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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
Western IRB (WIRB)
About the HSRO

Basic Folder Information

18.1 Sylvester Comprehensive Cancer Center Protocol Review Committee (PRC)

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

February 24, 2006

18.1 Sylvester Comprehensive Cancer Center Protocol Review Committee

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.


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