This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
An adverse event is an unexpected, harmful, or significantly negative occurrence affecting a participant, or any other significant safety issue that materially affects the continued ethical acceptability or conduct of an approved project. Applicants must have documented processes in place to monitor and manage safety, proportionate to the risk assessed in the application, and must notify Iris Ethics when a significant safety issue arises (Iris Ethics operating procedures, s.17).
What counts as an adverse event
In the evaluation, social research, and market research context, this includes:
- A participant experiencing significant distress during or following participation
- A participant disclosing that they are at risk of harm to themselves or others
- A participant experiencing harm as a direct result of the research
- A privacy or data security breach affecting research data
- A disclosure of illegal conduct by or affecting a participant (see Research that may discover illegal activity (NS 4.9))
- Any other unforeseen event that might affect the continued ethical acceptability of the project
Notification timeframes
Iris Ethics requires notification of all significant safety issues that adversely affect participant safety, or that materially affect the continued ethical acceptability or conduct of an approved project, within defined timeframes (Iris Ethics operating procedures, s.17):
- Urgent safety issues: notify within 72 hours of becoming aware of the issue.
- Other significant safety issues: notify within 15 calendar days of becoming aware of the issue.
Any amendment to the project arising from a safety issue, including a change to timing, should be submitted as soon as reasonably possible (see Amendments).
What a safety report should include
The report to Iris Ethics should describe: the nature of the event; the circumstances in which it occurred; the actions taken at the time; and the steps taken, or proposed, to prevent recurrence.
Researcher obligations at the time of the event
Participant welfare comes first. Depending on the event, this may include referring a distressed participant to appropriate support services, pausing data collection until the participant's welfare has been addressed, and preserving information about the event for reporting purposes. The obligation to the participant takes priority over the obligation to keep the research on schedule.
What happens after notification
On receiving a safety report, the HREC assesses whether the applicant's ongoing safety monitoring arrangements remain adequate and whether the change in circumstances is compatible with continued ethical approval (Iris Ethics operating procedures, s.16–17). Depending on severity, this can result in additional conditions, a required amendment, or, where continuance would compromise participant welfare, suspension or withdrawal of 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.