Post Approval / Amendments and Reporting

If the amendment requires approval from the external Reviewing HREC, submit the request for amendment to the Reviewing HREC (according to their instructions) first. Once the amendment is approved by the Reviewing HREC, submit a request for amendment to the Eye and Ear Research Office.

The Amendment Request form can be used to notify the Research Office of either:

• an amendment that has been approved by the Reviewing HREC
• a site-specific governance-only amendment that does not require ethical approval (e.g., change of research team or site specific PICF).

How do I submit these reports?

• Once you have received the Reviewing HREC approval, submit the Site Governance Amendment Request form via email to the Research Office.

What documents do I need to submit?

Amendments can be submitted at any time as follows:

• Eye and Ear site specific research governance – all post authorisation project management must be submitted via email to the Research Office.
• Change to Research Team Members – submit the following:
  • Eye and Ear Amendment Request Form
  • Research Team Member Declaration
  • Honorary Researcher Application (if applicable)

How is my submission reviewed?

The amendment will be reviewed by the Eye and Ear Research Office.

All research projects are monitored annually with a Progress Report and a Final Report at the completion of the project.

Some research projects may require more frequent reporting or additional reporting.  Please refer to the letter of governance authorisation regarding any specific reporting requirements.

How do I submit these reports?

• Once you have received the Reviewing HREC approval of the annual report, submit the Annual Progress form via email to the Research Office.

What documents do I need to submit?

Annual Progress Reports need to be submitted at least annually by the date of approval:

• Reviewing HREC Annual Progress Report
• Reviewing HREC Annual Progress Report Acknowledgement Letter/Correspondence

How is my submission reviewed?

• The report will be reviewed by the Eye and Ear Research Office.

Once you have received the Reviewing HREC approval of the annual safety report, submit the Annual Safety Report form via email to the Research Office.

What documents do I need to submit?

Annual Safety Reports need to be submitted at least annually by the date of approval:

• Reviewing HREC Annual Safety Report
• Reviewing HREC Annual Safety Report Acknowledgement Letter/Correspondence

How is my submission reviewed?

• The report will be reviewed by the Eye and Ear Research Office.

Once you have received the Reviewing HREC acknowledgement of the final report, submit the Final Report form via email to the Research Office.

What documents do I need to submit?

Final Reports need to be submitted at the completion of the project:

• Reviewing HREC Final Report
• Reviewing HREC Final Report Acknowledgement Letter/Correspondence

How is my submission reviewed?

• The report will be reviewed by the Eye and Ear Research Office.