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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 the WA Health Single Ethical Review process until the National Mutual Acceptance process is implemented within WA Health. 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.

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.

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. 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 availbale 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 Forms

Application

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

The following ethics application forms are available in the RGS for completion and submission to the relevant WA Health HREC(s):

  • Western Australian Specific Module (WASM)
  • WA Health Ethics Application Form (WAHEAF).

For non-WA Health HRECs not using the RGS, a copy of the WA Specific Module​​ is provided for use.

As an alternative to the WAHEAF for national multi-centre projects, if required the NHMRC's National Ethics Application Form (NEAF) or Human Research Ethics Application (HREA) is currenlty not available in the RGS. To facilitate its submission to WA Health HRECs, the NEAF or HREA must be completed externally and uploaded to the RGS as a pdf supporting document. Upload the NEAF or HREA as a supporting document named as HREA in the RGS. There is no requirement to attach supporting documents to the HREA (at the NHMRC website) as they should be uploaded separately into the RGS.

The HREA will be accepted by WA Health HRECs from 1 March 2017. To ensure a transition period, WA Health's HRECs will continue to accept the NEAF until 30 June 2017, at which time the NHMRC's NEAF website will be decommissioned.

 

Monitoring

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

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

​​​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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