This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Applicants must notify Iris Ethics of any significant safety issue that adversely affects participant safety or materially affects the continued ethical acceptability of an approved project. Urgent safety issues must be notified within 72 hours; all other significant safety issues must be notified within 15 calendar days of the applicant becoming aware of them (SOP section 17). This reporting duty sits within the National Statement's broader monitoring framework, which lists adverse event and other safety reports among the mechanisms institutions and review bodies use to monitor approved research (NS Chapter 5.4; NS 5.4.3). This article covers the HREC's assessment duties on receiving a report; for what researchers must submit, see Adverse events.
What applicants must have in place
Applicants must have documented processes to monitor and manage ongoing safety and avoid adverse events, including a mechanism for recording all reported adverse events, and must demonstrate in their application that safety monitoring is proportionate to risk (SOP section 17). Any amendment arising from a safety issue, including a change to timing, must be submitted to the HREC as soon as reasonably possible.
The HREC's assessment duties
On receiving a safety report, and as part of ongoing monitoring generally, the HREC (SOP section 17):
- Assesses the safety of proposed activities and whether the applicant's evaluation of anticipated benefits and risks is satisfactory, and whether the sponsor has proportionate systems to mitigate and manage identified risks.
- Satisfies itself that the applicant's ongoing safety monitoring arrangements are adequate, including criteria for withdrawing individual participants.
- Keeps the adequacy and completeness of the informed consent process and documentation under review in light of new information about risks and benefits.
- Assesses whether a reported change to the risk/benefit ratio is compatible with continued ethical approval.
- Advises applicants and their institutions of any decision to withdraw approval.
Researchers must not continue activities that give rise to unacceptable risk while a safety report is under review. Depending on the outcome of the assessment, the HREC may require additional monitoring, impose interim restrictions on data collection, require a protocol modification, or suspend or withdraw approval; see Suspension/withdrawal of approval.
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.