Ethical review and site assessment 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 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
- St Vincent’s Private Hospital
- The Mater Hospital
- St Joseph’s Hospital
- Sacred Heart Hospice
- The Victor Chang Cardiac Research Institute
Submission for Site Specific Assessment (SSA and LNRSSA)
To submit to a study for site-specific review by the Research Governance Officer, follow the Checklist SSA/LNRSSA (updated August 2016). This Checklist highlights frequently occurring mistakes and may help to assist in the preparation of your submission.
When submitting your SSA, please ensure that the email content or cover letter lists every document being submitted and that the site Principal Investigator is copied on the correspondence.
Your submission must be prepared using online forms using one of the following:
- Site Specific Assessment Form (for projects that were submitted for HREC review with a NEAF)
- Site Specific Assessment Form for Low and Negligible Risk (for projects submitted using an LNR Form)
- Access Request Form (for projects where there is access to participants, tissue or data, but no study procedures take place on sites and the researcher has confirmed use of the Access Request Form with the RGO in advance)
All applications to the Research Governance Officer must be submitted electronically, via email to SVHS.Research@svha.org.au. In addition, one hard copy of documents with original signatures must be submitted to the Research Office.
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 involved in the conduct of a research project at sites under St Vincent’s Research Office governance are required to obtain an Honorary Appointment. This includes but is not limited to medical students, research fellows, university academics, and other external parties who do not hold an existing appointment at SVH. 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 click on the link here PDF [301 KB] for additional important information on the Honorary Appointment process at St. Vincent’s sites.