Introduction

Co-design has become an increasingly valued approach in research and evaluation, recognising that those who will be affected by research and evaluation outcomes should have meaningful input into how research is conceived, designed, and conducted. This participatory approach aligns with the principles of respect, beneficence, and justice that underpin ethical research practice.

The National Statement on Ethical Conduct in Human Research 2025 edition explicitly recognises the value of early engagement with potential participants and communities, and provides important clarification about when such engagement activities require ethics review. However, the relationship between co-design activities and ethical review is more complex than it may initially appear, particularly when co-design outputs become part of the research and evaluation process itself.

This resource clarifies the ethical review requirements for co-design activities, addresses the potential for co-design outputs to become part of research and evaluation data, and provides guidance on best practice approaches to ensure appropriate ethical oversight while supporting meaningful participatory research and evaluation. 

Defining co-design

Co-design is a participatory approach in which researchers, evaluators, and stakeholders work collaboratively to shape research questions, methodology, data collection approaches, and analysis frameworks. 

Stakeholders may include: 

• potential research/evaluation participants;
• community members; 
• service users; and 
• other parties that may be affected by the process or the outputs of research and evaluation.

Unlike traditional consultation, which seeks input on predetermined options, co-design positions stakeholders as active partners in decision-making throughout the research or evaluation process. That said, the following guidance is also applicable to traditional consultation processes.

Co-design may involve various activities, including: 

• workshops; 
• deliberative sessions; iterative feedback processes; 
• collaborative planning meetings; and 
• development of research/evaluation tools and materials. 

These activities typically occur during the planning and design phase of a project, before formal data collection begins.

The National Statement encourages this type of early engagement, particularly for research and evaluation involving groups who may experience higher levels of risk based on their circumstances. Meaningful co-design can help identify and mitigate potential discomforts and harms, accommodate participants' needs and interests, and ensure research and evaluation delivery is relevant and respectful to those it involves. 

The National Statement's treatment of co-design activities

The National Statement provides important clarification about the ethical review requirements for co-design and engagement activities that occur during the planning phase of research.

The section on purpose and scope in the National Statement sets out clearly that:

"...consultation and engagement with potential participants, co-researchers and community representatives that precedes the development, design or conduct of the research is not itself human research and typically does not require ethics review."

This principle is reinforced in the guidance on engaging potential participants at Section 4.1:

"Potential research participants should be offered the opportunity to engage with researchers from early in the process to inform research and discuss perspectives that may be useful in identifying the likelihood of harms and their impact, and in accommodating participants' needs or interests at each stage of the research process. Such information may inform the design phase, the research activities affecting participants' experiences during the research, and processes after the research is completed (e.g. being given the results or being advised of the outcomes of the research)."

For research involving people with ill-health or disability, Section 4.5.2 makes this even more explicit:

"Inclusion and the self-determination of people with ill-health or disability should be paramount in decision-making about research. In planning and conducting research, researchers should consider consulting with people with ill-health or disability, individuals that support them such as carers or family members, or any relevant representative organisations."

These provisions establish a clear framework: co-design activities conducted during the planning phase, before research and evaluation data collection activities commence do not typically require ethical review. This exemption enables researchers and evaluators to engage meaningfully with communities and stakeholders to shape design without creating unnecessary barriers to participation.

The complexity: When co-design outputs become research data

This exemption for planning-phase co-design activities appears straightforward. However, the situation becomes considerably more complex when we consider how co-design outputs might be used once the research or evaluation proceeds.

The National Statement does not define research, but the Australian Research Council provides a widely accepted definition:

"Research is defined as the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies, inventions and understandings. This could include synthesis and analysis of previous research to the extent that it is new and creative."

This definition is notably broad. It encompasses not only traditional empirical data collection, but also synthesis, analysis, and the generation of new understandings from existing materials, naturally including materials generated as part of co-design processes.

Consider the following scenarios where co-design outputs might become part of research or evaluation:

• Process evaluation: An evaluation that examines how a program was designed, using recordings, minutes, or documentation from co-design workshops as evidence of participatory processes and stakeholder input.
• Reflective practice research: A study that analyses the co-design process itself as an example of participatory methodology, drawing on facilitator notes, participant feedback, and design artifacts to understand what enabled or constrained meaningful participation.
• Synthesis of stakeholder perspectives: Research that analyses themes, priorities, or perspectives that emerged during co-design activities to understand community values or service user needs.
• Documentation of Indigenous knowledge: Co-design activities that generate Indigenous cultural knowledge, stories, or data that are later incorporated into research outputs or publications.

In each of these scenarios, material generated during co-design activities is being used to create new knowledge or understandings. As such, it has become research and evaluation data. Yet if these activities occurred before ethical review, researchers and evaluators face a potential problem.

The National Statement is unequivocal at paragraph 5.1.6:

"Where ethics review is required, approval must be obtained prior to the commencement of the research. Retrospective ethics approval of research is not supported by the National Statement."

If co-design outputs are later treated as research data, collection has occurred prior to ethical review. While researchers and evaluators might seek retrospective consent or a waiver to make the use of this data ethically acceptable, they cannot obtain ethical approval for the collection activity itself as it has already taken place. This creates a grey area that researchers and evaluators must navigate carefully.

Our position: Review of co-design outputs

At Iris Ethics, we differentiate between the conduct of co-design activities themselves and the subsequent review and analysis of co-design outputs as part of research or evaluation.

When co-design outputs are used as part of research or evaluation, for example, in a process evaluation or methodological reflection, we treat the review of these materials similarly to a desktop review or as part of a broader qualitative or mixed-methods synthesis. Under the current National Statement, such activities require at least a lower risk review process.

This approach recognises that:

• The co-design activities themselves, conducted during planning, did not require ethical review under the National Statement exemption.
• However, the subsequent use of outputs from those activities as research data does constitute research/evaluation and requires ethical oversight.
• The review and analysis of existing documents or records is a recognised activity that warrants ethical consideration, albeit typically at the lower risk level.

This position will be further elaborated in our forthcoming guidance on the ethical considerations in completing desktop reviews, which responds to recent scholarly commentary in this area.

It is important to note that this approach addresses prospective use of co-design outputs. Researchers who plan to use co-design materials as research/evaluation data should include this in their initial ethics application or submit an amendment before such analysis begins. This ensures ethical review occurs before the research or evaluative use of co-design outputs commences, maintaining the principle of prospective oversight.

Best practice recommendations

To ensure appropriate ethical oversight while supporting meaningful co-design processes, we recommend the following practices:

1. Obtain consent for research/evaluative use of co-design outputs

Researchers and evaluators should explicitly seek consent from co-design participants for the potential use of outputs from co-design activities. This means being transparent at the outset about how materials generated during co-design might be used.

Best practice includes:

• Clearly explaining during co-design activities that materials, discussions, or data may be used as part of the research or evaluation itself.
• Providing participants with the opportunity to consent to this use, or to participate in co-design while declining to have their contributions used as research/evaluation data.
• Making consent for research/evaluative use part of standard engagement practice, rather than treating it as an afterthought.

For research involving Aboriginal and Torres Strait Islander peoples, this is particularly critical. The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research establishes clear principles around data sovereignty. Section 4.3 states:

"Indigenous people have the right to manage the creation, collection, analysis, interpretation, management, storage, dissemination, access, re-use, disposal of and access to their data."

Section 2.7(a) further requires:

"Ownership management and communication of research data and results should be negotiated between Indigenous peoples and the researcher or other parties based on the principles of Indigenous data sovereignty and governance."

These principles require that any use of outputs from co-design activities involving Aboriginal and Torres Strait Islander peoples be negotiated and agreed to by stakeholders (noting that these may include non-participant stakeholders such as community elders and knowledge holders), with explicit consideration of Indigenous data sovereignty and governance rights. 

2. Provide clarity around communication and publication of co-design outputs

Related to the issue of consent is the question of how co-design outputs might be used in communications, publications, and dissemination activities.

Researchers should clearly communicate:

• Whether co-design materials (such as workshop outputs, concept maps, or design artifacts) might be photographed, reproduced, or published.
• How participants will be acknowledged or credited for their contributions.
• What control or review rights participants will have over how their contributions are represented.

This clarity should be established at the beginning of co-design processes, not assumed or determined retrospectively.

3. Recognise and elevate co-design participants as peer practitioners

When co-design outputs become part of research and evaluation, participants whose knowledge and input generated those outputs are contributing to knowledge creation. This positions them as peer practitioners in the research process, not merely as sources of information.

Best practice includes:

• Incorporating relevant research codes, best practices, and ethical guidelines into training and capacity building for co-design participants. This might include guidelines such as the Autism CRC's Participatory and Inclusive Autism Research Practice Guides, the AIATSIS Code of Ethics, the Australian Government's Toolkit for engaging with people with disability in evaluation, and other relevant frameworks.
• Recognising co-design participants' expertise and knowledge contributions in ways that are meaningful and appropriate to them.
• Considering appropriate forms of authorship, acknowledgment, or other recognition when co-design outputs contribute to research publications or evaluation reports.

This approach represents a form of beneficence, by recognising and supporting the agency and expertise of those who contribute to research design and conduct.

4. Plan prospectively for research use of co-design materials

To avoid the grey area of retrospective research use of co-design outputs, researchers should consider at the project planning stage whether co-design materials might form part of the research or evaluation.

If there is any possibility that co-design outputs will be analysed, synthesised, or otherwise used as research data, this should be:

• Clearly articulated in the ethics application, even if submitted under our conditional approval process where full details are not yet available.
• Addressed through appropriate consent processes with co-design participants.
• Planned for in data management and analysis protocols.

This prospective approach ensures that all research activities receive ethical oversight before they commence, maintaining the fundamental principle of prospective review.

Navigating uncertainty

We recognise that the boundary between co-design activities and research can be unclear, particularly in participatory and adaptive designs where the distinction between "planning" and "conducting" research and evaluation is fluid.

In cases of uncertainty about whether co-design outputs might be used as research data, we recommend:

• Erring on the side of inclusion in ethics applications, making use of our conditional approval process if details are not yet finalised.
• Being transparent with co-design participants about potential uses of their contributions.
• Seeking advice from the HREC if questions arise about whether particular uses of co-design outputs require ethical review or amendment.

The National Statement supports proportionate approaches to ethics review based on risk. For most research uses of co-design outputs, lower risk review processes are likely to be appropriate. The administrative burden of including these activities in ethical review is minimal compared to the risks of retrospective recognition that research and evaluation have been conducted without appropriate oversight.

Summary

Co-design is a valuable approach that can enhance the quality, relevance, and ethical conduct of research and evaluation. The National Statement's recognition that planning-phase co-design activities do not typically require ethical review supports meaningful participatory processes without creating unnecessary barriers.

However, researchers and evaluators must be alert to the potential for co-design outputs to become relevant data through process evaluation, reflective analysis, synthesis of stakeholder perspectives, or other research and evaluation uses. When this occurs, ethical oversight is required.

Our position is that:

• Co-design activities conducted during the planning phase, before research commences, do not typically require ethical review under the National Statement.
• However, if outputs from co-design activities may be used as part of research or evaluation, this use constitutes research and requires ethical review, typically at the lower risk level.
• Retrospective ethical approval cannot be granted for data collection activities that have already occurred, creating a grey area that must be carefully managed.
• Best practice includes: obtaining explicit consent for research use of co-design outputs; providing clarity about potential publication and communication of co-design materials; recognising co-design participants as peer practitioners; and planning prospectively for any research or evaluation use of co-design materials.
• Adopting these best practices can enable ethical review to take place by treating the analysis as a step taking place after ethical review, with the use of prior data being already consented to by stakeholders.

These approaches ensure that participatory research and evaluation benefits from appropriate ethical oversight while respecting the expertise and contributions of co-design participants. By planning prospectively, obtaining appropriate consent, and being transparent about how co-design outputs might be used, researchers and evaluators can conduct meaningful participatory research within a robust ethical framework.

Iris Ethics is committed to supporting researchers and evaluators in navigating these complexities. We encourage applicants to engage with us early in their project planning to discuss how co-design activities and outputs should be addressed in ethics applications, and we are available to provide guidance on managing the interface between participatory design processes and ethical review requirements.

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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