Abstract #300976

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JSM 2003 Abstract #300976
Activity Number: 380
Type: Luncheons
Date/Time: Wednesday, August 6, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300976
Title: The Role of Statisticians and Statistical Review in the Institutional Review Board - THIS LUNCHEON IS SOLD OUT
Author(s): Charles F. Contant*+
Companies: Baylor College of Medicine
Address: 267 S. Crimson Clover Ct., The Woodlands, TX, 77381-3870,
Keywords: ethics ; IRB ; statistical review
Abstract:

The Institutional Review Board is the organization that is legally mandated to review all research concerning human subjects. The federal regulation of human subject's research is codified in 45 CFR 46 and draws heavily from the information contained in the Belmont Report. Other relevant documents include the World Medical Association Declaration of Helsinki and the International Conference on Harmonisation. We will discuss involvement of statisticians in IRB and the role statistical review could, and perhaps should, play in review of human subject research protocols. Specific arguments in favor of statistician involvement will be supported with the relevant documentation. The ethics of statistical review will be discussed.

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Revised March 2003