title: International analysis of institutional review boards registered with the u.s. Office for human research protections.
abstract: INSTITUTIONAL REVIEW BOARDS form the backbone of the human subject protection system. Yet little is known about the characteristics of these committees. This study compiles and analyzes the data on 1,326 IRBs in 113 countries registered with the Office for Human Research Protections. The study analyzes data on the following IRB characteristics: institutional affiliation, number of full-time administrative positions, approximate total number of protocols, and number of currently active protocols supported by DHHS or regulated by the Food and Drug Administration. The analysis found that the most common IRB profile is to be affiliated with a clinical organization (41.9% of IRBs) and to have one full-time staff member (40.0%). Regarding protocol volume, the most common IRB profile was to have 26-99 currently active protocols (42.0% of IRBs), to have 1-25 DHHS protocols (46.6%), and 1-25 FDA-regulated protocols (45.6%). Further analyses reveal considerable differences among countries. This study can provide a baseline for future IRB evaluations.
authors.affiliation: U.S. Office for Human Research Protections.
authors.forename: Edward E
authors.initials: EE
authors.lastname: Bartlett