2025 National Statement - Updates - Public Consultation

Overview

The National Statement on Ethical Conduct in Human Research (2025) (2025 National Statement) was issued on 1 April 2025 and became effective on 23 June 2026. After publication, stakeholders raised concerns about the definition of human research and some internal inconsistencies, prompting NHMRC to initiate a review and a targeted consultation.

NHMRC conducted a targeted consultation on proposed changes to the 2025 National Statement from 16 February to 6 March 2026. It is now presenting further revisions for public consultation from 5 November to 16 December 2026.

Proposed changes affect the Purpose, Scope and Limits section and Chapters 3.1 and 5.1 of the 2025 National Statement. The main issues are:

• the definition of human research and which research and related activities require ethics review
• the appropriate approach to exemption of human research from ethics review, and related requirements
• the criteria for exemption of human research from ethics review.

Feedback from the targeted consultation showed that the issues are complex and that stakeholders have differing views on what research may be exempt from ethics review.

Purpose, Scope and Limits section: Definition of human research

In response to concerns about the definition of human research in the 2025 National Statement, the definition has been amended to remove references to ‘research involving information associated with human beings that is not human research.’ Additional commentary has also been included on when ethics review may be needed for activities that are not human research but may overlap with it or use information collected for non-research purposes that may later be used in research.

This section also references Ethical Considerations in Quality Assurance and Evaluation Activities (2014). NHMRC has begun the process of comprehensively revising that document.

Chapter 3.1, Element 4: Secondary use of data or information

Language in the discussion of secondary use of data or information in Chapter 3.1, Element 4 and paragraph 3.1.51 has been revised to clarify the National Statement’s guidance on the use of publicly available data or information when consent for its use in research is unclear or has not been provided. These issues are also relevant to the criteria for research that may be exempt from ethics review in Chapter 5.1.

Chapter 5.1: Approaches to exemption of research from ethics review

In previous versions and in the 2025 National Statement, exemption of research from ethics review requires:

• a request by the researcher for an exemption
• a determination by the institution that the research is eligible for exemption
• the granting of that exemption, and
• the institution keeping a record of the decision.

The version of the 2025 National Statement released for targeted consultation replaced this approach with a discretionary approach. Under the discretionary approach, institutions choosing to exempt research from ethics review would have been required to publish a policy setting out the criteria used to make exemption decisions. In practice, this would have allowed institutions to apply their own interpretation of the National Statement criteria or to substitute their own criteria.

Targeted consultation feedback highlighted a central tension in approaches to exemption of human research from ethics review. This involves balancing the aim of allowing research that does not require ethics review to proceed without unnecessary burden against the need for institutions to maintain appropriate oversight and accountability for research conducted under their auspices. Feedback also raised concerns that some approaches to exemption could reinforce or increase inconsistency across institutions or jurisdictions, including in the standards applied and how they are interpreted and implemented.

In response, the Australian Health Ethics Committee (AHEC) Policy Issues Working Group considered several options across two different dimensions: decision-making, assessment, oversight and accountability; and the nature of potentially exempt research and its associated need for institutional scrutiny, however limited.

In selecting an approach for exemption of research from ethics review, consideration was given to

• the burdens on institutional resources associated with collecting and managing information and with maintaining procedures to assess whether research meeting the criteria in 5.1.17 requires review
• the diversion of resources from a human research ethics committee (HREC) and/or lower risk review processes to support administrative processes for assessing research for exemption from ethics review
• the importance of avoiding barriers to student coursework research and other research activities that have not always required ethics review
• existing and foreseeable inconsistency between institutions in determining whether research could be exempt, including its impact on collaborative and international research
• the locus of decision-making responsibility and accountability for determining which research is exempt from ethics review
• broader issues of governance of and accountability for the conduct of research activity within institutions
• concerns about researchers, institutions or review bodies incorrectly characterising research as exempt or not exempt from ethics review.

The changes proposed in the approach to exemption undergoing public consultation are not intended as a compromise solution but instead reflect a clear position: if research is eligible for exemption, it is exempt and need not be assessed by the institution. Where there is doubt about whether research is exempt, it should instead be submitted for review as lower risk research through an appropriate ethics review body or process.

Chapter 5.1: Criteria for exemption of research from ethics review

Prior to 2023, the criteria for exemption from ethics review were exceptionally narrow. Research was eligible for exemption only if it involved negligible risk and used existing collections of data or records containing only non-identifiable information about human beings. The 2023 National Statement expanded this single criterion into four criteria, which the 2025 National Statement retained.

The AHEC decision to move away from the category of ‘research involving information associated with human beings that is not human research,’ in response to stakeholder concerns raised following the release of the 2025 National Statement, led to the development of five additional exemption criteria. These criteria were intended to capture the types of research that were considered by AHEC to strike the right balance between risk to participants and administrative burden and to better align with how these types of research are managed internationally.

There are important issues arising from the proposed changes to the National Statement that will be addressed in greater detail through supporting material to accompany the next version of the National Statement on the NHMRC website. These issues include:

• the distinction between research and non-research activity and the ethical considerations that may apply to each
• the value of more nuanced definitions and commentary on ‘personal information’, ‘de-identified information’ and ‘publicly available information’ for the purposes of guidance under the National Statement
• the need for commentary and/or examples illustrating the kinds of research captured by the exemption categories in paragraph 5.1.17.