Applying to HREC

The CAHS Human Research Ethics Committee (HREC) conducts ethics reviews and provides advice for all research involving the patients, staff, or resources of KEMH and CAHS, primarily encompassing research conducted at KEMH, 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 KEMH.

The CAHS HREC operates under the Guidelines of the:

Scientific content, safety profile and clinical implications of clinical trials are first considered by the Clinical Trials Sub-Committee (CTS) prior to review by the HREC.

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

Governance Authorisation is required from KEMH Research Governance prior to the commencement of any human research which is run by KEMH staff or involves KEMH patients, their tissue or their data.

Ethical Approval may be provided by CAHS HREC or another lead HREC under the National Mutual Acceptance (NMA) Scheme (external site).

For help with ethics and governance submissions please contact the REG Office team at:

KEMHethics@health.wa.gov.au or ResearchGovernanceOffice.KEMH@health.wa.gov.au

 

WA Health's Research Governance Service (RGS)

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.

To sign-up for RGS and create a new project workspace, please go to RGS website (external site).

For information on RGS and guidelines for researchers please refer to the RGS help Wiki (external site).

Help with RGS technical difficulties is available from the RGS Support team: RGS.Support@health.wa.gov.au

Single Centre Research review and approval process

  1. A completed, signed application is submitted to the HREC office via the Research Governance Service (RGS) (external site).
  2. When all the necessary documentation has been provided, including the CAHS Ethics application coversheet - checklist (Word), 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: (08) 6456 0516 or (08) 6456 8539

 

2024 member lists

CAHS HREC members list 2024 (PDF)

CAHS LREC members list 2024 (PDF)

Multi Centre Research review and approval process

National – NMA Scheme

Under the National Mutual Acceptance (NMA) (external site) 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) (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 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 (external site)

WA Health only – Single Ethics Review

In WA Health, there is a single-ethics review process (external site) 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.

Low and Negligible Risk Projects review and approval process

Risk profiles of research (Source: National Statement 2023 – chapter 2.1 (external site))

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 (PDF)).

Refer to the following documents for more information:

Clinical Trials

The World Health Organization (WHO) definition for a clinical trial is:

Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

Clinical trial interventions include but are not restricted to:

  • experimental drugs
  • cells and other biological products
  • vaccines
  • medical devices
  • surgical and other medical treatments and procedures
  • psychotherapeutic and behavioural therapies
  • health service changes
  • preventive care strategies and
  • educational interventions

Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.

All clinical trial application must be reviewed by the Clinical Trials Sub-committee (CTS) prior to a full HREC review.

Clinical Trial / Interventional Research using Clinic D facilities must also complete and attach the CAHS Participant Safety Checklist for Interventional Research (Word) with their submission.

Refer to the following documents for more information:

In addition, the Australian Clinical Trials website (external site) has useful resources

Submission deadline

CAHS conducts one CTS meeting and one HREC meeting per month, with the exception of January.

There is one deadline date for both the CTS and HREC meetings.

There is no deadline date for low-risk ethics submissions.

Refer to the Schedule of CTS/HREC meetings (external site)

 

Review fees

Applications for new studies that are sponsored by external commercial agencies, e.g. pharmaceutical companies or other commercial bodies, incur a submission fee. Additional fees are charged for substantial amendments.

Fees are payable on submission prior to review.

Refer to the Schedule of Fees (external site)

Applications by researchers for non-sponsored research do not attract a submission fee.

Competitive research grant-funded applications do not incur a fee.

If the research is not considered to be a commercially funded project but has significant external funding, please contact the governance office to confirm if there will be a fee or if in-kind support will be available.

Submission requirements

All applications for research approval are submitted via the RGS website (external site).

The following documents are required for all studies and must be provided when submitting a research application for ethics review:

  • Ethics application form:

    WA Health Ethics Application Form (WAHEAF)
    OR
    WA-Specific Module (WASM) + Human Research Ethics Application (HREA)
  • Research protocol

In addition to the above, the following documents should be provided as required:

  • Participant information sheet and consent form (PICF)
  • Recruitment documents e.g.: letters, email template, poster, flyer, advertisement etc.
  • Data collection tools eg: questionnaire, survey, interview outline, focus group questions, data collection form, case report form etc.
  • Other participant documents eg: participant identification card, diary etc.
  • Investigator Brochure (for clinical trials involving a drug or device)
  • Other relevant HREC approvals e.g. WAAHEC
  • Radiation Safety Officer / Radiological Council report (external site)

 

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
  • 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.

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:

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 KEMH and you are encouraged to engage a Biostatistician in the early stages of your project.

 

Investigator's brochure (if applicable)

The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the product in human participants.

General considerations for an IB is outlined in the ICH Guideline for Good Clinical Practice E6 (R2) (external site)

Attach the Investigator's Brochure as a supporting document in RGS if it applies to your clinical trial submission.

 

Participant Information Sheet and Consent Form

The NHMRC templates are accepted by CAHS HREC and can be accessed at NHMRC Standardised PICFs (external site)

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 research ethics and governance (REG) office if you are unsure about version control requirements.

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

Waiver of consent and opt out consent

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 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 consent at a site level.

Additional HREC approvals

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 (external site) 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 (external site)

 

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 (external site).

Refer to the following websites for more information:

WA Data Linkage Branch website (external site)

Department of Health Human Research Ethics Committee (external site)

 

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 KEMH patients and / or KEMH staff or use KEMH 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.

Amendments and monitoring

Any changes to an approved research study must be approved by HREC prior to implementing the changes. This is done by submitting an Amendment application (PDF) via the Monitoring tab in the RGS workspace.

Amendments that are considered minor may be approved out of session by the REG office.

Amendments that are considered substantial are triaged according to the level of review the project first underwent:

  • Low risk review – review by Low Risk Ethics Committee (LREC) out of session
  • Clinical Trial – review by the Clinical Trial Subcommittee (CTS) at a scheduled meeting (may also be referred to HREC)
  • HREC – review by HREC at a scheduled meeting

 

HREC Approval extensions

CAHS HREC approval is for 3 years initially.

Approval up to a further 3 years may be approved out of session by the REG office.

Approval beyond 6 years requires review and approval by HREC.

To request an extension of HREC approval, an Amendment application (PDF) must be submitted to HREC via RGS.

 

Progress reports

It is a condition of approval that an annual progress report (PDF) be submitted on the anniversary of approval to the approving HREC.

Progress Reports may be approved out of session by the REG office.

Progress reports are submitted via RGS in the Monitoring tab of the project workspace.

 

Safety reporting in clinical trials

Annual safety reports (PDF) are required to be submitted on the anniversary of approval to the approving HREC for clinical trials.

Annual safety reports may be approved out of session by the REG office.

All Safety Reporting should adhere to the NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods (2016) (external site).

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.

These documents are available at Safety monitoring and reporting in clinical trials involving therapeutic goods (external site)

Safety reports are submitted via RGS in the Monitoring tab of the project workspace.

To report an adverse event or Serious Adverse Event to CAHS as the sponsor of research please refer to HealthPoint (internal WA Health only).

 

Final reports

A Project Final Report (PDF) is required to notify the HREC that the project is completed and all sites have been closed.

Each site in a project must be closed before the project itself can be closed. Site final reports are required to be completed and submitted to each site RGO when a project is complete.

The Project Final Report is also completed if the project closed prior to the expected completion date.

For a single site study – a site final report submitted to both HREC and RGO is sufficient to close the project workspace.

Site final and Project Final reports are submitted via RGS in the Monitoring tab of the project workspace.

Additional information regarding research monitoring requirements is available:

Last Updated: 12/11/2024