Existing Applications – The Royal Victorian Eye and Ear Hospital

This information relates to projects that
1. Have ethical approval from the Eye and Ear Human Research Ethics Committee
2. Have ethical approval from the Eye and Ear Low Risk Research Subcommittee
Research Governance

If this project involves the Eye and Ear, research governance elements will be reviewed concurrently with the ethical review.

Principal Investigators are required to advise the Eye and Ear HREC of any amendments to the project, including changes to members of the research team.

All amendments

Please use the Eye and Ear HREC Research Amendment Request Form (MS Word; v5.2 dated Jan 2021)

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 a Research Team Member (MS Word; v1.2 dated Mar 2021)

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

Submission instructions:
1. Amendments can be submitted at any time
2. Amendment fees
3. The Eye and Ear Research Office is not accepting HREC amendments via ERM. All Post Authorisation project management must be submitted using Eye and Ear forms via email to ethics@eyeandear.org.au
This information relates to projects that
1. Have ethical approval from the Eye and Ear Human Research Ethics Committee
2. Have ethical approval from the Eye and Ear Low Risk Research Subcommittee
Research Governance
If this project involves the Eye and Ear, research governance elements will be reviewed concurrently with the ethical review.

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.

Annual Progress Report and Self Audit
Submit an Annual Progress Report and Self Audit at least annually by the date of approval.

HREC Annual Report and Self Audit Form (MS Word; v25.1 Apr 2021)

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

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

HREC Final Report Form (MS Word; v9 February 2019)

Submission instructions:
1. Submit the relevant Report as directed above
2. The Eye and Ear Research Office is not accepting Reports via ERM. All Post Authorisation project management 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 (GDP) 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.

Risk Assessment
The Eye and Ear requires that all research projects are monitored according to a risk-based approach.

Risk assessment can be conducted using any model. Suggestions include:
- Table 1 of NHMRC Guidelines ‘Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods‘
- European Clinical Research Infrastructure Network
- Northern Sydney Local Health District Assessment for clinical trials
Monitoring and Safety Reporting
Refer to the sections below regarding monitoring and safety reporting requirements:

…
This information relates to projects that
1. Have ethical approval from the Eye and Ear Human Research Ethics Committee
2. Have ethical approval from the Eye and Ear Low Risk Research Subcommittee
Research Governance:
If this project involves the Eye and Ear, research governance elements will be reviewed concurrently with the ethical review.

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:

1. Cover Sheet for Reapplication (MS Word; version 4.1 dated November 2020)

Guidelines for completing the Eye and Ear Cover Sheet and Attachments (MS Word; version 1.0 dated 18 August 2020)

Attachment A – Clinical Trials (MS Word; version 1.2 dated October 2020)

Attachment B – Biospecimens and Genetic/Genomic Research (MS Word; version 1.2 dated October 2020)

Attachment C – Privacy Requirements (MS Word; version 1.2 dated November 2020)

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.
3. The Eye and Ear Research Office is not accepting HREC amendments via ERM. All Post Authorisation project management must be submitted using Eye and Ear forms via email to ethics@eyeandear.org.au

Approved Projects – Post Approval Management