This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
The justification requirement
Research is ethically acceptable only when its potential benefits justify any risks involved (NS 2.1). This requirement applies to every project regardless of risk level, and must be addressed explicitly in every ethics application, not left to be inferred by the reviewer.
Risk and benefit are assessed together, not separately. A reviewer does not ask only "is this risk acceptable?" but "is this risk justified by what the project is likely to achieve, and for whom?" The greater the risk, the more certain reviewers must be that it will be managed as effectively as possible, and that participants clearly understand the risks they are assuming (NS 2.1.4).
What counts as a benefit
Benefits of research and evaluation may include gains in knowledge, insight, and understanding; improved social welfare and individual wellbeing; gains in skill or expertise for individual researchers, teams, or institutions; or evidence-based responses to public health, policy, or practice challenges (NS 2.1). Some research offers direct benefits to participants themselves, their families, or a group with which they identify (NS 2.1).
In evaluation, social research, and market research, the benefit most often cited is the practical use of findings to improve a program, product, policy, or service. This is a legitimate benefit and should be described explicitly and specifically in an ethics application; a generic statement that a project will "contribute to knowledge" is weaker than a description of the decision the findings will inform and who will act on them.
The risk/benefit assessment
A judgement that research is ethically acceptable requires (NS 2.1.1):
- identifying the risks and burdens that may arise, and which participants or others might experience them
- assessing the likelihood and severity or magnitude of each risk
- describing actions or strategies that could effectively minimise, mitigate, or manage each risk, including changes to the research design
- identifying the potential benefits and to whom they are likely to accrue
- determining that the risks and burdens are justified by the potential benefits
This assessment must be based on the available evidence, whether quantitative or qualitative, and reviewers and researchers should consider seeking advice from others experienced with a similar methodology, population, or research domain (NS 2.1.2). Researchers and reviewers must also assess the research aims and the methods proposed to achieve them, in order to minimise or mitigate risk (NS 2.1.3). Care should be taken not to overstate benefits or understate risks in the application; reviewers assess both against the evidence provided, not against the project's stated intentions.
Participant perspective
Some research offers direct benefits to participants, who may be willing to accept a higher degree of risk than they might otherwise take on. Ethics review bodies should take into account any willingness by participant populations to assume greater risks or burdens because of their perception of the potential benefits to themselves, their families, or the groups or communities to which they belong (NS 2.1.5). This does not remove the obligation on researchers and reviewers to minimise risk; it means participant willingness is one factor in the justification, not a substitute for it.
Applying this in evaluation, social research, and market research
In program and policy evaluation, the benefit is usually improved service delivery or policy design, and the direct beneficiaries are often future service users rather than the participants themselves. Where a project carries a foreseeable risk of discomfort, such as a participant recalling a difficult experience with a service, the justification should identify who benefits from the evaluation and why that benefit is proportionate to the discomfort involved.
In social research, benefits are frequently indirect, such as improved public understanding of an issue. Where a topic carries risk of psychological harm, for example research into experiences of discrimination or family violence, the justification needs to explain why the research question cannot be answered with a lower-risk design, and how the value of the findings offsets the risk to participants.
In market research, the benefit is typically commercial: improved products, services, or customer experience. Commercial benefit is a legitimate benefit under the National Statement, but reviewers will expect the risk assessment to be proportionate; a low-risk commercial survey needs less justification than one probing sensitive purchasing behaviour, financial hardship, or health status.
What reviewers look for
Reviewers look for a risk/benefit assessment that names specific risks and specific benefits, rather than describing risk and benefit in general terms. An application that states risks are "minimal" without identifying what those risks are, or that claims broad benefit without saying to whom it accrues, does not meet the requirements of NS 2.1.1. Reviewers also check that mitigation strategies match the risks identified, and that the level of review requested (lower risk or full HREC) is consistent with the highest foreseeable risk described. See Risk assessment checklist for a structured approach to preparing this assessment.
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.