Governance

Site Specific Requirements for studies to be conducted in within the Sydney Local Health District

When any research project is conducted within the Sydney Local Health District, two (not one) approval/authorisations must be obtained before the research can commence:

1 An ethics application is submitted to an accredited Human Research Ethics Committee (HREC) for review and approval. The HREC grants overall scientific and ethical approval for a research project. HREC approval is necessary, but not sufficient, to conduct the research.

2 This is followed by submission of a Site-Specific Assessment Application (SSA) for authorisation in line with NSW Health policy (PD 2010_056 Authorisation to commence research in NSW Public Health Organisations). Site authorisation must also be obtained before the research can start.

The SSA application, and accompanying documentation, is submitted to the Research Governance Officer (RGO) at each study site via REGIS (see more below). The RGO makes a recommendation to the Chief Executive (CE) or the CE’s delegate who then authorises the research to be conducted at that site. This 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 can meet the needs of the research and the Local Health District's requirements for compliance with Ministry of Health directives and applicable laws. Considerations include:

· Do the investigators have the skills and credentialing to undertake the project?

· Are facilities and resources available at the site?

· Is the project adequately funded?

· Are adequate indemnity, insurance and clinical trial agreement arrangements in place for a clinical trial?

· Have legislative requirements been met?

· Has scientific and ethical approval been granted by a lead HREC?

Who completes the Site Specific Assessment application?

SSA applications should be submitted by the Principal Investigator (PI) i.e., the person responsible for the conduct and management of the research at Royal Prince Alfred Hospital. However, the PI can share access with others to assist with completion of the application.

How do I complete a Site Specific Assessment application?

For research to be conducted in NSW Public Health sites, the SSA application is completed and submitted online using the Research Ethics & Governance Information System (REGIS). Applications should be generated through REGIS https://regis.health.nsw.gov.au/

When can I submit a Site Specific Assessment application?

The Principal Investigator (PI) can commence filling in the SSA in REGIS once the Project Registration has been completed and the HREA has been submitted. Project Registration is the first step in initiating a research project in REGIS. The PI can submit the SSA after the HREA has been submitted as there are no submission dates for SSAs. Although SSAs can be submitted before ethics approval has been decided, they cannot be authorised until ethics approval for the study has been issued.

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. Ensure that all Heads of Departments have been contacted before SSA submission.

When can I start the study in the SLHD?

When you have received BOTH the valid ethics approval letter and site authorisation notification from the SLHD Research Governance Officer. Approval and Authorisation notifications are issued from the REGIS