The identification and engagement of independent data and safety monitoring resources has been challenging at UTMB and other UT Health Science campuses for many years. At the same time, the complexity and significance of research at the campuses have also increased, thereby enhancing the criticality of data and safety monitoring resources to protect patients and research data.
To that end, research leadership at UTMB has recently tasked the Interim AVP for Research Regulations to identify ways to fill this void and work with other UT Health Science campuses to establish a process for sharing faculty resources to serve as independent members of data and safety monitoring boards/data safety committees for high-risk studies.
We are pleased to announce the commencement of a UT System-wide Data and Safety Monitoring Board/Data Safety Committee (“DSMB/DSC”) initiative. UT Health Houston, UT Health San Antonio and UT System (the “Member Institutions”) have come together under the terms of a Memorandum of Understanding which outlines the manner in which a DSMB/DSC will be assembled at the request of a faculty member from any of the Member Institutions.
For example, a PI in the Department of Neurosurgery will be engaging in a complicated research study which requires a DSMB/DSC. He/she would contact the UTMB AVP for Research Regulations, who will reach out to their peers at the other Member Institutions and make a request for a senior neurosurgery faculty member as well as a biostatistician who has experience working on neurosurgery studies. The Member Institution representatives will identify possible independent candidates from their organization who have confirmed that they are willing to serve on the DSMB/DSC. The AVP for Research Regulations will then contact the PI to provide the names and contact information for the faculty members willing to serve.
Please keep in mind that faculty members requiring a DSMB/DSC will need to allocate budget dollars to serve as a stipend for the members serving on the DSMB/DSC.This amount will be negotiated between the PI of the study and the members of the DSMB/DSC.
This new resource hopefully will help to enhance research at UTMB and the other Member Institutions. Should you have any questions regarding this process, please contact the Interim AVP for Research Regulations, Lisa Murtha