Human Subjects Research Protection Improvement Plan

该提案的目标是建立在现有的电子基础设施的基础上 西奈山医学院将开发一个安全的基于计算机的系统，该系统将整合：a)调查员开发并向MSSM IRB提交申请，以便在 人类受试者；b)IRB办公室管理新的和继续的申请、最终报告、 修订、不良事件和广告，以及跟踪对IRB成员、工作人员和调查人员的教育；c)IRB审查新的和继续申请、最终报告、修订、不良事件和广告；d)准备议程和会议纪要格式，以及e)IRB与调查人员之间的快速沟通。拟议的软件设计将把应用程序与遵守法规要求紧密联系在一起，从而在我们调查人员的持续教育中发挥重要作用，这是保护人类受试者的基本要素。拟议的系统还将为IRB提供一个大大改进的、可搜索的系统，用于跟踪和监测研究项目中的不良事件，并作为数据安全监测委员会的行政支持引擎。这种独特的不良事件审查方法是拟议软件的一个至关重要的组成部分，应该会极大地增强IRB保护人类受试者的能力。此外，通过取消纸质提交和拒绝提交不完整的申请和/或过时的IRB表格，我们预计拟议的电子系统将成为提高IRB办公室不断增长的操作和管理需求的效率的核心，作为一种工具，减少调查人员和IRB工作人员发生人为错误的可能性(例如，文件放错地方)，最重要的是，作为一种机制，将允许IRB成员集中审查研究提案，包括招聘技术和同意文件，重点放在与人体受试者保护直接相关的实质性问题上。

The goal of this proposal is to build upon an electronic infrastructure that currently exists at the Mount Sinai School of Medicine to develop a secure computer based system that will integrate: a) an investigator's development and submission of applications to the MSSM IRB for research in human subjects; b) IRB office management of new and continuation applications, final reports, revisions, adverse events, and advertisements, as well as track the education of IRB members, staff and investigators; c) IRB review of new and continuation applications, final reports, revisions, adverse events and advertisements; d) preparation of agendas and minutes formats and e) rapid communication between the IRB and investigators. The proposed software design will tightly link the application process to compliance with regulatory requirements and thereby play a significant role in the ongoing education of our investigators, an essential element in protecting human subjects. The proposed system will also provide the IRB with a vastly improved, searchable system for tracking and monitoring adverse events across research projects and serve as the administrative support engine for Data Safety Monitoring Boards. This unique approach to adverse event review is a critically important component of the proposed software that should greatly enhance the ability of the IRB to protect human subjects. Additionally, by eliminating paper submissions and denying submission of incomplete applications and/or outdated IRB forms we envision the proposed electronic system as being central to an increase in the efficiency of the ever expanding demand on the operation and management of the IRB office, as a tool to reduce the potential for human errors by investigators and IRB staff (e.g. misplacement of documents) and, most importantly, as a mechanism that will permit the IRB members to focus their reviews of research proposals, including recruitment techniques and consent documents, on the substantive issues that directly relate to the )rotection of human subjects.