Post Approval / Amendments and Reporting

Amendments that alter approved and authorised research require review and approval/authorisation prior to implementation.

Amendments include:

• Changes to the approved protocol, Investigator’s Brochure (IB) or other project documentation, such as participant information and consent form (PICF), advertisements, questionnaires, patient documents.
• Changes to the Principal Investigator or other research personnel.
• Changes to the Research Team Members.
• Changes to research sites.
• Changes to any agreements +/- indemnity as a result of the above.

Projects approved by the Eye and Ear Human Research Ethics Committee (HREC) require an Amendment Request Form to be submitted which is reviewed by the Eye and Ear HREC Chair in the first instance.

How do I submit an HREC Approval Amendment?

• Submit the Eye and Ear HREC Amendment Request Form to the Research Office at any time via email ethics@eyeandear.org.au
• Attach other supporting documentation to the email. Please ensure you use ‘tracked changes’ for existing documents. Submit both the tracked changed document and the clean document.

What documents need to be submitted for an amendment to the Eye and Ear HREC?

Below is a list of the documents required for HREC amendment submission. 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
• All documents must have a version number and date including on each page in the footer

Core Documents	Project Dependent Additional Documents
Eye and Ear Amendment Request Form	Protocol
	Investigator’s Brochure
	Participant Information and Consent Forms
	Any other amended documents used in the project
	Research Team Member Declaration
	Research Team Member Good Clinical Practice certification (clinical trials only)
	Honorary Researcher Application Form

The Forms Library can be found here.

How is my ethics amendment reviewed?

The amendment will be reviewed by the HREC Chair in the first instance. Please allow up to 10 business days for a response.

How do I apply for Site Governance Authorisation of an Amendment?

In most cases, the HREC amendment documents will be considered simultaneously for site governance authorisation if the Eye and Ear is a research site. You will be notified if any additional documents are required.

• All research projects are monitored annually with an Annual Report and Self Audit and a Final Report at the completion of the project. Researchers must submit an annual progress report for every HREC approved project regardless of whether the research has started or level of progression.Some research projects may require more frequent reporting or additional reporting.  Please refer to the letter of ethical approval regarding any specific reporting requirements.How do I submit an Annual Progress Report?
  • Submit the Eye and Ear HREC Annual Progress Report and Self Audit Form to the Research Office by the HREC deadline via email ethics@eyeandear.org.au

  How is my report reviewed?

  The annual progress report will be reviewed by the HREC at their meeting which is held alternate months.

  How do I apply for Site Governance Authorisation of an Annual Report?

  In most cases, the HREC annual report documents will be considered at the same time for site governance authorisation if the Eye and Ear is a research site. You will be notified if any additional documents are required.

All research projects are monitored annually with an Annual Report and Self Audit and a Final Report at the completion of the project. Researchers must submit an annual progress report for every HREC approved project regardless of whether the research has started or level of progression.

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

If your project is a clinical trial, an annual safety report is required each year.

How do I submit an Annual Safety Report for a clinical trial?

• Submit an Annual Safety Report at least annually by the date of approval via email ethics@eyeandear.org.au

How is my report reviewed?

The annual safety report will be reviewed by the HREC Chair in the first instance. Please allow up to 10 business days for a response.

All research projects are monitored annually with an Annual Report and Self Audit and a Final Report at the completion of the project. Researchers must submit an annual progress report for every HREC approved project regardless of whether the research has started or level of progression.

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

How do I submit a Final Report?

• Submit a Final Report at the completion of the study or if discontinued early at any time via email ethics@eyeandear.org.au

How is my report reviewed?

The final report will be reviewed by the HREC at their meeting which is held alternate months.

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.

In general, the HREC provides ethical approval for five years. If the project is to continue beyond this period and prior to the ethics approval date expiry, Principal Investigators are required to request an extension to the term of ethical approval. Please check the HREC meeting and submission dates and ensure you submit your extension request to be considered by the HREC before ethical approval expires.

How do I submit these reports?

• Submit the Eye and Ear HREC Cover Sheet to the Research Office by the HREC deadline via email ethics@eyeandear.org.au

What documents do I need to submit?

Below is a list of the documents required for HREC approval extension. 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
• All documents must have a version number and date

Core Documents	Project Dependent Additional Documents
Eye and Ear Amendment Request Form	Participant Information and Consent Forms
Protocol	Any other approved documents used in the project
Annual Progress Report	Head of Supporting Department Declaration Form

The Forms Library can be found here.

How is my submission reviewed?

The reapplication will be reviewed by the HREC at their meeting which is held alternate months.

How do I apply for Site Governance Authorisation of an extension to the term of the project?

In most cases, the HREC extension to the term documents will be considered at the same time for site governance authorisation if the Eye and Ear is a research site. You will be notified if any additional documents are required.