If you would like to make changes to a project that has received either UREC or Division/School ethical approval*, please first read the Guidance on Submitting Amendments

If you decide that your request can be submitted via an amendment (and not via a new application) please complete the following steps:

For projects approved within the ERM system:

• Log into the ERM system: https://submission-ethicalreview.manchester.ac.uk
• Complete an amendment request as detailed in the user guide or Video, being sure to include ALL relevant updated supporting documentation (consent form, PIS, protocol, DMP etc)
• The Research Ethics Team will automatically forward your request to the relevant UREC Secretary or Division/School Chair for action
• You will receive an email with the details of who is handing your amendment request, please communicate with them directly should you have any queries
• You should receive a response within 10 working days of submitting your request

For projects approved outside of ERM

• If your project obtained research ethics approval from UoM outside of the ERM system as the project pre-dates the system's introduction, or because you transferred an active project when you joined UoM from another UK university, please contact research.ethics@manchester.ac.uk for advice.

*If your study received HRA approval in addition to UREC or Division/School ethical approval, please refer to the section below for guidance.

HRA (Health Research Authority) or NHS REC

Should you need to request a substantial amendment to a previously submitted HRA application in which you received favourable ethical opinion, please consult the detailed information found on the Research Governance Team’s SharePoint.

Should you need to request an amendment to a study that received approval by both the UREC and the HRA, please complete the following steps:

• Please submit your amendment request to the UREC prior to your amendment being sent to sponsor representative by following the steps as outlined above.
• Once UREC approval is received, forward your UREC approval confirmation, the amendment tool and any track changes documents (as applicable) or new documents (as applicable) to the sponsor's representative for review/authorisation. The amendment review from the sponsor’s representative will consist of checking the tool for any errors and documents for key features/GDPR compliance. Once any changes requested are made, the amendment will be approved for submission to the HRA.
• Once HRA approval is received, ensure that you submit a further UREC amendment if any changes were requested by either the sponsor's representative or the HRA.

If your study involves both NHS patients and international sites you will have obtained full NHS REC approval as well as UREC. For guidance on submitting amendments to these types of studies, please refer to the Research Governance Team's information page, which has detailed guidance.

In specific circumstances a new UREC approval can be associated with a current HRA approval. This is limited to where UREC have requested a new application is submitted due to the end date of an application passing, and an extension to a current approval is not as deemed viable/appropriate.

In this circumstance once UREC approval has been gained for the study, the study team should send the sponsor’s representative their new/updated documentation along with their amendment tool and UREC approval (updated documentation should include track changes). A cover letter should also be created to be submitted to the HRA to outline the submission and reasoning of any new version 1 documentation where this has replaced previous version 1 documentation.

The sponsor’s representative will review the amendment as a whole and either confirm if the amendment is appropriate to be submitted or confirm if a new HRA application will be required based on the changes, prior to issuing approval of the amendment in line with the process above.