FAQ sex and gender in research

Human and animal biological and physiological differences

Sex refers to a set of human and animal biological attributes that differentiate between individual organisms. It is primarily associated with physical and physiological attributes, including chromosomes, gene expression, hormone levels and hormonal functions, genitals and reproductive anatomy. Sex is usually differentiated as male or female, but there are variations in sexual biological attributes and the physical manifestation of these aspects.

The socioculturally determined aspects that differ between men, women and gender-diverse people

Gender refers to socially constructed identities, roles, relationships and institutionalised designations that differ for girls, women, boys, men and gender-diverse people. Gender influences how people see themselves and others, how they act and how they treat each other, and how power and resources are distributed across society. Gender has been traditionally regarded as a binary concept (male/female), but there is a tremendous variability in how individuals and groups understand, experience and express gender.

Paying greater attention to sex and gender differences in research and innovation will improve both the quality and relevance of the results. We will then be able to apply the results to the whole of society. The existing health disparities between men and women reveal that this is currently not the case by a long shot. In order to reduce existing health disparities, and to provide everyone with the healthcare he or she needs, we have to attend to biological, sociocultural and societal differences in humans and animals, i.e. sex and gender differences.

We now have many resources and tools developed specially for researchers that show you how to integrate sex and gender analysis into your project. At the bottom of this page you will find a full list of resources and tools. As your first port of call, we want to outline 3 highly useful, broadly relevant tools that help you integrate sex and gender into health research.

• These three interactive online training modules have been developed by the Institute of Gender and Health at the Canadian Institutes of Health Research (CIHR) for researchers in a wide range of fields. The modules each take 30-45 minutes to complete and provide an excellent basis for incorporating sex and gender analysis into health research.
• The Gendered Innovations project at Stanford University develops practical research methods for analysing sex and gender in scientific research. The project also offers a number of case studies that serve as useful examples of how attention to sex, gender and diversity leads to new scientific insights and innovations.
• The platform Genderful Research World provides an overview of key resources for integrating sex and gender at each stage or phase of research. Resources are classed separately for biomedical, basic research, clinical and public health research.

Below we provide further explanation for the different parts of an application. Answers to the questions were compiled based on checklists provided by the Canadian Institute of Health Research’s Institute of Gender and Health and Stanford University’s Gendered Innovations.

Research question

How do I decide whether attention to sex and/or gender is relevant to the research topic of my application?

Sex can be relevant if you will be working with cells, tissue, animals or human subjects. Gender is probably only relevant when a project deals with people.

Use your literature review to find out what the current state of knowledge is regarding (potential) differences between men and women for your research topic. Are there, for example, differences in the prevalence or incidence of something based on sex or gender? Are there known differences in the risk factors of a disease or condition? Or differences in the manifestation and/or the stages of illness? Do men and women respond differently to treatment?

Incorporate into the research question known differences between men and women, and whether such differences have a biological sex-related basis and/or a relation to sociocultural gender-related factors. If the scientific literature indicates that there are no proved sexual or gender-related differences relevant to your research topic, state this too.

Remember: differences between groups of men or groups of women – such as age, ethnicity or level of education – may also be significant to your research topic and hence require attention.

Tips:

• Insert the PubMed standardised MeSH terms for the literature review. We’re thinking here of terms like ‘sex factors’ or ‘sex characteristics’. Inserting search words like ‘sex differences’, ‘gender differences’, the name of a sex hormone or sex-specific genital attribute can also help you find relevant publications.
• Publications dealing with sex and gender are easier to find by using the PubMed Search Tool or the Gender Med Database.
• Professor Sabine Oertelt-Prigione has published a collection of essays that includes the most important scientific literature for the field of sex and gender in healthcare.

When is it not necessary to attend to sex and/or gender in my research?

You should always investigate whether sex and gender are relevant – or could be relevant – before ruling them out.  It’s not necessary to include sex and gender analysis if, based on existing knowledge, it is clear that sex and gender differences are not relevant to your research topic.

Remember: it may well be a valid strategy to consciously focus your research on just one sex (e.g. because a certain condition in one sex has hitherto not received the attention it deserves), or to decide to omit attention to gender in your research (e.g. because you are interested in investigating the biological basis of a condition). However, you need to provide support in your application why you made this decision; you also need to analyse and report the project results clearly within that framework.

Objective

Do I have to take account of sex and/or gender in my objective, research question or goal?

If sex and/or gender is relevant to your topic, we need to see explicit attention to this aspect in your objective, research question or goal. However, attention to sex and/or gender does not mean that the objective of your project is to focus on the discovery or testing of sexual or gender differences. When devising your objective, research question or goal, consider the following possibilities:

• Identify and/or explain sexual and/or gender-related differences.
• Determine similarities on the basis of sex or gender in disease mechanisms, or determine that there are no sexual or gender-related differences in the case of a specific intervention, treatment or outcome.
• Investigate a sex-specific path underlying a common phenotype.
• Include sex and/or gender as an interactive variable or as confounder when testing the research hypotheses.

Strategy

How do I take account of sex and/or gender in my research strategy and methodology?

Indicate how you would operationalise sex and/or gender in your proposal. We’re thinking here of such things as identifying the sex of the cells, tissue, animals or human subjects used in the research, and describing the method of documenting and verifying the hormonal status of female animals, if applicable. Also make clear which sexual and gender-related variables will be included in the investigation in order to capture data on sex and gender (for both quantitative and qualitative data).

Set both inclusion and exclusion criteria that are at least partly based on sex and/or gender differences. Be sure you have a good representation of both men and women, if applicable, to ensure meaningful analysis and useful statistics. Engage a statistician for the project, if necessary, well in advance.

Take account of male/female differences in your recruitment strategy in order to obtain the necessary sample size. We’re thinking here of things like whether there is a difference in places where your male or female target group is found, or whether they are responsive to participation for other reasons.  

Design outcome measures that are sensitive and responsive to sex and/or gender differences. Check that your outcome measures apply in the same way to men and women. Invite both male and female patients, for example, to give their input on the research design, so that you can incorporate both perspectives into your investigation.

Tips:

• Gendered Innovations offers definitions for terms and concepts related to sex, gender, race, ethnicity and intersectionality factors providing a basis for usage.
• Have a look at their checklist for integrating aspects of gender into your project.
• Read the Meet the Methods flyer about incorporating gender-related variables into your project.
• Read the article about the barriers and facilitators in the recruitment of women as subjects.
• Read the article on sex-specific and gender-specific aspects of patient reported outcomes and measures.

How do I take account of sex and/or gender in my analysis and reporting?

Design an analysis and reporting plan that takes account of sexual and/or gender differences. We’re thinking here of such things as analyses that are differentiated or stratified according to sex, or the use of sex and/or gender variables as interaction variables or as confounder.

Ensure that the sample size is sufficient for testing hypotheses according to sexual and/or gender difference. For example, calculate the statistical power for quantitative analyses.

Report even if no difference is found (or none that is statistically significant) for sex and/or gender variables, if applicable.

Tips:

• Gendered Innovations contains an overview of methods for the analysis of sex and gender, which includes both general methods as well as methods specifically applicable to biomedical and health research.
• Video recordings of useful lectures were made for the annual Summer School sponsored by ErasmusMC and ZonMw in 2021, such as lecture 4 given by Maryam Kavousi.
• The SAGER guidelines help with reporting on sex and gender in research.

Feasibility

Which sex and gender related factors will influence the feasibility of my project?

Recruitment strategy and data collection demand special attention in order to productively execute the investigation within the time available, with the resources available. In order to find enough women and men to generate good analyses, you need a target-oriented recruitment strategy and possibly more through time.

Tip:

• Read this article which discusses barriers and facilitators to participation in clinical trials experienced by men and women.

Project group

How do I take account of sex and gender in the composition of the project group?

If sex and/or gender is relevant to your topic, get someone to join your project group who has experience in investigating issues of sex and/or gender in your research field.

Tips:

• The CIHR’s Institute of Gender and Health gives criteria for the composition of the project group as part of the evaluation of sex and gender in research involving human subjects.
• In the Netherlands, researchers can come into contact with a pool of experts in sex and gender issues through ZonMw. Send an email to gender@zonmw.nl for more information.
• Video recordings of lectures were made in 2021 for the annual Summer School sponsored by ErasmusMC and ZonMw. Lecture 6, for example, given by Professor Sabine Oertelt-Prigione is very useful.

Knowledge transfer and dissemination of results

How do I take account of sex and gender when I get to the stage of knowledge transfer and dissemination of results?

Depending on the outcome of your investigation, it may be important to differentiate between men and women (or smaller subgroups) at the knowledge transfer and dissemination of results stage. We’re thinking here of things like modifying the form or contents of the message or project, or being selective in the places where you will actively disseminate the results.

Tips:

• In the article Why sex and gender matter in implementation research, the authors describe techniques for analysing sex and gender in implementation research.
• Video recordings of lectures were made in 2021 for the annual Summer School sponsored by ErasmusMC and ZonMw. Lecture 7, for example, given by Professor Sabine Oertelt-Prigione is very useful.

It’s important to consider diversity when assessing the quality and relevance of a research proposal. We created a checklist in our e-book for reviewers for evaluating how well an application integrates sex, gender and diversity analysis.

• We also offer the information on this page in published form as an e-book for grant applicants.
• View the main page about integrating sex and gender into scientific research.
• View the main page on sex and gender.