Site Specific Assessment is required for sites under the control of a NSW public health organisation, even if the project has low or negligible risk to participants, if the project involves one or more of the following activities:
- enrolling participants into research (e.g. obtaining informed consent, screening)
- carrying out protocol-specific research procedures with or on participants
- managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research.
Site Specific Assessment involves consideration of such matters as resources, staff, insurance and indemnity requirements etc.
The Site Specific Assessment and Human Research Ethics Committee ethical and scientific review may occur in parallel, however the decision to authorise or not authorise the commencement of a research project is only made by the public health organisation when the responsible Human Research Ethics Committee has granted approval and the Site Specific Assessment has been satisfactorily completed.
All applications for Site Specific Assessment must be made on the standard Site Specific Assessment Form in REGIS (Research Ethics and Governance Information System), and submitted to the relevant Research Governance Officer within the public health organisation.
For instructions on how to complete the SSA in REGIS, please see the Quick Reference Guide: SSA Part 1: Completing the Application & Requesting Head of Department Support.
Only the Principal Investigator (PI), as the person responsible for the research conducted at their nominated site can submit the SSA for Head of Department Support. Once the Head/s of Department/s have given their support decision, the PI can then submit the SSA in REGIS to the Research Governance Officer using the following Quick Reference Guide: SSA Part 2: Submitting SSA to Research Office.
The Checklist for Site Specific Assessment submissions to the ISLHD Research Governance Officer has been developed to assist investigators in preparing their SSA submission.
Research Protocol – the Research Protocol Template outlines the plan for how a study is run, a well-written and complete protocol is essential for a high quality study, ensures clarity as to what has been ethically approved and will make publishing the results easier.
A Research Budget Template must be completed for research conducted within the ISLHD which involves ISLHD staff, funding, or resources. The Business Rule: Process for Approval of Budgets for Research Projects has been developed to ensure that research projects involving funding or resource implications have the necessary ISLHD approvals in place.
Research policies and guidelines can be found here: www.medicalresearch.nsw.gov.au/policies-guidelines/.
In line with the NSW Health Policy Directive PD2023_015 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, ISLHD is required to charge the below fees for Research Governance Review.
|Institution-sponsored Clinical Trials
|Non-commercial External sponsor
|Commercial External Sponsor
|Non-standard contract review
|see section 4.6 of the PD