The National Statement on Ethical Conduct in Human Research (2007) - Updated 2018, sets national standards for use by any individual, institution or organisation conducting human research. This includes human research undertaken by governments, industry, private individuals, organisations, or networks of organisations.
In February 2022, all jurisdictions agreed to implement the Governance Framework in health service organisations as an embedded approach (as clinical research is core health service business) under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme.
All Australian sites are bound to abide by the Australian Code for the Responsible Conduct of Research. Adherence to the 2018 Code is a prerequisite for the receipt of funding by the National Health and Medical Research Council.
The Australian Clinical Trial Handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.