Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9

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 2.8.9
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Impartial witness, Informed consent, Consent form, Legal representative

Content

2.8.9 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.