Proactive Infrastructure for Human Subjects Protection

Thomas Jefferson University, Philadelphia PA

Investigators

Linked publications & trials

Abstract

In this application, Thomas Jefferson University (TJU) proposes to build on the results of its initial year's Human Subjects Research Enhancements Program (HSREP) project. During the first year, the Division of Human Subjects Protection (DHSP) expanded its pilot quality improvement/education program (QIP) by individually meeting with investigators and staff to discuss and evaluate the performance of their research studies. Also during this first year, we developed and implemented a campus-wide real-time, secure, internet-accessible management system that tracks all aspects of clinical trials. Included in this system is a human subjects protection database containing the information concerning the activities of the on-campus IRBs, an adverse event database, a QIP database, and a database of protocol patient treatment schedules.These databases are associated with a new database which serves as a comprehensive repository of information on all TJU clinical trials. The results of the DHSP's quality improvement program indicated a need for a certification course on all aspects of human subjects protection and good clinical practice for TJU investigators and research coordinators. We propose to develop such a course in this second year. Also, the functionality of the automated adverse event reporting system developed in the first year will be extended to streamline and document the subsequent review and actions associated with these events at TJU. The systems developed for the HSREP program will then be implemented at other two hospitals, Methodist Hospital and Ephrata Community Hospital, which conduct human subjects research, but do not receive support from the HSREP. Methodist Hospital is an urban community hospital located in Philadelphia, while Ephrata Community Hospital, is a rural facility located in Ephrata, Pennsylvania. All the elements of the quality improvement and education program and clinical trials management system developed during both years of TJU's HSREP will be put into service at these two hospitals. In its entirety, the proposed project will provide enhanced tools for TJU and the two associated community hospitals in their commitment to human subjects protection.