Application and approval process
Research ethics and governance applications are submitted to the Research Ethics and Governance Office (REGO) via the recently introduced Research Governance Service (RGS). Research Governance assessment commences following receipt of the Governance forms and takes place independently of the Ethics application process. The WNHS Human Research Ethics Committee (HREC) meets on the first Tuesday of the month, February to December (there is no meeting in January). The date of the HREC meeting is the deadline for submission for consideration at the next meeting’s agenda. SASC assessment occurs 1 week after the submission deadline (see schedule, right).
The WNHS HREC considers single-site applications and can approve WA Health multi-centre studies within its specific area of expertise or site jurisdiction. The application process requires access to RGS and registration as a research user. This site also contains the forms for research governance assessment. Monitoring and reporting will be accomplished via RGS in the latter half of 2017 (phase II); until then the old forms will continue to be used.
Applications that involve Aboriginal Australians as a specific focus will require Western Australian Aboriginal Health Ethics Committee (WAAHEC) (external site) approval in addition to WNHS HREC approval. All projects using linked data also require approval from the Department of Health WA Human Research Ethics Committee (external site).
For WNHS-based projects, where the coordinating principal researcher (CPI) will be responsible for submitting both the ethics and governance application forms and subsequent reports, the application and approval process is summarised in a simple flow chart. WNHS single site applications typically require completion of the following application forms:
- WA Health Ethics Application form (completed electronically via RGS)
- WNHS Participant Information and Consent forms (note these differ from the standard WA Health versions; see Supplementary links, right)
- WA Health Research Protocol Template (for clinical trials or non-clinical trials)
- WA Health Site-specific assessment form (SSA) – completed electronically via RGS*
- WA Health Research Conflict of Interest form.
- WA Health Declaration of Confidentiality (for non-WA Health employees)**
*If the research requires access to WA Health patients or personnel (or their tissues/data) but is not being conducted on-site, or on the participants directly (e.g. requires access to participants’ tissues or data, or distribution of letters/leaflets), then a WA Health Access Request form should be submitted instead of the SSA form. See section 2.5 of the WA Health Research Governance Policy and Procedures 2012 (external site).
**The Declaration of Confidentiality is not project specific and is only required to be signed once; it is then filed to cover all research conducted at WNHS.
Clinical trials must be lodged on a clinical trials registry and, if not already TGA approved, accompanied by a CTN template to allow on-line submission of a CTN application by the REGO (see Supplementary links, right). A Clinical Trial Research Agreement or similar plus other documentation may also be required, depending on the nature of the study and its funder/sponsor. Full details are in section 2 of WA Health Research Governance Policy and Procedures 2012 (external site).
The ethics and governance approval process
Ethics applications are reviewed at the HREC meeting and either approved with no changes, approved subject to specific amendments being made, resubmitted to HREC for further review following receipt of requested amendments, or rejected. While ethical review takes place, the Research Governance Officer reviews all applications to ensure they comply with the WA Guidelines and have the appropriate approvals and documentation. The REGO will liaise with the investigators if inadequate or insufficient documentation regarding the proposed study is received. A budgetary template is available from the RGS site (external site).
NOTE: All research governance requirements must be met before the application receives final approval from WNHS Chief Executive for the project to proceed. Upon ratification of the recommendations of the HREC and RGO by the Executive Director Medical Services, a formal letter of approval will be sent to the investigators of approved studies. Research can then commence.
Multi-centre studies
WA Health is committed to a single ethical review process for all multi-centre human research conducted in WA. This process entails the scientific and ethical approval of research by a single lead HREC (which may or may not be in WA). However, research governance approval will be required from the relevant Research Governance Officers at each WA site.
For multi-centre studies (e.g. large national or international clinical trials) the coordinating principal investigator is responsible for organising submission of documents for scientific and ethical review by an appropriate lead HREC. Principle investigators at each site must submit applications for governance review and will be responsible for local approvals and compliance. Multi-centre studies submitted for ethics approval in WA, whether originating from WA or other states must be submitted on a NEAF and be accompanied by the WA-Specific Module together with the appropriate research governance forms. Full details are outlined in WA Health Research Governance Policy and Procedures 2012 (external site), including details of exceptions and exclusions to the policies outlined above.
Post approval monitoring
- The principal investigator is required to submit a progress report to the HREC & REGO annually which is reviewed by the SASC and the HREC.
- All amendments/changes or request for extension of time must be submitted to the HREC for approval.
- All Adverse Events (AE) and Serious Adverse Events (SAE) must be reported to the Ethics Committee within 24 hours.