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The National Statement's starting point
The National Statement does not adopt a single fixed definition of research. It states plainly that "there is no generally agreed definition of research" and instead points practitioners to the Australian Research Council's definition: research is "the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies, inventions and understandings" (NS, Purpose, Scope and Limits of this Document, "What is research?"). This can include synthesis and analysis of existing material, provided the result is new and creative.
Rather than debating definitions, the National Statement directs practitioners to two more practical questions: what is human research, and when does human research, or activities such as quality assurance, audit, or evaluation, require ethics review (NS, Purpose, Scope and Limits of this Document, "What is research?").
What counts as human research
Human research is conducted with or about people, or their data or biospecimens, and is understood broadly. It includes:
- taking part in surveys, interviews, or focus groups;
- undergoing psychological, physiological, or medical testing or treatment;
- being observed by researchers;
- researchers having access to personal documents or other materials;
- the collection and use of biological material; and
- access to individual information in identifiable or potentially re-identifiable form, including in an unpublished source or database used for the research.
(NS, Purpose, Scope and Limits of this Document, "What is human research?")
The term "participants" is used broadly and can include people who are not aware they are participating, such as where consent to use their data or biospecimens has been waived by an ethics review body. This definition is broad enough to capture activities not usually labelled "research", including program evaluation, market research, social research, employee surveys, and much data analysis, provided the activity involves people or their data.
What is excluded
Consultation and engagement with potential participants, co-researchers, or community representatives that precedes the development, design, or conduct of research is not itself human research and typically does not require ethics review (NS, Purpose, Scope and Limits of this Document; see also NS Chapter 4.1, Introduction). This covers co-design and other pre-research engagement, discussed further at Co-design.
The National Statement also identifies activities that are not human research and do not, as independent activities, require ethics review (NS, Purpose, Scope and Limits of this Document, "What is human research?"):
- literature review that supports the development or design of a research project;
- research using public data - that is, information that has been published or has entered the public domain with the consent of the person(s) to whom it relates; and
- research using aggregate (group-level, non-identifiable) data.
These exclusions are fact-dependent. An activity that begins as a literature review, a co-design process, or analysis of public material can become research requiring review if its outputs are subsequently used as research data, or if it draws in information that is not truly public or aggregate. For a worked example of this boundary, see Public submissions and ethical review, which addresses the use of submissions to public policy inquiries as research or evaluation data.
The QA and evaluation continuum
Quality assurance (QA), evaluation, and research exist on a continuum, and an activity that begins as one can evolve into another over time. The National Statement directs institutions to the NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014) for guidance on when QA and evaluation activities require ethics review (NS 5.1.7). That guidance identifies triggers that, when present, require ethics review regardless of the label applied to the activity, including:
- potential infringement of privacy or professional reputation;
- secondary use of data;
- gathering information beyond what is routinely collected;
- use of non-standard or innovative protocols or equipment (including interviews and focus groups);
- comparison of cohorts;
- randomisation or the use of control groups or placebos; and
- targeted analysis of minority or higher-risk* groups separated from the main analysis.
Interviews with any stakeholders, including program staff, commissioners, or participants, are not exempt from ethics review, because interviews are non-standard instruments. This means most program evaluations involving interviews require at least a lower risk review. See Evaluation and quality assurance for detailed guidance on this continuum.
Practical test
When assessing whether an activity constitutes research requiring ethics review, apply the following questions in order:
- Is this an investigation, synthesis, or analysis intended to create new knowledge or understanding? If yes, it is likely to be "human research" if it involves people or their data or biospecimens; proceed to step 2.
- Does it meet one of the exclusions above, or the NS 5.1.17 exemption criteria? If it meets an exemption criterion, it may qualify for a statement of exemption. If not, formal review is required.
- Is there a foreseeable risk of harm? If yes, full HREC review is required. If the only foreseeable risk is discomfort, lower risk review is appropriate.
The National Statement Navigator can also help identify the most appropriate pathway for a project.
Related resources
- Evaluation and quality assurance: the QA/evaluation/research continuum in detail
- Exemptions from ethical review (NS 5.1.15-5.1.18): the exemption criteria
- Co-design: when co-design and engagement activities become research
- Public submissions and ethical review: using public submissions as research or evaluation data
- Market research
*As of the 2025 edition of the National Statement, the term "vulnerable" has been removed from use, though the 2014 QA Guidance has not been updated to reflect this. This statement treats the term as referring to any group identified as being at higher risk of harm in the context of the proposed activities, as outlined in Chapter 4.1 of the National Statement. More information can be found on these groups here.
This page was last updated on 9 October 2026.
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This article makes reference to the National Statement on Ethical Conduct in Human Research 2025. It is intended as practical guidance and does not constitute legal advice.
AI Disclosure: Resources in this library were prepared using Large Language Models with input from Iris Ethics staff who guided the scope and design. Subsequent revisions and final versions were developed and approved by Iris Ethics staff.