Paul Goebel, CIP

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Centralization of IRB Review
Paul Goebel, CIP Vice President, Chesapeake
Research Review, Inc. Felix Khin-Maung-Gyi,
Pharm.D, M.B.A., CIP CEO, Chesapeake Research
Review, Inc.
Veterans Administration IRB Chairs Meeting April
8, 2004 Washington, DC
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Overview

• Whether institutional or independent, a central
  IRB serves as a single IRB overseeing multiple
  research sites to protect the rights and welfare
  of research subjects at those sites.
• A central IRB may exist for a single study or
  as a vehicle for multiple studies subject
  protection review.
• Whether a central IRB is used or not, the IRB
  is part of the larger Human Research Protections
  Program for all clinical research.

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Centralization De-centralization Some Points
to Consider in Comparison/Contrast

• re Efficiency
• re Conflicts of Interest
• re Resource/Investment Dedication
• re Local Attitudes
• re Organizational Will
• re HRPPs Policies/Procedures

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Centralization of IRB Review
Paul Goebel, CIP Vice President, Chesapeake
Research Review, Inc. Felix Khin-Maung-Gyi,
Pharm.D, M.B.A., CIP CEO, Chesapeake Research
Review, Inc.
Veterans Administration IRB Chairs Meeting April
8, 2004 Washington, DC