Protocol Application Tracking System

保护人类受试者是所有临床研究者和机构的高度优先事项。阿尔伯特·爱因斯坦医学院，蒙蒂菲奥里医疗中心，心理学的费尔考夫研究生院和社会工作的Wurzweiler学校保持对人类受试者的安全和道德治疗的坚定承诺。两个机构审查委员会（IRB）位于阿尔伯特·爱因斯坦医学院（爱因斯坦）和蒙蒂菲奥里医学中心（MMC）监督这四个机构的所有人类研究方案。IRB在联邦批准的合作协议的支持下运作，该协议确保机构监督和遵守联邦法规。一个IRB担任主要审查员，另一个IRB通过特设机制随时了解情况。这两个机构间委员会定期举行联席会议，审查政策、程序和共同关注的问题。我们的目标是扩大 为Ferkauf心理学研究生院和Wurzweiler社会工作学院实施Einstein/MMC基于网络的协议应用和跟踪系统（PATS）。将PATS添加到Ferkauf和Wurzweiler将加强对行为和社会研究的监测和协调，减少提交错误，跟踪所有所需的文书工作（包括修正案，进度报告，不良事件等），并加强质量保证计划。此外，我们建议通过专门处理与以下方面有关的问题来定制Ferkauf和Wurzweiler的人类受试者教育组件： 行为和社会研究。量身定制的研讨会将在所有校园提供，使其更容易为教师和学生参加。这些定制将需要基础设施、技术和教育材料的开发。请求提供资源，用于继续开发和改造多平台网络应用程序以及教育部分。这将确保对每个机构进行的行为和社会研究方案进行高质量的监测和协调。

The protection of human subjects is of high priority to all clinical investigators and institutions. The Albert Einstein College of Medicine, Montefiore Medical Center, Ferkauf Graduate School of Psychology, and Wurzweiler School of Social Work maintain a strong commitment to the safe and ethical treatment of human subjects. Two Institutional Review Boards (IRBs) located at the Albert Einstein College of Medicine (Einstein) and Montefiore Medical Center (MMC) oversee all of the human research protocols at these four institutions. The IRBs function under the auspices of a federally-approved Cooperative Agreement which ensures institutional oversight and adherence to federal regulations. While one IRB serves as the Primary Reviewer, the other is kept informed via an Ad Hoc mechanism. The two IRBs meet regularly in a Joint Conference Committee to review policies, procedures and mutual concerns. Our aim is to extend the implementation of the Einstein/MMC web-based Protocol Application and Tracking System (PATS) to the Ferkauf Graduate School of Psychology and Wurzweiler School of Social Work. The addition of PATS to Ferkauf and Wurzweiler will enhance the monitoring and coordination of behavioral and social research, reduce submission errors, track all required paperwork (including amendments, progress reports, adverse events, etc), and enhance the quality assurance program. In addition, we propose to customize the human subjects educational component at Ferkauf and Wurzweiler by dealing specifically with issues related to behavioral and social research. Tailored seminars will be offered on all campuses to make it easier for faculty and students to attend. These customizations will require infrastructure, technology and educational materials development. Resources are requested for the continuing development and alterations to the multiplatform web-based application as well as the educational component. This will ensure high quality monitoring and coordination of the behavioral and social research protocols conducted at each institution.