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.
To submit an application for research governance review, a Site-Specific Assessment (SSA) application form must be completed in Ethical Review Manager (ERM).
To start a new SSA application, create a sub-form of the Human Research Ethics Application (HREA) in ERM.
Submit application
The SSA application is created as a sub-form of the HREA in ERM. The SSA application and all supporting documents are to be uploaded and submitted in ERM.
Applications for site authorisation can be considered as applications for ethical review are submitted to the HREC, known as parallel review. Site authorisation is contingent upon receipt of HREC approval. Research must not commence until the research delegate has approved the application and a site authorisation letter has been received.
Metro North Single SSA
Only one SSA is required for Metro North, regardless of how many Metro North sites are involved. Please note, some projects, such a commercially sponsored clinical trial, may require a separate SSA.
For example, if the research project is being conducted at RBWH and Redcliffe Hospital, one SSA is required. Tick all participating Metro North sites in the tick box located in the SSA form.
Mandatory Requirements
Cover letter
A cover letter is a mandatory requirement for all submissions for Metro North research governance review. The cover letter template provided below sets out the minimum requirements for inclusion in a submission.
HREC Documentation
Research approved by an external HREC
For research approved by an external HREC the following is required:
- Human Research Ethics Application (HREA)
- Human Research Ethics Committee (HREC) approval letter (including amendment approvals)
- All current HREC approved documents (e.g. protocol, data management plan, PICF)
You only need to submit the current documents listed in the HREC letter for RGO approval. For example, documents that have been superseded prior to your SSA submission do not need to be submitted as part of the SSA application.
Research approved by a Metro North HREC
The HREA and HREC approval does not need to be submitted with the SSA for research approved by Metro North Health HREC. However, the Metro North HREC approved documents that require research governance review must be listed in your cover letter. This is particularly important if several HREC amendments have been approved prior to SSA submission.
The version number and date of documents submitted for research governance review must be the same as the version number and date on HREC approved documents.
Budget
A budget is a mandatory component of research governance, and is necessary to demonstrate feasibility, value for money and cost implications (actual and in-kind) to the site where the research is to be conducted.
A research project budget, including all research income and costs, whether actual or in-kind, is required for research governance applications (excluding clinical trials). The budget must be signed-off by the relevant departmental Business Manager or hospital Director of Finance. It is important to discuss the research project budget with the relevant departmental Business Manager or hospital Director of Finance prior to request budget approval.
In-kind contributions should be quantified in order for the health service to calculate the actual cost of research. In-kind costs can include items like labour (salary) costs for investigators. For example, if you anticipate spending 20 hours on a research project during work hours as a Principal Investigator and MNH employee, you need to quantify the in-kind contribution (e.g. 20 hours x $35.50 hourly/rate = $710) for the SSA study budget. Facility and research Business Managers can assist with determining salary costs or with other queries relating to study budgets.
Where applicable, include funding information, including but not limited to a grant approval letter and grant agreement.
Clinical Trial budgets are usually represented in the Clinical Trial Research Agreement and a copy of the budget is signed by the relevant department Business Manager or hospital Director of Finance.
Signatures and approvals
Metro North SSA applications that include more than one Metro North site are only required to submit a single SSA. For each participating Metro North site, the Principal Investigator, head of department and business manager is required to provide their approval.
The final submission must include signatures of the:
- Principal Investigator (PI) at the site(s)
- Business Manager (BM) or finance delegate at each site. If less than $10,000 in-kind the site Head of Department can approve; however the governance office may still request confirmation from the BM.
- Head of Department (HoD) at each site
- Supporting Head of Department approval (for projects that go across departments and/or disciplines)
Tips
- Head of Department is the Manager or Director of the Department
- Business Manager (BM) is the BM for the Service Line or the Research BM at some facilities.
- Name, date and position of the signatory are required
- ERM signatures, wet ink signatures, electronic/wet-ink signed memo or email approval(s) are permitted.
Supporting departments/quotes for services
If the research goes across departments, uses the services of other departments or entities such as Queensland Pathology or uses coronial material the following is required
- The Director, Pathology Queensland needs to give approval if results or data are required from Pathology Queensland (even if the pathology results are located within the patient’s medical records). Information contained in pathology reports is owned by Pathology Queensland and not the HHS.
- Director, Radiology/Medical Imaging needs to give approval if patient radiology data are required for use in research.
- Forensic and Scientific Services (FSS) approval is required where studies require access to coronial material held by Queensland Health FSS
- Other quotes for services if applicable (e.g. pharmacy, radiology, nuclear medicine)
Additional Documents
Conflict of Interest
Where an employee participates in research activities conducted within Metro North Health, a conflict of interest must be declared at the time of submission of HREC and site-specific assessment (SSA) applications for research projects. Queensland Health staff can refer to the Metro North Policy Conflict of Interest.