The Research Governance Office (RGO) provides governance review prior to site authorisation of a research project. Site specific assessment is a key element of research governance review and ensures that the proposed research study complies with the governance requirements of each site under the review of the RGO.

This process includes consideration of:

• HREC approval
• HREC approved documents
• Site Specific Assessment (SSA) form
• Site specific documents
• Study budget
• Clinical Trial Research Agreements (CTRA)
• Indemnity arrangements
• Insurance

Before a research project can commence, site authorisation must be issued by the Adventist HealthCare Limited Chief Executive Officer.

Site Authorisation

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 Principal 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 pathways:

• The AHCL Site Specific Assessment (SSA) for research applications generated through the HREA from process on https://hrea.gov.au/ 
• The AHCL Site Specific Assessment (SSA) for RGO applications alone for multi-site ethics approvals from independent HREC, eg. Bellberry Limited

There are different application procedures for single centre research and multi-centre research. Refer to the Guide to Submitting Research for Governance Review on our Governance Forms and Guidelines page.

Multi-Centre Research

From 1 January 2014, AHCL implemented a single ethical review process for all multi-centre research projects. AHCL accepts the ethical and scientific review undertaken by a Lead HREC which is NHMRC Certified. Such studies will be eligible for governance review and will not require separate ethical and scientific review by the Adventist HealthCare Limited HREC, provided a Memorandum of Understanding is in place between AHCL and the Lead HREC. Where the Lead HREC is a NSW Health certified Lead HREC an external entity agreement must be in place between AHCL and the Lead HREC.