Relationship to the Institutional Review Board
The Protocol Review Committee (PRC) 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) performs ongoing review for accrual and for relevance to VCC goals.
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 PRC and IRB is collegial and is facilitated by both written exchange of minutes and by membership on CHRMS of a member of PRC (currently Ms. Luebbers, RN). The PRC and IRB are considered to perform complementary rather than sequential or identical functions. Although IRB submission and review is not a pre-condition, a cancer-related protocol cannot be activated within the Institution unless both committees approve it. When the IRB reviews and approves a cancer-related protocol, the IRB Approval Letter sent to the investigator includes a statement that an "Approval to Activate" must be received from the VCC 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 PRC and IRB Scientific Review and Oversight
As previously stated the relationship and interface between the Cancer Center's Protocol Review Committee and the IRB is complimentary but not overlapping. In its review, the PRC considers factors that the IRB does not consider, such as relevance to Center and programmatic goals and 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. Notably, the IRB administrator (Ms. Stalnaker) is a member of the VCC Clinical Research Oversight Committee.
With regard to Oversight, the PRC, 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 register all patients through the Study Manager database. This allows a real-time evaluation of accrual and monitoring for low or excessive accrual based upon stated accrual objectives. Chart audits are conducted on all studies that are not externally monitored. 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.
Last modified February 13 2013 12:43 PM