You intend to apply for / have ethical approval from a Reviewing HREC that is not the Eye and Ear HREC; and
Eye and Ear is involved as a research site
The Eye and Ear would be considered a research site if
Eye and Ear staff are the Principal Investigator or Associate Investigator in a research project (specifically related to their employment/role at Eye and Ear) and procedures are occurring on site
Eye and Ear operating theatre is involved
The research participants are Eye and Ear patients for the purposes of the research project
The research project involves the use of Eye and Ear health information (data)
Early notification:
To minimise delays, Principal Investigators are encouraged to communicate with the Eye and Ear Research Office as early as possible, such as, when the Eye and Ear Hospital has been selected as a site and advise the name and contact details of the Eye and Ear Hospital site Principal Investigator.
The Cover Sheet for new Research Projects collects information specific to the Eye and Ear which is not included in the Human Research Ethics Application Form or other documents.
Do not submit a separate cover letter. There is room in the Cover Sheet to include other relevant information for the project.
Submit the Human Research Ethics Committee approval letter.
The letter must include the following listed as a site ‘ The Royal Victorian Eye and Ear Hospital’.
The version of the Protocol approved in the Reviewing HREC letter of ethical approval (or amendment approval) must be uploaded into ERM in section ‘Supporting Documents’.
The version of the Investigator Brochure approved in the Reviewing HREC letter of ethical approval (or amendment approval) must be uploaded into ERM in section ‘Supporting Documents’.
Submissions using the Human Research Ethics Application Form (HREA) Complete the Victorian Specific Module on the Ethical Review Manager platform.
Low Risk Research submissions using the LNR VIC Application Form The Eye and Ear Hospital does not require the Victorian Specific Module (VSM) to be submitted with an LNR VIC application unless it is submitted under the National Mutual Acceptance scheme and the Reviewing HREC is not in Victoria and the HREA was used as the application form.
Applicants will need to submit the Master Participant Information and Consent Form(s) or equivalent that have been approved by the Reviewing HREC.
Applicants will also need to submit the Eye and Ear site specific Participant Information and Consent Form(s) which are the same as the Master PICF(S) amended as per Eye and Ear site specific requirements for PICFs.
Please refer the the Researcher Resources for Participant Information and Consent Form templates and Eye and Ear site specific requirements for PICFs.
Where the research project involves another organisation, a formal research agreement should be executed between the parties.
This includes:
commercially sponsored research
research with a collaborative group
collaborative research with another Australian or international organisation
Clinical Trials conducted under the TGA Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes have specific requirements for notification to the TGA.
Detailed information regarding Clinical Trials and TGA requirements are available in the Researcher Resources.
Research teams proposing to conduct a research project that utilises Eye and Ear departments must consult with the Head of the department and obtain a signed Head of Supporting Department Declaration Form to submit with the application form.
