Submit application
To submit an application for research governance review, the Site-Specific Assessment (SSA) application form must be completed in Ethical Review Manager (ERM) with all requisite mandatory documentation uploaded.
Within Metro North only one SSA is required regardless of how many Metro North sites are involved. 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.
Please note, some projects, such a commercially sponsored clinical trial, may require a separate SSA.
Applications for site authorisation can be considered as applications for ethical review are submitted to the HREC, known as parallel review, however HREC approval is required before site authorisation can be granted.
Research must not commence until a site authorisation letter signed by the research delegate is received.
WARNING: Metro North does not use the correspondence tab in ERM. Do not use this function to communicate with Metro North HREC or research governance.
Mandatory Requirements
Site-Specific Assessment (SSA) Application Form
Queensland Health uses the Site-Specific Assessment Application (SSA) to document the site-specific research governance arrangements for a study.
To start a new application for research governance review, create a Site-Specific Assessment (SSA) application form from a sub-form of the Human Research Ethics Application (HREA) in Ethical Review Manager (ERM).
Cover letter
The cover letter is a mandatory requirement as it provides the reviewing Research Governance Officer (RGO) with essential project information. The cover letter template provided below sets out the minimum requirements for inclusion in a submission.
HREC approval documentation
HREC approved documentation that requires research governance review must be uploaded with the SSA in ERM.
The version number and date of documentation submitted for research governance review must be the same as the version number and date on HREC approved documentation.
Only the current documents listed in the HREC approval letter need to be submitted for RGO approval (e.g. superseded documents and previously approved versions do not need to be submitted).
All documentation submitted for research governance review must be accurately listed in the cover letter. This is particularly important is several HREC amendments have been provided prior to SSA submission.
Depending on the reviewing HREC, the following documentation is required:
Research approved by an external HREC
- 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)
Research approved by a Metro North HREC
- All current HREC approved documents requiring governance review
For research approved by Metro North Health HREC, the HREA and HREC approval letter does not need to be submitted with the SSA.
Fee template
The completed and signed fee template must be provided with the relevant ethics/research governance submission via Ethical Review Manager (ERM). Failure to provide the form at time of submission will delay review and may result in the submission being withdrawn from review.
Budget
A research project budget including all research income and costs, whether actual or in-kind, 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.
Budget template
The research budget template provided includes provisions for all research income and costs, both actual or in-kind.
In-kind contributions, like labour (salary) costs for investigators, should be quantified in order for the health service to calculate the actual cost of research. For example, if you anticipate spending 20 hours on a research project during work hours as a Principal Investigator and Metro North 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 the research budget includes income and/or revenue, the applicable funding information such as a grant approval letter and grant agreement is to be uploaded with the SSA and listed in the research governance cover letter.
Budget approvals
When developing a research project budget, it is important to discuss the budget with the relevant departmental Business Manager(s) or hospital Director of Finance prior to requesting budget approval.
The budget must be signed-off by the relevant departmental Business Manager or hospital Director of Finance at each participating Metro North site.
For project budgets of less than $10,000 in-kind, the site Head of Department can approve. However, the research governance office may still request confirmation from the Business Manager.
See below for specific guidance on signatures and approvals.
Clinical trial budgets
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
Approval from the requisite delegates at each participating Metro North site is required before site authorisation can be granted. Researchers are expected to allow sufficient time for all delegates to review research governance submissions before providing their signature and approval.
The final submission must include signatures from the following delegate(s) at each participating Metro North site:
- Principal Investigator (PI)
- Business Manager (BM) or finance delegate
- Head of Department (HoD)
- Supporting HoD approval (where required)
Research projects that are carried out across more than one department, use the services (or data) of other departments or entities such as Queensland Pathology or Medical Imaging must seek approval from the relevant supporting department HoD. Where the research involves services from another department, a quote for services will be required, please see quotes for services below.
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
- Permitted signature formats include ERM signatures, wet ink document signature, electronic/wet-ink signed memo or email approval(s)
Additional documents
Submitting Additional Documentation
Additional documentation may be required depending on the specific research activities outlined in the HREA, SSA and the protocol. Where the required, additional documents must be:
- listed on the Research governance cover letter template
- uploaded with the SSA in ERM for research governance review
All documentation must include versions and dates that are consistent with the cover letter.
Clinical trials documentation
All clinical trials require additional ethics and governance documentation. All applications to the Metro North HREC to review a clinical trial must refer to the following information.
Data access and disclosure
Participant Information and Consent Form (PICF)
For research that involves the use of a Participant Information and Consent Form (PICF), HREC approval of the PICF must already have been granted prior to submitting an SSA application.
Multi-site research will require a Master PICF and a Site-Specific PICF. Research governance review and approval is required for site-specific PICF’s and research that has been reviewed by an external HREC.
Waiver of Consent
If a HREC has granted a waiver of consent, lawful access to data under the Public Health Act 2005 (PHA) or the Hospital and Health Boards Act 2011 (HHBA) must be granted. Evidence of the requisite approval must be provided before site authorisation will be granted.
Pathology Queensland
Approval from the Director, Pathology Queensland is required if results or data from Pathology Queensland are requested and a PHA Approval is required. Information contained in pathology reports is owned by Pathology Queensland and not the HHS.
Forensic and Scientific Services (FSS)
Access to coronial and non-coronial biological materials and data held by FSS require additional approvals.
Research involving coronial material raises distinct legal and ethical issues arising from the provisions of the Coroners Act 2003 and the unique vulnerabilities of the subjects and their next of kin. Approval is required from the Chief Forensic Pathologist, and requests that involve any coronial material (including when primarily ‘clinical’ in nature) and Queensland Health staff or facilities, should be referred to the Forensic and Scientific Services Human Ethics Committee (FSS-HEC), which has established arrangements with the State Coroner, developed expertise in the field, and which includes representatives from the Coroner’s Court.
Agreements
A research agreement is required for all research that involves any organisation external to Metro North.
This includes sponsored, collaborative and student research (e.g. where a Metro North staff member is undertaking the research as part of a Research Higher Degree).
Only the Metro North Health Chief Executive or delegated authority can authorise an agreement upon receiving a recommendation from the Research Governance Officer.
The SSA may be submitted without an executed agreement, or with a partially executed agreement, as the agreements will be reviewed and signed in conjunction with the SSA approval following research governance review.
Quotes for services
Any services provided for a research study considered outside of or in addition to standard care require a quote.
Internal services may include pharmacy, nuclear medicine, allied health services, radiology and medical imaging and pathology services. To obtain a quote for internal services, please contact the relevant local department.
When engaging external service providers, researchers must be aware of and comply with procurement frameworks. Metro North staff can refer to the Procurement | Metro North Hospital and Health Service for more information.
Pathology Queensland provide specific guidance on the use of services for research and clinical trials.
The medical imaging informatics systems Karisma and InteleConnect (PACS) are managed by the Metro North Medical Imaging Informatics team. Requests to access imaging data for the purposes of research are to be emailed to DMI_Research@health.qld.gov.au. Metro North staff can refer to Metro North Medical Imaging for facility information.
Ionising radiation
All research involving the use of ionising radiation procedures at a Metro North facility must receive HREC approval and site authorisation prior to commencing.
The approved ionising radiation information must be included in the site-specific PICF exactly as it is contained in the Radiation Dose and Risk Assessment Report and be submitted via ERM for research governance review.
External researchers
Research that involves an external researcher who requires access to a Metro North facility must comply with the Metro North Policy External Researchers.
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.
Related Information
After you have been approved
A notification of commencement form must be completed and submitted via ERM once all approvals are received and the research is ready to commence.