Today the Clinical Trials Transformation Initiative (CTTI) announced new recommendations that support the use of a single institutional review board (IRB) of record for multi-center clinical trials.  Included within the recommendations are tools, such as evaluation checklists, to help sponsors, research institutions and central IRBs implement this model.

In a multi-center clinical trial, full review by each site’s IRB can lead to significant delays in study start-up and may not enhance the protection of research participants.  Since 2010 CTTI has been working to understand and address barriers to using a single IRB of record for multi-center clinical trials in the United States. The project was initiated because some research sites were hesitant to use a central IRB, despite encouragement from the U.S. Food and Drug Administration (FDA) and the U.S. Office of Human Research Protections (OHRP).

“Using a single IRB for multi-site clinical research is an important step in accelerating the translation from discoveries to health benefits. The Clinical and Translational Science Awards (CTSA) program is working toward using a single IRB for multi-site studies. The CTTI Central IRB recommendations will be very helpful in advancing towards this goal,” said Petra Kaufmann, M.D., M.Sc., director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).

In addition to the evaluation checklists, CTTI has released a Considerations Document and an IRB authorization agreement template, to support communication and contractual relationships between institutions and a central IRB. CTTI has also hosted webinars during which individuals from sponsor and research organizations have presented their experience of adopting a central IRB model as examples that others can follow.

A complete list of recommendations can be found here.