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

ICH E6(R3) Guideline

participants may be given the option to use a paper-based approach as an alternative.

(d)

Obtaining consent remotely may be considered where appropriate.

(e) Whether the informed consent process takes place in person or remotely, the investigator should assure themselves of the identity of the participant (or legally acceptable representative) in accordance with applicable regulatory requirements. The participant or the participant’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue trial participation. The communication of this information and confirmation of the willingness to continue trial participation should be documented. New information that could im pact a participant’s willingness to continue participation should be assessed to determine if re-consent is needed (e.g., depending on the stage of the trial, consideration should be given to whether the new information is relevant only to new participants or to existing participants). If re-consent is needed (e.g., information on emerging safety concerns), new information should be clearly identified in the revised informed consent materials. Revised informed consent materials should receive the IRB/IEC ’ s approval/favourable opinion in advance of use. None of the information provided to the participant or the participant’s legally acceptable representative during the informed consent process should contain any language that causes the participant to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor or their service providers from liability for negligence. The informed consent process should be conducted by the investigator or other investigator site staff delegated by the investigator, in accordance with applicable regulatory requirements. If the participant is unable to provide consent themselves (e.g., minors, patients with severely impaired decision making capacity), the participant ’ s legally acceptable representative should provide their consent on behalf of the participant. Before informed consent may be obtained, the investigator or investigator site staff delegated by the investigator, in accordance with the protocol and conditions of IRB/IEC favourable opinions/approvals, should provide the participant or the participant ’ s legally acceptable representative ample time unless justified (e.g., in an emergency situation) and opportunity to enquire about trial details and to decide whether or not to participate in the trial. Questions about the trial should be answered to the satisfaction of the participant or the participant’s legally acceptable representative. Neither the investigator nor the investigator site staff should coerce or unduly influence a participant to participate or to continue their participation in the trial.

2.8.2

2.8.3

2.8.4

2.8.5

2.8.6

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