All cancer clinical trials at the University of Iowa Holden Comprehensive Cancer Center must be reviewed and approved by the Holden Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC). No investigator may have access to Cancer Center patients or resources without approval of the PRMC. All Cancer Center intramural studies, industry trials, or cooperative group studies require sanctioning by the PRMC.
Interventional studies utilizing cancer center resources or enrolling cancer center patients require review and approval by the PRMC. PRMC submission typically requires a separate written protocol document which is reviewed by scientific, biostatistician, and Pharmacy and Therapeutics reviewers. Protocol development and navigation assistance is available within HCCC’s Clinical Research Services (CRS). To request protocol development assistance, please complete the following request: Investigator-Initiated Protocol Development Survey
The purpose of the review is to:
- conduct a scientific review 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; and
- determine prioritization of patient referrals to competing protocols.
The National Cancer Institute (NCI) has additional reporting requirements for projects involving cancer. Enrollment information for studies that do not use HCCC resources may still need to be reported to the NCI via the Cancer Center. All HawkIRB applications for studies that involve the treatment, detection, supportive care, prevention, or observation of cancer should respond “Yes” to Section V.22 of the application. PRMC administrative staff will screen the application to determine and communicate applicable reporting requirements to the research team.
The project will not be scheduled for UI IRB review until the project is approved by the PRMC.
You should continue to submit your HawkIRB application concurrently with your PRMC application. The following memo outlines this review policy: PRMC/IRB Review Policy Memo
Refer to the HCCC website for more information.
Direct questions to:
Cena Jones Bitterman, MPP, CIP, CCRP
Clinical Trials Research Manager