Data and safety monitoring plays an essential role in ensuring integrity of research and the safety of human subjects. The KUMC Data and Safety Monitoring Board (DSMB) was established in July 2001 to oversee the conduct of studies referred by the Human Subjects Committee, the Conflict of Interest Committee and the Associate Vice Chancellor for Compliance. In April 2006, data and safety monitoring at KUMC was reorganized to provide more protocol-content experts for each study being monitored. Now, the DSM-EC provides multi-disciplinary, independent oversight of research by reviewing the monitoring conducted by individual, protocol-specific DSMBs.
Data and safety monitoring is particularly appropriate for high-risk research and for studies in which the investigator and/or the institution may have a real or potential conflict of interest. KUMC researchers may request oversight by the KUMC DSM-EC through the Associate Vice Chancellor for Compliance.