This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
There is an unanticipated paradox within the National Statement on Ethical Conduct in Human Research. It comes from the combination of two important elements of the National Statement that in isolation, make sense, but in combination do not have a clear answer. This is the case for whether an HREC can issue a Statement of Exemption for research or evaluation that has already been completed (“retrospective exemption”).
While the National Statement does not explicitly respond to this case, Iris Ethics has taken the position that it will not issue Statements of Exemption for research or evaluation that has already been conducted. This position statement outlines the scope of this statement, the rationale for our position, and provides advice to researchers and evaluators on how to avoid this scenario.
What kinds of scenarios would this apply to?
To understand the scenarios, it is worth understanding the practical reasons why a researcher or evaluator may seek a Statement of Exemption in the first place. Research and evaluation that meets the exemption criteria under the National Statement (Paragraph 5.1.17) does not require ethical review. And for a lot of research and evaluation in this category, a Statement of Exemption is not needed.
However, it is a requirement of many peer-reviewed publications that proof of ethical review is provided or proof of exemption, and the Statement of Exemption exists to provide a formal and independent statement that such research or evaluation is exempt from ethical review. This then satisfies the publication requirements.
Because of this driving purpose for Statements of Exemption, we can then understand the most common scenario for where it might be needed for research or evaluation already conducted. This is typically where the decision to publish happens after the activities have happened. Research and evaluation can occur for a range of reasons and audiences, and peer-reviewed publication is not always an intended outcome. For example, many evaluations are only intended for the use of the commissioner of the evaluation. However, in some instances the research or evaluation may uncover new insights that are worthy of publishing to a broader audience, and the original intent was not to publish. Since publication requires some form of review or an exemption, then any research or evaluation that would be exempt would need a Statement of Exemption to prove this.
It is worth noting that this scenario is rare: almost all research and evaluation does not meet the strict criteria for exemption, and requires at least a Lower Risk Review (which by itself meets publication criteria).
What guidance is there in the National Statement?
The National Statement clearly and explicitly prohibits retrospective review of research and evaluation projects (Paragraph 5.1.6). The rationale for this is clear: an HREC cannot work with applicants to mitigate potential risks if the activities that could give rise to those risks have already occurred. This position is foundational to the integrity of the ethical review system.
However, it can be argued that as exempt research does not need review by an HREC, then the above position does not apply. A Statement of Exemption is by definition not a review, but a confirmation that research meets the exemption criteria.
As this scenario is rare, it is not explicitly considered in the National Statement. Paragraph 5.1.6 is limited to research “where ethics review is required.”
Why has Iris Ethics taken the position to not provide exemptions in this situation?
We have given this position careful consideration, but believe it to be consistent both with the explicit prohibition on retrospective review provided at Paragraph 5.1.6, as well as the overarching principles of the National Statement which apply to all research and evaluation whether or not it is exempt.
From the standpoint of the prohibition on retrospective review, the rationale for the position is that a reviewing institution has responsibility for the research and evaluation it authorises, and a responsibility to ensure that it actively mitigates unnecessary risks to research and evaluation participants. Retrospective authorisation is incompatible with this, as there is no opportunity to mitigate such risks. Risks exist in all research and evaluation, therefore the responsibility to mitigate risk extends to all research and evaluation, including that which is exempt from review. Authorising exemptions retrospectively would undermine the ability of the HREC to exercise its responsibilities to research and evaluation participants.
Furthermore, the principles of the National Statement apply to all research and evaluation, and are collectively directly relevant to the case of retrospective exemption. The principles are written in such a way as to apply to proposed research (e.g. 1.1(b), 1.4(a)) and research in progress (1.7, 1.9), and not to cover research completed. This is especially true of Paragraph 1.1(a) which explicitly describes research as being: “Justifiable by its potential benefit.”
Retroactive review and exemption fails this because any benefit of the research has already been established prior to review. To allow retroactive exemption would introduce a scenario where research could take place where the benefits are not established, choosing only to proceed with publication when a benefit arises. This is both cherry-picking as well as disrespecting the participants’ intrinsic value for those research/evaluation activities which do not yield a benefit.
So what is best practice for researchers?
As noted, this scenario is rare, not least because most research and evaluation requires some form of review. However, for those cases where research and evaluation meets exemption criteria, the question should be asked in the planning phase as to whether there is a foreseeable possibility that publication in a peer-reviewed journal may be an outcome (and thus a need for formal exemption). This is especially important considering that the National Statement strongly encourages publication of research and evaluation findings where feasible.
If it is the case that findings might warrant future peer-reviewed publication, then a Statement of Exemption should be sought. Doing this not only complies with the above position and enables later publication if needed, it also benefits the project in two further ways:
- It provides independent confirmation that the proposed activities meet the criteria for exemption, which can be useful when responding to stakeholders that may have questions about the ethical review process for a project.
- While a statement of exemption is not a formal review process, at Iris Ethics it is still a process of analysing the project in view of the National Statement. Alongside meeting the exemption criteria, Iris Ethics considers whether there are opportunities for the project to further mitigate risk and align with the principles of the National Statement, and advises on steps that can be taken to do this. In this way, the exemption process provides added value to the research/evaluation team.
If you are unsure whether your project meets the criteria for exemption, the best thing to do is to contact us before you commence activities. We can provide general advice that can support your planning and identify the best review pathway for your project.
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.