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Overview
Assessing whether consent processes are adequate is a core task in ethics review, grounded in NS Chapter 2.2 (general requirements for consent) and NS Chapter 2.3 (qualifying or waiving consent). Reviewers must assess both the content of participant information and the process by which consent is obtained; see General consent requirements for the underlying standard.
Content adequacy
Participant information must give participants an adequate understanding of the purpose, methods, demands, risks and potential benefits of the research (NS 2.2.2), presented in a way suitable to the participant population (NS 2.2.3). The standard is not whether the information is technically present but whether a reasonable participant in the relevant population would be able to understand it and make an informed decision on its basis. Reviewers should assess:
- Is the language accessible for the participant population (literacy level, plain English, absence of jargon)?
- Is the information about risks accurate and complete, or does it minimise or omit foreseeable risks?
- Is the description of participation clear and specific enough for a participant to understand what they are agreeing to?
- Is the right to withdraw stated in terms that make it truly available, including any implications of withdrawal and whether withdrawal of data is possible (NS 2.2.6(g), 2.2.20)?
Process adequacy
Beyond content, reviewers assess whether the process by which consent will be obtained is likely to produce a voluntary decision based on adequate understanding (NS 2.2.1, 2.2.4):
- Is adequate time provided for participants to consider the decision?
- Is there opportunity for participants to ask questions and discuss the decision with others before consenting (NS 2.2.4)?
- Is the consent mechanism appropriate for the risk level and context (NS 2.2.5)?
- In organisational settings, are there adequate safeguards against explicit or implicit pressure to participate, including deference to a researcher's perceived position of power (NS 2.2.9)?
Assessing waivers and opt-out approaches
Where an application proposes an opt-out approach or a waiver of consent rather than explicit consent, reviewers apply the criteria in NS Chapter 2.3. For an opt-out approach, the research must carry no more than low risk, the public interest in the activity must substantially outweigh the public interest in privacy protection, and near-complete participation must be necessary to the research's validity (NS 2.3.5–2.3.6). Where limited disclosure or deception is proposed, reviewers apply the additional criteria at NS 2.3.1–2.3.2, including whether a full explanation will be offered to participants after their involvement ends. Only an HREC, and not a lower risk review pathway, can approve research involving active concealment, planned deception, or a waiver of consent (NS 2.3.4).
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.