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The exemption framework
NS 5.1.15 provides that some human research may be eligible for exemption from ethics review. The institution responsible for the research may choose to exempt research that meets the criteria set out in NS 5.1.17 (see below). Where there is no institution providing oversight, researchers should request a grant of exemption from an ethics review body. Statements of exemption are sometimes required for publication in peer-reviewed literature where formal ethical review has not otherwise been conducted. It is worth checking these requirements when designing research intended for publication, as retrospective approval cannot be granted (NS 5.1.6).
NS 5.1.16 provides an absolute restriction on this: research or evaluation that involves the use of personal information without consent cannot be granted an exemption. To conduct such activities, a waiver of the requirement for consent would need to be granted by an appropriate ethics review body, a process that is itself a form of formal review.
Exemption criteria (NS 5.1.17)
Research or evaluation may be eligible for exemption if it carries lower risk and meets one or more of the following conditions:
- It uses collections of data from which all personal identifiers have been removed prior to provision to the researcher/evaluator, and the researcher/evaluator agrees not to attempt re-identification and to take reasonable steps to prevent re-identification and unauthorised access;
- It is restricted to surveys and observation of public behaviour, using information collected and recorded without personal identifiers, and is highly unlikely to cause distress;
- It is conducted as part of an educational training program, where the activity is for training purposes only and any outcomes or documentation are for program use only; or
- It uses information that is publicly available through a mechanism set out by legislation or regulation, such as mandatory reporting information, birth and death registries, coronial investigations, or ABS data.
Additional criteria from the QA Guidance
The NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014) adds further conditions that sit on top of the NS 5.1.17 criteria. Even where those criteria are met, the QA Guidance treats an activity as still requiring ethics review where it:
- Compares cohorts;
- Uses randomisation, control groups, or placebos; or
- Involves targeted and separate analysis of minority or higher-risk* groups.
Practical implications
The exemption threshold is high. Interviews and focus groups do not meet condition (b), which explicitly lists surveys and observation of public behaviour. In most cases, if a researcher or evaluator is the interviewer or facilitator, condition (a) will also not be met, because the researcher is collecting identifiable information directly rather than receiving already de-identified data. This means projects using interview or focus group methods will almost always require formal ethics review, regardless of other risk factors.
Institutions and researchers must keep an auditable record of any research or evaluation exempted from ethics review under NS 5.1.17, in accordance with NS 5.3.9 and NS 5.1.18.
Related resources
- What counts as research: whether an activity is human research at all
- Lower risk vs full HREC review: the pathway that applies where exemption is not available
- Evaluation and quality assurance: how the QA Guidance's additional conditions interact with NS 5.1.17
*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.
This page was last updated on 16 September 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.