New guidance has been published to help improve understanding and application of the Ionising Radiation (Medical Exposure) Regulations – IR(ME)R in the context of research and clinical studies.
The guidance has been developed in consultation with key national bodies, including the Care Quality Commission (CQC) and the UK Health Security Agency (UKHSA), alongside Medical Physics Experts (MPEs) and Clinical Radiation Experts (CREs). Its aim is to provide greater clarity and consistency in how IR(ME)R is interpreted and applied across research settings.
The link to the new guidance is here;
https://ukcrd.org/ukcrd-projects/ukcrd-projects/study-set-up/study-set-up-latest-news/guidance-on-interpretation-of-irmer-in-nhs-research/
What Does the New Guidance Cover?
The guidance focuses on several areas that have historically caused uncertainty for research teams and imaging departments, including:
- Clarification of IR(ME)R interpretation in research studies
- Approval processes for research-related medical exposures
- Legislative responsibilities of duty holders under IR(ME)R
- Distinguishing between standard clinical practice and research exposures
By addressing these areas directly, the guidance is intended to make study set-up and research delivery more straightforward, particularly where imaging forms part of a research protocol.
Supporting Capacity in Imaging Departments
A key driver behind the guidance is the recognition that imaging and radiology departments are already under significant pressure. By improving clarity and consistency, the guidance aims to:
Encourage positive, informed discussions between researchers, MPEs, CREs, and clinical teams
Reduce unnecessary delays caused by uncertainty or inconsistent interpretation
Help release capacity by streamlining review and approval processes
This is particularly relevant for studies involving novel procedures or exposures with no direct medical benefit, where IR(ME)R requirements can be more complex.
Updates to Research Exposure Processes
To align with the new guidance, updates are planned to key supporting processes, including:
The Research Exposure Form (REF)
MPE and CRE review procedures, with clearer prompts to identify:
- Novel procedures
- Exposures of no medical benefit
While these considerations already exist within current processes, the updates will make them more visible and explicit, supporting consistency and compliance. Further communication is expected once these revised documents are published.
Why This Matters
Clear, consistent application of IR(ME)R is essential to ensure that research participants are protected, responsibilities are understood, and valuable research is not delayed unnecessarily. This new guidance represents an important step towards achieving that balance.
The contribution of MPEs and CREs has been central to the development of the guidance, and their ongoing involvement remains critical to its successful implementation.
How We Can Help
If you are involved in research studies that include medical exposures, now is a good time to review your IR(ME)R arrangements in light of this guidance.
If you need support with IR(ME)R compliance, including expert advice from a Medical Physics Expert or Clinical Radiation Expert, or help reviewing research exposure processes, please contact us for clear, proportionate advice.