2025 National Statement

The National Health and Medical Research Council has released the National Statement on Ethical Conduct in Human Research (2025) which replaces the 2023 version and took effect from 23 June 2026. Curtin’s Ethics Office is transitioning to the revised requirements and will refer to the 2025 version of the National Statement as of 25 September 2026. Updates to the HREA form are in progress, and researchers will be advised when relevant changes are implemented.

Researchers should begin referring to the 2025 National Statement now, particularly when their work involves the circumstances or participant groups addressed in Section 4. Section 4 applies where a specific population group is likely to be represented in significant numbers because of targeted recruitment, foreseeable inclusion, geography, recruitment strategy, analysis of identifying data, or the likely impact of research outcomes. Researchers must consider the relevant chapter throughout design, recruitment, consent, data management, monitoring and dissemination.

What has changed in Section 4

Section 4 adopts a more individualised and inclusive approach to ethical risk. Researchers should not assume that risk is inherent in membership of a particular group. Instead, risk may arise from a combination of personal, social, cultural, relational and research-specific factors. The revised guidance emphasises ethical inclusion, autonomy, self-determination, consultation and appropriate safeguards rather than excluding people solely to avoid potential risk.

Advice for researchers

Use the 2025 National Statement when planning and describing new research.
Identify whether chapters in Section 4 apply to the study context or proposed participants.
Assess risk at the individual and contextual level rather than relying on group labels.
Build inclusion, autonomy, consultation, cultural safety, consent and confidentiality safeguards into the study design.
Where relevant, consult people with lived experience, communities, cultural advisers, service providers or other experts before finalising the design.
Design for inclusion and autonomy by using accessible information, supported decision-making, appropriate assent and consent processes, culturally safe methods, independent recruitment and clear withdrawal arrangements.
Plan safeguards and responses. State how the team will manage distress, fluctuating capacity, disclosures, child safety concerns, privacy in shared settings, power imbalances, emergencies and researcher safety.
Refer to relevant clauses in Chapter 4 in the application to demonstrate how the guidelines have been addressed.
Check whether the revised guidance changes the appropriate review pathway, noting that some research may now be eligible for low-risk or exempt review while specified activities still require HREC review.
Monitor Ethics Office advice about HREA form updates and implementation arrangements.

Ethics Office staff are available to provide additional support including further advice on the updated National Statement, guidance regarding ethics application requirements, and assistance using InfoEd. Please contact the Ethics Office on (08) 9266 9223 or ROC-ethics@curtin.edu.au.

Summary of the updates to the 2025 National Statement

Full details of the new provisions are outlined on the NHMRC’s website.

Chapter 4.1 — Participants who may experience increased risk of harm

This new chapter moves away from labelling entire groups as “vulnerable”.
Researchers should assess the interaction of relevant factors in the specific research context and design studies that support appropriate participation rather than default exclusion.

Chapter 4.2 — Pregnancy, the human fetus and human fetal tissue

Low-risk review may be permissible where the research is highly unlikely to affect a pregnant participant or fetus.
For research likely to have pregnancy- and/or reproductive-related risk, researchers must also consider participants who may be pregnant or may become pregnant.
Researchers must address access to expert advice or counselling and the role of treating health professionals where relevant.
Research involving a fetus or fetal tissue cannot be exempt, although use of data may be eligible for exemption.
Where research carries risk to pregnant participants, all risks must be disclosed unless participants are known not to have reproductive potential.

Chapter 4.3 — Children and young people

There is greater emphasis on consent and assent, maturity, capacity and child safety.
Children should have greater agency to assent to or dissent from participation.
The new child-safety guidelines at 4.3.10–4.3.12 require specific researcher consideration.
A table has been included on page 80 of the National Statement which outlines ethical considerations for different categories of child participants on the basis of maturity.
Mature young people are assumed able to consent for themselves unless there is a specific reason to also seek parental consent.
HREC review is required when young people of developing maturity will consent for themselves (for example, in circumstances where no parental consent can be provided by parents); see 4.3.8.
Clause 4.3.7 provides new guidance for children and young people who have caseworkers or carers.
Chapter 4.5 now includes the table below (pg. 80) which outlines how participation of child and young people is authorised:

Chapter 4.4 — People in dependent or unequal relationships

The expanded guidance recognises economic and social factors that may create power imbalances.
Researchers should tailor consent processes where unequal relationships are present (4.4.4).
Researchers should consider pre-existing relationships (4.4.6) and confidentiality in settings such as hospitals and workplaces (4.4.8).

Chapter 4.5 — People experiencing physical or mental ill-health or disability

Some lower-risk research may be reviewed through low-risk pathways.
The chapter combines earlier guidance on people highly dependent on medical care and people with cognitive impairment, intellectual disability or mental illness.
Capacity must be assessed individually rather than inferred from a group label or diagnosis.
Study design should support inclusion, autonomy, self-determination, consultation and engagement.
Researchers must plan for capacity assessment, advance directives, and signs of distress or reluctance. Retrospective consent is prohibited.
More specific guidance applies to emergency, intensive-care and terminal-illness research.

Chapter 4.6 — Research conducted in other countries

The chapter now focuses more specifically on research conducted overseas in person, rather than activities such as online surveys.
Researchers must clarify responsibilities, undertake appropriate engagement and consultation, and consider cultural, social and political factors.

Chapter 4.7 — Aboriginal and Torres Strait Islander people and communities

The guidance adopts a strengths-based approach and places greater emphasis on consultation, engagement and cultural safety.
The core value “survival and protection” is replaced by “cultural continuity”, and “equality” is replaced by “equity”.
Researchers must consult and apply all four core NHMRC and AIATSIS guiding documents.
Applications must demonstrate cultural competency and provide evidence of engagement.
Low-risk review pathways may be available, but the researcher must fully address cultural safety, community needs and researcher capability.

Chapter 4.8 — Research during disasters, public health emergencies or other crises

This new chapter applies in specific, limited circumstances where the scale of a crisis requires additional ethical consideration.
Researchers must address additional risks to participants and researchers, avoid impeding the crisis response, collaborate with response agencies, consider rapid data sharing and justify the timing of the research.
Researchers must explain why the study can only be conducted during the crisis.

Chapter 4.9 — Research that may discover illegal activity

HREC review is now only mandated if research is intended to discover illegal activity (unless the research uses non-identifiable secondary data and may be eligible for a low-risk pathway).
The focus is now on research that may discover illegal activity, rather than on people involved in illegal activities.
Consent materials should give adequate notice of the possibility of discovering illegal activity and address potential disclosure obligations and implications for participants and researchers.

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2025 National Statement

What has changed in Section 4

Advice for researchers

Summary of the updates to the 2025 National Statement