Research Ethics and Dissemination (READ) Core

研究伦理与传播（READ）核心

• 批准号: 9211584
• 负责人: Jyoti Angal
• 金额: $ 12.43万
• 依托单位: SANFORD RESEARCH/USD
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9211584
• 关键词: American Indians; Area; Back; Centers for Population Health; Centers of Research Excellence; Communication; Communities; Complex; Consent; Documentation; Ensure; Environment; Ethics; Funding; Goals; Grant; Health; Human; Human Subject Research; Institutes; Institutional Review Boards; Knowledge; Lead; Link; Mission; Monitor; Pathway interactions; Periodicity; Process; Protocols documentation; Records; Regulation; Research; Research Ethics; Research Infrastructure; Research Personnel; Research Project Grants; Research Support; Resources; Rural Population; Services; Site; Time; TimeLine; Training; Training Programs; Translating; Trust; Work; community based participatory research; dissemination research; health disparity; human subject protection; improved; institutional capacity; investigator training; member; minority health; non-compliance; population health; programs; repository; research and development; research data dissemination; tool; tribal community

PROJECT SUMMARY The mission of the Research Ethics And Dissemination core is to provide investigator centered services to support high quality research and ensure compliance with federal, institutional and American Indian tribal regulatory requirements for community-linked, transdisciplinary human subjects' research. This core builds upon the existing Regulatory Knowledge Core of the Collaborative Research Center for American Indian Health (CRCAIH), funded by the National Institute of Minority Health and Health Disparities (NIMHD U54MD008164). In the proposed application, we will expand the services of the Regulatory Knowledge Core to focus on precise needs of COBRE Project Leaders, with the ultimate goal to help create a pathway towards an independent research program. The READ core will reduce the regulatory burden for investigators and optimize the use of resources by providing investigator support and guidance with Institutional Review Board (IRB) applications, including protocol and consent development, for research projects involving multiple sites and partners. As applicable, the core will lead the efforts for navigating the complex regulatory environment of multi-site research including research with American Indian tribal communities, to allow for timely initiation of the research projects. The READ core will also serve as a central repository of regulatory documentation, monitor timelines for IRB approvals and help minimize any issues related to investigator non-compliance, by providing guidance with study records management and periodic monitoring of research protocols. The READ core will identify gaps in training and provide tools and resources to increase investigator and IRB member knowledge of community based research to promote consistency in IRB review and build institutional capacity in this area. A special emphasis will be placed on the unique operational challenges involved in review of community based research that may lead to unnecessary delays in the review process. The READ core will also help the COBRE Project Leaders disseminate research progress and findings back to communities. This communication and engagement throughout the research process is vital to enhancing stakeholder engagement, building trust and maximizing community/tribal benefit from involvement in research.

项目概要 研究伦理与传播核心的使命是提供以研究者为中心的 支持高质量研究并确保遵守联邦、机构和美洲印第安人的服务 与社区相关的跨学科人类受试者研究的部落监管要求。这个核心 以合作研究中心现有的监管知识核心为基础 美洲印第安人健康 (CRCAIH)，由国家少数民族健康与健康研究所资助 差异（NIMHD U54MD008164）。在拟议的应用程序中，我们将扩展以下服务： 监管知识核心专注于 COBRE 项目负责人的精确需求，最终目标是 帮助创建一条通往独立研究计划的途径。 READ 核心将减轻调查人员的监管负担，并通过以下方式优化资源的使用： 为研究者提供机构审查委员会 (IRB) 申请的支持和指导，包括 协议和同意书的制定，适用于涉及多个地点和合作伙伴的研究项目。如适用， 该核心将领导努力应对多地点研究的复杂监管环境，包括 与美洲印第安部落社区进行研究，以便及时启动研究项目。这 READ 核心还将作为监管文档的中央存储库，监控 IRB 的时间表 批准并通过提供指导来帮助最大限度地减少与研究者不合规相关的任何问题 研究记录管理和研究方案的定期监控。 READ 核心将识别差距 培训并提供工具和资源，以增加研究者和 IRB 成员对社区的了解 基础研究，以促进 IRB 审查的一致性并建设该领域的机构能力。一个特别的 重点将放在审查基于社区的研究所涉及的独特的操作挑战上 这可能会导致审查过程出现不必要的延误。 READ 核心也将帮助 COBRE 项目 领导者将研究进展和发现传播回社区。此次沟通和 整个研究过程的参与对于增强利益相关者的参与、建立信任和 最大限度地提高参与研究的社区/部落利益。