Resources for researchers
St Vincent's Hospital and NSW Health Policies / Guidelines
St Vincent’s Hospital in principle adopts the New South Wales Ministry of Health policies and guidelines in relation to the review, approval, authorisation and oversight of human research activities.
New South Wales Research Handbook
Published in June 2024, this is a very useful reference and a must read for all researchers embarking on a human research project.
New South Wales Research Handbook
Research Ethics
Research - Ethical & Scientific Review of Human Research in NSW Public Health Organisations
Human Research Ethics Committees: Standard Operating Procedures for NSW Public Health Organisations
Operations Manual: Human Research Ethics Committee Executive Officers
Human Tissue - Requirements of the Human Tissue Act 1983 in relation to research & use of tissue
NHMRC - Ethical Issues and Resources
Research Governance
Research - Authorisation to Commence Human Research in NSW Public Health Organisations
Operations Manual: Research Governance Officers
Clinical Trial Research Agreements for Use in NSW Public Health Organisations
Clinical Trials - Insurance and Indemnity
Research Governance in NSW Public Health Organisations
REGIS Resources
REGIS Home Page
REGIS How To Guides
Research Involving Aboriginal and Torres Strait Islander People
Aboriginal and Torres Strait Islander Research Guidelines (August 2023)
Ethical Principles in Human Research
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
The NHRMC National Statement on Ethical Conduct in Human Research (Updated 2023)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Australian Code for the Responsible Conduct of Research
Clinical Trial Guidance and SOPs
Australian Clinical Trial Handbook (TGA)
NSW Health Clinical Trial Toolkit (clinicaltrialsNSW)
ICH Guideline for Good Clinical Practice
Australian Therapeutic Goods Administration
Australian Therapeutic Goods Administration
The Australian Clinical Trial Handbook
Clinical Trial Notification (CTN) Scheme / Clinical Trial Approval (CTA) Scheme information
Australian Regulatory Guidelines for Medical Devices
Authorised Prescribers
Clinical Trial Registries
Clinical trial registries allow you to find clinical trials in Australia. All Clinical Trials must be registered in a publically accessible registry prior to commencement.
It is strongly recommended that the Australian New Zealand Clinical Trial Registry (ANZCTR) be used.
NSW Health & Medical Research
Please visit the NSW Health & Medical Research website for information relating to the following:
- National Mutual Acceptance of Single Ethical and Scientific Review of Multi-Centre Human Research Projects
- Research Ethics and Governance
- Research Ethics and Governance Policies
- Clinical Trials in NSW
- REGIS
Standard Agreements
Standard Clinical Trial Agreements
Indemnity Forms (HREC review only and standard) and compensation guidelines
Multi-Jurisdictional Multi-Party non-Clinical Trial Collaborative Research Agreement – Final template (July 2022)
NSW Civil and Administrative Tribunal (NCAT) Guardianship Division
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 Civil and Administrative Tribunal (NCAT) Guardianship Division
Catholic Health Australia
Code of Ethical Standards for Catholic Health and Aged Care Services in Australia
Privacy NSW – Office of the NSW Privacy Commissioner
All research projects including low / negligible risk must comply with the NSW Health Privacy Act.
Privacy NSW – Office of the NSW Privacy Commissioner