Human Subjects Core

人类受试者核心

• 批准号: 6794554
• 负责人: RONALD GARY TOMPKINS
• 金额: $ 19.99万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6794554
• 关键词: biomedical facility; burns; clinical research; data management; human subject; informed consent; metabolism; sample collection; trauma

The Human Subjects Core provides the Burn Trauma Center with clinical, physiologic, pathophysiologic, and outcomes data to promote the analysis and interpretation of the multiple metabolic interactions in patients with a burn-induced immuno-inflammatory hypermetabolic response. It serves as a tool to establish a clinical infrastructure for study design, and accrual and analysis of data from critically ill patients. An advancement from this core is the establishment and dissemination of guidelines, tools, and standard operating procedures (SOPs), which can be accessed and utilized by investigators in the field of burns and trauma. The study of bum-injured patients and healthy volunteers is essential to our understanding of the human response to injury. This activity requires careful oversight and quality control to maintain maximum safety and patient protection and to insure high quality data collection. The Human Subjects Core personnel allow complex human studies to be performed at each of our study locations: the Burn Centers at the MGH and SHC, the MGH PET Camera Facility, the MGH general surgical units, and the MIT General Clinical Research Facility. The core acts most efficiently to prevent duplicate and unnecessary blood drawing and testing. To anticipate maximum coordination of research efforts and close cooperation among investigators, human study information obtained from our studies on the clinical units is effectively coordinated and organized in this core facility, thus providing an efficient mechanism of data management. Establishment of a separate human studies core within the P50 funding mechanism provides an excellent opportunity to consolidate acquisition and management of the human subjects for the first three projects. The Human Subjects Core is responsible for the development and implementation of standard operating procedures (SOPs), recruitment and obtaining consent of subjects, collection and distribution of samples, record-keeping, and coordination with the subprojects. This core allows the human research performed in our Burn Trauma Center to be conducted with remarkable accuracy, sensitivity, and reproducibility.

人类受试者核心为烧伤中心提供临床、生理、 病理生理学和结果数据，以促进多重分析和解释 烧伤引起的免疫炎症高代谢反应患者的代谢相互作用。它可作为建立临床基础设施的工具，用于研究设计、危重患者数据的累积和分析。这一核心的进步是建立和传播指南、工具和标准操作程序 (SOP)，烧伤和创伤领域的研究人员可以访问和使用这些指南、工具和标准操作程序 (SOP)。对烧伤患者和健康志愿者的研究对于我们了解人类对伤害的反应至关重要。这项活动需要仔细的监督和质量控制，以维持最大的安全和患者保护，并确保高质量的数据收集。人类受试者核心人员允许在我们的每个研究地点进行复杂的人体研究：MGH 和 SHC 的烧伤中心、MGH PET 摄像设施、MGH 普通外科病房和 MIT 普通临床研究设施。核心可最有效地防止重复和不必要的抽血和测试。为了最大程度地协调研究工作以及研究者之间的密切合作，从我们对临床单位的研究中获得的人类研究信息得到了有效的协调和 组织在此核心设施中，从而提供有效的数据管理机制。 在 P50 资助机制内建立独立的人类研究核心提供了 这是巩固前三个项目的人体受试者采集和管理的绝佳机会。人类受试者核心负责开发和 实施标准操作程序（SOP）、招募并获得相关人员的同意 主题、样本的收集和分发、记录保存以及与子项目的协调。该核心使我们烧伤中心进行的人体研究能够以极高的准确性、灵敏度和可重复性进行。