Post-approval and Monitoring Ethics

Eye and Ear HREC amendments

Please use the Eye and Ear HREC Amendment Request Form

Changes to Research Team Members

Please complete the Amendment Request Form for any changes to the research team.  If you are adding a new team member, you also need to submit the Addition of Research Team Member.

If members of research teams require an Eye and Ear Honorary Researcher Appointment, please refer to the Honorary Researcher Appointments section.

Submission instructions:

• Amendments can be submitted at any time as follows:
  – Eye and Ear HREC – all post approval project management must be submitted using Eye and Ear forms via email to ethics@eyeandear.org.au . The Eye and Ear Research Office is not accepting HREC amendments via ERM.
• Please refer to Fees for any applicable amendment fees.

All research projects are monitored annually with an Annual Report and Self Audit and a Final Report at the completion of the project.

Some research projects may require more frequent reporting or additional reporting.  Please refer to the letter of ethical approval regarding any specific reporting requirements.

HREC Annual Report and Self Audit Form

Annual Safety Reports for Clinical Trials
Submit an Annual Safety Report at least annually by the date of approval.

Final Report
Submit a Final Report at the completion of the study or if discontinued early.

Submission instructions:

Submit the relevant Report as directed as follows:

Eye and Ear HREC – all reports must be submitted using Eye and Ear forms via email to ethics@eyeandear.org.au

The Eye and Ear has adopted the following guidelines from 1 April 2019

1. NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods (NHMRC; November 2016)
2. NHMRC Guidance: Risk-based management and monitoring of Clinical Trials involving Therapeutic Goods (NHMRC; 2018)
3. NHMRC Guidance Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods (NHMRC; 2018)
4. NHMRC Guidance Data Safety Monitoring Boards (DSMBs) (NHMRC; 2018)

All guidelines are available from the NHMRC website.

The Eye and Ear Monitoring and Safety Reporting of Research Projects Procedures (including a summary table) have been reviewed and updated and apply from 23 October 2019.

Submission instructions:

All reports must be submitted in accordance with the requirements set out in the relevant guidance.

Principal Investigators are required to request an extension to the term of approval prior to expiry of the term of approval.

Prior to the end of the term of approval, submit an application for an extension to the term of approval including the following documents and relevant attachments (can be downloaded from our Researcher Resources ‘Forms, Templates and Guidelines’ page:

1. Cover Sheet for Research Project
2. Current version of the Protocol / research project plan / proposal
3. Current version of Participant Information and Consent Form
4. Annual Progress Report (see above)
5. Head of Supporting Department Declaration Form (if required)

Submission instructions:

1. Submit the request for extension by the respective submission dates.
2. Reapplications are considered by the full HREC at an HREC meeting.