This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Grounds
Where the HREC has reason to believe that continued delivery of an approved project will compromise participants' welfare, or that the project is not being, or cannot be, conducted in accordance with the conditions of its approval, it must immediately establish whether approval should be suspended or withdrawn (SOP section 19). This reflects the National Statement's requirement that a review body or institution act as soon as it has reason to believe continued research will compromise participant welfare or that conditions of approval, including reporting requirements, are not being met (NS 5.4.14).
Process
The Chair must convene, as soon as practicable, a meeting of a Panel to decide whether ethical approval should be suspended or withdrawn. Ideally this Panel has the same composition as the original Panel for the application; where that is not possible, it should have equivalent representation of expertise relevant to the subject matter (SOP section 19).
In urgent cases, the Chair may suspend approval immediately. The suspension holds until a Panel meeting can be convened, at which point the Panel may extend the suspension, end it, or permanently withdraw ethical approval (SOP section 19).
Notification
Whenever a project is suspended, Iris Ethics immediately notifies the applicant (and the Principal Investigator, if different) and their affiliated institution(s), including the reasons for suspension; participants are notified where possible and feasible (SOP section 19). The Panel's decision on reinstatement or withdrawal is communicated in writing to the applicant, the Principal Investigator, and affiliated institutions within three business days of the meeting, and the Secretariat updates the project's status on the applicant platform (SOP section 19). Communication of a decision to withdraw approval must be in writing and, consistent with the National Statement's general requirements for HREC decisions, supported by a rationale referencing the relevant provisions relied on (NS 5.2.7; NS 5.2.13(a)).
Conditions for resumption
An applicant cannot continue research while approval is suspended and must comply with any special conditions imposed. Research may resume only once (SOP section 19):
- The applicant and Principal Investigator satisfy the HREC that continuation will not compromise participants' welfare and/or will be conducted in accordance with the ethical approval; and
- Any necessary modification has been reviewed and approved by a Panel of the HREC; and
- The affiliated institution(s) authorise the continuation of the research.
Withdrawal
Where approval is withdrawn, Iris Ethics immediately notifies the applicant, Principal Investigator and affiliated institution(s), with reasons. The applicant, affiliated institutions and Secretariat cooperate to inform participants where necessary, provide support if required, ensure activities are halted, and confirm to the HREC and institutions that these steps have been taken (SOP section 19). Continuation of the project after withdrawal is only possible through a fresh application and re-approval by the HREC (SOP section 19).
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.