Research principles and guidelines
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 2009 (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)
- 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)
Ethics, regulations, and getting started.
- Getting started
- How to talk to potential participants
- Research principles and guidelines
- The regulatory environment
- Good Clinical Practice (GCP) in Australia
- Harmonisation of Multi-centre Ethical Review and the National Approach
- National Ethics Application Form
- Ethical review process for each Australian state and territory
- Research governance
- Useful links
Find a clinical trial website
Search for clinical trial registries, organisations, research networks, coordinating hubs and support groups by specific disease or condition.
Links to relevant government bodies, clinical trials and other human research resources and ethics guidelines.