White paper on return of data

Introducing the FACILITATE White Paper on the Return of Individual Participant Data (RoIPD)

We are pleased to share the FACILITATE White Paper on the Return of Individual
Participant Data (RoIPD) in clinical trials across the European Union.

This publication sets out a vision for a participant-centric, ethical, and legally
grounded framework that makes the return of clinical trial data both feasible and
meaningful. Developed collaboratively by FACILITATE partners, the White Paper
builds on ethical principles, legal analysis, and stakeholder experience to propose a
flexible “RoIPD by design” approach, embedding data return into the planning,
conduct, and follow-up of clinical trials from the very start.

By aligning ethical integrity, regulatory compliance, and participant empowerment,
this White Paper aims to create a new standard of trust and transparency in clinical
research, one where returning data is not an exception, but a shared expectation.

Core Principles

Participant-centric
Shifting from a “we know what’s best” mindset to collaboration and shared decision-
making, participants are active partners who help shape research and data sharing.

RoIPD by Design
Data return is planned from the start – built into protocols, consent, and post-trial
communication – making it a structured part of every trial, not an afterthought.

Flexible
Recognizing that one size doesn’t fit all, this approach adapts to different diseases,
study phases, and local realities, ensuring consistent yet responsive implementation.

Together, these principles form the basis of the FACILITATE White Paper, translating
ethical intent into practical, transparent action for all research stakeholders.

Shape with us this new reality: have your say on it by answering a brief survey.

Explore the full document or read the highlights below