New guidance for the set-up of NHS studies involving ionising radiation

We have published new guidance for the set-up of NHS studies involving ionising radiation and the interpretation of the Ionising Radiation (Medical Exposures) Regulations.

The guidance is applicable to 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.

The guidance has been developed in response to inconsistencies in the interpretation of IR(ME)R in NHS organisations’ Standard Operating Procedures (SOPs). This has resulted in unnecessary steps in the set-up of research studies involving ionising radiation exposures, which causes delays.

The inconsistencies were identified by the UK Clinical Research Delivery (UKCRD) programme, a cross-sector programme of work which the HRA is part of.

The programme is aimed at creating a faster, more efficient, more accessible and more innovative clinical research delivery system. Read more about our involvement in the programme.

Written in consultation with the Care Quality Commission (CQC) and the UK Health Security Agency (UKHSA), Medical Physics and Clinical Radiation Experts, this guidance has been led by the HRA in partnership with the Devolved Governments in England, Wales and Northern Ireland. It provides key clarifications on interpretation, approval processes, and legislation to make study set-up and research delivery easier.

The 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 and Northern Ireland. We continue to work with colleagues in the devolved Scottish government to support UK-wide adoption.

The HRA provides a UK-wide radiation assurance service to help identify any inconsistencies or omissions relating to ionising radiation procedures in applications at an early stage.

Protecting research participants always comes first, and IR(ME)R is a critical part of that, where studies involve ionising radiation. But there isn’t always enough capacity to carry out all the radiation reviews that are needed when they are needed. The HRA supports study-wide radiation reviews that reduce the need for duplicate reviews at site, and provides consistent technical information to help set-up start early. This guidance will help local reviewers make the best use of those national assessments.

Radiation reviewers, sponsors and sites have been asking for this guidance for some time. We are grateful to our colleagues in CQC, UKHSA and the devolved governments for working with us. It will provide the clarity needed to reduce duplication, inconsistency, delays, and to improve capacity. Not only will this guidance better support sites to protect participants, it will help start studies rapidly and support achieving the Prime Minister’s target of setting up clinical trials within 150 days.

Matt Westmore, Chief Executive

This government is committed to accelerating and streamlining clinical trial delivery, and this guidance clarifying the use of radiation in research is a crucial step in reducing delays in study set-up.

With this guidance, we can ensure that studies are nimble and safe, which will benefit our life sciences sector and help patients access cutting edge treatment and therapies.

Lucy Chappell, Chief Scientific Advisor for the Department of Health and Social Care