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Evaluation and quality assurance

OverviewDefinitionsTwo tests, applied on top of the National StatementInterviews and non-standard instrumentsWhat matters mostRelated resources

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

Overview

Quality assurance (QA), evaluation, and research are related but distinct types of activity. The NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014) (QA Guidance) acknowledges that these activities exist on a continuum, and that work that begins as one form of activity can evolve into another over time. Understanding where a given activity sits on this continuum is essential to determining what level of ethical oversight is required. Whether an activity is called evaluation, quality assurance, or research does not decide the question; what decides it is the activity itself and the risk it carries to participants.

Definitions

The QA Guidance defines these activities as follows:

  • Quality assurance: an activity whose primary purpose is to monitor or improve the quality of service delivered by an individual or organisation. Terms such as 'peer review', 'quality assurance', 'quality improvement', and 'audit' are used interchangeably.
  • Evaluation: the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency, and/or appropriateness of an activity.
  • Research: the creation of new knowledge and/or the use of existing knowledge in a new and creative way to generate new concepts, methodologies, inventions, and understandings (Australian Research Council definition, adopted in NS, Purpose, Scope and Limits of this Document).

Two tests, applied on top of the National Statement

The QA Guidance sets out two tests that sit on top of, and do not substitute for, the National Statement's own requirements. The first test asks whether three conditions are all met:

  1. the data is collected and analysed in a way that is coincidental to standard operating procedures;
  2. the data is collected expressly to maintain standards or identify areas for improvement in the environment from which it was obtained; and
  3. the data is not linked to individuals.

Only where all three conditions are met does the second test apply, asking whether any of the following triggers is present:

  • the activity potentially infringes the privacy or professional reputation of participants, providers, or organisations;
  • data or analysis from the QA or evaluation activity is used for another purpose (secondary use);
  • information is gathered about participants beyond what is routinely collected;
  • non-standard or innovative protocols or equipment are used (including interviews and focus groups);
  • cohorts are compared;
  • randomisation, control groups, or placebos are used; or
  • data involving minority or higher-risk* groups is analysed separately from the main analysis.

When one or more of these triggers apply, the National Statement's requirements must be followed, typically meaning at least a Lower risk vs Full HREC review process is required.

Interviews and non-standard instruments

A particularly common area of confusion concerns interviews with stakeholders. Interviews with any stakeholders, including commissioners of research or evaluations, program delivery staff, or participants, are generally not exempt from ethics review. A semi-structured interview guide developed for a specific evaluation is not a standard operating procedure of the service being evaluated; it is a non-standard, bespoke protocol, and it triggers the requirement for ethics review under the QA Guidance, unlike a standardised, validated tool.

A useful diagnostic is to ask who the work is really for. Genuine quality assurance is internal improvement work, conducted within and for the organisation delivering the service, using its own routine processes. An externally commissioned evaluation that produces findings for a funder, board, or department is a different activity, even when the methods look familiar. The former has a reasonable claim to the QA framing; the latter usually does not.

Consider a program evaluation involving interviews with a program director, two team leaders, and four frontline workers, written up with references to "senior staff" and "frontline perspectives" and no names used. The conclusion that no review is needed, because participants are professionals rather than service users, is difficult to defend: the interviews collect personal information through a bespoke protocol, participants are identifiable given the small pool and their roles, and the findings will be used to make judgements that may affect the people who work in the program. This is human research and does not fit the QA carve-out.

What matters most

Irrespective of whether an activity is called research, QA, or evaluation, the fundamental question is whether the people involved are exposed to any risk, burden, inconvenience, or possible breach of their privacy. Where they are, some form of ethical oversight is warranted. The QA Guidance dates from 2014 and the National Statement is the 2025 edition; where the two appear to diverge, the National Statement takes precedence (NS 5.1.7). Exemption is also not the same as "no review": where an activity does constitute human research, exemption is a formal decision against the criteria in NS 5.1.17, and it must be documented (NS 5.1.18), not reached informally by the person doing the work.

Related resources

*As of the 2025 edition of the National Statement, the term "vulnerable" has been removed from use, though the 2014 QA Guidance has not been updated to reflect this. This statement treats the term as referring to any group identified as being at higher risk of harm in the context of the proposed activities, as outlined in Chapter 4.1 of the National Statement.

This page was last updated on 10 September 2026.

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This article draws on the National Statement on Ethical Conduct in Human Research (2025) and the NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014). It is intended as practical guidance and does not constitute legal advice. If you have questions about whether your project requires ethics review, or which additional approvals apply, get in touch.

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.