title: 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.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00068861 and NCT00719186.
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Academic Office Building 1, 12631 E. 17th Avenue, Aurora, CO 80045, USA. william.schlaff@ucdenver.edu
authors.forename: William D
authors.initials: WD
authors.lastname: Schlaff
authors.forename: Heping
authors.initials: H
authors.lastname: Zhang
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.forename: Christos
authors.initials: C
authors.lastname: Coutifaris
authors.forename: Peter R
authors.initials: PR
authors.lastname: Casson
authors.forename: Robert G
authors.initials: RG
authors.lastname: Brzyski
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Christman
authors.forename: Kurt T
authors.initials: KT
authors.lastname: Barnhart
authors.forename: J C
authors.initials: JC
authors.lastname: Trussell
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Krawetz
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Snyder
authors.forename: Dana
authors.initials: D
authors.lastname: Ohl
authors.forename: Nanette
authors.initials: N
authors.lastname: Santoro
authors.forename: Esther
authors.initials: E
authors.lastname: Eisenberg
authors.forename: Hao
authors.initials: H
authors.lastname: Huang
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
mesh_terms: D028744:Ethics Committees, Research / Q000592:standards* / Q000639:trends; D005260:Female; D006801:Humans; D007247:Infertility, Female / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D011247:Pregnancy