. "3 Back to Basics: A Scientific, Conflict of Interest, and Ethical Review of Research Protocols." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
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Responsible Research: A Systems Approach to Protecting Research Participants
Research ERB Conflicts of Interest
Research ERBs themselves can also have conflicts of interest at multiple levels. Critics have charged that academic IRBs, by virtue of their constitution and location, are too close to the scientific community whose research they review and that their role has shifted from protecting research participants to protecting the research institution (Annas, 1991; Francis, 1996). Eventually, as the HRPPP system continues to evolve, it may be desirable for Research ERBs to become structurally independent, without any institutional links to academic centers or other research organizations. Although the process of forming independent IRBs has already begun,8 substantial restructuring of the present system undoubtedly will take several years. In the meantime, it is essential for Research ERBs within academic centers to protect and maintain their independence within organizational structures in order to reduce the risk that participant protections will be compromised by institutional interests. To signify the importance of this realignment, the committee encourages academic centers and other constituencies in the research community to begin to structure their IRBs as “independent” review boards rather than “institutional” review boards in addition to renaming the board, as suggested in Recommendation 3.1. Such a change in vocabulary will not by itself eliminate the potential for conflict when research organizations utilize internal Research ERBs within their HRPPPs. However, it may encourage the development of structural mechanisms that would insulate Research ERB operations from institutional power structures as the broader discussion concerning the appropriateness of moving to a system that utilizes completely unaffiliated and wholly independent Research ERBs develops.
Beyond the structural relationship of Research ERBs to research organizations, conflict of interest can occur at the individual member level. Members of these bodies, particularly when the board is located at an academic research institution, may have ties to the researchers whose proposals they are reviewing; they may have concern for an institution’s financial well-being and reputation; or they may have an excessive faith in science that could be harmful to human participants if potential consequences are overlooked. One possible way to address this problem is to ensure that the Research ERB has sufficient representation of members from the nonscientific and noninstitutional communities (NBAC, 2001b; Levinsky, 2002; also see Recommendation 3.5). An increase in the percent-
In addition to commercial IRBs, there are also examples of academic centers or regional research facilities coming together to form IRB consortia. Well-known examples of academic consortia include the Multicenter Academic Clinical Research Organization (MACRO) and the Biomedical Research Alliance of New York (BRANY).