About
In Australia, all health and medical research which poses more than a low risk to participants needs to be reviewed by a Human Research Ethics Committee (HREC) functioning in accordance with the National Statement on Ethical Conduct in Human Research. HRECs advise on protecting research participants and the scientific validity of the proposed research.
National standards
Status of work
The draft standards for HRECs were developed in consultation with the Inter-governmental Policy Reform Group (IGPRG) and an expert Ethics Committee Advisory Group (ECAG). The draft has been informed by a literature review published in 2023, the National Statement on Ethical Conduct in Human Research and other relevant guidelines.
Public consultation on the draft standards occurred in March and April 2025. The Quality Standards for Human Research Ethics Committees (HRECs) and their Host Institutions – Report on Public Consultations 2025, summarises feedback from the consultation.
We are revising the standards based on consultation feedback and continue work to refine the model for accreditation.
Guiding principles
The guiding principles are that the standards should:
- 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.
Quality areas
The draft standards are based on the National Statement on Ethical Conduct in Human Research (and other relevant guidelines) and consist of 3 quality areas:
- Quality Area 1: Establishment of ethics review processes
- Quality Area 2: Support for ethics review quality
- Quality Area 3: HREC (including Secretariat) and HREC members
Each quality area contains:
- explanatory notes
- desired outcomes
- suggested strategies for institutions, HRECs or HREC members to meet the standards
- examples of evidence that could be used to show that the standards have been met.
The draft standards include new requirements for HRECs and their host institutions to:
- be more transparent about the expertise, experience and positions of their members, and to publish contact information
- implement national processes for quality assessment, and to share their findings through local, regional and/or national workshops and forums
- adhere to national policies, guidance and training about:
- disclosing HREV members' interests
- Identifying and managing conflicts of interests
- protect the committee’s review time, helping members to focus on the important issues
- ensure that ethics review processes are culturally safe, by providing standardised training for researchers, HREC members and administrators involved in ethics review.
Accreditation
- Work is underway to develop national accreditation aimed at assessing HRECs and their host institutions against the national standards.
- Accreditation will involve an independent body assessing how well the ethics review processes meet the standards.
- Once accreditation is in place, all Australian HRECs reviewing health and medical research involving humans will be able to apply for accreditation to the standards.
- Accreditation will improve the ethics review process, as part of national reforms to strengthen and streamline health and medical research in Australia.
Why this is important
Currently, ethics review decisions can vary, depending on:
- the HREC’s access to relevant scientific expertise
- differences in local policies
- differences in state and territory legislation.
Accreditation will:
- make the ethics review process efficient and consistent
- build confidence in HREC decisions across institutions
- 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.
Who we work with
We established an expert Ethics Committee Advisory Group to guide the development of the standards. Dr Conor Brophy MBBS, MD, MBioethics, FRCP, AFRACMA is the independent Chair.
We work with all state and territory governments through the Inter-Governmental Policy Reform Group to develop the draft standards and accreditation.
Learn more
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