Topic: Sex and Gender in Biomedical Research

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.

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, as set out in the Gender Equality Strategy.

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.

Key Ethical, Legal and Societal Issues

The key issues to consider when integrating sex and gender research include:

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.

Relevant EU Legislation

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.

Note: For further relevant EU legislation that may be applicable, please take a look here.

BBMRI Resources

The below resources have been developed by those included in the BBMRI network:

BBMRI-ERIC ELSI Dialogues Webinar: 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.

BBMRI-ERIC ELSI Dialogues Webinar: 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.

BBMRI-ERIC ELSI Dialogues Webinar: 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.

BBMRI-ERIC ELSI Dialogues Webinar: “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 why sex/gender integration should be standard practice across biomedical fields, following by a Q&A session.

External Resources

The below resources have been developed outside of the BBMRI network:

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.  

What are Sex & Gender? And why do they matter in health research?
by the National Institutes Of Health, Office of Research on Women’s Health

This webpage highlights the importance of integrating both sex and gender in health research, highlighting the two.  A particular webpage of interest includes:

Understanding Influences of Sex and Gender in Health and Disease.

This infographic illustrates the influences of sex and gender in health and disease.

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.

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

Why Is Sex/Gender-Specific Medicine Needed?

by Kim, N., & Schiebinger, L.

Springer Nature (2022)

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, organized by BSC (Bioinfo4Women programme), BBMRI-ERIC, INB/ELIXIR-ES, EATRIS.

Last Updated: May 2024