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2022 PRIM&R Annual Conference

Applying the FDA Framework in Conducting IRB Review

Tuesday, December 6, 2022

2:30 PM – 5:30 PM ET

Location: Livestreamed

Speaker(s)

Ann Meeker-O'Connell, MS (she/her/hers)

FDA
Silver Spring, Maryland
Ada Sue Selwitz, MA

University of Kentucky
Lexington, Kentucky
Belinda M. Smith, MS, RD, CCRC

University of Kentuckky
Lexington, Kentucky

IRB review of FDA-regulated research requires the interpretation and application of regulatory standards that are different from, and often in addition to, those of the Common Rule. Effective review requires the ability to identify studies that are FDA-regulated, an understanding of how diverse products become test articles, and knowledge of investigational new drug (IND)/investigational device exemption (IDE) requirements. This workshop will provide participants with a stepwise process and framework to identify and apply these unique regulatory requirements to IRB review and the oversight of FDA-regulated research. This session will take place in Zoom meeting. The use of attendee video is encouraged for participation and interaction with your peers.

Learning Objectives:

Examine when an activity falls under FDA regulations
Outline a step by step framework for applying FDA regulations in clinical investigations