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Institutional Data Safety & Monitoring Board

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 of 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 will 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.

Cost

I-DSMB is available to provide oversight and monitoring for human research studies conducted by WFBMC and WFBMC-affiliated faculty investigators. The cost is $78 per hour. 

Contact Information

Issis Kelly Pumarol: ikellypu@wakehealth.edu | 336-716-8372

We especially encourage you to consider your clinical research study monitoring needs during the grant or IRB pre-submission phase of your study.

Membership

Effective 7/1/2016

  • Dr. Kaycee Sink, Chair
  • Dr. Capri Foy, Vice Chair
  • Dr. James Thompson
  • Dr. Claudia Campos
  • Dr. Nkechinyere Emejuaiwe
  • Dr. Mahta McKee
  • Dr. Chadwick Miller
  • Professor Nancy King
  • Dr. Haiying Chen
  • Dr. Thomas Wesley Templeton
  • Dr. Wei Lang
  • Dr. Xiauyan Iris Leng
  • Dr. Mustafa Saad Siddiqui

Ad hoc members:

  • Dr. Preston Miller (for monitoring artificial skin study in burn patients)
  • Dr. Marina Nunez (Dr. Atala transplant trial)
  • Dr. Jeffrey Rogers (Dr. Atala transplant trial)
  • Dr. Brian Strittmatter (as needed for pharmaceutical trials)

Ex officio (without vote) members:

  • Dr. Richard Weinberg, MD, IRB Executive Chair; Gastroenterology
  • Dr. Joseph Andrews, PHD, MA, CIP, Director of IRB and Human Research Protection Program
  • Ms. Paula Means, MPA, Assistant Dean for Research

New to Research?


Review Getting Started with Clinical Research for tips and guidance on conducting clinical research at Wake Forest.

Register to Be Involved

Be Involved is an opportunity for volunteers to learn more about clinical studies conducted at Wake Forest Baptist Medical Center. Be involved in changing the future of health care. Register today.