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Research Ethics

​​​​​​​​​​​​​​​​​Human Research Ethics Committees

Human Research Ethics Committees (HRECs) provide the scientific and ethical review of proposed human research projects, taking into consideration:

  • the scientific design and proposed conduct of the project
  • how participants will be recruited, including the means of obtaining consent
  • care and protection from harm of research participants
  • protection of research participants' confidentiality.

Scientific and ethical approval must be obtained and form part of ​the governance approval, prior to a request for authorisation to the chief executive or delegate. Ethics Executive Officers (EEOs) provide administrative support to the HREC.

All human research conducted in WA Health must undergo ethical and scientific review, approval and monitoring by a HREC registered with the National Health and Medical Research Council's (NHMRC's) Australian Health Ethics Committee (AHEC) and operating in accordance with the NHMRC National Statement on Ethical Conduct in Human Research 2007.

In addition investigators conducting:

  • single-centre research within WA Health should apply to their site's local HREC for ethical approval
  • multi-centre research should use either the WA Health Single Ethical Review process or the National Mutual Acceptance process. Refer to multi-centre research for more information.

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

Multi-centre Research​ provides further information on the two Single Ethical Review schemes including the WA Health Single Ethical Review​ and National Mutual Acceptance (NMA).​

Information on specific ethical and scientific review processes at each health service provider (HSP) can be obtained from the relevant site or HSP. Find contacts for WA Health HRECs.

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

Clinical Trials

The Australian clinical trial handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, HRECs, investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.

Australian Consent and Guardianship Laws

Research involving individuals who lack decision-making capacity presents a number of ethical and legal challenges for researchers and HRECs. Specific information relevant to WA is available on the RGS Help WA Specific Information Public Pages.

These challenges are compounded for multi-jurisdictional studies as each jurisdiction has different requirements. The  NHMRC has produced a Report on the relevant State, Territory and National laws that relate to consent and guardianship requirements for human research, including clinical trials. A series of Australian guides/checklists to consent and guardianship laws are available for use by HRECs and researchers.

The NHMRC Guide to WA Laws Factsheet provides information for WA HRECs and researchers. The Factsheet does not constitute legal advice and researchers and institutions in particular should discuss their specific proposal with their own legal advisors.

Quality Improvement

For information on the difference between quality improvement (QI) and research, and the requirements for QI ethical review refer to the NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities 2014. ​​

​​Ethics Application Forms

Electronic forms in RGS:

The following ethics application forms are available for electronic completion in RGS: 

  • Western Australian Specific Module (WASM) - must accompany the HREA; OR
  • WA Health Ethics Application Form (WAHEAF).

Find a sample of all questions in the WASM and WAHEAF Sample Forms.

For applications to WA HRECs not using RGS (i.e. external to WA Health)​ and not involved in NMA, a hard copy of the WASM is available on request from RGS Support​​. 

The NHMRC's Human Research Ethics Application (HREA)​ is not available electronically in RGS. If the ethical review is by a WA Health HREC, the HREA must be completed via the NHMRC HREA website​ and uploaded to RGS as a pdf supporting document.  There is no requirement to attach supporting documents to the HREA (on the NHMRC website) as they should be uploaded separately into RGS.​ If ethical review is by a NMA non-WA Health HREC, the HREA should be completed via Online FormsPlease ensure you list the sites involved in the research project in the HREA form.

Which form to complete?

Find information on which ethics application forms to complete in the WA Health Research Authorisation Monitoring Form Guidelines.

WA Health Single Ethical Review scheme

For intra-jurisdictional​ (within WA) single-centre or multi-centre research either the WAHEAF or the HREA accompanied by the WASM can be used for an ethics application. 

Note: the WAHEAF is shorter than the HREA and contains the same WASM questions.

National Mutual Acceptance (NMA) scheme

For NMA inter-jurisdictional (outside WA) multi-centre research the HREA and WASM must be used (not the WAHEAF). Refer to Multi-centre Research for additional information on forms.

How do I submit my form?

For ethical review by WA Health HREC(s): the WASM and HREA (pdf) or WAHEAF and supporting documents must be submitted via the RGS.

For ethical review by non-WA Health HRECs participating in the NMA: the WASM must be completed within RGS, printed and submitted via Online Forms to the reviewing HREC.​ Refer to Multi-centre Research for additional information on the submission process for NMA forms.

Ethics Monitoring Forms

How do I submit monitoring forms for projects within 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. All Ethics Forms can be completed by members of the project team (including the sponsor) but must be submitted to the HREC by the CPI or CPI 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.

How do I submit monitoring forms for projects not in RGS?

All projects that are currently outside of RGS will continue to have their monitoring forms processed outside of RGS until the projects can be migrated into RGS i.e. complete the word documents below and email them directly to the relevant WA Health HREC or RG Office. Migration will occur in late 2018:  

Find information on WA ethics monitoring requirements in the NMA Monitoring and Reporting Tables July 2017 (PDF 156KB)​, these are based on the NHMRC's:

Find information on ethics monitoring forms in the  WA 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 ethics committee please complete this form within RGS. RGS users can complete and submit a complaint form on behalf of research participants who may or may not wish to remain anonymous.
​​​Ethics Supporting Documents

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

  • Research Protocol Templates
  • Participant Information & Consent Forms. ​​​

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