About research governance authorisation
Research governance is about making sure that your research meets legal, financial, reporting and risk management requirements. It's also about making sure that you have the right resources and staff to support your project.
To get research governance authorisation you'll need to apply for a site-specific assessment (SSA) in the Ethical Review Manager (ERM).
You can contact our team to talk about your research project before you develop your SSA application. We can talk you through the submission requirements and answer any questions you may have.
How to apply
Get ethics approval for your project
You need to get ethics approval before you can apply for your SSA.
Fees
You may need to pay a fee when you apply. Make sure you include any fees as part of your research budget.
There is no fee for an SSA for Central Queensland Health employees.
For studies with a commercial sponsor, an SSA fee of $6000 applies.
Step 1: Prepare a budget
Prepare a budget that shows how you’ll manage your project’s funding and costs. You’ll need to include any income or funding, actual costs, and in-kind costs that don’t involve money.
You'll also need to consider the cost of staff time for their help during work hours. You can look up wage rates on the Queensland Health website.
You can use our research budget template [XLSX 89 KB].
Step 2: Research agreements
You’ll need a research agreement if you’re doing research with a third party. For example, a university or sponsor.
Your research agreement depends on the type of research you’re doing. You can find clinical trial agreement templates on the Medicines Australia website. For projects that don't involve clinical trials, there's a collaborative research agreement template on the Australian Clinical Trials website.
Contact our team for advice on agreements for your type of research. They also need to review the agreement before you get signatures.
If you're not sure which template to use, or need a different template talk to our team.
Step 3: Get signatures and endorsement
You need support from any heads of departments that will lead or support your project. Ask the Head of Department to sign the SSA.
Step 4: Prepare any other supporting documents
You need to give us the following documents when you submit your SSA.
- Checklist or cover letter
- CVs for the principal investigator and local investigators
- A copy of the human research ethics committee approval letter
- A copy of all project documents used at our site – these must have ethics approval and be listed in your cover letter
- Any site-specific versions of project documents – please include a tracked version and clean version
- Proof of insurance
- Indemnity forms
- Professional certifications, including Good Clinical Practice (GCP) certificates for researchers and their teams working on clinical trials.
We may also need any approvals and notifications from health regulators, including:
- clinical research approvals for people with impaired decision-making from the Queensland Civil and Administrative Tribunal (QCAT)
- Clinical Trial notifications (CTN) or Clinical Trial approvals (CTA) from the Therapeutic Goods Administration, as part of their Good Clinical Practice Inspection Program
- Queensland Government Public Health Act approvals.
Step 5: Submit your SSA
Use the online Ethical Review Manager (ERM) to submit your SSA and supporting documents. Read the ERM help guides for more help.
We’ll review it and send you an email to let you know the outcome.
Reporting
Once you have ethics approval and governance authorisation, you can start your project. While your study is running, you’ll need to meet ongoing reporting requirements.
You'll need to make a progress report at least once a year to both the Human Research Ethics Committee (HREC) and our Research Governance Office (RGO).
When the study is finished, submit a final report to both the HREC and RGO.
Use the RGO annual progress report or final report template [DOCX 1012.45 KB].
You'll submit your reports through the ERM.
Contact us
Contact us if you have any questions about the research governance process by either:
- phone: 07 4920 6989
- email: cqhhs-rgo@health.qld.gov.au.