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: