Research Governance is a framework through which Metro South Health is accountable for the research it authorises to be conducted within any one of its facilities. Site Specific Authorisation relates to activities that are occurring within Metro South Health.
The following information applies to all research projects conducted at or by Metro South Health, irrespective of whether the Metro South Human Research Ethics Committee (HREC) has provided ethical review for the project.
Complete the following steps
Your Site Specific Application must include
- Cover letter or MSF31 HREC and Governance Checklist (XLS, 655 KB)
Please outline the reason for submission and itemise all documentation submitted.
- Research Contract Approval and Study Execution Form (PDF, 89.62 KB)
- Only complete Part A of the form. Part B is to be completed by Metro South Research Governance staff.
- The Metro South Health Principal Investigator is only required to sign assuming full responsibility for the conduct of the study at site and ownership of the research agreement/contract (if applicable)
- Head of Department at the site in which the study is to be conducted, normally the Director of the department. This person must not be a member of the research team. If necessary, please seek approval from the executive director of the department. Their signature notes that they are happy to support the conduct of the study within the department
- Business Manager of the department in which the study is to be conducted. Their signature notes that there are sufficient resources available to conduct the study. It is a Metro South Research Management requirement to include a research cost centre code.
- Site Specific Assessment Form
A standard template is available on the Online Forms website. Please ensure all information is completed Signatures are no longer required on the SSA. Required signatures are now captured on the Research Contract Approval and Study Execution Form - see section 2.
- Other Documents:
- Research Agreement/Contract as applicable.
- HREC Clearance/Approval
- For Non Metro South HREC approved studies, please supply a copy of the NEAF/Protocol, Master PICF and any other study documents
- Copy of signed Quotes for service providers such as Pharmacy, Pathology and Radiology Services
- Current curriculum vitae (CV) for all investigators
Maximum two pages.
- One copy of all Site Specific documentation All Site Specific Participant Information and Consent Forms require the following information in the footer of the document:
Master Version X approved XX/XX/XXXX by XXXXX HREC
PAH Site Specific version X dated XX/XX/XXXX.
May need to include
In addition, you may need to include the following depending on your project:
- Health Support Queensland pathology or coronial material approval
Researchers seeking access to HSQ resources (e.g. data, equipment, biological materials, tissue blocks and slides, etc) are required to seek approval from the relevant Senior Branch Director.
- Public Health Act 2005 (PHA) approval
This is required where confidential patient medical information is to be obtained without consent and being accessed by non-Queensland Health employees. Please contact the relevant data custodian and complete the PHA Application Form as required. Please ensure that when your PHA approval is received it is immediately forwarded to MSH-RGO@health.qld.gov.au.
Where do I submit my application?
Governance applications for research to be undertaken at any facility within Metro South Health can be submitted to:
- Centres for Health Research
Level 7, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
- only one original copy of each document is required
- Metro South Research Governance provides authorisation for SITE SPECIFIC DOCUMENTS only. Protocols, Investigators Brochures are not considered site specific documents and as such will not be included in the Authorisation Letter.
Applications for research projects at any other Metro South Health (excluding PAH) facilities should be directed to the relevant Director of Medical Services for site approval/authorisation. Once received the project will be reviwed by the Research Governance Office and appropriate authorisation to commence the research obtained.