SMART IRB GOVERNANCE, ADMINISTRATION, AND OPERATIONS SUPPORT

智能 IRB 治理、管理和运营支持

• 批准号: 10950112
• 负责人: MATTHEW BARSTOW
• 金额: $ 200万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10950112
• 关键词: SMART; IRB; GOVERNANCE; ADMINISTRATION; OPERATIONS

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/.

45篇第46部分，人类受试者保护，也称为通用规则，要求由机构审查委员会（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，机构建立自己的IRB，这对于多中心研究可能会导致多个IRB审查相同的研究。但是，NIH要求多中心研究指定一个IRB（sIRB）。参见非OD-16-094。此外，《共同规则》要求对任何《共同规则》签署机构支持或开展的多中心研究进行单一IRB审查。 NCATS于2016年建立了SMART IRB计划，以协调和简化多中心研究的IRB审查流程。SMART IRB目前由第三方管理，并由NIH临床和转化科学奖（CTSA）计划资助。参见https://smartirb.org/。