SMART IRB GOVERNANCE, ADMINISTRATION, AND OPERATIONS SUPPORT

45 C.F.R.第46部分，保护人类受试者，也被称为共同规则，要求机构审查委员会(IRB)审查任何由任何联邦部门或机构进行、支持或监管的涉及人类受试者的研究。从历史上看，各机构建立了自己的IRBs，对于多站点研究，这可能导致多个IRB审查同一项研究。然而，美国国立卫生研究院需要进行多点研究才能指定一个单一的IRB(SirB)。请参阅非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研究的多地点研究进行单一的IRB审查。 NCATS于2016年建立了SMART IRB计划，以协调和简化多站点研究的IRB审查流程。SMART IRB目前由第三方管理，并由NIH临床和翻译科学奖(CTSA)计划资助。请参阅https://smartirb.org/.

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/.