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Lower risk vs full HREC review

The risk thresholdFull HREC reviewLower risk reviewThe exemption optionPractical guidanceRelated resources

This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.

The risk threshold

The key distinction between full HREC review and lower risk review is whether the research presents a foreseeable risk of harm (NS 5.1.11). Low risk research is research in which the only foreseeable risk is no greater than discomfort (NS Chapter 2.1). If a foreseeable risk of harm is present, full HREC review is required. If the only foreseeable risk is discomfort, inconvenience, or burden, but not harm, lower risk review is appropriate.

Full HREC review

Full committee review must be conducted by an HREC constituted and operating in accordance with the National Statement (NS 5.1.11). The committee assesses all aspects of the research proposal against the National Statement's requirements. This pathway is required for research where contextual factors significantly elevate risk, research involving sensitive topics with high potential for distress, and any research where a foreseeable risk of harm has been identified.

At Iris Ethics, full committee Review is completed in under 10 business days from application confirmation, with meetings commencing within 1 business day of confirmation (3 business days for international projects) and decision notification within 1 business day of the panel's decision.

Lower risk review

Lower risk review is conducted by a qualified individual or small group rather than the full HREC. Institutions must ensure that those conducting lower risk review have the necessary competence (NS 5.1.13–5.1.14). The review applies the same ethical principles as full HREC review but focuses proportionate attention on the risk profile of the project; it examines the same core elements, including the adequacy of participant information, the approach to consent, and data management arrangements, at a level of process proportionate to the risk involved.

In practice, the vast majority of market research, social research, and program evaluation activities will fall within the lower risk pathway. The presence of discomfort, inconvenience, or burden does not escalate a project to full review. Instead, those factors are managed through the lower risk process. What triggers full review is evidence of a foreseeable Risk of harm. At Iris Ethics, lower risk review is completed in under 5 business days from application confirmation, on the same commencement and notification timeframes as full committee review.

The exemption option

Some research may qualify for exemption from formal ethics review under NS 5.1.15–5.1.18. However, the criteria are strict and many commonly used research methods, particularly interviews and focus groups, do not qualify. See Exemptions from ethical review (NS 5.1.15-5.1.18) for full detail.

Practical guidance

When assessing a project's risk level, consider:

  • the nature of the population (does membership in this group magnify risk?);
  • the sensitivity of the topics covered;
  • the likelihood that participation could cause distress; and
  • whether any foreseeable physical, psychological, social, economic, cultural, or legal harms could result from participation.

Related resources

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.