Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies
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- 作者：William D. Schlaff ; Heping Zhang ; Michael P. Diamond ; Christos Coutifaris ; Peter R. Casson ; Robert G. Brzyski ; Gregory M. Christman ; Kurt T. Barnhart ; J.C. Trussell ; Stephen A. Krawetz ; Peter J. Snyder ; Dana Ohl ; Nanette Santoro ; Esther Eisenberg ; Hao Huang ; Richard S. Legro ; Reproductive Medicine
- 关键词：Multicenter clinical trials ; ethical review ; institutional review boards ; human experimentation
- 刊名：Fertility and Sterility
- 出版年：2011
- 出版时间：July 2011
- 年：2011
- 卷：96
- 期：1
- 页码：15-18
- 全文大小：86 K
文摘
Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants.
Clinical trial registration: ClinicalTrials.gov NCT00068861 and NCT00719186.