When you need to get a project amendment approval

You need to get an amendment approval for any of the following changes to your research project:

  • adding or removing investigators
  • changes to the protocol, participant information and consent form or other study documents
  • adding or removing study documents
  • adding or removing study sites (facilities/hospitals) involved in the research
  • changes to agreements, indemnity or insurance.

Both the authorising Human Research Ethics Committee (HREC) and Sunshine Coast Hospital and Health Service research governance team need to approve a project amendment.

How to get approval

Use the Ethics Review Manager to submit a project amendment. Submission instructions can be found in the ERM forms.

Your submission should include:

  • rationale and summary of the amendment from the principal investigator (to be completed on the ERM Amendment form)
  • a copy of all additional and amended documents (one tracked and one clean copy of each revised document including a new version number and date in the footer).

You can find more information about the project amendment process either:

Last updated: May 2022