Q: Do I have to use Radiation Assurance?
A: Radiation Assurance is currently not mandatory, but the process. It is particularly important that applicants use the process should be used for all studies taking place in secondary care within the NHS. The quality of the information in the review can reduce regulatory review time by Research Ethics Committees (RECs) and the Administration of Radioactive Substances Advisory Committee (ARSAC), as well as potentially reducing site-specific queries during 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 understanding of the risks of the exposure to ionising radiation as part of the trial, which will support the informed consent procedure.
Using and becoming familiar with the Radiation Assurance process will help you in future, when the new Integrated Research Application System (IRAS) system is in place and all ionising radiation studies taking place in the NHS/HSC will be processed through Radiation Assurance
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 you to submit your application to us as soon as the radiation aspects of the trial are finalised 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. For reviewers reviewing on an independent basis, appropriate personal indemnification should be in place for all self-managed reviews.
Q: Does the HRA have a quality assurance programme in place for Radiation Assurance?
A: A robust 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're 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're 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: 7 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: Once you submit your self-managed submission, we'll register it and complete a consistency review. This is 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 7 calendar days for amendments. This excludes the time in which the HRA raises and clarifies any queries with you.
Once this part of the process is complete, the timeline for completing the review process is entirely managed by you. We would recommend you aim to complete the review in a timely manner to avoid delays to submitting for regulatory approvals. You should also note that Radiation Assurance will not be issued until the Technical Assurances Team have received the completed review.
If any changes are made to the study documentation during the review, you should provide any updated documents to the Radiation Assurance team along with the completed Research Exposure Form (REF).
Q: Should I get the reviews for a Self-Managed Study completed before submitting to Radiation Assurance?
A: No. if your application is coming through Radiation Assurance via the Self-Managed route you should not get your chosen reviewers to undertake reviews prior to submission. This is to avoid potential duplication of work for the reviewers, as the reviews may need to be redone following any changes and clarifications required following our consistency review.
Q: What can I do to ensure that the Radiation Assurance process is completed within the HRA's target timelines?
A: Whether your submission will be HRA-managed or self-managed studies we recommend you read our guidance on the IRAS website. The guidance there gives information on preparing your application, important documents (and how to complete them), and common issues identified during the consistency reviews (which raises queries and causes delays to applications).
Q: How do I know if a study we are participating in has Radiation Assurance?
A: To identify if a study has Radiation Assurance you should:
- check your Local Information Pack (LIP). If the study has Radiation assurance it should contain a completed copy of the REF and email confirmation that Radiation Assurance is in place. The REF detail all ionising and non-ionising research exposures for the study. An example of this form can be found on the IRAS website.
- check the HRA and HCRW Approval letter (if you’re based in England or Wales) which will include confirmation if Radiation Assurance is in place. This can be found in the ‘Additional Information for Sites’ section of the letter.
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. In this scenario if you’re 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. If your chosen reviewers are unavailable, we’ll contact you to discuss how to progress your application.
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. If you need the services of a CRE through the HRA for your study, you would need to submit it through the HRA-managed route and all reviewers would be selected by the Technical Assurances team on your behalf.