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Investigator Resources

Information for Research Participants
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Institutional Review Boards
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
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

19.1 The Central IRB (CIRB) of the National Cancer Institute


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 20, 2007



19.1(a) General Principles

19.1(a) General Principles

In consultation with the Department of Health and Human Services Office for Human Research Protections (OHRP), the National Cancer Institute implemented a Central IRB (CIRB).  This is designed to reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants.  Use of the CIRB facilitated review mechanism is available to investigators seeking to enroll subjects into adult and pediatric, national, multi-center (Cooperative group) cancer treatment trials. 

The Adult CIRB has been meeting twice monthly and reviewing clinical trials since January 2001.  The Adult Board currently reviews all Phase 3 Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies opened in the Cancer Trials Support Unit (CTSU).  The Pediatric CIRB was constituted in June 2004 and began meeting in November 2004.  It reviews all NCI-approved COG Phase 2, 3, and Pilot protocols.   Both Boards are composed of individuals who represent a broad range of oncology scientific and nonscientific disciplines. 

The NCI CIRB processes are incorporated into the UM IRB policies and procedures per approval by both organizations.  This permits participating investigators to log into the CIRB website and submit studies for CIRB review as outlined in the NIC CIRB Operations Office Standard Operating Procedures.  The CIRB may take one of the following actions for each study:  approve, approve pending modification, table or disapprove.  After approval or disapproval, the Study Chair of the Cooperative Group shall be formally notified.

For each study, the CIRB's primary reviews, minutes, notification letters, and any other correspondence are posted in its web site for participating institutions to access.

In addition to conducting initial reviews, the CIRB conducts Continuing Reviews and reviews of Serious Adverse Events (SAEs), Data Safety Monitoring Board (DSMB) reports, protocol amendments, national subject recruiting materials, etc. These actions are also posted on the CIRB web site for access by participating institutions.



19.1(b) UM Review Procedures Pre- and Post-CIRB Review

19.1(b) UM Review Procedures Pre- and Post-CIRB Review

In addition to UM IRB requirements, policies of the UM Sylvester Cancer Center (SCCC) must be followed in the submission of studies, amendments, continuing reports and other items for CIRB approval (see above).  In brief, investigators must receive approval from the SCCC Protocol Review Committee prior to submitting the study or other items to CIRB.  Once the SCCC-PRC has approved, the study or item may be submitted to CIRB and a “short-form” version of the study or item must be forwarded to the HSRO.  If the study or item is approved by CIRB, the HSRO shall be so notified by the CIRB and the information from CIRB and the HSRO shall be processed for facilitated UM IRB review as required. 

Amendments to an approved study need not be reviewed by the UM IRB.  Following CIRB approval of a study, continuing report or final report, however, facilitated UM IRB review shall be conducted by the UM IRB chair or designees.  A goal of this review is to determine whether there are local concerns that need to be addressed and whether to accept the CIRB review as constituting approval by the UM IRB.  This requires that the UM reviewer examine the submitted study materials including the protocol and informed consent documents to confirm that they are appropriate to the local context.

The UM reviewer may make the following determinations:

1)  Accept the CIRB review without modifications

2)  Accept the CIRB review "with modification to the protocol and/or consent form".  Although no CIRB approved information may be deleted from the consent document, the UM reviewer may make minor word substitutions or additions to facilitate local comprehension and make also add information on additional risks. 

3)  Not accept the CIRB review.  This shall occur if the reviewer believes that revisions/changes to the protocol or consent documents are more than those described above and require full board review at the local level.  Once a CIRB review is deferred to the UM IRB, the CIRB shall not serve as the serve as the IRB of record for the study at the UM site. 

If the CIRB review is accepted, CIRB will become the IRB of record for the protocol.  CIRB will review amendments, non-local SAEs, and continuing reports for this study and will take all necessary actions.  These reviews will be posted on the CIRB website.  If the CIRB review is deferred to UM IRB, the UM IRB rather than CIRB will be the IRB of record for this study.  The UM IRB shall be responsible for review of local SAE’s and for oversight of local conduct of the study.



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