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 研究伦理和传播核心的使命是为调查员提供以式研究人员为中心 支持高质量研究并确保遵守联邦，机构和美洲印第安人 对社区有联系的跨学科人类受试者的研究的部落监管要求。这个核心 建立在合作研究中心现有的监管知识核心的基础上 美国印第安人卫生（CRCAIH），由美国国家少数民族卫生与卫生研究所资助 差异（NIMHD U54MD008164）。在拟议的申请中，我们将扩展 监管知识的核心核心专注于毛茸茸的项目负责人的精确需求，最终目标是 帮助创建通往独立研究计划的途径。 读取核心将减轻调查人员的监管负担，并通过 提供调查人员的支持和指导，并向机构审查委员会（IRB）申请，包括 协议和同意开发，用于涉及多个站点和合作伙伴的研究项目。适用， 核心将领导努力在多站点研究的复杂监管环境中进行努力 与美洲印第安人部落社区的研究，允许及时启动研究项目。这 阅读核心还将作为监管文档的中央存储库，监视IRB的时间表 批准并通过提供指导的指导 研究记录研究协议的管理和定期监控。读取核心将确定差距 培训并提供工具和资源，以增加调查员和IRB成员的社区知识 基于促进IRB审查并在该领域建立机构能力的一致性的研究。特别 重点将放在基于社区研究的审查中所涉及的独特操作挑战 这可能会导致审核过程中不必要的延迟。读取核心还将帮助毛绒项目 领导者将研究进度传播给社区。这个交流和 在整个研究过程中的参与对于增强利益相关者的参与，建立信任和 从参与研究中最大化社区/部落利益。