This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Monitoring arrangements must be commensurate with the risk, size and complexity of the research (NS 5.4.2). Iris Ethics, through the HREC and Secretariat, monitors approved projects to ensure compliance with the conditions of approval and to protect the rights, safety and welfare of participants (SOP section 16). As a condition of approval, investigators must immediately report anything that might warrant review of ethical approval, including proposed protocol changes, unforeseen events affecting continued ethical acceptability, serious or unexpected adverse events, and abandonment of the project (SOP section 16).
Standard mechanisms
- Progress and final reports: required from researchers at intervals reflecting the project's risk and at least annually, and at completion (NS 5.4.8). See Progress report review.
- Safety reports: urgent safety issues and other significant safety issues must be reported within fixed timeframes. See Safety reporting.
- Amendment review: continuation of approval is conditional on researchers submitting any amendment to the protocol for approval before it is implemented (NS 5.4.10). See Amendments.
Discretionary mechanisms
Beyond the standard reporting cycle, the HREC has discretion to adopt further mechanisms depending on the complexity, design and risk of a project (SOP section 16), including:
- Discussion of relevant aspects of the project with investigators, at any time.
- Random inspection of research or evaluation sites, data, or consent documentation.
- Interviews with participants, or other forms of feedback from them.
- Requesting and reviewing reports from independent agencies.
The HREC may also recommend, as a condition of approval, that the applicant coordinate onsite monitoring at set intervals or at random points throughout the project (SOP section 16).
Escalation
Where monitoring reveals a compliance concern, such as a protocol deviation, an unreported adverse event, or evidence of participant harm, the HREC's response can range from requiring further information or additional reporting through to suspending or withdrawing approval. See Suspension/withdrawal of approval.
Related resources
This page was last updated on 16 September 2026.
Was this helpful? We'd appreciate your feedback!
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.