Radiation Assurance

If you will 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

• An amendment request when the REC favourable opinion is in place

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

• The main study has already been processed through Radiation Assurance; or

• The change or amendment 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 an amendment to other relevant review bodies, please refer to the amendment guidance for all review bodies here.

This page provides the following information:

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

When to notify changes/amendments to Radiation Assurance

Any changes to the study that will affect the information in Part B Section 3 will constitute a change or amendment that needs to be submitted to Radiation Assurance. This includes, but is not limited to, any changes to the following:

• The number of scans – this can be an addition or reduction, 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 CT may be introduced as an alternative to MRI

• The dose calculation – for instance change in number of scans, new scans or to allow for new sites 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 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 entry regarding the risk of ionising radiation exposure in the participant information sheet (PIS) where this substantially alters the meaning of the text, as this will have been previously reviewed and authorised by the MPE and CRE.

• Radiotherapy procedures – for example, changing the way the radiotherapy is delivered, 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 e.g. GFR, or the inclusion or removal of the need for biopsies that could be CT-guided.

An amendment to Radiation Assurance is not required for the following:

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

Substantial amendments 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 amendment to the Research Ethics Committee (REC). Where there are non-substantial changes 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/amendments to Radiation Assurance

Submission

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

You should submit the following documents affected by the change/amendment in tracked changes (where possible):

• Protocol

• IRAS Form

• Post-REC favourable opinion amendments only: completed Amendment Tool

• All participant information sheet(s) and consent form(s)

• Imaging manual (if available)

• Radiotherapy protocol (if available)

• Research exposure form with part F1 amended

• Self-managed submissions only: Self-Managed Study Registration Form

• HRA-managed submissions only, where requested: HRA-Managed Study Reviewing Trust/Health Board Request Form

As 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 change/amendment submission for Radiation Assurance”. The change or amendment should be managed in the same way as the initial submission i.e. HRA-managed or self-managed but if this does need to change this should be explained in the body of the email. If an amendment is being submitted to add ionising radiation exposures for the first time please 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 – see 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 to give you further information about what to do at this point, such as:

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

• Seek authorisations from the lead MPE and CRE;

• Make payment to the reviewing trust(s)/health board(s);

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

• Pre-REC favourable opinion: include this email in the submission to ARSAC (where required), and in the local information pack to participating sites.

• Post-REC favourable opinion: include this email in the amendment submission to the regulatory bodies specified in the Amendments for projects conducted in the NHS/HSC section of the Help pages, the ARSAC (where required), and in the amendment notification to participating sites.

You should be aware that the standardised fee to pay for a change or an amendment is different to that for new submissions (except for an amendment to add ionising radiation exposures for the first time). Further guidance on payment is available in the amendments section of the Payments Framework Guidance.

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Page last updated: 11 November 2020