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.
Membership
Effective 7/1/2019
- Chair - Xiaoyan Iris Leng, MD, PhD
- Vice Chair - Thomas Wesley Templeton, MD
- Nancy King, JD
- Anna Snavely
- Kate Hayden, PhD
- Leon Lenchik, MD, PhD
- Clancy Clark, MD
- Capri Foy, PhD
- Heidi Munger Clary, MD, MPH
- Arjun B. "Raja" Chatterjee, MD, MS, FACP, FCCP, FAASM
- Wendy Moore, MD
- Chadwick Miller, MD
- Timothy Harwood
Ad Hoc Members
- Dr. Preston Miller
- Dr. Marina Nunez
- Dr. Jeffrey Rogers
- Dr. Brian Strittmatter
- Dr. Robert Evans
Ex Officio (without vote) Members
- Joseph Andrews, Director, PhD, MA, CIP Regulatory Affairs and Research Integrity Office
- Richard Weinberg, MD, Gastroenterology, IRB Executive Chair
- Brian Moore, MS, Director of IRB and Human Research Protection Program
- Issis Kelly Pumarol, MD, Research Subject Advocate