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IRB Process Improvements: A Machine Learning Analysis.

Kimberly Shoenbill1, Yiqiang Song1, Nichelle L Cobb2

  • 1Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.

Journal of Clinical and Translational Science
|October 31, 2017
PubMed
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This summary is machine-generated.

Identifying predictors of delays in institutional review board (IRB) reviews, such as review type and staff involvement, can improve clinical research efficiency. Process changes based on these findings enhance IRB operations.

Area of Science:

  • Clinical Research Administration
  • Health Services Research

Background:

  • Clinical research is vital but often faces lengthy and costly review processes.
  • Institutional Review Board (IRB) approval is a common requirement for human subjects research.
  • Optimizing IRB review is crucial for accelerating research timelines and reducing costs.

Purpose of the Study:

  • To identify key predictors influencing delays or accelerations in the IRB review process.
  • To leverage identified predictors for implementing process improvements in IRB operations.
  • To enhance the efficiency, transparency, consistency, and communication of IRB reviews.

Main Methods:

  • Analysis of protocol submission timelines to correlate protocol or IRB characteristics with processing times.
  • Utilized single variable analysis and machine learning to pinpoint significant predictors of IRB processing duration.
Keywords:
Ethics CommitteesIRBInstitutional Review Boardmachine learningprocess improvement

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  • Implemented workflow and staffing modifications based on initial findings and re-evaluated the analysis.
  • Main Results:

    • Identified specific predictors of IRB review delays, including the type of review required.
    • Determined that protocols under Veteran's Administration purview and specific IRB staff assignments were associated with processing times.
    • Statistical and machine learning methods effectively identified factors impacting IRB protocol review duration.

    Conclusions:

    • Successfully identified predictors of IRB protocol review delays using advanced analytical methods.
    • Process improvements implemented in two IRBs resulted in demonstrably increased protocol review efficiency.
    • Ongoing workflow and system enhancements aim to achieve improved IRB efficiency, consistency, transparency, and communication.