(individual, group, community, societal or global)
Greater than low
High
Risk of harm (+/- foreseeable burden)
Risk of significant harm (+/- foreseeable burden)
All research projects involving humans undertaken in, or under the support and oversight of the Eye and Ear Hospital, require formal approval prior to commencement.
Higher risk projects are reviewed to ensure the project is ethically sound and approved by the Eye and Ear Human Research Ethics Committee (HREC).
In parallel, the Eye and Ear Research Office reviews governance assessment to determine whether a project is feasible and appropriate to conduct at the Eye and Ear Hospital and can be authorised to commence at the site.
Higher Risk Research Approval and Authorisation Requirements
Research Ethics + Research Governance = Higher Risk Project can now commence
How to apply to the Eye and Ear HREC for higher risk research ethical 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.
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
All documents must have a version number and date
Core Documents
Project Dependent Additional Documents
Eye and Ear Cover Sheet
Cover Sheet Attachment A – Clinical Trial
Human Research Ethics Application (HREA) Form (via ERM)
Cover Sheet Attachment B – Biospecimen and Genomic Research
Victorian Specific Module (VSM)
Participant Information and Consent Forms
Protocol
Head of Supporting Department Declarations
Data Collection Tools/Instruments
Recruitment/Advertising Materials
Research Agreements
Eye and Ear forms, templates and guidelines can be found here.
Remember:
The Principal Investigator must be a senior staff member of the Eye and Ear unless otherwise authorised by the Research Office.
Further details can be found below.
The Eye and Ear 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.
Download the Eye and Ear Cover Sheet for Research Project and any attachments required (as detailed within the cover sheet):
The Eye and Ear Human Research Ethics Committee accepts the Human Research Ethics Application (HREA) for higher risk research projects. You can access the HREA Application Form on the online Ethical Review Manager (ERM) platform.
For further information about ERM, including how to access assistance and training, review the Ethical Review Manager website.
Committee selection on HREA
When you complete the question ‘Select the committee that your ethics application will be submitted to.’
If you have selected ‘Multi-site’ earlier in the HREA application then the Eye and Ear HREC will not be available to select. Please change the earlier section to single site to allow the Eye and Ear HREC to be selected.
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.
Submit a detailed protocol including but not limited to:
Literature review
Research questions defined including hypotheses
Study design aligned with questions and likely to answer them
Potential to contribute to field or add to body of knowledge
Statistical analysis/power
All documentation provided to participants
All data collection instrument
Please ensure that the protocol has a version and date in the footer of the document.
Ensure that the protocol template is appropriate for the research to be conducted.
For non-commercially sponsored studies you can use this template.
The InFORMed Participant Information and Consent Form (PICF) is the nationally endorsed approach for developing participant information and consent materials in Australia. It provides a clearer, more consistent and participant centred structure for explaining research studies.
Please refer to the Participant Information and Consent Form section here for Eye and Ear site specific requirements.
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.
Submit the following documents, as applicable, depending on the medicines, devices, biologicals used in your study
Investigators Brochure (IB), or equivalent
Product Information sheet
Public Summary of any relevant ARTG entry
Device user brochure
If the project is a clinical trial, a CTN or CTA eForm must be submitted to the TGA by the Sponsor.
If the research project involves the use of ionising radiation the application must include a letter.
If the use of ionising radiation is not additional to standard care, the site Principal Investigator should write a letter to this effect. Further details and a template letter is available from the Clinical Trials and Research website.
If the use of ionising radiation is additional to standard care, an independent assessment report by a Medical Physicist is required for review by the ethics committee. One report is required for each site.
