Human Subject Core

人类学科核心项目摘要 人文学科核心(HSC)是为研究人员的人文学科研究目标服务的资源 参加土著创伤和复原力研究中心，更广泛地说，参加联合国开发计划署。HSC将 促进专业环境，以促进个人项目负责人的进步 为人类受试者研究寻求R01和类似的资助机制。HSC还将协助 扩大联合国开发计划署的人体研究能力。HSC主任有多年的研究经验 他还将负责包括人体研究在内的行政管理工作，并将与PD/PI协调HSC活动。 目标 1.协助科布雷项目调查人员进行人体受试者研究。 2.在北达科他州大学(UND)建立人类研究能力。 3.促进有关人类研究对象的有效和适当的部落参与。 方法：将雇用两个工作人员职位以确保成功的HSC结果，包括一项研究 一名协调员和一名征聘协调员。HSC提供的服务包括：研究设计技术 援助(助教)；机构审查委员会(IRB)和知情同意助教；受试者招募和 日程安排。HSC将评估与土著开发生物样本数据库的可行性 与社区参与和外联核心(CEOC)合作的社区。我们将发展 不良事件报告程序和政策，与联合国开发计划署机构审查委员会协作；以及 我们将为雷德弗斯博士的项目和未来的临床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与部落居民和部落IRBs接触的文化安全培训 研究人员与CEOC合作。我们还将参与元奖学金，并将出版 关于让美国印第安人参与人类主题的最佳和有前景的做法的手稿 研究。将对这些活动进行评估，以确保我们实现HSC目标和成果。可持续性 并将通过与联合国开发计划署的其他IDEA方案，包括 表观遗传学科布雷，以及其他非IDEA研究项目。HSC服务将提供给其他 因此，提供了获得额外资金来源的途径，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.