Resources
Ethical Considerations in Quality Assurance and Evaluation Activities
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.
NHMRC Corporate Plan 2018–2019
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.
Guidelines to promote the wellbeing of animals used for scientific purposes
These guidelines have been developed by NHMRC on advice from its Animal Welfare Committee to promote the wellbeing of animals used for scientific purposes and aim to minimise their experience of pain and distress. They advocate the consideration of an animal's "whole of life" experiences, argue the potential risk to the reliability/validity of research data from unintended pain or distress, and promote the 3R's (replacement of animal research with other types of research when possible, reduction of the number of animals used in research and refinement of research techniques to minimise pain and distress).
National Quality Use of Medicines Indicators for Australian Hospitals
The National Quality Use of Medicines Indicators for Australian Hospitals (National QUM Indicators) is a set of process indicators developed for Australian hospitals and health professionals.
Promoting consistency in safety monitoring and reporting of Clinical Trials (Website)
As part of the initiative to have more efficient research governance processes, NHMRC and the Therapeutic Goods Administration (TGA) are working to achieve a safety reporting system that is efficient and reflects contemporary reporting requirements.
Development of a Good Practice Process for site assessment and authorisation of clinical trials
To improve clinical trial start-up times, following extensive stakeholder consultation and under the guidance and leadership of the NHMRC Research Governance Working Group, NHMRC has developed the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process).
NHMRC: Genetics in Family Medicine: The Australian Handbook for General Practitioners
In late 2004, The Australian Government agency Biotechnology Australia initiated a project to develop a national educational resource on genetic medicine for Australian GPs. The outcome of this project is the Genetics in Family Medicine: The Australian Handbook for General Practitioners, published in 2007. It includes a range of short factsheets on each topic for patients and their families, which are available for download below. In May 2015 responsibility for the Genetics in Family Medicine: The Australian Handbook for General Practitioners resource was transferred to The Royal Australian College of General Practitioners (RACGP).
Structural Review of NHMRC’s Grant Program
Feedback from the research sector has indicated that the work required to prepare and evaluate the high numbers of grant applications that will not be funded is placing an unsustainable burden on applicants and peer reviewers. Concerns have also been raised that many researchers, especially those at early and mid-career stages, are also becoming discouraged from pursuing research and that there are disincentives to exploring new areas of research. To address these challenges, an over-arching review of NHMRC’s grant program has been undertaken to determine whether the suite of funding schemes can be streamlined and adapted to current circumstances, while continuing to support the best Australian research and researchers for the benefit of human health.
The decision about whether to introduce a change in the structure of our grant program is incredibly important and the Office of NHMRC is working through a number of details before we present the proposal to Government. The newsletter provides an update on the reform by Professor Anne Kelso AO, NHMRC CEO.
Safety monitoring and reporting in clinical trials involving therapeutic goods
This Guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products and investigational medical devices for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.
NHMRC has also developed the following documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods. This supplementary guidance covers the following topics:
- Data Safety Monitoring Boards (DSMBs)
- Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.
Institutions with certified ethics review processes
The NHMRC National Certification Scheme of Institutional Processes Related to the Ethical Review of Multi-centre Research (National Certification Scheme) reviews ethics review processes of institutions to ensure that they can facilitate single ethics review and that they meet the requirements of the National Statement on Ethical Conduct in Human Research (2007). NHMRC has assessed and certified the ethics review processes of the institutions listed in this document.

