The National Statement on Ethical Conduct in Human Research is the principal reference for research involving humans in Australia and is the guiding document for Human Research Ethics Committees. The National Statement is released by the National Health and Medical Research Council (NHMRC) and is periodically updated to stay relevant to evolving research practices, ethical understanding and community needs.
The 2025 revision, originally due to take effect on 1 October 2025, has been postponed until early 2026. However, institutions are encouraged to adopt it earlier and Bellberry will apply the changes from 1 October 2025.
The 2025 revision of the National Statement incorporates a fully revised Section 4 and consequential or minor changes to almost all other sections. The revised National Statement includes the following major thematic changes in Section 4:
- framing the need for additional consideration for individual participants or groups of participants in terms of increased risk of harm, rather than in terms of vulnerability
- emphasis on inclusion of individuals and groups frequently excluded or under-represented in research
- drawing a distinction between research with people who are at increased risk due to characteristics or circumstances, and increased risk due to research contexts
- removal of the need for research involving participants potentially at increased risk to automatically require review by a full HREC, enabling the use of alternative review processes for lower risk research with the same participants, where appropriate.
The revisions also include recognition of issues related to research with Aboriginal and Torres Strait Islander people and communities in the Preamble and Section 1 of the National Statement and a revised Chapter 4.7.
We encourage all researchers to become familiar with the updates. A summary of the changes can be found on the NHMRC website.