The project aims to enhance scientific research, particularly for rare diseases, by integrating biological samples and structured health data from biobanks, disease registries, and health records. The main objectives are:
1. to create a FAIR (Findable, Accessible, Interoperable e Reusable) health data system for the secondary use of data for regulatory purposes.
2. to collect and process biological samples in compliance with regulations to improve therapeutic strategies.
3. to develop a digital tool for dynamic informed consent, encouraging patient participation in research.
The project's holistic approach seeks to improve diagnosis, treatments, patient safety, and reduce healthcare costs.

ROLE OF THE FOUNDATION
The Foundation provides the project with its expertise on ethics and regulatory, especially in the field of rare disease research. As part of the project, the Foundation coordinates the ethical and regulatory activities related to the processing of personal data and handling of biosamples and their regulatory-compliant use for research. For the whole project duration, FGB ensures the compliance of research activities with the relevant provisions. Partners will be advised on the need for ethics approvals to collect personal and health data, on any potential ethics and regulatory issue that might arise and on how to solve them.

FUNDED BY: PNRR-MR1-2023-12377715. Mission 6/component 2/Investment: 2.1 “Strengthening and enhancing biomedical research in the NHS”, financed by the European Union – NextGeneration EU. CUP H93C24000380006

DURATION: August 2024 - August 2026; project extended until February 2027

PARTNERS:

• IRCCS Rizzoli Orthopaedic Institute (coordinator)
• Agenzia nazionale per i servizi sanitari regionali (Agenas)
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
• Fondazione per la Ricerca Farmacologica Gianni Benzi - ETS