Advancing the return of individual participant data

Putting participants at the centre of clinical research

Data generated in clinical trials are a cornerstone of scientific evidence. Yet, despite their central role in advancing medicine, participants rarely receive their own clinical trial data, and opportunities for responsible reuse are often constrained. The EU-funded project FACILITATE addressed these challenges by developing a comprehensive framework for the responsible Return of Individual Participant Data (RoIPD), enabling ethically sound, legally compliant and technically feasible approaches for returning and reusing clinical trial data.

While FACILITATE focused specifically on clinical trial data rather than biobanking, its efforts closely align with biobanks’ objectives of enabling high-quality, interoperable and trustworthy health data for research. Many principles addressed by FACILITATE, including FAIR data, semantic interoperability, informed consent, ethical governance and long-term data stewardship, are equally relevant for the European biobanking community, where biological samples gain additional value through their linkage with well-curated clinical and research data.

A European collaboration for responsible data sharing

Over four and a half years, FACILITATE brought together experts from academia, healthcare, patient organisations, industry and European research infrastructures to develop practical approaches for implementing RoIPD across Europe. The consortium addressed technical, legal, ethical, organisational and societal aspects of returning individual participant data while actively involving them throughout the process, recognising that successful implementation requires close collaboration among diverse stakeholder groups. In particular, patients and participants were actively involved alongside researchers, clinicians, ethics experts and regulators, ensuring that the project’s recommendations are not only scientifically robust but also reflect participant needs and expectations.

As a project partner, Med Uni Graz was involved in the stakeholder engagement activities of FACILITATE and coordinated a stakeholder group of clinicians and healthcare professionals. The team organised expert discussions and contributed its expertise to the FACILITATE discussions on the project’s work on responsible return of individual participant data.

RoIPD by design: embedding data return from the start

One of FACILITATE’s central achievements is the RoIPD by Design concept, presented in the project’s white paper. Rather than treating the return of individual participant data as an optional step after study completion, the concept advocates integrating it into clinical trial planning from the outset, including study design, governance and consent procedures.

Building on this foundation, FACILITATE provides practical outputs, including governance recommendations, legal and ethical guidance, best practices and implementation frameworks to support organisations in navigating the complexities of RoIPD within the European regulatory landscape. The project also emphasises that successful implementation requires flexible approaches tailored to study characteristics, participant expectations, available infrastructures and national requirements.

Strengthening trust through responsible data sharing

By translating these principles into practical guidance, FACILITATE has laid an important foundation for more participant-centred clinical research. Its results demonstrate that responsible data sharing can strengthen trust in research, improve transparency and foster closer links between clinical research, healthcare systems and the infrastructures that enable biomedical discovery.

For the European biobanking community, the project’s outcomes further reinforce the importance of interoperable, trustworthy and participant-oriented data management, contributing to a more connected and sustainable European health research ecosystem.