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

William D. Schlaff, Heping Zhang, Michael Peter 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

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)15-18
Number of pages4
JournalFertility and sterility
Volume96
Issue number1
DOIs
Publication statusPublished - Jan 1 2011
Externally publishedYes

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Keywords

  • Multicenter clinical trials
  • ethical review
  • human experimentation
  • institutional review boards

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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