IRB Update: FDA Guidance on Translating Long Form Consent after Short Form Process- Nov. 13, 2024

Per FDA Informed Consent guidance published August 2023, after consenting a research participant using the short form process, “the investigator must obtain a translated copy of the IRB-approved English version of the long form”. This class will discuss the FDA guidance and recent IRB policy/guidance updates, operational and GCP related considerations, and budgeting considerations.

By attending this class, you will:

• Learn about the new FDA guidance recommendations regarding enrolling individuals who do not understand English into a research study 
• Discuss operational and GCP related issues
• Learn how to incorporate potential additional expenses into the research budget

Clinical Research Operations Program: Elective

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Date: Wednesday November 13^th, 2024

Time: 9:00 – 10:30 AM

Location: Virtual Class, please return to the course website for Zoom information