Correspondence
The Costs of Institutional Review Boards
N Engl J Med 2005; 353:315-317July 21, 2005
- Article
To the Editor:
The data that Sugarman et al. (April 28 issue)1 collected in 2002 seriously underestimate the current costs of human-research oversight. Since 2002, more than 75 percent of academic medical centers have begun preparing for, have applied for, or have achieved accreditation of their human-research protection programs (Speers M: personal communication). The self-study required by this process inevitably reveals deficiencies, and correction requires the investment of significant additional resources. Indeed, the accreditation process in itself may play an important role in eliminating the inadequate support for these programs that has been reported.2
Most research universities are unable to recover these costs (or those of related, unfunded federal mandates) from federal research sponsors because of the cap on administrative indirect costs imposed by the Office of Management and Budget in 1993. The cap is unfair and perverse: unfair, because it applies only to universities (and not to teaching hospitals, nonprofit research institutes, or for-profit research organizations), and perverse, because rather than promoting investment in strengthened institutional oversight, it is a negative incentive that most severely penalizes those institutions willing to go the extra mile in protecting human research subjects.
2 ReferencesHoward B. Dickler, M.D.
David Korn, M.D.
Association of American Medical Colleges, Washington, DC 20037
hdickler@aamc.org 1
Sugarman J ,Getz K ,Speckman JL ,Byrne MM ,Gerson J ,Emanuel EJ . The cost of institutional review boards in academic medical centers. N Engl J Med 2005;352:1825-1827
Full Text | Web of Science | Medline2
Department of Health and Human Services. Institutional review boards: a time for reform. Washington, D.C.: Office of Inspector General, June 1998. (OEI-01-97-00193).
To the Editor:
Sugarman et al. emphasize the financial burdens brought about by institutional review boards (IRBs), which are an important mechanism to protect human research participants. Whereas IRBs in the United States may be underfunded, resources for IRBs in the developing world are acutely scarce — a deficiency that we recently encountered firsthand in India. In many countries where active research involving human subjects is occurring, costs have come to present a major barrier to effective ethical review.1 Particularly because human subjects in developing nations are increasingly becoming the focus of studies originating in the United States and because ethical review by both the sponsoring institution and a local committee is important for ethical coherency,2 the academic community in the developed world is partially responsible for promoting a worldwide ethical-review infrastructure. This effort may, in turn, mean that institutions in developing nations will need to be educated about maintaining efficient IRBs or, in some cases, that independent, systemic financial support will need to be provided. Science and ethics are integrally linked; it is essential that effective IRBs be supported wherever research involving human subjects occurs.
2 ReferencesSuneel Bhat
Princeton University, Princeton, NJ 08544
sbhat@princeton.edu Timmanna T. Hegde, M.B., B.S.
Indian Medical Association, Kumta 581343, India1
Hyder AA ,Wali SA ,Khan AN ,Teoh NB ,Kass NE ,Dawson L . Ethical review of health research: a perspective from developing country researchers. J Med Ethics 2004;30:68-72
CrossRef | Web of Science | Medline2
Shapiro HT ,Meslin EM . Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med 2001;345:139-142
Full Text | Web of Science | Medline
Author/Editor Response
Determining the true costs of operating IRBs is a critical first step in identifying ways of reimbursing academic medical centers for this important activity. Dickler and Korn claim that in our letter we “seriously underestimate” the current costs of operating IRBs in academic medical centers. Perhaps we do, since our estimates represent a snapshot of costs at a single point in time; the costs of many things change, and there can be intermittent needs for increased spending. Indeed, Dickler and Korn suggest that we underestimate costs because of the substantial expense associated with voluntary accreditation and the concomitant recognition of the need to enhance IRB systems within institutions. In addition, for our index year, academic medical centers expended considerable effort in preparing for compliance with the Health Insurance Portability and Accountability Act, an effort that should be minimized in later years. Thus, it seems naive simply to assume that the costs of IRBs must be higher now. Rather, it would be helpful if actual data on this point were provided. Nevertheless, our work offers a benchmark to help guide academic medical centers, government sponsors, regulators, and others to determine what resources IRBs require. We welcome future efforts that measure the costs of IRBs longitudinally.
Regardless of the disagreement about the precision of our benchmark, Dickler and Korn raise an important issue regarding the ability of academic medical centers to recover the costs of IRBs. Data such as those we present in our letter should be helpful in bringing this and related reimbursement issues into focus.
Bhat and Hegde claim that IRB work in developing nations is often underfunded. Again, it would be helpful to have actual data on the current levels of funding and the costs of this activity, which is aimed at being a key mechanism for ensuring the protection of research participants in these settings. Until there are better data regarding the true costs of IRB oversight in developing countries, our benchmarks may provide a means for estimating the time needed for oversight and thus help international organizations and sponsors establish appropriate levels of support for it.
Jeremy Sugarman, M.D., M.P.H.
Johns Hopkins University, Baltimore, MD 21202Ezekiel J. Emanuel, M.D., Ph.D.
National Institutes of Health, Bethesda, MD 20892for the Consortium to Examine Clinical Research Ethics
