National Cancer Institute Central IRB (NCI CIRB) Basics
What is the NCI CIRB?
The NCI CIRBs provide centralized IRB oversight for institutions conducting certain multi-site oncology trials. The Adult Late Phase IRB reviews all Phase 3 Cooperative Group trials from 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 Adult - Early Phase IRB (newly formed in 2013) reviews NCI-sponsored early pahse trials. The Pediatric IRB reviews all NCI-approved COG phase 2, 3, and pilot protocols.
How does UW-Madison use the NCI CIRB?
In 2006, the UW began offering study teams conducting cooperative group oncology research the option to use the Adult NCI CIRB. In 2012, the UW expanded its use of the NCI CIRB to include pediatric studies. Study teams had the option to request NCI CIRB facilitated review or to request UW IRB oversight. In 2013, in light of National Clinical Trials Network guidelines and the NCI CIRB's adoption of an independent review model, the UW now requires study teams to request deferral of IRB oversight to the NCI CIRB for all new oncology trials that have been approved by an NCI CIRB.
Which Studies are NOT Eligible for Deferral to an NCI CIRB?
- Studies not on the NCI CIRBs menu of approved trials (see www.ncicirb.org)
- Studies involving prisoners
- Studies involving VA subjects, VA facilities, or conducted as part of a VA appointment
- Studies for which UW study personnel have a financial conflict of interest
UW-Madison requirements for review of NCI CIRB studies
Study teams wishing to open a new study under NCI CIRB purview must:
- Obtain approval from the UW Carbone Cancer Center Protocol Review and Monitoring Committee
- Obtain agreement from the UW Health Sciences IRBs (HS-IRBs) Office for deferral of IRB oversight to the NCI CIRB
NOTE: In addition to IRB approval, study teams need institutional approval from the UW and the UW Hospital and Clinics (UWHC) to conduct research when either or both institutions are involved. When an internal IRB is used, the institutional approval is built into this IRB approval process. When an external IRB such as the NCI CIRB is used, however, this additional step to obtain institutional approval is needed; the Health Sciences IRBs Office will serve as a proxy for the UW institutional approval and will obtain approval from the UWHC as well when relevant. Under federal regulations, both the UW and UWHC retain institutional authority to decline approving the conduct of a research study even if IRB approval has been granted.
NCI CIRB requirements
Starting in 2013, each institution that uses the CIRB submits an annual description of state and local policies and guidelines that govern conduct of human subjects research and institutional procedures for monitoring research. In addition, each principal investigator (PI) conducting research under NCI CIRB oversight is required to submit an annual description of resources, staff, subject population, recruitment and informed consent processes, privacy and confidentiality practices, and other human subjects protections applicable to their research. The NCI CIRB also requires a study-specific description of local conduct for each trial a PI conducts under CIRB oversight. A subcommittee of the NCI CIRB ensures that PIs’ plans for study conduct are consistent with institutional and federal requirements for human subjects protection. Study teams must follow NCI CIRB requirements. See the NCI CIRB website (www.ncicirb.org) for more information.
How do UW Investigators Use the NCI CIRB Process?
- Follow UW-Madison Procedures for Using the National Cancer Institute Central Institutional Review Board (NCI CIRB) Independent Review Model for submitting a request for deferral to the NCI CIRB.
- See www.ncicirb.org for information about the CIRB Initiative, the “menu” of studies approved by the NCI CIRB, and detailed instructions for local study teams.