For example, one seriously overlooked cost in providing participant protection is that of providing the highly skilled professionals who are required to staff, manage, and serve on IRBs the time necessary to perform their duties, and monetary compensation for their services. Evaluation of protocols requires a variety of skills and knowledge, ranging from technical scientific design expertise to a strong working knowledge of the ethical literature. Both senior staff and IRB members should be familiar with the potential participant communities that will be enrolled and affected by a particular study. Even assuming that an individual—or a collection of individuals— possesses the needed skills, a rigorous and thoughtful review of protocols will still be time consuming. In most academic settings, unfortunately, the time needed to participate in dedicated IRB service is not provided.

To help address these issues, IRB membership should be viewed as an institutional obligation, and those who serve on IRBs should receive release time from other job responsibilities without financial or academic penalty (similar to that provided for jury duty). Ideally, such coverage might also be extended to community representatives who serve on IRBs. At a minimum, research organizations should provide such allowances to their faculty members so that they have more time to participate in dedicated IRB efforts.

Few data have been published that quantify the costs of ethics review, making it difficult to determine reasonable compensation for offices or individuals involved in the process (NBAC, 2001b; Wagner, unpublished data).7 The committee once again stresses the need for data collection and applauds the efforts now under way by the Consortium to Examine Clinical Research Ethics at Duke University to systematically begin addressing this task (Duke University, 2002).

One existing model that might be instructive in estimating costs are for-profit and not-for-profit independent fee-for-service IRBs; their fee structure can provide some notion of what the private sector now pays for protocol review. Although the committee acknowledges that academic and nonacademic boards operate under different frameworks, because both must accomplish the same mandated tasks, some comparability exists.

In general, research is funded by NIH, the National Science Foundation, or other federal agencies, private foundations, or industry. The private sector generally pays for its initial and ongoing IRB review explicitly, and other sponsors should do so as well.

The committee anticipates that some government agencies will argue that the funds for obtaining ethical review of individual protocols are pro-

7  

RAND has published a report, “Paying for University Research Facilities and Administration,” that addresses the “indirect” cost issues of research, but not the costs of research involving human participants explicitly (Goldman, 2000).



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