Higher risk research

How to apply to the Eye and Ear HREC for higher risk research ethical review

• Application Cover Sheet

  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 and any attachments required (as detailed within the cover sheet):

  Eye and Ear Cover Sheet for New Research Project

  Guidelines for completing the Eye and Ear Cover Sheet and Attachments

  Attachment A – Clinical Trials

  Attachment B – Biospecimens and Genetic/Genomic Research

  Attachment C – Privacy Requirements

• Application Form

  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.

• Research Team Members and 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:

  1. Ink signature on hard copy document
  2. Scanned version of ink signature on hard copy document – research team must retain original hard copy ink signature
  3. 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.

• Victorian Specific Module

  Complete the Victorian Specific Module on the Ethical Review Manager platform.

  A guidance document is available, Victorian Specific Module Guidelines.

• Protocol

  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
• Patient Information and Consent Forms

  Please refer to the Participant Information and Consent Form (PICF) section below for templates and Eye and Ear site specific requirements for PICFs.

• Medicine, device and biologicals information

  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.

• Medical Physicist Letter

  If the research project involves the use of ionising radiation the application must include a letter.

  1. 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.
  2. 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.
• Submission dates

  Refer to the Eye are Ear HREC Meeting schedule and submission deadlines for submission dates and meeting dates.

  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)