The Five Safes RO-Crate
FAIR Digital Objects for Trusted Research Environments for Health Data Research
DOI:
https://doi.org/10.52825/ocp.v5i.1419Keywords:
RO-Crate, Trusted Research Environment, Five Safes Framework, Secure Data, Sensitive Data, HDR UK, Health Data, DARE UKAbstract
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.
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Copyright (c) 2025 Stian Soiland-Reyes, Stuart Wheater, Thomas Giles, Jonathan Couldridge, Philip Quinlan, Carole Goble

This work is licensed under a Creative Commons Attribution 4.0 International License.
Accepted 2025-02-14
Published 2025-03-18
Funding data
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UK Research and Innovation
Grant numbers MC_PC_23007 -
HORIZON EUROPE Framework Programme
Grant numbers 101046203