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 7 of the Research Governance Procedures.
**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
The process of ethical approval and monitoring of research within the Women and Newborn Health Service is detailed in the WNHS Human Research Ethics Standard Operating Procedures (PDF). 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 not approved. 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 authorisation by the WNHS Director of Clinical Services for the project to proceed. Upon ratification of the recommendations of the HREC and RGO by the WNHS Director of Clinical Services, a formal letter of approval will be sent to the investigators of approved studies. Research can then commence.
Neonatology research projects may require site authorisation from both CAHS (PCH) and WNHS (KEMH), depending on what access is required in carrying out the research project e.g. patients, staff, data, samples, facilities. Please view the Research Governance Requirements for Neonatology Projects (PDF) for more information.
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 more information please visit the Multi-Centre Research Information Page on the RGS.
Post approval monitoring