Ethics

In line with the centralisation of ethics approval for all Western Australian health and medical research,or any other HREC accredited under the National Mutual Acceptance (NMA) scheme.

CAHS’ HREC can only accept submissions that are:

  • clinical trials submitted under the National Mutual Agreement (NMA) scheme
  • other national multi-site ethics submissions – under the NMA scheme
  • low-risk risk applications qualifying for review under the low-risk ethics review process.

Applying to HREC

The CAHS Human Research Ethics Committee (HREC) conducts ethics reviews and provides advice for all research involving CAHS’ patients, staff, or resources.

CAHS HREC is also the HREC for our collaborators for projects conducted at Perth Children’s Hospital or other CAHS premises.

For important information regarding the ethics review process at CAHS, refer to the following documents:

  1. A completed, signed application is submitted to the HREC office via the Research Governance Service (RGS). 
  2. When all the necessary documentation has been provided, including the CAHS Ethics application coversheet - checklist, the project will be triaged to one of 3 review pathways:
    1. Low risk research – low risk applications will be reviewed by members of the CAHS Low Risk Ethics Committee (LREC) out of session.
    2. Clinical Trials – clinical trials/interventional research will be reviewed by the Clinical Trials Sub-Committee (CTS) at a scheduled meeting prior to a full HREC review.
    3. Full HREC review – research not deemed “lower risk” and not a clinical trial/intervention, will be reviewed by the HREC at a scheduled meeting.
  3. The Coordinating Principal Investigator (CPI) and CPI delegate will receive notification via email by the REG office regarding which level of review your submission requires and time frame for when you will receive notification of the review outcome.
  4. The outcome of the ethics review will be communicated to the CPI via RGS.

If you have any questions about the process or requirements, please contact the REG office team:

Email

CAHS.HREC@health.wa.gov.au

Phone

6456 0516 or 6456 8539

See below for the current 2024 member lists:

National – NMA Scheme

Under the National Mutual Acceptance (NMA) Scheme, all multi-centre research projects being conducted at public health organisations (PHO) can be ethically and scientifically reviewed by a single NHMRC Certified Lead HREC participating in the NMA. The exception are those research projects that require additional specialist review (refer to the NMA document below for further information). CAHS HREC is a NHMRC certified Lead HREC under the NMA. 

Multi-centre studies submitted for ethics approval in WA, whether originating from WA or other states, must be submitted on a Human Research Ethics Application (HREA) uploaded as a document in RGS. This should be accompanied by the WA-Specific Module (for WA sites) and the Victorian-Specific Module (for Victorian sites).  

For multi-centre studies (e.g. large national or international clinical trials), the CPI is responsible for organising submission of documents for scientific and ethics review by an appropriate lead HREC. 

For further information regarding multi-centre ethics applications, please see RGS Multi Centre Research

WA Health only – Single Ethics Review

In WA Health, there is a single-ethics review process in place whereby multi-centre projects to be undertaken at more than one WA Health site (but not occurring outside WA) requires ethics approval from only one WA Health HREC. CAHS HREC is the HREC with expertise and certification in paediatric research. 

Principle investigators (PI) at each site must submit applications for governance review and will be responsible for local approvals and compliance.

Risk profiles of Research (Source: National Statement 2023 – Chapter 2.1)

Lower risk

Higher risk
(individual, group, community, societal, global)
Minimal Low Greater than low High

No risk of harm
or discomfort

No risk of harm

Risk of discomfort

  Risk of harm  
Potential for minor burden
or inconvenience		  +/- foreseeable burden  +/- foreseeable burden  +/- foreseeable burden

 

Research projects deemed 'lower risk' will follow a low-risk review pathway for both ethics review, site authorisation and final approval.

Level of risk will be determined by the use of a checklist coversheet and REG office staff will triage submissions accordingly.

Low risk approval pathways are accepted by the National Mutual Acceptance (NMA) Scheme (NMA Standard Principles for Operation).

Refer to the following documents for more information:

 

Research that is to be undertaken without the consent of those whose data, tissue or DNA is to be used must include a request for a waiver of consent in the application to the HREC.

All sub-sections of section 2.3.10 (a-i) of the National Statement should be addressed in the application – outlined in either section 6.1.2 of the WA Health Ethics Application Form or Consent section of the Human Research Ethics Application (HREA) and the protocol. 

The opt-out approach to recruitment (or 'opt-out consent') is characterised by:
  • providing information to the potential participant about the research and their involvement
  • participation is presumed unless action is taken to decline.

All sub-sections of section 2.3.6 (a-i) of the National Statement must be addressed in the application – outlined in either section 6.1.2 of the WA Health Ethics Application Form or the consent section of the HREA and the protocol.

Please confirm with the research governance office, prior to site selection, any local or legislative requirements that may impact the researcher’s ability to conduct research with a waiver of consent or opt out approach at a site level.


Aboriginal and Torres Strait Islander people

The Western Australian Aboriginal Health Ethics Committee (WAAHEC) is registered with the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC) and exists to promote and support good ethically based health and medical (or the determinants of health) research, which will benefit Aboriginal people. 

In addition to the local or lead HREC approval it is a requirement that WAAHEC approve the conduct of health and medical research in WA where the research project involves the following categories:

  • Aboriginality is a key determinant
  • Data collection is explicitly directed at Aboriginal people
  • Aboriginal people, as a group, will be examined in the results
  • The information has an impact on one or more Aboriginal communities
  • Aboriginal health funds are a source of funding. 
Refer to the Aboriginal Health Council of Western Australia for the WAAHEC Values and Ethics Statement and the ethics application form. 

Submissions to CAHS HREC and WAAHEC may be made in parallel.

If you are thinking about conducting research with Aboriginal and/or Torres Strait Islander peoples, please refer to the following set of principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities:

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities | NHMRC (external website)

WA Health data collections

Research that requires access to WA Health data collections and/or involve data linkage must be submitted to the Department of Health WA HREC. 

Refer to the following websites for more information:

WA Data Linkage Branch website (external website)

Department of Health Human Research Ethics Committee (external website)

University HRECs

Ethics approval by a university HREC cannot be accepted in place of a certified lead HREC under the NMA or WA Health HREC under the single site review.

For research seeking recruitment of CAHS patients and/or CAHS staff or use CAHS facilities, ethics approval from the CAHS HREC (or other WA Health HREC or certified HREC in accordance with NMA) must be obtained. 

WA Health institutions cannot currently accept the ethics approval granted to a project by a university HREC. University HRECs may choose to accept the ethics review of the CAHS or other WA Health HRECs.

Other matters requiring Ethics approval

  1. Access to unapproved therapeutic goods – Authorised Prescribers
  2. Case Report: Please confirm with the HREC office regarding the process and documentation requirements

To amend an authorised research project or to meet the requirements of research monitoring (such as safety reporting and progress reports) please complete the required submission within RGS. Information is available in RGS under the Title Governance Monitoring Forms.

Additional information is available in our Standard Operating Procedures for the Approval of Research (PDF).

All Safety Reporting should adhere to the NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods (2016). NHMRC has also developed other documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods. 

This supplementary guidance covers the following topics:
  • Data Safety Monitoring Boards (DSMBs)
  • Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods
  • Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.

Please access these documents here.

To report an adverse event or Serious Adverse Event to CAHS as the sponsor of research please refer to HealthPoint (internal WA Health only).
Last Updated: 12/02/2025