Every ethics application, no matter how routine the project appears, must address the same foundational question: do the potential benefits of this evaluation or research justify its risks? This is not a box-ticking exercise. It is a substantive ethical requirement at the core of the National Statement on Ethical Conduct in Human Research 2025 (National Statement), and getting it right matters both for the integrity of the application and for the people who participate.

This article unpacks the risk/benefit requirement as it applies to social research, market research, and program evaluation. It explains what counts as a benefit, how to structure a risk/benefit assessment, and what ethics review bodies look for when they examine this part of an application.

The justification requirement

The National Statement is unambiguous: research is ethically acceptable only when its likely benefits justify any risks involved in the research (NS 1.6 and 2.1.1). This applies to every human research and evaluation project, regardless of risk level. Lower risk projects* still need to satisfy the requirement. 

What this means in practice is that evaluators and researchers cannot simply assert that their project is beneficial and expect that assertion to satisfy reviewers. The application needs to identify the benefits, identify the risks, and demonstrate that the former justifies the latter. An application that does this well gives the review body a clear framework to work with. One that does not will typically come back with a request for more information, and often a request that could have been anticipated.

What counts as a benefit

The National Statement identifies several categories of potential benefit. These include (but are not limited to): 

• gains in knowledge, insight, and understanding; 
• improved social welfare and individual wellbeing; 
• gains in skill or expertise for individual evaluators and researchers, teams, or institutions; 
• evidence-based responses to public health emergencies; and, 
• direct benefits to participants themselves, such as access to information or services they might not otherwise receive.

For those working in applied settings, this list matters because it validates the kinds of benefits most commonly relevant in social research, market research, and evaluation. A program evaluation does not need to generate peer-reviewed academic knowledge to satisfy the benefit requirement. The practical use of findings to improve programs, inform policy, or refine services is a legitimate and often substantial benefit. So is the evidence a market research project generates to help an organisation better understand what its customers need.

A few examples illustrate the range:

A market research project exploring how people make decisions about superannuation might generate commercially useful intelligence. It also contributes to an evidence base that can inform financial literacy programs and guide product design toward outcomes that better serve consumers.

A social research project examining how culturally and linguistically diverse communities experience primary health services can generate findings that directly improve how those services are designed and delivered. The benefit to future service users, not just to current participants, is part of what can be counted.

A process evaluation of a community-based family support program, commissioned by a state government, may not break new theoretical ground. But it directly informs whether a program receiving public funding is working, and what needs to change if it is not. That is a clear and significant benefit, and it should be described as such in the ethics application.

One practical implication is that evaluators and researchers should describe benefits explicitly rather than treating them as obvious. An ethics review body cannot weigh benefits that have not been identified.

Structuring the risk/benefit assessment

A favourable risk/benefit assessment requires more than a general assurance that the project is worthwhile. The National Statement sets out what is needed (NS 2.1.1):

• identifying the risks and burdens potentially arising from the research, and who might be at risk of harm, discomfort, or burden
• assessing the likelihood and severity or magnitude of those risks
• considering and describing actions or strategies that could effectively minimise, mitigate, or manage each risk, including modifications to the research design
• identifying the potential benefits and to whom they are likely to accrue; and
• determining that any risks and burdens are justified by the potential benefits.

Working through these steps systematically is the most effective way to build a credible risk/benefit case.

Identifying risks and burdens:

For most social research, market research, and evaluation projects, the risks are not dramatic. Common risks include excessive time involved for participants; discomfort if topics are sensitive; breach of privacy or confidentiality if data management is inadequate; and potential reputational or social harm if participants can be identified from published findings. Burdens, which the National Statement treats as distinct from risks, include inconvenience, effort, and the cognitive demands of participation.

The National Statement uses the word "foreseeable." Evaluators and researchers are not expected to anticipate every conceivable harm. They are expected to think carefully and honestly about what could go wrong given the specific design of their project, and to explain who bears those risks.

Assessing likelihood and severity: 

Not all foreseeable risks are equally concerning. A brief online survey about workplace practices carries a different risk profile than an in-depth interview series with people who have experienced family violence. The assessment should reflect this. A risk that is unlikely to materialise and would cause minimal harm if it did is in a different position than one that is both likely and potentially serious.

Minimising, mitigating, and managing: 

Having identified and assessed the risks, evaluators and researchers then need to explain what they will do about them. This is where project design choices become visible. De-identification of data, secure storage, professional facilitation of sensitive discussions, referral pathways following difficult interviews, and careful question framing to avoid unnecessary intrusion are all examples of practical risk mitigation. The application should explain the specific strategies chosen for this project, not just list generic principles.

Identifying benefits and their recipients: 

The benefits section should be specific. Who benefits, and how? Is it the participants themselves? Future program users? A commissioning agency? The broader public? The strength of a benefits case depends partly on whether benefits are near-term or long-term, certain or speculative, and who bears the costs relative to who gains.

Making the determination: 

Having laid out risks and benefits, the application should make the case that the risks are justified. This does not need to be elaborate. In many evaluation and social research projects, the risks are modest and the benefits are clear. But the determination should be stated rather than assumed.

Risks to non-participants

One aspect that is sometimes overlooked in applied research and evaluation contexts is the possibility of harm to people who are not themselves participants. The National Statement explicitly notes that harms to non-participants are relevant to the risk assessment.

In social research or evaluation contexts, this might arise where findings about a small, identifiable community could affect property values, social cohesion, or community relationships. A neighbourhood-level evaluation of a social housing program, for example, might generate findings that carry social or economic implications for residents who did not participate. Evaluators and researchers should consider whether such risks are foreseeable and, if so, how they will be managed.

Burdens and inconvenience

The National Statement draws a clear distinction between risks of harm and burdens or inconvenience. Neither burden nor inconvenience is classified as harm or discomfort. But the National Statement is equally clear that they should be considered in ethics review and that they require justification by the potential benefits of the evaluation or research.

For most applied projects, participant burden is modest. A telephone survey of program participants, an online feedback questionnaire, or a brief stakeholder interview all impose minimal burden. But some projects are more demanding. A multi-stage qualitative study, a longitudinal panel, or an evaluation requiring participants to provide access to records or complete detailed diaries can impose real costs on participants' time and attention. These burdens should be named honestly and the mitigation strategy (whether that is keeping instruments short, offering flexible scheduling, or providing proportionate reimbursement) should be explained.

The participant perspective

One of the more nuanced aspects of the National Statement's approach to risk/benefit is its treatment of participant perspectives. When considering whether the potential benefits justify the risks and burdens involved, ethics review bodies are directed to take into account any willingness by participant populations to assume greater risks or burdens because of their perception of the potential benefits to them, their families, or groups or communities to which they belong (NS 2.1.5).

This matters in several practical contexts. Participants in an evaluation of a program they value, or in community research on issues that directly affect them, may regard participation as meaningful in its own right. They may see a degree of inconvenience or discomfort as an acceptable price for contributing to an outcome they care about. There is also a vital dimension of a person's autonomy and empowerment that can be supported through their decision to contribute to projects that impact their lives or those of their communities.

This does not give evaluators and researchers licence to expose willing participants to unreasonable risks. The National Statement is clear that participant willingness does not remove the obligation to minimise risks. But it does mean that risk/benefit assessments should be contextually sensitive rather than applying a generic risk calculus.

For example, consider a community-controlled organisation commissioning research into the barriers its members face in accessing housing support. Participants in that project are likely to have a genuine stake in the findings and a strong sense of why the research matters. That context is relevant to how the risk/benefit balance is assessed and described.

What ethics committees look for

Understanding the review body's perspective helps evaluators and researchers prepare applications that answer the questions being asked.

When an application comes before a committee, reviewers will typically examine the risk/benefit section with several questions in mind: 

• Has the applicant thought honestly about the risks, or does the application claim the project carries no risks at all? (Almost no project carries zero risk, and an application that says so will usually be asked to look again.) 
• Is the assessment specific to this project, or does it read like a generic template? 
• Has a genuine determination been made that the benefits justify the risks, or are risks and benefits simply listed without any weighing? 
• For projects involving potentially sensitive topics or vulnerable populations, are the mitigation strategies adequate?

The National Statement also notes that in describing and assessing potential benefits and risks, evaluators, researchers, and reviewers should exercise care not to overemphasise either. Overstating benefits can make a project look more worthwhile than it is. Overstating risks can make participation look more dangerous than it actually is. Both distort the picture the committee needs to make a sound judgement.

A note on proportionality

One of the most useful practical principles is proportionality. The depth and detail of a risk/benefit assessment should match the risks actually involved. A low-risk online survey about consumer preferences for packaging design does not require an elaborate risk/benefit analysis. A qualitative study involving in-depth interviews with people in contact with the criminal justice system does.

Getting the level of detail right is itself an exercise in judgement. An application that dramatically over-reports risk for a genuinely low-risk project can be as unhelpful as one that under-reports risk for a complex one. The goal is an accurate account, not a list designed to demonstrate thoroughness for its own sake.

The National Statement reinforces this through the framework for risk-proportionate review. Institutions may differentiate between levels of lower or higher risk for review purposes. Ethics review bodies applying proportionate review need good risk/benefit information to do so well, and applications that provide it accurately make the review process work better for everyone.

Summary

The risk/benefit requirement under the National Statement applies to all human research and evaluation, regardless of risk level. It requires evaluators and researchers to identify foreseeable risks and burdens, assess their likelihood and severity, describe how they will be mitigated, and make a clear case that the potential benefits justify what participants are being asked to bear. In applied research and evaluation settings, benefits are legitimate and often substantial, but they need to be described specifically rather than assumed. Burdens matter too, not as risks, but as costs to participants that require justification. Participant perspectives on risk are relevant to the assessment but do not reduce the obligation to minimise risks. Ethics committees look for honest, specific, and contextually sensitive assessments, and applications that provide them tend to move through review more smoothly.

If you have questions about how to structure the risk/benefit assessment in your next application, or if your project involves a population or context that raises particular complexity, get in touch with the team at Iris Ethics.

*Even projects that are exempt from ethical review do, in principle, need to satisfy the requirement.

This article draws on the National Statement on Ethical Conduct in Human Research (2025) and the NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014). It is intended as practical guidance and does not constitute legal advice. If you have questions about whether your project requires ethics review, get in touch.

AI Disclosure: Initial drafts of the content for this article 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.

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