HUMAN SUBJECTS CORE PROJECT ABSTRACT The Human Subjects Core (HSC) is a resource to serve the human subjects research aims of investigators participating in the Indigenous Trauma & Resilience Research Center and more broadly at UND. The HSC will promote a professional environment that will facilitate the progress of Individual Project Leaders (PLs) to pursue R01 and similar funding mechanisms for human subjects research. The HSC will also assist in expanding human subjects research capacity at UND. The HSC Director has years of experience in research administration, including human subjects studies, and he will coordinate HSC activities with the PD/PI. Objectives 1. Assist COBRE project investigators with human subjects research. 2. Build human subjects research capacity at the University of North Dakota (UND). 3. Promote effective and appropriate tribal engagement regarding human subjects research. Methods: Two staff positions will be hired to ensure successful HSC outcomes, including a Research Coordinator and a Recruitment Coordinator. Services provided by the HSC include: Study Design Technical Assistance (TA); Institutional Review Board (IRB) & Informed Consent TA; and subject recruitment and scheduling. The HSC will assess the feasibility of developing a Biosample Database with Indigenous communities in collaboration with the Community Engagement & Outreach Core (CEOC). We will develop Adverse Event Reporting processes and policies in collaboration with the UND Institutional Review Board, and we will establish and administer a Data Safety Monitoring Board for Dr. Redvers' project and for future clinical trials. In addition, cultural safety training for engaging tribal populations and tribal IRBs will be provided to UND researchers in collaboration with the CEOC. We will also engage in Meta Scholarship and will publish manuscripts regarding best and promising practices for engaging American Indians into human subjects research. These activities will be evaluated to ensure we achieve HSC objectives and outcomes. Sustainability and growth of the HSC will be enhanced through collaboration with other UND IDeA Programs, including the Epigenetics COBRE, as well as other non-IDeA research programs. HSC services will be available to other UND researchers, thus providing access to additional funding sources to ensure sustainability of the HSC.
