Research Policies & Guidelines

Ethics

• Fees: 
  • NSW Health Research Fee Policy 
  • Fee Schedule Information Bulletin
  • Q & A Communication for Fee Policy
  • Fee Schedule Decision Map
• NHMRC / Ethical Guidelines: 
  • NHMRC National Statement on Ethical Conduct in Research Involving Humans
  • Australian Code for the Responsible Conduct of Research
  • Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
  • Ethical Considerations in QA and Evaluation Activities - NHMRC Guide
  • Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
  • Data Safety Monitoring Boards (DSMBs)
• NSW Health Policies and Guidelines:
  • Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
  • Quality Improvement & Ethical Review: A Practice Guide for NSW
  • Requirements of the Human Tissue Act 1983 in relation to research and use of tissue
  • Research - Ethical & Scientific Review of Human Research in NSW Public Health Organisations
  • Operations Manual: Human Research Ethics Committee Executive Officers
  • Operations Manual: Human Research Ethics Committees
  • Standards of Scientific Review of Clinical trials 
• SESLHD Guidelines:
  • Research Ethics and Governance Complaints
• Other guidelines and resources:
  • Australian Clinical Trial Handbook
  • National Mutual Acceptance Scheme
  • International Conference on Harmonisation (ICH) - Good Clinical Practice Guidelines (E6)
  • The Declaration of Helsinki (2008)

Governance

• Research - Authorisation to Commence Human Research in NSW Public Health Organisations
• Clinical Trial Research Agreements for Use in NSW Public Health Organisations
• Clinical Trials - Insurance and Indemnity
• NSW Health Research Ethics and Governance
• Operations Manual: Research Governance Officers
• Research Governance in NSW Public Health Organisations
• Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations 
• Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
• Australian Code for the Responsible Conduct of Research
• National Statement on Ethical Conduct in Human Research 2023

All Research related SESLHD policies and guidelines can be located here.

The inclusion of links to external websites does not imply any endorsement or support by South Eastern Sydney Local Health District or Ministry of Health or the State of New South Wales. See our Disclaimer for more information.