Get access

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

Authors

  • Eric J. MacLaughlin,

    Corresponding author
    1. Departments of Family Medicine and Internal Medicine, TTUHSC School of Medicine, Amarillo, TX
    • Department of Pharmacy Practice, Texas Tech University Health Sciences Center (TTUHSC) School of Pharmacy, Amarillo, Texas
    Search for more papers by this author
  • Gail Ardery,

    1. Department of Pharmacy Practice and Science, University of Iowa College of Pharmacy, Iowa City, Iowa
    Search for more papers by this author
  • Eric A. Jackson,

    1. Department of Family Medicine, University of Connecticut School of Medicine, Farmington, Connecticut
    Search for more papers by this author
  • Timothy J. Ives,

    1. Division of Practice Advancement and Clinical Education, University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina
    Search for more papers by this author
  • Rodney B. Young,

    1. Department of Pharmacy Practice, Texas Tech University Health Sciences Center (TTUHSC) School of Pharmacy, Amarillo, Texas
    2. Department of Family and Community Medicine, TTUHSC School of Medicine, Amarillo, Texas
    Search for more papers by this author
  • David S. Fike,

    1. School of Graduate Studies and Research, University of the Incarnate Word, San Antonio, Texas
    Search for more papers by this author
  • Barry L. Carter

    1. Department of Pharmacy Practice and Science, College of Pharmacy, Iowa City, Iowa
    2. Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, Iowa
    Search for more papers by this author

  • Supported by the National Heart, Lung, and Blood Institute (RO1 HL091841). Dr. Carter is also supported by the Comprehensive Access and Delivery Research and Evaluation (CADRE), Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (HFP 04-149). The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. All of the authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
  • Presented at the University of the Incarnate Word's Research Week 2013, University of the Incarnate Word, San Antonio, Texas, February 25–March 1, 2013.

For questions or comments, contact Eric J. MacLaughlin, Texas Tech University Health Sciences Center, 1300 Coulter Drive, Amarillo, TX 79106-1712; e-mail: Eric.MacLaughlin@ttuhsc.edu

Abstract

Study 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.

Design

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.

Measurements and Main 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.

Conclusion

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.

Get access to the full text of this article

Ancillary