Checklist, templates and exemplars

Guidelines, policies and legislation

Research at Justice Health NSW, is designed, reviewed, approved and conducted in accordance with local, national and international guidelines, policies and legislation, including the following.

International ethical guidelines

National ethical guidelines

NSW Ministry of Health policies and guidelines

  • PD2007_035 Human Research Ethics Committees: Standards for Scientific Review of Clinical Trials
  • PD2008_030 Fee Policy for Review of Commercially Sponsored Research
  • PD2008_046 Ethical Review for External Entities
  • PD2010_055 Ethical and scientific review of human research in NSW Public Health Organisations
  • PD2010_056 Authorisation to commence human research in NSW Public Health Organisations
  • PD2011_006 Clinical Trials – Insurance and Indemnity
  • PD2011_028 Clinical Trial Research Agreements for Use in NSW Public Health Organisations
  • GL2006_021 Human Tissue – Requirements of the Human Tissue Act 1983 in relation to research & use of tissue
  • GL2007_016 Standardised Patient Information Sheets (PIS)
  • GL2007_020 Quality Improvement & Ethical Review: A Practice Guide for NSW
  • GL2010_014 Operations Manual: Human Research Ethics Committee Executive Officers
  • GL2010_015 Operations Manual: Research Governance Officers
  • GL2011_001 Research Governance in NSW Public Health Organisations
  • GL2013_009 Human Research Ethics Committees: Standard Operating Procedures for NSW Public Health Organisations
  • PD2017_039 Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations

Therapeutic Goods Administration guidelines

  • Note for guidance on good clinical practice (CPMP/ICH/135/95 – Annotated with TGA comments)
  • Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95 – Annotated with TGA comments) (July 2000)

Privacy legislation and guidelines

  • Health Records and Information Privacy Act 2002 (NSW)
  • Information and Privacy Commission NSW – Statutory Guidelines on Research (2004)
  • Privacy and Personal Information Protection Act 1988 (NSW)
  • Australian Privacy Principles

Network guidelines and policies

Crimes legislation