National Statement on Ethical Conduct in Human Research

The National Statement on Ethical Conduct in Human Research is Australia’s core human-research ethics document, issued by NHMRC, the ARC, and Universities Australia, with the 2025 update as its current operative edition, effective 23 June 2026. It is applied by every Human Research Ethics Committee (HREC) in Australia when reviewing human-research proposals.

The National Statement on Ethical Conduct in Human Research is Australia’s core ethics-governance document for research involving human participants. It is jointly developed and issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and Universities Australia, and is made under the National Health and Medical Research Council Act 1992. Every Human Research Ethics Committee (HREC) in Australia — the Australian equivalent of a US Institutional Review Board (IRB) — applies the National Statement when it reviews a proposed study, making it functionally analogous to the US Common Rule (45 CFR 46) and Belmont Report combined, and to Canada’s TCPS2 (Tri-Council Policy Statement).

What the National Statement covers

The National Statement applies to research involving humans as participants, whether directly (through recruitment, intervention, or observation) or indirectly (through their data, records, or biospecimens). Compliance with the National Statement is a prerequisite for institutions receiving NHMRC funding, which is why essentially every Australian university, publicly funded medical research institute, and public hospital and health service has adopted it as binding institutional policy for human research generally — not only for the subset of projects that happen to carry NHMRC or ARC funding. It covers the full span of ethical considerations relevant to designing, reviewing, and conducting human research: consent, risk and benefit assessment, privacy and confidentiality, research involving specific populations, and the governance and review process itself.

Structure: values, general requirements, and topic-specific chapters

The National Statement is organised as a Preamble followed by numbered Sections and Chapters, each combining a statement of values or requirements with explanatory commentary rather than a flat list of rules:

• Chapter 1 sets out four core values — research merit and integrity, justice, beneficence, and respect — that frame every other chapter.
• Sections 2 and 3 address themes and issues relevant to the design and review of most human research, including risk and benefit (Chapter 2.1), consent (Chapter 2.2), and research using different methodologies.
• Section 4 addresses ethical considerations specific to particular participants or contexts — for example women, children and young people, people in dependent or unequal relationships, people with cognitive impairment or mental illness, and Aboriginal and Torres Strait Islander peoples and communities (Chapter 4.7).
• Section 5 sets out research governance and ethics review requirements, including how a Human Research Ethics Committee must be constituted and how it operates.

This structure — a small set of core values plus modular, topic-specific chapters — is what distinguishes the National Statement from a single codified regulation like 45 CFR 46: an HREC applies the core-values chapter to every protocol, then layers in whichever topic-specific chapters are actually triggered by that protocol’s participants and methods.

Core values (Chapter 1)

The four values are described as complementary and interdependent; how much weight each carries depends on the research being reviewed.

Research merit and integrity

Research must be designed and conducted, by qualified researchers using appropriate methods, in a way likely to generate useful knowledge, and researchers must adhere to the values and principles of the Australian Code for the Responsible Conduct of Research (the companion NHMRC/ARC/Universities Australia document governing research integrity generally, distinct from the National Statement’s human-participant focus) throughout.

Justice

Requires fair processes for recruiting and selecting participants, fair distribution of the benefits and burdens of research, and no exploitation of participants or communities involved in the research process.

Beneficence

Requires that the likely benefit of the research justify any risks of harm or discomfort to participants, and that risks be minimised through careful research design.

Respect

Recognises the intrinsic value of participants as human beings and their right to make free and informed decisions about their own participation, including the right to withdraw — the basis for the National Statement’s informed consent requirements.

History and current version

The NHMRC first issued ethics guidance for human experimentation in 1966. A substantially expanded document, the National Statement on Ethical Conduct in Research Involving Humans, was released in 1999 following development by the Australian Health Ethics Committee (AHEC). A further revision produced the National Statement on Ethical Conduct in Human Research 2007, later updated in 2018. The current lineage is:

• 2023 update — released July 2023, effective from 1 January 2024, revising Chapter 2.1 (Risk and Benefit) and Section 5 (Research Governance and Ethics Review) and superseding the 2007 (updated 2018) edition.
• 2025 update — released 1 April 2025, revising Section 4 (ethical considerations specific to particular participants) and making minor consequential changes elsewhere, including strengthened recognition of Aboriginal and Torres Strait Islander peoples and communities in the Preamble, Section 1, and Chapter 4.7. Its effective date was postponed from 1 October 2025 to 23 June 2026 to give institutions more time to update policies, templates, and application forms; it is the current operative edition.

Institutions could opt to adopt the 2025 edition ahead of its effective date, provided they told researchers and applicants which version applied via their own submission processes — so during the transition window, confirming which edition a given HREC was actually applying (2023 or 2025) mattered more than assuming the latest PDF on the NHMRC website was automatically in force. Updates are typically incremental (revising specific chapters or sections) rather than full rewrites; the underlying core-values framework in Chapter 1 has remained stable across the 2007, 2018, 2023, and 2025 revisions.

Who it binds: HRECs and researchers

An HREC is the committee that applies the National Statement when reviewing a proposed study, and Section 5 sets out how one must be constituted: a minimum of eight members drawn from defined categories, including members with current relevant research experience and lay members with no affiliation to the institution, so that scientific, legal, pastoral-care, and community perspectives are all represented on every decision. Researchers at a bound institution must obtain HREC approval — or confirm the research qualifies for an alternative review pathway under Section 5 — before recruiting participants or collecting identifiable data or biospecimens, mirroring the role 45 CFR 46 assigns an IRB in the United States. Where a study runs across multiple Australian sites, the NHMRC’s National Certification Scheme allows a single certified HREC’s review, conducted under the National Statement, to be accepted by all participating sites under the National Mutual Acceptance (NMA) scheme, rather than requiring separate site-by-site review.

National Statement compared to the US Common Rule and Canada’s TCPS2

All three frameworks build outward from a small set of core ethical values toward a mandatory institutional ethics-review process, and all three trace to the same research-ethics lineage as the Belmont Report. They differ in legal status and administering body:

• The Common Rule (45 CFR 46) is a codified US federal regulation, adopted by twenty federal departments and agencies, that regulates covered research by force of law.
• TCPS2 is a joint policy of Canada’s three federal research funding agencies (CIHR, NSERC, SSHRC), binding as a condition of Tri-Agency funding eligibility rather than as a direct statute.
• The National Statement is jointly issued by NHMRC, the ARC, and Universities Australia under the NHMRC Act, and binds institutions as a condition of NHMRC funding eligibility and, in practice, as adopted institutional policy across the Australian research sector — closer to TCPS2’s funding-conditioned model than to the Common Rule’s direct statutory one, though it sits within its own dedicated enabling Act rather than existing purely as agency policy.

Because none of the three frameworks automatically satisfies another, consent language, review documentation, and HREC/IRB/REB approvals obtained under one framework do not automatically transfer to a study site governed by a different one — a multi-jurisdictional study needs to confirm, site by site, which framework actually governs and document compliance with each separately.

Frequently asked questions

Is the National Statement a law?

Not in the way the US Common Rule is a codified federal regulation. The National Statement is issued under the National Health and Medical Research Council Act 1992 and binds institutions as a condition of NHMRC funding eligibility; because nearly every Australian university, medical research institute, and public health service depends on that funding relationship, they adopt the National Statement as binding institutional policy for human research generally, making HREC review effectively mandatory in practice.

What is the difference between an HREC and an IRB?

They perform the same function — prospective and ongoing ethical review of human-participant research — but HREC is the Australian term (constituted under National Statement Section 5) and IRB is the US term (constituted under 45 CFR 46). The terms are not interchangeable across jurisdictions, and approval from one does not substitute for the other at a site the other framework actually governs.

How often is the National Statement updated?

Updates have historically been incremental rather than full rewrites: major revisions in 1999 and 2007, an update in 2018, a further update in 2023 (effective 2024), and the current 2025 update (effective 23 June 2026). Each update has typically revised specific chapters or sections rather than replacing the whole document, and the Chapter 1 core-values framework has remained stable throughout.

Does the National Statement apply to research outside Australia?

No. It has no jurisdiction outside institutions bound to it by NHMRC funding eligibility or voluntary adoption. A study conducted solely at non-Australian sites is governed by whatever framework applies in those jurisdictions — the Common Rule in the United States, TCPS2 in Canada, or the relevant national/institutional framework elsewhere — not by the National Statement, even where the research design is similar.

References

• NHMRC, “National Statement on Ethical Conduct in Human Research 2025” (nhmrc.gov.au)
• NHMRC, “National Statement on Ethical Conduct in Human Research” overview page (nhmrc.gov.au/research-policy/ethics/national-statement-ethical-conduct-human-research)
• NHMRC, “National Statement on Ethical Conduct in Human Research 2025 Update: Frequently Asked Questions” (nhmrc.gov.au)
• NHMRC, “National Statement on Ethical Conduct in Human Research 2023 Update: Frequently Asked Questions” (nhmrc.gov.au)
• NHMRC, “Human Research Ethics Committee (HREC) Registration Guide” (nhmrc.gov.au)
• NHMRC, “National Certification Scheme for the ethics review of multi-centre research” (nhmrc.gov.au)
• National Health and Medical Research Council Act 1992 (Cth)