As a NSW Public Health Organisation, we follow the policy directives and guidelines of the NSW Ministry of Health. The following policies and guidelines in particular guide our operations:

Human Research Ethics policies and guidelines

•  Operations Manual: Human Research Ethics Committee Executive Officers [GL2010_014] 
  
• Operations Manual: Human Research Ethics Committees [GL2013_009] 
•  Requirements of the Human Tissue Act 1983 in relation to research and use of tissue [GL2006_021] 
• Research - Ethical & Scientific Review of Human Research in NSW Public Health Organisations [PD2010_055] 
• Quality Improvement & Ethical Review: A Practice Guide for NSW [GL2007_020] 
• Standards for Scientific Review of Clinical Trials [PD2007_035] 

Human Research Governance policies and guidelines

• Clinical Trials - Insurance and Indemnity [PD2011_006] 
• Operations Manual: Research Governance Officers [GL2010_015] 
  
• Research Governance in NSW Public Health Organisations [GL2011_001] 
• Authorisation to Commence Human Research in NSW Public Health Organisations [PD2010_056] 
• Research Agreements in NSW Health Organisations​
  
• Click herefor further information on human research ethics and governance.
  

Human Research Ethical Principles

• WMA Declaration of Helsinki  - Ethical Principles for Medical Research Involving Human Subjects
• The NHRMC National Statement on Ethical Conduct in Human Research 
• ICH Harmonised Tripartite Guideline for Good Clinical Practice 
• Australian Code of the Responsible Conduct of Research 
  

Australian Therapeutic Goods Administration (TGA)

• Australian Therapeutic Goods Administration (TGA) 
• Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 – Annotated with TGA Comments) 
•  The Australian Clinical Trial Handbook 
• Clinical Trial Notification (CTN) Scheme / Clinical Trial Exemption (CTX) Scheme information 
• Australian Regulatory Guidelines for Medical Devices 
• Authorised Prescribers 

• NSLHD Intranet linkto RNSH/Ryde Drug Committee information
  Please contact the Research Office to discuss your application

NSW Guardianship Tribunal

A clinical trial conducted in NSW, which may include persons who are 16 years of age or older who are unable to provide informed consent to treatment, must have the approval of the Guardianship Tribunal under Part 5 of the Guardianship Act 1987 . Requirements for Guardianship review vary from state to state and investigators coordinating multi-state studies are advised to consult the relevant state Tribunal.

• NSW Guardianship Division 

Privacy | Office of the NSW Privacy Commissioner

All research projects including low / negligible risk must comply with the NSW Privacy Act.

• Office of the NSW Privacy Commissioner