SMART IRB GOVERNANCE, ADMINISTRATION, AND OPERATIONS SUPPORT

45 C.F.R.第46部分，人体受试者保护，也被称为共同规则，要求由机构审查委员会（IRB）对任何联邦部门或机构进行，支持或监管的涉及人体受试者的任何研究进行审查。从历史上看，机构建立自己的irb，这对于多站点研究可能导致多个irb审查相同的研究。然而，NIH要求多位点研究指定单个IRB （sIRB）。见OD-16-094。此外，共同规则要求对任何共同规则签署机构支持或进行的多地点研究进行单一IRB审查。

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. In addition, the Common Rule requires single IRB review of multi-site research for research supported or conducted by any of the Common Rule signatory agencies. NCATS established the SMART IRB program in 2016 to harmonize and streamline the IRB review process for multi-site studies. SMART IRB is currently administered by a third party and funded by the NIH Clinical and Translational Science Awards (CTSA) Program. See https://smartirb.org/.