Research Ethics and Dissemination (READ) Core

项目总结 研究伦理与传播核心的使命是提供以研究者为中心 支持高质量研究并确保符合联邦、机构和美国印第安人要求的服务 部落法规要求与社区联系的、跨学科的人类受试者的研究。这个核心 建立在合作研究中心现有监管知识核心的基础上 美国印第安人健康(CRCAIH)，由国家少数民族健康和健康研究所资助 差异(NIMHD U54MD008164)。在建议的应用程序中，我们将扩展 监管知识核心关注Cobre项目负责人的精确需求，最终目标是 帮助开辟一条通往独立研究项目的道路。 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使用 就机构审查委员会(IRB)的申请向调查员提供支持和指导，包括 为涉及多个站点和合作伙伴的研究项目制定协议和同意。如适用， 核心将领导驾驭复杂的多站点研究监管环境的努力，包括 与美国印第安人部落社区进行研究，以便及时启动研究项目。这个 READ CORE还将作为法规文件的中央存储库，监控IRB的时间表 批准并帮助最大限度地减少与调查员违规相关的任何问题，方法是提供指导 研究记录管理和研究方案的定期监测。读取器核心将识别 培训并提供工具和资源，以增加调查员和IRB成员对社区的了解 以研究为基础，促进内部审查委员会审查的一致性，并建设这一领域的机构能力。一份特别的 重点将放在审查以社区为基础的研究中涉及的独特操作挑战 这可能会导致审查过程中不必要的拖延。Read核心还将帮助Cobre项目 领导者将研究进展和研究成果传回社区。此通信和 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 最大限度地从参与研究中获得社区/部落利益。

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.