The documents below are essential for any medical researcher working in Australia, WA and within the WA public health sector. It is also a requirement for researchers at CAHS to complete Good Clinical Practice Training prior to conducting any research activity. 

Understand your broad responsibilities as a researcher in Australia: 

• National Health and Medical Research Council, Australian Research Council and Universities Australia Australian Code for the Responsible Conduct of Research, 2018

Understand how to design and conduct ethically acceptable research: 

• National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research 2007, updated 2018
• World Medical Association's Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects 2018

Understand the fundamentals of conducting clinical trials and all human research: 

• Therapeutics Goods Administration's Australian Clinical Trial Handbook
• Therapeutics Goods Administration's Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments
• Good Clinical Practice online training available via Western Australian Health Translation Network – see below under GCP for more detail.

Read about how research is governed within WA Health here.

See content under 'Essential reading and references' folder. 

Understand the principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities: 

• National Health and Medical Research Council Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders

Follow available guidance on NHMRc requirements on safety reporting and monitoring requirements: 

• Safety monitoring and reporting in clinical trials involving therapeutic goods, November 2016 
• Data Safety Monitoring Boards (DSMBs) 2018 
• Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018 
• Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods 2018 

For information on the difference between quality improvement (QI) and research, and the requirements for QI ethical review refer to: 

• NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities 2014 

Don’t forget to sign-up to get an ORCID (Open Researcher and Contributor ID) – be found and build your profile as a researcher.