HUMAN SUBJECTS RESEARCH ENHANCEMENTS PROGRAM

University Of Hawaii At Manoa, Honolulu HI

Investigators

Abstract

-The Human Subjects Research Enhancements Program is intended to provide the means for sustainable improvements to the Univerity's program for the oversight of human subjects in research. The first goal of this project will significantly advance the system-wide education program for students, faculty and research personnel through additional training of current personnel and the acquisition of support resources. This first element of the project will also provide the basis for ensuring the long lasting ability to maintain program adherence to relevant federal requirements and guidelines through the development of comprehensive and up-to-date set of policies and procedures. The second goal is to improve the computer-based ability to track research projects, maintain a log of active projects and associated approval periods, provide timely notice to investigators of pending expiration dates, and be able to monitor adverse events related to specific protocols. A sub aim is to create an integrated system that builds on the current structure of the University's IRB and creates a formal mechanism to conduct periodic data safety monitoring and reporting under the IRB's oversight authority. These two elements will also provide the infrastructure to support the development of a cooperative IRB panel based at the University of Hawaii that includes the other major research institutions in our state: a single IRB for university-based, multi-site, cooperative research protocols and clinical trials. The third goal of this project is to support the creation and implementation of an active compliance program at the University medical school. The primary objective of this goal is to provide initial support to focus the activities of the medical school compliance office on the needs of the university with respect to having a comprehensive and effective data safety monitoring system for clinical trials conducted at UH. This will be the administrative component of the DSMB system established at UH; the IRB will provide the oversight authority and responsibility.