Human Subjects Research Enhancements at Harbor-UCLA REI

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The Human Subjects Research Enhancements at Harbor-UCLA REI program is intended to strengthen the protection of human research subjects at Harbor-UCLA REI by improving the data collection and tracking processes and by implementing a long term program to ensure accreditation of the programs of the IRB's at REI. Specifically, the program identifies three major areas for improvement: (a) Development of Infrastructure/technology for computer tracking of human subjects protocols, secure record retention, electronic protocol submission. (b) Development of system to permit the "cradle to grave" monitoring of investigational drugs on campus (c) Implementation of an accreditation system to ensure continuing adherence to high standards of human subjects oversight The first two enhancements will permit closer tracking of research protocols, including monitoring investigational drugs. The first enhancement will also permit the IRB's and their support arm, the Compliance Office, to automate a number of essential but labor- and time-intensive operations, such as preparation of agendas, minutes and investigator memos, as well as establishing a direct link to the study sites for real time communication of IRB decisions and reporting of adverse events. The third component, by initiating regular accreditation, will permit the IRB/Compliance operations to be continually upgraded and maintained at the industry standard level for protection of human study volunteers.