Relationship to the Institutional Review Board

The Protocol Review and Monitoring Committee (PRMC) has the authority to approve and authorize activation of cancer related research within UVM and the University of Vermont Medical Center.  These studies should align with the scientific priorities of the University of Vermont Cancer Center (UVMCC).  The PRMC evaluates studies based on scientific merit, assigns priority based on recommendations from the Transdisciplinary Teams (TDTs), and approves prioritization of UVMCC resources in alignment with the UVMCC scientific mission.  The PRMC is responsible for continuing review of open studies, including monitoring trials progress (i.e., accruals), and continued scientific relevance.  The PRMC has the authority to terminate protocols that do not demonstrate adequate progress.  These decisions are communicated to the UVM Institutional Review Board. 


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 study cannot be activated within the Institution unless it is approved by both committees. 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 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. 

Regarding oversight, the PRMC, through the Cancer Center's Office of Clinical Research and Clinical Research Management Core, is charged with monitoring studies on an ongoing basis. Investigators are required to submit quarterly reports to the UVMCC CTO 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, patient safety and accrual.