Clinical Trials are a form of research design to find out the effects of an intervention, including a treatment or diagnostic procedure, and requires Human Research Ethics Committee (HREC) approval and governance authorisation.
ACU is committed to the highest standards of conducting and collaborating in clinical trials, whilst upholding ACU's mission and core values. Our staff, researcher's and students conducting research within ACU, in addition to the Code of Conduct, are required to adhere to ACU The Research Code of Conduct (the "RCoC") and ACU Clinical Trials Governance Policy.
ACU's Research Ethics and Integrity Office is available to assist with your Clinical Trial queries.
The definition of a Clinical Trial according to the World Health Organisation (WHO) is "any research study that prospectively assigns human participants or groups of humans to one or more health-related intervention to evaluate the effects on health outcomes".
The purpose of a Clinical Trial is to determine the efficacy of a product or treatment without exposing Clinical Trial participants to undue harm or risk.
The ACU HREC will provide the ethical review for a Clinical Trial that is being conducted at an ACU facility. Clinical Trials conducted at a hospital site must seek ethical approval from the designated hospital HREC. If multiple sites are involved, the National Mutual Acceptance scheme may be accessed if available, otherwise separate ethical approvals must be sought from each site.
All external HREC approvals require ratification by ACU HREC Committee
For more information about conducting Clinical Trials, the Clinical Trials Toolkit provides useful information and resources for conducting a Clinical Trial in Australia.
Researchers should be aware of their roles and responsibilities of conducting a Clinical Trial. ACU mandates that the principal Investigator at ACU has Good Clinical Practice (CPMP/ICH/135/95) certification and encourages certification within their research team.
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