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 if you need help with any of the steps below.
How to apply
Get ethics approval for your project
You can apply for ethics approval and governance authorisation at the same time. But you’ll only get final governance authorisation if you have ethics approval.
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 can use our templates to help you prepare your budget:
- single year study budget template [XLTX 100.64 KB]
- multi-year study budget template [XLTX 143.61 KB].
If your project has costs greater than $10,000, our finance team will need to endorse your budget before you submit your SSA. Email your budget to our team at WM_Research_Finance@health.qld.gov.au.
Step 2: Prepare any research contracts
You may need to prepare contracts and agreements if you’re doing research with a third party. For example, a university or sponsor.
You can use one of the following templates that relates to your research.
- Research passport agreement – Health Translation Queensland
- Collaborative research agreement template for projects not involving clinical trials – Australian Clinical Trials
- Clinical trial research agreement – Medicines Australia
- Clinical investigation research agreement – Medical Technology Association of Australia
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. This includes supporting departments, like Pharmacy and Pathology. Ask the Head of Department to sign the SSA, or our letter of support template [DOCX 311.44 KB].
Step 4: Prepare any other supporting documents
You need to give us the following documents when you submit your SSA:
- CV for the principal investigator
- a cover letter outlining our role in the study
- a copy of all study documents used at our site – include a list of these in your cover letter
- any site-specific versions of study documents – please include a tracked version and clean version
- proof of insurance
- indemnity forms
- professional certifications, including Good Clinical Practice (GCP) certificates for study coordinators, investigators and nurses who work on your project.
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
If another HREC is approving your research, you also need to upload:
- the original letter approving the study
- the approval letter that adds our site to the study
- any letters approving amendments to the study.
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.
Fees
You may need to pay an administration fee [PDF 341.86 KB] when you apply. Make sure you include any fees as part of your research budget.
Contact us
Contact us if you have any questions about the ethics review process by either:
- phone: 07 3413 7475
- email: WM_EthicsandGov@health.qld.gov.au
By post:
West Moreton Health HREC and Research Governance Office
Ipswich Hospital
PO Box 73
Ipswich Qld 4305