Correspondence

The Cost of Institutional Review Boards in Academic Medical Centers

N Engl J Med 2005; 352:1825-1827April 28, 2005

Article

To the Editor:

An important concern with respect to protecting human research participants is that institutional review boards (IRBs) have insufficient resources.1 However, there are few reports of the actual costs of IRB review.2-4 To estimate the cost of operating academic IRBs in 2002, we undertook a survey with the support of the Doris Duke Charitable Foundation and the Burroughs Wellcome Fund. We surveyed 121 U.S. medical schools with active IRBs; 63 representative institutions responded. Institutions documented the education, experience, and job titles of IRB staff; the composition of the IRB itself; the estimated amounts of time spent on various activities; the costs of equipment, supplies, travel, and space; and the use of outside services. Telephone interviews were then conducted. Activities were converted to costs with the use of nationally published wage rates, costs of office space, and other standardized cost figures.

Low-volume institutions (those with fewer than 350 new protocols per year) had on average 6 IRB staff members, and high-volume institutions (with 700 or more new protocols per year) had 14. The mean number of IRB panels was 1.8 in low-volume institutions and 4.1 in high-volume institutions. Fifteen percent of institutions outsourced some portion of the reviews — ranging from 2 to 378 protocols annually; 41 percent of new protocols underwent expedited review. Forty-three percent of institutions provided no monetary payments to IRB members.

On average, 29 percent of IRB staff time was spent on general administration, 27 percent on review and approval of protocols, 12 percent on monitoring of compliance, 11 percent on training, 9 percent on adverse-event reporting, 7 percent on compliance with the Health Insurance Portability and Accountability Act (HIPAA), and 5 percent on conflicts of interest. The time spent by IRB members on these activities was distributed in various ways. For instance, chairs and vice-chairs spent more than half their time on review and approval of protocols and less than 10 percent on each of the other activities.

Estimates of costs are displayed in Table 1Table 1Estimated Median Costs of Institutional Review Boards at U.S. Medical Schools in 2002.. Total cost was correlated with total protocol volume (ρ=0.61, P<0.001) and with the number of new protocols (ρ=0.52, P<0.001).

The median amount spent by academic medical centers for the system of protecting human research participants is nearly $750,000 per year, exceeding previously reported estimates based on older data or single institutions.3-5 As previously reported, there are economies of scale in IRB activities5; a greater volume of reviews can be conducted at a lower cost per protocol reviewed. However, efforts to enhance efficiency need to be assessed critically. Expedited review is used quite frequently, but it costs about the same as full protocol review. Although there are sound pragmatic reasons for the expedited-review procedures outlined in federal regulations, the reasons for this finding are unclear. Expedited review may be conducted by the chair or other members of IRBs who incur a relatively large opportunity cost.

Deliberations about the appropriate compensation of academic medical centers for IRB oversight should incorporate its true costs. Our data may be useful in preparing institutional budgets and securing adequate resources. Future research is needed to understand how these investments relate to the quality of IRB review and oversight and whether these investments are sufficient to meet the ethical goal of protecting participants in research with human subjects.

Jeremy Sugarman, M.D., M.P.H.
Johns Hopkins University, Baltimore, MD 21205

Kenneth Getz, M.S., M.B.A.
Tufts University, Medford, MA 02111

Jeanne L. Speckman, M.Sc.
Boston University, Boston, MA 02118

Margaret M. Byrne, Ph.D.
University of Miami, Miami, FL 33136

Jason Gerson
Johns Hopkins University, Baltimore, MD 21205

Ezekiel J. Emanuel, M.D., Ph.D.
National Institutes of Health, Bethesda, MD 20892

for the Consortium to Evaluate Clinical Research Ethics

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   J M Kramer, P B Smith, R M Califf. (2012) Impediments to Clinical Research in the United States. Clinical Pharmacology & Therapeutics
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   GEORGE SILBERMAN, KATHERINE L. KAHN. (2011) Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform. Milbank Quarterly 89:4, 599-627
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   Bernard Ravina, Lisa Deuel, Andrew Siderowf, E. Ray Dorsey. (2010) Local institutional review board (IRB) review of a multicenter trial: Local costs without local context. Annals of Neurology 67:2, 258-260
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   Scott Kim, Peter Ubel, Raymond De Vries. (2009) Pruning the regulatory tree. Nature 457:7229, 534-535
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   Scott Burris. (2008) Regulatory innovation in the governance of human subjects research: A cautionary tale and some modest proposals. Regulation & Governance 2:1, 65-84
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   Heidi Ledford. (2007) Human-subjects research: Trial and error. Nature 448:7153, 530-532
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   Kenneth De Ville, Gregory Hassler, Michael J. Lewis. (2007) Rejuvenating a Foundering Institutional Review Board: One Institution???s Story. Academic Medicine 82:1, 11-17
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   Robert J. Levine. (2006) Empirical Research to Evaluate Ethics Committees' Burdensome and Perhaps Unproductive Policies and Practices: A Proposal. Journal of Empirical Research on Human Research Ethics 1:3, 1-4
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   Margaret M. Byrne, Jeanne Speckman, Ken Getz, Jeremy Sugarman. (2006) Variability in the Costs of Institutional Review Board Oversight. Academic Medicine 81:8, 708-712
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    Page S. Morahan, Hisashi Yamagata, Sharon A. McDade, Rosalyn Richman, Ray Francis, Victoria C. Odhner. (2006) New Challenges Facing Interinstitutional Social Science and Educational Program Evaluation Research at Academic Health Centers: A Case Study from the ELAM Program. Academic Medicine 81:6, 527-534
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    Barbara E. Barnes, Charles P. Friedman, Jerome L. Rosenberg, Joanne Russell, Ari Beedle, Arthur S. Levine. (2006) Creating an Infrastructure for Training in the Responsible Conduct of Research: The University of Pittsburgh??s Experience. Academic Medicine 81:2, 119-127
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    Julio Sotelo. (2006) Regulation of Clinical Research Sponsored by Pharmaceutical Companies: A Proposal. PLoS Medicine 3:7, e306
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13. 13

    (2005) The Costs of Institutional Review Boards. New England Journal of Medicine 353:3, 315-317
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