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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