Information to assist you with submitting changes to your project and required reporting.
Research teams are required to advise the Eye and Ear HREC/Research Office of any amendments or extensions, progress or final reports, or any safety reports for the approved project. This refers to projects approved by the Eye and Ear HREC or an alternate external HREC where the Eye and Ear is a research site. Reports submitted to an external Reviewing HREC must also be submitted to any/all approving authorities for site governance.
External Reviewing HREC
Projects that are approved by an external Reviewing HREC where the Eye and Ear is a research site or providing a service each require a Site Governance Amendment Request Form to be reviewed and authorised by the Eye and Ear Research Office.
Refer to details below for any amendments or extensions or reporting requirements.
Amendments
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:
The amendment will be reviewed by the Eye and Ear Research Office. Please allow up to 10 business days for a response.
Annual Progress, Safety and Final Reports
All research projects are monitored annually with an Annual 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 and acknowledgement letter 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:
The report will be reviewed by the Eye and Ear Research Office.
Once you have received the Reviewing HREC approval and acknowledgement letter 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:
In general, governance authorisation is granted for the period of HREC ethical approval. If the project is to continue beyond this period and prior to the ethics approval date expiry, Principal Investigators are required to request an extension to the term of governance authorisation. Please submit your extension request to be considered by the Research Office before ethical approval expires.
How do I submit a request for extension of governance authorisation?
Submit the Eye and Ear HREC Cover Sheet to the Research Office via email
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