About the scheme
In Australia, any human research that poses more than a low risk to participants needs to be reviewed by an HREC. HRECs advise on protecting research participants and the scientific validity of the research.
Once the accreditation scheme is in place, all Australian HRECs reviewing health and medical research and their host institutions will be able to apply for accreditation to the quality standards.
Accreditation will involve an independent body assessing how their processes meet the standards.
This will improve the ethics review process, as part of major national reforms to strengthen and streamline health and medical research in Australia.
Why it is important
Currently, the quality of ethics reviews can vary, depending on:
- the HREC’s access to scientific expertise
- local policies
- differences in state and territory legislation.
These inconsistencies can undermine trust and confidence in the ethics review process.
National quality standards and accreditation will:
- make the ethics review process more efficient and consistent
- build confidence in HREC decisions
- reduce duplication of ethics review processes for research that takes place at more than one institution (multi-site studies), enabling faster start-up
- strengthen the safety and quality of health and medical research
- reassure communities about participating in research.
Guiding principles
The guiding principles for the project are that the quality standards:
- have a primary focus on safety and quality
- distinguish and leverage Australia’s competitive advantage and reputation for quality
- ensure there are a proportionate number of ethics committees nationally
- ensure transparency and accountability
- enable scientific review processes of the highest standards
- model and champion the highest standards of integrity and ethical review.
The quality standards
The standards are in line with the National Statement on Ethical Conduct in Human Research (and other relevant guidelines). They include the:
- Institutional Support for Ethics Review Standard – describes how institutions support the process of ethics review, by
- developing a research governance framework
- appropriately setting up a HREC and selecting its membership
- reducing duplication of ethics review
- Institutional Operations Standard – describes how the institution operates the HREC by
- regularly assessing the HREC’s processes
- ensuring cultural safety
- HREC and HREC Member Standard – describes the responsibilities of the HREC and its members, including
- the promotion of good ethics review practices by the HREC
- members ensuring that research they approve meets ethical and scientific standards, maintaining confidentiality, and disclosing relevant interests.
Each standard lists:
- the actions against which HRECs will be assessed for accreditation
- suggested strategies to meet the actions
- examples of evidence that show how the HREC is meeting the actions.
The standards also include new requirements for HRECs to:
- establish an appropriate mechanism, such as a staffed research office, to
- do initial reviews of ethics applications
- ensure that processes are in line with the National Statement on Ethical Conduct in Human Research
- implement national processes for quality assessment, and take part in workshops and forums to share their findings
- adhere to national policies, guidance and training on
- disclosing HREC members’ interests
- identifying and managing conflicts of interest
- adopt national policies on paying external HREC members
- promote community engagement and cultural safety, including
- reflecting on their own cultural identity
- addressing interpersonal power differences that may occur in research settings.
Who we work with
We established an expert Ethics Committee Advisory Group to advise on and guide the development of the quality standards. Dr Conor Brophy MBBS, MD, MBioethics, FRCP, AFRACMA is the independent Chair.
We have worked with all state and territory governments through the Inter-Governmental Policy Reform Group to develop the draft quality standards.
Status
Public consultation on the draft quality standards and options for the accreditation scheme ended on 17 April 2025.
We will publish the consultation report soon and progress refining the model of the accreditation scheme.
Learn more
See the literature review used to help develop the quality standards and accreditation scheme.