title: Variability in the costs of institutional review board oversight.
abstract: BACKGROUND
  Previous studies have shown wide differences between institutions in economies of scale with regard to the costs of institutional review board (IRB) oversight of research. In this study, the authors explored variability among IRB costs, taking into account organizational size, components of the costs of oversight, and protocol type.
  
  
  METHODS
  The authors conducted a survey of academic medical centers to collect information on resource utilization associated with IRB oversight in 2002. They used national cost weights to assign a cost to each type of resource used, and summed weighted resource utilization for IRB costs. Descriptive statistics were generated for costs over all, tertile of protocol volume, cost component, and type of review. They also determined where the greatest cost variability is found.
  
  
  RESULTS
  IRB costs per protocol reviewed are highly variable both overall and within tertiles of volume. Higher-volume institutions have lower costs, which is indicative of economies of scale. However, not all components of IRB costs (e.g., board time) are subject to economies of scale. Expedited reviews of protocols are not less expensive at low-volume institutions.
  
  
  CONCLUSIONS
  IRB costs for oversight are highly variable, and only some of the variation may be attributable to economies of scale. Given such wide variation in costs, the authors conclude that some institutions are conducting reviews in a manner that is inefficient or of low quality. Future work is needed to determine specific practices in reviews, and what leads to the best quality and most efficient oversight and review system.
authors.affiliation: Miller School of Medicine, University of Miami, Miami, Florida 33101, USA. mbyrne2@med.miami.edu
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Byrne
authors.forename: Jeanne
authors.initials: J
authors.lastname: Speckman
authors.forename: Ken
authors.initials: K
authors.lastname: Getz
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D035843:Biomedical Research / Q000191:economics* / Q000941:ethics; D002985:Clinical Protocols; D003365:Costs and Cost Analysis; D028744:Ethics Committees, Research / Q000191:economics*; D005378:Financial Support; D006801:Humans; D014481:United States