Submitting for Governance & Site Authorisation (SSA)
HREC review and Site Specific Assessment (SSA) are two distinct processes relating to the ethical approval and institutional authorisation of research involving humans. They are both components of Research governance.
Research governance is a framework through which institutions ensure that research conducted conforms to relevant institutional, jurisdictional and national standards and laws. Research governance addresses protection of research participants, the safety and quality of research, privacy and confidentiality, financial probity, legal and regulatory matters, risk management and monitoring arrangements and promotes good research culture and practice.
Site Specific Assessment (SSA)is a key element of research governance, and involves the review of HREC approval (either by St Vincent’s HREC or another Certified Lead HREC), HREC approved documents, Site Specific Assessment (SSA) form, study budget, Clinical Trial Research Agreements (CTRA), insurance and indemnity arrangements. Research projects undergo Site Specific Assessment before authorisation can be granted by the Executive Director (or delegate) of the organisation.
Relevant policy documents and guidelines are also listed on the Resources for Researchers page of our website.
St Vincent’s Hospital Research Office provides site/governance review for the following sites:
- St Vincent’s Hospital (via REGIS)
- St Joseph’s Hospital (via REGIS)
- Sacred Heart Health Service (via REGIS)
- St Vincent’s Private Hospital (please contact Research Office)
- The Mater Hospital (please contact Research Office)
- The Victor Chang Cardiac Research Institute (please contact Research Office)
Submission for Site Specific Assessment via REGIS:
To submit a study for site-specific review by the Research Governance Officer, please click on the link:
REGIS Checklist - SSA or LNRSSA Submission
When submitting your SSA, please ensure that your cover letter lists every document being submitted.
Your submission must be prepared using REGIS
All applications to the Research Governance Officer must be submitted via REGIS, however contracts must be submitted as hard copies to the Research Office directly.
Submission for Site Specific Assessment for Private Sites (SVH Private, TMH, VCCRI) ONLY:
To submit to a study for site-specific review by the Research Governance Officer, follow the link to the Checklist SSA Private Sites
If uncertain, please contact the Research Office in first instance via SVHS.Research@svha.org.au (8382 4960).
Clinical Trial Research Agreements
Standard Clinical Trial Research Agreements have been developed by the NSW, QLD, VIC and SA Health Departments in conjunction with Medicines Australia. Templates are available on the Medicines Australia website.
Please note that St Vincent's Hospital Research Office is unable to accept contracts with special conditions listed in Schedule 4/7 unless evidence of NSW Health approval of the clauses is provided. This is a NSW Health requirement. Information relating to the process by which special conditions may be submitted for review to the relevant Health Department is also available on the Medicines Australia.
- All external researchers who are not current St Vincent’s Hospital employees and are involved in the conduct of a research project at sites for which St Vincent’s Research Office provides governance review are required to obtain an Honorary Appointment.
- This includes but is not limited to undergraduate students, graduate students, research fellows and university academics.
- The requirement for an Honorary Appointment may be waived if evidence of current ClinConnect Clearance is provided however this is at the discretion of the Research Office Manager.
- The need for an Honorary Appointment is identified by the Research Officers during SSA review. An external researcher may not commence research related activities at sites under the governance of St Vincent's Research Office until the Honorary Appointment has been granted.
- Please contact the Research Office Directly for additional important information on the Honorary Appointment process.
Tel: 02 8382 4960