title: Time required for institutional review board review at one Veterans Affairs medical center.
abstract: OBJECTIVE
  Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research.
  
  
  OBJECTIVE
  To measure the overall and incremental process times for IRB review as a process of quality improvement.
  
  
  METHODS
  After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation.
  
  
  METHODS
  Calendar days from initial submission to final approval of research protocols.
  
  
  RESULTS
  Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair.
  
  
  CONCLUSIONS
  Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies.
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania2Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Hall
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
authors.forename: Barbara H
authors.initials: BH
authors.lastname: Hanusa
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania3Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Roslyn A
authors.initials: RA
authors.lastname: Stone
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania4Department of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Bruce S
authors.initials: BS
authors.lastname: Ling
authors.affiliation: Department of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Arnold
mesh_terms: D002985:Clinical Protocols; D028744:Ethics Committees, Research; D006801:Humans; D017064:Process Assessment, Health Care / Q000458:organization & administration*; D058996:Quality Improvement; D012107:Research Design; D013997:Time Factors; D014481:United States; D014493:United States Department of Veterans Affairs