Who will take informed consent? {26a}
All participants must provide written informed consent before being part of any study procedure. When obtaining and documenting informed consent, the investigator must comply with the applicable regulatory requirement(s) and must adhere to Good Clinical Practice (GCP) and to the ethical principles laid down in the Declaration of Helsinki. Prior to the beginning of the trial, the investigator must have the Jules Bordet Institute and Antwerp Hospital Ethics Committees’ written approval/favourable opinion of the written informed consent form and of any other written information to be provided to subjects.Any revised written informed consent form and written information must receive in advance the Ethics Committee’s approval/favourable opinion.The language used in the oral and written information about the trial, including the written informed consent form, will be as non-technical as practical and should be understandable to the subject or the subject’s legal representative and the impartial witness, when applicable. The trial details will be explained orally in a quiet consulting room.Before informed consent may be obtained, the investigator, or a person designated by the investigator, must give the subject 1 week (7 days) to inquire about the details of the trial and to decide whether or not to participate in the trial. All questions about the trial must be answered to the satisfaction of the subject or the subject’s legal representative.Prior to a subject’s participation in the trial, the written informed consent form must be signed and dated by the subject or by the subject’s legal representative and by the person who conducted the informed consent discussion. A copy of the signed informed consent form will be given to each participant.