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WA Health Central Human Research Ethics Committee
WA Health Central Human Research Ethics Committee
The WA Health Central Human Research Ethics Committee (HREC) provides ethical review of research involving humans, their biospecimens and/or their information and is bound by state and national policies and legislation.
The operation of the HREC is governed by the terms set out by the NHMRC in the National Statement on Ethical Conduct in Human Research 2023 (external site).
The WA Health Central HREC is charged with providing advice to both the WA Department of Health (the Department) and the wider WA health system on matters of ethical conduct in human research. The WA Health Central HREC is also responsible for the ethical oversight of human research involving the use and linkage of data held by the Department.
For more information about the operations of the WA Health Central HREC, please refer to the following documents below:
Central Office for Research Ethics
The Central Office for Research Ethics (CORE), based at the Department of Health provides administrative support to the WA Health research ethical review process.
If you have questions about the WA Health Central HREC application process, contact HREC@health.wa.gov.au or phone 08 9222 4214.
How to apply for ethics approval
All new research projects must be submitted through the Research Governance Service (RGS) information technology system. The RGS system can be accessed through the RGS website (external site).
Applicants for ethics approval
Applications should be finalised (proofread, edited, and corrected) before submission.
This particularly applies to participant information sheets and consent forms. Participant information sheets should be appropriate to the needs of the participants in each project and written in plain English. All projects requesting linked or un-linked statewide data must also complete and upload relevant data application forms after having received in-principle support from data custodians.
Please refer to the follow resources for more information:
Authorised prescriber information
Applications from medical practitioners seeking to become an authorised prescriber of an ‘unapproved’ therapeutic good should not be submitted via the RGS.
The medical practitioner’s application for HREC approval to apply for authorised prescriber status with the Therapeutic Goods Administration (TGA) must be made in writing and provide sufficient evidence to justify the use of the ‘unapproved’ therapeutic good. More information on applying to be an authorised prescriber can be found on the TGA website, the CORE, or via your relevant HSP research office.
Case reports and series information
Case reports or case series are considered anecdotal and can proceed without ethical review.
Case reports: a report of a single individual with a unique disease or condition.
Case series: a retrospective, noncomparative investigation that evaluates a group of patients with a known medical condition, disease, exposure, or who have undergone a similar procedure.
If publication of the findings is a possibility, researchers must discuss the publication with the participant (or their parent(s)/guardian if under 18 years of age) and obtain their signed consent to publish.
Where consent cannot be obtained, guidance must be sought from the relevant HSP on a case-by-case basis. The matter may be referred to the WA Health Central HREC if deemed necessary.
Research governance
Research governance (RG) offices provide guidance to assist a WA Health site in meeting its obligation for the effective governance of research involving humans.
The role of a Research Governance Officer (RGO) is to provide a governance review, involving a site-specific assessment (SSA) or access request review, prior to authorisation of a research project.
This process includes consideration of:
- the suitability of the site and the investigators to conduct the research
- the assessment and management of site risk
- the identification of actual and in-kind resources required to conduct the research
- scientific and ethical approval of the research project.
All human research conducted within WA Health must undergo a governance review which is the mechanism for professional, legal and financial accountability and transparency and is consistent with the NHMRC's Australian Code for the Responsible Conduct of Research 2018 (the Code).
The governance review is a separate process to the ethical and scientific review.
For further information about the research governance review process or about your obligations to obtain site authorisation, visit the Research Governance Office webpage on RGS.
Contact
For assistance with developing your research project or preparing a submission to the WA Health Central HREC, contact one of our local WA Health Service Provider (HSP) research offices for support.
Last reviewed: 21-06-2024
Produced by
Office of Medical Research and Innovation