What is the National Cancer Institute Central IRB (NCI CIRB) "independent review model" and what does this mean for UW study teams?
NCI CIRB Frequently Asked Question
"Independent review model" refers to the approach used by the NCI CIRB to review and provide regulatory oversight for studies under its purview. Independent review replaces the facilitated review approach used until 2012. The main difference between the two approaches is that, under the independent review model, the NCI CIRB serves as the sole IRB of record, rather than sharing oversight with the IRB for each local site participating in a CIRB study. The HS-IRB Office determines whether a study is eligible for deferral to the CIRB.
What this means for UW study teams
- Transitioning to the NCI CIRB Independent Review Model in which UW Principal Investigators (PIs) were approved to conduct studies under NCI CIRB purview and current NCI CIRB studies were "rolled over" to use the new model
- UW study teams are required to use the NCI CIRB for all eligible studies.
- New studies are entered in ARROW to request deferral to the NCI CIRB, but the application is brief.
- UW PIs must submit forms required by the NCI CIRB.
- Once a study is deferred to the NCI CIRB, the CIRB is the IRB of record for that study; there is only limited review conducted by UW Health Sciences IRBs (HS-IRBs) Office to ensure adherence to local requirements. Continuing reviews and protocol amendments are reviewed and approved only by the NCI CIRB.
- Reportable events must be submitted to the NCI CIRB in accordance with their requirements.
What doesn't change
- Review by the UW Health Sciences IRBs Office is required before the UW is approved by the NCI CIRB as a participating site
- Changes to UW personnel must be submitted in ARROW
- Consent forms must include UW-required language
- UW Carbone Cancer Center compliance and monitoring requirements apply to all studies deferred to the NCI CIRB