HREC (Human Research Ethics Committee)

The Australian term for the committee that reviews and approves research involving human participants before it may lawfully or ethically proceed. An HREC is constituted and registered under the National Health and Medical Research Council (NHMRC)'s National Statement on Ethical Conduct in Human Research, and its review is the Australian institutional counterpart to an IRB (Institutional Review Board) in the United States or an REC (Research Ethics Committee) in the UK/EU. A study is subject to HREC review whenever it involves human participants, their identifiable data, or their tissue and is designed to produce generalisable knowledge; the depth of that review is graded by risk rather than uniform for every protocol.

ByCASRAI Editorial Board

· Last updated 23 Jul 2026

Worked examples

Is an instance

A university researcher planning semi-structured interviews with hospital patients submits a protocol, participant information sheet, and consent form to the institution's HREC and must receive approval before recruitment begins.

Is an instance

A multi-site clinical trial spanning several Australian hospitals uses the National Mutual Acceptance (NMA) scheme so that a single reviewing HREC's approval is recognised across all participating sites, rather than requiring separate approval from each site's own committee.

Looks similar, but isn't

Not an instance

A project using only pre-existing, publicly available, de-identified aggregate data (e.g. published government statistics) generally does not require HREC review, since no identifiable human data is being collected or accessed.

Not an instance

Quality-assurance or clinical-audit activities that only evaluate an existing service against its own standards, without an intent to produce new generalisable knowledge, are typically routed to local clinical-governance sign-off rather than full HREC review -- though the boundary between audit and research is assessed case by case, and institutions increasingly ask researchers to formally justify that categorisation rather than assume it.

An HREC (Human Research Ethics Committee) is the Australian committee responsible for reviewing and approving research involving human participants. It is Australia’s institutional equivalent of an IRB (Institutional Review Board) in the United States or an REC (Research Ethics Committee) in the UK and EU — three different national terms for functionally the same role: an independent body that weighs the risks and benefits of a study before human participants can be recruited into it.

Terminology bridge: HREC vs IRB vs REC

Researchers moving between jurisdictions, or reading multi-national protocols, regularly encounter all three terms describing the same underlying function of prospective ethical review:

United States: IRB, operating under the US Common Rule (45 CFR 46).
United Kingdom / European Union: REC, most visibly the NHS Research Ethics Service in the UK.
Australia: HREC, operating under NHMRC’s National Statement on Ethical Conduct in Human Research.

None of these bodies are interchangeable as a matter of law — approval from one does not substitute for approval in another jurisdiction — but they occupy the same procedural position in the research lifecycle, and grant agreements, journal submission systems, and multi-national collaboration protocols frequently ask for ‘IRB/REC/HREC approval’ as a single bundled requirement.

What governs HRECs in Australia

HRECs are constituted and must operate under the National Statement on Ethical Conduct in Human Research, developed by the National Health and Medical Research Council (NHMRC)‘s Australian Health Ethics Committee and issued jointly by NHMRC, the Australian Research Council, and Universities Australia. Section 5.2 of the National Statement sets out HREC composition and operating requirements, including minimum membership categories intended to bring lay, professional, and pastoral-care perspectives together on a single committee, rather than leaving review solely to researchers’ peers.

HRECs review protocols under a risk-graded model rather than treating every application identically:

Greater-than-low-risk research requires full HREC review.
Low-risk research may be eligible for a delegated or lower-risk review pathway rather than review by the full committee.
Negligible-risk research may proceed via a statement of exemption rather than requiring HREC approval at all.

For multi-site studies, Australia’s National Mutual Acceptance (NMA) scheme allows a single reviewing HREC’s ethics and (where applicable) scientific approval to be accepted by other participating sites, reducing duplicate review of the same protocol across institutions.

What HREC review actually assesses

Consistent with the National Statement’s core values — research merit and integrity, justice, beneficence, and respect (including specific provisions for research involving Aboriginal and Torres Strait Islander peoples) — an HREC’s review typically covers:

Scientific and methodological merit relative to the risks participants will bear.
Risk-benefit balance, including physical, psychological, social, and economic risks.
The adequacy of the informed consent process and any participant information materials.
Privacy and data-handling arrangements for identifiable participant data.
Additional safeguards for research involving groups the National Statement identifies as requiring particular attention, such as children, people with cognitive impairment, or Aboriginal and Torres Strait Islander communities and their data.

HREC approval vs related Australian oversight bodies

HREC ethics review should not be confused with other Australian research-governance functions it is frequently paired with: the Australian New Zealand Clinical Trials Registry (ANZCTR) provides public trial registration rather than ethics review; the Therapeutic Goods Administration (TGA) governs lawful supply of unapproved therapeutic goods for trial use under its Clinical Trial Notification and Clinical Trial Approval schemes; and institutional research-integrity offices handle allegations of research misconduct under the Australian Code for the Responsible Conduct of Research, a separate document from the National Statement that governs integrity conduct broadly rather than ethical review of human-participant studies specifically.

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