SmartIRB

智能IRB

• 批准号: 10950046
• 负责人: GARY MAYS
• 金额: $ 419.11万
• 依托单位: AXLE INFORMATICS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-17 至 2024-04-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10950046
• 关键词: SmartIRB

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/.

45 C.F.R.第46部分，《对人类受试者的保护，也称为共同规则，都要求机构审查委员会（IRB）对任何涉及任何联邦部门或机构进行，支持或监管的人类受试者的研究。从历史上看，机构建立了自己的IRB，对于多站点的研究，这可能会导致多个IRB审查相同的研究。但是，NIH需要多站点的研究来指定单个IRB（SIRB）。参见Not-OD-16-094。 NCAT在2016年建立了Smart IRB计划，以协调和简化用于多站点研究的IRB审查过程。 Smart IRB由哈佛大学管理，并由NIH临床和转化科学奖（CTSA）计划资助。 请参阅https://smartirb.org/。