Art.61
EU AI Act Guide › Chapter VI — Measures in Support of Innovation › Article 61

Article 61 – Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes

Governance SME Relevant ~2 min read · 478 words

Article 61 sets out the specific informed consent requirements that must be met before any person participates in real-world AI testing under Article 60. Consent must be freely given, specific, informed, and documented — and test subjects must be told everything they need to know to make a genuine choice about participating.

⚠ Medium compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The consent framework for real-world AI test subjects

Article 61 establishes the informed consent requirements for persons who participate in real-world testing of high-risk AI systems outside regulatory sandboxes. It mirrors the principles of GDPR and medical research consent frameworks — ensuring that participation is voluntary, informed, and genuinely free from coercion or undue influence.

WHAT IT SAYS

Prior, informed, freely given — with specific information requirements

  • Freely given informed consent must be obtained from test subjects before their participation and after they have been provided with clear, relevant and understandable information
  • The information provided must cover: the nature and objectives of the testing, the expected duration, the conditions under which testing will occur, the subject’s rights including the right to withdraw at any time without detriment, arrangements for reversing or disregarding AI decisions made during testing, and who is responsible for the testing
  • Consent must be documented, dated, and a copy provided to the participant
  • Participants have the right to withdraw consent at any time without explanation and without suffering any negative consequences — this right cannot be waived
  • Consent is not valid if obtained through deception, coercion or undue influence
  • Special protections apply for vulnerable groups — additional safeguards must be in place where test subjects may be in a situation of dependency or vulnerability
  • Exceptions apply for law enforcement contexts where consent cannot practically be obtained in advance

WHO IS AFFECTED

Providers conducting real-world testing and the test subjects themselves

  • Providers conducting real-world testing under Article 60 — they must design and implement the consent process
  • Natural persons who are test subjects — they have clear rights and protections
  • Market surveillance authorities monitoring whether consent requirements are met
  • Data protection authorities where personal data is processed in connection with testing

WHAT IT MEANS FOR SMES

Design your consent process carefully — it is a legal prerequisite

  • A real-world testing programme without valid informed consent is unlawful — this is not a procedural formality but a substantive legal requirement that must be met before testing begins
  • The consent information requirements are specific and comprehensive — use Article 61 as your checklist when designing participant information sheets and consent forms
  • The right to withdraw without detriment is non-waivable — ensure your testing infrastructure can accommodate mid-test withdrawals without data integrity problems
  • The documentation requirement means you must keep signed, dated consent records — store these securely and for as long as your testing programme runs
  • If your test subjects include employees, customers, or others in a relationship of dependency with your organisation, apply additional safeguards — the power imbalance means consent may not be genuinely free without extra protections

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