About research governance authorisation
Research governance is about making sure your research meets legal, financial, reporting and risk management requirements. It's also about making sure you have the right resources and staff to support your project.
To get research governance authorisation you'll need to submit a site specific assessment (SSA) application in 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
Make sure you include any fees as part of your research budget, and your research agreement.
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 grant 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.
Include quotes from radiology, pharmacy and pathology if they support your project.
If your research project is funded by a grant, you’ll need proof of the grant.
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 research governance officer for advice on agreements for your type of research. They also need to review the agreement before you get signatures.
Step 3: Supporting signatures
Use our letter of support template [DOTX 155 KB] to get signatures from the people who will lead or support your project. This includes heads of departments, investigators, other researchers, supervisors and mentors.
Our research governance officer will help you get signatures from our executive. If you don't work for our health service, we’ll also help you get signatures from heads of departments.
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 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.
Our research governance checklist [PDF 188.34 KB] will help you keep track of the documents you need for your application. Our research governance checklist guideline [PDF 112.42 KB] goes into more detail. Some of the documents in the checklist might not be relevant to your project.
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 your application and send you an email to let you know the outcome.
Contact us
If you have any questions about research governance email mky-rgo@health.qld.gov.au.