Table 2.
Comparison of policies, mechanisms, and lessons learned
| United States | Canada | European Union | |
|---|---|---|---|
| Policy | Consideration of SABV in NIH-funded research (15) | Sex- and gender-based analysis (21) | Gender dimension (sex and/or gender analysis) |
| Definition | Researchers are expected to perform the following: | Sex and/or gender considerations are integrated into every step of the research project, including project rationale, experimental design, methods, analysis, and knowledge translation and dissemination. | Researchers are required to integrate intersectional sex and gender analysis into each stage of the research and innovation process, where relevant. |
| 1) consider the influence of sex and/or gender when formulating research questions | |||
| 2) review the literature for the influence of sex and/or gender | |||
| 3) account for the influence of sex and/or gender in study design | |||
| 4) incorporate males and females into studies or justify using only one sex and/or gender | |||
| 5) collect, analyze data, and report data disaggregated by sex and/or gender | |||
| 6) characterize the influence of sex and/or gender in the interpretation of results | |||
| 7) communicate appropriately generalized findings. | |||
| Requirement | Required for vertebrate animal and human studies supported by NIH | Included in instructions to applicants. Questions on the application form for all competitions ask whether sex and/or gender are accounted for in the proposal. Justification is required for the inclusion or omission of sex and/or gender. | Horizon Europe requires all proposals to include intersectional sex and gender analysis, unless the exclusion is justified. Institutions must implement a GEP for their PIs to be eligible to apply for EC funding. |
| Strong justification required for single-sex studies | |||
| Funding opportunities | 1) Administrative supplements enable researchers to add sex/gender analyses to ongoing research. | 1) Investigator-initiated grants that seek ideas with the greatest potential to advance health-related fundamental or applied knowledge, health research, health care, health systems, and/or population health and policy research require consideration of sex and/or gender. | 1) Supplements for training in gender analysis. |
| 2) SCOR(E) program integrates basic, preclinical, clinical, and translational research and serves as a vital hub for education and dissemination of innovative sex-based and informed translational research methods and best practices. | 2) Strategic team grants on personalized health, immunology, microbiome, developmental origins of chronic disease, healthy cities, and others | 2) The EC has funded many projects to support and disseminate the gender dimension and the GEPs, including Gender Academy Training (22) and those discussed in the text. | |
| 3) U3 supplements support active NIH parent grants for 1 year to address research on the effect of sex/gender influences at the intersection of several social determinants, including race/ethnicity, socioeconomic status, education, health literacy, and other social determinants in human health and illness. | 3) Strategic catalyst grants for basic scientists are intended to stimulate research on a particular topic. | ||
| 4) Common Fund Administrative Supplements | 4) Sex and Gender Science Chair grants are intended to form a cadre of experts across all disciplines | ||
| 5) Investigator-initiated funding opportunities such as The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)–RFA-OD-19-029 | |||
| Mechanisms | 1) Required in all relevant applications within the research strategy section and assessed as part of the application’s score | 1) For specific competitions, the nominated principal applicant is required to complete an online training module on sex and gender integration. | 1) The Funding and Tenders portal contains all relevant information for applicants and evaluators, with links to appropriate tools. |
| 2) Training of investigators and reviewers via online courses | 2) For specific competitions, a sex and gender champion is required on the research team. | 2) Including the gender dimension is the default requirement for Horizon Europe. | |
| 3) Governance structures | 3) Requirement for a cross-cutting sex and gender platform across specific strategic consortium grants | 3) Training in integrating the gender dimension has been given to commission staff (program writers, members of executive agencies). | |
| 4) Specific language is embedded in relevant funding opportunity announcements | 4) Embedded within the objectives and evaluation criteria for specific strategic funding opportunities | 4) Training in integrating the gender dimension has been organized for national contact points in member states. | |
| 5) Trans-NIH Strategic Plan for Advancing the Health of Women | 5) EC monitors the percentage of projects with a gender dimension in the project design. | ||
| Peer-review processes | 1) Methods and study design of the application are reviewed for compliance with SABV; overall score for approach reflects how issues are addressed. | 1) Chairs and scientific officers on project peer-review committees are required to complete the sex and gender online training modules. | 1) Evaluator briefings |
| 2) Decision tree guidelines provided to assist peer review 3) Summary statement reflects study section discussion and reviewer critiques |
2) A designated sex and gender expert is assigned to each project peer-review committee. | 2) Training modules on avoiding implicit bias in evaluations | |
| 3) Structural change on peer-review forms requires peer reviewers to comment on the strength or weakness of integration of sex and gender and to provide recommendations for improvement. | |||
| 4) Included in the evaluation criteria for specific strategic funding opportunities | |||
| 5) Members of each peer-review committee receive discipline-specific training on how to critically appraise sex and gender in research content | |||
| Lessons learned | 1) Training needed to understand why sex and gender considerations are important; training and resources need to help researchers and reviewers understand the SABV policy and to promote adherence. | 1) Sex- and gender-specific funding policies provide the most leverage for funders to influence applicant and evaluator behavior | 1) The gender dimension in research design is easily ignored unless required. The new Horizon Europe requires this element in proposals, unless a justification is provided. |
| 2) Importance of preparing the scientific community for a shift in science culture | 2) There is no magic formula. Serial multicomponent interventions are required to gradually shift culture over time for the research community | 2) Researchers, evaluators, and agency staff require training in sex, gender, and intersectional analysis. | |
| 3) Understanding that many sectors and disciplines are at different stages of integrating sex and gender into research approaches; hence, “interventions” need to be tailored or entity based on where a particular field is in the process. | 3) Requiring evaluators to provide checkbox (strength, weakness, not applicable) and written feedback to applicants on whether sex and gender were appropriately considered improves accountability. Asking evaluators to discuss this feedback with each other during the peer review committee increases accountability among peer reviewers to provide quality assessments. | 3) The agency must fund training resources, such as Gendered Innovations, the Gender Academy, and Gender-NET ERA-NET. | |
| 4) Identifying and enlisting champions in various fields can be an effective strategy. | 4) Reviewers and applicants benefit from discipline-specific tools to increase capacity. | 4) Evaluation criteria for proposals must be tailored to each research and innovation domain. | |
| 5) Major cultural shifts take time regardless of the structural and process changes that are implemented to facilitate them. | 5) Sex and gender champions on research teams and review committees add value; however, in isolation, they are not a feasible solution as they exist in insufficient numbers to populate all team grants and committees. | 5) The output of funded research (ie, peer-reviewed articles) should be monitored for quality integration of sex, gender, and intersectional analysis and be reported in the biennial EU She Figures (23). |
Abbreviations: EC, European Commission; EU, European Union; FDA, US Food and Drug Administration; GEP, Gender Equality Plan; NIH, National Institutes of Health; PI, principal investigator; SABV, sex as a biological variable; SCOR, Specialized Centers of Research; SCORE, Specialized Centers of Research Excellence; SGBA, sex- and gender-based analysis; U3, Understudied, Underrepresented, and Underreported.