of only one sex must state the sex of the samples in the title and abstract of the paper, with the obvious exception of sex-specific issues (e.g., prostate or ovarian function). Authors must also state the rationale for using samples from one sex rather than from both.
2. All papers must clearly state in the methods section the number of samples/subjects of each sex used in the research. For cellular work, the sex of origin of cells used should be reported in most cases. If cells or tissue from both sexes were used without regard to sex, this fact should be indicated.
3. JNR is particularly interested in experiments involving both male and female subjects studied at the same time, and with sufficient sample size to ensure meaningful statistical comparisons. The inability for any reason to study sex differences where they may exist should be discussed as a study limitation.
4. Manuscripts reporting exploratory analyses of potential sex differences in studies not explicitly designed to address them are encouraged. JNR understands the real risk of false-positive errors associated with subgroup analysis, but that risk is balanced by the equal or greater risk of false-negative errors resulting from a failure to consider possible sex influences. JNR also understands that false negative results may result from underpowered analyses, but given the dearth of such analyses in neuroscience to date, and the now clear imperative to change the status quo on this issue, explicitly exploratory analyses are called for in many circumstances.
5. Clinical work should be designed with stratified randomization by sex. Post hoc analyses may also be useful, again perhaps explicitly designated as exploratory.Editorial: E. Prager, "Addressing Sex as a Biological Variable."
Nordic Studies on Alcohol and Drugs Nordic Studies on Alcohol and Drugs endorses the SAGER guidelines. PLoS Biology Endorses ARRIVE guidelines for animal experiments (report sex) and CONSORT and TREND for human research trials (includes demographic data of participants). PLoS Medicine Endorses ARRIVE guidelines for animal experiments (report sex) and CONSORT and TREND for human research trials (includes demographic data of participants). Reproductive Health Matters The RHM journal recommends the Sex and Gender Equity in Research (SAGER) guidelines. If authors have not disaggregated data by sex, they should provide a justification. Science Authors should report the sex of animals and the gender of human subjects. Editorial Polices Journal of Surgical Research Subscribes to ICMJE recommendations. For animal experiments, the journal endorses the ARRIVE guidelines. Author Information Surgery “For animal experiments, the sex of animal used must be indicated. If both males and females were used, the number of animals from each sex must be indicated, and it must be indicated whether the sex of animal was considered a factor in the statistical analysis of the data. If only one sex was used for the animal studies, the rationale for using only one sex must be indicated. For cell culture experiments, the sex from which primary cell cultures or tissues were obtained must be indicated. The authors are also encouraged to include sex of cell lines. If cells or tissues from both sexes were used without regard to sex, this should be indicated.” Guide for Authors. July 2018 Editorial SAGER Guidelines
General principles• 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. Introduction Authors should report, where relevant, whether sex and/or gender differences may be expected. Methods 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. Results 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. Discussion 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. 
SAGER flowchart guiding editors' initial screening of submitted manuscripts
