This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Participant information must include the contact details of a person to receive complaints, distinct from the research team (NS 2.2.6(d)). This article covers complaints from participants, or others, about the conduct of an approved project. For complaints about Iris Ethics' own review process or decisions, see Complaints handling; for a formal challenge to an HREC decision, see Appeals process.
What can be complained about
Under the Iris Ethics complaints policy, a complaint about an approved project may relate to:
- Participation, recruitment, or consent for the project
- Activities not being conducted in accordance with the approved research or evaluation plan
- Misuse of data, including use of AI systems inconsistent with the Iris Ethics AI Policy or the conditions of approval
- Breaches of privacy or confidentiality
- The outputs of AI tools used as part of the project's activities
Lodging a complaint
Complaints about a project are lodged directly with Iris Ethics, not with the research team. A complainant is asked to provide: the organisation and researchers/evaluators involved; the project name and reference number (usually shown on the consent form); details of the complaint; the outcome they are seeking; whether they wish to be contacted about it; whether they consent to information being shared with the research team; and whether they wish to be identified.
How complaints are handled
The Managing Director receives and acknowledges the complaint as soon as possible, then forwards it to the HREC Chair for review and action, unless the Chair is the subject of the complaint, in which case the Managing Director handles it directly (Iris Ethics operating procedures, s.18). The Chair investigates, which may include reviewing existing project records and gathering further information from stakeholders, and makes a recommendation on the appropriate course of action. Iris Ethics keeps a record of the outcome, including any action taken, and notifies the complainant of it at the earliest possible time.
If a complainant is not satisfied with the outcome, the complaint can be referred directly to the Managing Director, or the complainant can ask the Chair to do so.
Researcher obligations
Researchers must acknowledge complaints raised directly with them, investigate the circumstances described, and respond to the complainant. Where a complaint raises a potential ethics breach, it must also be reported to Iris Ethics; where it also involves participant safety, see Adverse events. Contact details for lodging a complaint with Iris Ethics, independent of the research team, must appear in the participant information sheet (NS 2.2.6(d)).
Possible outcomes
Depending on the nature and seriousness of the complaint, Iris Ethics may notify the project team of the complaint, request further information or evidence of compliance, impose conditions on continued approval, request that research data be provided for secure storage, suspend or revoke the project's approval (see Suspension/withdrawal of approval), or advise the National Health and Medical Research Council of the complaint.
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.