Return of Individual Participant Data (RoIPD) from clinical trials can empower
participants, improve health decision-making, and strengthen trust in research.
However, RoIPD remains rare in the EU due to unclear responsibilities, limited
infrastructure, and a lack of legal guidance. Most importantly, RoIPD is not yet built into the design of clinical trials. A clear, ethical, and practical framework is needed to make RoIPD an integral and routine part of trial planning and conduct.
FACILITATE promotes a new model of trust in clinical research:
- Participant-centric: Shared decision-making replaces the “we know best” mindset.
- By design: Data return is built into every stage of the trial, not added later.
- Flexible: Adaptable to diverse diseases, timelines, and local realities.
Together, these principles make clinical trials more transparent, respectful, and responsive to the people who make them possible. This White paper sets out recommendations for the operationalisation of RoIPD within clinical trials that empowers participants and drives progress in medical research and healthcare delivery.
