This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Developmental evaluation is an approach used for complex, emergent initiatives where the program theory, design, or activities are still evolving as the evaluation proceeds. Because the full scope and methods cannot always be specified before work begins, it raises a specific question for ethics review: how can a review body approve work that is not yet fully designed? The National Statement's 2025 edition answers this directly, and Iris Ethics operates a conditional approval process built on that answer.
The ethics challenge
The National Statement's general expectation is that researchers describe the total project in their application. It also recognises, however, that some projects truly cannot be described in full at the outset: "where the total project cannot be described in advance because the design and detail of successive stages will be informed by preceding stages, researchers should provide a description of the stages that are foreseen and how they intend to seek ethics approval for each stage" (NS 3.1.8). This is explicit permission for staged, or partial-protocol, approval; a complete instrument-by-instrument plan is not a precondition for beginning review.
Chapter 4.8, although written for research conducted during crises, sets out a comparable model that reviewers can draw on more broadly, including pre-review of generic or partial protocols and proportionate, accelerated review where the full detail of a project cannot be settled in advance (NS 4.8.6(a)). The same underlying principles, early engagement, transparency about what is provisional, and a structured process for updating approvals, apply to developmental evaluation.
Where this intersects with QA and evaluation status
Developmental evaluation often begins close to, or within, an organisation's own quality improvement work, and its status can shift as it develops. The NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014) (QA Guidance) notes that quality assurance, evaluation, and research exist on a continuum, and that work which begins as one form of activity can evolve into another over time. An evaluation that starts as internal, low-risk quality improvement can, as later stages are designed, begin to use bespoke protocols, compare cohorts, or produce findings for an external funder or board; any of these can move the work from QA into human research requiring ethics review (see Evaluation and quality assurance for the full two-test analysis). Each stage of a developmental evaluation should be assessed against these triggers on its own terms, rather than inheriting the classification given to the first stage.
Iris Ethics approach
Iris Ethics approves developmental evaluations through a conditional approval process:
- An initial application describes the known components of the evaluation: the overall purpose, the populations and contexts likely to be involved, the types of methods likely to be used, and the data management approach
- The HREC grants conditional approval for the known components, on the basis that later stages will be submitted for review as they are confirmed
- As subsequent stages are designed, amendments are submitted describing the additional components and seeking approval before they are implemented
Because the ethical framework for the project is already established at the first stage, these later submissions are typically treated as amendments rather than fresh applications; see Amendments for how minor and major amendments are distinguished and submitted, and Types of ethical review for how conditional approval sits alongside Iris Ethics' other review pathways.
Consent in developmental evaluation
Where the full scope of participant involvement cannot be described at the time of initial consent, the initial consent process should describe the overall purpose of the evaluation, the types of activities that may be involved, and how participants will be informed of and asked to consent to specific activities as they are confirmed. Research using multiple methods or involving successive groups of participants may properly require consent to be revisited and renegotiated over time, rather than obtained once and treated as covering everything that follows (NS 3.1.23). Participants must not be subjected to activities for which they have not consented, even within an approved developmental evaluation framework.
What reviewers look for
- Whether the initial application is honest about what is not yet known, rather than presenting a speculative full design as settled
- Whether the plan for seeking approval of later stages is concrete, not just a statement that amendments "will be submitted in due course"
- Whether the consent strategy for later, unspecified stages is workable, not only the consent strategy for the stage in front of the committee
- Whether the evaluation's classification against the QA Guidance has been reassessed as its design has developed, rather than fixed at the first stage
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.