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Amendments to Ethics Applications

UREC or Division/School Review

Should you need to request an amendment to a previously submitted UREC or Division/School application in which you received favourable ethical opinion, please complete the following steps:

For Projects Approved Prior to the Launch of ERM (the new online system for ethical review):

  • Log into the ERM system: https://submission-ethicalreview.manchester.ac.uk
  • Complete a historical project form as detailed in the PDF Training Guide or Video
  • Complete an amendment request (for the historical project form) as detailed in the PDF Training Guide or Video, being sure to include ANY updated supporting documentation (consent form, PIS, protocol, etc)
  • The Research Office 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 within ERM (the new online system for ethical review):

  • Log into the ERM system: https://submission-ethicalreview.manchester.ac.uk
  • Complete an amendment request as detailed in the PDF Training Guide or Video, being sure to include ANY updated supporting documentation (consent form, PIS, protocol, etc)
  • The Research Office 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

Breaches and Adverse Events

Should you need to report any serious breaches or adverse events that occur during the duration of your study, please refer to the Incident SOP 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 complete the following steps:

  • Please consult the HRA website for information regarding submission of substantial amendments to the REC, including definitions of what constitutes a substantial and non-substantial amendment. 
  • Before submitting a substantial amendment to the REC, it must be reviewed by the sponor in order to confirm support of the amendment.
  • Please complete the Notice of Substantial Amendment (NoSA) in IRAS via your original application, providing details of the amendment in the 'summary of changes' section of the form and referencing any relevant sections of the original IRAS form. Please note: you DO NOT need to amend the original application, you simply need to reference the relvant sections in your summary for review by the sponsor and REC
  • Please ensure that any amended documentation has the changes clearly highlighted or in tracked changes. You may wish to include both your original documentation as well as the updated version if there have been a large number of changes. If this is the case, please include a list of all the changes in a separate document for reference and list all attachments under the 'List of enclosed documents' on the NoSA form.
  • After completion, please email the NoSA form to your sponsor for approval. For FBMH please contact Lynne Macrae and for all other faculties please contact Genevieve Pridham.
  • After sponsor approval, the NoSA and updated documentation must be submitted to the REC via the IRAS portal. The REC co-ordinator will be in touch within 5 working days to confirm if the NoSA is deemed to be valid. You should expect a final decision by the REC regarding approval of your requested amendment to take place within 35 days. 
  • All non-substantial amendments must be sent to the Trust R&D for information as well as to the reserach team for auditing purposes. If your non-substantial amendment is with regard to contact details of the sponsor or sponsors' representative, chief or principal investigator or other study staff, then you must also notify the REC for information purposes.