Course Description

This web seminar will review the updated FDA Guidance Document titled EEInformed Consent Guidance for IRBs, Clinical investigators and SponsorsEE dated August 2023. This guidance i"ended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDAEEs informed consent regulations for clinical investigations. The revisions include significant changes to the provisions regarding informed consent and provide guidance related to the requirements described in 21 CFR part 50; as well as regulations pertaining to informed consent found in FDAEEs regulations on Investigational New Drug Applications (21 CFR part 12) and Investigational Device Exemptions (21 CFR part 812). An overview of the guidance will include general consent requirements and exceptions, review of the basic elements, documentation requirements, and responsibilities of each party. Additional questions to be addressed include consideration in pediatrics, non-English speakers, considerations for Legally Authorized Representatives (LARs), and electronic informed consent.

Video Preview

Learning Objectives

• Review contents and key elements in the new Guidance Document
• Discuss responsibilities for informed consent for IRBs, clinical investigators, sponsors, and FDA
• Evaluate applications in pediatrics, non-English speakers, LARs, and electronic informed consent