BAREC statement for the sponsors and EC’s on the collection of ethnicity data in clinical trials

This advice was endorsed by the College during the plenary meeting of 10/10/2025.

The participants in a clinical trial should reflect the target population. Adequate reporting of ethnicity can potentially contribute to better understanding of cultural, social, and biological differences, enabling the identification of population groups disproportionately affected by certain diseases, along with genetic information collected from study participants.

• Elements in favor of collecting these data in clinical trials/studies:
  • Increased cultural and racial diversification in Europe. The number of clinical trials worldwide has surged, yet clinical trial populations often lack sufficient diversity, which can lead to incomplete or skewed medical data.
  • Crucial to include study populations reflecting the general population’s diversity in terms of age, sex, ethnicity, and lifestyle. Documentation thereof is necessary.
  • Subgroups may respond differently to medicinal products/devices.
  • Possible risk of subgroups not/disproportionately represented in the trial.
  • Adequate reporting can potentially contribute to better understanding of cultural, social, and biological differences.
• Clinical trials/studies considering the collection of ethnicity data should provide:
  • Clear justification for doing so, explicitly stated in the study protocol and ICF. The collection of ethnicity data must be scientifically relevant and comply with GDPR principles.
  • Detailed plans on how  ethnicity will be defined, measures to promote diversity, how the information will be collected and handled, the option to refuse collection on these data, measures to avoid, identify and address discrimination,…
  • Appropriate safeguards to protect participants’ privacy and ensure data confidentiality.
• It is crucial to:
  • communicate to participants the importance of voluntarily providing these sensitive data.
  • ensure that individuals have the freedom to decide whether they wish to share such information.

• Ethics Committees should verify compliance with these principles in the ICF and the protocol.

We would also like to refer to the advice nr. 17 of the Belgium’s Advisory Committee on Bioethics: https://www.health.belgium.be/en/node/46162

Note on Terminology – Ethnicity versus Race

• This advice specifically refers to the collection of ethnicity data, not race.
• Though still in use in the Anglo-Saxon culture and language, the European Union rejects theories which attempt to determine the existence of separate human races. BAREC thus elected not to use this term in any of its documents (e.g ICF template).
• Given this cultural difference, the use of the term ‘racial origin’/’race’ in a protocol however does not imply an acceptance of such theories. If an Anglo-Saxon sponsor chooses to use the term race in the study protocol, BAREC does not consider it necessary to systematically request changes to this terminology, as long as it is applied respectfully and within the applicable legal and ethical frameworks.
• The term “race” should however not be used in any patient facing documents.
• BAREC expects EC’s to critically assess its appropriateness within the specific study context.