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Definition of harm
Harm is more serious than discomfort in the National Statement's risk framework. Any foreseeable risk of harm, however small the likelihood, requires review by a full Human Research Ethics Committee (HREC); it cannot be reviewed through a lower risk pathway (NS Chapter 2.1; NS 5.1.11). While no list of harms can be exhaustive, the National Statement sets out the following classification of potential harm from research or evaluation (NS Chapter 2.1):
- Physical harm: injury, illness, pain, or death
- Psychological harm: feelings of worthlessness, distress, guilt, anger, fear, or anxiety, including distress related to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease
- Devaluation of personal worth: humiliation, manipulation, or other disrespectful or unjust treatment
- Cultural harm: misunderstanding, misrepresenting, or misappropriating cultural beliefs, customs, or practices
- Social harm: damage to social networks or relationships; discrimination in access to benefits, services, employment, or insurance; social stigmatisation; or unauthorised disclosure of personal information
- Economic harm: direct or indirect costs imposed on participants
- Legal harm: discovery and prosecution of criminal conduct
Any of these types of harm can be experienced individually or collectively, and can extend to non-participants, such as a participant's family member (NS Chapter 2.1). See Harm vs discomfort for how harm is distinguished from discomfort in practice.
Harm to non-participants and to groups
Harm and discomfort to non-participants may be relevant to the assessment of a project's risks. The National Statement gives the example of distress for a participant's family member identified as having a serious genetic disorder, or the effect of published research or evaluation findings on family or friends (NS Chapter 2.1). Some social research carries wider social or economic risks; research in a small community into attitudes toward specific subpopulations may lead to unfair discrimination or affect social cohesion, and research into the social determinants of health may carry a risk of harm to a whole community, not only to individual participants (NS Chapter 2.1).
Risk of harm in applied research
In market research, social research, and program evaluation, the most commonly encountered categories of harm are psychological harm, particularly distress related to sensitive topics, and social harm, particularly re-identification and privacy breaches. Physical and legal harms are less common in these settings but may still arise, for example where a project involves physical activity, or where a participant discloses information suggesting illegal conduct (and where there may be mandatory disclosure obligations). See Common risks in evaluation, market research, and social research for a fuller discussion of these risk categories as they arise in applied practice.
Some participants may be at higher risk of harm than others in the same project. This can arise from the nature, design, or setting of the research; from specific attributes or characteristics of individual participants or the groups to which they belong; or from an interaction of both (NS Chapter 2.1). Research involving participants who are already in circumstances that predispose them to a higher risk of harm requires particularly careful design. See Section 4 for guidance on Specific populations and Research contexts.
What reviewers look for
Where an application identifies any foreseeable risk of harm, reviewers expect to see the likelihood and severity of that harm assessed, the participants or groups who may be exposed identified, and mitigation strategies described that are proportionate to the risk (NS 2.1.1, NS 2.1.2). A risk of harm does not make a project unethical or unapprovable; it means the project requires the higher level of scrutiny an HREC provides, so that the risk is properly justified by the project's likely benefits and effectively managed (NS Chapter 2.1).
Applications sometimes describe a risk of harm using language that minimises it, for example calling a risk of psychological harm "minor discomfort" because the researcher hopes to access a lower risk pathway. Reviewers assess the risk on its substance, not on the label the applicant has given it. Where the facts described in an application indicate a foreseeable risk of harm, the project requires full HREC review, whatever term is used to describe the risk in the application (NS Chapter 2.1; NS 5.1.11).
Documenting harm in an application
An application should state, for each identified harm: which participants or groups are at risk; how likely the harm is to occur; how severe it would be if it occurred; and what specific steps will reduce the likelihood or severity, such as referral pathways, trained facilitators, or design changes that avoid the higher-risk element altogether. General statements that "risks will be managed sensitively" are not sufficient; reviewers look for the specific mechanism proposed for each harm identified (NS 2.1.1).
Related resources
This page was last updated on 24 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.