A. The responsibilities of the IRB and the CPRC are distinct. The CPRC operates independently from the IRB. The CPRC collaborates with the IRB to assure a minimum of administrative overlap.

1. The CPRC/TI responsibility is that of scientific review and prioritization.
2. Review of consents and risk/benefit assessments are the purview of the IRB.
3. Issues of risk may be discussed within the CPRC/TI, but do not form the basis of Committee approval/disapproval.
4. Clinical cancer research protocols approved by the CPRC/TI will be reviewed for safety, ethical considerations and quality control by the IRB.

B. Clinical cancer research protocols may be submitted simultaneously to the CPRC/TI and the IRB. The IRB will be notified by the CPRC/TI when the committee has approved a protocol.

C. Approval by the CPRC/TI and the IRB is required before any cancer-related clinical research protocol is activated.