Human Subject Core

人类受试者核心项目摘要 人类受试者核心（HSC）是服务于研究者人类受试者研究目标的资源 参加土著创伤和复原力研究中心，更广泛地在UND。HSC将 促进专业环境，促进个人项目领导人（PL）的进步， 为人类受试者研究提供R 01和类似的资助机制。HSC还将协助 扩大UND的人类研究能力。HSC主任具有多年的研究经验 他将与PD/PI协调HSC活动。 目标 1.协助COBRE项目研究人员进行人类受试者研究。 2.在北达科他州大学（UND）建立人类受试者研究能力。 3.促进部落对人类受试者研究的有效和适当参与。 方法：将雇用两名工作人员职位，以确保成功的HSC结果，包括研究 协调员和招聘协调员。HSC提供的服务包括：研究设计技术 协助（TA）;机构审查委员会（IRB）和知情同意TA;以及受试者招募和 日程安排HSC将评估与土著人建立生物样本数据库的可行性。 社区参与和外展核心（CEOC）。我们将开发 与UND机构审查委员会合作的不良事件报告流程和政策，以及 我们将为Redvers博士的项目和未来的临床研究建立和管理一个数据安全监测委员会。 审判此外，还将向联合国开发计划署提供文化安全培训，以使部落人口和部落宗教审查机构参与进来。 研究人员与CEOC合作。我们还将从事Meta奖学金，并将出版 关于使美洲印第安人参与人类受试者的最佳和有希望的做法的手稿 research.这些活动将被评估，以确保我们实现HSC的目标和成果。持续性 将通过与其他UND IDEA计划（包括 表观遗传学COBRE，以及其他非IDEA研究计划。HSC服务将提供给其他 UND研究人员，从而提供额外的资金来源，以确保HSC的可持续性。

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.