Once you have approval

• Protocol deviations and breaches

  For studies that have obtained NHS ethics approval and are sponsored by the University:

  • you must notify the sponsor and the host organisation of deviations from the study protocol
  • serious breaches of the protocol or adverse events (for example, harm to participants or loss of personal data) must be reported as soon as possible.
  • changes to the study must be submitted as an amendment.

  Details of contacts for adverse events are given on the useful resources page.

• Amendments and extensions

  If you make any changes to your study, including extension of the study period, you must submit an amendment for both your NHS ethics approval and your University ethics approval. 

  You should complete your NHS ethics amendment first and your University ethics amendment second. 

  NHS ethics amendments

  Guidance on NHS ethics amendments can be found on the IRAS help page:

  • contact research governance to discuss your amendment
  • complete the Amendment Tool (this determines what category the amendment will come under – A, B, or C)
  • the sponsor will submit the amendment
  • the amendment will be shared with the REC via IRAS
  • if there is more than one NHS R&D department involved, they will be notified of the amendment and supplied with the documents by the NRS PCC 
  • if only a single NHS R&D department involved, they must be notified of the amendment and supplied all the relevant documents directly by email

  After submission

  • You will receive an automated confirmation of submission
  • You will not receive confirmation of approval, instead:
    • Category A or B amendments – can be implemented after 35 days if there are no objections from the REC or R&D
    • Category C amendments – can be implemented immediately.

  University ethics amendments

  Visit the guidance page on the University’s ethics amendment and extension processes. University ethics approval is valid for five years from the approval date as standard.

  Other approvals

  If you have any other approvals, such as PBPP or Caldicott, you must amend these as appropriate.

• Annual progress reports

  Annual progress reports are required for studies that have undergone full REC review and which will last for two years or more.

  You may receive an email from the REC on the anniversary of your approval requesting an annual report and providing a template however you should not rely on this and proactively plan for your annual report.

  Annual reports should be completed within 30 days of the end of the reporting period. A copy should also be sent to the sponsor. 

• End of study report

  The date or definition of the end of your study is given in your protocol or IRAS form.

  You must declare the end of your study to the REC within 90 days of the end of your study.

  At the end of your study, you must prepare an end of study report for submission to the REC which approved your study. This must be sent to the REC within 12 months of the end of your study. You should also send a copy to the sponsor.