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. 2010 Feb 1;28(4):662-6.
doi: 10.1200/JCO.2009.23.2470. Epub 2009 Oct 19.

Costs and benefits of the national cancer institute central institutional review board

Todd H Wagner  1 , Christine Murray, Jacquelyn Goldberg, Jeanne M Adler, Jeffrey Abrams
Affiliations

Costs and benefits of the national cancer institute central institutional review board

Todd H Wagner et al. J Clin Oncol. .

Abstract

Purpose: In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials.

Methods: We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective.

Results: CIRB affiliation was associated with faster reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savings of $717 per initial review. The estimated cost of running the CIRB was $161,000 per month. The CIRB yielded a net cost of approximately $55,000 per month from a societal perspective. Whether the CIRB results in higher or lower quality reviews was not assessed because there is no standard definition of review quality.

Conclusion: The CIRB was associated with decreases in investigator and IRB staff effort and faster protocol reviews, although savings would be higher if institutions used the CIRB as intended.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Break-even calculations for Central Institutional Review Board (CIRB) between March 2006 and May 2008, showing the number of initial reviews at CIRB and non-CIRB sites between March 2006 and May 2008. The horizontal dashed lines represent thresholds above which the CIRB had a net savings. The top dashed line assumes that all of the administrative costs of operating the adult and pediatric CIRB are borne by the adult CIRB. The bottom dashed line assumes adult and pediatric CIRBs share the administrative costs.
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