Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of all four UK nations.
The process ensures that the information regarding radiation exposures in study documents are clearly set out at an early stage in the research regulatory approvals pathway.
It also coordinates the lead Clinical Radiation Expert (CRE) and lead Medical Physics Expert (MPE) reviews in Part B section 3 of the Integrated Research Application System (IRAS) application form.
What are the benefits of this process?
For sponsors and applicants, Radiation Assurance can:
- provide guidance on the information requirements for a Radiation Assurance review, which can lead to a quicker review time
- identify any inconsistencies or omissions relating to ionising radiation procedures in applications at an early stage
- provide support to applicants by identifying the experts with the correct specialist knowledge to conduct the reviews
- provide assurance to applicants, Research Ethics Committees (RECs) and the Administration of Radioactive Substances Advisory Committee (ARSAC) that the information provided in the review contains all the required information, to a set standard
- set a standard research cost for the completion of the review within a new payment framework, making it easier for sponsors to request the correct amount of funding.
For participating sites and participants, Radiation Assurance can:
- reduce site set-up times by providing higher quality information to sites and reducing queries
- make it easier for participants to understand the risks of exposure to ionising radiation by using generic risk statements in participant information sheets.
Feedback on the process
The reviews have been well accepted by all UK sites participating in our studies
Streamlining the process through a central contact and inbox has also taken a lot of the burden away from the research teams. Reviewers are quickly identified, and we are always kept up to date on progress. Overall it has been a very positive experience for our centre.
Can I submit for Radiation Assurance?
Radiation Assurance is currently going through a phased rollout, but we expect that all eligible studies will be submitted.
Detailed submission guidance is available on the IRAS website, but our Applying for Radiation Assurance page provides information about which studies are currently eligible to be submitted and options for how to submit.
Performance metrics for Radiation Assurance
We regularly publish updates on our performance in relation to Radiation Assurance. The below is the latest performance data for April to June 2020.
HRA-managed studies are currently progressing through Radiation Assurance in 27 calendar days. This time is measured from the point of submission by the study sponsor, to completed review and issuing of Radiation Assurance. This data excludes queries.
Consistency review times for HRA-managed studies:
Timelines are measured from the date a complete submission pack is received by the HRA, to the date on which the HRA confirms to the sponsor that the consistency review is complete. This data excludes queries.
Total review times for HRA-managed studies:
Timelines are measured from the date a complete submission pack is received by the HRA, to the date on which the HRA issues Radiation Assurance. This data excludes queries.
For all studies submitted through the self-managed route from Radiation Assurance opening in April 2018, the consistency review is completed in an average of 13 calendar days. This data excludes queries. We do not publish total review timelines for self-managed studies because it is the applicant’s responsibility to manage the CRE and MPE review.