Cost of Institutional Review Board Procedures in Multicenter Observational Research, The

Background: In recent years, there has been significant controversy over how institutional review board (IRB) procedures are structured, administered, and balanced against other concerns (for example, the feasibility of multicenter research). Formal economic analysis has been largely absent in these debates. With hospitals and research facilities under budgetary pressures, it is essential that cost-effective IRB systems be developed.

Objective: To estimate the cost of IRB procedures in an eight-site observational substance abuse treatment study.

Methods and Findings: We estimated the cost of each IRB "action" (initial reviews, continuing reviews, amendments, and adverse event reports) at each project site using a method that has been described in detail elsewhere. In brief, a national administrative database on IRBs was consulted to determine the estimated total cost of operating IRBs of various sizes. These total costs comprised personnel, space, supplies, and training. Dividing these total costs by the total number of actions conducted per year by an IRB yielded a cost per action. When these data were used as a reference point, each of the eight IRBs in our study was estimated to have a cost per action equal to that of IRBs of a comparable size in the national database.

All study procedures for the substance abuse treatment study were approved by our local university IRB. Nevertheless, the IRBs at each of the eight participating medical centers elected to conduct an independent, full-board review of the research protocol. The focus of our economic study was the costs of these "supplemental" IRB actions. In other words, how much money was expended on further reviewing the study after the home IRB had approved the project?

Expenditures for the supplemental IRB activities were estimated at $56 191 in 2001 dollars. This consumed 16.8% of the total research grant budget for all activities (recruiting sites, enrolling and interviewing participants, analyzing data) over the same period. Most of these costs ($29 824) reflected the IRBs' expenditures for 70 supplemental actions. Coordinating center personnel, space, and supply costs made up the second largest expense, at $16 951. The additional effort for the investigators at the eight participating sites totaled $9416.

Discussion: The high costs of IRBs were driven by several factors. First, our home IRB and committees at local sites frequently disagreed on the formatting of consent procedures and patient survey forms, and all expected final say on study implementation. This resulted in consent forms and patient survey instruments being reviewed and re-reviewed many times. Second, participating institutions required review both by hospital and affiliated university IRBs. We believe this redundancy was due to fear generated by recent high-profile cases in which research institutions were penalized for human subjects violations. Third, our coordinating center was often not allowed to directly contact IRB staff at the participating sites, nor would the nine IRBs involved (including our home IRB) communicate with each other. Coordinating center staff thus spent long periods translating and retransmitting information to IRB staff and local investigators scattered throughout the country, which slowed and sometimes garbled communication.

Conclusion: These extensive IRB procedures had no discernible impact on human subjects protection. The essential procedures of the study never changed substantially, despite exchanges of over 15 000 pages of material among the nine sites. In addition, as an empirical matter, no adverse incidents occurred among the participants. Researchers and policymakers should weigh the cost and benefits of multisite review for minimal-risk studies, such as observational health services research. The National Cancer Institute's centralized IRB for multisite phase III trials is an intriguing model. Other systems exist, although none has explicitly discussed minimal-risk studies. If costs such as those identified in this project continue to grow without consideration of the benefits of facilitating scientific projects, we worry that future research may be unjustly affected.