Institutional Review Board

Institutional Review Board: Management And Function [Hardcover]

Author: Elizabeth A. Bankert Robert J. Amdur | Language: English | ISBN: 0763730491 | Format: PDF, EPUB

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Institutional Review Board: Management And Function
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This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research regulations. This reference provides a step-by-step approach to practical details of IRB administration and includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.

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• Hardcover: 530 pages
• Publisher: Jones & Bartlett Learning; 2 edition (October 25, 2005)
• Language: English
• ISBN-10: 0763730491
• ISBN-13: 978-0763730499
• Product Dimensions: 11 x 8.7 x 1.2 inches
• Shipping Weight: 3.5 pounds (View shipping rates and policies)
• Amazon Best Sellers Rank: #534,898 in Books (See Top 100 in Books)

INSTITUTIONAL REVIEW BOARD is one of the most inspiring books that I have ever read. INSTITUTIONAL REVIEW BOARD has so many shortcomings, that it inspired me to write my own book on the same topic. My new book, CLINICAL TRIALS, was published by Elsevier/Academic Press in January 2012.

INSTITUTIONAL REVIEW BOARD by E. Bankert and R. Amdur is 530 pages long, where the subject matter is divided up into about 100 tiny chapters. Most of these chapters consist of some 2 to 5 pages. Generally, this book serves as an excellent issue-spotting guide. But a problem is that the book refuses to disclose much in the way of concrete information. Please consider the following reviews of some of the chapters. "CSP" means Clinical Study Protocol.

Chapter 5-1. This chapter tells us that the first step of an IRB review is receipt of the CSP. The IRB assesses if the study design (randomization, nature of placebo or control, inclusion & exclusion criteria) is adequate to answer the qeustions. The book tells is that the IRB also assesses how the CSP is different from standard of care, whether the Schema is consistent with the text in the CSP, and if sample size is sufficient.

But I am not sure if this statement about sample size is correct. My understanding, is that the IRB does NOT necessarily include a statistician. This book does not state that the IRB includes a statistician. The relevant chapters on IRB composition (Chapters 3-7, 5-14) fail to mention anything about IRB members knowing about statistics. My understanding is that IRBs are concerned with ethics, Consent Forms, and "big picture" types of things, and NOT sample size and NOT statistics. Therefore, I am not sure why Chapter 5-1 says that the IRB evaluates sample size.

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