This checklist is intended as an aid for researchers, grant writers, project directors and evaluators, and funding organizations addressing health and medicine. It presents key steps for incorporating sex and gender analyses into health and biomedical research. As such, it complements and should be read in conjunction with the methodology described in Designing Health & Biomedical Research. Important resources when considering research design include: Oertelt-Prigione, S. et al., Sex and Gender Aspects in Clinical Medicine; Schenck-Gustafsson et al., Handbook of Clinical Gender Medicine; and Regitz-Zagrosek, Sex and Gender Differences in Pharmacology. Additional resources: U.S. National Institutes of Health online course: The Science of Sex and Gender in Human Health; the European Curriculum in Gender Medicine online course.
Step 1: Determining Relevance (see Rethinking Research Priorities and Outcomes)
- ● Understand the analytical distinctions between “sex” and “gender.”
- ● Sex is likely relevant when a study involves human subjects, animals, tissues, or cells. Gender is likely relevant for humans and, in some instances, animals (see Animal Research, Next Steps, #4).
- ● Sex and gender are also likely of relevance when the project develops or modifies health policies.
- ● Sex and gender must be investigated before they can be ruled out (see Not Considering Sex Difference as a Problem). Not all sex or gender differences are significant (see Overemphasizing Sex Differences as a Problem).
- ● Gender reduces less easily than sex to independent variables that can be included in a statistical analysis, but its explanatory power can be enormous (see Analyzing Gender).
Step 2: Literature Search
Perform a literature and database search with adequate terms for “sex” and “gender.” MeSH (Medical Subject Headings)—the U.S. National Library of Medicine controlled-vocabulary thesaurus used for indexing articles for PubMed)—does not distinguish consistently between sex and gender (in large part because authors do not). Hence, researchers need to develop search strategies to identify the full range of previously documented sex and gender differences.
- ● Several studies suggest combining the name of a condition or biomedical research topic with standardized MeSH terms, such as “sex factors” and “sex characteristics,” or text words, such as “gender differences” and “sex differences.” A number of complex search terms have been developed that yield better results than “sex” or “gender” alone (Oertelt-Prigione et al., 2010; Moerman et al., 2008).
- ● In basic life sciences research, search terms related to the female/male distinction, such as sex steroid hormones, gonadal hormones, sex chromosomes, estrogens, and androgens or steroid receptors may be required.
- ● A database has been established that includes a survey of sex and gender related references in major clinical disciplines and biomedical basic research (see http://bioinformatics.charite.de/gender/. This website has two login prompts. At the first prompt, enter User: "gender" and Password: "ppgm". At the second prompt, enter User: "guest" and Password: "guest"). In basic life sciences research, it may also be helpful to use search terms related to the female/male distinction, such as sex hormones or reproductive biology.
- ● Researchers have created a search engine tool which can help identify sex- and gender-related research in the U.S. National Library of Medicine's PubMed database (Jenkins et al., 2012).
Step 3: Establishing Research Questions and Hypotheses (see Formulating Research Questions)
- ● Using the results of steps 1 and 2, consider how the current project will include methods of sex and gender analysis (see Rethinking Concepts and Theories).
- ● Study design should allow for gathering of sex-disaggregated data.
- ● Study populations can be configured in different ways depending on the types of questions to be asked:
Step 4: Establishing Research Methods and Planning Data Analysis (see Designing Health & Biomedical Research)
- ● Research instruments (questionnaires, surveys, or protocols, etc.) should be developed for both women and men or females and males (see Rethinking Standards and Reference Models).
- ● Data can be analyzed in many different ways. Clarify whether sex needs to be controlled for, or whether the study is investigating the effects of sex on outcomes.
- ● A study that includes both women and men must use statistical tests to determine the confidence with which similarities or differences can be asserted.
- ● Consider the following questions in data analysis:
- 1. Does the treatment have a favorable balance of benefits and risks in a mixed-sex population overall?
- 2. Is the treatment effective and safe enough to be indicated in both women and men?
- 3. Are there sex differences in effect—i.e., is the treatment more effective or safer in one sex?
- 4. Do differences between women’s and men’s existing treatment options make the proposed treatment more important for one sex?
Step 5: Interpreting Data through Concepts and Theoretical Models
- ● Analyze all concepts and theoretical models for unfounded assumptions (see Rethinking Concepts and Theories).
- ● Studies should take care not to:
- ♦ Assume that findings in one sex apply to the other.
- ♦ Create a non-representative norm, such as assuming a male norm for a disease that affects both sexes or a technology used by both women and men (see Rethinking Standards and Reference Models).
- ♦ Pathologize normal biological processes, such as pregnancy or menopause.
- ♦ Interpret results in a sex- or gender-blind manner.
Step 6: Reporting Findings (see Analyzing Sex).
- ● Report the sex of research subjects and materials.
- ● Report null findings. Researchers should report when sex differences (main or interaction effects) are not detected in their analyses to reduce publication bias and enable meta-analysis.
- ● Check that sex or gender differences are properly visualized in the tables, figures, and conclusions (see Rethinking Language and Visual Representations).
- ● Check that sex and gender related findings are presented correctly in the title, abstract, and keywords.
Step 7: Establishing Conclusions and Making Recommendations
- ● Where significant sex differences and gender effects emerge, what follow-up research is necessary?
- ● Do results have specific implications for women and men patients? Do these differences have implications for clinical practice or future research?
- ● How can results showing significant sex or gender differences be translated into preventive, diagnostic, and therapeutic practices to improve patient outcomes?
This Checklist is adapted from: Nieuwenhoven, L., & Klinge, I. (2010). Scientific Excellence in Applying Sex- and Gender-Sensitive Methods in Biomedical and Health Research. Journal of Women’s Health, 19 (2), 313-321.
Jenkins, M., & Wilson, J. (2012). Finding the Evidence: A Sex- and Gender-Specific Medicine (SGSM) PubMed Search Engine Tool. Lubbock: Texas Tech University School of Medicine Health Sciences Center.
Moerman, C., Deurenberg, R., Haafkens, J. (2009). Locating Sex-Specific Evidence on Clinical Questions in MEDLINE: A Search Filter for Use on OvidSP. BioMed Central Medicine Medical Research Methodology, 9 (25).
Oertelt-Prigione, S., Parol, R., Krohn, S., Preissner, R., & Regitz-Zagrosek, V. (2010). Analysis of Sex and Gender-Specific Research Reveals a Common Increase in Publications and Marked Differences between Disciplines. BioMed Central Medicine, 8, 70-80.
Oertelt-Prigione, S.& Regitz-Zagrosek, V. (Eds.) (2012). Sex and Gender Aspects in Clinical Medicine. London: Springer Verlag.
Regitz-Zagrosek, V. (Ed.) (2012). Sex and Gender Differences in Pharmacology. London: Springer Verlag.
Schenck-Gustafsson, K., DeCola, P., Pfaff, D., Pisetsky, D. (Eds.) (2012). Handbook of Clinical Gender Medicine. Basel: Karger.