Human Subject Core

人类主体核心

• 批准号: 10596985
• 负责人: Barry Ira Milavetz
• 金额: $ 28.38万
• 依托单位: UNIVERSITY OF NORTH DAKOTA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10596985
• 关键词: Adverse event; American Indians; Biological Specimen database; Biometry; Biostatistics Core; Centers of Research Excellence; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communities; Community Outreach; Consent Forms; Data Analyses; Databases; Engineering; Ensure; Environment; Environmental Protection; Epidemiology; Epigenetic Process; Funding Agency; Funding Mechanisms; Future; Growth; Guidelines; Health Sciences; Human Subject Research; Indigenous; Individual; Informed Consent; Institution; Institutional Review Boards; International; Manuscripts; Methods; North Dakota; Outcome; Participant; Pilot Projects; Policies; Population; Positioning Attribute; Process; Publishing; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Resources; Role; Safety; Schedule; Scholarship; Science; Services; Study Subject; Training; Trauma Research; Tribes; United States National Institutes of Health; Universities; community engagement; data management; experience; human subject; indigenous community; nutrition; operation; professor; programs; recruit; resilience research; synergism; tribal institution

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.

人类主题核心项目摘要 人类受试者核心（HSC）是为人类受试者研究目的服务的资源 参加土著创伤和弹性研究中心，并更广泛地参加。 HSC会 促进专业环境，以促进个人项目领导者（PLS）的进步 为人类受试者研究追求R01和类似的资金机制。 HSC也将有助于 扩大人类受试者的研究能力。 HSC主任在研究方面拥有多年的经验 管理，包括人类受试者研究，他将与PD/PI协调HSC活动。 目标 1。协助COBRE项目调查人员进行人类受试者研究。 2。在北达科他大学（UND）建立人类学科的研究能力。 3。促进有关人类受试者研究的有效和适当的部落参与。 方法：将聘请两个员工职位以确保成功的HSC成果，包括一项研究 协调员和招聘协调员。 HSC提供的服务包括：研究设计技术 援助（TA）；机构审查委员会（IRB）和知情同意书；和主题招聘以及 调度。 HSC将评估使用本土开发生物样品数据库的可行性 社区与社区参与与外展核心（CEOC）合作。我们将发展 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博士的项目和将来的临床建立和管理数据安全监控委员会 试验。此外，将向参与部落人口和部落IRB的文化安全培训提供 研究人员与CEOC合作。我们还将参与元奖学金，并将出版 关于使美洲印第安人参与人类主题的最佳和有前途的做法的手稿 研究。这些活动将进行评估，以确保我们实现HSC目标和成果。可持续性 HSC的增长将通过与其他和其他想法计划的合作来增强 表观遗传学鞋底以及其他非IDEA研究计划。 HSC服务将提供给其他 研究人员，从而提供了获得额外资金来源的访问，以确保HSC的可持续性。