Institutional review boards (IRBs) have been criticized for overstepping their authority by requiring research protocols to meet requirements that go beyond regulatory approval criteria. The youngest National Cancer Institute (NCI) central IRB (CIRB), the Cancer Prevention and Control (CPC) CIRB, was studied with the NCI Stipulation Analysis Review Tool (StART), which categorized 1,049 stipulations in 51 determination letters covering 30 approved protocols. NCI StART reduced the potential for subjective uncertainty in assessing the wide range of content in the stipulations. The tool determined the board functioned in accordance with federal mandates, with 80% of rendered stipulations aligning with IRB approval criteria. A complementary article provides background data and findings from the first 3 years’ experience of the CPC CIRB.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.