This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Determining the appropriate risk level is the key task in assigning a research proposal to the correct review pathway. Reviewers at Iris Ethics apply the risk threshold framework set out in NS Chapter 2.1 and NS 5.1.10–5.1.11; see Understanding risks in ethical review for the underlying concepts.
The threshold question
The primary question is whether the research presents a foreseeable risk of harm, as opposed to discomfort, inconvenience, or burden only. If yes, full HREC review is required (NS 5.1.11). If the only foreseeable risk is discomfort or below, the research meets the National Statement's definition of low risk research and a lower risk review pathway is appropriate (NS Chapter 2.1). See Harm vs discomfort for how reviewers draw this boundary.
Factors in risk level assessment
In assessing risk level, reviewers consider:
- Topic sensitivity: Does the research address topics that may cause distress in a significant proportion of participants? Topics involving trauma, stigma, mental health, and discrimination require particular care.
- Population vulnerability: Are participants from a group whose membership may magnify the risk of participation (children, people with illness or disability, people in dependent relationships)?
- Probability of adverse response: Even for low-risk topics, is there a realistic possibility that some participants could experience harm? Where a participant's reactions might exceed discomfort and become distress, this is potential harm (NS Chapter 2.1).
- Privacy and re-identification: Does the research involve identifiable data or small samples where re-identification is feasible? Privacy breaches constitute social harm.
Common assessment errors
Reviewers should be alert to two common errors in risk level assessment: under-assessment (treating harm as mere discomfort by failing to account for vulnerable subsections of the population) and over-assessment (applying full HREC review to simple lower risk research, creating unnecessary burden). Both errors have costs to researchers and to the system.
Related resources
This page was last updated on 16 September 2026.
Was this helpful? We'd appreciate your feedback!
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.