Ethics
In line with the centralisation of ethics approval for all Western Australian health and medical research, all new child health ethics applications may now be submitted to WA Health’s Central HREC (Human Research Ethics Committee) 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.
CAHS HREC operates under the following Guidelines, all of which are also accessible from our Resources page:
- National Statement on Ethical Conduct in Human Research
- Australian Code for the Responsible Conduct of Research
- WA Health Research Governance Framework
- ICH Guide to Good Clinical Practice
For important information regarding the ethics review process at CAHS, refer to the following documents:
- HREC Terms of Reference
- Clinical Trials subcommittee Terms of Reference
- Low Risk Ethics Committee Terms of Reference
- CAHS Research Ethics & Governance Standing Operating Procedures.
Maintaining integrity across CAHS research
Three key documents outline CAHS expectations for good research conduct. These documents also detail the processes in place for managing potential breaches of the Australian Code for the Responsible Conduct of Research.
They are:
- Research Policy
- Investigator Responsibilities – Research
- Managing Potential Breaches in the Conduct of Research
Anybody concerned about potential breaches of good research conduct can seek the counsel of 5 trained Research Integrity Advisors:
- Professor Tim Jones, Diabetes and Endocrinology, CAHS Director of Research
- Professor Elizabeth Davis, Head of Department, Diabetes and Endocrinology
- Ms Arielle Jolly, Research Co-ordinator, Paediatric Critical Care
- Dr Santosh Valvi, Consultant, Oncology and Haematology
- Dr Weihao Lee, Paediatric Registrar, Emergency Department.
The advisors are available to provide guidance and advice on issues relating to potential breaches of conduct such as conflicts of interest, authorship disputes or concerns about the management of participants in a study. Each advisor is an experienced clinician with substantial research experience and additional training to further equip them in their advisory role.
Individuals who reach out to an advisor with conduct-related concerns can expect their initial inquiries to be kept confidential. The advisors will be able to advise whether the concerns warrant submission of a formal breach complaint. They can also give direction on next steps.
Review and approval processes for:
- A completed, signed application is submitted to the HREC office via the Research Governance Service (RGS).
- 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:
- Low risk research – low risk applications will be reviewed by members of the CAHS Low Risk Ethics Committee (LREC) out of session.
- 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.
- Full HREC review – research not deemed “lower risk” and not a clinical trial/intervention, will be reviewed by the HREC at a scheduled meeting.
- 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.
- 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:
Phone
(08) 6456 0516 or (08) 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, see Resources)
| Lower risk |
Higher risk |
||
| Minimal | Low | Greater than low | High |
|
No risk of harm |
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 (see the NMA Standard Principles for Operation on our Resources page).
Refer to the following documents for more information, also accessible from Resources.
- Low Risk Ethics Committee Terms of Reference
- Research Ethics & Governance Standard Operating Procedures for the Approval of Research
- National Statement on Ethical Conduct in Human Research
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.
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). See Resources.
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:
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 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
- Access to unapproved therapeutic goods – Authorised Prescribers
- 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.
Submit 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 Safety monitoring and reporting in clinical trials involving therapeutic goods (NHMRC). See Resources.
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). See Resources.
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 complete, 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.
For additional information regarding research monitoring requirements refer to CAHS Standard Operating Procedures for the Approval of Research (see Resources).