The National Statement on Ethical Conduct in Human Research is Australia’s guidance document governing ethical review of research involving human participants — consent, risk and benefit, and Human Research Ethics Committee (HREC) oversight. It is issued jointly by NHMRC, the Australian Research Council, and Universities Australia, and is distinct from the Australian Code for Responsible Conduct of Research.
What the National Statement is and who issues it
The National Statement on Ethical Conduct in Human Research is developed by NHMRC’s Australian Health Ethics Committee (AHEC) and issued jointly by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and Universities Australia, under the authority of the National Health and Medical Research Council Act 1992. It is Australia’s counterpart to the US Common Rule (45 CFR 46): the document that defines how research involving human participants must be ethically reviewed before it begins, and by whom.
The current edition is the 2025 National Statement, which took effect 23 June 2026 and revised Section 4 (guidance on particular methods and participant groups) relative to the 2023 edition. Institutions and Human Research Ethics Committees (HRECs) are expected to apply the current edition; researchers working from an older saved PDF should confirm they are citing the current version, since NHMRC has updated the document on a multi-year cycle (2007, updated 2018, 2023, 2025).
The four core values
The National Statement organizes its requirements around four values meant to apply throughout a project’s design, review, and conduct, not just at the point of ethics-committee sign-off:
- Research merit and integrity. A study must be designed and conducted so that it is capable of producing useful knowledge, using methods appropriate to the question, and by researchers with the competence and resources to carry it out. Research that cannot answer its own question does not clear this bar regardless of how low-risk it is.
- Justice. The burdens and benefits of research should be distributed fairly. This covers both who is asked to participate (avoiding recruitment of vulnerable groups purely for convenience) and who stands to benefit from the resulting knowledge.
- Beneficence. The likely benefits of the research must justify any risks of harm or discomfort, and risks should be minimised wherever possible.
- Respect. For participants’ autonomy, dignity, privacy, and cultural values — including, in the National Statement’s own text, explicit recognition of the rights of Aboriginal and Torres Strait Islander peoples to be engaged in research that affects or is of significance to them.
Structure of the document
The National Statement runs across five sections, and knowing which section answers which question saves time for anyone using it as a working reference rather than reading it cover to cover:
- Section 1 sets out the four values above and the National Statement’s purpose, scope, and limits.
- Section 2 covers themes that recur across the whole research lifecycle — including risk and benefit (Chapter 2.1), which sets out how to assess, minimise, and manage risk, and general requirements for consent.
- Section 3 covers ethical considerations specific to particular research topics and methods.
- Section 4 (revised in the 2025 edition) addresses ethical considerations for particular participant populations and methodologies — for example research involving Aboriginal and Torres Strait Islander peoples, children and young people, people with cognitive impairment, and human genetics or biobanking research.
- Section 5 covers research governance and ethics review: the responsibilities of institutions (5.1), of HRECs and other review bodies (5.2), of researchers (5.3), monitoring (5.4), minimising duplication of review across sites (5.5), conflicts of interest (5.6), complaints (5.7), and accountability (5.8).
How ethical review is risk-graded
The National Statement does not require every human-research project to go through a full committee meeting. Review is scaled to risk:
- Greater-than-low-risk research must be reviewed by a full HREC — a multidisciplinary committee, typically including lay members, a person with pastoral-care experience, and a lawyer, alongside researchers.
- Low-risk research — where the only foreseeable risk is discomfort rather than harm — may be reviewed through a lower-risk review pathway, such as a delegated subcommittee or a small number of reviewers, rather than the full HREC.
- Negligible-risk research can, in some circumstances, proceed with a statement of exemption from a person other than the researcher confirming the project has been considered and does not require full review, rather than a formal HREC approval.
This is structurally similar to the exempt/expedited/full-board categories under the US Common Rule, though the terminology and exact criteria differ — a project that would be expedited-reviewable under 45 CFR 46 is not automatically equivalent to a National-Statement low-risk review, and researchers working across both systems (for example, a multi-country trial) should not assume approval under one jurisdiction satisfies the other’s requirement.
How the National Statement differs from the Australian Code for the Responsible Conduct of Research
Both documents are jointly issued by NHMRC, the ARC, and Universities Australia, and both function as de facto binding institutional policy because compliance is a condition of NHMRC and ARC funding — but they answer different questions:
- The Australian Code for the Responsible Conduct of Research (2018) covers research-integrity conduct across all disciplines: authorship, data management, supervision, peer review, conflicts of interest, and how institutions investigate a suspected breach. It applies whether or not human participants are involved.
- The National Statement covers ethical review specifically for research involving human participants: consent, risk and benefit, HREC composition and process, and the responsibilities of researchers and institutions toward participants.
A single human-participant study is typically governed by both at once, for different aspects of its conduct — the Code governs how the data is handled and how authorship is assigned; the National Statement governs whether and how the study was allowed to recruit and interact with participants in the first place. Neither document substitutes for the other, and an institution’s research-integrity office and its HREC are usually separate bodies with separate remits, even though both ultimately answer to the same funding-conditioned compliance framework.
Where NHMRC’s other guidance fits
NHMRC also issues guidance that sits alongside, rather than inside, the National Statement — most notably ethical guidelines specific to Aboriginal and Torres Strait Islander health research, and guidance on the use of excess human biological material. These are generally read together with the relevant sections of the National Statement rather than as freestanding alternatives to it. NHMRC’s funding-scheme rules (Ideas Grants, Investigator Grants) are a separate matter again — administrative eligibility and budget requirements for a grant application, not ethics-review requirements — and are covered separately on this site (see the NHMRC Ideas Grant and NHMRC Investigator Grant terms).
Frequently asked questions
Is the National Statement the same as the Australian Code for the Responsible Conduct of Research?
No. They are jointly issued by the same three bodies and both function as funding-conditioned institutional policy, but the Code covers research-integrity conduct across all disciplines while the National Statement covers ethical review of human-participant research specifically. See the comparison above.
Does the National Statement apply outside Australia?
It is Australian guidance, developed under the NHMRC Act, and applies to research conducted by or through Australian institutions. Researchers collaborating internationally on a study involving Australian participants or an Australian institution should expect their local HREC to require National Statement-compliant review regardless of where a partner institution is located, and should not assume approval under a different jurisdiction’s framework (such as the US Common Rule or the UK’s Health Research Authority process) substitutes for it.
Who reviews research under the National Statement?
A Human Research Ethics Committee (HREC) registered with NHMRC reviews greater-than-low-risk research. NHMRC maintains a register of HRECs; lower-risk and negligible-risk pathways allow for review by a delegated subcommittee, a small number of reviewers, or in some cases a statement of exemption, depending on the level of risk involved.
What edition of the National Statement is currently in force?
The 2025 edition, which took effect 23 June 2026 and revised Section 4 relative to the 2023 edition. Institutions should confirm they are working from the current edition rather than an older saved copy, since NHMRC revises the document periodically.
Does the National Statement cover animal research?
No. Animal research in Australia is governed separately by the Australian code for the care and use of animals for scientific purposes, a different NHMRC-associated document with its own institutional animal ethics committee (AEC) structure, not by the National Statement.
