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Article 61

Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

1.   For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:

(a)

the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;

(b)

the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;

(c)

their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;

(d)

the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;

(e)

the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.

2.   The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.

Frequently Asked Questions

Informed consent means participants clearly understand and freely choose to take part in AI testing after learning about its goals, possible risks or inconveniences, duration, their rights, and how they can withdraw or challenge AI decisions; they agree willingly and receive detailed documentation about their consent for their records.
Yes, you have the full right to refuse or withdraw from AI tests at any time without needing to explain why, and without experiencing any harmful consequences or disadvantages from your decision; this protects your freedom and ensures your participation remains entirely voluntary throughout the process.
Before consenting, you should be informed clearly about the test’s purpose and method, possible inconveniences or risks, expected testing duration, your rights including participation withdrawal, how to reverse or ignore AI recommendations, the test’s unique identification number, and the contact details of the AI provider or their representative for further questions.
Yes, after you give consent, your decision should be officially recorded with a date, documented thoroughly, and a copy of this informed consent documentation must be provided to you or your legal representative to keep for your personal records or future reference if needed.

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