WA Health Research Governance and Single Ethical Review Standard Operating Procedures

Applicable to: The standard operating procedures apply to:

  • all persons employed in WA Health (including visiting medical officers, visiting health professionals, contractors, consultants, agents and volunteers); and
  • 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.

Description: In accordance with the WA Health Research Governance Policy and Procedures 2012, the WA Health Research Governance and Single Ethical Review Standard Operating Procedures have been developed to support the requirements of the policy and promote a consistent approach within WA Health to research governance and the single ethical review of multi-centre research projects. The document outlines the WA Health Single Ethical Review, National Approach and National Mutual Acceptance processes; and describes the requirements for the authorisation and ongoing monitoring of research projects conducted within WA Health or accessing WA Health participants, their tissue or data.

To be read in conjunction with: OD 0411/12 WA Health Research Governance Policy and Procedures

WA Health Research Governance and Single Ethical Review Standard Operating Procedures

The WA Health Research Governance and Single Ethical Review Standard Operating Procedures have been developed to support the requirements of the WA Health Research Governance Policy and Procedures 2012 OD. The procedures were developed in consultation with key stakeholders across WA Health to provide a consistent approach to research governance as well as the WA Health Single Ethical Review, National Approach and National Mutual Acceptance processes. 

In accordance with the Standard Operating Procedures, WA Health sites must accept the ethical and scientific review undertaken by their local Human Research Ethics Committee (HREC) or where relevant, another Lead HREC as sufficient ethical and scientific review for the purposes of the multi-centre projects conducted at sites under their control. In addition, Health Services 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); and
  • 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.

It is the responsibility of managers to ensure that all staff have access to a copy of the WA Health Research Governance and Single Ethical Review Standard Operating Procedures as it is mandatory that public health organisations comply with this operational directive. The Department of Health and Health Services may develop additional local operating procedures to address local detail and procedural requirements. It is expected that where the Department of Health or Health Services amend the standard operating procedures to reflect local matters, that the amendments will extend the requirements of the WA Health Research Governance and Single Ethical Review Standard Operating Procedures.


Prof Bryant Stokes
A/DIRECTOR GENERAL
DEPARTMENT OF HEALTH WA

Date of effect: 29 July 2013 to 29 July 2018

Policy Framework

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