A European vision for returning data in Clinical Trials

The FACILITATE project, a European initiative dedicated to making clinical research more transparent and participatory, has released its new white paper. This document is an important contribution to the European debate on the return of individual participant data in clinical trials and addresses the ethical, legal and operational challenges of this process.

The project's mission is to develop models and tools that enable the safe and responsible sharing of data, placing citizens and patients at the centre. The White Paper introduces an innovative approach that treats data return as an essential component of trial design, not an optional step.

The document underlines the importance of planning data return from the initial stages — integrating it into the protocol, informed consent and participant communication. Data return is not just about sharing information; it is about recognising every participant’s right to be informed, involved, and valued. This requires designing clear, secure and understandable processes that respect privacy and foster trust.

The White Paper also addresses practical considerations, such as which data should be returned, when, and how. It proposes solutions to make information accessible and useful, such as simplified summaries, local translations, and secure digital tools. Through this publication, FACILITATE is calling on all stakeholders, including sponsors, researchers, ethics committees, patients and citizens, to take a step towards more open, people-centred science.

Access the full document here

Next milestone: The White Paper will be officially presented to the European Commission on 4 December 2025. This is an opportunity to share this vision and engage in dialogue with EU institutions.