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 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:

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 CAHS, please refer to the following documents:

Governance Authorisation is required from CAHS Research Governance prior to the commencement of any human research which is run by CAHS staff or involves CAHS 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. 

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

CAHS.Ethics@health.wa.gov.au or CAHS.RGO@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.

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

Help with RGS technical difficulties is available from the RGS Support team: 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, 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:

 

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 using the Western Australian Specific Module (WASM) and Human Research Ethics Application (HREA), not the Western Australian Health Ethics Application Form (WAHEAF).

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

Refer to the following documents for more information:

In addition, the Australian Clinical Trials website has useful resources:

Trial registration involves posting the details of a trial’s design, conduct and administration on a publicly accessible database known as a clinical trial registry. Researchers must ensure that their clinical trial is registered in a publicly accessible database before recruitment of the first participant. 

Trial registration is important for participant recruitment because it allows people interested in participating in a clinical trial to search for relevant clinical trials on a single website. Registration also assists health professionals to identify relevant trials for their patients. 

Researchers should register trials as early as possible and ensure information such as contact details and trial status is kept up to date. The details of trial registration are required in RGS. 

CAHS Templates for a Clinical Trial Master File

The following templates are available for your adaptation and use:

 

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.

 

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

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.

 

All applications for research approval are submitted via the RGS website.

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 e.g.: questionnaire, survey, interview outline, focus group questions, data collection form, case report form etc.
  • Other participant documents e.g.: 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 website)

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: 

WA Health Document 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.

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 website)

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 website)

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 (e.g. 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). 

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

Amendments

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 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 must be submitted to HREC via RGS.

Progress reports

It is a condition of approval that an annual progress report 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 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).

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 | NHMRC (external website)

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 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: 04/06/2024