Research Governance Information and Tips

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 East Metropolitan Health Service (EMHS) sites until they have:

  1. ethical and scientific approval (HREC approval) and
  2. site governance approval

The ethical and site governance reviews are independent processes, but usually conducted in parallel.

EMHS retains the right not to authorise a research project at its sites, even if the project has ethical approval and/or site approval at other institutions.

All human research conducted within WA Health must undergo a site specific assessment (SSA) which is the mechanism for professional, legal and financial accountability and transparency and is consistent with the NHMRC’s Australian Code for the Responsible Conduct of Research 2018 (external link) (the Code).

Review of the SSA is a governance process separate to ethical and scientific review and can be conducted in parallel to the ethics approval process. It is not necessary to await the ethics outcome before preparing and submitting an SSA Form.

Investigators must complete a SSA Form (or Access Request) for each site involved with the project via the Research Governance Service (RGS). On submission, this is reviewed by an EMHS Research Governance Officer (RGO), who provides guidance to assist EMHS to be sure it is meeting its obligation for the effective governance of research involving humans.

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. WA Health’s Research Development Unit has a number of presentations and resources available to assist:

For assistance in calculating salary related research costs and completing the budget section of the SSA form, the following template and example are available:

Please note, these are offered as examples. Please ensure you speak with your Business/Operations Manager to ensure you use the correct rates, allowances and most up to date costing procedures applicable to your project budget.

For additional assistance in compiling clinical trial budgets (and other research projects) refer to Independent Hospital Pricing Authority's (IHPA) Determination of Standard Costs Associated with Clinical Trials in Australian June 2015 (external link).

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 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) 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.”

This approach is supported by the ICMJE, which includes many of the world’s leading journals. In 2004, ICMJE declared that they would not consider a trial for publication without evidence that it had been registered in a publicly accessible clinical trials registry prior to enrolment of the first participant.

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.

Last Updated: 08/05/2019