Guidelines and legislation

In Australia there are a number of guidelines and legislation clinical trials have to adhere to.

All research in Australia has to abide by the Australian Code for the Responsbile Conduct of Research, 2018

Clinical trials are subject to a number of national laws and regulations. The Australian Clinical Trials Toolkit explains the overarching legislation and guidance when conducting a clinical trial in Australia. The toolkit provides information on using unapproved therapeutic goods.

The NHMRC e-learning modules provide an overview and importance of the clinical trials environment and approval process.

The purpose of the National Statement on Ethical Conduct in human research is to promote ethically good human research and requires that participants be accorded respect and protection. It helps identify ethics issues that arise in the design, review and conduction of human research.

Clinical trials that require access to personal or sensitive information held by the Commonwealth are subject to the Privacy Act 1988 (Cth).

The national privacy act may not apply to some clinical trials, QLD has their own privacy laws and laws protecting medical records.

The consumer and community involvement statement aims to guide research institutions, researchers, consumers and community members in the active involvement of consumers and community members in all aspects of health and medial research.