Useful Links

Human Ethics

Australian Code for the Responsible Conduct of Research, 2018

National Statement on Ethical Conduct in Human Research (2023)

These documents replace the previous Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research 2003 and Keeping Research on Track: A guide for Aboriginal and Torres Strait Islander peoples about health research ethics 2005. These older documents have now been revoked.

•  Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders provides a set of principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities. 

• Keeping research on track II was developed to provide advice on how the values and principles outlined in Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders can be put into practice in research.

Health Records and Information Privacy Act 2002 (NSW) – Statutory Guidelines on Research

Health Records and Information Privacy Act 2002 (NSW) – Statutory Guidelines on the collection of health information from a third party

Guidelines approved under Section 95 of the Privacy Act 1988

Guidelines approved under Section 95A of the Privacy Act 1988

Guidelines approved under Section 95AA of the Privacy Act 1988 (Cth)

Office of the Australian Information Commissioner: Australian Privacy Principles – Privacy fact sheet 17 (January 2014)

NHMRC - Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2017) 

Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations - (PD2010_055)

Human Tissue – Requirements of the Human Tissue Act 1983 in relation to research & use of tissue - (GL2006_021)

Human Research Ethics Committees: Quality Improvement & Ethical Review: A Practice Guide for NSW - (GL2007_020)

NHMRC - Ethical Considerations in Quality Assurance and Evaluation Activities

HREC and Research Governance: Fee Policy for Review of Commercially Sponsored Research - (PD2008_030)

Human Research Ethics Committees: Ethical Review for External Entities - (PD2008_046)

Youth Health Resources - Legal and Ethical Framework for consenting children for medical treatment

Data Management (courtesy of the Australian National Data Service (ANDS))

10 medical and health research data Things

ANDS Guide: De-identification

ANDS Guide: Publishing and sharing sensitive data

ANDS Webinars: Health and medical data webinar series

Clinical trials

The Australian Clinical Trial Handbook

Integrated Addendum to ICH E6 (R1): Guidance of Good Clinical Practice 
(Replaces: Note for guidance on good clinical practice (CPMP/ICH/135/95))

Human Research Ethics Committees: Standards for Scientific Review of Clinical Trials - (PD2007_035)

NHMRC – Safety monitoring and reporting in clinical trials involving therapeutic goods, November 2016

Safety Monitoring and Reporting for Clinical Trials conducted in NSW Public Health Organisations - (PD2017_039) 

 
Clinical Trial Research Agreements for Use in NSW Public Health Organisations - (PD2011_028)

Clinical Trials – Insurance and Indemnity - (PD2011_006)  

Authorised Prescriber Scheme

Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors, (Version 4.0, October 2020) 

Animal Ethics

Animal Ethics Infolink

Information paper: The Implementation of the 3Rs in Australia (September 2019)

Biosafety and Genetically Modified Organism (GMOs)

Office of the Gene Technology Regulator (OGTR)