Before any research project can be conducted within the Sydney Local Health District (RPAH Zone) an ethics application must be submitted to an accredited human research ethics committee for review and approval followed by submission of a Site-Specific Assessment Form (SSA) for site authorisation.
The SSA and accompanying documentation is submitted to the Research Governance Officer (RGO). This is in line with the NSW Ministry of Health Policy (PD 2010_056 Authorisation to commence research in NSW Public Health Organisations). This process ensures compliance with a broad range of regulations, legislation and codes of good practice to achieve and continuously improve research quality across all aspects of healthcare by:
• Safeguarding the dignity, rights, safety and well-being of participants
• Protecting and promoting the integrity of research and investigators
• Enhancing ethical and scientific quality
• Minimising risk
• Monitoring practice and performance and
• Promoting good practice
Why is Site Specific Assessment required?
It ensures that each site is able to meet the needs of the particular project and the Local Health District's requirements for compliance with Ministry of Health directives and applicable laws. The elements considered include:
• Do the investigators have the skills and credentialing to undertake the project?
• Are facilities and resources available at the particular site?
• Is the project adequately funded?
• Are adequate indemnity, insurance and clinical trial agreement arrangements in place for a clinical trial?
Who completes the Site Specific Assessment application?
The Principal Investigator who is the person responsible for the conduct and management of the research.
How do I complete a Site Specific Assessment application?
The person who created the ethics application (NEAF/HREA/LNR) should log-on to the Online Forms website (www.ethicsform.org/au) then:
• Open the ethics application
• Select the “SSA” tab which will automatically populate some of the information from the ethics form into the SSA
• Once completed click on the “Submission” tab and print a hard copy of the form.
• Obtain all the necessary signatures and keep a copy for your own file.
When can I submit a Site Specific Assessment application?
It can be submitted at any time after HREC approval has been obtained as there are no submission dates for SSAs.
NB: For clinical trials: whilst HREC approval is pending, the Indemnities, Insurance and Clinical Trial Agreements can be emailed to the Research Governance Officer (RGO) in DRAFT version to sort out any issues. This will help to expedite the site authorisation of the clinical trial.