Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction

Document information
Reference	USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
Validity area	USA
Scope(s)	G
Document name	Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors
Version / Revision	Aug-2023
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.1.1
Scope	G
Document part	II. Introduction
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Consent process, Informed consent, Signature, Consent form
Comment	Common misunderstanding of informed consent as a document

Content

II. SUMMARY OF THE CONSENT PROCESS To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form;9 however, obtaining documentation of a subject’s informed consent is only part of the consent process. Informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment. Informed consent also involves facilitating the prospective subject’s understanding of the information, providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate, obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires.10 [...]