The Institutional Data and Safety Monitoring Board (I-DSMB) is a standing committee available to provide independent oversight for human research studies conducted by WFBH or WFBH-affiliated faculty.
Details
- An independent Data and Safety Monitoring Board may be needed for high-risk human research studies, for studies in which the investigator and/or the institution may have a potential conflict of interest, for studies involving vulnerable populations or for multi-site studies. I-DSMB members review on a regular basis study information pertaining especially to human subject safety and study integrity.
- The I-DSMB can provide oversight for appropriate WFBH investigator-initiated, locally conducted (single- or multi-site) clinical trials receiving NIH, departmental, or other non-industry support. The I-DSMB may also serve as the primary independent monitoring body for some trials sponsored by industry (a fee for monitoring services would be involved).
- I-DSMB members have expertise in clinical trial methodology and conduct, epidemiology, biostatistics, ethics, and clinical research. Ad hoc members may be invited to serve on the I-DSMB based on a need for unique expertise represented by regular members.