Radiation Assurance

If you’ll be changing any of the information in Part B Section 3 of the IRAS Form, you should notify Radiation Assurance of this by submitting: 

• a change request when the REC favourable opinion is not in place
• a modification request when the REC favourable opinion is in place

This page provides guidance on how you should prepare and submit your change/ modification to Radiation Assurance. You should note that Radiation Assurance will only accept changes to Part B Section 3 where one of the following criteria are met: 

• Radiation Assurance has already processed the main study 
• the change or modification is adding ionising radiation exposures to the research for the first time and the study falls within the current roll-out phase (see HRA website for further details on the phased roll-out)

If you meet neither of these criteria then you should follow your local processes to update Part B Section 3.

For information on notifying a modification to other relevant review bodies, refer to the  modification guidance for all review bodies.

This page provides the following information:

• When to notify changes/ modifications to Radiation Assurance
• How and when to submit changes/ modifications to Radiation Assurance
• The review process

When to notify changes/modifications to Radiation Assurance

If a change or modification will affect the information in Part B Section 3 you’ll need to submit these to Radiation Assurance. This includes, but is not limited to, any changes to:  

• the number of scans – this can be an addition or reduction (for example as a result of change in length of time participants are in follow-up, addition of new arms to the study which include scans)

• the type of scans – for instance a CT scan may be introduced as an alternative to MRI

• the dose calculation – for instance a change in number of scans, new scans or to allow for new trial locations having different procedures or equipment which do not fit into the limits given in the original review

• ·nuclear medicine procedures – for instance, changes to the radionuclide used on any site

• the participant group – this may affect the clinical radiation expert (CRE) justification. Particular regard should be taken when adding adults aged 18-64, adults aged over 65, children, healthy volunteers, or pregnant participants for the first time, though the addition of other participant groups may also require re-review

• the text within the participant information sheet (PIS) regarding the risk of ionising radiation exposure, particularly where the modification/change substantially alters the meaning of the text, as this will have been previously reviewed and authorised by the medical physics expert (MPE) and CRE.

• radiotherapy procedures – for example, changing the way the radiotherapy is provided, adding or removing sessions, or amending the dose to be administered.

• ·other radiation exposures – these could be the use of a test that may include exposure to ionising radiation, for example Glomerular Filtration Rate (GFR), or the inclusion or removal of the need for biopsies that could be CT-guided

A modification to Radiation Assurance is not required for:

• administrative changes to the wording in the PIS statements regarding radiation exposures, where the meaning has not been changed from the approved version.

Substantial modification s will be processed through Radiation Assurance as any change to the Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) reviews will constitute a substantial modification to the Research Ethics Committee (REC). Where there are minor modifications to documents that were reviewed as part of the Radiation Assurance process these will not need to be notified to Radiation Assurance.

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How and when to submit changes/modifications to Radiation Assurance

Submission

You should submit your change/ modification to Radiation Assurance once all proposed changes to research exposures are agreed with the sponsor but before you submit for any other regulatory approvals.

You'll then need to wait for the Radiation Assurance review to take place. Once you receive the amended CRE and MPE reviews in the Research Exposure Form you'll be able to update Part B Section 3, obtain the necessary authorisations and proceed to submit this part of the IRAS Form alongside your modification to the REC and the ARSAC (where required).

Documents you should submit, if they are affected by the change/modification, in tracked changes format (where possible) include:

• the protocol
• the IRAS Form
• the  Modification Tool (post-REC favourable opinion modifications only)
• all participant information sheet(s) and consent form(s)
• the imaging manual (if available)
• the radiotherapy protocol (if available)
• the Research exposure form with part F1 amended
• the Self-Managed Study Registration Form (for self-managed submissions only)
• where requested the HRA-Managed Study Reviewing Trust/Health Board Request Form (HRA-Managed submissions only)

As Radiation Assurance occurs before regulatory approval submission, the documents should be sent by email to radiation.assurance@hra.nhs.uk with the email subject “IRAS ID xxxxxx - New change/ modification submission for Radiation Assurance”.

The change or modification should be managed in the same way as the initial submission (meaning either HRA-managed or self-managed) but if this does need to change this should be explained in the body of the email. If  a modification is being submitted to add ionising radiation exposures for the first time you should ensure that this is clear in the body of the email.

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The review process

The review process will be managed in the same way as a new submission through Radiation Assurance. For more information you should review our guidance on new submissions in the Preparing and Submitting Applications section of the Help pages.

When the review is completed the HRA will email you to confirm that Radiation Assurance has been secured, and give you further information about what you should then do such as:

• copying the MPE and CRE reviews from the research exposure form into IRAS Part B Section 3
• seeking authorisations from the lead MPE and CRE
• making payments to the reviewing trusts/health boards
• making any changes the reviewers have requested to be made to the Participant Information Sheet

In addition, the email from the HRA will also explain how the email confirming Radiation Assurance is in place should be shared. Who you share the email with will depend on whether a REC favourable opinion for the main study has been obtained. If your application has:

• ·not yet received a REC favourable opinion you should include this email in the submission to ARSAC (where required), and in the local information pack to participating organisations.
• received a REC favourable opinion you should include this email in the modification submission to the regulatory bodies specified in the  modification for projects conducted in the NHS/HSC section of the Help pages, the ARSAC (where required), and in the modification notification to participating organisations.

You should be aware that the standardised fee to pay for a change or a modification is different to that for new submissions (except for a modification to add ionising radiation exposures for the first time). For further guidance you should review the modifications section of the Payments Framework Guidance.

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