Table 1.

Centralized Review Models

ModelExampleCentral ReviewLocal Review
IRB = institutional review board; CIRB = Central Institutional Review Board; NCI = National Cancer Institute; MACRO = Multicenter Academic Clinical Research Organization.
Newly established national IRBCIRB: A national IRB of the NCI composed of people with cancer expertise across the country who are not NCI employeesThe CIRB conducts initial review of all NCI phase III cancer-related trialsLocal IRB review occurs after CIRB review. Local IRBs may approve without changes, a “facilitated review,” or conduct their own review. Local IRBs, however, may not change the approved protocol—they can only disapprove participation researchers from their institution of
Designated primary IRB among a consortium of IRBsMACRO: A consortium of 5 universities that collaborate on multisite trialsA participating university IRB serves as the IRB of record for a given protocol (the assignment rotates among the 5)The IRBs of the 4 other universities conduct only administrative review (review with less than a full IRB committee) of the approved protocol to ensure that local issues have been addressed