On 1 April 2025, NHMRC released an updated National Statement on Ethical Conduct in Human Research 2025 (National Statement) incorporating changes to Section 4 Ethical considerations specific to participants in research and minor changes to other sections of the National Statement. This is an update to the National Statement released in 2023.

1. Which sections and chapters have been revised as part of the 2025 National Statement update? 

 Section 4 has been fully revised and minor changes have been made to all other sections of the document.

2. What are the major changes that have been made to Section 4?

The following are major changes that have been made to Section 4. A table of the new chapter organisation and significant changes is also provided below.

  • thematic changes and changes in the way that causes of increased risk are described
  • the removal of the need for research involving research participants potentially at increased risk to automatically require review by a Human Research Ethics Committee (allowing for the use of alternative review processes for lower risk research with the same participants, where appropriate)
  • extended guidance on research involving children and young people
  • extended and consolidated guidance on research involving people experiencing physical or mental ill-health or disability
  • revised guidance on research with Aboriginal and Torres Strait Islander people and communities, responsive to input from key stakeholders
  • a new chapter on research conducted during natural disasters, public health emergencies or other crises.
New chapter organisation and significant changes
Ch# Chapter title Significant changes 
4.1 Ethical issues in recruitment and involvement of research participants who may experience increased risk New introductory chapter 
4.2 Pregnancy, the human fetus and human fetal tissue Focus shifted to ‘pregnancy’ rather than ‘pregnant women’ as a defined group 
4.3 Children and young people Extended guidance on research involving children and young people, including the introduction of the concept of ‘assent’ to participation in research 
4.4 People in dependent or unequal relationships None 
4.5 People experiencing physical and mental ill-health or disability Extended guidance on research involving people experiencing physical or mental ill-health or disability. Merger of two previously existing chapters. 
4.6 Research conducted in other countries None 
4.7 Research with Aboriginal and Torres Strait Islander people and communities Strengthened guidance responsive to input from key stakeholders 
4.8 Research conducted during natural disasters, public health emergencies or other crises New chapter 
4.9 Research that may discover illegal activity None 
3. Why have the changes to Section 4 been made?

The changes to Section 4 have been made in response to input from stakeholders provided during public consultation and as part of further targeted consultation. They reflect strong trends in the research sector toward inclusion of participants who are or may be at increased risk of harm (sometimes referred to as ‘vulnerable populations’) and toward a more nuanced assessment of increased risk based on people’s characteristics, circumstances and the context of the research itself. Additionally, in response to global events in recent years, Section 4 includes a new chapter that recognises the need for guidance for research conducted during natural disasters, public health emergencies or other crises.

4. What are the changes that have been introduced to other sections of the National Statement?

Some changes to Section 4 have prompted minor changes to other sections of the National Statement as a result of the public consultation process. These changes are predominantly clarifications of ambiguous phrasing and other language or grammatical changes that were identified during the editing process.

5. When do these changes take effect?

The 2025 National Statement will take effect in early 2026 (date to be advised). The effective date has been postponed from 1 October 2025 to give institutions additional time to prepare the necessary adjustments to policy, processes, templates and forms. Researchers, reviewers and other stakeholders should become familiar with the new guidance well before that date and have any necessary adjustments to policy, processes or individualised application or project description templates in place in preparation for the effective date.

Applications for ethics review that were submitted to an HREC prior to the effective date (but not yet reviewed) or applications that are under review on the effective date can be considered under current National Statement guidance.

6. Can institutions / HRECs apply the 2025 National Statement prior to the effective date? 

Yes. The effective date is the date that NHMRC expects institutions, HRECs and researchers to be applying the revised National Statement. The revised guidelines in Section 4 may be implemented progressively prior to the effective date. However, institutions will need to communicate any early adoption of the 2025 National Statement to all relevant stakeholders at the time they are adopting it.

7. Will there be training offered to assist in the uptake of the changes?

While NHMRC will not be providing a formal training program or online educational modules to introduce the updated National Statement, we will be exploring options to present information on the changes and opportunities for stakeholders to ask questions and provide feedback.

8. Will these changes be accompanied by changes to the Human Research Ethics Application (HREA)? 

Yes. Although the changes to the HREA are minor, we will be making the necessary adjustments, resulting in a revised HREA.

9. When will the HREA changes be introduced? 

The release of the revised HREA will be coordinated with the effective date for the updated National Statement in early 2026.

10. Are there any other reviews of the National Statement planned? 

No. The National Statement has been undergoing review continuously since 2016. There are no further reviews of the National Statement planned at this stage. 

11. Can I get a hard copy of the updated National Statement? 

The National Statement is only available online in PDF format, although stakeholders are welcome to print it if they wish.

12. Whom should I contact with questions about the updated National Statement?

Any questions or feedback on the National Statement should be addressed to ethics@nhmrc.gov.au.