| Literature DB >> 21645894 |
William D Schlaff1, 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.
Abstract
UNLABELLED: 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.Entities:
Mesh：
Year: 2011 PMID： 21645894 PMCID： PMC3151556 DOI： 10.1016/j.fertnstert.2011.05.069
Source DB: PubMed Journal: Fertil Steril ISSN： 0015-0282 Impact factor: 7.329