This lecture, delivered by Ms. Annalisa Landi (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus), explores the ethical, legal and social implications (ELSI) of collecting, processing and sharing rare disease data. The session addresses the regulatory and ethical frameworks that govern the use of sensitive health data, with particular emphasis on data protection, confidentiality and compliance with the General Data Protection Regulation (GDPR) in the context of research and patient registries.
Within the HemaFAIR framework, the lecture highlights how ELSI considerations are integrated into FAIR data practices to ensure responsible data sharing, secure access and trustworthy reuse. It discusses key challenges such as informed consent, governance models, data access procedures and the balance between data utility and patient privacy, providing practical guidance for researchers and registry managers working with rare disease data.
Learning objectives:
-Describe the main ethical, legal and social implications (ELSI) related to rare disease data
-Explain the impact of GDPR and data protection regulations on health research and registries
-Identify key requirements for handling sensitive personal data in a secure and compliant way
-Understand the role of informed consent and data governance in FAIR data sharing
-Recognise the challenges of balancing data accessibility with patient privacy
-Apply best practices for responsible data access, sharing and reuse in rare disease research