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Consent requirements checklist

OverviewBefore seeking consentParticipant information requirementsProcess requirementsConsent to future useOngoing consent

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

Overview

This is a quick-reference checklist of consent requirements, organised by National Statement paragraph, for a fast check against an application. For a process-design checklist that walks through building a consent process step by step, use the Consent checklist. For the substantive guidance behind both, see the Consent section.

Before seeking consent

  • Has the requirement for consent been assessed? Could a waiver apply? (NS 2.3.9–2.3.12)
  • Is the proposed consent mechanism appropriate to the nature, complexity and risk of the project, and to participants' personal and cultural circumstances (written, verbal, or conduct implying consent, such as return of a survey)? (NS 2.2.5)
  • For research involving children: is parental or guardian consent required in addition to, or instead of, child assent? (NS 4.3.3–4.3.5)
  • For research involving people who may lack capacity: how will capacity be assessed, and who has lawful authority to consent on the person's behalf? (NS 2.2.12)
  • For research using an opt-out approach on Commonwealth privacy-sensitive information: has HREC approval been sought, where the s95 or s95A Privacy Act 1988 (Cth) guidelines apply? (NS Chapter 2.2)

Participant information requirements

  • Purpose, methods, demands, risks and potential benefits: described so participants can adequately understand them? (NS 2.2.2)
  • Who is conducting and funding the research, and any declarations of interest: identified? (NS 2.2.6(h)–(i))
  • What participation involves: described clearly?
  • Data storage, access, privacy and confidentiality protections: addressed? (NS 2.2.6(f))
  • How and whether findings will be communicated, including likelihood of publication: stated? (NS 2.2.6(k))
  • Right to withdraw at any stage, and any implications of withdrawal for data already collected: explicit? (NS 2.2.6(g))
  • Contact for complaints and for the researchers: provided? (NS 2.2.6(d)–(e))
  • Any payments to participants: disclosed? (NS 2.2.6(j))

Process requirements

  • Information presented in a way suitable to each participant, including plain language appropriate to the population? (NS 2.2.3)
  • Consent process aimed at mutual understanding, with an opportunity to ask questions and discuss the decision with others? (NS 2.2.4)
  • Consent free from coercion or pressure, including subtler forms such as deference to a researcher's perceived position of power? (NS 2.2.9)
  • All recruitment and consent materials approved by the review body before use? (NS 5.2.15–5.2.16)

Consent to future use

  • Is the consent sought specific to this project, extended to closely related future research, or unspecified for any future research? (NS 2.2.14)
  • Where extended or unspecified consent is sought, have its terms and wide-ranging implications been clearly explained and recorded? (NS 2.2.16)

Ongoing consent

  • Right to withdraw communicated throughout, not just at the initial stage? (NS 2.2.20)
  • Process in place for managing withdrawal of data already collected?
  • For longitudinal or complex projects: process for renegotiating or reconfirming consent if the scope changes? (NS 2.2.8)

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.