Relationship to the Institutional Review Board

The Protocol Review and Monitoring Committee (PRMC) is charged to review all clinical cancer protocols proposed at the University of Vermont prior to initiation and on an ongoing basis, with full institutional authority to prevent activation of protocols that are deemed unacceptable and to close or suspend active protocols that do not meet standards for performance or safety. The Clinical Research Oversight Committee (CROC) had performed ongoing review for accrual and for relevance to the University of Vermont Cancer Center's goals. CROC will be replaced with a new committee in the winter of 2016.

The University of Vermont Institutional Review Board (IRB) supports two committees through which cancer-related research is reviewed: 1) the Committee on Human Research in the Medical Sciences (CHRMS) and 2) the Committee on Human Research in the Behavioral Sciences (CHRBS). The former is the committee through which all treatment and prevention trials are reviewed, and the latter through which most cancer control/ behavioral research is reviewed. The relationship between PRMC and IRB is collegial and is facilitated by written exchange. The PRMC and IRB are considered to perform complementary rather than sequential or identical functions. Although IRB submission and review is not a precondition, a cancer-related protocol cannot be activated within the Institution unless both committees approve it. When the IRB reviews a cancer-related protocol, an "Approval" must be received from the University of Vermont Cancer Center's PRMC prior to accrual of any subjects or commencement of any part of the protocol. Failure to accept the conditions of joint approval can result in immediate suspension of the protocol by either committee.

Relationship/Interface of PRMC and IRB Scientific Review and Oversight

As previously stated the relationship and interface between the Cancer Center's Protocol Review and Monitoring Committee and the IRB is complimentary but not overlapping. In its review, the PRMC considers factors that the IRB does not consider, such as relevance to the Center's programmatic goals as well as availability and demand on Cancer Center resources. In general, the IRB focuses on the informed consent and the risk/benefits to human subjects rather than scientific merit or programmatic or institutional priority. 

With regard to Oversight, the PRMC, through the Cancer Center's Office of Clinical Research and Clinical Research Management Core, is intimately involved in monitoring studies on an ongoing basis. Investigators are required to submit Quarterly Reports to the UVMCC office. This allows periodic monitoring for low or excessive accrual based upon stated accrual objectives. The ongoing monitoring done by the IRB includes the submission of an annual report to include any significant changes in the protocol/consent and accrual.