Applying to HREC

The CAHS Human Research Ethics Committee (HREC) conducts ethical reviews and provides advice for all research involving the staff, patients or resources of CAHS, primarily encompassing research conducted at Perth Children’s Hospital (PCH), Community Health, Mental Health and affiliated organisations. 

The CAHS HREC is the HREC for our collaborators for projects conducted on site at CAHS. 

The CAHS HREC operates under the Guidelines of the NHMRC National Statement on Ethical Conduct in Human Research (2007) and the WA Health Research Governance Framework. Scientific content and clinical implications of projects are considered by the Scientific Advisory Safety Committee (SASC) prior to review by the HREC.  

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All projects conducted at a CAHS site require approval via WA Health’s Research Governance Service (RGS). The RGS is an online application submission service. All new HREC applications and all governance applications must be submitted using this service.  

For assistance with using the system and to find more information please visit the RGS website (for optimum website performance, please use Google Chrome or Internet Explorer 11).  

For information on RGS and guidelines for researchers please refer to the RGS help Wiki. 

Help with RGS is available from the Research Support team at CAHS and RGS.Support@health.wa.gov.au. 

  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, the project is included on the agenda for a Scientific Advisory Safety Committee (SASC) meeting (see schedule) where the scientific content is reviewed. 
  3. The SASC assess the project according to the National Statement with particular reference to scientific methodology and provide feedback to the investigators regarding any clarifications or revisions required prior to recommending the project to HREC for further consideration. 
  4. Communication to the research team following SASC review is via the RGS.
  5. Once recommended by the SASC the project is included in the next CAHS HREC agenda. 
  6. The project is then reviewed at the HREC meeting and is either: 
    1. Approved with no changes
    2. Approved subject to specific requirements of the committee being addressed
    3. To be resubmitted to HREC for further review following receipt of requested amendments 
    4. Rejected 
  7. The outcome of the HREC meeting will be communicated to the investigator via the RGS.  
  8. Upon ratification of the recommendations of the HREC by the Chief Executive, formal authorisation is sent to the investigators of approved studies (via the RGS and also signed letter). 
If you have any questions about the process or requirements please contact the HREC administrative team on 6456 0516.
Since 31 August 2017, WA Health has been a member of the National Mutual Acceptance (NMA) scheme. 

Under the NMA, all multi-centre research projects being conducted at public health organisations within the participating jurisdictions (Queensland, NSW, ACT, Victoria and South Australia) must be ethically and scientifically reviewed only once by a NHMRC Certified Lead HREC participating in the NMA. The exception is those research projects that require additional specialist review (refer to NMA documents below for further information). CAHS HREC is a NHMRC certified Lead HREC. 

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) (external site) 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 coordinating principle investigator is responsible for organising submission of documents for scientific and ethical review by an appropriate lead HREC. 

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

Since September 2013, there is a single-ethical review process in place within WA Health whereby multi-centre projects to be undertaken at more than 1 WA Health site but not occurring outside WA need ethics approval from only one WA Health HREC. CAHS HREC is the HREC with expertise and certification in paediatric research. 

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

The National Health and Medical Research Council (NHMRC) defines research as “low risk” where the only foreseeable risk to the participant is discomfort. Research is of “negligible risk” where the only foreseeable risk to the participant is inconvenience (NHMRC Statement on Ethical Conduct in Human Research, 2007 (Updated 2018)).

The Low and Negligible Risk (LNR) ethical review pathway is a process for examining studies where the foreseeable risk to the participant is either low or negligible. All submissions are made via the Research Governance Service (RGS).

Here's the 2022 - 2023 schedule of meetings for the Ethics Committee and Scientific Safety Committee and the HREC application fee schedule.
 
The membership of the CAHS HREC conforms to the requirements set out in the NHMRC National Statement on Ethical Conduct in Human Research and includes the minimum of one third of the members from outside the Health Service. 

A statement confirming the CAHS HREC compliance with the National statement requirements is available on request to the Ethics Office.

Applications for review by the CAHS HREC should be submitted to the Ethics office via the RGS by the submission date and must include: 

Health Research Ethics Application (HREA)

To be uploaded as supporting document in RGS plus Western Australian Specific Module, WASM (completed online in RGS) or WA Health Ethics Application form - completed online in RGS (only to be used for projects occurring solely in WA).

Protocol 

All research conducted in WA Health must have a protocol. The protocol is a document that describes how the research project will be conducted, describing the background, aims and hypotheses, design/methodology and statistical/analysis plan. A well-developed protocol ensures the safety of the participants and integrity of the data collected and increases the likelihood that the project will be seen to a successful conclusion, generating publishable and/or translatable findings. 

The World Health Organisation website has a summary of what is typically included in a good research protocol.

There are many protocol templates available and the exact format/template used is less important than the quality of the content. Any well thought out format and style is acceptable, but WA Health has prepared several templates to assist those who do not already have a preferred template:(see under Research Protocol Templates). Only include sections relevant to your project and delete the instructions/notes prior to submission. The protocol should be attached as a supporting document in RGS. 

Please note that statistical support for your project is available within CAHS and you are encouraged to engage a Biostatistician in the early stages of your project. Find out more about the support available from CAHS. 

Investigator brochure (if applicable)

Attach the Investigator brochure as supporting document in RGS.

Participant Information Sheet and Consent Form

The NHMRC templates are accepted by CAHS HREC  and can be accessed here at Participant Information and Consent Forms. Attach these as supporting document(s) in RGS.

It is advised that children considered to be mature enough to understand the project and provide consent are provided with the equivalent of the parent information sheet and can co-sign the consent form with the parent. Those children not considered mature enough to fully understand and consent should be involved in the discussion about the project and provided with a simplified information sheet but do not sign any form. The consent discussion with the child should be documented in the participant notes, particularly the degree of involvement of the child.

Diary, questionnaire(s), brochure, advertising material etc

If these are applicable, attach as supporting document(s) in RGS.

Please ensure that the protocol, information/consent forms, other participant documents (eg questionnaires) have a version number and/or date in the document footer – the document title in the footer should reflect the title on the front page of the document. 

The same title should also be reflected in the naming of the document when submitted in RGS. Please ask for help from the ethics office if you are unsure about version control requirements.

WA Health employees can access further guidelines and document templates via HealthPoint (internal WA Health only). 

Two letters of approval are required before your research project can commence - an ethics approval letter from the approving HREC (which may be CAHS or another lead HREC under NMA) and an authorisation letter from the Child and Adolescent Health Service. 

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). 

Where participant recruitment involves opt-out consent, which is characterised by:
  • providing information to the potential participant about the research and their involvement
  • participation is presumed unless action is taken to decline.

A specific request for approval of this recruitment process must be included in the application to the HREC. All sub-sections of section 2.3.6 (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 the consent section of the HREA.

Please confirm with the 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 consent at a site level.

Aboriginal and Torres Strait Islander people

The Office of Aboriginal Health of the Department of Health WA in partnership with the Western Australian Aboriginal Community Controlled Health Organisations established the Western Australian Aboriginal Health Information and Ethics Committee in August 1996. This has since been renamed the Western Australian Aboriginal Health Ethics Committee (WAAHEC) and now sits within the Aboriginal Health Council of WA.  

WAAHEC is registered with the Australian Health Ethics Committee of the National Health and Medical Research Council 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 of WAAHEC to 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 Western Australian Aboriginal Health Ethics Committee (WAAHEC) Values and Ethics Statement and the ethics application form. 

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

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.

If you are interested in how to access WA’s state-of-the-art data linkage as part of a research project, it can be helpful to attend a workshop that explains how this niche area of research works. The WA Data Linkage Branch now offers a tailored workshop for researchers and other applicants interested in applying for linked data.

Both new and experienced researchers can benefit from the workshop, which covers these core essentials:
  • the data linkage process
  • the preparation of data
  • the datasets available to researchers
  • ethical considerations
  • the application process.
To find out about upcoming workshops visit the WA Data Linkage Branch website.

University HRECs

Where the Project Initiator (PI) is a staff member of a Western Australian university but the project will recruit CAHS patients and/or involve CAHS staff or 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 ethical approval granted to a project by a university HREC. University HRECs may choose to accept the ethical 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 2MB).

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: 13/03/2023