Research Ethics and Dissemination (READ) Core

项目总结

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.