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Australia has an enviable track record in health and medical research, but we need to remain competitive internationally to ensure our future health and prosperity.
Australian researchers successfully developed penicillin, the bionic ear, the human papilloma virus (HPV) vaccine, spray-on skin, and identified Helicobacter pylori as a cause of gastritis and peptic ulcer disease. The beneficial effects of these and many other Australian medical discoveries on patients’ lives cannot be overstated.
Health and medical research not only informs how we can improve the health and wellbeing of Australians; it also makes a significant and long-lasting contribution to our economy. In Australia, about $10 billion is spent each year on health and medical research, and this investment provides an outstanding return of $3.90 for every dollar invested.
It is therefore critical for our future health and prosperity that Australia remains internationally competitive in this area. Australian businesses’ expenditure on research and development has fallen in recent decades: figures from the clinical trials sector (~$1.6 billion spent annually, employing 7700 Australians) suggest that investment in this area has stagnated since 2019, and that we may be missing out on some larger, later-phase international clinical trials.
To ensure that we remain a world leader in health and medical research, the Australian Government Department of Health and Aged Care, in collaboration with all state and territory governments via the enduring Inter-Governmental Policy Reform Group (IGPRG), is leading national reforms to enable a vibrant, optimised health and medical research ecosystem.
One of these reforms is the development of quality standards and an accreditation scheme for human research ethics committees (HRECs), and the institutions that establish and support them.
Current issues with ethics review
HRECs promote the ethical conduct of human research, by providing advice on the protection of research participants and the scientific validity of the research. Any human research determined to pose more than a low risk to participants must be reviewed by an HREC that is functioning in accordance with the National Statement on Ethical Conduct in Human Research (the National Statement).
In Australia, HRECs are usually affiliated with a host institution, which establishes the HREC as part of its responsibility for research. The institution may be a hospital, a university, a medical research institute, a government agency or a private organisation.
Currently, ethics review processes in Australia can be inconsistent and inefficient — leading to delays, especially for studies involving multiple sites. Sometimes institutions taking part in a multi-site study lack confidence in the ethics review performed by the “lead” HREC and choose to perform their own review instead. This duplication of review processes can slow down research, waste valuable resources, and reduce public trust and confidence in ethics approval processes.
Consultations with the health and medical research sector attribute this lack of confidence in ethics review to differences in committee operations, variable access to appropriate scientific expertise, and different jurisdictional requirements. There are also different ethics application platforms in use by the different states and territories. This issue will be resolved in the future with the National One Stop Shop data system.
Quality standards for HRECs and their host institutions
The Department has recently developed a set of quality standards for HRECs and their host institutions. The quality standards aim to improve the quality, consistency and efficiency of ethics reviews, while maintaining the highest standards of integrity.
The quality standards are aligned with the National Statement and other relevant research guidelines, and include new requirements for HRECs and their host institutions to:
- establish an appropriate mechanism, such as a staffed research office, to perform preliminary reviews of ethics applications and to ensure that processes are in accordance with the National Statement;
- implement national processes for quality assessment, and participate in workshops/forums to share the results of their quality assessment;
- adhere to national policies, guidance and training regarding disclosure of HREC member’s interests, and the identification and management of conflicts of interest;
- adopt policies providing remuneration for external HREC members; and
- promote community engagement and cultural safety, which involves reflecting on our own cultural identity and addressing interpersonal power differences that may occur in research settings.
All HRECs in Australia, and their host institutions, will be able to nominate themselves for accreditation to the quality standards.
Accreditation will involve assessment of HRECs and their host institutions by an independent entity, to examine how well their processes meet the new quality standards. The national accreditation scheme will:
- improve the consistency of ethics reviews;
- reduce duplication;
- speed up research approvals;
- increase transparency;
- build trust and confidence in ethics review; and
- reassure communities about their participation in health and medical research.
An anticipated outcome of the accreditation scheme will be a system that seeks to strike the right balance, through achieving a proportionate number of HRECs nationally, while ensuring specialist scientific expertise, high standards of ethics review, efficiency, and professionalism.
Public consultations
We are seeking your input into the quality standards and the design of the national accreditation scheme. You can access the quality standards and complete our consultation survey via this link or by scanning the QR code below. The consultation survey is open from 3 March to 17 April 2025.
Help us to design an accreditation scheme for HRECs that will improve the consistency and efficiency of ethics review, maintain participant safety, and improve the competitiveness of Australia’s health and medical research sector.
For details on these and other reforms, visit the Australian Clinical Trials website.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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