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Risk thresholds
The National Statement establishes a continuum of risk (NS Chapter 2.1). For the purpose of determining the review pathway, the key distinction is between lower risk research, where the only foreseeable risk is no greater than discomfort, and higher risk research, where a risk of harm is foreseeable and full HREC review is required (NS 5.1.11).
At Iris Ethics, the full HREC reviews higher-risk research. Lower-risk research is assessed through the lower risk review pathway, by a separate team within the company who specialise in such reviews and who meet the National Statement's requirements for non-HREC review bodies (NS 5.1.12-5.1.14). Some research may qualify for exemption, or for an expert determination addressing a specific question; see Types of ethical review.
Review criteria (National Statement principles)
In reviewing a research proposal, reviewers assess whether it meets the requirements of the National Statement. The primary criteria, corresponding to the principles of the National Statement, are:
- Research merit: the research has a valid purpose, is appropriately designed, and is based on adequate knowledge of the field. See Merit (NS 1.1-1.2).
- Integrity: the research is conducted with rigour and accountability, and researchers deal fairly and openly with participants. See Integrity (NS 1.3).
- Justice: participants are fairly selected and the burdens and benefits of research are equitably distributed. See Justice (NS 1.4-1.5).
- Beneficence: the potential benefits of the research justify the risks and burdens, and risks are minimised. See Beneficence (NS 1.6-1.9).
- Respect: the dignity, autonomy, and welfare of participants are protected. See Respect (NS 1.10-1.13).
Thresholds in practice
For market research, social research, and program evaluation contexts, the most commonly encountered risk levels are discomfort and inconvenience. Harm is less frequent, but may arise in studies involving sensitive topics, vulnerable populations, or significant power imbalances. See Assessing risk levels and Harm vs discomfort for detailed guidance on risk categorisation.
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.