Evaluation of feedback from phase one roll-out of our Radiation Assurance process has indicated a positive response.
The new review process includes the introduction of a standardised fee and clarity around the process to gaining Medical Physics Expert (MPE) and Clinical Radiation Expert (CRE) review.
It also includes generic risk statements, which provide clear guidance on the explanation of risk in participant information sheets. The statements have been designed to meet the requirements of most studies and to ensure that information is provided to Research Ethics Committees (RECs) and trial participants in a consistent manner.
Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of all four UK nations. It clarifies the information regarding radiation exposures for sites at an early stage in the research regulatory approvals pathway to support site set-up. It also coordinates the lead CRE and lead MPE reviews in Part B section 3 of the Integrated Research Application System (IRAS) application form.
Dr Janet Messer, Director of the HRA Approvals Service
We are delighted to see such a positive response to a UK-wide standardised review process for research involving ionising radiation.
The feedback and evaluation has highlighted necessary amendments that will improve the process further and provide more consistent, predictable set-up of studies in the NHS involving radiation.
The phased roll-out of the process was launched on 16 April 2018, to accept oncology studies taking place in secondary care. Phase two, which begins on 12 November, includes studies taking place in the NHS involving cardiology, neurology and rheumatology studies.
Before the launch of phase two, feedback was collected via an online survey, as well as email correspondence from applicants, REC members and our reviewers.
The findings and recommendations were assessed by the HRA and the Four Nations Radiation Assurance Working Party, made up of representatives from the HRA, the Administration of Radioactive Substances Advisory Committee (ARSAC) and radiation experts from all four UK nations.