By clicking “Accept”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.

Article 61

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

Updated on May 21st 2024 based on the version and article numbering approved by the EU Parliament on May 14th 2024.

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:

  1. the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
  2. the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
  3. 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;
  4. the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
  5. 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.

[Previous version

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

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:

  1. the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
  2. the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects' participation;
  3. 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;
  4. the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
  5. 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.

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall 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:

  1. the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
  2. the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects' participation;
  3. 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;
  4. the arrangements for requesting the reversal or the disregard of the predictions, recommendations or decisions of the AI system;
  5. 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.

Suitable Recitals
Report error

Report error

Please keep in mind that this form is only for feedback and suggestions for improvement.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.