FOCUS-5: The feasibility of RO-Crates as a standards-based framework for auditing federated analyses and projects

FOCUS-5 set out to develop the first standards-based framework for auditing federated analyses - when data from different physical locations is analysed. It is important that patients know that their data is handled responsibly and in line with legal and ethical standards during this type of analysis. We specifically focussed on the application and enhancement of the TREvolution Five Safes Research Object Crates (5SROC) concept in the NHS England Secure Data Environment (SDE) network and within an SDE-DataSHIELD context – as a method to log where data comes from, where it goes, and how it is used when analysis occurs across multiple locations. We had further opportunity to explore the compatibility of these concepts with K8TRE, to help the provisioning of open-source federated analysis tools like DataSHIELD that are commonly used by researchers. We worked across DARE UK TRE adopter projects and the SDE network to develop clear and shared definitions of federated data and federated analysis that anyone can use, regardless of which technology or system they work with.