title: Variation in local institutional review board evaluations of a multicenter patient safety study.
abstract: Several highly visible quality improvement (QI) projects led to controversy over their ethical oversight, attracting attention from institutional review boards (IRBs) and the Office for Human Research Protection. While QI research has increased dramatically, there is limited empirical evidence regarding how multiple IRBs review the same study. This paper describes the variations in local IRB reviews for the same a multicenter QI study. The study, entitled "Locating Errors through Networked Surveillance", used multiple data collection methods to identify patient safety risks in cardiovascular operating room services. This study involved 2-day site visits to 5 hospitals by the research team to observe cardiac surgery procedures and interview staff regarding clinical practice and hazards. Surveys were self-administered. The IRB process varied widely across the 5 hospitals. Reviews ranged from full committee review and approval with verbal consent required from patients and operating room staff, to an IRB determining the study exempt from review and participant consent. The time to IRB approval ranged from 6 weeks to 6 months. This variation suggests there is wide interpretation of the Federal regulations put in place to guide IRBs. The adoption of uniformity would not only reduce inefficiencies but also attenuate the perceived arbitrary nature of current IRB review processes that often inappropriately influence hypothesis-generation and study design.
authors: Departments of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, School of Nursing Division of Acute and Chronic Care, Baltimore, MD, USA. dthomps1@jhmi.edu
authors: David A
authors: DA
authors: Thompson
authors: Nancy
authors: N
authors: Kass
authors: Christine
authors: C
authors: Holzmueller
authors: Jill A
authors: JA
authors: Marsteller
authors: Elizabeth A
authors: EA
authors: Martinez
authors: Ayse P
authors: AP
authors: Gurses
authors: Marc
authors: M
authors: Kanchuger
authors: Nanette
authors: N
authors: Schwann
authors: Charles S
authors: CS
authors: Gibson
authors: Laura
authors: L
authors: Bauer
authors: Peter J
authors: PJ
authors: Pronovost
mesh_terms: D006348:Cardiac Surgical Procedures; D028744:Ethics Committees, Research / Q000592:standards*; D005161:Facility Regulation and Control; D006801:Humans; D015337:Multicenter Studies as Topic; D009873:Operating Rooms; D061214:Patient Safety; D011446:Prospective Studies; D014481:United States