Q: Do I have to use Radiation Assurance?
A: Radiation Assurance is not mandatory, but we strongly recommend that applicants use the process. It is particularly important that applicants use the process as soon as they are able to in order to support them using the new IRAS system, when all ionising radiation studies taking place in the NHS/HSC will be processed through Radiation Assurance.
The quality of the information in the review can reduce regulatory review time by REC and ARSAC, and reduce site-specific queries when sites conduct their capacity and capability assessments.
Additionally, the generic ionising radiation risk statements created for use in the Participant Information Sheets (PIS) are designed to provide participants with a clearer appreciation of the risks of the exposure to ionising radiation as part of the trial, which will support the informed consent procedure.
Q: When should I apply/submit to Radiation Assurance?
A: Radiation Assurance should be completed before applying for relevant regulatory approvals, including Research Ethics Committee (REC), HRA & HCRW Approval and Administration of Radioactive Substances Advisory Committee (ARSAC) review. We advise applicants to submit their application to us as soon as the radiation aspects of the trial are fixed and will not change, to ensure that pre-submission changes are not required.
Q: How do I apply/submit to Radiation Assurance?
A: Documents should be submitted to radiation.assurance@hra.nhs.uk. Full submission guidance is available on our IRAS help page. A summary of the application process is available on our Applying for Radiation Assurance page.
Q: How much is the fee for Radiation Assurance?
A: Please see our Review Fee page for further details on funding and payment. Funders should ensure that the review fee has been included in the costing template as a Part A research cost (exclusive of VAT).
Q: What indemnification does the HRA have in place for Radiation Assurance?
A: The HRA will indemnify reviewers for the completion of HRA-managed reviews, but not the payment aspect of the process. Indemnification of self-managed reviews should be provided by the reviewing trust/health board and/or reviewer (depending on local arrangements). The HRA will not indemnify any aspect of self-managed reviews.
Q: Does the HRA have a quality assurance programme in place for Radiation Assurance?
A: A quality assurance programme has been developed and put in place. This includes any issues raised being triaged to a suitable individual to ensure they are resolved appropriately, whether this is HRA staff, a reviewer, or the Four Nations Radiation Assurance Working Party. Feedback from applicants, reviewers and participating sites is also being monitored on a frequent basis.
Further details about quality assurance and implications on payment can be found on our Review Fee page.
Q: What is the overall timeline for a HRA-managed submission to be processed through Radiation Assurance?
A: We are currently working to the timeline of 40 calendar days (excluding queries) for a new study to be processed through HRA Radiation Assurance as a HRA-managed study. The 40 calendar day timeline includes: 14 calendar days for our consistency review (excluding queries), allocating reviews to appropriate experts, and the time it takes the experts to complete their reviews (excluding queries).
We are currently working to a timeline of 30 calendar days (excluding queries) for amendments to be processed through Radiation Assurance as an HRA-managed submission. The 30 calendar day timeline includes: 10 calendar days for our consistency review (excluding queries), allocating reviews to appropriate experts, and the time it takes the experts to complete their reviews (excluding queries).
Q: What are the expected timelines for a self-managed submission?
A: We will register and complete a consistency review for self-managed studies to provide the same level of assurance to stakeholders as HRA-managed submissions. The consistency review and registration process timeline is 14 calendar days for new studies, or 10 calendar days for amendments, excluding queries the HRA may have with the applicant. Once this part of the process is complete, the timeline for the completion of the review process is entirely managed by the applicant.
Q: What can I do to ensure that the Radiation Assurance process is completed within the HRA's target timelines?
A: For both HRA-managed and self-managed studies you should read our tips for a successful application on the IRAS website. This gives guidance about what you should do to prepare your application before submission to reduce the number of potential queries. We have listed the most common issues we come across during the consistency reviews, with tips on how to prevent them. You can also see our Consistency Review Guidelines in the section about how to apply for Radiation Assurance on the IRAS website.
Q: How do I know if a study we are participating in has Radiation Assurance?
A: There are two ways of identifying if a study has Radiation Assurance:
- a completed copy of the Research Exposure Form should be included in your local information pack together with the email confirming that Radiation Assurance is in place, detailing all ionising and non-ionising research exposures for the study. An example of this form can be found on the IRAS website.
- if your study is taking place in England and/or Wales, the HRA & HCRW Approval letter will include confirmation that Radiation Assurance is in place.
Q: I have chosen to self-manage my review and have a lead MPE and CRE but am unable to source an additional MPE required to complete the review. Can I ask the HRA to source an additional MPE and continue to self-manage my review?
A: No. If you have chosen to self-manage your review and then find that you are unable to source lead and/or additional reviewers, your review should be processed as HRA-managed so that we are able to source reviewers on your behalf. We would still use any reviewers that you have chosen (subject to their availability) to complete the review within the HRA-managed study timelines.
Q: I am not submitting my study through Radiation Assurance. However, I have a lead MPE to complete my review, but I am unable to source a CRE. Can I ask the Radiation Assurance team to source a CRE?
A: No, we would not be able to source a CRE for you to use outside of the Radiation Assurance process. In this instance you would need to submit your study to Radiation Assurance for us to source HRA registered reviewers for you - both CRE and MPE. If the MPE already identified was registered with us we would be able to continue to use them. The review would be entirely managed through the Radiation Assurance process.