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.

项目摘要 研究伦理和传播中心的使命是提供以研究者为中心的 服务，以支持高质量的研究，并确保符合联邦，机构和美国印第安人 部落对与社区相关的跨学科人类受试者研究的监管要求。这一核心 建立在现有的监管知识核心的合作研究中心， 美国印第安人健康（CRCAIH），由国家少数民族健康与健康研究所资助 差异（NIMHD U 54 MD 008164）。在建议的申请中，我们会扩展 监管知识核心侧重于COBRE项目负责人的准确需求，最终目标是 帮助建立一个通往独立研究项目的途径。 READ核心将通过以下方式减轻研究者的监管负担并优化资源的使用 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，用于涉及多个地点和合作伙伴的研究项目。如适用， 该核心将领导在多地点研究的复杂监管环境中导航的工作，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。的 READ核心还将作为监管文件的中央存储库，监测IRB的时间表 批准，并通过提供以下指导，帮助最大限度地减少与研究者不依从相关的任何问题 研究记录管理和研究方案的定期监测。READ核心将确定以下方面的差距： 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 基于研究，以促进IRB审查的一致性，并建立这一领域的机构能力。一个特殊 重点将放在审查以社区为基础的研究所涉及的独特的业务挑战上 这可能导致审查进程出现不必要的拖延。READ核心还将帮助COBRE项目 领导者将研究进展和发现传播回社区。本函及 在整个研究过程中的参与对于加强利益相关者的参与，建立信任和 最大限度地提高社区/部落参与研究的利益。