Site Authorisation is a governance process separate to ethical and scientific review and can be conducted in parallel to the ethics approval process. However, commencement of a research study must not commence until site authorisation is issued by the Research Governance Office (RGO).
A Site Specific Assessment (SSA) form must be completed for human research projects to be conducted at sites under the review of the RGO.
Applications for site authorisation are submitted by the Prinicipal Investigator (i.e. the person responsible for the conduct and management of the research at a site under the review of the RGO) using one of the following forms:
- The Site Specific Assessment (SSA) form for research projects that have been submitted for full HREC review, using the NEAF
- The Site Specific Assessment form for Low and Negligible Risk Research (LNR SSA), for research projects that have been submitted for HREC expedited review, using the LNR form
- Access Request Form for research projects which require access to participantsm tissue or data at a site under the review of the RGO, but no study procedures take place at the site.
Forms are completed via the Australia Online Forms for Research website, www.ethicsform.org/au and are submitted to the Research Governance Office.
There are different application procedures for single centre research and multi-centre research. Refer to the Guide to Submitting Research for Governance Review on the Forms and Guidelines web page.