Response to the public consultation on the EDPB guidelines 1/2026 on processing of personal data for scientific research purposes

Abstract

We welcome the European Data Protection Board’s preparation of dedicated guidance on the processing of personal data for scientific research purposes. The Guidelines address many long-standing areas of uncertainty and have the potential to provide useful clarification concerning broad consent, further processing, transparency, data subject rights, the allocation of responsibility and safeguards under Article 89(1) GDPR.

Our comments focus primarily on the practical application of the Guidelines within universities, hospitals, research infrastructures and international research consortia. These organisations vary considerably in their financial resources and technical capacity. Measures that are proportionate for a large national research infrastructure may be difficult to implement within a smaller university, regional hospital or investigator-led research group.

We write from an academic perspective, with particular experience in neuroimaging research and research data infrastructures. Several of our examples, therefore, draw on medical imaging, brain MRI, research repositories and secondary use of health-related datasets. These examples are intended to illustrate broader issues that arise across data-intensive scientific research. However, we would recommend a stronger acknowledgement of the diversity of practices across different fields of scientific research, ideally through the active involvement of practising researchers.

The final Guidelines should therefore distinguish more clearly between mandatory legal requirements, recommended good practice, and safeguards that may be appropriate only in particular circumstances. Without that distinction, non-mandatory recommendations may be treated by institutions, ethics committees or supervisory authorities as universal compliance requirements. Additionally, in order to be effective and efficient, they should further avoid duplication of assessment and avoid introducing slippery slopes for the freedom of science.