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Paul Goebel, CIP

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Whether institutional or independent, a central IRB serves as a ... Vice President, Chesapeake Research Review, Inc. Felix Khin-Maung-Gyi, Pharm.D, M.B.A., CIP ... – PowerPoint PPT presentation

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Title: Paul Goebel, CIP


1
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
2
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.

3
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

4
(No Transcript)
5
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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