The French Biotrial tragedy highlighted the potential for healthy volunteers to suffer tragic injuries in clinical trials and the need for clear and effective regulatory oversight. The Australian system for approving clinical trials has been reviewed continually over the past three decades, resulting in a considerable degree of deregulation. Approval to commence a trial largely depends upon assessment by voluntary Human Research Ethics Committees (HRECs), without much government oversight of the investigational products or trial procedures. Once a trial has been initiated, ongoing review of its safety is conducted by Data Safety and Monitoring Boards (DSMBs), which operate largely outside the boundaries of Australian or international regulations. Australia should carefully audit its regulatory frameworks for ensuring the safety of participants who consent to enrol in clinical trials.