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)'.

 

Clinical Trial Liaison Officer

The goal of the Clinical Trial Liaison Officer is to contribute to reduced start-up times for clinical trials. To achieve this, the Clinical Trials Liaison Officer is available to provide assistance to researchers with submissions, contracts and agreements, and liaising with sponsors.

If you have clinical trials underway, are looking to commence a clinical trial, or would simply like to make contact to discuss Clinical Trials Research, you can contact the Clinical Trials Liaison Officer through NMHS.CTLO@health.wa.gov.au.

 

Research Governance Procedure Guides

Last Updated: 28/09/2021