Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of all four UK nations for studies which are taking place in NHS/HSC secondary care settings.
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.
Can I submit for Radiation Assurance?
We expect that all studies taking place in the NHS/HSC and involving ionising radiation are submitted through Radiation Assurance.
Detailed submission guidance is available on the IRAS website, but our Applying for Radiation Assurance page provides information about options for how to submit.
Feedback on the process
Commercial sponsorThe reviews have been well accepted by all UK sites participating in our studies
NHS sponsorStreamlining 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.
Radiation Assurance performance
We regularly publish updates on our review times for Radiation Assurance.
You can find out more in the 'our performance' section of our website.
What next?
We value all feedback. If you would like to tell us about your experience of using Radiation Assurance, please email radiation.assurance@hra.nhs.uk.
We also have guidance for sponsors and sites about what happens after Radiation Assurance.