By Gary Stephenson
Johns Hopkins Medicine

Institutional review boards, the committees that oversee protections for human research participants, often come with a higher than expected price tag, according to results of a study published in the April 28 edition of the New England Journal of Medicine.

Researchers, led by Jeremy Sugarman, professor of bioethics and medicine at the Johns Hopkins Berman Bioethics Institute, examined data from 63 academic medical centers in the United States to assess the costs for running their IRBs. They found that the annual operating costs ranged from $171,014 to $4,705,333, with a median cost of $741,920.

"Previous reports tended to understate the true costs of IRBs," Sugarman said. "Our study demonstrates that institutions and policy-makers need to recognize the important role of the IRBs in protecting research participants so that they are not shortchanged."

To derive the full costs, the researchers calculated costs of salaries of IRB members, time spent on various IRB-related activities, the costs of office space, equipment, supplies and travel, and the use of outside services to facilitate and complement the work of the IRB. Low-volume institutions (fewer than 350 new research protocols reviewed by an IRB per year) had on average six IRB staff members, and high-volume centers (700 or more new protocols per year) had 14. The mean number of IRB panels in low-volume institutions was 1.8 and in high-volume institutions, 4.1.

Low-volume institutions had the lowest IRB costs, with a mean of $402,369. Intermediate-volume centers had a mean cost of $805,620, while high-volume institutions had the highest mean cost of $1,150,417 per year.

High-volume medical centers, while spending more for IRBs in total, did benefit from an economy of scale, Sugarman said. At these institutions, each IRB review averaged $431 vs. $644 at low-volume counterparts. Intermediate-volume centers' cost per IRB review was $612.

Other members of the team conducting the study included members of the Consortium to Examine Clinical Research Ethics, funded by the Doris Duke Charitable Foundation and the Burroughs Wellcome Fund, as well as researchers from Boston University and the University of Miami.

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