WA health system ethics reform: researchers
At each step of the reform, researchers will receive updates via various channels from the Department of Health (the department), the Research Governance Service (RGS), and Health Service Provider (HSP) ethics offices outlining the impact of any changes and seeking feedback about the process.
The department and HSPs will endeavour to minimise disruption during transition to the WA Health Central Human Research Ethics Committee (Central HREC).
On 21 August 2024, Phase 2A of the reform commenced with the Central HREC undertaking the review of new applications intended for review by the DoH, Royal Perth Hospital (RPH) and North Metropolitan Area Mental Health Service (NMAMHS) HRECs.
On 16 September 2024, Phase 2B of the reform commenced with the Central HREC taking over the ethics review of new, more than low risk, non-NMA projects intended for review by Sir Charles Gairdner Osborne Park Healthcare Group (SCGOPHCG) HREC.
If you have recently submitted or intend to submit a new project application to an HREC which is no longer reviewing new more than low risk, non-NMA research proposals, the application will be redirected to the Central HREC.
The relevant ethics office and CORE will contact affected researchers to facilitate any changes required to the affected RGS workspaces.
Until you are advised otherwise. monitoring submissions (amendments, safety reports, annual progress reports and site and project final reports) should continue to be submitted to the HREC that provided ethics approval for the project. Oversight of all previously approved projects will be progressively transferred to the WA Health Central HREC with the system-wide integration anticipated to be complete by mid-2025.
When the Central HREC is fully operational, all submissions for ethics review should be sent to the Central HREC via the RGS, and queries should be directed to the CORE staff at HREC@health.wa.gov.au
Research governance process
Research governance processes will not change as part of the ethics reform and the research governance offices will continue to operate as usual. Governance submissions should be submitted to the relevant research governance office/s as usual.
Approved projects
At this stage, there will be no change for projects which have already received ethical approval. Monitoring submissions for ethics review (amendments, annual progress reports, safety reports, and site and project final reports) will continue to be reviewed by the HREC(s) who first approved the project.
Ethics monitoring (post-approval) submissions
For existing approved projects, researchers should continue to send monitoring submissions (amendments, annual progress reports, safety reports, and site and project final reports) to the HREC(s) that approved the project.
When the WA Health Central HREC has the operational capacity to oversee monitoring submissions, existing projects will be progressively transferred across from the approving HREC to the Central HREC.
Submissions to the WA Aboriginal Health Ethics Committee (WAAHEC)
Submissions to WAAHEC will continue to be managed via their existing processes. WAAHEC is a specialist HREC that operates externally to WA Health and is therefore outside the scope of this reform.
Please refer to the WAAHEC website for more information on their submission processes: Western Australian Aboriginal Health Ethics Committee – AHCWA (external site).
New projects
Existing ethics offices based in the health service providers (HSPs) will be able to advice about the submission of new projects throughout the reform implementation. The CORE can provide additional support, if required.
Where a redirection or resubmission needs to occur, projects will be redirected to an HREC with the capacity to provide a review that complies with the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research (The National Statement) (external site).
This process will be supported by staff at HSP ethics offices and the CORE to ensure a smooth transition.
More information
For more information on the reform, contact the CORE via HREC@health.wa.gov.au
Last reviewed: 02-10-2024
Produced by
Office of Medical Research and Innovation