Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8

Document information
Reference	ICH ICH E6 Guideline R3 (2025)
Validity area	ICH
Scope(s)	HM
Document name	ICH E6 Guideline
Version / Revision	R3 (2025)
Status	Current
Document type	International guideline
Language(s)	EN
Description	GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.1.4
Scope	G
Document part	III. Annex 1 2.8.8
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Informed consent, Legal representative, Urgent safety measure, Ethics committee
Comment	Emergency consent provisions when prior consent not possible

Content

2.8.8 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.