In Australia, all research involving humans must comply with the principles set out in the following guidelines:
- National Statement on Ethical Conduct in Human Research (2007) — updated March 2014 (National Health and Medical Research Council)
- Australian Code for the Responsible Conduct of Research (developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia)
- Applicable State and territory guidelines.
Clinical trials of medicines and medical devices also must comply with
- Note for guidance on good clinical practice (CMP/ICH/135/95) (Therapeutic Goods Administration)
Clinical trials of medical devices must also comply with
- ISO 14155:2011 Medical devices — Clinical investigation of medical devices for human subjects: Good clinical practice (ISO)