Protocol Application Tracking System

协议应用跟踪系统

• 批准号: 6773082
• 负责人: DOMINICK PURPURA
• 金额: $ 30万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6773082
• 关键词: Internet; behavioral /social science; behavioral /social science research tag; clinical research; ethics; health science research support; human data; human rights; informatics; information dissemination; information systems; informed consent; method development; training

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.

对人类受试者的保护是所有临床研究人员和机构的高度优先事项。阿尔伯特·爱因斯坦医学院、蒙特菲奥里医学中心、费尔考夫心理学研究生院和伍兹韦莱社会工作学院对人类受试者的安全和合乎道德的治疗保持着坚定的承诺。位于阿尔伯特·爱因斯坦医学院(爱因斯坦)和蒙特菲奥里医学中心(MMC)的两个机构审查委员会(IRBs)监督这四个机构的所有人类研究方案。IRBs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。虽然一个IRB担任主要审查员，但另一个则通过特别机制保持了解情况。这两个机构定期在一个联合会议委员会举行会议，审查政策、程序和相互关注的问题。我们的目标是扩大 在费尔考夫心理学研究生院和伍兹韦莱社会工作学院实施爱因斯坦/MMC基于网络的礼宾应用和跟踪系统。FERKAUF和WURZWELER增加的PAT将加强对行为和社会研究的监测和协调，减少提交错误，跟踪所有必要的文书工作(包括修订、进度报告、不良事件等)，并加强质量保证计划。此外，我们建议在费尔考夫和维尔茨韦勒定制人类科目教育部分，具体处理与以下方面有关的问题 行为和社会研究。所有校园都将举办量身定做的研讨会，让教职员工和学生更容易参加。这些定制将需要基础设施、技术和教育材料的开发。请拨资源继续开发和改建基于网络的多平台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。