Radiation Assurance

This page provides the following information:

• What is Radiation Assurance?
• Should you apply for Radiation Assurance?
• How to Apply for Radiation Assurance
• Tips for a successful application
• After you have submitted your application
• After Radiation Assurance
• Providing feedback

What is Radiation Assurance?

Radiation Assurance is a pre-submission process, meaning it takes place before e-submission of the IRAS Form and before an application is made to the Administration of Radioactive Substances Advisory Committee (ARSAC). 

Its purpose is to assist you in securing the Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) reviews in Part B Section 3 of the IRAS form ready for you to submit it for the required regulatory approvals. It’s managed by the HRA on behalf of all four UK nations and is designed to: 

• implement a Radiation Assurance consistency review prior to CRE and MPE reviews, leading to greater consistency of information regarding ionising radiation information in applications
  

• assist you in finding CREs and MPEs with the appropriate expertise to review your study
  

• give greater clarity for CRE and MPE reviewers, who review through Radiation Assurance, on which information should be in Part B Section 3 of the IRAS form

• provide generic statements about the risk of the exposure of ionising radiation to Research Ethics Committees (RECs) and the Administration of Radioactive Substances Advisory Committee (ARSAC) within the IRAS Form, and to participants in the participant facing material 

• provide assurance to applicants, regulatory bodies and participating sites that the information within the IRAS Form contains the required information to the set Radiation Assurance standards

• reduce site set up times by reducing the number of individual queries raised at site level, as a result of more consistent and accurate application documents

Radiation Assurance has introduced a standardised review fee for some studies. Further information is available in the Payments Framework Guidance on the HRA website.

The Radiation Assurance process is in continued development and will go through a phased roll-out. Meaning in future it will become an integrated pre-submission aspect of the IRAS Form. 

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Should you apply for Radiation Assurance?

Radiation Assurance is a pre-submission process and occurs before you apply for other regulatory approvals such as REC and ARSAC reviews. This is due to the need to obtain MPE and CRE sign-off in Part B Section 3. 

If your study will involve ionising radiation exposures taking place in secondary care in the NHS/HSC you should apply for Radiation Assurance.  You should also read the guidance on defining research exposures before beginning your application.

If you intend to submit your application through combined review you should read the guidance on this web page, along with the additional guidance on IRAS Help and the HRA website, before you submit.

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How to Apply for Radiation Assurance

HRA and Self Managed applications

There are two review routes through Radiation Assurance – self-managed and HRA-managed. You can see the flowcharts on the HRA website for an overview of what happens in each review process. Detailed guidance on how to apply, depending on which route you intend to use, is available below.

Self-managed studies

If you have an agreement in place with all CRE and MPE reviewers needed to complete your review, and the reviewers are registered with the HRA, you can use the self-managed process. You can check whether a CRE or MPE is registered with the HRA by using our Registered Reviewer List. If the reviewers you want to use are not registered, you can read the 'Can I become a HRA-registered radiation reviewer?’' page on the HRA website to see how your intended reviewers can apply to become registered.

In this process, the HRA will conduct a consistency review on the application, but you’ll manage the review process with the reviewers yourself once the consistency review is complete. It’s your responsibility to ensure that CREs and MPEs of the appropriate expertise are selected to conduct the review. If you’re not sure, you can contact the Technical Assurances team for help (radiation.assurance@hra.nhs.uk).

If you’re planning to submit via the self-managed route and have reviewers in place, you should not complete any of the reviews before submitting to Radiation Assurance. This is to avoid the need for the reviews to be redone following any clarifications and changes required during the consistency review, which may alter the existing review.

Further information on reviewer specialisms and implications for payment of self-managed reviews is available in the Payments Framework Guidance on the HRA website.

HRA-managed studies

Any study which cannot be self-managed will be processed as HRA-managed as long as the standard review fee is available to pay for the review. Further information on payment is available in the Payments Framework Guidance. You should note that different payment arrangements apply for any reviewers used who are based in Scotland.

Under the HRA-managed process, the HRA will conduct a consistency review on the application and assign HRA-registered reviewers to review the study. The HRA will also manage the review process with reviewers, working with you when required. You can request up to three trusts or health boards and, if known, reviewers at these organisations, to complete the review. There may be instances where the requested reviewers or organisations are not available, if this situation arises the HRA will contact you to discuss further options.

Submission process

Submissions for Radiation Assurance should be made before Part B Section 3 of the IRAS Form has been completed and authorised. Because of this, submission to Radiation Assurance cannot happen in parallel with submission to other approvals, such as REC and ARSAC.

Radiation Assurance Consistency review 

HRA staff carry out a consistency review on all applications received for Radiation Assurance. This ensures all documents the MPE and CRE will need have been provided, and that all documents are consistent in their descriptions of ionising radiation exposures involved in the research.

Before you submit for Radiation Assurance we recommend you review the HRA’s Radiation Assurance consistency review guidance document which explains:

• what criteria the what the HRA will check your application against
• what studies are eligible for Radiation Assurance
• what documents you need to submit
• what sections within each document you should ensure are consistent
  

Documents you should submit 

The documents you need to submit to Radiation Assurance differ somewhat depending on the type and modalities of the study. For example, a combined review application (meaning a CTIMP or a combination trial of an IMP and device) involving nuclear medicine will require slightly different documents to a combined review application without nuclear medicine.

The table below provides information on the document requirements for combined review and non-combined review studies

Supporting documents can be in draft format as long as the references to ionising radiation exposures will not be changed before the subsequent submission to the REC and ARSAC (where required).

Template documents for your Radiation Assurance application

There are several forms important to the Radiation Assurance Process that you may need to complete and include in your submission. Templates of these forms are available below: 

• Research Exposure Form (Word format) with the relevant sections of part F1 completed as appropriate for your study

• Self-Managed Study Registration Form for studies using the self-managed route

• HRA-Managed Study Reviewing Trust/Health Board Request Form  for studies using the HRA-managed route (if you wish to request specific reviewers and/or Trusts/Health Boards to conduct the review).

You’ll also need to submit all copies of your participant information sheets and consent forms that involve ionising radiation research exposures. These documents should include text describing the risk of radiation exposure involved in an accessible way. You can find generic risk statements you can use in these documents at the following Consent and Participant Information Guidance webpage

Submitting your application to Radiation Assurance

Radiation Assurance occurs prior to regulatory approval submission, the documents should be sent by email to radiation.assurance@hra.nhs.uk with the email subject “IRAS ID xxxxxx - New submission for Radiation Assurance”. You should specify within the covering email whether you would like your submission to be HRA-managed or self-managed.

Some HRA-registered reviewers are classed as ‘independent reviewers’. These are reviewers that are registered as sole traders or limited companies; they do not review for a Trust/Health Board or private company. If you’re submitting through the HRA-managed route and do not want the HRA to assign a study to an independent reviewer, you should specify this in your covering email.

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Tips for a successful application

To avoid unnecessary delays or issues in your submission you should

• make sure that you’ve identified and recorded all research exposures in the IRAS Form and the Research Exposure Form
  
  
• ensure that protocols are clear regarding radiation exposures in the research. All research exposures should be detailed in the protocol. Even if the exposure is standard of care, it may still be considered a research exposure in some cases. We recommend you review our guidance on defining research exposures
  
  
• read the guidance within the Research Exposure Form when completing it to ensure all questions are answered fully. For further guidance you can also view our examples for completing the research exposure form for studies with a clear end date and for studies that are open ended
  
  
• check that any information requested in the Research Exposure Form is also captured in other study documents. If you cannot find matching information in your study documents it’s recommended that you speak to the sponsor or chief investigator to find this information out before you submit
  
  
• ensure that the maximum number of exposures for all radiological procedures is stated in both the IRAS Form and the Research Exposure Form This will differ for open-ended studies, we recommend you view the open-ended exemplar form linked above.
  
  
• make sure all references to research exposures are consistent throughout all study documents before you submit (for further guidance see the Radiation Assurance consistency review guidance).
  
  
• if available, you should provide a copy of the imaging manual or radiotherapy protocol at submission as this will speed up the consistency review process. If either of these documents are referenced in the protocol, the HRA will request them prior to review. If an imaging or radiotherapy manual will be applicable to your study, we strongly recommend providing it for review. 

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After you have submitted your application

Whether your study is self-managed or HRA-managed, the HRA will complete a consistency review within a maximum of 14 calendar days of a submission being received, excluding any time it takes you to respond to queries. This timeline may be extended during busy periods.

The HRA needs this amount of time to fully check the study against the consistency review criteria. This ensures all documents the CRE and MPE need have been provided before the application is sent to them, and assures RECs, ARSAC and sites that the information submitted has been checked to ensure it’s consistent across the study documents. For further information on the consistency review, and guidance on ensuring your application passes this review, see the Radiation Assurance consistency review guidance.

Self-managed studies

When the consistency review is complete, you’ll receive an email from the HRA confirming this (and also that it has been registered for self-managed review). You should send this email together with the documents checked in the consistency review to the MPE and CRE reviewers who were listed in the Self-Managed Study Registration Form so that they can complete the review in part 2 and part 3 of the Research Exposure Form respectively. It’s your responsibility to work with the reviewers and ensure that the review is completed. There are no timelines set by the HRA for this part of the process. 

Once the review is completed, you should ensure that the full Research Exposure Form is sent back to the HRA at radiation.assurance@hra.nhs.uk. This is so that the HRA can confirm by email that Radiation Assurance has been secured. Radiation Assurance will not be provided until the HRA is in receipt of the completed review.

HRA-managed studies

When the consistency review has been complete, you’ll receive an email from the HRA confirming this. The HRA will then assign CRE and MPE reviewers to the study to conduct the review if you haven’t already specified reviewers or Trusts/Health Boards to be selected.

Where the HRA-Managed Study Reviewing Trust/Health Board Request Form isn’t submitted, the HRA will choose the first available reviewers of the appropriate specialisms from its list.

Where the HRA-Managed Study Reviewing Trust/Health Board Request Form is submitted, the HRA will assign reviewers from the requested organisations wherever possible. If reviewers at the organisations are not available, you’ll have the option to wait for them to become available or the HRA will choose the first available reviewers of the appropriate specialisms from its list. If you wait for reviewers to become available, you should be aware that this will not count towards the HRA’s review timeline.

You should be aware that reviewers have the option to refuse to conduct a review (for example because they are about to go on annual leave, or their existing workload requires prioritisation). Where this occurs the HRA will then select the next available reviewer of the appropriate specialism from its list.

The HRA will provide reviewers who accept the review a copy of the study documents and the research exposure form. If the reviewers have any queries about the information in the application, the HRA will work with you on their behalf to resolve any issues. The HRA will also give the reviewers your contact details so that they can contact you directly to begin payment arrangements whilst the review is ongoing.

Once the review is completed the HRA will send the completed Research Exposure Form back to you and confirm by email that Radiation Assurance has been secured. The HRA aims to send you this email within 40 calendar days of the initial submission being made, excluding the time it takes for you to respond to any queries raised. This timeline includes the consistency review, assigning MPE and CRE reviewers, and the completion of the MPE and CRE reviews. During busy periods, this timeline may be extended.

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After Radiation Assurance

The email confirming that Radiation Assurance has been secured will include further information about what to do at this point, such as:

• copying the MPE and CRE reviews from the research exposure form into IRAS Part B Section 3

• making any changes the reviewers have requested to be made to the Participant Information Sheet

• seeking authorisations from the lead MPE and CRE

• making payment to the reviewing trusts/health boards. The Payments Framework Guidance recommends that payment is made within 30 days of Radiation Assurance being issued, in line with NHS standard payment terms

• including this email in the submission to ARSAC (where required), and in the local information pack to participating sites

If the research exposures change after Radiation Assurance has been secured this may result in a change in the information in Part B Section 3. If this is the case, Radiation Assurance will not be valid. A change (pre-REC favourable opinion) or substantial amendment (post-REC favourable opinion) request should be submitted to Radiation Assurance prior to submission to the appropriate regulatory bodies to ensure the continuation of Radiation Assurance

Further information on which changes to the research exposures would lead to a new submission being made to Radiation Assurance can be found in the Maintaining Your Approvals section of the IRAS Help pages, together with guidance about how to submit.

Providing feedback 

We welcome all feedback on the Radiation Assurance process, including from RECs and sites who have received an application which has been through Radiation Assurance. You can contact us at radiation.assurance@hra.nhs.uk to provide feedback.

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Page last updated: 24 October 2024