- Human Research Ethics Committees (HRECs)
- Ethics Application Forms
- Research Protocol Templates
- Patient Information Consent Forms (PICFs)
- Ethics Amendment and Monitoring Forms
Human Research Ethics Committees (HRECs)
Human Research Ethics Committees (HRECs) provide guidance to assist an institution in meeting its obligation for the effective governance of research involving humans. The role of an HREC is to provide an ethical review of the proposed research including consideration of:
- the scientific design and proposed conduct of the study
- how participants will be recruited including the means of obtaining consent
- care and protection from harm of research participants
- protection of research participants’ confidentiality
All human research conducted in WA Health must undergo ethical and scientific review, approval and monitoring by a HREC registered with the National Health and Medical Research Council's (NHMRC) Australian Health Ethics Committee (AHEC) and operating in accordance with the NHMRC “National Statement on Ethical Conduct in Human Research” 2007 (external site) (National Statement). Scientific and ethical approval must be obtained and form part of the governance approval, prior to a request for authorisation to the Chief Executive or delegate.
Investigators conducting single-centre research within WA Health should apply to their site's local HREC for ethical approval. For multi-centre research investigators should utilise the WA Health Single Ethical Review process (from the 1 September 2013) until the National Mutual Acceptance and National Approach processes are implemented within WA Health (refer to multi-centre research webpage for more information).
Ethics Forms are located below. Governance Forms are available on the Research Governance webpage.
The WA Health Research Governance Framework (policy and standard operating procedures) provides further information on WA Health ethical and governance review processes. Information on specific ethical and scientific review processes at each Health Service can be obtained from the relevant site or Health Service, through the contacts below.
Western Australian Human Research Ethics Committees registered with the NHMRC (external site).
WA Health and Specialist Human Research Ethics Committees
|HREC||Facilities covered by the HREC||Chair||Executive Officer||Contact details||National Approach Certified HREC||WA Health Single Ethical Review Process|
|Child and Adolescent Health Service (CAHS)|
|Princess Margaret Hospital for Children Ethics Committee||Princess Margaret Hospital for Children||Magistrate Jenny Hawkins||
Ms Anne O’Leary
Princess Margaret Hospital for Children
GPO Box D184
PERTH WA 6840
P: (08) 9340 8221
|North Metropolitan Health Service (NMAHS)|
|North Metropolitan Health Service, Mental Health Human Research Ethics Committee||North Metropolitan Health Service, Mental Health
||Prof Mathew Martin-Iverson||Ms Camelia Zota||Human Research Ethics Committee
Locked Bag No. 1 CLAREMONT WA 6910
P: (08) 9347 6502
|Sir Charles Gairdner Hospital Group Human Research Ethics Committee||Sir Charles Gairdner Hospital Group
||Hon Hal Jackson||Mr Sean Howarth||Human Research Ethics Committee Office
2nd Floor, A Block
Sir Charles Gairdner Hospital,
Hospital Avenue NEDLANDS WA 6009
P: (08) 9346 2999
|Women and Newborn Health Service Ethics Committee||King Edward Memorial Hospital||Hon Gavin Fielding||Ms Karen Taylor
Ethics Committee Secretary
Princess Margaret Hospital for Children
GPO Box D184
PERTH WA 6840
P: (08) 9340 7845
|South Metropolitan Health Service (SMAHS)|
|Royal Perth Hospital Human Research Ethics Committee||Royal Perth Hospital
||Prof Frank Van Bockxmeer||Mr Mark Woodman
Level 5, Colonial House
Royal Perth Hospital
Perth WA 6000
P: (08) 9224 7006
|South Metropolitan Health Service Human Research Ethics Committee||Fremantle Hospital
Rockingham Health Service
Kwinana Health Service
|Dr Phillip Claringbold||Ms Amanda Carter
|Human Research Ethics Office
South Metropolitan Health Service
PO Box 480
FREMANTLE WA 6959
P: (08) 9431 2929
|Western Australia Country Health Services (WACHS)|
|WA Country Health Service Board Research Ethics Committee||WA Country Health Service
||Prof Samar Aoun||Ms Martine Carroll||WACHS Board Research Ethics Committee
WA Country Health Service
189 Wellington Street
PO Box 6680
EAST PERTH BUSINESS CENTRE WA 6892
|Coronial Ethics Committee WA||Office of the State Coroner WA
(not WA Health)
|Dr Adrian Charles||Ms Kate Ellson
|Coronial Ethics Committee
Coroner’s Court of WA
Level 10 Central Law Courts
501 Hay Street
PERTH WA 6000
P: 9425 2918
|Note: All human research projects that require access to coronial samples, data or information must be referred to the Coronial Ethics Committee WA. For further information refer to the WA-Specific Module.|
|Department of Health WA Human Research Ethics Committee||Department of Health WA||A/Prof Judy Allen||Michelle King||Department of Health WA Human Research Ethics Committee
Level 1, C block
189 Royal Street EAST PERTH WA 6004
P: (08) 9222 4278
|Note: The use or disclosure of personal information from the Department of Health WA (DoHWA) data collections for use in research must be approved by the DoHWA HREC. For further information refer to the WA-Specific Module.|
|Western Australian Aboriginal Health Ethics Committee||Aboriginal Health Council of WA
(not WA Health)
|Ms Tammy Prouse||Ms Chelsea Bell||Western Australian Aboriginal Health Ethics Committee
2 Bulwer Street
PERTH WA 6000
|Note: Approval by the WA Aboriginal Health Ethics Committee (WAAHEC) is required before you may conduct health and medical research if Aboriginality is a key determinant or explicitly directed at Aboriginal people. For further information refer to the WA-Specific Module.|
Ethics Application Forms
The following ethics forms are to be used throughout WA Health for the ethical and scientific review of research projects. They should be submitted to the relevant HREC and include:
National Ethics Application Form (NEAF) & Western Australian-Specific Module (WA-Specific Module)
The NEAF can be used for ethical and scientific review irrespective of risk for both single-centre and multi-centre research projects involving humans. It is mandatory for ethics applications utilising the National Mutual Acceptance and National Approach processes. The NEAF is available from www.neaf.gov.au.
For health and medical research projects conducted within WA or intending to access WA participants, tissue or data the Western Australian-Specific Module (Word 232KB) must be completed in conjunction with the NEAF. This module addresses additional ethical issues, specific to WA that are not addressed in the NEAF and must be considered when conducting both single-centre and multi-centre research in WA. Within WA Health the WA-Specific Module must accompany all ethics applications using the NEAF.
The WA-Specific Module covers areas including:
- Recruitment of adults (18 years and over) who may lack the capacity to give consent
- The use of health information from the Department of Health Data collections and/or WA Health Biobanks
- Recruitment of Aboriginal people
- Recruitment of minors (aged less than 18 years of age)
- The use of human tissue from persons who were the subject of a post mortem
- A WA institution which functions in accordance with the Catholic Health Australia’s “Code of Ethical Standards for Catholic Health and Aged Care Services in Australia” 2001
- Human research in WA schools
WA Health Ethics Application Form (for research conducted within WA Health)
This form is available for use by investigators who are conducting human research projects within WA Health or accessing WA Health participants, their tissue or data; as an alternative to the NEAF plus WA-Specific Module. The WA Health Ethics Application Form (Word 674KB) can be used for ethical and scientific review, irrespective of risk, for both single-centre and multi-centre research projects (except when using the National Mutual Acceptance and National Approach). For the National Mutual Acceptance and National Approach processes, the NEAF plus WA-Specific Module must be completed.
Research Protocol Templates
The WA Health Research Protocol Template for Clinical Trials (MS Word) and the WA Health Research Protocol Template for Non-Clinical Trials (MS Word) are provided as a guide for investigators who do not already have a protocol for their research project. It is a requirement of WA Health that a protocol is submitted with the ethics application.
These templates are based on the Therapeutic Goods Administration “Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)” 2000 (external site) and the World Health Organisation “Recommended format for a Research Protocol” (external site). To meet Good Clinical Practice Guidelines the Protocol should contain, but not be restricted to, the information contained within these templates.
Patient Information Consent Forms (PICFs)
As part of the NHMRC National Approach to Single Ethical Review this suite of standardised Participant Information and Consent Forms (PICFs) has been developed and approved by representatives from all States and Territories, to serve as a starting point for researchers.
WA Health services are encouraged to utilise these standardised documents, which provide guidance and assist Researchers, Institutions and HRECs in the formulation of PICFs for both single-centre and multi-centre research projects.
The 12 forms are available from the NHMRC Human Research Ethics Portal (HREP) (external site).
The forms include three categories of participant as identified by the National Statement:
- Individual participant;
- Child participant; and
- Participants unable to provide consent.
Within each category of participant, three specific research type templates are available:
- Genetic Studies;
- Health and Social Science Studies;
- Interventional Studies; and
- Non-Interventional Studies.
These documents should be used as a minimum starting point for consent forms. Jurisdiction and study specific information should be added as necessary and sections that are not applicable to the research project may be removed as required.
Ethics Amendment and Monitoring Forms
The following ethics forms are to be used throughout WA Health to amend an authorised research project and meet the requirements of research monitoring. Please note the Department of Health HREC has their own specific Ethics Amendment Form (which is used for both Administrative and Substantial Amendments, this should not be used for any other WA Health HREC).
The forms should be submitted to the HREC responsible for approving the project and include:
- Department of Health WA HREC Amendment Form
- WA Health Ethics Administrative Amendment Form (Word 186KB)
- WA Health Ethics Substantial Amendment Form (Word 139KB)
- WA Health Annual Progress Report Form (Word 261KB)
- WA Health Final Progress Report Form (Word 336KB)
- WA Health Adverse Event Notification Form (Word 166KB)
- WA Health Protocol Deviation/Violation Notification Form (Word 182KB)
- WA Health Suspension/Early Termination Notification Form (Word 137KB)
- WA Health Research Complaint Form (Word 135KB)