Transition to a Single IRB Model: Piloting the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance

Apr 14, 2019 | Institutional Review Board, Multi-Site Studies, National Institutes of Health

A group of researchers came together to study the National Institutes of Health move to a single institutional review board (IRB)to streamline and ultimately accelerate clinical trial start up.  For multi-site clinical trials, obtaining ethical approval from multiple IRBs often leads to delays in the clinical trials.  As of January 25, 2018, the National Institutes for Health (NIH) initiated use of a single IRB for U.S. multi-site clinical trials.

The researchers sought to use this study to evaluate the efficiency, resource use, and user perception of a nascent IRB model.  The results were interesting. They found the move to a single IRB exemplifies a shift in practice and culture for many institutions. The research team observed study start up efficiencies in the move to a single IRB model. However, they anticipate a learning curve  as institutions and teams implement necessary process and resource adjustments to adapt to this new model. Moreover, the findings were limited due to the small number of sites and lack of a control group for this study.

Lead Research/Investigators

  1. Vardeny, University of Minnesota, School of Medicine
  2. Hernandez, Duke University School of Medicine
  3. Cohen, Duke University School of Medicine
  4. Franklin, Duke University School of Medicine
  5. Baqai, Duke University School of Medicine
  6. Palmer, Duke University School of Medicine
  7. Bierer,  Brigham and Women’s Hospital and the Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA,
  8. Cobb, Health Sciences Institutional Review Boards, University of Wisconsin-Madison, Madison, WI

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