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Returning Individual Participant Data in Clinical Trials “by Design”. Setting a new standard for Patients’ Rights in Europe On 4 December 2025, the final IHI FACILITATE project event presented at the EU Parliament in Brussels the project’s main results within the framework of the MEPs Interest Group on Patients’ Rights and Cross-Border Healthcare. Clinical trials generate valuable individual-level data, which is rarely returned to participants. FACILITATE has addressed this gap by developing an ethically and legally robust framework for the Return of Individual Participant Data (RoIPD) in the EU. The event – hosted by the MEP Vytenis Andriukaitis - highlighted progress made in shaping RoIPD processes in line with EU law, including the Clinical Trials Regulation (CTR) and GDPR, while drawing on international best practices. It showcased how RoIPD can empower participants, improve health literacy, and advance medical research. A key outcome has been to offer practical recommendations for the ethical, legal and operational implementation of RoIPD. This guidance is intended to support patients, researchers, the private sector, healthcare providers and regulators in making RoIPD a reality across Europe. Read more: https://www.activecitizenship.net/eve...