. "6 Procedures for EPA Review of Intentional Human Dosing Studies." Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press, 2004.
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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues
studies are conducted at institutions that do not require IRB review of all research. Although it appears that all of the pesticide experiments reviewed by the committee were approved in advance by IRBs or their foreign equivalents, the committee believes that this decision should not be left to the discretion of the sponsors.
Recommendation 6-1:IRB Review of All Studies
EPA should require that all human research conducted for regulatory purposes be approved in advance by an appropriately constituted IRB or an acceptable foreign equivalent. Research conducted by EPA scientists should be reviewed by an EPA-authorized IRB.
EPA may wish to use FDA’s implementation of its equivalent of the Common Rule (21 CFR Part 50) as a guide for its adoption of such a requirement (see Chapter 2).
EPA itself has sponsored intentional human dosing studies. At least some of those experiments were approved by IRBs at the institutions that conducted the research. The committee was informed that EPA does not have an IRB, but instead has an Ethics Review Officer who typically ensures that EPA-sponsored or conducted studies undergo IRB review.
If all EPA-sponsored human research is conducted at nonfederal institutions and those institutions have appropriate IRBs operating in compliance with the Common Rule, the federal requirements might be satisfied. If EPA were to conduct human research in-house without prior IRB review, it would be violating the Common Rule.
The IRB that reviews EPA-sponsored research should contain the requisite expertise to review human dosing studies (as well as other human research in support of EPA’s mandate). In preparing this report, the committee spent considerable time assessing protocols that were submitted to EPA for registration purposes and that were made available to the committee and/or its staff. In reviewing these protocols, the committee was tasked with ascertaining the meaning and applicability, in the context of EPA research, of “procedures … which do not unnecessarily expose subjects to risk” (40 CFR 26.111(a) (1)) and “the importance of the knowledge that may reasonably be expected to result” (40 CFR 26.111(a) (2)). Despite the expertise of the toxicologists, clinicians, and biostatisticians on the committee, this was not an easy task, but it was one that led the committee to appreciate the difficulty of making these determinations. Thus, for EPA’s IRB to carry out its assigned duties in reviewing intentional human dosing studies, it must include members with the range of disciplines and perspectives and the array of skills needed for this task. This requirement is equally true for IRBs reviewing studies sponsored by or conducted by non-EPA institutions. All IRBs that undertake the review of intentional