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.
How to apply to the Eye and Ear HREC for lower risk research ethical review
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.
Download the Eye and Ear Cover Sheet for Research Project, along with any attachments required (as detailed within the cover sheet) from our Researcher Resources page ‘Forms, Templates and Guidelines’.
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
For further information about ERM, including how to access assistance and training, review the Ethical Review Manager platform.
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 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.
The Eye and Ear Hospital does not require the Victorian Specific Module (VSM) to be submitted with a Low 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.
Submit 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
Ensure that the protocol template is appropriate for the research to be conducted. For non-commercially sponsored studies there are several templates you could use as a starting point:
The Spirit Group has developed a Standard Protocol Items: Recommendations for Interventional Trials which can be accessed from the SPIRIT website
Please refer to the Participant Information and Consent Form section here for templates and Eye and Ear site specific requirements for PICFs.
Lower Risk Research applications can be submitted to the Research Office at any time.
Eligible applications will be reviewed out of session and applicants will receive an initial response within 14 working days from the date of submission.
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 are Ear HREC Meeting schedule and submission deadlines.
