FDA's Updated Informed Consent Guidance: What’s New?

Course Description

This web seminar will review the updated FDA Guidance Document titled “Informed Consent Guidance for IRBs, Clinical investigators and Sponsors” dated August 2023. This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s 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 FDA’s 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.

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

Who Should Attend

• Clinical Trial Investigators and Coordinators
• Regulatory Affairs Professionals/Compliance Officers
• Ethics Committee Members
• Institution Review Board (IRB) Members
• Clinical Research Associates
• Quality Assurance Professionals
• Research Ethics Professionals/Legal Counsel

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

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Registration Fees

$835

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-036-L99-P. Released: 1/24. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.