Data access and consent to use health systems data in clinical trials

This Green Paper sets out recommendations to streamline access to health systems data for UK clinical trials, focusing on consent assessment and faster approvals. Developed by a Working Group of the Clinical Trials Stakeholder Prioritisation Forum within HDR UK’s Transforming Data for Trials programme, it synthesises stakeholder input and highlights five barriers, including fragmented approvals and variable consent requirements. We propose: (1) a centralised data access approval system, (2) an overarching, objective standard to assess the adequacy of consent to the release of health data, and (3) precedent set review pathways for common datasets and specific trial uses.

We invite comments from researchers, data custodians, regulators, patients and the public to refine these proposals; a consultation survey is open until 19 December 2025.