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In 2016 National Health and Medical Research Council (NHMRC) released new guidance on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (the Guidance) to replace the 2009 Australian Health Ethics Committee Position Statement of the same name (the Position Statement).  In 2018 the NHMRC released new guidance on Reporting of Serious Breaches of

National Health and Medical Research Council (NHMRC) NHMRC National Statement on Ethical Conduct in Research Involving Humans NHMRC Challenging Ethical Issues in Contemporary Research on Human Beings NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities Regulatory Bodies Therapeutic Goods Administration (TGA) – Australia TGA Research Ethics Committees and the TGA legislation TGA Accessing Unapproved