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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

2011; Elsevier BV; Volume: 96; Issue: 1 Linguagem: Inglês

10.1016/j.fertnstert.2011.05.069

1556-5653

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 A. Ohl, Nanette Santoro, Esther Eisenberg, Hao Huang, Richard S. Legro,

Reproductive Biology and Fertility

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.ClinicalTrials.gov NCT00068861 and NCT00719186.