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Risk level: general Title VI — Measures in Support of Innovation

Article 61 — Informed Consent to Participate in Testing

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,...

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.

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