This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
A waiver dispenses with the requirement for consent entirely. It is the most significant departure from the consent principle in NS 2.2, and the National Statement reserves it for cases where neither explicit consent nor an opt-out approach is workable (NS 2.3, Introduction). Where a waiver is granted, participants will characteristically not know that they, or their data or tissue, are involved in the research or evaluation at all.
Who can grant a waiver
Only a full HREC may grant a waiver of the requirement for consent for research or evaluation using personal information in medical contexts, or personal health information. Other review bodies (including lower risk pathways) may grant a waiver for other research or evaluation (NS 2.3.9). In practice this means a lower-risk review can waive consent for research involving other kinds of personal information, provided the project does not otherwise meet the threshold requiring full HREC review, for example because it carries a foreseeable risk of harm. See Lower risk vs full HREC review.
Research that involves personal information without consent cannot be exempted from an ethics review; a waiver of consent from an appropriate review body is required instead (NS 5.1.16). Where a project uses only aggregate, non-identifiable data, the exemption framework at NS 5.1.17 may be the relevant pathway rather than a waiver.
Conditions for a waiver (NS 2.3.10)
Before waiving the requirement for consent, the review body must be satisfied that:
- involvement carries no more than low risk to participants (see Assessing risk and benefit (NS 2.1));
- the benefits from the research or evaluation justify any risks of harm associated with not seeking consent;
- it is impracticable to obtain consent, for example because of the quantity, age, or accessibility of records (impracticable means not actually achievable, not merely inconvenient or costly);
- there is no known or likely reason to think participants would not have consented if asked;
- there is sufficient protection of participants' privacy;
- there is an adequate plan to protect the confidentiality of data;
- where results may be significant for participants' welfare, there is, where practicable, a plan for making that information available to them, for example via a disease-specific website or regional media;
- any commercial exploitation of derivatives of the data or tissue will not deprive participants of financial benefits to which they would otherwise be entitled; and,
- the waiver is not prohibited by state, federal, or international law.
The low-risk threshold is non-negotiable: if the research or evaluation carries a foreseeable risk of harm, a waiver is not available and consent, an opt-out approach, or limited disclosure must instead be pursued (see Opt-out approaches and When consent can be modified).
Waivers involving illegal activity (NS 2.3.11)
Where a waiver is sought for research or evaluation aiming to expose illegal activity, an HREC must additionally be satisfied that the value of exposing the activity justifies the adverse effects on those exposed, that privacy and data confidentiality are sufficiently protected, and that the waiver is not otherwise prohibited by law (NS 2.3.11). Only an HREC can grant this category of waiver (NS 2.3.9). See Research that may discover illegal activity (NS 4.9).
Transparency obligations
Each institution must make publicly accessible, for example in annual reports, summary descriptions of all research or evaluation projects for which consent has been waived under NS 2.3.10 or NS 2.3.11 (NS 2.3.12). For the illegal-activity category specifically, this disclosure must not occur until the research has been completed (NS 2.3.12). At Iris Ethics, this obligation is met through the annual reporting process, which includes summary information on projects for which a waiver has been granted.
A note on retrospective consent
Some research and evaluation designs waive consent prospectively while seeking consent or notification retrospectively where practicable, for example in observational studies where prospective consent would compromise the research but participants can be informed and given an opportunity to withdraw their data afterward. This remains subject to the same NS 2.3.10 conditions; retrospective notification is good practice within a waiver, not a separate category of approval.
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.