The FACILITATE White Paper on the return of individual participant data (RoIPD) in clinical trial is online! This relevant document turns “what if” into a practical roadmap, showing how “Why return individual data?” connects to real-world steps that make sharing back possible, lawful, and genuinely useful for people who take part in a clinical study. It’s not just guidance, it’s a shift in mindset toward participant partnership.
FACILITATE promotes a new approach in clinical research:
Participant-centric: active and equal partners in the research process
This model promotes shared decision-making, transparency, and respect for autonomy by aligning clinical trials with participants’ needs, preferences, and expectations.
By Design and Flexible: How to make return of individual data work
This approach shows how to build RoIPD by design, from protocol to post-trial, while keeping it flexible for different diseases, timelines, and site realities. The result is a participant-centred process that can be scaled, adapted, and audited.
What Data and When: Setting clear expectations
The White Paper explains how to decide what will be shared back (and what won’t) and at what point in the journey (during the study, at the end, or in stages). The key is to state this clearly up front and keep participants informed, so the return is meaningful without affecting study integrity.
Building Trust: Principles to put into practice
The FACILITATE approach translates values like autonomy, fairness, utility, and privacy into practical steps: co-design, clear roles, trained communicators, secure systems, and feedback loops. This is how trust and trustworthiness grow together.
Health Literacy and Support: Make data return useful, not overwhelming
Sharing back matters only if people can understand and use it. The White Paper offers practical design ideas to support participants: plain-language summaries, local-language versions, visuals, and supportive conversations. Whether via a secure portal, clinician, or blended models, the aim is clear: return data that participants can use.
In conclusion, whether through a secure portal, a clinician, or a blended model, the aim is the same: help participants to a clinical trial make sense of their own data, reduce uncertainty, and decide what to do next. FACILITATE calls for a shift in clinical trial culture to make RoIPD routine, ethical, and participant-centred. By embedding RoIPD into trial design, and grounding it in both legal and ethical standards, FACILITATE envisions a clinical research landscape that respects participant rights, enhances transparency, and fosters long-term public trust.
