Abstract
The FACILITATE project aims to address the ethical and legal challenges of returning individual participant data (RoIPD) from clinical trials to participants within the European Union (EU) involving individuals who are 18 and older. Despite growing recognition of the value that such data holds for participant empowerment and healthcare decision-making, RoIPD remains rare due to unclear responsibilities, limited infrastructure, and a lack of regulatory guidance. This White Paper presents a flexible, participant-centric framework for the ethical and legally compliant return of individual-level clinical trial data. It outlines the current regulatory landscape, including the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR), and concludes that there is an absence of a legal mandate for RoIPD. An ethical framework underpins the FACILITATE approach for RoIPD, grounded in principles such as autonomy, beneficence, transparency, privacy, justice, and empowerment. The FACILITATE approach to RoIPD emphasizes co-creation with patient representatives, health literacy support, and clearly defined roles and responsibilities for all stakeholders involved in implementing RoIPD. The proposed RoIPD framework promotes RoIPD “by design" i.e. the integration of data return into clinical trial planning and execution. It supports flexible operationalisation of RoIPD that is tailored to diverse trial contexts while ensuring participant rights and preferences are respected. Guidance is provided on informed consent, privacy notices, and the operationalization of RoIPD through online platforms or designated individuals. By establishing a robust and participant-informed framework for RoIPD, FACILITATE seeks to improve the ethical conduct of clinical trials, enhance trust in the research process, and contribute to more informed and equitable healthcare outcomes across Europe.