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Research Governance Framework

​​​​Background

The WA Health research governance framework governs the scientific, ethical and governance review, approval, conduct and monitoring of human research within WA public health organisations.

The Research Policy Framework specifies the research requirements that all Health Service Providers (HSPs) must comply with in order to ensure effective and consistent research activity across the WA health system.

Under this policy framework HSPs and the Department of Health must comply with all mandatory requirements related to the WA Health research governance framework including:​

The Research Governance Service (RGS) supports the framework and single ethical review of multi-centre research, by hosting standard ethics and governance forms​ and agreements​, as well as facilitating the research governance approval and monitoring process of projects.​​

WA Health Research Governance Policy and Procedures

The WA Health Research Governance Policy and Procedures 2012 (OD 0411/12) has been implemented to ensure all human research conducted within WA Health has undergone research governance, which consists of ethical, scientific and governance review.

All human research must be reviewed, authorised, conducted and monitored in accordance with the policy and procedures to ensure that:

  • it is ethically and scientifically sound
  • it is conducted by authorised personnel with appropriate professional qualifications, credentials and institutional approvals
  • it is conducted in a safe and responsible manner according to regulatory and professional standards and complies with relevant national and State legislation, guidelines and codes of conduct
  • the ethical and governance review and monitoring is transparent, accountable, minimises duplication, risk and is conducted in an efficient and timely manner
  • it is authorised by the chief executive or delegate before commencement. ​

The policy and procedures applies to:

  • all persons employed in WA Health (including visiting medical officers, visiting health professionals, contractors, consultants, agents and volunteers)
  • non-WA Health employees (including clinical and non-clinical university academics) who propose to undertake, manage, review and govern human research; and/or access WA Health participants, their tissue or their data. 

In accordance with the directive, all human research conducted within WA Health will be reviewed, approved, conducted and monitored, under the guidance of its established bodies and in accordance with the:

Authorisation to commence research is conditional upon ethical and scientific review and approval by a HREC and  governance review by a WA Health research governance officer; consisting of either a site specific assessment or access request review.  The applicant must receive written notification of authorisation by the WA Health chief executive or delegate before commencement.  Once the research has commenced, WA Health sites are responsible for the appropriate governance of research activity carried out within their services to ensure it is conducted in a safe and responsible manner.

WA Health Standard Operating Procedures

The WA Health Research Governance and Single Ethical Review Standard Operating Procedures 2013 (OD 0446/13) have been implemented to support the requirements of the WA Health Research Governance Framework.

The procedures were developed to provide a consistent approach to the WA Health Single Ethical Review and National Mutual Acceptance processes.

WA Health sites must accept the ethical and scientific review undertaken by a WA Health Lead HREC as sufficient ethical and scientific review for the purposes of conducting research projects at sites under their control.

HSPs and the Department of Health must implement the research governance procedures for the authorisation and ongoing monitoring of research projects conducted at their sites or accessing their participants, tissue or data.

The standard operating procedures apply to:

  • all persons employed in WA Health (including visiting medical officers, visiting health professionals, contractors, consultants, agents and volunteers)
  • non-WA Health employees (including clinical and non-clinical university academics) who propose to undertake, manage, review and govern human research; and/or access WA Health participants, their tissue or data.

The Department of Health and HSPs may have developed additional local operating procedures to address local detail and procedural requirements. These will be available on their local websites.

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