HDR UK Statement on Trusted Research Environments
9 June 2021
We welcome Jo Churchill's House of Common’s statement on GP Data for Planning and Research yesterday that "The implementation date will now be September 1, and we will use this time to talk to patients, doctors, health charities and others to strengthen the plan, build a trusted research environment and ensure that data is accessed securely."
Health Data Research UK (HDR UK) convenes the UK Health Data Research Alliance (the Alliance) – an independent alliance of over 50 leading healthcare and research organisations united to establish best practice for the ethical use of UK health data for research at scale. The Alliance is committed to an approach to data access based - wherever possible and appropriate - around Trusted Research Environments (TREs), with robust and independent accreditation, monitoring and auditing. TREs are an important part of the established Five Safes approach to protecting patient privacy whilst enabling large scale data to be used for research that has the potential to deliver public benefit.
As set out in the Alliance Green Paper, TREs provide approved researchers (safe people) who have an approved project (safe project) with access to the data that they require, which is de-identified (safe data) and provided within a secure analysis environment (safe setting) to perform their analysis and generate research outputs without the risk of disclosing a person’s identity (safe outputs). This provides greater assurance that sensitive data is handled securely, as its use can be tracked, with technical safeguards to ensure that no potentially disclosive data leaves the secure environment.
The approach to using TREs is long established in other areas of research, and has been a central element of the COVID-19 Data & Connectivity National Core Study with TREs providing data access across the four nations of the UK:
- Office for National Statistics Secure Research Service – which gives accredited or approved researchers secure access to de-identified, unpublished data (including the Census) for research projects for the public good. Data within this TRE has been used for research into COVID-19, including for the Local Data Spaces programme which used data to understand the spread of the pandemic in different areas and its impact on their communities.
- Secure eResearch Platform (SeRP) – which includes the Adolescent Mental Health Data Platform (ADP), Dementia Platform UK (DPUK) and SAIL Databank – have enabled researchers to access data derived from millions of depersonalised health records since 2011. Data within this TRE has also been used for research into COVID-19, including to monitor any links between vaccination and rare blood clots.
- The electronic data research and innovation service (eDRIS) hosted by Public Health Scotland which has supported 100s of research studies since 2014. In COVID, eDRIS supported the EAVE 2 study which was the first data in the world to show the effectiveness of the single dose of vaccine in reducing hospitalisation at 28 days.
- NHS Digital is working with the BHF Data Science Centre to develop its TRE – this is already being used to support research investigating the impact of COVID on cardiovascular diseases, and the safety of vaccines.
- Health & Social Care Northern Ireland is establishing a new TRE in partnership with SeRp.
SeRP, ONS SRS and eDRIS have al been accredited for the preparation and provision of data under Chapter 5 of Part 5 of the Digital Economy Act NHS Digital is seeking accreditation.
Through the Alliance, HDR UK is working together with members of the public, data custodians and researchers on approaches (including TREs) that enable increased transparency and security, better access to and better use of data. By using these more trustworthy approaches to linking UK health data, we are enabling discoveries to help save and improve people’s lives.