Quick answer: It depends on what the investigation is designed to learn, how participants are involved and the risks created by the research. A business collecting ordinary product feedback may raise different issues from a university team systematically studying human responses to an experimental technology. Where an activity constitutes human research, the applicable ethics review pathway should be determined before participants are recruited or data are collected. Ethics review and R&D Tax Incentive eligibility are separate assessments.
A Prototype Trial Can Also Be Human Research
An engineering company is developing a new haptic control mechanism for industrial equipment.
The proposed design provides physical feedback through a handheld controller, allowing operators to detect changes in machine behaviour without relying entirely on visual information.
The company wants to investigate whether the mechanism improves operator response under demanding conditions.
Its engineering team has completed preliminary mechanical testing.
However, the relationship between the proposed feedback mechanism and human response remains uncertain.
A university research group is invited to design a controlled investigation.
Volunteers would operate the prototype in a simulated environment while researchers record response times, control movements and participant feedback.
The company regards this as prototype testing.
The university researchers recognise that it may also constitute human research.
Both descriptions can be accurate.
The distinction matters because technical validation and research involving people introduce different responsibilities.
Australia's National Statement on Ethical Conduct in Human Research is intended for research involving human participants and provides guidance for researchers, ethics review bodies, institutions and participants. The current 2025 National Statement came into effect on 23 June 2026. NHMRC — National Statement on Ethical Conduct in Human Research
The presence of volunteers does not, by itself, determine the review pathway.
The purpose of the activity, the information collected, the way participants are recruited and the risks created by the research all matter.
Product feedback and human research are not automatically the same thing
A company may ask users to try an interface and comment on whether instructions are clear or controls are easy to use.
That may form part of routine product development or evaluation.
A different investigation might systematically examine whether a proposed tactile-feedback mechanism changes response behaviour under controlled conditions.
Researchers might develop a hypothesis about the relationship between the feedback mechanism and human response, expose participants to defined experimental conditions and compare the resulting observations.
That investigation is designed to generate knowledge about the relationship being studied.
It may therefore require consideration under the institution's human research governance and ethics processes.
The classification does not depend simply on whether the activity is called a pilot, usability test or experiment.
It depends on what is actually being done.
Determine the Review Pathway Before Recruiting Participants
Human research ethics review is not a single approval process applied identically to every project.
Under the 2025 National Statement, institutions are responsible for establishing review procedures appropriate to the level of risk.
Research assessed as involving greater than low risk must be reviewed by a Human Research Ethics Committee (HREC).
Research involving no more than low risk may be reviewed through other institutional processes, and institutions may determine that some human research is exempt from ethics review where the applicable criteria are satisfied.
National Statement on Ethical Conduct in Human Research 2025
The important point for a commercial collaboration is that the project team should not decide informally that ethics review is unnecessary simply because the activity looks like product testing.
Where a university is conducting or overseeing the study, the relevant institutional process should determine the appropriate pathway.
NHMRC — Human Research Ethics Committees
Assess the risks created by the investigation
In the haptic-controller example, the team should consider more than whether the device is mechanically safe.
Testing may involve physical movement, repeated tasks, unexpected tactile feedback or simulated operating conditions.
Depending on the design, participants may experience fatigue, discomfort or other foreseeable effects.
The research team should identify those risks and determine how they will be managed.
The study should also establish how participants can stop taking part and what will happen if an unexpected event occurs.
The 2025 National Statement places the emphasis on assessing the risks of the particular research rather than automatically assigning a review pathway solely because a particular type of participant is involved.
National Statement on Ethical Conduct in Human Research 2025
Establish meaningful consent
Consent to participate in research should be voluntary and based on sufficient information and understanding of what participation involves.
The National Statement explains that participants should understand the purpose, methods, demands, risks and potential benefits of the research.
Obtaining a signature is therefore not, by itself, the objective.
The participant should understand what they are agreeing to.
This becomes particularly important when participants are employees of the company commissioning or conducting the research.
The 2025 National Statement specifically recognises employer or supervisor–employee relationships as examples of dependent or unequal relationships that may affect voluntary decision-making.
An employee may reasonably feel that declining participation could be viewed negatively, even where management does not intend to create that pressure.
Recruitment arrangements should therefore consider how to reduce the influence of that relationship.
For example, an independent person may sometimes be better placed to approach potential participants or manage consent.
The important principle is that employees should be able to make a genuine decision about participation without the research relying on their employment relationship to secure involvement.
Clarify institutional responsibilities
When a business commissions a university to conduct human research, the parties should establish responsibility for ethics review and research governance before recruitment begins.
The university may already have procedures for determining whether the proposed research requires HREC review, a lower-risk pathway or another institutional determination.
Where several institutions participate, the applicable governance arrangements may need to address whether an existing review can be recognised or whether further institutional authorisation is required.
NHMRC provides the Human Research Ethics Application (HREA) as a template for preparing ethics applications. HREA version 1.6 was updated to align with the 2025 National Statement.
NHMRC — Human Research Ethics Application
The commercial partner should therefore confirm the applicable process with the research institution rather than assuming that participant recruitment can begin while the governance arrangements are resolved later.
Protect Participant Information Without Weakening the Research Evidence
Human-centred engineering research can generate information that is technically useful while also identifying or describing individual participants.
In the controller study, the research team might collect response times, movement trajectories, observations and recordings of participants interacting with the prototype.
Those observations may be necessary to evaluate the proposed mechanism.
That does not mean every person involved in commercial product development needs access to participant-level information.
Collect the information the research actually needs
The experimental plan should identify what information is necessary to test the hypothesis.
If response times and controller movements are sufficient, collecting additional personal details simply because they are easy to obtain may add little research value.
Researchers should therefore distinguish technical observations required for the investigation from information collected for administrative convenience.
Where the Australian Privacy Principles apply, personal information must also be handled consistently with the Privacy Act framework.
For organisations subject to APP 3, collection of personal information must generally be reasonably necessary for the organisation's functions or activities. Sensitive information is subject to additional requirements and generally requires consent unless an exception applies.
OAIC — Collection of Personal Information
OAIC — Consent to the Handling of Personal Information
Research consent and Privacy Act requirements should not be treated as the same assessment.
An ethics process may address participant consent for the research, while privacy law separately governs how relevant personal information is collected, used, disclosed and protected where those laws apply.
Preserve technical traceability
Protecting participant information does not mean that the experimental method should become impossible to reconstruct.
The research record should preserve the hypothesis, experimental conditions, prototype configuration, procedures and relevant observations.
It should also make clear how participant-level observations were processed or transformed into the evidence used to reach the technical conclusion.
Appropriate access controls, de-identification where suitable and other data-management arrangements can help limit unnecessary exposure of participant information while preserving the evidence required for authorised research review.
The specific arrangements should reflect the project, the institutional requirements and the nature of the information involved.
Ethics approval and technical validity are different questions
An ethics approval does not establish that an experiment is technically capable of answering its research question.
For example, a study may have appropriate participant information, consent and risk controls but still use an experimental comparison that cannot distinguish the proposed haptic effect from ordinary learning or practice effects.
Conversely, a technically rigorous experimental design does not remove the need to address applicable ethics and governance requirements.
The two assessments protect different aspects of the research.
Keep Ethics Review Separate From R&DTI Eligibility
A further distinction is necessary for businesses considering Australia's R&D Tax Incentive.
Human research ethics review concerns how research involving people should be conducted and governed.
R&DTI eligibility concerns whether particular activities satisfy the legislative criteria for core or supporting R&D activities.
Ethics approval does not establish R&DTI eligibility.
Under the current R&DTI requirements, a core R&D activity must be conducted for the purpose of generating new knowledge.
Its outcome must be unable to be known or determined in advance by a competent professional on the basis of knowledge, information or experience that is publicly available or reasonably accessible anywhere in the world at the time the activity begins.
The outcome must then be determined through a systematic progression of work based on principles of established science, involving hypothesis, experiment, observation, evaluation and logical conclusions.
Australian Government — Conducting Core R&D Activities
In the haptic-controller example, ordinary user feedback about whether participants like the interface or find it comfortable does not, by itself, establish a core R&D activity.
A different technical question may exist if the company genuinely cannot determine from existing knowledge how its proposed feedback mechanism affects a defined aspect of human–machine interaction and must investigate that outcome experimentally.
Even then, the particular activities need to be assessed against the applicable R&DTI criteria.
Likewise, ethics approval does not make an activity eligible.
The absence of a requirement for formal HREC review does not make an otherwise eligible activity ineligible.
These are separate assessments.
Preserve the Research and Governance Record
Current Australian Government R&DTI guidance states that records should be created at the time the activity is conducted.
Records should show relevant background research and details of what was done, how the work was performed, when it occurred and who carried it out.
Australian Government — Record Keeping for the R&D Tax Incentive
For a human-participant engineering investigation, the technical record may include:
• the unresolved technical question and hypothesis;
• the prototype version and experimental configuration;
• the conditions participants were asked to perform under;
• the observations and measurements collected;
• the method used to evaluate those observations; and
• the reasoning behind subsequent technical decisions.
The ethics and governance record may separately contain the applicable review determination, participant information and consent materials, data-management arrangements and other institutional documentation.
These records serve different purposes and should not be treated as interchangeable.
The list above is a practical research-management approach, not a prescribed R&DTI documentation template.
For founders and CTOs, the immediate objective is to design an investigation that is both technically meaningful and appropriately governed.
For CFOs, separating these elements helps distinguish expenditure on research governance, ordinary product testing and experimental activities that may require separate R&DTI assessment.
Conclusion
A prototype trial does not cease to be engineering research merely because people are involved.
But once a project systematically studies participants or their responses, the research team may need to address responsibilities that do not arise in mechanical testing alone.
The key questions are:
What are we actually trying to learn from the participants?
What risks does their participation create?
Which institutional review pathway applies?
What information do we need to collect?
And separately, does the technical activity satisfy the requirements of the R&DTI?
A business should not wait until participant testing has begun to resolve these questions.
The appropriate research pathway should address both the technical uncertainty and the people whose participation makes the investigation possible.
Sources & Further Reading
NHMRC — National Statement on Ethical Conduct in Human Research
Australian Government — Record Keeping for the R&D Tax Incentive
Talk to Ignition Research if your engineering or technology project involves testing an experimental interface with human participants and you need to define the technical question alongside the appropriate research-governance arrangements. As a Registered Research Service Provider, Ignition Research assists businesses with research question definition, experimental design, technical investigations and contemporaneous supporting records within its registered research fields.
RSP registration confirms that the provider has met the relevant registration requirements for its registered research fields. It does not constitute government endorsement of a project or guarantee R&DTI eligibility.
We do not determine R&DTI eligibility or provide tax advice. The R&D Tax Incentive is a self-assessment program, and companies remain responsible for assessing their activities, expenditure and circumstances and obtaining appropriate tax advice.
This article provides general information only and is not tax, legal or financial advice.
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