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，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）。看到没有,od - 16 - 094。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由哈佛大学管理，由美国国立卫生研究院临床和转化科学奖（CTSA）计划资助。见https://smartirb.org/。