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. 2008 Dec;3(4):57-69.
doi: 10.1525/jer.2008.3.4.57.

Survey of u.s. Human research protection organizations: workload and membership

Joseph A Catania  1 , Bernard Lo, Leslie E Wolf, M Margaret Dolcini, Lance M Pollack, Judith C Barker, Stacey Wertlieb, Jeff Henne
Affiliations

Survey of u.s. Human research protection organizations: workload and membership

Joseph A Catania et al. J Empir Res Hum Res Ethics. 2008 Dec.

Abstract

IN A NATIONAL SURVEY OF INSTITUTIONS with federally assured human research protection programs, we obtained workload and other relevant data on their Institutional Review Boards (IRBs) and management organizations. The number of IRBs increased substantially from 1995 to 2005/06 (491 to 2,728 IRBs) with a further increase in 2008 to 3,853 IRBs. Nationally, IRBs reviewed over a quarter million research applications in the year prior to our survey, of which 35% were new applications requiring full committee review. Compared to estimates from 1995, current IRBs review more new and full committee review applications, but the relative percentage of new and full committee applications remained about the same. High volume research institutions have IRBs with a substantially larger per person workload, relative to smaller volume IRBs (i.e., members spent nearly seven times more hours reviewing new applications outside formal committee meetings). Virtually all IRBs included community representatives as members (92%); however, a small number may not be compliant with federal regulations. The present findings suggest the need for research to (a) examine workload and its effects on review quality, research costs, and faculty morale, (b) develop methods for determining optimal fit between IRB workload demands and institutional labor and financing requirements, (c) construct benchmarks for judging reasonable workload for individual IRB members, and (d) examine if the need to recruit IRB scientific expertise from outside the institution, particularly true for smaller research institutions, causes delays in IRB review, and if a more effective way of locating and recruiting experts would improve quality and time to completion.

Keywords: IRB Survey; structure; workload.

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References

    1. American Association of University Professors Research on human subjects: Academic freedom and the institutional review board. 2006 Retrieved November 1, 2006 from http://aaup.org/AAUP/comm/rep/A/humansubs.htm.
    1. Bell J, Whiton J, Connelly S. Evaluation of NIH implementation of section 491 of the Public Health Service Act, mandating a program of protection for research subjects. U.S. Department of Health and Human Services; Washington, D.C.: 1998.
    1. Bledsoe CH, Sherin B, Galinsky AG, Headley NM, Heimer CA, Kjeldgaard E, et al. Regulating creativity: Research and survival in the IRB iron cage. Northwestern University Law Review. 2007;101(2):593–641.
    1. Campbell E, Weissman J, Clarridge B, Yucel R, Causino N, Blumenthal D. Characteristics of medical school faculty members serving on institutional review boards: Results of a national survey. Academy of Medicine. 2003;78:831–836. - PubMed
    1. Citro CF, Ilgen DR, Marrett CB. Protecting participants and facilitating social and behavioral sciences research. National Academies Press; Washington, D.C.: 2003.

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