Background
The Department of Health research governance framework governs the scientific, ethical and governance review, approval, conduct and monitoring of human research within WA public health organisations. The Research Policy Framework specifies the research requirements that all Health Service Providers (HSPs) must comply with in order to ensure effective and consistent research activity across the WA health system. Under this policy framework HSPs and the Department of Health must comply with all mandatory requirements related to the Department of Health Research Governance Policy and the Research Governance Procedures. The Research Governance Service (RGS) supports the framework and single ethical review of multi-centre research, by hosting standard ethics and governance forms and agreements, as well as facilitating the research governance approval and monitoring process of projects. |
This Policy outlines the principles that WA health system entities must uphold under the National Health and Medical Research Council (NHMRC) Australian Code for the Responsible Conduct of Research and the NHMRC National Statement on Ethical Conduct in Human Research (National Statement), to ensure research is conducted with the highest ethical and scientific standards and is appropriate to be undertaken at a specific site. It is recognised that the high quality, accountable and responsible research underpins the delivery of contemporary health policy and practice.
WA health system entities must ensure that all human research is reviewed, approved and monitored in accordance with the Research Governance Procedures.
All processes described in these policy requirements must be performed through the RGS where applicable, as described in the Research Governance Procedures.
Research governance ensures that the principles, requirements and standards of research are upheld. It addresses the protection of research participants, the safety and quality of research, privacy and confidentiality, financial probity, legal and regulatory matters, risk management, and monitoring arrangements. Effective research governance promotes a positive research culture and sustainable practices that facilitate the conduct of high-quality clinical research.
Research governance consists of:
- ethical and scientific review by a Human Research Ethics Committee (HREC) or appropriate other ethical review body
- site authorisation by each participating site, following review by the Research Governance Office (RGO)
- monitoring by HRECs and sites throughout the project life cycle.
These Procedures describe the mandatory requirements that apply to WA health system entities for implementing research governance for their site/s. These mandatory requirements apply to human research activities only. They do not apply to research involving animals or nonresearch activities.
These Procedures are mandatory pursuant to the Research Governance Policy and are applicable to all WA health system entities.
