This scenario raises the issue of an IACUC's authority to carry out scientific and technical reviews of animal research projects. The Animal Welfare Act and Regulations (AWARs)1 and Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals2 provide only limited guidance on this subject. The AWARs indicate that “except as specifically authorized by law or these regulations, nothing in this part shall be deemed to permit the Committee or IACUC to prescribe methods or set standards for the design, performance, or conduct of actual research or experimentation by a research facility.”1 Although the IACUC should evaluate the “rationale for involving animals, and for the appropriateness of the species and the numbers of animals to be used,”1 the IACUC does not have the authority to dictate a reduction in animal numbers, especially if Smith has provided a valid scientific justification for not using each animal as its own control. Similarly, PHS has indicated that review of “the scientific and technical merit of an application is considered the purview of the NIH Scientific Review Groups (SRGs)”, whereas “the IACUC is expected to include consideration of the US Government Principles in its review of protocols.”3 This guidance suggests that the IACUC should defer to the opinion of the external review panelists who are subject matter experts, especially because, in this case, the review panel is an NIH SRG.
Of further relevance in this situation is US Government Principle III4, which indicates that “the animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results.” Therefore, if it is not good science to use each animal as its own control, the IACUC should ensure that the number of animals being used will yield “valid results” rather than demand a further reduction in animal numbers that might invalidate the study. Using each animal as its own control might, on the surface, seem to reduce the number of animals used, but if the study has to be repeated with separate controls because both ears are affected by the drug, more animals will have to be used in the end.
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