Paediatric biobanking in the era of precision medicine: ethical, regulatory, and scientific challenges from childhood to adulthood.

UNLABELLED: Biobanks are increasingly central to precision medicine, particularly in rare diseases and paediatric oncology, where small and molecularly heterogeneous populations make access to high-quality, longitudinally annotated biological material essential. This narrative review examines the scientific value of paediatric biobanking and the ethical, regulatory, and organisational challenges that distinguish it from adult biobanking. Relevant scientific literature, European and Italian regulatory sources, international biobanking standards, and guidance on data protection and research governance were narratively reviewed, with particular attention to paediatric oncology, rare diseases, consent and assent, secondary use, interoperability, and emerging European frameworks. Paediatric biobanks can support biomarker discovery, molecular stratification, investigation of treatment resistance, and future analyses not foreseeable at the time of collection. Their governance is complicated by evolving child autonomy, the significance of dissent, transition to adulthood, future reuse of samples, and the distinction between consent to sample donation and the legal basis for processing associated personal data. Quality management, traceability, interoperable metadata, and controlled access are essential to preserve scientific utility. Emerging frameworks, including the European Health Data Space and EDPB guidance, favour a shift from one-time consent towards accountable life-cycle governance.

CONCLUSION: Paediatric biobanking should be conceived as a longitudinal research infrastructure rather than a storage activity. Sustainable models must integrate evolving autonomy, robust ethical oversight, data protection, quality, interoperability, and responsible secondary use while preserving irreplaceable biological resources for future research.

WHAT IS KNOWN: • Biobanks are essential to precision medicine and are particularly valuable in rare diseases and paediatric cancer. • Paediatric biobanking raises specific issues concerning parental consent, assent, future use, and transition to adulthood.

WHAT IS NEW: • Emerging European frameworks support a shift from static consent towards accountable life-cycle governance of samples and data. • A European paediatric sample-data continuum could connect biospecimens, longitudinal clinical information, omics data, and evolving participant preferences across infrastructures.