The National Statement on Ethical Conduct in Human Research (2025) (2025 National Statement), published by the National Health and Medical Research Council (NHMRC), is in effect from 23 June 2026. The 2025 National Statement incorporates amendments to the previous 2023 version and introduces additional sections with implications for researchers nationally.

What is the National Statement?

The NHMRC is a statutory body established by the National Health and Medical Research Council Act 1992 (Cth). The National Statement has been developed to fulfil the NHMRC's obligations under this Act and the obligations of its Chief Executive Officer and Principal Committee. The National Statement has also been jointly developed with the Australian Research Council, which is a statutory body, and Universities Australia, a peak industry body.

The National Statement represents the national standard for any individual, institution, or organisation conducting research that is with or about people, their data, or biospecimens (i.e. human research). This includes ensuring that participants' safety is a paramount consideration, and that participants are treated with respect throughout the research process and in the dissemination of research outputs. The National Statement applies in addition to relevant laws applicable to human research.

Failure by researchers to comply with the standards in the National Statement may result in consequences including:

• Complaints made to Human Research Ethics Committees (HRECs) which must be annually reported to the NHMRC;
• Potential disciplinary action under employment or engagement contracts with research institutions; and
• Withdrawal of research funding under the NHMRC Funding Agreement.

What has changed?

The key changes are concentrated in revisions to 'Section 4: Ethical considerations specific to participants in research' and include:

• additional consideration for participants based on increased risk of harm, rather than based on participant vulnerability;
• inclusion of marginalised or under-represented groups in research;
• distinguishing between participants at risk of harm due to their characteristics or circumstances, versus risk of harm due to research contexts;
• introduction of an alternative review process (other than automatic HREC review) for lower risk research, where appropriate; and
• a new Chapter 4.8, providing guidelines for research conducted during natural disasters, public health emergencies, and other crises.

These changes are discussed in more detail below.

Key change 1: From 'vulnerable' participants to participants who 'may be at increased risk'

2023 approach: The 2023 National Statement identified certain groups (e.g. children, people with cognitive impairments, pregnant women) as 'vulnerable' and automatically required full HREC review for research involving them, often leading to conservative exclusion of such participants from studies and benefits of associated research insights.

2025 approach: The 2025 National Statement retires the blanket label “vulnerable” in favour of assessing specific sources of risk to individuals in context. The 2025 National Statement recognises that risk is not a fixed characteristic of any particular demographic. Rather, risk exists on a spectrum and may arise from multiple sources and can vary over time for a participant. Chapter 4.1 provides a list of key questions for researchers to consider and guidelines to facilitate researchers with evaluation of risk factors on a case-by-case basis. Automatic exclusions of particular participant groups no longer apply. Further, studies including participants who may be at increased risk do not automatically go to a full HREC review. Less onerous review pathways (delegated review by a subcommittee or expedited processes) are valid where appropriate. Corresponding changes have also been made to Chapter 5.1, which now obliges institutions to have processes for risk assessment and to deploy alternative review pathways (e.g. sub-committee or delegated Chair review) for lower risk studies.

Key change 2: Refocusing on 'pregnancy'

2023 approach: The 2023 National Statement focused on regulating research involving 'women who are pregnant'.

2025 approach: The 2025 National Statement uses gender-neutral terminology to shift the focus to participants who 'are, may be, or may become pregnant'. This is intended to reduce the blanket exclusion of women from research and enable the inclusion of biologically female participants in appropriate investigations, improving access to research insights.

Key change 3: Assent for child participants

2023 approach: Researchers were previously required to consider whether a child participant had the requisite level of maturity to consent to involvement in a study. If a child did not have capacity to provide consent, parental consent could be substituted.

2025 approach: The 2025 National Statement introduces the concept of child 'assent' which sits at the mid-point between incapacity and parental consent. Researchers can obtain a child's agreement or 'assent' to participate in research by providing appropriately tailored information about the study's aims, benefits, and risks. Assent can be obtained from children where they may otherwise lack maturity to provide legal consent. While a child's assent does not do away with the requirement to obtain parental consent, it enables children to be more meaningfully involved in the recruitment process.

Key change 4: Increased inclusivity of people experiencing mental or physical ill-health or disability

2023 approach: The 2023 National Statement separately classified participants into groups such as 'people highly dependent on medical care who may be unable to give consent' and 'people with cognitive impairment, an intellectual disability, or a mental illness'. The 2025 National Statement acknowledges that these classifications had the effect of disempowering or excluding participants from research, due to assumptions about their inability to make decisions or provide consent.

2025 approach: The 2025 National Statement provides an 'ethical imperative' to promote a more inclusive approach with respect to people with mental or physical ill-health or disabilities. The relevant Chapter 4.5 guidelines state researchers should cater for fluctuating consent. Further, the 2025 National Statement removes the requirement for HREC review of studies involving such participants and instead provides the option of less onerous reviews where studies are 'lower risk'.

Key change 5: Research involving Aboriginal and Torres Strait Islander people

2023 approach: The 2023 National Statement provided limited guidance as to what research required the consideration of the NHMRC's 'Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders' (Ethical Guidelines) and recommended (but did not require) consideration of other relevant documents.

2025 approach: The 2025 National Statement provides additional clarification on the types of research covered by Chapter 4.7 and requires consideration of the Ethical Guidelines as well as specified resources produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies. The relevant guidelines are also further set out to promote meaningful involvement and consideration of these participant groups in the design and conduct of research, and the access to, and distribution of research outcomes and benefits to relevant communities.

Key change 6: Research during disasters and public health emergencies

2025 approach: The 2025 National Statement includes Chapter 4.8 which sets out guidelines for research conducted during natural disasters, public health emergencies, and other crises (e.g. public unrest and armed conflict). Key principles include that research must be scientifically valid and 'rapidly implementable' without compromising ethical standards and obtaining proper consents. Researchers should also be mindful of the potential for re-traumatisation and exploitation of individuals experiencing or responding to crises. Entities responsible for reviewing research may be permitted to accelerate or streamline their review processes where appropriate.

Implications for researchers

The 2025 National Statement provides:

• A more flexible, triaged approach to ethics reviews, enabling 'fast-tracked' reviews for low-risk studies without sacrificing participant safety. For research projects that pose anything greater than 'low risk', the requirement for full HREC review remains in place.
• A flow-on requirement for researchers to justify their study's 'low risk' status by providing evidence of tailored risk mitigation measures (e.g. supported decision-making processes for consent, extra participant monitoring, independent advocates). Revisions to Chapter 2.1 provide clarification on risk justification requirements.
• A more inclusive approach to participant recruitment, providing opportunities to conduct research with previously automatically excluded groups.
• An opportunity for previously excluded groups to be involved in research and benefit from insights and learnings relevant to their demographic.

Next steps

The 2025 National Statement is available on the NHMRC website for download. Researchers should review their research protocols and study designs to ensure compliance with the 2025 National Statement. They should also familiarise themselves with the updated ethics approval processes and HREC considerations, including fast-tracked reviews for low-risk studies. Procedures may need to be developed to obtain 'assent' from child participants and consent from specific groups such as individuals with mental ill-health or physical disabilities.

For tailored advice on how the 2025 National Statement may affect your research programs, please contact our team.