Criteria for Integration of Sex & Gender – Biomedical Research
Letter of Intent Stage
1. Quality of the proposed research program
- Statement of any known sex differences in the biology or epidemiology of the disease under study
- Brief discussion of the influence of sex on the mechanism under study (e.g. genetic, sex hormone receptors, immune response)
- Clear articulation of whether or not the research question intends to examine sexual dimorphism
- Sample size considerations with respect to sex
- Description of additional ways in which sex and/or gender will be accounted for in research programs involving cells, tissues, animals and humans
- If sex and gender considerations are being omitted, a scientifically sound justification should 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 they relate to sex and/or 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 that the phenomenon/condition/ disease under study has or does not have a diferent incidence or prevalence based on sex or gender
- Literature review describing known mechanisms explaining sex or gender diferences, or lack thereof, in research area under study
Research question
- Clear articulation of the type of research question being considered with respect to sex and/or gender, including:
- Identifying sex and/or gender diferences;
- Explaining sex and/or gender diferences;
- Establishing sex and/or gender similarities in the mechanism under study;
- Investigating sex-specific pathways underlying a common phenotype; and
- Studying sex/gender as a confounder or interaction variable while testing the main study hypothesis.
Study Design and Methods
- Scientifically sound justification for proposing a single-sex study, if applicable
- Identification of the sex of the cells, tissues or animals being used, if applicable
- Description of the method for documenting/controlling the hormonal status of experimental female animals, if applicable
- Description of the method for including equal numbers of male and female human participants for translational research, if applicable
Analysis & Reporting
- Description of the analysis and reporting plan for sex-disaggregated data, if applicable
- Sample size calculations to show adequate power for a sex-disaggregated analysis, where appropriate
- Inclusion of a statement that negative findings with respect to sex 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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