- tell you whether you need to notify a review body and if so, in what capacity.
- provide detailed instructions on submission of amendments.
It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial. To help you with this categorisation, we have provided examples of substantial and non-substantial amendments.
If you are seeking guidance on whether you need to take any action for your research project in order to comply with the new General Data Protection Regulations, please refer to our GDPR guidance.
All substantial amendments should be signed off by the sponsor before submission to the HRA.
The flowchart below provides an overview of this process for studies led from England, with an English REC.
1. SubmissionUse the Notice of Substantial Amendment form in IRAS to generate a PDF form for your amendment.
Email the PDF to the REC that approved your original application.
2. Validation and categorisationREC staff will validate the
amendment and categorise it if necessary. A validation letter with any categorisation will then be sent to you. At this stage, applicants
should notify sites of the amendments and their categories. Further information on categorisation is available on IRAS.
3. REC review
The REC will review the amendment. There are three possible outcomes:
- Unfavourable opinion - you will need to return to the start of the process and resubmit
- Favourable opinion no further review from HRA required - applicants should communicate this to sites (both the research team and the R&D office), and the local CRN. If any amendments are category A or B, sites have 35 days to raise any objections, after which if no objections have been raised, the amendment can be implemented. Category C amendments can be implemented immediately.
- Favourable opinion further assessment needed - applicants will receive an email following further evaluation, after which the same process of notification as above should be followed.
The flowchart below provides an overview of this process for studies led from England.
You will not get a validation email but you will receive a categorisation email. There are two possible outcomes:
- HRA Approval for the amendment confirmed
- HRA Approval for the amendment pending
3. HRA review
Where a HRA review is required, we will review the amendment and issue HRA Approval of the amendment. Applicants should then notify sites of the outcome and provide the final approved documents.
Implementing amendments at NHS organisations in England
We have produced a series of email templates to support sponsors when notifying NHS organisations in England of an amendment and to confirm when an amendment can be implemented.
The use of these email templates are optional, however we believe their contents will allow sponsors to provide NHS organisations with the information they need to enable amendments to be implemented. The templates can be found below:
Can I start my research project while waiting for amendment approval?
No. With the exception of urgent safety measures, if your amendments require approval your changes cannot be implemented until the relevant approvals are in place.