Introduction

Ethical review is a cornerstone of responsible research and evaluation practice. It provides independent oversight to ensure that projects are conducted with appropriate consideration of the rights, welfare, and dignity of participants and stakeholders. However, the effectiveness of ethical review depends fundamentally on clarity about what is being reviewed.

The National Statement on Ethical Conduct in Human Research 2025 edition requires that institutions establish clear terms of reference for their Human Research Ethics Committees (HRECs), including "the scope of its responsibilities for ethics review" (paragraph 5.1.29(a)). This requirement recognises that ethical approval is meaningful only when all parties understand precisely what activities have been reviewed and approved.

Through our work reviewing applications across market research, evaluation, and social research projects, we have observed a few area around the definition and communication of scope that can benefit from greater clarity. These include applications where activities have already commenced, where key activities have been excluded from review, and where applicants are unclear about what falls within and outside the boundaries of our approval.

To support ethical and high-quality research and evaluation, we have developed this position statement to clarify our expectations regarding scope definition, the limitations of our approval, and our recommendations for managing activities that fall outside the scope of formal ethical review.

The importance of clearly defined scope

The scope of ethical review refers to the specific activities, methods, participants, timeframes, and settings that are subject to the committee's consideration and approval. A clearly defined scope serves multiple purposes:

• It establishes the boundaries of what the committee has reviewed and approved;
• It enables the committee to provide appropriate consideration to all activities that may pose ethical risks;
• It ensures applicants understand what they can and cannot do under the approval granted; and,
• It protects both participants and researchers by providing clarity about ethical oversight.

Clear scope definition is essential to determining what requires review and ensuring that review is appropriately targeted. Part of our application form includes a question on the scope of the review, so that applicants can clarify the elements of the project plan that are outside of the review process. The following sections provide more detail on the cases where scope might be confined, how our committee treats activities outside of scope, and how applicants can manage activities that lie outside of this scope. 

Activities must not have commenced prior to approval

A fundamental principle of ethical review is that it must occur before activities involving participants begin. The National Statement is unequivocal on this point 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" 

The Iris Ethics HREC adheres strictly to this principle. We cannot provide ethical approval for activities that have already been undertaken.

This principle exists because ethical review is designed to:

• Identify and mitigate potential risks before participants are exposed to them;
• Ensure that appropriate consent processes are in place from the outset;
• Allow for modifications to research/evaluation design where ethical concerns are identified; and,
• Provide prospective, rather than retrospective, oversight.

Where applicants have already commenced activities with participants, we cannot review those activities as part of an ethical approval process. Applicants who have begun work prior to seeking approval should:

• Clearly identify which activities have been completed and which are yet to commence;
• Seek approval only for future activities; and,
• Understand that our approval does not extend to, or validate, work already undertaken.

In cases where preliminary or pilot work has been conducted, applicants should be transparent about this in their application and clearly delineate what is being submitted for prospective review.

It is worth noting that the National Statement does allow for co-design activities to take place prior to ethical review and considers such activities to not typically require ethical review (see the discussion on “Risk Mitigation” in the introduction to Section 4.1 of the National Statement).

Our approval is limited to the defined scope 

When our HREC grants ethical approval, that approval extends only to the activities explicitly described in the application and any approved amendments. Activities that fall outside this scope are not covered by our approval, regardless of how closely related they may be to the approved project.

The National Statement recognises that the scope of a project may evolve during its conduct. Paragraph 5.4.10(b) requires that researchers submit for approval any amendments that "change the scope of the project." This provision acknowledges that scope is a defined parameter of ethical approval, and changes to it require formal review and approval.

While we are able to provide informal advice or guidance on activities outside the scope of an application, applicants must understand that:

• Such advice does not constitute ethical approval;
• The limitations of our formal approval are strictly confined to the scope we have reviewed;
• Applicants bear full responsibility for ensuring that out-of-scope activities are conducted ethically and in accordance with relevant standards and legislation; and,
• Out-of-scope activities cannot be represented as having received Iris Ethics HREC approval.

This distinction is particularly important in contexts where ethical approval is a contractual or funding requirement, or where it provides assurance to participants, commissioning bodies, or other stakeholders. Misrepresenting the scope of ethical approval can have serious consequences for trust, compliance, and the reputation of both the practitioner and our committee.

We strongly recommend comprehensive scope inclusion

Given the limitations and potential risks associated with conducting activities outside the scope of ethical review, we strongly encourage applicants to include as much of their full project scope as possible when submitting applications.

We recognise that in some research and evaluation contexts, project design evolves throughout delivery. This is particularly common in:

• Co-designed research and evaluation, where participants or stakeholders are involved in shaping methodology;
• Exploratory evaluation methods, where the approach may be refined based on early findings;
• Phased projects, where later phases depend on the outcomes of earlier work; and,
• Responsive research designs that adapt to emerging contexts or participant needs.

The National Statement supports proportionate and flexible approaches to ethics review. Building on this framework, the Iris Ethics HREC has established a conditional approval process specifically to accommodate projects where elements may not be fully confirmed at the time of initial application. Under this process:

• Applicants can submit applications that outline anticipated activities, even where specific details are not yet finalised;
• The committee can grant conditional approval subject to review and approval of updated research plans as the design evolves;
• Applicants can progressively submit amendments as elements are confirmed, ensuring ongoing ethical oversight; and,
• The scope of approval expands iteratively as additional components are reviewed and approved.

This process allows applicants to maintain comprehensive ethical oversight without requiring all details to be fixed at the outset. We encourage applicants to make use of this process rather than excluding uncertain elements from their initial application.

By including the full anticipated scope, even if this is conditional, applicants benefit from:

• Unified ethical oversight across all project activities;
• Reduced risk of conducting work that later proves problematic from an ethical standpoint;
• Greater confidence that the project as a whole has been designed with appropriate ethical safeguards; and,
• Clearer communication with participants, commissioners, and other stakeholders about the ethical governance of the project.

Ethical review of out-of-scope activities

Despite our strong recommendation to include comprehensive scope, we acknowledge that there may be legitimate reasons why certain activities are not submitted for formal ethical review through our committee. These might include activities that:

• Are outside the mandate or expertise of our committee;
• Are subject to other ethics approval processes;
• Are deemed by the applicant to pose minimal ethical risk; or,
• Occur as unforeseen extensions or tangential elements of approved work.

Where activities involving participants fall outside the scope of Iris Ethics HREC approval, we strongly recommend that applicants ensure some form of ethical review is conducted.

The National Statement supports proportionate approaches to ethics review based on risk level. For out-of-scope activities, appropriate review processes might include:

• A lower risk review process such as that delivered by our HREC; or,
• An independent peer review by a qualified individual within the applicant's organisation who is not directly involved in project delivery and who meets the competency requirements outlined in paragraph 5.1.14.

Such review processes, while less formal than full HREC review, serve important functions:

• They provide a check on potential ethical issues that may not be immediately apparent to those embedded in the project;
• They demonstrate a commitment to ethical practice even where formal approval is not sought;
• They may identify risks that warrant reconsideration of whether formal ethics review is appropriate; and,
• They create a documented trail of ethical consideration.

While we cannot mandate that applicants undertake such processes for out-of-scope activities, we view them as an important element of responsible practice. Applicants who conduct their own ethical review of out-of-scope work should document this process and be prepared to explain it if required by commissioners, participants, or other stakeholders.

Responsibilities of applicants

Applicants to any HREC bear significant responsibilities in relation to scope definition and management, consistent with the broader responsibilities of researchers outlined in Chapter 5.3 of the National Statement.

Before submitting an application, applicants should:

• Carefully consider the full scope of their project and what should be included in the ethics application;
• Be realistic about which elements are likely to involve participants or raise ethical considerations;
• Plan for conditional approval where elements are not yet finalised; and,
• Ensure that no activities within the scope of review have commenced prior to submission, in accordance with paragraph 5.1.6.

In the application itself, applicants must:

• Clearly define and describe the scope of activities being submitted for review;
• Be explicit about any activities that are excluded from the scope and explain why;
• Provide sufficient detail for the committee to understand the context, methods, participants, and potential risks; and,
• Be transparent about any preliminary or pilot work already undertaken.

Following approval, applicants must:

• Conduct only those activities that fall within the approved scope;
• Seek amendment approval before undertaking any changes that "change the scope of the project" (paragraph 5.4.10(b)(iv));
• Take full responsibility for ensuring that any out-of-scope activities are conducted ethically; and,
• Not represent out-of-scope activities as having received Iris Ethics HREC approval.

Throughout project delivery, applicants should:

• Maintain clear documentation of what activities are within and outside the scope of approval;
• Consider submitting amendments to bring additional activities within scope where appropriate;
• Ensure that participants and other stakeholders understand the scope of ethical oversight; and,
• Maintain records consistent with paragraph 5.3.9 for any activities exempted from ethical review.

Summary

The scope of ethical review is not merely an administrative detail; it is fundamental to the integrity and effectiveness of the review process. Clear scope definition protects participants, supports researchers and evaluators in conducting ethical work, and enables HRECs to provide meaningful oversight.

Our position is that:

• Applicants must clearly define the scope of activities submitted for ethical review;
• We cannot review activities that have already commenced with participants;
• Our approval is strictly limited to the scope we have reviewed, and applicants are fully responsible for any out-of-scope activities;
• We strongly encourage applicants to include as much of their full project scope as possible, making use of our conditional approval process for evolving designs; and,
• Where activities fall outside our scope, we strongly recommend some form of ethical review, such as a lower risk process or confirmation that such activities are exempt. Importantly, interviews with any stakeholders (including commissioners of research/evaluations and program delivery staff) are not exempt from ethical review. Under the National Statement, such activities do not typically meet the requirements of paragraph 5.1.1.7 and because of their usually bespoke nature are non-standard instruments* and so trigger ethical review as per the NHMRC’s “Ethical Considerations in Quality Assurance and Evaluation Activities” 2014.

By approaching scope with clarity, comprehensiveness, and careful planning, applicants can ensure that their work receives appropriate ethical oversight while maintaining the flexibility needed for responsive and participatory research and evaluation practice. This approach upholds the ethical principles that guide our work while supporting the practical realities of contemporary research and evaluation in market research, evaluation, and social research contexts.

Ultimately, ethical review is a collaborative process. Iris Ethics is committed to working with applicants to ensure that scope is appropriately defined and that projects receive the level of oversight they require. We encourage open communication about scope questions or uncertainties, and we are always available to provide guidance during the application development process.

*for comparison, a “standard” instrument is a validated data collection tool. Examples include the Kessler-10 (K10) questionnaire and the Personal Wellbeing Index (PWI) instrument.

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