Biobanking rare gynaecological tumours – How harmonised is data collection?

Introduction: GYNOCARE, the European Network for Gynaecological Rare Cancer Research, set out to evaluate the current status of biobanks with access to rare gynaecological tumours, with a view to harmonising sample and data collection and associated consent, to facilitate collaborative cross-border research, enabling clinical trials and translational research. Methods: Two digital surveys were formulated, one covering clinical and scientific parameters and one exploring ethical and regulatory issues around informed consent. Results: Data were analysed for 20 common responses, from 7 European countries. Tissue was the main sample type biobanked with 63 % also banking blood. Documentation of clinical data, treatment regimens and classification systems varied. Eighty percent collected pathological information. Most biobanks were linked to medical records but only one fifth with national registries. The Information Sheet covered governance, benefits/risks, sharing (mainly for non-profit research), return of results and data protection safeguards. Only 37 % informed patients about sample and data storage, although about half stored samples for an indefinite time. Pseudonymisation and Data Protection Officer approval were the prime data safeguards. Less than half explained the difference between anonymisation and pseudonymisation. Broad consent was the norm (84 %) and 95 % granted the right to withdraw consent. Three countries have Biobank legislation. Conclusion: These surveys provide a snapshot of the current state of biobanks and highlight divergences in the consent process and data management. More work is needed to understand what parameters are being gathered across more EU countries and thus harmonise the sample and data collection processes to facilitate cross-border research.