DefinitionIn forcev1.0.0

Informed consent

A subject's freely given, specific, unambiguous and voluntary expression of willingness to take part in a particular real-world test, after having been informed of all aspects relevant to that decision.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier: praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming
Payload hash (sha256): ab248474c9e870bf5f61b6dc9b78cd334224361527ea7ef7012cf449b5261b7c

Citation line

Praxikon, "Informed consent", praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z, sha256 ab248474c9e870bf5f61b6dc9b78cd334224361527ea7ef7012cf449b5261b7c

Version: 1.0.0
Legal time (effective_at): 8 August 2026
Knowledge time (known_at): 8 August 2026
Closed on: Not closed
Application date: 1 August 2024
Topics: definitions

Review status: Placed against the official source (8 August 2026). Next check due by 4 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

What this object is about

1 of 1 shown

The object is about this role. Undifferentiated: it does not follow that the duty rests on this role.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 3(59)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

Article 3(59) defines informed consent as a subject's freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject's decision to participate.
- Locator: Article 3(59)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

Note the word particular: consent applies to one specific test, not to your testing programme as a whole and not to a next version of the system. A general clause in terms of use or an employment contract does not meet this. It is also a concept of its own under the AI Act and not the same as consent as a legal basis under the GDPR, so you cannot cover both with a single form. If the design of the test changes materially, you need fresh consent.
- Locator: Article 3(59)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

Recommended step

A practical step we consider appropriate. Not an obligation following from the Regulation.

Use a separate consent form for each test containing the information relevant to the decision, and record when and how consent was given and how it can be withdrawn. Document separately that consent was voluntary, particularly for employees.
- Locator: Article 3(59)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

When this applies

No condition recorded on this object.

When this does not apply

No exception recorded on this object.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Informed consent",
praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 ab248474c9e870bf5f61b6dc9b78cd334224361527ea7ef7012cf449b5261b7c,
https://www.praxikon.com/en/verkenner/definition/definitie-geinformeerde-toestemming
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Adefinition%3Adefinitie-geinformeerde-toestemming&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-23)

Short form

praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming@1.0.0 (sha256 ab248474)

BibTeX

@misc{praxikon-eu-ai-act-definition-definitie-geinformeerde-toestemming-1-0-0,
  author       = {{Praxikon}},
  title        = {Informed consent},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 ab248474c9e870bf5f61b6dc9b78cd334224361527ea7ef7012cf449b5261b7c},
  url          = {https://www.praxikon.com/en/verkenner/definition/definitie-geinformeerde-toestemming},
  urldate      = {2026-08-23},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming@1.0.0",
    "type": "dataset",
    "title": "Informed consent",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:definition:definitie-geinformeerde-toestemming",
    "URL": "https://www.praxikon.com/en/verkenner/definition/definitie-geinformeerde-toestemming",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          23
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0; schema 1.4.0; effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 ab248474c9e870bf5f61b6dc9b78cd334224361527ea7ef7012cf449b5261b7c; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Adefinition%3Adefinitie-geinformeerde-toestemming&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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