title: How variability in the institutional review board review process affects minimal-risk multisite health services research.
abstract: BACKGROUND
  The Department of Health and Human Services recently called for public comment on human subjects research protections.
  
  
  OBJECTIVE
  To assess variability in reviews across institutional review boards (IRBs) for a multisite, minimal-risk trial of financial incentives for evidence-based hypertension care and to quantify the effect of review determinations on site participation, budget, and timeline.
  
  
  METHODS
  A natural experiment occurring from multiple IRBs reviewing the same protocol for a multicenter trial (May 2005 to October 2007).
  
  
  METHODS
  25 Veterans Affairs (VA) medical centers.
  
  
  METHODS
  Number of submissions, time to approval, and costs were evaluated; patient complexity, academic affiliation, size, and location (urban or rural) between participating and nonparticipating VA medical centers were compared.
  
  
  RESULTS
  Of 25 eligible VA medical centers, 6 did not meet requirements for IRB review and 2 declined to participate. Of 17 applications, 14 were approved. The process required 115 submissions, lasted 27 months, and cost close to $170 000 in staff salaries. One IRB's concern about incentivizing a particular medication recommended by national guidelines prompted a change in our design to broaden our inclusion criteria beyond uncomplicated hypertension. The change required amending the protocol at 14 sites to preserve internal validity. The IRBs that approved the protocol classified it as minimal risk. The 12 sites that ultimately participated in the trial were more likely to be urban and academically affiliated and to care for more complex patients, which limits the external validity of the trial's findings.
  
  
  CONCLUSIONS
  Because data came from a single multisite trial in the VA system that uses a 2-stage review process, generalizability is limited.
  
  
  CONCLUSIONS
  Complying with IRB requirements for a minimal-risk study required substantial resources and threatened the study's internal and external validity. The current review of regulatory requirements may address some of these problems.
authors.affiliation: Health Services Research and Development (152), Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Boulevard, Houston, TX 77030, USA. laurap@bcm.edu
authors.forename: Laura A
authors.initials: LA
authors.lastname: Petersen
authors.forename: Kate
authors.initials: K
authors.lastname: Simpson
authors.forename: Richard
authors.initials: R
authors.lastname: Sorelle
authors.forename: Tracy
authors.initials: T
authors.lastname: Urech
authors.forename: Supicha Sookanan
authors.initials: SS
authors.lastname: Chitwood
mesh_terms: D028744:Ethics Committees, Research / Q000191:economics / Q000592:standards*; D019983:Guideline Adherence; D006302:Health Services Research / Q000191:economics / Q000592:standards*; D006787:Hospitals, Veterans / Q000191:economics; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D017410:Practice Guidelines as Topic; D012052:Reimbursement, Incentive; D015203:Reproducibility of Results; D012306:Risk; D013997:Time Factors