Making a submission
The WA Health Research Governance Framework governs the scientific, ethical and site governance review and approval, and the conduct and monitoring of human research within WA public health organisations.
The policy and procedures apply to WA Health employees and non-WA Health employees (including clinical and non-clinical university academics) who propose to undertake, manage, review and govern human research involving patients, their tissue or data accessed through WA Health.
Research projects cannot commence at KEMH until they have:
- ethical and scientific approval (HREC approval)
- site governance approval
The ethical and site governance reviews are independent processes, but usually conducted in parallel.
KEMH retains the right not to authorise a research project at its site, even if the project has ethical approval and/or site approval at other institutions.
Preparing a research budget
All research projects conducted in WA Health must have a budget that accounts for the cost of the project and allocates funding to cover those costs. Funding can be monetary or ‘in-kind’, but there must be a source of funding attached to all costs, including staff time and consumables.
Many researchers find completing a budget for their project to be challenging. There are a number of presentations and resources available to assist:
For additional assistance in compiling clinical trial budgets (and other research projects) refer to Independent Hospital Pricing Authority's (IHPA) Development of standard costs for conducting clinical trials in Australia (external site)
Clinical trial registration
Trial registration involves posting the details of a trial’s design, conduct and administration on a publicly accessible database known as a clinical trial registry. The National Statement (external site) obligates researchers to ensure that their clinical trial is registered in a publicly accessible database before recruitment of the first participant.
The International Committee of Medical Journal Editors (ICMJE) (external site) also has a policy requiring trial registration prior to publication. The Declaration of Helsinki now also states that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”
Trial registration is also important for participant recruitment because it allows people interested in participating in a clinical trial to search for relevant clinical trials on a single website. Registration also assists health professionals to identify relevant trials for their patients.
Researchers should register trials as early as possible and ensure information such as contact details and trial status is kept up to date. The details of trial registration are required in RGS.