UTMB Human Subjects Education and Monitoring Programs

德克萨斯大学医学分校提议建立两个截然不同但相互关联的项目，这两个项目将显著加强对人类主体的保护。首先是一项创新的教育努力，将建立一个关于人类主体保护的正式认证计划。该计划旨在促进和鼓励研究人员参与，但将向所有研究团队人员开放。完成认证计划有五个主要要求，预计参与者将在12个月内完成该计划。这种培训的一个独特方面将是强调与人类主体保护中的伦理问题有关的教育。第二个计划是临床研究监测计划，它将审查和监测正在进行的人类受试者研究 指挥。该计划将包括研究风险评估，将利用为审查计划建立的特定政策和程序，并将审查关键研究要素，如知情同意过程、知情同意书、IRB通信、数据文档和严重不良事件的管理。这两个项目都将在负责研究的副总裁办公室之外启动，将在整个校园范围内进行，并将在拨款的正式授权期之后得到支持。我们对这些项目的意图是传达对精心设计、合乎伦理和适当地进行人类受试者研究的深刻承诺的至关重要。

The University of Texas Medical Branch proposes to establish two distinct but interrelated programs that would significantly enhance human subject protections. The first is an innovative educational effort that will establish a formal Certification Program on human subject protections. The Program has been designed to facilitate and encourage Investigators to participate, but will be open to all research team personnel. There will be five major requirements for completion of the Certification Program and participants will be expected to complete the program within a 12-month period. A unique aspect to this training will be the emphasis on education relevant to ethical issues in human subject protections. The second program is a Clinical Research Monitoring Program that will review and monitor human subject studies as they are being conducted. This Program will include a study risk assessment, will utilize specific policies and procedures established for the review program, and will examine critical study elements such as the informed consent process, informed consent forms, IRB correspondence, data documentation, and management of serious adverse events. Both programs will be activated out of the Office of the Vice President for Research, will be campus-wide, and will be supported beyond the official award period of the grant. Our intent with these Programs is to convey the critical importance for a profound commitment to carefully designed, ethically sound, and appropriately conducted human subject research studies.