Core D - Human Subjects and Analytical Core

项目总结(见说明)： 在过去的几年里，随着人们更多地认识到隐私保护、研究的道德行为以及仔细和可用的数据获取的必要性，人类受试者研究的复杂性大幅增加。调查人员面临着启动研究的一些额外要求，这往往会导致项目过度拖延和进展受阻。此外，随着数据集变得越来越复杂，并经常与从患者那里获取生物标本联系在一起，对改进数据收集、样本获取和与临床数据的联系的需求日益增加。认识到人类受试者研究的巨大复杂性和个人研究人员面临的障碍，我们在RDRCC内开发了一个中央核心来导航和解决这些问题。人类主题研究和分析核心的总体目标是精简和集中人类主题研究在区域研究和发展协调委员会内启动和运作的过程。 该中心的具体目标是：1.通过各种批准步骤、研究启动和持续的管理要求，从研究初始阶段开始，为人类受试者研究的管理和操作过程提供协助；2.)为研究人员提供临床和转化性研究设计的中心资源，以便考虑到适当的统计学考虑。 3.)提供数据库开发和维护、创建数据表格及其与数据库的连接的系统，使用基于TeleForm的平台，并通过安全的网络和平板电脑平台直接获取数据；以及4.通过综合条形码系统，为标本编码、存档、跟踪和检索以及与临床数据的连接提供一个通用平台和中央资源。 该核心由Clifton Bingham博士和Jonathan Ellen博士领导，汇集了两位经验丰富的临床和翻译研究人员，他们在人类受试者研究的各个方面都有经验，从纵向队列研究、生物标记物分析、人类病理组织研究、干预性研究、临床结果测量和人类疾病的跨学科研究。所提供的服务将与RDRCC的其他核心和风湿病中心整合。这一核心将与约翰·霍普金斯大学的其他资源对接，为调查人员提供额外的咨询和培训。

PROJECT SUMMARY (See instructions): In the last several years, the complexity of human subjects research has increased substantially with a greater appreciation of the need for privacy protection, ethical conduct of research, and careful and usable data acquisition. Investigators face a number of additional requirements to initiate studies, often leading to excessive delays and impairment of progress on projects. Moreover, as datasets become more complex and are frequently linked with the acquisition of biological specimens from patients, there are increasing demands for improved data collection, sample acquisition, and linkage to clinical data. Recognizing the great complexity of human subjects research and the barriers faced by individual investigators, we have developed a Central Core within the RDRCC to navigate and address these concerns. The overall goal of the Human Subjects Research and Analytical Core is to streamline and centralize the process for the initiation and operationalization of human subject research within the RDRCC. The Specific Aims of the Core are: 1 .)To provide assistance for the regulatory and operational process of human subject research beginning at the study inception phase, through various approval steps, study initiation, and continuing regulatory requirements; 2.)To provide a central resource to investigators for clinical and translational study design so that appropriate statistical considerations are taken into account. 3.) To provide a system for database development and maintenance, and the creation of data forms and their linkage with databases using a Teleform-based platform and direct data acquisition via secure Web based and tablet computer platforms; and 4.)To provide a common platform and central resources for specimen coding, archiving, tracking and retrieval, and linkage with clinical data through an integrated barcoding system. This core is led by Dr. Clifton Bingham and Dr. Jonathan Ellen bringing together two seasoned clinical and translational researchers with experience in various aspects of human subjects research, ranging from longitudinal cohort studies, biomarker analysis, studies of human pathological tissues, interventional studies, clinical outcome measurements, and interdisciplinary investigations of human disease. The services provided will integrate with other RDRCC Cores and Rheumatology Disease centers. This Core will interface with other resources at Johns Hopkins to provide additional consultation and training for investigators.