Journal of Clinical Research Best Practices: Implementing NIH Single IRB Policy Using the National Center for Advancing Translational Sciences (CTSA) Program

The NIH has mandated the use of a single IRB for NIH-funded clinical research. In response, 62 CTSA members have joined together to create the SmartIRB initiative. Initially, Johns Hopkins, University of Utah, and Vanderbilt University IRBs will perform reviews for consortium members. SmartIRB has created a standard reliance agreement and is now creating software to facilitate communications between referring and reviewing institutions. Any healthcare facility or IRB with an FWA number can join SmartIRB. In addition, reviewing IRBs must be AHHRPP-accredited. Referring IRBs must be accredited or pass a quality assessment by a qualified external party. Eventually, any qualified IRB will be able to review any study from willing IRBs, so SmartIRB could be the framework for all sorts of consortia and network reviews. Reviewing IRBs will use their own software, forms and business processes. NIH has issued guidance on allowable budgets for IRB reviews, but further clarification will be required. Schulman IRB has already joined SmartIRB, and more independent IRBs are sure to follow. It remains to be seen how the competition between local and independent IRBs will play out.

Originally published in the Journal of Clinical Research Best Practices, Vol.11, No.12, December 2016