Policies, guidelines & regulations
Researchers and HREC members must be familiar with the relevant policies, guidelines and regulations relating to human research.
The principal documents which govern human research in Australia are:
- National Statement on Ethical Conduct in Human Research (2007)
- Australian Code for the Responsible Conduct of Research (2018)
- Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice ICH E6 (R2) - Annotated with TGA comments (2016)
- Australian Clinical Trial Handbook – Guidance on conducting clinical trials in Australia using ‘unapproved’ therapeutic goods (2018)
- Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities (2018)
- Keeping research on track II (2018)
As well as being familiar with the national guidelines, all Alfred Health researchers must conduct their research in accordance with the Alfred Health policies and guidelines.