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.

A Rare Opportunity: Examining the Experience of a New Institutional Review Board

“…Thus, the NCI developed the Stipulation Analysis Review Tool (NCI StART) and used the tool to code the stipulations in the CIRB determination letters to assess whether the board was exhibiting signs of excessive scope creep or wordsmithing, two behaviors often attributed to IRBs by investigators. The process of developing the tool and the outcomes of this review are described in the companion article by Rooney et al (Rooney, Covington, Dedier & Samuel, 2019).…”

“…This census data will serve as a baseline “point in time” observation against which data from this board can be compared in the future. In addition to this overall observation, a second article about this board’s early experience by Rooney et al takes a closer look at the nature and quality of the stipulations issued by this board (Rooney, Covington, Dedier & Samuel, 2019). The second purpose of this article is to add to the body of knowledge regarding the dynamics, experiences, challenges, and early outcomes of constituting a new IRB.…”

“…Notwithstanding these numerous challenges, little has been documented about the dynamics and outcomes of constituting an entirely new IRB even though the number of new IRBs registered with the U.S. Department of Health and Human Services Office of Human Research Protections (OHRP) has steadily increased from 326 in 2014 to 438 in Rooney et al takes a closer look at the nature and quality of the stipulations issued by this board (Rooney, Covington, Dedier & Samuel, 2019). The second purpose of this article is to add to the body of knowledge regarding the dynamics, experiences, challenges, and early outcomes of constituting a new IRB.…”