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Model Example Central Review Local Review IRB = institutional review board; CIRB = Central Institutional Review Board; NCI = National Cancer Institute; MACRO = Multicenter Academic Clinical Research Organization. Newly established national IRB CIRB: A national IRB of the NCI composed of people with cancer expertise across the country who are not NCI employees The CIRB conducts initial review of all NCI phase III cancer-related trials Local 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 IRBs MACRO: A consortium of 5 universities that collaborate on multisite trials A 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