Criteria that will be used for evaluating the integration of sex and gender into CIHR strategic funding initiatives – Biomedical & Translational 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, epigenetic, sex hormone receptors, immune response)
  • Clear articulation whether the research question intends to examine sexual dimorphism
  • Sample size considerations with respect to sex
  • Description of additional ways in which sex/gender will be accounted for in research programs involving cells, tissues, animals and humans
  • If sex/gender are being ommitted, a scientifically sound justification should be provided

2. Strength of the team

  • Identification of a Sex and Gender Champion within the research team
  • Evidence that the Sex and Gender Champion has credibility and research experience in sex and/or gender science as relates to the field of study (i.e. graduate training, publication history, and/or IGH core competency certificate in sex/gender methodology related to the topic under investigation)
  • Appropriateness of the role described for the Sex and Gender champion (i.e. responsible for guiding the formulation of sex/gender-related research questions within the research proposal; assurance that experimental design elements, analysis, reporting and knowledge translation plans reflect gold standard sex/gender approaches)

Scoring of the letter of intent

The appropriateness of the Sex and Gender Champion will be evaluated.

Reviewers will be asked to assess whether sex/gender integration is:

  • Outstanding: extremely thoughtful integration into the research question and proposal
  • Excellent: reasonably thoughtful integration into the research question and proposal
  • Good: good integration, not compelling
  • Fair: incomplete integration
  • Poor: no mention of sex and gender, the omission is unjustified

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 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/gender

  • Literature review
    • Clear articulation that the phenomenon/condition/disease under study has a different incidence or prevalence based on sex.
    • A literature review that describes known sex differences, or lack thereof, in the research area under study.
  • Research question
    • Clear articulation of the type of research question being considered with respect to sex/gender:
      • Identifying sex/gender differences
      • Explaining sex/gender differences
      • Establishing sex/gender similarities in the mechanism under study
      • Investigating sex-specific pathways underlying a common phenotype
      • 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 and women/boys and girls; will the content/messages/products vary by sex or gender
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