Human Subjects Core

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，以促进分析和解释多重 烧伤后免疫炎症性高代谢反应患者的代谢相互作用。它作为一种工具，用于建立临床基础设施，用于研究设计、评估和分析危重患者的数据。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。对烧伤患者和健康志愿者的研究对于我们理解人类对损伤的反应是必不可少的。这项活动需要仔细的监督和质量控制，以保持最大限度的安全和患者保护，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普通外科单位和MIT普通临床研究设施。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人员之间的密切合作，从我们的临床单位研究中获得的人体研究信息被有效地协调和 在这一核心设施中进行组织，从而提供了一个有效的数据管理机制。 在P50供资机制内设立一个单独的人体研究核心提供了 为前三个项目巩固人类主体的获取和管理提供了绝佳的机会。人类学科核心负责发展和 执行标准操作程序(SOP)、招聘和获得以下人员的同意 主题、样本的收集和分发、记录的保存以及与次级项目的协调。这一核心允许在我们的烧伤创伤中心进行的人体研究以惊人的准确性、敏感性和重复性进行。

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.