The Cost of Institutional Review Boards in Academic Medical Centers
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《新英格兰医药杂志》
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.2,3,4 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 1. Total cost was correlated with total protocol volume (=0.61, P<0.001) and with the number of new protocols (=0.52, P<0.001).
Table 1. Estimated Median Costs of Institutional Review Boards at U.S. Medical Schools in 2002.
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.3,4,5 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
References
Department of Health and Human Services, Institutional review boards: a time for reform. Washington, D.C.: Office of Inspector General, 1998. (DHHS publication no. OEI-01-97-00193.)
Institute of Medicine. Responsible research: a systems approach to protecting research participants. Washington, D.C.: National Academies Press, 2002.
Brown JHU, Schoenfield LS, Allan PW. The costs of an institutional review board. J Med Educ 1979;54:294-299.
Wagner TH, Bhandari A, Chadwick GL, Nelson DK. The cost of operating institutional review boards (IRBs). Acad Med 2003;78:638-644.
Wagner TH, Cruz AME, Chadwick GL. Economies of scale in institutional review boards. Med Care 2004;42:817-823.
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 1. Total cost was correlated with total protocol volume (=0.61, P<0.001) and with the number of new protocols (=0.52, P<0.001).
Table 1. Estimated Median Costs of Institutional Review Boards at U.S. Medical Schools in 2002.
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.3,4,5 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
References
Department of Health and Human Services, Institutional review boards: a time for reform. Washington, D.C.: Office of Inspector General, 1998. (DHHS publication no. OEI-01-97-00193.)
Institute of Medicine. Responsible research: a systems approach to protecting research participants. Washington, D.C.: National Academies Press, 2002.
Brown JHU, Schoenfield LS, Allan PW. The costs of an institutional review board. J Med Educ 1979;54:294-299.
Wagner TH, Bhandari A, Chadwick GL, Nelson DK. The cost of operating institutional review boards (IRBs). Acad Med 2003;78:638-644.
Wagner TH, Cruz AME, Chadwick GL. Economies of scale in institutional review boards. Med Care 2004;42:817-823.