Australian Clinical Trial Guidelines

In Australia, all research involving humans must comply with the principles set out in the following guidelines:

1. National Statement on Ethical Conduct in Research Involving Humans,

   National Health and Medical Research Council (NHMRC) is Australia's federal peak body for providing advice and support to health and medical research. Amongst other duties, the NHMRC oversees Human Research Ethics Committee (HREC) Review in Australia. All clinical trials conducted in Australia must comply with the National Statement on Ethical Conduct in Research Involving Humans (2007)

   Additional Requirements for Research in NSW

   NSW Health has created a document to assist all those concerned with the lawful and ethical conduct of research in the NSW public health system named the NSW Supplement to the National Statement of Ethical Conduct in Human Research. The Supplement summarises relevant New South Wales laws and policies.

   The following Acts are referenced in the supplement:

   • Statutory Guidelines on Research
   • The Human Tissue Act 1983 (NSW)
   • Human Cloning for Reproduction and Other Prohibited Practices Act 2003 (NSW)
   • Research Involving Human Embryos Act 2003 (NSW)
   • Children and Young Persons (Care and Protection) Act 1998 (NSW)
   • Guardianship Act 1987 (NSW)
   • Health Records and Information Privacy Act 2002 (NSW)

2. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)

   The Therapeutic Goods Administration  (TGA) is the Australian regulatory agency for clinical trials. They provide the guide to conducting clinical trials in Australia and regulatory approval to conduct clinical trials.

   ICH-GCP has been adopted by the TGA, however in some instances the requirements of the National Statement exceed those of ICH GCP. To manage this, the TGA has issued the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) document which is annotated with comments, indicating which sections have not been adopted by the TGA to reflect local regulatory requirements. 

3. ISO 13485:2003 Medical devices – Quality management systems –Requirements for regulatory purposes.

   Medical device clinical trials must also comply with this ISO standard: ISO 13485:2003 Medical devices

   The objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

4. The Australian Code for the Responsible Conduct of Research

   The 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, guides institutions and researchers in responsible research practices and promotes integrity in research for researchers.

   The Code shows how to manage breaches of the Code and allegations of research misconduct, how to manage research data and materials, how to publish and disseminate research findings, including proper attribution of authorship, how to conduct effective peer review and how to manage conflicts of interest.