Forms and Templates

To ensure you are using the latest version of the template forms, please download the document directly from the Research web site each time you prepare a new application.

Applications
Participant Information and Consent Form
Annual Reporting
Amendments and Modifications
Adverse Events
Final Report
External Researchers

Applications
For all research, full ethical review is required and you will be required to complete and submit a full application to the Ethics Committee for review and approval. Ethical approval can be granted for up to 5 years.

If you require hospital resources to conduct your research project, please ensure you submit a Head of Supporting Department Declaration form for each hospital department involved.

Download HREC Application Form
HREC Head of Supporting Department Declaration top

Participant Information and Consent Form
For other than retrospective studies, appropriate written informed consent must be obtained for all participants.

Download HREC Participant Information and Consent Form for Clinical Drug Trial Projects
Download HREC Participant Information and Consent Form for Non-Clinical Drug Trial Projects top

Annual Reporting
The Ethics Committee is required to monitor all approved research in accordance with the National Statement on Ethical Conduct in Human Research (2007). Part of the monitoring process includes the review of progress reports.

Researchers are required to submit a progress report to the HREC for each research project approved by the Ethics Committee. Reports are usually due on the anniversary of approval, but occasionally they are requested at a more frequent interval.

The Ethics Committee will notify researchers about the due date of the progress reports at least 4 weeks in advance.

Ethics approval is ongoing but will lapse if the progress report is not received by the anniversary of the approval date, or, is not deemed satisfactory by the Ethics Committee. If the Committee is not satisfied with the progress report, researchers will be informed about subsequent action.

Download HREC Annual Report top

Amendments/Modifications
From time to time amendments are required to research projects. These are usually initiated by the researchers or by external study sponsors. Notifications of protocol amendments must be made in writing and addressed to the HREC Secretary, Royal Victorian Eye & Ear Hospital, Locked Bag 8, East Melbourne, Vic, 8002.

Download Amendment Form top

Adverse Events
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that:

• results in death;
• is life-threatening;
• requires in-patient hospitalisation or prolongation of existing hospitalisation;
• results in a persistent or significant disability/incapacity;
• is a congenital anomaly/birth defect; or
• is a medically important event or reaction.

An event should be considered unexpected if the nature, severity or frequency of that event is not consistent with the information in the Investigator’s Brochure if the product or device being trialled is unapproved or if it is not documented in the current Australian Product Information if the product is approved for marketing.

Researchers must report adverse events where necessary, to the appropriate authorities including the HREC.

Notification of SAEs
Researchers are obliged to notify the HREC within 24 hours of all serious or unexpected adverse events relating to participants in approved research projects at RVEEH. Reports involving participants in project sites outside RVEEH must be submitted to the Ethics Office as soon as possible.

The following information is a summary of requirements for adverse event reporting in Australia (as per the NHMRC HREC Alert No. 1, 18 April 2007)

Types of Adverse Event/Reaction	Reporting Requirements
Expected adverse reactions	• Provide to HREC if investigator considers the event will impact the research and action is planned as a result (e.g. protocol amendment)
Serious Adverse Events (SAEs) at sites under HREC approval and for which an Australian institution is responsible	Provide to HREC: • If investigator considers the event will impact the research and action is planned as a result (e.g. protocol amendment) OR • If reporting to institution is required as per jurisdictional requirements OR • If required under conditions of HREC approval
Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in Australia	Provide to HREC: • With comment by investigator re planned action, or if no action planned • Also report to TGA in accordance with pharmacovigilance requirements
Annual summary of all SAEs (Australian and international events) for research for which an Australian institution is responsible	• All SAEs for the trial with comment by investigator re action in regard to trial, or if no action planned • More frequent reporting if requested by HREC, e.g. in early phase trial
All SUSARs (Australian and international)	• Listing at least quarterly with comments re planned action or if no action planned • Timing to allow EU reports to be utilised

Download Adverse Event Reporting Form top

Final Report
Reports are due on the completion of a project or if the research is discontinued before the expected date of completion.

Download Final Report Form top

External Researchers
Researchers who are not RVEEH staff members, and wish to be involved in research conducted at RVEEH, must complete a Privacy Declaration for External Researchers form. If non-RVEEH staff members require access to RVEEH medical records for research purposes, then an Approval to access medical records for research purposes form also needs to be completed and submitted.

Download HREC Privacy Declaration Form for External Researchers
Download Approval Form to Access Medical Records for Research Purposes top

Disclaimer | Contact | Site Map | Privacy | Patient Charter Page Last Updated: 10/21/2008