The FACILITATE project seeks to address the ethical and legal challenges surrounding the return of individual participant data (RoIPD) from clinical trials to participants aged 18 and older within the European Union (EU).
Although there is growing recognition of the potential of RoIPD to empower
participants, enhance healthcare decision-making, and build trust in research, its implementation remains rare. This is largely due to unclear responsibilities, limited infrastructure, and the absence of clear legal or regulatory guidance.
Critically, RoIPD is not yet integrated into the design of most clinical trials.
FACILITATE aims to change this by establishing a clear, ethical, and practical
framework that supports the routine incorporation of RoIPD into 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.
