This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Consent design checklist
Consent gets two chapters in the National Statement (NS 2.2 and NS 2.3) because it is more complex than it first appears, and because it is one of the elements of a project most easily done poorly through oversight rather than intent. Use this checklist when designing consent processes for an ethics application. It is not exhaustive; consult General consent requirements, Information required, When consent can be modified, When consent can be waived, and Opt-out approaches for the underlying requirements, and NS Chapter 4 for population-specific considerations.
Information to be provided (NS 2.2.2, NS 2.2.6)
- Purpose of the research/evaluation: clearly stated?
- Who is conducting the research and who is funding it: identified, with any declarations of interest?
- Methods: described in plain language, including what participation involves and how long it takes?
- Foreseeable risks and potential benefits: accurately and proportionately described?
- Alternatives to participation: identified, where they exist?
- How the research/evaluation will be monitored, and how adversely affected participants will be supported?
- Data storage, access, retention, and privacy protection: described?
- How findings will be reported and disseminated: addressed?
- Contact details for the research team and for complaints: provided, and distinct from each other?
- Right to withdraw at any time, any consequences of withdrawal, and whether data can be withdrawn: stated? See Withdrawal of consent.
Form and process (NS 2.2.3-2.2.5, NS 3.1.24-3.1.25)
- Is the information presented in language and format appropriate to the participant population? See Plain language, Easy English and Easy Read.
- Are translated versions available where participants are not proficient in English?
- Is the information accessible to participants with relevant disabilities?
- Is there sufficient time for participants to consider, ask questions, and discuss their decision with others if they wish?
- Is the consent process free from coercion or undue pressure, including power dynamics between participants and the commissioning organisation?
- Is the mechanism for recording consent proportionate to the risk and complexity of the project (written, verbal, or conduct-based, such as return of a survey)?
- Has the participant information and consent form (or equivalent) been approved by the review body before use?
Ongoing consent and withdrawal
- Is the right to withdraw made clear throughout the research/evaluation, not only at the initial consent stage?
- For longitudinal or long-running studies, is there a process for renegotiating or reconfirming consent if the research scope or terms change?
- Does the consent form specify a cut-off point, whether a date or a project stage, after which data withdrawal becomes impracticable, for example once data has been de-identified or aggregated?
- Is there a protocol for managing withdrawal, including withdrawal of data already collected where this remains feasible?
Survey non-completion
Where a project uses self-completed surveys, decide in advance how partial or abandoned responses will be treated. Iris Ethics' position is that, as a default, non-completion of a survey should be treated as a withdrawal of consent, since most survey platforms have no built-in way to distinguish a participant who has withdrawn from one who was simply distracted or ran out of time. Options for managing this risk include:
- Removing incomplete responses from the analysed dataset, or
- Building in a mechanism that better distinguishes withdrawal from incompletion, such as reaffirming consent before new survey sections, offering opt-out of specific sensitive questions, or sending reminder contacts to incomplete respondents where this is practicable.
Special circumstances
- If participants lack capacity, who provides consent on their behalf, and under what lawful authority (NS 2.2.12)?
- If limited disclosure or deception is proposed, has an alternative means of achieving the research aims with fuller disclosure been considered and ruled out (NS 2.3.1-2.3.2)? See When consent can be modified.
- If opt-out is proposed, does it meet the conditions at NS 2.3.5-2.3.8 and any applicable Privacy Act 1988 (Cth) section 95/95A guidelines? See Opt-out approaches.
- If a waiver of consent is proposed, does it meet the conditions at NS 2.3.10 (or NS 2.3.11 for research exposing illegal activity), and is the correct review pathway being used? See When consent can be waived.
- If data may be reused in future projects, has the consent form specified whether consent is specific, extended or unspecified (NS 2.2.14)?
Related resources
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This page was last updated on 10 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.