The closing dates for the GCHHS HREC applications and HREC meeting dates can be found here. Closing dates for all Queensland Health HRECs can be found here. 

The Human Research Ethics Committee (HREC) works on a 60-day clock to approve research. This timeframe is taken from the closing date until you are advised whether your application has been approved. On average, we approve:

• standard risk applications within 27 days
• low- and negligible-risk applications within 14 days.

This does not include site specific assessment (SSA) authorisation.

Ethics approval is granted for an initial three-year period, with continuation dependant on the submission of an annual report.

• Choose an achievable start and finish date, allowing processing time for the Human Research Ethics Committee (HREC) and Research Governance Officer. We recommend a minimum of one-year for a project.
• Research data must comply with the ‘Australian Code for the Responsible Conduct of Research 2018’ and the supporting guide ‘Management of Data and Information in Research’ 
• Include version numbers and dates on supporting documents.
• Head of Department (HoD) approval, and/or letters of support, must be signed by the appropriate personnel. In instances where a HoD is part of the research team, HoD line manager approval is required. 
• Include key references to support the study.
• Have someone review your submission for errors you may have overlooked. Complete a spelling and grammar check to ensure your documents are professionally presented, and regardless of level of risk, you must have a protocol. The Human Research Ethics Application (HREA) is not your protocol or study plan.

Yes, please ensure that you upload all documents into ERM. Any documents requiring review post ethics approval or governance authorisation are also to be submitted.  These can include:

• Annual reports
• Final reports
• Safety reports
• Protocol deviations
• Any changes to Human Research Ethics Committee (HREC) approved documents, such as participant information and consent forms (PICF), protocol, surveys etc
• Changes to study personnel

Yes, you will be required to submit a report for each research project. Annual reports are due on the 30th April each year. Based on information in the progress report, the Human Research Ethics Committee (HREC) or Research Governance Office may decide to undertake a monitoring visit.

Ethics review is required to ensure that the rights, safety and welfare of participants is respected, whereas governance is to ensure that the research adheres to the relevant institutional standards, including financial, legal, contractual and legislation requirements. 

Our Ethics and Governance Officers will guide you simultaneously through both processes, to facilitate a streamlined review of your application.

Any changes to your research project that occur after ethical approval has been obtained must also be ethically approved. This includes changes in study procedures, overall direction of project, project title, source/manner of recruitment, consent forms, advertising materials, research personnel and research sites.

Steps to submit an Ethics Amendment for your project:

1. Log into ERM Splash Page - ERM Applications (ethicalreviewmanager.com)
2. When you are in the “Work Area” page, select the HREA for the project that you wish to submit the amendment for.
3. On the left-hand side of the screen, click on the “Create Sub Form” tile from the Actions pane.
4. Select the jurisdiction that the application will be submitted to.
5. Select the form to be created (QLD Amendment Form) and click on the “Create” button to continue.
6. Follow the prompts to complete the Submission and upload any required supporting documentation. At a minimum, the submission should include a cover letter addressed to the HREC Chairperson and all new and updated documents for which ethical approval is being sought. Please contact the Research Ethics Officer if you are unsure what documents are required.
7. Click the “Submit” on the left-hand side of the screen once all signatures have been obtained.
8. To confirm the status of an application, please check the top right-hand side of the screen – the status should now be ‘submitted’. If not, please click the ‘Submit’ tile.

Please note: Amendments must also be authorised by the participating sites’ Research Governance Office. Once ethical approval for an amendment has been obtained, the amendment should also be submitted to the Research Governance Office via ERM as a ‘Post Authorisation Notification Form’.

Steps to submit a Post Authorisation Notification (PAN) for your project:

1. Log into ERM Splash Page - ERM Applications (ethicalreviewmanager.com) 
2. Select your project from the “Work Area” page.
3. Use the “Project” tab to select the intended SSA. “SSA Form Qld - Gold Coast HHS RGO” should appear darker grey in the Project Tree when selected. Any previously submitted PANs will appear below this item in the Project Tree.
4. On the left-hand side of the screen, click on the “Create Sub Form” tile from the Actions panel.
5. Select “Post Amendment Notification” as the form to be created and click on the “Create” button to continue.
6. Follow the prompts to complete the PAN form and upload any required supporting documentation. At a minimum, the submission should include the ethics approval letter for the amendment along with the ethically approved versions of any new and updated documents relevant for the site. Please contact the Research Governance Officer if you are unsure what documents are required.  
7. Click the “Submit” tile on the left-hand side of the screen. To confirm the status of an application, please check the top right-hand side of the screen – the status should now be ‘submitted’. If not, please click the “Submit” tile.

For other GCHHS HREC approved templates that may be required to support your project, please refer to the Standard Reporting Templates.
 

We welcome research feedback to continuously improve on our research-related processes. Please use the form in our contact support centre to initiate your contact with us. 

Any complaint will be investigated promptly and you will be informed of the outcome.

The Delegation for signing off Confidential Disclosure Agreements (CDAs) at Gold Coast Hospital and Health Service sits with the Manager for the Research Office. Please contact GCHResearch@health.qld.gov.au in relation to CDA submissions.