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
Amendments that alter approved and authorised research require review and approval/authorisation prior to implementation.
Amendments include:
Changes to the approved protocol, Investigator’s Brochure (IB) or other project documentation, such as participant information and consent form (PICF), advertisements, questionnaires, patient documents.
Changes to the Principal Investigator.
Changes to the Research Team.
Changes to any agreements +/- indemnity as a result of the above.
How do I submit these reports?
Submit the request for amendment to the Reviewing HREC (according to their instructions) first. 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?
Once the amendment is approved by the Reviewing HREC, submit the following:
Site-Specific Version of Master participant-facing documents
If the amendment includes changes to the Master participant-facing document(s), you also need to submit an amendment request for the site-specific versions of those documents to the Eye and Ear Research Office.
Change of Research Team at the Eye and Ear
If the amendment is for a change to the research team at the Eye and Ear (excluding the site Principal Investigator which requires approval by the Reviewing HREC), please 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 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 Report to the Research Office via email.
What documents do I need to submit?
Annual 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 for site governance.
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?
