Key considerations for the appropriate integration of sex and gender in research
Key considerations for the appropriate integration of sex as a biological variable
It is recommended that applicants consider accounting for sex as a biological variable in basic science, clinical, health system and population health studies where appropriate.
Situations when sex is applicable:
The following key considerations apply for reviewers to rate the quality of integration of sex as a biological variable in the proposal, in order to meet standards for rigour and reproducibility in science, and to allow for the discovery of sex differences and their underlying mechanisms:
Strength:
- Clear articulation that the phenomenon, condition or disease under study has, or does not have, a different incidence or prevalence based on sex
- Inclusion or recruitment of male and female cells, tissues, animals or humans when studying models of disease that affect males and females
- Documentation and analysis of the sex of the cells, tissues, animals or humans used in the protocol
- Proposed experimental design that disaggregates results by sex
- Builds on what is already known about sex differences and sex-related mechanisms in the field of study
Weakness:
- Does not provide a compelling justification for a single-sex study
- Ignores observed sex differences already reported in the literature, or fails to build on published data in the design of the proposed studies
- Does not report the sex of the cells, tissues, animals or humans being studied
- Does not describe how sex will be accounted for and considered in the analysis plan
- Does not demonstrate a commitment to disaggregate the data by sex
- Conflates and/or confuses the terms sex and gender
Situations when gender may not be applicable:
The integration of sex as a biological variable may not be applicable in research involving:
- Pathogens grown in vitro in an acellular environment
- The pre-clinical design and application of some biomedical technologies
A reasonable explanation should inform the decision why it is not possible or relevant to account for sex as a biological variable.
Key considerations for the appropriate integration of gender as a social determinant of health
It is recommended that applicants consider accounting for gender as a sociocultural determinant of health in clinical, health system and population health studies where appropriate.
Situations in which gender is applicable:
The following key considerations apply for rating the quality of integration of gender as a sociocultural determinant of health in the proposal as a strength or a weakness:
Strength:
- Literature review: reports what is known about gender, gender-theories, and/or intersectionality in the field of study, where relevant
- Methods: describes how gender will be measured or investigated in the population under study
- Recruitment method: addresses and mitigates bias
- Analysis: describes how gendered sub-groups will be compared and that the findings will reported separately in the results section
- Implementation and knowledge translation plan: considers aspects affected by gender
Weakness:
- Reports that gender is irrelevant without adequate justification
- Does not measure gender within the population under study when it is possible and relevant to do so
- Does not describe how gender will be accounted for and considered in the analysis plan
- Does not demonstrate a commitment to disaggregate the data by gender and/or present suitable subgroup analyses
- Conflates and/or confuses the terms sex and gender
Situations when gender may not be applicable:
The integration of gender as a sociocultural determinant of health may not be applicable in research describing:
- Biomedical research studies that exclusively use cells, tissues and animals
- Certain single-sex studies using existing datasets
- Secondary data analyses where it is impossible to create a new gender variable
Resources
- CIHR Sex and Gender Online Training Modules
- CIHR YouTube Video: Assessing Sex and Gender Integration in Peer Review
- CIHR Resources for Applicants and Peer Reviewers: How to Integrate Sex and Gender in Research
- Sex and Gender Equity in Research (SAGER) Guidelines [ PDF (567 KB) - external link ]
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