External Reviewing HREC (Eye and Ear is a research site)
Research Governance Authorisation is a complex mix depending on which research partner organisations are involved and the role of each organisation and how ethical approval is obtained.
If the Eye and Ear is involved in the research project in any way, then the Eye and Ear will need to grant Research Governance Authorisation.
Site Specific Assessment (SSA)
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)
How to apply to the Eye and Ear for research governance review?
Applications are submitted via Ethical Review Manager (ERM). If you do not have an account, register here. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
Some governance fees may apply.
What documents need to be submitted?
Below is a list of the documents required for submission. Minimum standards apply to all applications:
Applications must be complete; incomplete applications will be returned to the researcher
Handwritten applications will not be accepted
Principal Investigators must sign all correspondence
Download the Cover Sheet and any attachments required (as detailed within the cover sheet).
The Cover Sheet collects information specific to the Eye and Ear which is not included in the 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 Reviewing Human Research Ethics Committee approval letter.
The letter must list The Royal Victorian Eye and Ear Hospital as a research site.
Complete the Site Specific Assessment (SSA) Form on Ethics Review Manager (ERM) platform.
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’.
A detailed protocol including but not limited to:
Statistical analysis plan and safety and data management plan as appropriate
Copies of all data collection instruments.
Any Investigator Brochure or equivalent approved in the Reviewing HREC letter of ethical approval (or amendment approval) must be uploaded into ERM in section ‘Supporting Documents’.
The Eye and Ear Hospital only requires the Victorian Specific Module (VSM) to be submitted if the Reviewing HREC is not in Victoria. Complete the Victorian Specific Module on the Ethical Review Manager platform.
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 based on the approved Master PICF(s) and amended as per Eye and Ear site specific requirements.
Please refer to the Participant Information and Consent Form section here for Eye and Ear site specific requirements.
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
Any clinical trial involving the use of unapproved therapeutic goods must provide acknowledgement of either TGA Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) listing the Eye and Ear as a clinical trial site.
Detailed information regarding Clinical Trials and TGA requirements are available via the TGA website.
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 Supporting Department Declaration Form to submit with the application form.
Principal Investigator – A copy of a Curriculum Vitae (CV), professional registration and GCP certificate for the Principal Investigator should be uploaded to ERM as part of the submission.
Members of the Research team – CVs for research team members are to be submitted, if they have not been submitted to the Research Office within the last two years. For clinical trials also submit current GCP certificates for all research team members. All members of the research team must be listed as part of the ‘Project Team’ and all members of the research team must sign the application. Please ensure that the Investigator Team Declaration is completed by all team members. These signatures can be provided in a number of ways (electronically within the application form or upload evidence of signature as a separate document). Please read the instructions carefully in the application form relating to electronic signatures and locking of the form. Also refer below for more guidance on signatures. All staff who have patient contact and / or are consenting patients / participants must be listed as part of the ‘Project Team’ on the application form as either Investigator/Researcher or Other and then specify the role.
The following types of signatures are accepted by the Eye and Ear:
Ink signature on hard copy document
Scanned version of ink signature on hard copy document – research team must retain original hard copy ink signature
Electronic signatures – DocuSign
ERM Signatures and Submission Guidance is also available on the website. This guide provides step by step instructions for signatories and those submitting an application form.
Fees apply for certain categories of applications.
Tax invoices for Human Research Ethics Committee or Research Governance Authorisation review fees will be sent by the hospital directly to sponsors/public health bodies following submission of applications.
The following schedule of fees applies from 1 July 2016. These include 10% GST.
Non-commercially sponsored, Unaffiliated studies (e.g. No affiliation with this hospital)
$825
$825
Amendment Fees
Commercially sponsored studies
$825
$825
Investigator Brochure Revision and Administrative Change Fees
Commercially sponsored studies
$200
$200
Submission Dates
Site Specific Assessment applications can be submitted at any time via the Ethical Review Manager platform.
How is my application reviewed?
Applications will be reviewed by the Research Office and applicants will receive an initial response within 10 business days from the date of submission. A research governance authorisation letter will be provided where the Eye and Ear is a research site.
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