Institutional Data & Safety Monitoring Board (I-DSMB)
The Wake Forest School of Medicine (WFSM) Institutional Data and Safety Monitoring Board (I-DSMB) is a Dean-appointed, multi-disciplinary, standing committee that provides independent oversight for human research studies conducted by WFSM or by WFSM-affiliated investigators. The I-DSMB can provide (at no cost) oversight for appropriate WFSM investigator-initiated, locally conducted (single- or multi-site) clinical research pilot studies receiving NIH, departmental, or other non-industry support. The I-DSMB can also serve as the primary independent monitoring body for full-scale trials sponsored either by NIH or by industry (a fee for monitoring services would be involved; see link below for further information). Clinical studies originating at institutional affiliates of WFSM (WFU Reynolda campus, Translational Science Institute affiliates) may also utilize the WFSM I-DSMB for their qualifying research studies.
An independent Data and Safety Monitoring Board (DSMB) 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. DSMB members review on a regular basis study information pertaining especially to human subject safety and study integrity.
For questions about the I-DSMB or about other study monitoring issues, please contact Dr. Abbie Eaton, firstname.lastname@example.org, phone: 336-716-9134. We especially encourage you to consider your clinical research study monitoring needs during the grant or IRB pre-submission phase of your study.
Further information about the I-DSMB: