This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Determining whether your activity requires ethics review involves two questions.
- Does the activity constitute human research under the National Statement?
- If so, is it exempt from review, or does it require a formal review process?
See What counts as research for detailed guidance on the first question.
Activities that do not require ethics review
The following activities are not considered to be human research under the National Statement and do not, as independent activities, require ethics review (NS, Purpose, Scope and Limits of this Document):
- Pre-research consultation and engagement with potential participants, co-researchers, or community representatives that precedes the development, design, or conduct of research or evaluation
- Literature reviews that support the development or design of a research/evaluation project
- Research or evaluation using public data, such as information that has been published, or information that has entered the public domain with the consent of the person(s) with whom it is associated
- Research or evaluation using aggregate (that is, non-identifiable, group-level) data
Activities that may qualify for exemption
Some human research may be eligible for exemption from ethics review. Under NS 5.1.17, research may be exempted if it is both lower risk in nature 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 re-identify the data
- It is restricted to surveys and observation of public behaviour, does not collect personally identifying information, and is highly unlikely to cause distress
- It is conducted as part of an educational training program and any outcomes or documentation are for program use only
- It uses information that is publicly available through legislation or regulation
NS 5.1.16 specifies that research involving the use of personal information without consent cannot be granted an exemption, because such research would require a waiver of consent that only an ethics review body can grant. The NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014) sets out further triggers that indicate ethical review is needed rather than exemption, including secondary use of data for a different purpose, gathering information beyond what is routinely collected, testing non-standard protocols, comparison of cohorts, randomisation or the use of control groups, and targeted analysis of data relating to minority or vulnerable groups.
More information on this is provided at Is ethics review required?
Activities that require formal review
If an activity constitutes human research and does not meet the exemption criteria, it requires ethics review. The level of review depends on the risk profile: higher-risk projects require full HREC review, and lower-risk projects may proceed through a lower risk review pathway. See Lower risk vs full HREC review for the distinction and Types of ethical review for an overview of each option available through Iris Ethics. We've also created a National Statement Navigator to help guide your decision making.
When in doubt, contacting Iris Ethics before commencing is strongly recommended. The committee can provide pre-submission advice.
If data that appear to meet the exemption criteria have already been published, the activity may fall outside the scope of ethics review altogether rather than requiring a formal exemption. If in doubt, contact Iris Ethics.
This page was last updated on 24 September 2026.
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This article draws on the National Statement on Ethical Conduct in Human Research (2025) and the NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014). It is intended as practical guidance and does not constitute legal advice. If you have questions about whether your project requires ethics review, get in touch.
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.