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Paul Goebel, CIP Vice President, Chesapeake Research Review, Inc. Felix Khin-Maung-Gyi, Pharm.D, M.B.A., CIP CEO, Chesap

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. Overview.

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Paul Goebel, CIP Vice President, Chesapeake Research Review, Inc. Felix Khin-Maung-Gyi, Pharm.D, M.B.A., CIP CEO, Chesap

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  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. 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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