CPR Project Approvals & Data Flow Plans

Project Approval and Data Flow

Project Approval

The first stage of the project links de-identified data from GP, community and hospital records. This stage has been reviewed by the NHS Research Ethics Council and approved by the NHS Health Research Authority Approvals (IRAS project ID 188345 REC reference 16/NE/0155).

The approval involved reviews by those providing the data and the University of Leeds Integrated Research Campus in line with their ISO-27001 accredited Information Security Management System. The University of Leeds also approved a Privacy Impact Assessment of the project.

Data Flow

Our Health Research Authority approved data flow document is available here and a flow diagram is viewable here. A presentation by our Data Services Team member, Samantha Crossfield, explains de-identification processes for sensitive data, and is free to watch here.

What Data is Being Used?

GP and community records data that are opted into ResearchOne, a non-identifiable research database held by The Phoenix Partnership (TPP). TPP maintains electronic health records for over 5,000 UK healthcare organisations.

Patient hospital records and financial data held at the Leeds Teaching Hospitals NHS Trust, to support patient care. This is significantly more detailed than national registry data.

How Will Data Be Linked?

The data is encrypted and transferred to the Integrated Research Campus – a secure research environment within the Medical Research Council Medical Bioinformatics Centre at the Leeds Institute of Data Analytics, University of Leeds. The Integrated Research Campus Data Services Team will link the data using encryptions created using a process called OpenPseudonymiser. Data will remain securely in the Integrated Research Campus with approved access by the research team, only.

The data flow protocol (IRAS project ID 188345 REC reference 16/NE/0155) may be adapted for use by other projects.

Ethical Approval

This project has been independently reviewed by an NHS Research Ethics Committee and the NHS Health Research Authority, both of whom have granted approval for the project (IRAS project ID: 188345 REC reference: 16/NE/0155). This project has also sought the opinion of the Confidentiality Advisory Group at the Health Research Authority who advised that their input was not needed as the data being used is de-identified.

Privacy Impact Assessment (PIA)

A privacy impact assessment was conducted by the Information Governance Manager at the Integrated Research Campus. This was to check that the data flow protocol is compliant with privacy and data protection obligations. The legal team and the Chair of the Integrated Research Campus Information Governance Management Group at the University of Leeds both reviewed and approved the assessment.