If our Ethics Committee provides the ethical review for a project, a committee or review panel must review substantial amendments to approved project documents. We provide upcoming submission due dates at Submission and Meeting Dates.
The Ethics Committee Secretariat can review and approve other amendments and you can submit these at any time. Examples include:
- Addition of sites
- Addition or change of study personnel
- Update to contact or sponsor details
- Correction of minor errors
- Increase in accrual
If the reviewing Human Research Ethics Committee (reviewing HREC) is an external Ethics Committee, you must submit the approved amendment for governance review. You can submit these amendments to the Research Governance Office at any time.
Amendment review pathway summary
Amendments for ethical review
SOP004 Monitoring Ongoing Research describes the requirements for submitting Amendments to our Ethics Committee.
Substantial Amendments
If our Ethics Committee provided the ethical review for a project, then you must submit all subsequent amendments to the project documents to our Ethics Committee for review. Please see Substantial amendments - ethical review.
Additional Sites
You may add sites to a project that received ethical approval from our Ethics Committee depending on the type of research, date of ethical approval and the site's location. Please see Addition of sites - ethical review.
Urgent Amendments
Implicating patient safety or requests to vary the protocol for the benefit of a specific research participant may be eligible for Interim Approval. Please see Urgent amendment requests - ethical review.
Amendments for governance review
Multisite ethical review projects must submit amendments to the reviewing Human Research Ethics Committee (reviewing HREC) for that project.
Once the reviewing HREC has issued an amendment ethical approval, you can submit a Governance Amendment application for our site. Please see Amendments - governance review.
Resources
