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SDR 07-353 – HSR Study

SDR 07-353
The Cost and Benefits of the VA Central Institutional Review Board
Todd H. Wagner, PhD
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, CA
Funding Period: May 2008 - April 2011
Most research organizations have created their own institutionally-based local institutional review board (local IRB) to oversee research involving human subjects. In recent years, federal regulators have temporarily halted research at several organizations for human subjects violations. One alternative system that has been suggested by researchers and ethicists is the use of centralized IRBs. The VA designed its own central IRB and we assessed the costs and benefits of the VA Central IRB relative to local IRB review.

Our specific aims were to:
1. Assess whether the VA Central IRB reduces researcher's effort (hours) for a review
2. Assess whether the VA Central IRB reduces timing (days) from submission to approval of a review
3. Compare the estimated costs of IRB work between the VA Central IRB and local IRBs
4. Collect data on researcher perceptions of IRBs

We followed all multi-site research protocols funded by ORD after January 1, 2008 for one year (or until annual review approval). We surveyed researchers to determine effort, timing and perceptions following each IRB approval. The researcher consent rate was 52% (41 who used their local IRB and 77 who used the VA Central IRB).

There were no significant differences in hours of effort for investigators who used the VA Central IRB or local IRBs. Differences in elapsed time (days) were also not significantly different. Perceptions of the Central IRB and local IRBs were similar and largely positive.

We expect these data will provide researchers, policymakers, and the VA Central IRB with greater information on how to best protect human subjects while simultaneously expediting research.

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Journal Articles

  1. Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J. Costs and benefits of the national cancer institute central institutional review board. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2010 Feb 1; 28(4):662-6. [view]

DRA: Health Systems
DRE: none
Keywords: none
MeSH Terms: none

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