Measuring IRB Regulatory Compliance: Development,Testing,and Use of the National Cancer Institute StART Tool

Abstract

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.

Keywords

IRB stipulations regulatory compliance tool clinical trials

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