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Review: red flags and concerns

OverviewRisk and benefitConsentPower dynamics and coercionData managementSpecial considerationsRelated resources

This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.

Overview

Reviewers should be alert to indicators in applications that suggest ethical concerns may require further examination. This article identifies common red flags across the key areas of ethics review. No single indicator is decisive on its own, but each warrants closer scrutiny of the application as a whole.

Risk and benefit

  • Risk assessment appears generic or template-based rather than specific to the project
  • Foreseeable risks have been identified but no mitigation strategies are described
  • Research benefits appear to accrue primarily to the commissioning body rather than to participants or the broader community
  • The research population faces elevated background risks and this has not been addressed

Consent

  • Participant information is written at a literacy level inappropriate to the population
  • The right to withdraw without disadvantage is not clearly stated (NS 2.2.6(g), 2.2.19)
  • Consent for all aspects of the research, including data storage and secondary use, is not addressed
  • The consent process appears to rely on implicit or assumed consent without the justification required for an opt-out approach or a waiver (NS Chapter 2.3)

Power dynamics and coercion

  • Participants are employees, students, service recipients, or others in dependent relationships with no independent consent administration
  • Incentives are large relative to the participant population's likely financial circumstances (NS 2.2.10)
  • Participation rates will be monitored or reported in ways that could generate social pressure

Data management

  • Data storage and security arrangements are vague or inadequate given the sensitivity of the data
  • De-identification procedures are described but re-identification risk has not been assessed
  • No data retention or destruction plan is provided

Special considerations

  • The application involves a population or context addressed in NS Chapter 4 (for example, children, Aboriginal and Torres Strait Islander peoples, or people in dependent relationships), but the relevant additional requirements are not addressed
  • Overseas activities are proposed without consideration of NS Chapter 4.6 or local regulatory requirements

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.