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Research Governance

​​​​​​​​​Research Governance Offices

Research Governance (RG) Offices provide guidance to assist a WA Health site in meeting its obligation for the effective governance of research involving humans.

The role of a Research Governance Officer (RGO) is to provide a governance review, involving a site specific assessment (SSA) or access request review, prior to authorisation of a research project. This process includes consideration of:

  • the suitability of the site and the investigators to conduct the research
  • the assessment and management of site risk
  • the identification of actual and in kind resources required to conduct the research
  • scientific and ethical approval of the research project.

All human research conducted within WA Health must undergo a governance review which is the mechanism for professional, legal and financial accountability and transparency and is consistent with the NHMRC's Australian Code for the Responsible Conduct of Research 2007 (the Code).

The governance review is a separate process to the ethical and scientific review and should be conducted in parallel to the ethics approval process.  It is not necessary to await the ethics outcome before preparing and submitting a governance application to the relevant RG Office. ​

Scientific and ethics approval must be obtained and form part of the final governance review, prior to a request for authorisation to the chief executive or delegate.

The WA Health Research Governance Framework provides further information on WA Health governance review processes.

Information on specific research governance review processes at each site can be obtained from the associated RG Office.  RG Offices are responsible for several sites within a Health Service Provider (HSP). ​Find contacts for WA Health RG Offices.

Contractual Assistance

​​For assistance with local contractual issues contact the local RG Office. For contractual issues that relate to more than one site within WA Health contact the Department of Health Legal and Legislative Services.

Find research governance forms (below) or research ethics forms.

Governance Forms

Application

The following governance forms are available in the RGS for completion and submission to the relevant WA Health RG Office(s):

  • WA Health Site Specific Assessment (SSA) Form and Budget Form
  • WA Health Access Request Form
  • WA Health Declaration of Confidentiality
  • WA Health Research Conflict of Interest Form.

A copy of the WA Health Declaration of Confidentiality and WA Health Research Conflict of Interest Form​ are provided for use if these are required for project amendments, prior to the monitoring stage (stage 2) being developed in the RGS (estimated 2017).

Find information on governance application forms in the WA Health Research Authorisation Monitoring Form Guidelines.

Monitoring

The following governance monitoring forms are available for completion and submission to WA Health RG Offices, to amend an authorised research project and meet the requirements of research monitoring at the site. At this time, these forms should be submitted directly to the RG Office, not through the RGS:   

Find information on governance monitoring forms in the WA Health Research Authorisation Monitoring Form Guidelines​.

Governance Supporting Documents

The following governance supporting documents are available from the RGS as document templates. These can be completed externally and uploaded to the RGS as supporting documents:

  • Student Research and Confidentiality Declaration
  • Confidentiality Agreement
  • Clinical Trial and Clinical Investigation Research Agreements
  • Research Agreements
  • Indemnity Forms. 

Additional Governance Information​

Budgets

For assistance in calculating salary related research costs and completing the Budget Form, the following non-mandatory template and example are available. Please use a CHROME Browser to download these templates:

Please note, these are offered as examples. Please ensure you speak with your business or financial representative to ensure you use the correct rates, allowances and most up to date costing procedures applicable to your project budget.

For additional assistance in compiling research budgets refer to guidance at Research Education and the Independent Hospital Pricing Authority (IHPA) Determination of Standard Costs Associated with Clinical Trials in Australia June 2015  

The determination does not bind jurisdictions and should be used as a starting point for discussing the unique features of each proposed trial and the associated costs. The determination is intended to be applied only to those clinical services that are over and above normal standard care delivered to patients. Investigators should be aware that hourly rates of salaries quoted are fully absorbed i.e. they include on costs​​ and overheads already built in.

Further guidance for compiling budgets can be found in the RGS Budget Form​.

Insurance

WA Health insurance requirements are contained within the schedules of the clinical trial research agreements and outlined in the WA Health Research Governance Policy and Procedures 2012 (OD 0411/12).


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