F08 - Trust, But Verify—Conducting Routine Audits of IRB to Help Ensure Compliance

Friday, November 19, 2021

1:30 PM – 2:30 PM ET

Location: Livestreamed

The IRB is the hub of much of the regulatory activities that surround research compliance. The work this group carries out is mission critical to safeguard the participants, as well as the institution. But, the IRB is a very dynamic realm where human or system errors can create a very unfortunate confluence of circumstances. This session will discuss the value of periodic spot checks on standard practices involved in regulatory review. It will offer an opportunity to also think about building in efficiencies wherever possible to ensure the focus on quality is not overshadowed by clunky, duplicative, or altogether unnecessary processes.

Learning Objectives:

Discuss the various areas within the IRB review that would benefit from periodic spot checks
Describe the value in proactively identifying opportunities for enhancement/ improvement in IRB processes
Provide practical strategies to identify procedural gaps that may otherwise lead to undesirable trends and ultimately noncompliance

Speaker(s)

DD

Debra A. Dykhuis, CIP

University of Minnesota
Minneapolis, MN
John Heldens, RAC, CIP

University of Colorado Denver, Anschutz Medical Campus
Aurora, CO
Kenia F. Viamonte, MA

University of Miami
Coral Gables, FL