Research governance refers to the processes institutions use to ensure they are accountable for the research conducted under their care.
Research Governance is one of the two essential components to responsibly conduct research (Ethics being the other). A Human Research Ethics Committee (HREC) provides ethics approval, while an institution authorises, via a governance process, for a study to be conducted at a particular site.
Public health facilities use the Site Specific Assessment Application (SSA) within Queensland Health to document all research governance arrangements for a study at a site. This involves assessing the legal, financial, regulatory, and contractual matters related to research.
Only one SSA is required to cover all Gold Coast Hospital and Health Service (GCHHS) sites.
SSA application elements
All projects submitted for governance review must provide a budget.
Key items to consider when preparing a budget for GCHHS are:
- time of staff in completing surveys/focus groups/training/consenting of participants
- researchers time involved within work hours.
You are required to submit quotes from the following areas if they support the project:
If you submit a budget that is not adequate or incomplete, you will have to resubmit. As such, the Office for Research Governance and Development recommends consulting with Research Finance Team to ensure appropriate budget template completion. To contact us about finance services, refer to the additional contacts page.
Please note: If your research project is funded from a grant, please upload evidence of success to online forms.
In accordance with the Australian Code for the Responsible Conduct of Research (PDF, 829kB), all research involving Gold Coast HHS staff, premises, resources or patients and at least one other institution requires a written agreement. This is required even when the project is not funded.
You must include the correct legal entity exactly as outlined below on both the cover page of the contract/agreement, signature page and any other legal agreements such as indemnification forms.
Gold Coast HHS information for all Agreements
Legal entity name:Gold Coast Hospital and Health Service
ABN: 82 616 992 416
Address: 1 Hospital Boulevard, Southport QLD 4215
Contact for Notifications
Refer to the additional contacts page to contact the Research Governance Office for notifications.
Research Agreements – clinical trials
Medicine Australia’s Clinical Trial Research Agreements (CTRA) are mandatory for all industry sponsored and contract research organisation sponsored clinical trial studies conducted within GCHHS facilities.
For device trials please use the Medical Technology Association of Australia Clinical Investigation Research Agreement.
All commercially sponsored research must include the Medicines Australia Standard Form of Indemnity for Clinical Trials.
Research Agreements – all other research
A contract is required if any of the following apply:
- the research will involve a third party such as a pharmaceutical company or research organisation, or a non-Queensland Health institution
- the investigators are university employees or the research is to be conducted by a student undertaking a Research Higher Degree.
Only the GCHHS Chief Executive or delegated authority can authorise an agreement upon receiving recommendation from the Research Governance Office.
Invoicing and payment clauses
All funding agreements to which GCHHS is a party must include the standard invoicing and payment clauses in the schedule for payments.
Confidentiality Disclosure Agreement
Where a sponsor or collaborative group requires the GCHHS to enter into a Confidentiality Disclosure Agreement, these documents should first be forwarded to the Principal Investigator for review and confirmation of agreement terms.
Confidentiality Disclosure Agreements are made between the external organisation and either the Principal Investigator or the GCHHS.
All commercially sponsored research must provide evidence of appropriate insurance before Research Governance authorisation can be given. Other external collaborators may also be required to provide evidence of current insurance appropriate to research type.
Take the following steps using Ethics Review Manager (ERM) to complete the Site Specific Assessment application:
- Login to the ERM website.
- Select the tile Create Sub-form from the list of Actions on the left-hand side.
- On the Create Sub-form page, select Queensland Health as your jurisdiction and SSA Form QLD as the Main Form type, then select Create.
- Complete the SSA and attach relevant supporting documents, including your site finance budget.
For detailed guidance, visit the ERM Help page or contact the Research Governance Officer on (07) 5687 8311.
A SSA form can be generated after the ethics form (HREA) has been created.
Researchers must use Ethical Review Manager to sign and submit their completed SSA application, with all supporting documents attached.
The Principal Investigator must sign the form. You can do this electronically (recommended) or alternatively, print the form, obtain the "wet-ink" signature, and upload the page to the LNR Form.
The SSA application for a research project can be submitted at any time. Queensland Health encourages researchers to submit ethics and governance applications concurrently for the project to commence earlier.
- Submission processes differ if you conduct multicentre research and the GCHHS are not the reviewing HREC. If any documentation has been updated after HREC review, forward it to the Governance Office available on the additional contacts page. Research governance authorisation cannot occur until HREC approval is granted.