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 2018(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 andethics approval must be obtained and form part of the final governance review, prior to a request for authorisation to the chief executive or delegate.
TheWA 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 localRG Office. The review of an agreement may include direct negotiation with the external entity and referral of the research agreement to Legal and Legislative Services.
The Australian clinical trial handbook provides guidance on the legislative, regulatory andgood clinical practice (GCP)requirements when conductingclinical trialsin Australia using 'unapproved'therapeutic goods. It assists trial sponsors, HRECs, investigators and approving authorities (institutions) to understand their roles and responsibilities under thetherapeutic goods legislation.
Electronic forms in RGS:
The following governance forms are available for electronic completion and submission via RGSto WA HealthRG Office(s):
- WA Health Site Specific Assessment (SSA)Formand Budget Form
- WA Health Access Request Form
Finda sample of all questions in the SSASample Form.
Findinformationongovernance application forms in theWA Health Research Authorisation Monitoring Form Guidelines.
How do I submit monitoring forms for projectswithin RGS?
From 1 September 2018, all projects within RGS that are being monitored by WA Health HRECs or RG Offices will require monitoring forms to be completed and reviewed via RGS, including NMA projects.AllGovernance Forms can be completed by members of the project team (including the sponsor) but must be submitted to theRG Officeby the PI orPI Delegate.
The available monitoring forms include:
- Amendment Form (Ethics)
- Governance Only Amendment Form with additional Amended Budget Form
- Safety Form
- Progress Report
- Site Final Report
- Project Final Report.
Find information on WAgovernance monitoring requirements in the NMAMonitoring and Reporting Tables May 2020 (PDF 444KB), these are based on the NHMRC's:
- Safety monitoring and reporting in clinical trials involving therapeutic goods November 2016
- Data Safety Monitoring Boards (DSMBs) 2018
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018
- Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods 2018
Findinformationongovernancemonitoring forms in theWA Health Research Authorisation Monitoring Form Guidelines.
WA Health Research Complaint Form
There is now a complaints module within RGS. If you wish to lodge a complaint about a project or a WA Health RG Officeplease complete this form within RGS. RGS userscan complete andsubmit a complaint form on behalf of research participants who may or may not wishto remain anonymous.
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 Researchand Confidentiality Declaration
- Confidentiality Disclosure Agreement
- Clinical Trial and Clinical Investigation Research Agreements
- Research Agreements
- Indemnity Forms.
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 Chromeweb browser to download templates:
- WA Health Research Budget Template v5.0Nov2021
- WA Health Research Budget Template v4.0Nov 2016 – Example
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 budgetsrefer to guidanceatResearch Educationandthe 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.
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.
Indemnity
For commercially sponsored research projects, the sponsor is required to provide indemnity for both the site and the HREC providing the ethical review. Links to the Medicines Australia indemnity forms can be found atDocument Templates.
In accordance with the WA Health Single Ethical Review scheme and the National Mutual Acceptance scheme, WA's Health Service Providers (HSPs) accept ethical reviews conducted by their own and external HRECs. The following sets out the indemnity arrangements applying to HRECs in respect of commercially sponsored projects:
1. Project not conducted within HSP: The HSP's HREC provides ethical review for commercially sponsored projects to be conducted at sites not under the control of the HSP. Hence, the HSP provides only the HREC review. It is the HSP's responsibility for ensuring that its HREC is indemnified by the sponsor by way of theMA HREC Review Only Form of Indemnity.
2. Project conducted only within HSP: The HSP's HREC provides ethical review for commercially sponsored project to be conducted only at sites under the control of the HSP. It is the HSP's responsibility for ensuring that its HREC is indemnified by the sponsor by way of the MA Standard Form of Indemnity.
3. Project conducted within and outside of HSP: The HSP's HREC provides ethical review for commercially sponsored project to be conducted by both sites under its control and sites not under its control. The HSP is responsible for ensuring that its HREC is indemnified by the sponsor by way of the MA Standard Form of Indemnity.
4. Ethical review not conducted by HSP's HREC: The HSP proposes to conduct a commercially sponsored project and the ethical review is provided by an HREC external to the HSP. The HSP is not responsible for ensuring that the external HREC is indemnified by the sponsor. The HSP is only responsible for ensuring that its site is indemnified by the sponsor by way of the MA Standard Form of Indemnity.
