Differences in incidence, mortality, and survival statistics between men and women make it imperative for researchers and health professionals to communicate scientific results disaggregated by sex and/or gender. The final purpose is to enable accurate interpretation and dissemination of the advances in the scientific-medical field, so that they can be extrapolated in an inclusive and safe way to the whole population.1,2 In this context, the scientific literature has highlighted the importance of examining how science has historically been constructed from an androcentric perspective, that do not democratise the production of knowledge and do not include the voice and experience of all genders.3 This has resulted in certain biases that have influenced research in biomedicine and health care, including the gender gap in scientific teams and the failure to integrate a gender approach at all stages of research, from design to communication.4 At present, many clinical trials still lack a gender perspective, as they often do not include or analyse variables that capture the specific inequalities arising from the disadvantaged position of women. Therefore, gender bias in biomedical research persists due to the lack of disaggregated data collection and analysis, the fragmentation of health information systems, and the underrepresentation of women in clinical trials, all of which subsequently influence clinical practice.2,5 As a result, important data gaps arise from potential sex and gender inequalities in infection rates, disease manifestation and progression, hospitalization, mortality, vaccination, and other related factors.4 Most strikingly, these variables are often collected but not reported in a transparent or accessible manner, making difficult a meaningful analyses of the interaction between sex, gender, and health.1 These problems are compounded by implicit constraints on research priorities and a lack of resources to conduct detailed studies that could address health inequities. One proposal to improve this situation would be for research projects to include a section on gender ‘principles and values’ in the research project.6

In this regard, clinically relevant differences in the functioning of the immune system, resistance to antibiotics, the effects of drugs, body composition, or the development of tumors have been identified, so that incorporating the gender perspective into the research process and health care activities would lead to significant advances in diagnostic and therapeutic approaches.7 The goal is to achieve more personalised care, where health professionals develop clinical strategies, as well as health promotion and disease prevention measures, based on prior scientific activity that takes into account the sex and gender of each patient, including community LGBTQ+.8 To promote the integration of a gender perspective in research, numerous strategic plans have been launched by governmental institutions, funding agencies and academic structures.9 The growing awareness of biases related to sex and gender has led to the development of tools such as the Sex and Gender Equity in Research guidelines (SAGER)1 and the Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER).10 The SAGER guidelines, published in 2016, are a widely accepted standard for reporting sex- and gender-disaggregated data in scientific research,1 while the GATHER guidelines, adopted by the World Health Organization (WHO) in 2023, promote ensuring transparency in notifying estimates in global health. WHO adopted SAGER recommendations as GATHER guidelines to improve the collection, analysis and reporting of sex- and gender-disaggregated health data. The endorsement of this guideline by WHO as the global health authority, as well as by the EQUATOR network in 202211 and by the International Committee of Medical Journal Editors in January 202412 in its recommendations for the presentation of the main types of biomedical studies, constitutes a stimulus for academic publishers and scientific journals, which have included it among their requirements or standards, urging them to improve the quality of scientific publications and reports made with data disaggregated by sex and gender, promoting an update of health policies.9 In the same vein, an increasing number of health journals are promoting the dissemination of knowledge from a gender perspective.13

Quality research requires not only the incorporation of a a gender approach in study design and content of research, but also effective gender equality within research teams. Among the main reasons are social responsibility and equity, scientific excellence and innovation, and the creation of better research teams.9

Healthcare, in particular, has historically been a male-dominated field, with women facing significant challenges in entering and advancing their careers. Although the situation has improved in recent decades and the percentage of female biomedical academics now exceeds that of men, it could be even better. The presence of women in scientific workforce has grown but their leadership positions, publications and funding could still improve,14,15 which limits their ability to carry out large-scale, high-impact projects. In addition, there is a significant gap in publication output and citations, which negatively impacts the advancement of women in science. Moreover, studies show that gender inequality affects manuscript review times, with longer review and acceptance periods for papers authored by women in the first or last position. Increased awareness of this bias could help implement corrective measures.16 Moving to the cardiovascular field, the paper by Blumer et al.17 showed that while women's research participation is increasing, their representation in lead author and leadership roles remains limited. In turn, the lack of dedicated time for research is a major barrier for women who also have caregiving responsibilities. This issue is particularly relevant in the fields of oncology and cardiovascular health, where clinical demands can be particularly high.18 Interestingly, the scientific literature shows that mixed-sex teams are better managed and more efficient than single-sex teams because they are more creative, have a greater diversity of viewpoints, and demonstrate higher quality decision making.4 In this line, previous studies observed that the disaggregation of results by sex is more common when women are the first authors or when women make up the majority of the authorship.19

Many policy initiatives have been developed in recent years to minimise gender bias in science; however, despite progress, health research is still reluctant to fully adopt a gender perspective.9 Often this is not due to a lack of will, but to a lack of knowledge and tools to analyze or evaluate this situation of inequality.20 The aim of this study is to develop a questionnaire that will serve as a tool to evaluate and train the inclusion of a gender perspective in health and biomedical research studies, targeting both researchers and health professionals.

In order to develop the HEIRES (HEalth Inclusive RESearch) questionnaire (Fig. 1), a literature review has been conducted followed by a simplified Delphi method.

Figure 1.

Methodology conducted for the development of the HEIRES questionnaire.

(0.39MB).

The HEIRES questionnaire represents a tool for assessing, raising awareness and identifying improvements in the integration of a gender perspective in each of the phases of biomedical research, from the establishment of the research team within its institutional framework, through the experimental design of the project itself, to the communication of results and the choice of dissemination methods. It has been designed and structured in five thematic blocks comprising a total of 41 questions. In addition, the respondent is asked to provide information on various socio-demographic variables.

The previous SAGER,1 GATHER10 and Uppsala Universitet22 checklists include 12, 16 and 13 items, respectively, on the research data and information to be collected, detailed and reported to ensure transparent health science accessible to all populations, focusing on the description of objectives and funding, data acquisition and analysis, results and discussion. Likewise, the Gendered Innovations Division of Stanford University23 provides a checklist to ensure that gender differences are recognised and addressed in research design in various scientific disciplines, which, in the field of health, specifies the choice and use of the measurement tool, the type of study, the protocol, analysis and dissemination, and specifies the application of the SAGER guidelines.1 However, in none of the cases are indicated aspects related to the composition of research teams or journal committees.

Regarding team configuration, the University Warwick Toolkit28 complements for other dimensions of research team composition which also are vaguely mentioned by the Equal4Europe26 and Saskatchewan University.24 At this respect, questionnaire HEIRES includes, in a concise and direct way, items relevant to the gender balance in the institution and in the research groups considering atypical careers and employment conditions for reconciling work and family life. Percentage of women researchers and leaderships are also assessed, helping to identify gaps and weaknesses in career development for each category of biomedical research, including specification of the type of research they conduct (basic, clinical, translational or public health), according to the of Canadian Institute of Health Research recommendations.25 Investing in equal opportunities for all in science and care improves the dynamics and functioning of groups and attracts high-level research personnel.31 Several initiatives and policies have been implemented to promote gender equality in scientific teams,9,32 including mentoring programs, specific funding programs for women, and the implementation of gender quotas in R&D calls. However, the effectiveness of these policies varies and needs to be continuously evaluated and improved, making it imperative to create conditions and work cultures that allow all people, regardless of sex/gender, to have enriching careers with equal opportunities for advancement. These efforts attract and retain the best talent, encourages and motivates people to achieve a satisfying work-life balance and improve awareness and attitudes towards equality among health professionals.33,34

The HEIRES questionnaire collects data on sex, ethnicity and gender and incorporates the intersectional vision, taking into account socio-demographic variables (social class, ethnicity, religion or functional diversity), both in the sample content analysed in the studies and in the research team and type of institutions involved. In accordance with the NIH-Wide Strategic Plan for Research on Women's Health 2024-2028,21 this procedure helps identify gaps and supports deeper investigation into traditionally understudied, underrepresented and underreported populations. HEIRES provides direct and objective feedback that quantifies the integration of the gender approach and stimulates a change in the policies of research teams and institutions to contribute to the promotion of re-entry, reintegration and retraining in health research careers,21 committed to an equitable distribution of opportunities and resources.

Another essential and differentiating feature of the HEIRES questionnaire is its focus on the selection of journals for publication. It emphasizes a preference for journals or publications platforms that promote and uphold gender equality through key variables, such as the composition of editorial teams, the use of full names in the authorship, inclusive literature citation and inclusive language. The HEIRES survey becomes a tool to extend this strategy to gender equality to the composition of other committees for the organising of scientific congresses, societies or scientific tribunals.

The developed checklist offers several key advantages: 1) it provides a concise summary of concepts related to the gender perspective as a tool to help before answering the questionnaire; 2) promotes scientific excellence by supporting the development of research that supports comprehensive, fair, transparent and truthful results; 3) fosters the formation of stable, diverse, and talented research teams by supporting the inclusion of people with diverse and atypical careers; 4) enables innovation by enhancing the creation of new approaches and better solutions to meet society's needs, and openness to new ideas; 5) advances the recognition and inclusion of gender diversity and the defence of human rights, thus contributing to better, more personalised and tailored health care, which also generates greater social cohesion; 6) raises awareness of gender mainstreaming across various fields, including basic, preclinical and clinical research translational studies and epidemiology and public health, while encouraging reflection on the diversity of patients and challenging stereotypes, taboos and fears in health research participation; 7) is simple and cost-effective requiring no additional resources, prior user training or the hiring of teams of staff specialised in gender or more complex technologies; 8) delivers immediate results through an automatic, objective global score indicating the level of inclusiveness and sensitivity to the gender perspective, along with feedback on a three-level green-orange-red scale; 9) it is multi-level as it can be used at any stage of a biomedical study, even in ongoing studies or those at an advanced stage of development, as it allows each block to be evaluated independently and accurately; and 10) provides a quality certificate that validates and supports biomedical science, research groups and institutions in their commitment to more inclusive and sustainable progress in line with global challenges and the 2030 Agenda,35 the WHO,10 and the NIH,21 and other previously published guidelines.14

In conclusion, the HEIRES questionaire is presented as a verification tool to help researchers, scientific groups, institutions, publishers and policy makers to make science inclusive, transparent and fair, to improve biomedicine and bring it closer to the personalisation of each patient, to avoid the default consideration of all individuals as “single sex and gender beings” and to encourage the development of inclusive scientific career models, transforming the view of patients, researchers and health professionals towards a broader and more inclusive vision to improve public health.

Data made available for individuals requesting them.

Julia Rey-Brandariz.

The corresponding author, on behalf of the other authors guarantee the accuracy, transparency and honesty of the data and information contained in the study, that no relevant information has been omitted and that all discrepancies between authors have been adequately resolved and described.

C. Rius: conceptualization, data extraction and curation, formal analysis, investigation, methodology, project administration, visualization, writing original draft, review and editing. R. Lucas-Domínguez: conceptualization, data extraction and curation, formal analysis, funding acquisition, investigation, methodology, project administration, visualization, writing original draft, review and editing.

The authors thank for technical and documentary support to Betlem Ortiz Campos (beneficiary of the Call for Technical Support Staff Grants. Spanish Ministry of Science and Innovation co-financed by the European Union. PTA2021-019882-I) and Celia Martínez-Córdoba (beneficiary of the Valencian Regional Ministry of Education, Culture, Universities and Employment. Generalitat Valenciana. CIACIF/2023/317), as well as the collaboration of the members of the UISYS group and the EQUALITUM project.

This research was funded by the Spanish Ministry of Equality (MUJER-PI-21-3-ID24; MUJER-PI-41-2-ID22), the Valencian Regional Ministry of Innovation, Universities, Science, and Digital Society. Generalitat Valenciana (CIAICO/2021/205) and Cátedra Género y Salud of the University of Valencia.

None.