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.
Effective early 2026 (date to be confirmed).
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 effective date of the 2025 National Statement has been postponed to early 2026 (date to be advised). From the effective date, the National Statement on Ethical Conduct in Human Research 2023 will be revoked and researchers submitting human research proposals for ethics review, ethics review bodies and those involved in research governance will be expected to apply the guidance in the 2025 National Statement.
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 The information in the brackets [(CPMP/ICH/135/95)] is out of date.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.'
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.
