Numerous policies, guidelines and regulations, at national and international levels, which prescribe best research governance practice to help ensure research is conducted to the highest governance and ethical standards possible.
The principal documents which govern human research in Australia are listed below:
- National Statement on Ethical Conduct in Human Research (2007)
- Australian Code for the Responsible Conduct of Research (2007)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2000)
- Access to unapproved therapeutic goods – Clinical Trials in Australia (2004)
- The Australian Clinical Trial Handbook – A simple practical guide to the conduct of clinical trials to international standards of Good Clinical Practice (GCP) in the Australian Context (2006)