Assessing the Quality and Performance of Human Research Protection Programs to Guide Compliance Oversight Activities.

Abstract

Routine on-site reviews should focus primarily on facilities that are at risk of harming human subjects. Using human research protection program performance metric data from 107 facilities, we defined a facility to be at risk when one of its noncompliance/incident rates was among the top three highest rates of that performance metric. Based on 14 performance metrics with noncompliance and incidents in 2017, 27 facilities were identified to be at risk. These 27 facilities at risk, while constituting only 25% of all facilities, contributed to 70% ± 25% ( M ± SD; range = 32%-100%) of all reported noncompliance/incidents. Thus, performance metric data can be used to guide compliance oversight activities.