Site specific applications
Applying for site specific authorisation (SSA) to conduct projects under the streamlined review schemes.
Site specific assessment (SSA) applications
The two requirements for commencement of a streamlined research project include:
- Ethics approval from an accredited Victorian or certified interstate Ethics Committee
- Site authorisation from Alfred Health
Site specific assessment takes into account the appropriateness of the research and whether the institution has the resources, expertise and facilities to conduct the research project.
Researchers planning to submit an SSA to Alfred Health under the streamlined review process should refer to the Victorian Department of Health and Human Services (DHHS) website to read the instructions 'How to make a HREC application' and 'Site specific assessment and research governance' and obtain checklists for:
Site specific assessment will occur concurrently with ethics review for research submitted to the Alfred Hospital Ethics Committee for ethics review.
Researchers can commence preparing their SSA application at any time, but for research involving ionising radiation, will need to complete the relevant documentation for submission to and approval by the reviewing HREC prior to any submission for site authorisation.
It should be noted that site authorisation cannot be completed until HREC approval has been given.
Where Alfred Health is an accepting site, the ethics approval will be granted by an external Ethics Committee.
Preparing an SSA application
Early on researchers will need to:
- Consult the Office of Ethics and Research Governance about the eligibility, feasibility and requirements of the research for site authorisation at Alfred Health
- Read The Alfred Streamlining Ethical Review Guide
- Be familiar with the Alfred Health site requirements and follow any relevant instructions
- Take action to identify and prepare site documentation including the budget, legal and resource documentation and to obtain relevant signatures
- Create or have the SSA form shared in the Ethics Review Manager (ERM) system (Department of Health & Human Services).
Where Alfred Health services are being used in the course of the study, a declaration will need to be signed by the relevant Resource Centre Manager. This applies to routine tests as well as additional tests.
Where a service does not have a specific resource declaration, the general resource declaration can be used.
Researchers must complete:
- SSA form in the ERM website
(Signatures in the SSA can be electronic if registered in the system or obtain wet ink signatures and scan and submit a PDF. For studies involving any form of intervention, select one of the ‘Clinical trial’ options at Q1.2)
- Use of Alfred Health services form
- Ethics and Governance fee payment form
After ethics approval
Following ethics approval researchers should:
- Use the ethics approval certificate to ensure the correct versions of the ethically approved documents are submitted
- Finalise any post-ethics approval documentation such as site participant information and consent forms/information sheets
- Contact the Office of Ethics and Research Governance when the application for site authorisation is ready to be made
- Email the application and submit the SSA form in the ERM system.
Applications for site authorisation will be assessed by a Research Governance Officer. The Research Governance Officer will make a recommendation regarding authorisation.
Evidence of HREC approval must be provided before the Director of Research/CEO delegate can authorise (or not authorise) the project.
If an application can be authorised, researchers will be provided with a site authorisation letter and must be in receipt of this letter prior to commencing the project.