Resources for researchers

St Vincent's Hospital 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.

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

National Standard Operating Procedures for Clinical Trials

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

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 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

Standard Agreements

Medicines Australia

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