What: Important clarifications on national research review processes and IR(ME)R legislation in England, Wales and Northern Ireland, to help make NHS study set-up and the delivery of research easier.
Who: NHS and HSC organisations in England, Wales and Northern Ireland, R&D and Radiation Communities.
This guidance is for all those involved in the set-up and delivery of research studies involving ionising radiation as part of medical (diagnostic or therapeutic) exposures delivered in the NHS in England, Wales or Northern Ireland. We continue to work closely with colleagues in the devolved Scottish Government to support UK-wide adoption.
When: From 29 January 2026.
 We are pleased to publish guidance to help improve understanding of the Ionising Radiation (Medical Exposures) Regulations 2017 (IR(ME)R17) applicable to England, Scotland, and Wales, and the Ionising Radiation (Medical Exposures) Regulations (Northern Ireland) 2018 (IR(ME)R18) applicable to Northern Ireland, and subsequent amendments, as a basis for further streamlining of study set-up at sites.
The guidance has been developed in response to inconsistent interpretation of IR(ME)R in NHS organisations’ Standard Operating Procedures (SOPs), identified by the UK Clinical Research Delivery (UKCRD) Programme.
These inconsistencies result in unnecessary steps in the set-up of research studies involving ionising radiation exposures, causing delays.
Written in consultation with the Care Quality Commission (CQC) and the UK Health Security Agency (UKHSA), Medical Physics and Clinical Radiation Experts, this guidance provides key clarifications on interpretation, approval processes, and legislation to make study set-up and research delivery easier.
What do I need to do?
This guidance should prompt a review of NHS site governance processes, SOPs for research study set-up and employer’s procedures. This review should ensure that these local processes are aligned with this guidance and in all cases involve local R&D offices working in conjunction with clinical departments involved in delivering ionising radiation to patients and participants.
If you have any queries or feedback on the guidance, please email queries@hra.nhs.uk.
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