Background

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multicenter trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections1 recommending this approach.

 

Goal

Identify potential solutions to address barriers to the adoption of central IRBs for multicenter clinical trials.

Objectives

• Solicit current perceptions of barriers to the use of central IRBs in multicenter clinical trials
• Develop strategies to address the identified barriers
• Test reactions to such proposed solutions

 

Methods

 

Team Organization

 

Funding and Other Support

Financial support is being provided by the CTTI general project fund and grant U19 FD003800 from the FDA. Volunteer time is being provided by Chesapeake Research Review Inc., Duke University, the Feinstein Institute for Medical Research, a patient advocate, and Pfizer Inc.

Contact Information

Please send your questions or comments to

 

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¹ Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med. 2010; 363:1591-1593.