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

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 在全国范围内开展合作。部署共同信赖协定，并由一个 集中的信息技术平台，提高了进行单一内部审查机构监督和审查的效率。 然而，仍然存在一些障碍，包括研究方面的延误、合规问题和挑战 研究人员在熟悉依赖、审查和执行多点研究方面的经验。 此外，还需要对协议进行更多修改，以适应 其他联邦机构。为了克服这些和其他障碍，SMART IRB计划(目标1：加入) 通过开发退伍军人管理局所需的智能IRB MRA 3.0来扩展智能IRB的覆盖范围和容量， 国防部、能源部和其他联邦机构、健康中心和研究机构签署SMART IRB。 SMART IRB将在SMART IRB 3.0最终敲定后重新签署当前的签字人，方法是 值得信赖的大使网络；(目标2：启用)教育、沟通和改善货币、深度和 通过提高教育和培训资源来传递知识，从而提高IRB的一系列智能能力 IRBs、大使、机构联络点以及国内外的监管和网络团队 CTSA。SMART IRB将继续为这些人开发额外的教育和培训资源 以及开发工具包和针对PI和研究团队的培训机会 使用单个IRB；(目标3：协调)通过以下方式协调、统一和简化工作流程和策略 确定审查IRBs、依赖机构和调查人员的政策、程序和过程 他们的研究团队不同，以确定共同的元素和差异，学习目前 实践，并提出成功的工作流程。这是设计未来的必备条件。 在全国范围内管理人类研究保护的全面解决方案。