ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

2.8.7

Prior to trial participation, the informed consent form should be signed and dated by the participant or by the participant ’ s legally acceptable representative and, where appropriate, by an impartial witness and by the investigator or delegated investigator site staff who conducted the informed consent discussion. By signing the consent form, the investigator or delegated investigator site staff attests that the informed consent was freely given by the participant or the participant’s legally acceptable representative and the consent information was accurately explained to and apparently understood by the participant or the participant’s legally acceptable representative. The informed consent process may involve a physical or an electronic signature and date (see the glossary term “ signature ” ). In emergency situations, when prior consent of the participant is not possible, the consent of the participant ’ s legally acceptable representative, if present, should be requested. When prior consent of the participant is not possible and the participant’s legally acceptable representative is not available, enrolment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the participant’s rights, safety and well-being and to ensure compliance with applicable regulatory requirements. The participant or the participant ’ s legally acceptable representative should be informed about the trial as soon as possible, and consent as appropriate should be requested. If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) during the entire informed consent discussion. After the informed consent form and any other information is read and explained to the participant or the participant ’s legally acceptable representative and they have orally consented to the participant ’s trial participation and, if capable of doing so, have signed and dated the informed consent form, the witness should sign and date the consent form. By signing the consent form, the witness attests that the consent information was accurately explained to and apparently understood by the participant or the participant ’ s legally acceptable representative and that informed consent was freely given by the participant or the participant ’s legally acceptable representative.

2.8.8

2.8.9

2.8.10

The informed consent discussion and the informed consent materials to be provided to participants should explain the following as applicable:

(a)

The purpose of the trial;

(b) That the trial involves research and summary of the experimental aspects of the trial;

(c) The trial ’s investigational product(s) and the probability for random assignment to the investigational product, if applicable;

(d)

The trial procedures to be followed including all invasive procedures;

(e)

What is expected of the participants;

17