Sex and gender in biomedical research

Table Of Contents

Overview #

Biobanking and biomedical research should be inclusive, whereby there is equal opportunity for everyone in society to participate and to benefit. Integrating both sex and gender in research is therefore crucial.  

Historically, consideration of sex and gender has been overlooked in research. Instead, males have tended to be the default study population, with most clinical trials and preclinical studies using participants, animal models or cell lines that are male. The assumption made was that study findings and subsequent medical treatment could be generalised to the entire population, with a one-size-fits-all approach being applied.  However, this systematic underrepresentation of females, transgender individuals, and those with diverse sex characteristics and gender identities, has created critical gaps in our knowledge and had a detrimental impact on overall patient care.  

Disease emergence and progression, as well as response to treatments vary between sexes. For example, despite differences in how some medicines are metabolised between sexes, many drug trials previously underrepresented female participants. This lack of representation and the absence of sex-based data analysis compromised the ability to develop safe and effective dosing for female patients.    In addition to this, health-seeking behaviour, access to healthcare and any outcomes are affected by societal gender norms and roles. For instance, gender inequalities can restrict women’s and girls’ access to healthcare and, at the same time, gender norms and stereotypes around masculinity can discourage the way in which men and boys seek health treatments.   

Both sex and gender influence health and wellbeing. As a result, it is critical they are factored in at every stage of the research process. In recognising this, the European Commission requires all recipients of research grants to incorporate analyses of sex and gender in their study design.  

When doing so, it is essential to take a nuanced and context-specific approach. History, geography, and culture are all relevant when integrating sex and gender dimensions into biomedical research but contextual factors inevitably vary across different populations, research areas, scientific fields, and applications. For example, analysing gender norms around reproductive health in a rural community requires a very different lens compared to studying gender influences on cardiovascular disease in an urban setting. 

The specific socio-cultural backdrop matters and rather than a blanket methodology and universal findings, it is advisable to take a case-by-case approach. This often calls for interdisciplinary expertise from the outset, not only to contextualise each study and its findings, but also to ensure that harmful stereotypes or biases are not reinforced.  

BBMRI-ERIC promotes sex and gender inclusive research that takes an intersectional approach. In order to gain a better understanding of sex and gender dimensions in biobanking and biomedical research, we encourage institutions and researchers to explore the materials available, engage in comprehensive training and build interdisciplinary expertise so that sex and gender influences can be proactively integrated into the research study design.  

Note: The terms ‘sex’ and ‘gender’ are often used interchangeably. However, there is a distinction between the two. Sex refers to biological characteristics, referring to factors such as anatomy and physiology, while gender refers to socio-cultural aspects, encompassing societal and cultural influences. 

While gender and sex can be separated for analytical reasons, biological and social aspects of our lives are related. This means that sex and gender shape each other.    

Sex refers to biology. In humans, sex refers to the biological attributes that distinguish male, female, and/or intersex.  See more.   

Gender refers to sociocultural norms, identities, and relations that: 1) structure societies and organisations; and 2) shape behaviors, products, technologies, environments, and knowledges (Schiebinger, 1999). Gender attitudes and behaviors are complex and change across time and place. Importantly, gender is multidimensional (Hyde et al., 2018) and intersects with other social categories, such as sex, age, socioeconomic status, sexual orientation and ethnicity. Gender is distinct from sex (Fausto-Sterling, 2012). See more.    

Gender bias and sex assumptions in biomedical research can have an adverse impact in the lives of patients. For this reason, it is important to include the categories of sex and gender biomedical research. This inclusion can help raise awareness on:  

  • How new concepts and theories of gender can bring to light new evidence. 
  • How background assumptions about sex and gender can shape concepts and theories in the field. 

Important questions that can be asked to assess this influence:  

  • Do researchers assume certain gender roles?  
  • Are researchers aware of possible gender biases in their field?  
  • Do researchers assume that sex and gender are binary?  
  • Do researchers take into consideration the interactions between sex and gender? 

Key ethical, legal and societal issues  #

Inclusive representation  #

It is necessary to ensure there is active recruitment of research populations that are representative across biological sexes, gender identities and expressions, as well as other intersecting demographics. Actively engaging with such groups, particularly those which are underrepresented, builds trust and enables participants to have a voice in studies that impact their health and wellbeing. 

Data privacy and governance    #

Collecting data on personal characteristics such sex traits and gender variables is highly sensitive. Robust data governance procedures are required to protect participant privacy and confidentiality in compliance with regulations such as the GDPR.  

Avoiding bias and discrimination  #

There is risk to perpetuating harmful stereotypes, biases or discriminatory practices, when exploring the dimensions of sex and gender in research. Study designs, analyses and subsequent communication of findings must be carefully constructed to identify and mitigate potential biases. 

Context matters – Integrating societal and cultural impacts   #

Analysing sex and gender dimensions can involve complex sociocultural dynamics. Potential societal implications in studies, whether positive and negative, require consideration along with the need for stakeholder engagement. Studies should take a contextual approach, involving interdisciplinary expertise.  

The specific socio-cultural backdrop matters and rather than a blanket methodology and universal findings, it is advisable to take a case-by-case approach. This often calls for interdisciplinary expertise from the outset, not only to contextualise each study and its findings, but also to ensure that harmful stereotypes or biases are not reinforced.  

Legal and ethical international and EU sources   #

General Data Protection Regulation (GDPR) 

The GDPR provides a regulatory framework for lawfully processing personal data.  While not explicitly about sex and gender integration, the GDPR would apply given that health information, along with gender, sex characteristics and sexual orientation are considered sensitive personal data. 

Horizon Europe Regulation (Regulation (EU) 2021/695). Horizon Europe integrates gender equality as a cross-cutting priority throughout the research and innovation programme. 

The Regulation requires applicants, where relevant, to: 

  • integrate the gender dimension into research and innovation content;  
  • promote gender equality in research teams and decision-making;  
  • develop Gender Equality Plans (GEPs) as an eligibility criterion for many participating institutions. 

WHO Programme on Gender, Equity and Human Rights. It provides guidance for integrating sex and gender into health research, emphasising that biological sex and socially constructed gender both influence: 

  • disease susceptibility;  
  • diagnosis;  
  • treatment response;  
  • health outcomes.  

WHO – Incorporating intersectional gender analysis into research on infectious diseases of poverty – A toolkit for health researchers. A toolkit offering methodological guidance on integrating gender analysis throughout the research process. 

Relevant EU approach   #

Horizon Europe Framework Programme (2021–2027): Though not a regulation per se, participation in Horizon Europe requires compliance with:  

  • Gender Equality Plans (GEPs) for public institutions as a condition of eligibility.  
  • Sex/gender analysis in the research content (a mandatory ethics assessment criterion).  

The European Commission’s gender equality strategy 2020-2025 

The European Commission is committed to promoting gender equality in research and innovation. It is part of the European Commission Gender Equality Strategy for 2020-2025, which sets out the Commission’s broader commitment to equality across all EU policies. 

Gendered Innovations 2: How Inclusive Analysis Contributes to Research and Innovation. Developed by the European Commission together with international experts, this guidance explains how sex, gender and intersectional analysis improve research quality across disciplines, including biomedical research, genomics, AI and precision medicine. It provides practical methodologies and numerous biomedical case studies.

BBMRI resources   #

Publications  #

    • Delgado J, Cano Abadía M, Akyüz K, Goisauf M, Rodríguez-Arias D. Uncovering the persistent gap: The ongoing challenge of integrating sex and gender in biomedical research. J Biomed Res. 2024. https://doi.org/10.7555/JBR.38.20240157  
    • Akyüz K, Cano Abadía M, Goisauf M. Artificial intelligence, sex, and gender: Hypes, hopes, and potential risks in biobanking. In: Mayrhofer MT, Slokenberga S, Mežinska S, editors. Artificial Intelligence in Biobanking: Ethical, Legal and Societal Challenges. 1st ed. Routledge; 2025. doi:10.4324/9781032634487 

    Webinars  #

      • The Incorporation of Sex and Gender in Medical Research: This webinar is designed for researchers, healthcare professionals, and anyone interested in learning about the importance of considering sex and gender in medical studies. Experts provide their perspectives on research developments and effective approaches for integrating sex and gender considerations into biomedical research.  
      • Visualising the Complexity of Sex Determination: This webinar focuses on visualising the complexity of biological sex determination through innovative graphic design. The speaker explains their creative process for developing visuals to depict the spectrum of sex characteristics, as well providing understanding about the biological realities of sex, which move beyond the outdated binary model.  
      • EU Support to Gender Equality in Research and Innovation : This webinar provides an overview of gender equality under Horizon Europe, explaining how the new requirements around gender equality plans have become integral in driving transformative change for research organisations. The webinar also provides important context by reviewing the European Commission’s overarching policy goals, as well as giving an overview of practical resources available to support implementation of effective gender equality plans.  
      • “Gendered Innovations’ – The Importance of Gender in Biomedical Research : This webinar underscores why sex- and gender-sensitive approaches are crucial for rigorous and impactful biomedical research. Expert speakers showcase several case studies that demonstrate the value of analysing data disaggregated by biological sex and sociocultural gender factors. The presenters explain why sex/gender integration should be standard practice across biomedical fields, following by a Q&A session.  

      External resources   #

      • Gender Equality in Academia and Research – GEAR tool: Integration of the sex/gender dimension into research and teaching content by the European Institute of Gender Equality . The GEAR toolkit hosts a collection of resources to integrate the sex and gender dimension in research, as well as teaching content.   
      • Gender equality and health in the EU (2021) : This report, managed by Fondazione Giacomo Brodolini Srl SB (FGB), provides a cross-cutting view of key health topics in the EU from a gender perspective, analysing the main issues with a specific focus on differences between women and men. A view on gender issues in COVID-19 is provided. Recognising the importance of social, environmental and economic determinants on health (WHO, 2019c), the conclusions and recommendations locate the data within the broader framework of social policies and gender health equity (Beckfield et al., 2017).  
      • How to Integrate Sex and Gender into Research by Canadian Institutes of Health Research . These guidelines, tools and resources support researchers and reviewers to better account for sex and gender in health research.  The definition of sex and gender are outlined as here.   
      • Gendered Innovations in Science, Health & Medicine, Engineering and Environments by Schiebinger, L., Klinge, I., Sánchez de Madariaga, I., Paik, H. Y., Schraudner, M., and Stefanick, M.   Thirty years of research have revealed that sex and gender bias are socially harmful and expensive. This website includes case studies as concrete illustrations of how sex and gender analysis lead to new ideas and excellence in research in several fields including health & medicine.  This project harnesses the creative power of sex, gender, and intersectional analysis for innovation and discovery. Considering these approaches may add valuable dimensions to research. Particular webpages of interest include:  
        • Analyzing Sex: This webpage presents a methodology to integrate the analysis of sex into research. 
        • Analyzing Gender: This webpage presents a methodology to integrate the analysis of gender into research. 
      • Complexity of Gender: GSSO – Gender, Sex and Sexual Orientation Ontology by the Ontology Lookup Service, the Samples, Phenotypes and Ontologies Team at EMBL-EBI. Given then both sex and gender are highly complex, any classification of them will be limited. This ontology showcases multiple classifications within gender, sex and sexual orientation.  

      Relevant literature   #

      • Cell: Focus on Sex and Gender,  Cell Issue 6 (2024). This Issue’s emphasis on sex and gender in this issue encourages researchers to deconstruct sex and gender into their precise biological and sociocultural components. The articles highlight the need to carefully delineate specific sex characteristics and gender-related factors relevant to each study.  

      Acknowledgements #

      This entry stems from the work done within the Train the Trainer “Integration of the Sex and Gender dimension in Life Sciences Research”, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 824087, organised by BSC (Bioinfo4Women programme), BBMRI-ERIC, INB/ELIXIR-ES, EATRIS. 

      ELSI, ethics, gender, gender equity
      Updated on 14 July, 2026