What studies will be monitored by the KUMC DSM-EC?
The DSM-EC will monitor studies referred by the Human Subjects Committee (HSC), the Conflict of Interest Committee (COIC) and the Associate Vice Chancellor for Compliance (AVC-C). KUMC investigators may also request oversight by the KUMC DSM-EC through the AVC-C. 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 potential conflict of interest.
How does the KUMC DSM-EC interface with a protocol-specific KUMC Data and Safety Monitoring Board (DSMB)?
The DSM-EC provides multi-disciplinary, independent oversight of research studies conducted by University of Kansas Medical Center (KUMC) faculty. Members of the DSM-EC work with the investigator to develop a data and safety monitoring plan which is reviewed at a full DSM-EC meeting. An important part of the plan is to establish a protocol-specific DSMB for the investigator's study. This DSMB will be comprised of two content experts and a statistician and will meet on a schedule appropriate to the level of monitoring required by the study. The DSMB reports its recommendations to the DSM-EC following each meeting. If the DSM-EC concurs with the DSMB's recommendations, these are forwarded to the referral source and the HSC if not the referral source. If the DSM-EC has questions, these might be sent to the DSMB and/or the investigator.