New pilot launched to get feedback on Information Governance Guide

The Health Research Authority (HRA) has launched a pilot to get feedback on a new Information Governance (IG) Guide, which aims to reduce uncertainty and duplication to support study set up.

The guide, which is aimed at sponsors and NHS and HSC organisations involved in research, clarifies how IG is reviewed centrally for study-wide review when NHS / HSC research studies are submitted for HRA approval and what local IG local activity participating NHS organisations still may need to do.

It is part of our ongoing work as part of the UK Clinical Research Delivery (UKCRD) programme, a cross-sector programme of work aimed at creating a faster, more efficient, more accessible and more innovative clinical research delivery system.

Information governance was one of the areas identified where improvements could be made. In 2024 we published seven proposals for change, one of which was to review local level guidance.

Our new Guide was developed following a review of existing guidance.

England focus, grounded in UK-wide IG principles

This first version of the IG Guide focuses on England-specific research approval processes and responsibilities, including study-wide review through the HRA and requirements that apply to NHS organisations in England (such as the Data Security and Protection Toolkit).

While operational detail reflects the England context, the guidance is grounded in UK-wide information governance principles, including data protection law, confidentiality, transparency and accountability, which apply consistently across health and care research.

The Guide is being piloted to gather feedback on how these principles are applied in practice within the England system at study set-up. Learning from the pilot will help inform future iterations of the guidance and support wider discussions about alignment with equivalent governance and assurance arrangements in the devolved administrations, where appropriate.

The IG Guide brings together, in one place, the IG information sponsors are already expected to provide under Section 5.1 of the UK Study-Wide Governance Criteria. It explains:

• what good IG looks like at sponsor level
• how this can be evidenced clearly and proportionately in IRAS
• what is reviewed and assured nationally
• what participating organisations can rely on without repeating checks
• when limited local checks may still be needed

Processors and the IG Annex

The Guide includes a proposed approach to documenting sponsor processor arrangements (for example through a Processor Matrix within an IG Annex). This approach is being piloted and is not intended to introduce a new mandatory requirement at this stage.

The aim of the pilot is to explore whether presenting information that sponsors already provide for study-wide review in a clearer, more structured way helps participating organisations rely on national assurance, rather than re-checking supplier arrangements locally or requesting additional forms.

The intention is to reshape how existing information is brought together and shared, not to require trial-specific or vendor-by-vendor scrutiny. Feedback on whether this approach is helpful, proportionate and workable in practice will be a key focus of the pilot period.

Feedback

The Guide is the third major output from the HRA’s programme to improve national IG assurance. It builds on updates to the Study-Wide Governance Review Criteria, findings from the HRA’s 2022 UK-wide survey on site-specific IG processes, and earlier work on improving IG assurance in research.

In the past, feedback from sponsors and sites has consistently highlighted uncertainty around IG expectations as a driver of duplication, variable local checks and avoidable delays. By clarifying the IG criteria and expectations, the guide will help to reduce uncertainty, duplication and delay at study set-up.

We want to hear from anyone who reads or uses the IG Guide to understand their experiences of the Guide. We are particularly interested in your thoughts on the concepts of an IG Annex and Processor Matrix.

Additionally, we want to hear from people in Northern Ireland, Scotland and Wales to learn more about how the principles are applied across the UK and how the guide would need to be adapted to fit UK-wide purposes.