What is a central IRB?
The federal IRB regulatory requirements evolved at a time when most clinical trials were conducted at a single study site or at a small number of sites. In the intervening years, however, there has been substantial growth in the volume of multi-center trials and the size and complexity of late-stage clinical trials. An IRB that provides review services for multiple sites participating in a trial is considered to be a “central” IRB, while an IRB that provides review only for the researchers of its organization is considered to be a “local” IRB. A large trial might have an independent IRB serving as the central IRB and providing review services for multiple sites (especially nonaffiliated sites) at the same time as one or more local IRBs are providing review services for the researchers of their organizations participating in the same trial. An independent IRB frequently acts as a central IRB for multisite trials. However, the role of a central IRB also can be filled by an institutionall
The federal IRB regulatory requirements evolved at a time when most clinical trials were conducted at a single study site or at a small number of sites. In the intervening years, however, there has been substantial growth in the volume of multi-center trials and the size and complexity of late-stage clinical trials. An IRB that provides review services for multiple sites participating in a trial is considered to be a “central” IRB, while an IRB that provides review only for the researchers of its organization is considered to be a “local” IRB. A large trial might have an independent IRB serving as the central IRB and providing review services for multiple sites (especially nonaffiliated sites) at the same time as one or more local IRBs are providing review services for the researchers of their organizations participating in the same trial. An independent IRB frequently acts as a central IRB for multisite trials. However, the role of a central IRB also can be filled by an institutionall