Human Subjects Issues and IRB Review in Practice-Based Research

Article Figures & Data

Table 1.

Centralized Review Models

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