Table 1.
Comparative historical overview of key events and policy implementation
| Epoch | United States | Canada | European Union |
|---|---|---|---|
| 1990s | 1990: ORWH formed | 1995: Commitment to gender-based analysis plus on all legislation, policies, and programs | 1997: Treaty of Amsterdam, which reported on the status of women across EU countries in terms of equal pay, maternity leave, education, and other issues |
| 1993: NIH Revitalization Act mandated inclusion of women and minorities in clinical research | 1998: Sector on women and science created to mainstream gender throughout the EC | ||
| 1994: NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research: “NIH Inclusion Policy” developed NIH Guide, Vol. 23, No. 11, March 18, 1994 | 1999: Communication: Women in Science, Mobilising Women to Enrich European Research | ||
| 1999: European Technology Assessment Network working group on Women and Science delivered its report: Science Policies in the EU: Promoting Excellence through Mainstreaming Gender Equality | |||
| 2000s | 2001: NIH and FDA fund the IOM report, “Exploring the Biological Contributions to Human Health: Does Sex Matter?” (12) | 2000: CIHR is formed; 13 funding institutes are designated by an act of parliament with equal budget and decision-making capacity, one of which is the CIHR IGH. A GBA policy that applies broadly to the entire government of Canada is implemented. | 2000: Gender Impact Assessment Studies for FP5 |
| NIH Inclusion Policy amended Oct. 9 (2001 NOT-OD-02-001). The amended policy provides additional guidance on the analyses and reporting of analyses of sex/gender, racial/ethnic, and other effects for NIH-defined phase 3 clinical trials. | 2006: CIHR begins to integrate SGBA into applications through funding policy and applicant and reviewer guidelines. | 2001: First Gender in Research Conference | |
| 2006: Organization for the Study of Sex Differences formed | 2009: The Government of Canada’s Health Portfolio updates its policy to an SGBA policy to differentiate sex as a biological variable from gender as a sociocultural determinant of health. | 2002-2006: FP6 requirement to address the “gender dimension,” which integrates both sex and gender analysis into research design, where appropriate (later referred to as “sex and/or gender analysis”). This requirement forms the third objective of the EC’s Gender Equality Policy. | |
| 2006: NIH ORWH and FDA OWH deploy an online continuing education course: “Science of Sex and Gender in Human Health” | 2004-2008: Gender Monitoring Studies | ||
| 2007: NIH announces SCOR on Sex Differences to integrate basic, preclinical, clinical, and translational research to facilitate innovative, interdisciplinary studies on sex differences and on diseases and conditions that affect women’s health. | 2009: Treaty of Lisbon: All policy areas must ensure equality of women and men. | ||
| 2010s | 2010: Moving into the Future with New Dimensions and Strategies for Women’s Health Research—A Vision for Women’s Health Research (NIH strategic plan for women’s health and sex/gender difference research); NIH supports IOM’s Sex-Specific Results Reporting Workshop and Report | 2010: Reporting on sex/gender in study design during the submissions of CIHR grant applications is implemented. | 2011: The expert group, Innovation through Gender, is formed. |
| 2014: NIH ORWH and FDA OWH update and expand the online course (currently being updated again) | 2014: Sex and Gender Champion program launched | 2013: GENDER-NET is formed to promote gender equality through structural change in research institutions and to integrate sex and gender analysis into research. The network consists of 16 organizations from 12 European countries and Canada. | |
| 2013: NIH Sex/Gender Administrative Supplement funding began, to encourage sex/gender comparisons in preclinical and clinical studies already being conducted. | 2015 and 2017: Catalyst grants launched | 2014-2020: FP8 (Horizon 2020); AGG launched | |
| 2015: Rigor and Reproducibility policy (13) requiring applicants to report plans to balance male and female cells and animals in preclinical studies instituted (14) | 2016-2017: New SGBA Research Action Plan to better integrate SGBA in CIHR’s research funding programs is developed and implementation begins. | 2017: GENDERACTION project launched; GENDER-NET Plus reformed | |
| 2016: Consideration of SABV in NIH-funded Research policy, which applies to vertebrate and human studies, is instituted (15); 21st Century Cures Act passed (16) | 2016: Completion of sex and gender training modules as an eligibility criterion for specific funding opportunities | 2018: Proposal for Horizon Europe (FP9) 2021 to 2027 published. | |
| 2017: Amendment to NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research now requires recipients conducting applicable NIH-defined phase 3 clinical trials to ensure results of valid analyses by sex/gender, race, and/or ethnicity are submitted to ClinicalTrials.gov (16). | 2018: SGBA research action plan, includes peer review assessment of the appropriateness of sex and gender integration in investigator-initiated project grants through structural changes to the peer-review assessment form and capacity building among reviewers. | 2018: The Expert Group to Support Sex, Gender, and Intersectional Analysis in Horizon Europe is formed. | |
| 2018: Inclusion Across the Lifespan policy (17); SCOR is converted to SCORE, which requires a Career Enhancement Core to support training of innovative sex-based and informed translational research methods and best practices and to provide leadership in the development and promotion of standards and polices for the consideration of sex differences. | 2018: CIHR makes systematic monitoring of the integration of sex and gender considerations into CIHR-funded research a performance indicator in its departmental results accountability framework to government. | ||
| 2019: Advancing Science for the Health of Women: 2019 to 2023 trans-NIH Strategic Plan for Women’s Health Research was released; ORWH issues first Funding Opportunity Announcement for R01 (RFA-OD-19-029) that solicits applications on the influence and intersection of sex and gender in health and disease. | 2019: CIHR approves IGH’s sex and gender science strategy, which includes an interdisciplinary cadre of Sex and Gender Science Chairs. | ||
| 2020s | 2020: CIHR introduces new gender policies to mitigate the effects of the COVID-19 pandemic (18). | 2020: The first Horizon Europe Strategic Plan (2021-2024) includes 2 new developments: 1) sex and gender analysis in research design is required in all applications unless its nonrelevance is justified; and 2) institutions must implement a GEP to be eligible to apply for EC funding. The GEP includes sex, gender, and intersectional analysis in research design (20). | |
| 2021: CIHR launches its 2021 to 2031 Strategic Plan that emphasizes equity and attention to sex and gender as an integral component of scientific excellence (19). |
Abbreviations: AGG, Advisory Group for Gender; CIHR, Canadian Institute for Health Research; EC, European Commission; EU, European Union; FDA, US Food and Drug Administration; FP, Framework Programme; GBA, gender-based analysis; GEP, Gender Equality Plan; IGH, Institute of Gender Health; IOM, Institute of Medicine; NIH, National Institutes of Health; ORWH, Office of Research on Women’s Health; OWH, Office of Women’s Health; SABV, sex as a biological variable; SCOR, Specialized Centers of Research; SCORE, Specialized Centers of Research Excellence; SGBA, sex- and gender-based analysis.