Resources

National Codes and Guidelines

NHMRC Chapter 5.4: Conflicts of Interest

Uploaded 10 Jan 2019

This is a chapter from National Health and Medical Research Council's (AU) National Statement on Ethical Conduct in Human Research (2007) (Updated in May 2018).

National Codes and Guidelines

NHMRC Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods

Uploaded 10 Jan 2019

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.

National Codes and Guidelines

NHMRC Funding Rules 2016

Uploaded 10 Jan 2019

This book contains key statistics on the outcomes of the 2014 application rounds for NHMRC’s research funding, as well as historical information relating to research funding and activity over the last ten years. 

National Codes and Guidelines

Biobanks information paper

Uploaded 10 Jan 2019

This paper provides information on the establishment, management and governance of biobanks in Australia. A biobank is a collection of human biological material held for health and medical research. Biobanks facilitate this research, while protecting participants’ interests and privacy.

National Codes and Guidelines

National Health and Medical Research Council: The Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance

Uploaded 10 Jan 2019

NHMRC is pleased to be able to publish the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process). The Good Practice Process was developed and finalised, following stakeholder consultation, by the NHMRC’s Research Governance Working Group. This group has broad representation from clinical trials sites, clinical trial sponsors and State/Territory health departments. The Good Practice Process aims to streamline the site assessment and site authorisation of clinical trials by: • Outlining a set of principles and critical success factors for site assessment and site authorisation; • Detailing a set of planning and preparation activities that can made a site more responsive to commencing clinical trials; and • Proposing a streamlined workflow for site assessment and authorisation. 

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.