There are 2 pathways for ethical review for human research from the Eye and Ear Human Research Ethics Committee:
Ethical approval for Low Risk Research from the Eye and Ear Low Risk Research Subcommittee
Ethical approval for Greater than Low Risk Research from the Eye and Ear Human Research Ethics Committee
If the project involves more than one organisation, it is important to understand the Streamlining Ethical Review pathways prior to submitting an application (refer below).
Presubmission review
The HREC Chair is happy to meet with researchers prior to submitting the application. The following information should be prepared for review:
Protocol (which includes the following):
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
Please contact the Research Office to organise a meeting time.
Ethical approval for Low Risk Research – Eye and Ear Low Risk Research Subcommittee
This information relates to applications that:
are low risk research projects
are able to be reviewed by Eye and Ear Low Risk Research Subcommittee
To submit a new application for ethical review of a low risk research project to the Eye and Ear Low Risk Research Subcommittee, follow the procedures below.
What is Low Risk Research?
The definition of Low Risk Research is research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.
The following types of research require review by a Human Research Ethics Committee (HREC) and are excluded from review by the Low Risk Research Subcommittee:
(a) all research that involves more than low risk;
(b) research falling under the following chapters of the National Statement (except where research on collections of non-identifiable data under these chapters satisfies the conditions for exemption from review – see paragraphs 5.1.22 and 5.1.23 of the National Statement):
Chapter 3.2: Human Biospecimens in Laboratory Based Research
Chapter 3.3: Genomic research
Chapter 4.1: Women who are pregnant and the human foetus
Chapter 4.4: People highly dependent on medical care who may be unable to give consent
Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness
Chapter 4.7: Aboriginal and Torres Strait Islander Peoples and some categories of research falling under
Chapter 4.6: People who may be involved in illegal activities (see first bolded paragraph for details).
Before applying to the Eye and Ear Hospital for ethical approval, there are essential Eye and Ear HREC and Eye and Ear Hospital site specific elements to understand to assist with your application and conducting your research project. It is recommended that the Principal Investigator, study coordinator and other members of the research team are familiar with these elements prior to completing an application.
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.
The Eye and Ear Low Risk Research Subcommittee accepts the LNR VIC Application Form for low risk research:
Applicants (researchers, research coordinators etc.) can access the LNR VIC Application Form on the online platform Ethical Review Manager (ERM) at https://au.forms.ethicalreviewmanager.com
For further information about ERM, including how to access assistance and training, review the ERM webpage
Instructions Choose the LNR VIC application form from the Main Form drop down box.
Choose The Royal Victorian Eye and Ear Hospital from the HREC or ethics review body to which this application will be submitted drop down box.
Complete the Application Form and then submit.
Victorian Specific Module 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.
Members of the Research Team and Application Form Signatures
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.All members of the research team must be listed as part of the ‘Project Team’ in the HREA and all members of the research team must sign the HREA. 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 HREA or upload evidence of signature as a separate document). Please read the instructions carefully in the HREA 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 HREA 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 two-page quick guide provides step by step instructions for signatories and those submitting an application form.
Eye and Ear HREC Participant Information and Consent Form requirements
Eye and Ear site specific requirements for PICFs
Participant Information and Consent Form templates
Applications can be submitted to the Low Risk Research Subcommittee at any time.
Submit your application online via ERM.
Applications will be reviewed out of session and applicants will receive a response within 14 days from the date of submission.
NOTE: If the project requires the use or disclosure of information from a public health organisation and requires a Waiver of Consent, then the application will need to be considered by the full HREC, as per the Health Records Act 2001. Please refer to deadlines for HREC submission.
Ethical approval for Greater than Low Risk Research – Eye and Ear Human Research Ethics Committee
This information relates to applications that
are greater than low risk research projects
are able to be reviewed by Eye and Ear Human Research Ethics Committee
To submit a new ethics application to the Eye and Ear Hospital HREC, follow the procedures below:
Before applying to the Eye and Ear Hospital for ethical approval, there are essential Eye and Ear HREC and Eye and Ear Hospital site specific elements to understand to assist with your application and conducting your research project. It is recommended that the Principal Investigator, study coordinator and other members of the research team are familiar with these elements prior to completing an application.
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.
The Eye and Ear accepts the following application form for submission to the Human Research Ethics Committee:
Human Research Ethics Application (HREA) is suitable for research to be conducted at either the Eye and Ear alone or at more than one institution.
For further information about ERM, including how to access assistance and training, review the ERM webpage
Please note
The Eye and Ear Common Application Form (CAF) is no longer accepted
All HREA applications must be submitted via ERM and not via the NHMRC HREA page
From 9 July 2019, Online Forms is no longer available. Ethics Review Manager (ERM) went live on 16 July 2018.
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
Applications must be submitted by the closing date (according to the HREC meeting schedule)
Eye and Ear specific details for HREA
Updated 29 August 2018
Committee selection 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.
Members of the Research team All members of the research team must be listed as part of the ‘Project Team’ in the HREA and all members of the research team must sign the HREA.
All staff who have patient contact and / or are consenting patients / participants must be listed as part of the ‘Project Team’ on the HREA as either Investigator/Researcher or Other and then specify the role.
Members of the Research Team and Application Form Signatures
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.All members of the research team must be listed as part of the ‘Project Team’ in the HREA and all members of the research team must sign the HREA. 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 HREA or upload evidence of signature as a separate document). Please read the instructions carefully in the HREA 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 HREA 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 two-page quick guide provides step by step instructions for signatories and those submitting an application form.
Please refer the the Researcher Resources for Participant Information and Consent Form templates and Eye and Ear site specific requirements for PICFs.
Additional site information For investigator initiated studies there are several templates you could use as a starting point:
The Spirit Group have developed a Standard Protocol Items: Recommendations for Interventional Trials which can be accessed from the SPIRIT website
Transcelerate offer a Common Protocol Template which can be accessed from the Transcelerate website
Submit the following documents depending on the medicines, devices, biologicals used in your study
Investigators Brochure (IB)
Medicines technical information sheet
Device user brochure
If the project is a clinical trial, a CTN or CTX Form 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. A template is available from the Department of Health and Human Services 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.
Research teams conducting research projects at the Eye and Ear will need to obtain Research Governance Authorisation prior to commencing the study.
Responses to HREC conditions of approval must be submitted via ERM.
Streamlining Review Pathways
The Eye and Ear is committed to minimising duplicate scientific and ethical review of research projects and participating in streamlining initiatives.
The Eye and Ear HREC can review single-site research projects if the Eye and Ear is the investigation site.
The Ear and Ear HREC can also review multi-site research projects if the sites include our research partners that do not have their own HREC and / or private sites (ie private clinics).
If another Victorian public hospital is a research site then the project must be reviewed by a Victorian Accredited Reviewing HREC under the Streamlining Scientific and Ethical Review Framework in Victoria pathway.
If an interstate site is a research site and the study has been or will be approved by a Certified Reviewing HREC then the Eye and Ear will accept the approval of that Certified Reviewing HREC under the National Mutual Acceptance scheme according to the information below.
It is recommended that Eye and Ear staff send an email to the Eye and Ear Research Office listing the known and any potential sites for the project to facilitate identifying the options for HREC and Research Governance Authorisation for the specific project.
The Eye and Ear will accept the ethical approval of a Certified Reviewing HREC. The Eye and Ear will conduct a site specific review and may then issue Research Governance Authorisation for the site.
If the Eye and Ear is involved in the research project in any way then the Eye and Ear will also need to grant Research Governance Authorisation using one of the Research Governance Authorisation pathways.
Eye and Ear Research Governance Authorisation is not required if the Eye and Ear is not involved in the project (ie, Research Partner research project being conducted only at research partner site).
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