Human Subject Core

人类主体核心

• 批准号: 10091061
• 负责人: Barry Ira Milavetz
• 金额: $ 28.88万
• 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/10091061
• 关键词: Adverse event; Aerospace Engineering; 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; Ensure; Environment; Environmental Protection; 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; Time; Training; Trauma; United States National Institutes of Health; Universities; community engagement; data management; epidemiology study; experience; human subject; indigenous community; nutrition; operation; professor; programs; recruit; resilience; synergism; tribal college

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) 是服务于研究人员人类受试者研究目标的资源 参与土著创伤和复原力研究中心以及更广泛的UND。 HSC 将 促进专业环境，促进个人项目负责人 (PL) 的进步 追求 R01 和类似的人类受试者研究资助机制。 HSC 还将协助 扩大联合国开发计划署的人类受试者研究能力。 HSC主任拥有多年研究经验 他将与 PD/PI 协调 HSC 活动。 目标 1. 协助COBRE项目研究者进行人体受试者研究。 2. 建设北达科他大学 (UND) 的人类受试者研究能力。 3. 促进部落有效且适当地参与人类受试者研究。 方法：将聘用两名员工职位以确保 HSC 取得成功，其中包括一名研究人员 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；和受试者招募和 调度。 HSC 将评估与土著人一起开发生物样本数据库的可行性 社区与社区参与和外展核心 (CEOC) 合作。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建立并管理一个数据安全监测委员会 试验。此外，将为 UND 提供文化安全培训，以吸引部落人口和部落 IRB 研究人员与 CEOC 合作。我们还将参与元奖学金并将发布 关于让美洲印第安人参与人类研究的最佳和有前途的实践的手稿 研究。我们将对这些活动进行评估，以确保我们实现 HSC 目标和成果。可持续发展 HSC 的发展将通过与其他 UND IDeA 计划的合作得到加强，包括 表观遗传学 COBRE 以及其他非 IDeA 研究项目。 HSC 服务将提供给其他人 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。