SmartIRB

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45 C.F.R. Part 46, Protection of Human Subjects, also known as the Common Rule, requires review by an institutional review board (IRB) of any research involving human subjects that is conducted, supported, or regulated by any Federal department or agency. Historically, institutions establish their own IRBs, which for multi-site research could result in multiple IRBs reviewing the same research. However, multi-site research is required by NIH to designate a single IRB (sIRB). See NOT-OD-16-094. NCATS established the SMART IRB program in 2016 to harmonize and streamline the IRB review process for multi-site studies. SMART IRB is administered by Harvard University and funded by the NIH Clinical and Translational Science Awards (CTSA) Program. See https://smartirb.org/.