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Use this SOP (Standard Operating Procedure) if you have Human Research Ethics approval from an NMA (National Mutual Acceptance) hospital and require Austin Health Site Specific Authorisation (SSA)
This process was previously known as the “Research Governance” process and is replaced with the terminology “ External HREC approval”.
If your new project hasn’t received Human Research Ethics approval, please follow the steps in the relevant guidance material (called a Standard Operating Procedure (SOP)) below.
We are using new language to make it easier for you to identify the SOP you should follow, intentionally moving away from “high risk”, “low risk”, “audit applications” etc… This is because it is confusing and causes many delays, and that’s not who we are, we want to help you get your project approved as smoothly as possible. We are therefore presenting the information in a new way to try and save everyone time and effort.
Use this SOP if your project is sponsored by a Pharmaceutical or Medical Device company and uses an Investigational Product (IP i.e., a drug) and/or an Investigational Medical Device Product (IMPD i.e., a device)
Use this SOP if your project uses funds administered from a University or Medical Research Institute. This can include competitive grants (e.g., NHMRC and MRFF) and/or funding from other granting bodies.
Use this SOP if your project does not have a health/medical intervention and has been designed and developed by Hospital staff (i.e., no funding from University/Medical Research Institute/Commercial Sponsor). Commonly these projects are asking for retrospective data, provide surveys or other qualitative methods. This is process now replaces the following retired pathways: Audit, Quality Improvement, Quality Assurance, and some Low-Risk Projects.
There are very few projects that will use this SOP. If you have an investigator initiated clinical trial generally this should be sponsored by your affiliated University or Medical Research Institute.
Before you start using this SOP, you should contact firstname.lastname@example.org to confirm your suitability for using this pathway.