Institutional Data and Safety Monitoring Board (IDSMB)

In response to NIH policies, the IRB at the University of Pittsburgh has stipulated that all clinical research projects that are submitted for IRB approval must have an appropriate plan for data and safety monitoring. In some cases, this will require periodic review of study data by an independent review committee. Many sponsoring agencies will have such DSMBs built into their clinical protocols, but OCR has established an institutional DSMB for those projects that require but don't have in place an independent review board. In addition, OCR, through its contacts with the IRB, is available to advise clinical researchers about the need for a DSMB prior to the submission of a protocol to the IRB.