All studies involving human subjects that may be included within the definition of "oncology-related clinical trials" must be reviewed and approved by the Protocol Review Committee (PRC) of the University of Miami's Sylvester Comprehensive Cancer Center (SCCC). The SCCC functions as a matrix cancer center in the University of Miami's Miller School of Medicine.
The Protocol Review Committee of the SCCC serves as an evaluating body for the scientific quality of cancer-related studies, involving therapy and/or prevention. PRC review and approval are a prerequisite to consideration by the IRB. In this regard, the PRC functions as a required "ancillary committee" and the policy applies that studies may not be submitted to the IRB until all applicable "ancillary committee" approvals have been given.
The PRC is charged by the SCCC with the responsibility to ensure that studies conducted under the auspices of the SCCC meet peer-review standards for scientific rationale, specific aims, study endpoints and design, proposed analysis, ability to accrue subjects, adverse event reporting requirements, and plans for data and safety monitoring. The PRC reviews all proposed clinical trials for scientific merit with the exception of those designated as exempt on the basis of external peer review, such as those sponsored by designated cooperative groups.
The PRC also assigns a level of risk (low, moderate or high) to institutional trials that will be monitored internally by the Data and Safety Monitoring Committee (DSMC). This risk rating determines the frequency of DSMC review. The PRC also determines any exceptional requirements for specialized expertise in conducting DSMC reviews.
The requirement for PRC review/approval applies to (but is not limited to) all prospective, therapeutic trials that involve interventions such as chemotherapy, surgery, radiation therapy, immunotherapy, gene therapy, hormonal therapy, complementary therapy, or any combination thereof for which a UM faculty member serves as principal investigator.
The requirement for PRC review/approval does not apply to studies involving human subjects when these studies have only a behavioral or rehabilitative intervention. The policy also does not apply to studies that involve solely quality of life outcomes from standard therapies.