Research Governance Office

Research Governance Review / Site Specific Assessment (SSA)

All research studies undertaken at Sir Charles Gairdner Hospital and Osborne Park Hospital must undergo a research governance review (or site specific assessment - SSA) before site authorisation can be granted by the Chief Executive or delegate to commence at site.

Research Governance is a framework which ensures the principles, requirements and standards of research are implemented. Research governance review addresses the protection of research participants, privacy and confidentiality, financial probity, legal and regulatory matters, risk management, monitoring arrangements and promotes good research culture and practices.

The governance process is separate to ethical and scientific review and can be conducted in parallel to the ethics approval process. That is, it is not necessary to wait for the ethics outcome before preparing and submitting a governance application.

For more information on research governance please visit the Research Governance Service (RGS) (external site).

Guardianship Act – Next of Kin legislation (Oct 2020)

The Department of Health (DoH) have developed supporting documents for the Guardianship and Administration Amendment (Medical Research) Act 2020 to assist researchers, HRECs and health services in conducting research in accordance with legislative requirements. These supporting documents have now been approved for use by the Minister for Health.

• Guidance Document - provides an overview of the relevant legislation including roles and responsibilities and enrolment pathways.
• Medical Research Decision Forms – to be completed during the enrolment process for both the 'Medical Research with consent of Research Decision-Maker' and 'Urgent Medical Research without consent' pathways.
• Medical Research Decision Report - to be completed by researchers to notify the Minister for Health when a research candidate is enrolled under the Act.

The documents are available c/o RGS Document Templates (external site) under 'Research Involving Incapacitated Adults (GAA)'.

Research Governance Procedure Guides

• Affiliation and Acknowledgements Guidelines for the North Metropolitan Health Service (PDF)
• Quick Guide for RGS amendment forms (PDF)
• RGS Sample - Site Specific Assessment (SSA) Form (PDF)

Schedule of Administrative Charges

The following fees¹ apply to all applications to review research projects made to Sir Charles Gairdner Osborne Park Health Care Group (SCGOPHCG) sites.

For commercially sponsored research, these fees are incurred by the sponsor. The payment will be invoiced directly to the external sponsor by the Research Business Support Office, irrespective of whether the research project commences.

Non-commercial trials must still record these fees within the Budget Form on the Research Governance Service. However, these fees are funded by in-kind support from SCGOPHCG Executive and will not be invoiced.

This applies to all research governance applications lodged with the SCGOPHCG Department of Research. Review of fees will be conducted after 3 years.

For fees which apply to all Human Research Ethic Committee (HREC) applications please see WA Health Central Fee Information (PDF)

Fees for the review of commercially sponsored research (excluding GST)

*Substantial amendments include any changes to project documentation beyond language, spelling and grammar changes. This includes changes in the methodology, procedures undertaken by participants and additional project documentation (GP letters, PICFs, invitation letter). Substantial amendments also include any contractual amendments including budget and legal revisions. The SCGOPHCG Department of Research does not charge for administrative amendments (changes to spelling and grammar, changes to investigators).

¹ Fees do not influence the decision of the HRECs and the same fee is charged regardless of the outcome of the submission. The fees cover the cost of reviewing the documents and the associated administrative responsibilities and are used to support the functions of the SCGOPHCG Department of Research.