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Human Ethics Resources
The National Statement on Ethical Conduct in Human Research (2007) (National Statement (2007) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992.
The 2018 Code is also supported by guides on specific topics to encourage responsible research conduct. These guides articulate the broad principles and responsibilities of the 2018 Code.
Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders provides a set of principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities.
An Act to regulate the collection, maintenance, use, correction and disclosure of personal information relating to individuals
These guidelines provide a framework in which medical research involving personal information obtained by Commonwealth agencies should be conducted, to ensure the information is protected.
The Guidelines approved under Section 95A of the Privacy Act 1988 are issued for the purposes of Australian Privacy Principles (APPs) and sections 16B(2) and 16B(3) of the Privacy Act.
A practical guide to support those on Human Research Ethics Committees to confidently assess applications that propose to share data.
Guides from the Australian Research Data Commons on confidential and other sensitive information in research, including identifiable data, health and medical data and Indigenous data.
Clinical Trial Resources
The Guideline for Good Clinical Practice is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The Guideline for Good Clinical Practice is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial.
This course is recommended for Committee Members providing ethical review of Clinical Trials.
- Upon completion of this course, you will have an understanding of:
- What Good Clinical Practice (GCP) is
- The basic principles of GCP
- What being ‘GCP’ qualified means and why conducting a study according to GCP is important
- The responsibilities of the investigator
- How GCP should be adopted in the conduct of clinical research
This handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.
- Therapeutic Goods Administration - Clinical Trials
- Safety monitoring and reporting in clinical trials involving therapeutic goods
This document clarifies the responsibilities of those involved in clinical trials to monitor and report adverse events and other safety issues. Supplementary guidance on other clinical trial safety monitoring and reporting issues is also available
The Guideline for Good Clinical Practice is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The Guideline for Good Clinical Practice is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial.
HRECs and specialist colleges provide the initial assessment of a medical practitioner's application to become an Authorised Prescriber for products not included in sub regulation 12B(1B) of the Therapeutic Goods Regulations 1990.
The purpose of the Australian code for the care and use of animals for scientific purposes (the Code) is to promote the ethical, humane and responsible care and use of animals used for scientific purposes. It provides guidance for investigators, institutions, animals ethics committees, animal carers and all those involved in the care and use of animals for scientific purposes
The 2018 Code is also supported by guides on specific topics to encourage responsible research conduct. These guides articulate the broad principles and responsibilities of the 2018 Code.
ANZCCART is pleased to provide this information package for members of animal ethics committees (AECs). It is particularly important for new category C (animal welfare) and D (lay) members of AECs to be provided with background information about how ethics committees function, as well as what is expected of them as members.
An Act to prevent neglect of, and cruelty to, animals, to ensure the welfare of animals, to repeal the Cruelty to Animals Prevention Act 1925 and for related purposes
This course is recommended for Committee Members of the AEC.
This free online course covers the Australian Code and NZ Guide and welfare issues relating to animal use in research and teaching. Successful completion of the Phase one of the course and its quiz fulfills the mandated basic training needs of researchers and teachers using animals as well as members of Animal Ethics Committees (AEC) in Australia and NZ
Legislative and regulatory environment for veterinary professionals