Session number: 1119
Abstract title: The cost of operating institutional review boards (IRBs)
Author(s):
TH Wagner - VA Health Economics Resource Center
Stanford University
A Bhandari - University of California at Berkeley
GL Chadwick - University of Rochester
DK Nelson - University of North Carolina at Chapel Hill
Objectives: There are increasing concerns that institutional review boards (IRBs) are not keeping human subjects out of harms way, and many have requested more funding. This study estimated the actual costs for operating low-volume and high-volume IRBs, thus providing information on economies of scale. To see the degree to which IRBs are under funded, we used suggested staffing benchmarks to estimate "adequate" costs.
Methods: Actual IRB costs were calculated from summary data. Personnel effort was based on a report that surveyed all IRBs with a multiple projects assurance in 1995. Supplies, training and capital costs were estimated by interviewing a convenience sample of IRB directors. Adequate IRB cost estimates used the same summary information, but we constrained the number of personnel to adhere to staffing benchmarks.
Results: The estimated actual cost per action at the high-volume IRB was almost one fifth that of the low-volume IRB ($319 vs $1,460, respectively). As expected, the adequate cost estimates for the high-volume and low-volume IRBs were greater than the actual costs: $549, and $2,026 per action, respectively.
Conclusions: We find evidence for economies of scale in the operation of IRBs. In addition, our estimates of adequate costs, while limited, suggest that both high-volume and low-volume IRBs are under funded. These findings are particularly important for VA medical centers, which combined involve over 110 large and small IRBs.
Impact statement: The options for increasing funding to IRBs are fraught with problems. Adding regulatory requirements may help quality, but they will disproportionately affect low-volume IRBs. More research is needed on the factors that contribute to quality so that IRBs do not shave quality to compete on prices. Policy debates should consider creative ways, such as regional cooperatives, to harness the economies of scale without giving up local oversight.