National Cancer Institute Central Institutional Review Board (NCI CIRB)

UW-Madison requirements and procedures for deferring studies to the NCI CIRB

The National Cancer Institute Central Institutional Review Board (NCI CIRB) provides centralized IRB oversight for institutions conducting certain cooperative group oncology trials. The University of Wisconsin - Madison has agreed to defer IRB review of eligible protocols to the NCI CIRB.

See the documents below for information about UW-Madison requirements and procedures related to the NCI CIRB.

The primary UW-Madison contact for questions regarding the NCI CIRB is Mike Bingham, Commercial IRB Specialist, in the Health Sciences IRBs Office.

News and Announcements

Required use of NCI CIRB
Since 2006, UWCCC study teams conducting cooperative group oncology research have had the option to use the Adult NCI CIRB for Phase 3 cooperative group studies. UW-Madison's use of the NCI CIRB expanded to include pediatric studies in 2012.

In 2013 the NCI CIRB adopted an independent review model, similar to that used by the Western IRB. With this change in the CIRB's practice, UW-Madison also revised its expectations regarding use of the CIRB. UW investigators intending to conduct a clinical trial that has been reviewed and approved by an NCI CIRB are now required to use the CIRB as the IRB of record for the study. When planning to conduct any NCI-sponsored cooperative group trial, UW-Madison study teams should consult the NCI CIRB website to see if the trial is listed on the menu of CIRB-approved trials. The menu is available using the "studies" link on the NCI CIRB homepage (title/group and current status only) or by logging in to the Participant's Area (registered users only; all study-related documents available).

UW-Madison review required prior to submission to NCI CIRB
At UW-Madison, investigators planning to conduct a study for which the NCI CIRB can serve as the IRB of record must first undergo review in the UW's Health Sciences IRB Office. This review is to ensure compliance with institutional requirements that are not assessed by the CIRB's Local Context Subcommittee.

Highlights of UW-Madison submission and review for NCI CIRB studies
UW-Madison procedures for NCI CIRB studies have changed to accommodate the CIRB's new independent review model. Major changes include:
    • New studies for deferral to the NCI CIRB must be submitted to the Health Sciences IRBs Office for compliance review using an abbreviated ARROW application.
    • o Changes to UW personnel, changes to HIPAA authorizations, and study closures must be submitted for review in ARROW.
    • Once the NCI CIRB becomes the IRB of record for a study, no UW IRB review of continuing reviews or amendments is required. 
    • Locally-occurring reportable events must be submitted to the NCI CIRB in accordance with their requirements.

Guidance Documents

New guidance documents are being created as the transition to the independent review model proceeds. Documents may also be revised as the new procedures are being refined.

National Cancer Institute Central IRB (NCI CIRB) Basics

Keywords:NCI CIRB, National Cancer Institute, central IRB, cooperative group, oncology, UWCCC, defer, CIRB forms, CIRB continuing review   Doc ID:19695
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-08-10 19:00 CDTUpdated:2015-10-13 15:16 CDT
Sites:Health Sciences IRBs
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