title: Institutional review board barriers and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now Study: a national multicenter practice-based implementation trial.
abstract: OBJECTIVE
  To categorize institutional review board (IRB) challenges and solutions encountered in a multicenter practice-based research network (PBRN) study and to assess the impact of IRB requirements on the willingness of individual principal investigators (PIs) to participate in future PBRN studies.
  
  
  METHODS
  Descriptive analysis of IRB challenges and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial, a multicenter prospective cluster-randomized study conducted by the National Interdisciplinary Primary Care PBRN, and a correlational analysis from a survey of individual site PIs.
  
  
  RESULTS
  IRB barriers encountered and solutions were categorized for study sites. A survey of study-site PIs was conducted with a correlational analysis assessing the impact of various IRB requirements and the willingness of individual PIs to participate in future PBRN studies; of 31 study sites participating in the CAPTION study, 28 study-site PIs were surveyed. IRBs posed a number of challenges including bias regarding the source of the application, issues regarding study design, study instruments, access to patient records, study procedures, Spanish-only speaking subjects, role of clinic physicians, interdepartmental concerns, and updates at continuing review. Responses from the PI survey (21 of 28 PIs surveyed [75% response rate]) indicated that the willingness of an individual to serve as a PI in the future was inversely related to the perceived difficulty of obtaining initial (rS  = -0.599, p=0.004) and continuing (rS  = -0.464, p=0.034) IRB approval.
  
  
  CONCLUSIONS
  Significant time and resources were required to address various challenges associated with IRB approval, which had a negative impact on an individual PI's willingness to participate in future PBRN projects. A revision of current rules and regulations regarding the protection of human subjects for practice-based studies, improvement in IRB processes, and support from coordinating centers may decrease the burden associated with IRB approval and increase participation in practice-based research.
authors: Department of Pharmacy Practice, Texas Tech University Health Sciences Center (TTUHSC) School of Pharmacy, Amarillo, Texas ; Departments of Family Medicine and Internal Medicine, TTUHSC School of Medicine, Amarillo, TX.
authors: Eric J
authors: EJ
authors: Maclaughlin
authors: Gail
authors: G
authors: Ardery
authors: Eric A
authors: EA
authors: Jackson
authors: Timothy J
authors: TJ
authors: Ives
authors: Rodney B
authors: RB
authors: Young
authors: David S
authors: DS
authors: Fike
authors: Barry L
authors: BL
authors: Carter
mesh_terms: D001290:Attitude; D003299:Cooperative Behavior; D003625:Data Collection; D028744:Ethics Committees, Research; D006801:Humans; D015337:Multicenter Studies as Topic; D010595:Pharmacists; D010820:Physicians; D016032:Randomized Controlled Trials as Topic; D012108:Research Personnel / Q000523:psychology*
keywords: IRB; barriers; institutional review board; practice-based research network
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