Prepare your ethics submission and site-specific application and prepare any regulatory applications.

Should you do this clinical trial? Can you do the trial here? These are the key questions for ethics and governance of clinical trials.

Clinical trials in Australia are subject to laws and regulations in relation to their conduct and researchers have responsibilities in relation to these laws and regulations and the conduct of their clinical trial.

 These laws and regulations address the following subjects but are not limited to:

• Ethical and scientific review
• Financial management
• Gene technologies and related therapies
• Guardianship
• Human embryos and cloning
• Human Tissue
• Intellectual property
• Ionising radiation
• National Health and Medical Research Council Act
• Privacy
• Record keeping
• Risk management
• Site authorisation

An international listing of human research standards, including Australia, is located here