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创伤中心提供临床，生理， 病理生理学和结果数据，以促进对多种疾病的分析和解释。 烧伤诱导的免疫炎症高代谢反应患者的代谢相互作用。它作为一种工具，用于建立研究设计的临床基础设施，以及重症患者数据的采集和分析。从这一核心的进步是建立和传播的指南，工具和标准操作程序（SOP），这可以访问和使用的烧伤和创伤领域的调查人员。对烧伤患者和健康志愿者的研究对于我们理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，以保持最大的安全性和患者保护，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摄像机设施、MGH普通外科单位和麻省理工学院综合临床研究设施。核心最有效地防止重复和不必要的抽血和测试。为了最大限度地协调研究工作和研究者之间的密切合作，我们对临床单位研究中获得的人体研究信息进行了有效协调， 组织在这个核心设施，从而提供了一个有效的数据管理机制。 在P50资助机制内建立一个单独的人类研究核心， 这是一个极好的机会，可以巩固前三个项目的人体受试者的采集和管理。人类受试者核心负责开发和 执行标准作业程序、征聘和征得 研究主题、样本收集和分发、记录保存以及与子项目的协调。该核心允许在我们的烧伤创伤中心进行的人类研究具有显着的准确性，灵敏度和可重复性。