As per the National Statement, Chapter 2.1, low risk research describes research, in which the only foreseeable risk is no greater than discomfort. Accordingly, research in which the risk for participants or others is greater than discomfort is not low risk research. Research in this category is considered higher risk research and carries risk of harm. Higher risk research requires review by an HREC.
Lower Risk
Minimal
Low
No risk of harm or discomfort; potential for minor burden or inconvenience*
No risk of harm; risk of discomfort (+/- foreseeable burden)
* Neither burden nor inconvenience should be considered a type of harm or discomfort and therefore should not be viewed as a risk.
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.
Lower 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.
How to apply to the Eye and Ear HREC for lower 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
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 Cover Sheet 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 Cover Sheet, along with any attachments required (Att A – Clinical Trials, Att B – Biospecimens and Genomic Research, Att C – Privacy Requirements) from our Researcher Resources ‘Forms, Templates and Guidelines‘ page.
If a Waiver of Consent is required, please ensure you complete Cover Sheet Att C, Privacy Requirements form. Your application will need to be submitted and reviewed by the full HREC. Refer to ‘Submission Dates‘.
The Eye and Ear accepts the Low Risk VIC Application Form for lower risk research. You can access the Low Risk VIC Application Form on the online platform Ethical Review Manager (ERM) at https://au.forms.ethicalreviewmanager.com
Instructions Choose the Low Risk 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, upload any supporting documents (including at a minimum Eye and Ear cover sheet and protocol) and then submit.
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. 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 Eye and Ear Hospital does not require the Victorian Specific Module (VSM) to be submitted with a Lower Risk 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.
If required, complete the Victorian Specific Module on the Ethical Review Manager platform.
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 Supporting Department Declaration Form to submit with the application form.
*NOTE: If the project requires a Waiver of Consent (i.e., research participants characteristically will not know that they, or their tissue or data, are involved in the research) then the application will need to be considered by the full HREC (National Statement Chapter 2.3) and as per relevant privacy legislation. Please refer to deadlines for the Eye and Ear HREC Meeting schedule and submission deadlines.
How is my application reviewed?
Eligible applications will be reviewed out of session by the Lower Risk Research Sub-Committee and applicants will receive an initial response within 10 working days from the date of submission. Some applications may be referred to the full HREC for review. If this is the case, you will notified of the outcome after the HREC meeting. Once approved, you will be provided with an HREC approval letter.
A separate research governance authorisation letter will be provided where the Eye and Ear is a research site.
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