Governance Recommendations for Non-Traditional Researchers in Trusted Research Environments (TREs)

Trusted Research Environments (TREs) provide secure and trusted infrastructures and services to create an efficient and safe approach to store, link and enable access to data. However, data access to support AI, software development or researchers outside academia or clinical settings has been limited and remains largely aspirational due to a perceived lack of public trust, and changes required in legal, technological and governance structures.

To respond to this challenge, DataLoch and the electronic Data Research and Innovation Service (eDRIS) embarked on this DARE UK (Data and Analytics Research Environments UK) Sprint Exemplar Project to design a governance framework supporting safe data use for researchers developing novel technologies or from outside academia (from this point on referred to as non-traditional researchers). This activity included a quantitative and qualitative public engagement process of survey and workshops to examine public requirements to allow these types of data uses, and creating a researcher training module specifically for these types of researchers to supplement current national training offerings. Based on this work and engagement within the TRE community, DataLoch has a governance framework in place that is currently being tested for health and social care data in Scotland.

This report provides a brief description of the challenges for TREs to support non-traditional researcher access, and recommendations for governance structures, with supporting evidence from public and TRE engagement, alongside a case study example of one Scottish TRE’s implementation. While this report focuses on the use of health data and is based in Scotland due to the contributing TREs, the recommendations are likely to be applicable across secure data use in the UK – including the NHS (England) plans for Secure Data Environments.

This project was partly funded by UK Research and Innovation [Grant Number MC_PC_21029] as part of Phase 1 of the DARE UK (Data and Analytics Research Environments UK) programme, which is delivered in partnership with Health Data Research UK (HDR UK) and ADR UK (Administrative Data Research UK).