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Glossary

Key terms

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

Key terms

The following terms are used throughout the Iris Ethics Knowledge Base. Where a term is defined in the National Statement on Ethical Conduct in Human Research 2025 (National Statement), that definition is used and cited by paragraph or chapter. Where a term is specific to Iris Ethics operations, this is noted.

  • Adverse event: an occurrence during the conduct of research that causes harm or significant distress to a participant, or that changes the risk or benefit assessment of the research.
  • Assent: agreement by a child or young person to participate in research, given where the child has sufficient maturity to understand the research but formal consent rests with a parent or guardian (NS 4.3.4–4.3.5).
  • Burden: see Inconvenience.

  • Consent: voluntary agreement to participate in research, based on sufficient information and adequate understanding of the proposed research and the implications of participation (NS 2.2.1). Consent may be specific, extended, or unspecified (NS 2.2.14):

    • Specific consent is limited to the project under consideration.
    • Extended consent is given for use of data or tissue in future research that is an extension of, or closely related to, the original project, or in the same general area of research.
    • Unspecified consent is given for use of data or tissue in any future research; its terms and wide-ranging implications must be clearly explained to participants and recorded (NS 2.2.16).
  • Data sovereignty: the rights of communities, particularly Aboriginal and Torres Strait Islander communities, to control, manage, and govern data about their peoples, cultures, and lands. Relevant to research governed by NS Chapter 4.7.
  • Discomfort: an impact considered less serious than harm, such as minor side effects, discomfort from a non-invasive test, or mild anxiety associated with an interview. Where a participant's reaction might exceed discomfort and become distress, this is treated as potential for harm, not discomfort (NS Chapter 2.1). See Harm vs discomfort.
  • Exemption: a decision by the institution responsible for a project (or, where there is no such institution, by an ethics review body) that research is not required to undergo ethics review, because it meets the criteria in NS 5.1.17. Research using personal information without consent cannot be exempted, because a waiver of consent can only be granted by an ethics review body (NS 5.1.15–5.1.18).
  • Harm: a physical, psychological, social, economic, legal, or cultural impact, or a devaluation of personal worth, that is more serious than discomfort. The National Statement's non-exhaustive list of harms covers physical harm; psychological harm; devaluation of personal worth; cultural harm; social harm; economic harm; and legal harm (NS Chapter 2.1). See Harm vs discomfort.
  • HREC (Human Research Ethics Committee): a committee that reviews research assessed as carrying more than low risk, constituted and operating in accordance with the National Statement, including its minimum membership requirements (NS 5.1.11, 5.1.30). Iris Ethics is an NHMRC-registered HREC (EC00484).
  • Human research: research conducted with or about people, or their data or biospecimens. The term is understood broadly to include surveys, interviews, focus groups, observation, testing, and access to personal documents or identifiable information (NS: Purpose, scope and limits of this document).
  • Identifiability spectrum: identifiability is the degree to which a specific individual can reasonably be ascertained from data or information, whether directly or by linkage with other data. The National Statement treats identifiability as a continuum affected by contextual and technical factors, and states explicitly that it does not use "identifiable", "potentially identifiable", "re-identifiable", "non-identifiable" or "de-identified" as fixed descriptive categories, because these labels are ambiguous (NS Chapter 3.1, Element 3, including footnote 6). In practice, evaluators commonly describe data along a spectrum from individually identifiable (identifiers present) through re-identifiable (identifiers removed but re-identification remains possible) to non-identifiable (no reasonable possibility of re-identification); when using these terms, assess the actual risk of re-identification in context rather than treating the label as fixed. See Privacy and identifiability.
  • Inconvenience (and burden): the time, effort, or cost imposed on participants by taking part in research, such as time given up, filling in forms, or travel costs. Neither inconvenience nor burden is a type of harm or discomfort and neither is a risk, but both must be considered and justified by the likely benefit of the research (NS Chapter 2.1).
  • Merit: research merit and integrity is the first of the National Statement's four values. Research has merit where it is justifiable by its potential benefit, based on a thorough study of current literature, designed to ensure participants are not exposed to unnecessary risks, and conducted or supervised by researchers with the necessary skills and experience (NS 1.1–1.2).
  • Lower risk research: research in which there is no risk of harm, but there is a risk of discomfort and possibly a foreseeable burden ("low risk"), or research in which there is no risk of harm or discomfort but there is potential for minor burden or inconvenience ("minimal risk") (NS, Terms used in this document; NS Chapter 2.1, Figure 1). May be reviewed through a lower risk review pathway rather than by full HREC review (NS 5.1.10–5.1.14).
  • National Statement: the National Statement on Ethical Conduct in Human Research 2025 edition, jointly developed by the NHMRC, the Australian Research Council, and Universities Australia, and the primary authoritative source for ethics review requirements in Australia. See National Statement.
  • Opt-out approach: a method of recruitment in which information about the research is provided to potential participants and their participation is presumed unless they take action to decline. An opt-out approach is unlikely to satisfy consent requirements under Commonwealth privacy legislation for sensitive or health information; where the Section 95 or 95A Privacy Act 1988 (Cth) guidelines apply, only an HREC may approve an opt-out approach (NS, Terms used in this document; NS Chapter 2.2).
  • Panel (Iris Ethics): the subgroup of the Iris Ethics HREC assigned by the Chair and Managing Director to review a specific application, constituted to meet the National Statement's membership requirements (NS 5.1.30–5.1.32, 5.1.36).
  • Participant: the National Statement uses the term broadly to include anyone whose involvement falls within the scope of human research, including people who may not know they are participating, such as where the requirement for their consent has been waived by an ethics review body (NS: Purpose, scope and limits of this document). The National Statement speaks of research participants rather than "subjects" to reflect a relationship of trust, respect, and mutual responsibility.
  • PICF (Participant Information and Consent Form): the document, often combining an information section and a consent section, through which researchers and evaluators communicate what a project involves and invite potential participants to decide whether to take part. Content requirements are set out in NS Chapter 2.2, particularly NS 2.2.2 and 2.2.6. Not every project requires a written PICF; consent should be proportional to the risk and sensitivity of the project.
  • QA Guidance: the NHMRC's Ethical Considerations in Quality Assurance and Evaluation Activities (2014).
  • Re-identification: the process of linking data or information back to an identifiable individual, for example by unlocking a code or linking to another dataset that contains identifiers. The National Statement treats re-identification and de-identification as processes that change the character of information, not as fixed labels (NS Chapter 3.1, Element 3, footnote 6).
  • Research: an investigation undertaken to gain knowledge, understanding or insight, with the intention that the findings will be generalised beyond those who are the immediate subject of the investigation.
  • Research governance: the framework, set out in an institution's policy, by which research is developed, reviewed, authorised, conducted, and monitored. Ethics review and institutional authorisation are both part of research governance; authorisation should take into account, but not re-review, matters already considered during ethics review (NS Chapter 5.1).
  • Secondary use of data or information: use of data or information that was originally generated or collected for a different research project or for a non-research purpose, such as routinely collected administrative data. The main ethical issue is the scope of the original consent or, where consent is impracticable to obtain, whether a waiver applies (NS Chapter 3.1, Element 4; NS 3.1.50). See Secondary use of data.
  • Waiver (of consent): a decision by an ethics review body that the requirement for consent may be dispensed with for a specific project, subject to conditions. Only an HREC may grant a waiver of consent for research using personal information in medical research or personal health information; other review bodies may grant a waiver for other research (NS 2.3.9–2.3.12).

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.