On June 21st, the NIH released its final policy on the use of the single Institutional Review Board (sIRB) for multisite research. The notice establishes the expectation that an sIRB of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the U.S. The policy will go into effect as of May 25, 2017, and applies to all competing grant applications (new, renewal, revision, or resubmission).

Release of the new NIH sIRB policy will not come as a surprise to those within the CTSA community. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance platform, under development by NCATS in partnership with CTSA program representatives including the CCTS and experts across the nation, seeks to provide a “roadmap” for implementation of the new NIH sIRB policy. It is based on a demonstration project using an sIRB model, called IRBrely, and aims to provide a flexible option that can be used to set up a central IRB for a network of many studies or an sIRB for one multisite study.

The NCATS website provides authorization and joinder agreements based on the SMART platform and has conducted training on how to use the platform. It is also working on guidance documents and best practices to ensure a harmonized (i.e., consistent) approach across the clinical research network.

The overarching purpose in streamlining the IRB process is to reduce redundancy and mitigate a roadblock that slows the translation of research discoveries into health benefits. As noted by NCATS Director Dr. Christopher P. Austin in his June 16th Director’s Corner message, there are “countless patients who desperately need new therapies” and for whom “time…really can mean a life.”