Human Subjects Research Protection Improvement Plan

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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 Additionally, by eliminating paper submissions and denying submission of incomplete applications and/or outdated IRB forms we envision the proposed electronic system as being central to an increase in the efficiency of the ever expanding demand on the operation and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.