Resources

National Codes and Guidelines

Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research

Uploaded 10 Jan 2019

Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (Values and Ethics) provides guidance to researchers and Human Research Ethics Committees (HRECs) on the complex considerations necessary in the conception, design and conduct of appropriate research in Aboriginal and Torres Strait Islander communities. Values and Ethics was developed by an Australian Health Ethics Committee working committee in 2003 and replaced the Guidelines on ethical matters in Aboriginal and Torres Strait Islander Health Research (1991).

National Codes and Guidelines

Determination of standard costs associated with conducting clinical trials in Australia

Uploaded 10 Jan 2019

On 19 December 2014, the Pricing Authority received a Direction under the National Health Reform Act subsection 131(3) from the Commonwealth Minister of Health to determine the costs for the refined list of items and any other items (above those costs required for standard care), as determined necessary by the Pricing Authority, associated with conducting clinical trials in Australia (Direction No. 1 of 2014). The refined list of standard items was determined by the National Health and Medical Research Council (NHMRC).

National Codes and Guidelines

National Health and Medical Research Council (AU). Framework for Monitoring: Guidance for the national approach to single ethical review of multi-centre research

Uploaded 10 Jan 2019

The purpose of this National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community

National Codes and Guidelines

Ethical considerations specific to research methods or fields (Website)

Uploaded 10 Jan 2019

This section discusses various research methods and fields. Some chapters are a result of the further expansion of this revised National Statement beyond health and medical research. The focus is on general principles – the section is not intended to be exhaustive. It reflects the interdisciplinary nature of many types of research and the use, in some research projects, of a number of different research methods.

National Codes and Guidelines

National Statement on Ethical Conduct in Human Research

Uploaded 10 Jan 2019

This brief guide describes the structure of the document and suggests how each of these groups might use it. Note that ‘review body’ refers both to Human Research Ethics Committees (HRECs) and to non-HREC review bodies.

National Codes and Guidelines

Ethical Considerations in Quality Assurance and Evaluation Activities

Uploaded 10 Jan 2019

The National Health and Medical Research Council (NHMRC) recognises the important contributions that quality assurance (QA) and evaluation activities make to better outcomes, and more efficient and effective work processes. 

National Codes and Guidelines

NHMRC Corporate Plan 2018–2019

Uploaded 10 Jan 2019

The NHMRC Corporate Plan 2018–2019 covers the period 2018–19 to 2021–22. It identifies the major health issues for this period, how we will deal with these issues and a strategy for medical research and public health research, in line with the requirements of the NHMRC Act. It also describes NHMRC’s purposes, planned activities and performance measures for the period and addresses our capability, environment and risk oversight and management.

Ethical Considerations in Research

National Statement on Ethical Conduct in Human Research 2007

Uploaded 10 Jan 2019

The purpose of this National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and
protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of:
• institutions and researchers for the ethical design, conduct and dissemination of results of human research; and
• review bodies in the ethical review of research.
The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them
 

Scientific Concepts and Research Design

Ethical Considerations in Quality Assurance and Evaluation Activities

Uploaded 10 Jan 2019

The National Health and Medical Research Council (NHMRC) recognises the important contributions that quality assurance (QA) and evaluation activities make to better outcomes, and more efficient and effective work processes. However, there can be uncertainty about what level of oversight QA and evaluation activities require and there can be confusion about whether an activity is research or evaluation or QA. This can be because QA and evaluation activities may include the use of methods or approaches also used in research such as surveys and observation.This advice is designed to assist organisations in deciding the appropriate level of oversight for QA and evaluation. Organisations should consider this guidance when developing policies/advice on QA activities, particularly as related to the triggers for ethical review listed below.

Content and Methods Based Electives

FDA: Guidance for industry, investigators and reviewers: Exploratory IND studies

Uploaded 07 Jan 2019

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approaches can be used if the approach satisfies the requirements of the applicable statutes and regulations. Discussions of an alternative approaches can be scheduled by contacting the FDA staff responsible for implementing this guidance. If the appropriate FDA staff cannot be located, contact can be made using the telephone number listed on the title page of this guidance.