EvidenceApplicablev1.0.0

Dated and documented informed consent of test subjects

For every test subject you record freely given informed consent, covering five prescribed information elements, dated, documented, with a copy provided to the subject.

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:evidence:article-61-informed-consent-record
Payload hash (sha256): 83c5561586bc98fb077ea5fd1b38b139c7cc36ea6e0393d7d6c05ea8f99346df

Citation line

Praxikon, "Dated and documented informed consent of test subjects", praxikon:eu:ai-act:evidence:article-61-informed-consent-record@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 83c5561586bc98fb077ea5fd1b38b139c7cc36ea6e0393d7d6c05ea8f99346df

Version: 1.0.0
Legal time (effective_at): 8 August 2026
Knowledge time (known_at): 8 August 2026
Closed on: Not closed
Application date: 2 August 2026
Topics: innovation

Review status: Editorially reviewed (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.

The obligation this hangs off

1 of 1 shown

The object belongs to this obligation. The source line it hangs off sits there.

Source
This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(1)-(4), Article 60(9), Article 113
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies to every natural person who is a subject of testing in real world conditions under Article 60, prior to their participation.
- ExceptionArticle 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the AI system from being tested, testing may proceed without consent, provided that the testing and its outcome have no negative effect on the subjects and that their personal data are deleted after the test is performed. Outside that specific context there is no exception to consent.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ObligationArticle 60: testing in real world conditions outside a sandbox
  praxikon:eu:ai-act:obligation:article-60-real-world-testing

What this object is about

2 of 2 shown

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

Source
This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(1)-(4), Article 60(9), Article 113
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies to every natural person who is a subject of testing in real world conditions under Article 60, prior to their participation.
- ExceptionArticle 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the AI system from being tested, testing may proceed without consent, provided that the testing and its outcome have no negative effect on the subjects and that their personal data are deleted after the test is performed. Outside that specific context there is no exception to consent.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Consequence
- ActorDeployer
  praxikon:eu:ai-act:actor:deployer
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

What points at this object

Where this evidence comes from

1 of 1 shown

This is what has to be in the file to show that the action was carried out.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 60(1)-(4), Article 60(9), Article 113
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
- ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Relation recorded on: Article 60: testing in real world conditions outside a sandbox
Consequence
- ObligationArticle 60: testing in real world conditions outside a sandbox
  praxikon:eu:ai-act:obligation:article-60-real-world-testing

When this applies

1Applies to every natural person who is a subject of testing in real world conditions under Article 60, prior to their participation.

When this does not apply

Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the AI system from being tested, testing may proceed without consent, provided that the testing and its outcome have no negative effect on the subjects and that their personal data are deleted after the test is performed. Outside that specific context there is no exception to consent.

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, "Dated and documented informed consent of test subjects",
praxikon:eu:ai-act:evidence:article-61-informed-consent-record@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 83c5561586bc98fb077ea5fd1b38b139c7cc36ea6e0393d7d6c05ea8f99346df,
https://www.praxikon.com/en/verkenner/evidence/article-61-informed-consent-record
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aevidence%3Aarticle-61-informed-consent-record&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:evidence:article-61-informed-consent-record@1.0.0 (sha256 83c55615)

BibTeX

@misc{praxikon-eu-ai-act-evidence-article-61-informed-consent-record-1-0-0,
  author       = {{Praxikon}},
  title        = {Dated and documented informed consent of test subjects},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:evidence:article-61-informed-consent-record},
  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 83c5561586bc98fb077ea5fd1b38b139c7cc36ea6e0393d7d6c05ea8f99346df},
  url          = {https://www.praxikon.com/en/verkenner/evidence/article-61-informed-consent-record},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:evidence:article-61-informed-consent-record@1.0.0",
    "type": "dataset",
    "title": "Dated and documented informed consent of test subjects",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:evidence:article-61-informed-consent-record",
    "URL": "https://www.praxikon.com/en/verkenner/evidence/article-61-informed-consent-record",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          25
        ]
      ]
    },
    "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 83c5561586bc98fb077ea5fd1b38b139c7cc36ea6e0393d7d6c05ea8f99346df; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aevidence%3Aarticle-61-informed-consent-record&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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