The National Statement on Ethical Conduct in Human Research (2025) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992.
Publication Data
Release of the 2025 National Statement
The National Statement on Ethical Conduct in Human Research 2025 incorporates a revised Section 4 as well as changes to other sections and some additional minor changes (see below).
The 2025 National Statement is effective from 23 June 2026.
The National Statement on Ethical Conduct in Human Research (2025) is available in the Downloads section below.
Correction: Please note that paragraph 5.3.3 of the 2025 National Statement contains an error. The information in the brackets [(CPMP/ICH/135/95)] is out of date. Paragraph 5.3.3 of the 2025 National Statement should read:
'Where required, researchers should adhere to the current requirements of the ICH Guideline for Good Clinical Practice (as in force from time to time), ISO 14155 Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice, the World Health Organization International Clinical Trials Registry Platform and the Therapeutic Goods Administration.'
Guidance on implementation of Section 4
Section 4 of the 2025 National Statement provides guidance on ethical considerations specific to participants in research. It focuses on ethical issues that should be considered by those planning, developing, reviewing and conducting research involving participants who may be at increased risk of harm arising from their characteristics, circumstances or the context of the research.
Section 4 maintains that any proposed research defined by type, method or participant cohort should be assessed for its risks and may be assessed as lower risk or higher risk, in accordance with the guidance in Chapter 2.1. Research that is often considered to be greater than low risk, such as clinical trial research or research involving participants that are commonly considered to be at increased risk of harm may, in some instances, be assessed as carrying low risk and therefore may be eligible for review via a low-risk review pathway.
The Section 4 guidelines apply to research where a specific population group is likely to be represented in significant numbers in the research cohort due to targeted recruitment, likely or foreseeable inclusion, geography, recruitment strategy, identifying data analysis, or impact of research outcomes (2025 National Statement, page 65). The guidance in Section 4 is also supported by advice in the Human Research Ethics Application (HREA) which distinguishes between a participant cohort that is created by targeted recruitment or when the presence of individuals from a particular participant group is likely or foreseeable, as opposed to the presence of individuals in the cohort due to incidental recruitment (see guidance on recruitment in the Information section of the HREA).
Both the National Statement and the HREA require that researchers follow guidance on ethical considerations specific to groups of participants who are at increased risk of harm when they are specifically recruited or their presence in the cohort is likely or foreseeable. Application of the guidance is not required when the presence of such individuals in the cohort is due to incidental recruitment.
For more information, please see the Frequently Asked Questions.
Minor changes to the 2025 National Statement
As part of the revisions of the 2025 National Statement, AHEC made some minor changes to support the revisions to Section 4 and other sections of the National Statement. These changes include corrected references, clarifications of ambiguous phrasing and other grammatical, punctuation and/or formatting changes that were identified during the editing process.
As the changes raise issues that are of minor significance only, there is no requirement for public consultation (National Health and Medical Research Council Act 1992 sub section 14B(1)(b)).
To fulfill notification requirements in accordance with section 9 of the National Health and Medical Research Council Regulation 2016 a summary of proposed changes is made available.
A summary of changes to the National Statement 2025 is available in the Downloads section below.