Criteria for Integration of Sex & Gender – Research with Human Participants
Letter of Intent Stage
1. Quality of the proposed research program
- Statement of any known sex and/or gender differences in the epidemiology, risk factors, conditions, diseases or effects of treatment under study
- Brief discussion of how sex and/or gender will be considered in the research question under study
- Description of the ways in which sex and/or gender will be accounted for in the research program, methods, analysis, reporting and knowledge translation plan
- Description of the sex- and gender-related variables under study
- If sex and/or gender are being omitted, a scientifically sound justification must be provided
2. Strength of the team
- Evidence that one or more of the applicants has credibility and research experience in sex and/or gender science as relates to the field of study
Examples may include:
- graduate training;
- publication history; or
- IGH core competency certificate in sex- and gender-based analysis.
Full Application Stage
1. Vision, rationale and added value
- Clarity of the vision regarding the analysis and expected results/outcomes as relates to sex and gender
- Evidence of explicit consideration being given to achieving equitable health impacts across diverse patient/population sub-groups
2. Quality and appropriateness of research approach with respect to sex and/or gender
Literature review
- Clear articulation of any known sex and/or gender differences in the epidemiology, risk factors, conditions, diseases or effects of treatment under study
- Literature review describing known sex and/or gender differences, or lack thereof, in the research area under study (determinants of gender include ethnicity, income, occupation and other key social determinants of health)
Research question
- Clear articulation of type of research question being considered with respect to sex and/or gender:
- Identifying sex and/or gender differences in the intervention/treatment/outcomes under study;
- Explaining these sex and/or gender differences;
- Establishing that there are no sex and/or gender differences in the intervention/treatment/outcomes under study; and
- Intention to study sex and/or gender as confounder or interaction variable while testing study hypothesis.
Study Design and Methods
- Scientifically sound justification for proposing a single-sex study, if applicable
- Inclusion and exclusion criteria that consider sex and/or gender in diverse populations of men, women, boys, girls and gender-diverse people
- Recruitment strategies to obtain required sample size of men, women, boys and girls
- Outcome measures that are sensitive and responsive to sex and/or gender issues and are not gender biased
- Description of the data collection tools/use of administrative datasets with respect to capturing sex- and gender-related variables of interest (both quantitative and qualitative data)
Analysis and Reporting
- Description of data analysis plan (i.e. sex-disaggregated or stratified analyses, pathway modeling, use of sex and gender variables as confounders or in interaction terms, if applicable)
- Sample size calculations to show adequate power for testing hypotheses with respect to sex and/or gender differences
- Inclusion of a statement that negative findings with respect to sex and/or gender will be reported
3. Knowledge Translation Plan
- Description of how the knowledge translation strategies intend to maximize uptake by men, women, boys, girls or gender-diverse people (e.g. will the content, messages or products vary by sex or gender?)
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