SMART IRB, A NATIONAL SINGLE IRB RELIANCE PLATFORM TO SUPPORT MULTI-SITE HUMAN RESEARCH STUDIES

SMART IRB，一个支持多站点人类研究的国家单一 IRB 信赖平台

• 批准号: 10370538
• 负责人: Lee Marshall Nadler
• 金额: $ 183.68万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10370538
• 关键词: Address; Adoption; Advanced Development; Affect; Agreement; Collaborations; Competence; Consultations; Development; Elements; Familiarity; Federally Qualified Health Center; Fostering; Future; Health; Human; Human Resources; Informatics; Infrastructure; Institution; Institutional Review Boards; Knowledge; Lead; Learning; Methodology; Neighborhood Health Center; Policies; Procedures; Process; Research; Research Personnel; Resources; Site; Standardization; Training; Training and Education; Trust; United States; United States National Institutes of Health; Update; Work; common rule; design; expectation; experience; improved; research study; success; training opportunity; Address; Adoption; Advanced Development; Affect; Agreement; Collaborations; Competence; Consultations; Development; Elements; Familiarity; Federally Qualified Health Center; Fostering; Future; Health; Human; Human Resources; Informatics; Infrastructure; Institution; Institutional Review Boards; Knowledge; Lead; Learning; Methodology; Neighborhood Health Center; Policies; Procedures; Process; Research; Research Personnel; Resources; Site; Standardization; Training; Training and Education; Trust; United States; United States National Institutes of Health; Update; Work; common rule; design; expectation; experience; improved; research study; success; training opportunity

PROJECT SUMMARY/ABSTRACT The SMART IRB platform has transformed the process of conducting multi-site studies and fostering collaboration on a national scale. The deployment of a common reliance agreement, supported by a centralized IT platform, has led to improved efficiencies in conducting single IRB oversight and review. However, several obstacles remain, including delays in research, compliance issues, and challenges experienced by investigators regarding familiarity with reliance review and execution of multisite studies. Furthermore, additional changes to the agreement are required in order to accommodate the onboarding of additional federal agencies. To overcome these and other barriers, SMART IRB plans to (AIM 1: JOIN) Extend the reach and capacity of SMART IRB by developing a SMART IRB MRA 3.0, necessary for the VA, DoD, DOE, and other federal agencies, health centers and research institutions to sign onto SMART IRB. SMART IRB will re-sign current signatories when SMART IRB 3.0 is finalized, through the engagement of the trusted Ambassador network; (AIM 2: ENABLE) Educate, communicate and improve the currency, depth, and range of SMART IRB competencies by advancing educational and training resources to transfer knowledge to IRBs, Ambassadors, institutional Points of Contact, and regulatory and network teams both within and beyond the CTSAs. SMART IRB will continue to develop additional education and training resources for these constituencies, as well as develop a toolkit and training opportunities targeted to PIs and research teams who work with a single IRB; (AIM 3: HARMONIZE) Reconcile, unify, and simplify workflow and policies by identifying policies, procedures, and processes of Reviewing IRBs, Relying Institutions, and investigators and their study teams that differ in order to identify common elements and differences, learn from current practices, and propose successful workflows. This is an essential predicate to the design of a future comprehensive solution for managing human research protections across the nation.

项目摘要/摘要 智能IRB平台改变了进行多站点研究和培养的过程 全国范围内的合作。部署一项共同依赖协议，由 集中的IT平台，导致进行单一IRB监督和审查提高了效率。 但是，仍然存在几个障碍，包括延迟研究，合规性问题和挑战 研究人员经历了有关熟悉依赖审查和执行多站点研究的经验。 此外，为了容纳协议的其他更改以适应 其他联邦机构。为了克服这些障碍，Smart IRB计划（AIM 1：加入） 通过开发智能IRB MRA 3.0（VA所需 国防部，母鹿以及其他联邦机构，卫生中心和研究机构签署Smart IRB。 当Smart IRB 3.0最终确定时，Smart IRB将重新签名当前签名人 值得信赖的大使网络； （目标2：启用）教育，交流和改善货币，深度和 通过推进教育和培训资源以将知识转移到 IRB，大使，机构联系点以及内外的监管和网络团队 CTSA。 Smart IRB将继续为这些开发额外的教育和培训资源 选区，以及针对PIS和研究团队的工具包和培训机会 与一个IRB一起工作； （AIM 3：协调）通过 确定审查IRB，依赖机构和调查人员的政策，程序和过程以及 他们的研究团队不同，以确定共同的要素和差异，从当前学习 实践，并提出成功的工作流程。这是未来设计的重要谓词 全国范围内管理人类研究保护的综合解决方案。