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The Protocol Review and Monitoring Committee must review all cancer clinical trials at the University of Iowa Holden Comprehensive Cancer Center (HCCC). No investigator may have access to HCCC patients or resources without approval of the Protocol Review and Monitoring Committee. All HCCC intramural studies, industry trials, or cooperative group studies require sanctioning by the Protocol Review and Monitoring Committee.
The purpose of the Protocol Review and Monitoring Committee review is to:
- Conduct a scientific review (oncologic science, pharmacy & therapeutic science, and biostatistical science) of all proposed and ongoing institutional cancer clinical research.
- Monitor all clinical cancer research protocols for sufficient progress.
- Terminate those cancer protocols that are not achieving goals in a reasonable time frame; determine prioritization of patient referrals to competing protocols.
It is a requirement that an investigator have Protocol Review and Monitoring Committee approval prior to University of Iowa IRB or Western Institutional Review Board review. A Protocol Review and Monitoring Committee member who is an investigator or consultant on a protocol that the Protocol Review and Monitoring Committee reviews is required to identify their relationship to the protocol. They will be excused from the room while the protocol is being discussed and the vote taken. If the Protocol Review and Monitoring Committee Chair is an investigator or consultant on a protocol, the co-Chair will take over and the Chair will leave the meeting. In the event both the Chair and co-Chair have conflict of interest regarding the same protocol, the HCCC Executive Director will Chair the meeting. When a statistician has helped in the development of a protocol under consideration, an alternate statistician should review the protocol.