Existing Applications

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

Eye and Ear HREC amendments

Please use the Eye and Ear HREC Research 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 a Research Team Member form.

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

 

Eye and Ear site specific research governance

If the amendment requires approval from the Reviewing HREC, submit the request for amendment to the Reviewing HREC (according to their instructions) first. Once the amendment is approved, submit a request for amendment to the Eye and Ear Research Office using the Site Governance Amendment Request Form on ERM.

The Site Governance Amendment Request form can be used to notify the RGO of either:

• an amendment that has been approved by the reviewing ethics committee
• a site specific governance-only amendment that does not require ethical approval (eg. change of research team or site specific PICF).

 

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Submission instructions:

• Amendments can be submitted at any time as follows:
  – Eye and Ear HREC – all post authorisation project management must be submitted using Eye and Ear forms via email to ethics@eyeandear.org.au 
  – Eye and Ear site specific research governance – all post authorisation project management must be submitted via ERM using SSA notification forms.
• Amendment fees

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.

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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.

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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

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

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Submission instructions:

Submit the relevant Report as directed as follows:

• Eye and Ear HREC – all progress reports must be submitted using Eye and Ear forms via email to ethics@eyeandear.org.au
• Eye and Ear site specific research governance – all progress reports must be submitted via ERM using SSA notification forms.

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.

This may include unforeseen events, or any matters not covered elsewhere which may impact on the conduct of the project.

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.

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

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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:

Cover Sheet for Research Project (v16.1; Jun 2022)

Guidelines for completing the Eye and Ear Cover Sheet and Attachments (v1.0; 24 Aug 2020)

Attachment A – Clinical Trials (v1.3; Apr 2021)

Attachment B – Biospecimens and Genetic/Genomic Research (v1.2; 14 Oct 2020)

Attachment C – Privacy Requirements (v1.2; Nov 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)

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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