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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