The Five Safes RO-Crate

Trusted Research Environments (TREs) are secure locations in which health and other sensitive data are placed and made available for researchers to analyse under strict controls. TRE’s in the UK operate under the Five Safes governance framework of safe data, safe people, safe projects, safe settings and safe outputs to protect data confidentiality. However, there is no standardised mechanism for streamlining the exchange of the metadata needed between analysis toolkits and TREs to follow Five Safes procedures. This lack of standardised interoperability is exacerbated when undertaking federated analysis across multiple TREs. The “Five Safes RO-Crate” digital object is a proposed approach for packaging the metadata needed for exchanging research requests and results between analysis tools and TRE providers, enabling them to operate Five Safe compliant processes. The approach has been piloted by the DARE UK TRE-FX project with commercial and open-source analysis toolkits and two health data TREs. The work will continue to be developed in Health Data Research UK’s Federated Analytics work programme and incorporated into the TRE Blueprints currently being developed by EOSC-ENTRUST European Network of Trusted Research Environments and DARE-UK. Five Safes RO-Crate is an important component of the metadata middleware necessary for implementing scalable TRE federated analysis.