The task at hand for the Great Eastern University IACUC was to evaluate a pilot study. Although research cost and career sustainability are valid concerns for investigators, neither should be the sole or a major factor influencing the IACUC's discussion. Assuming that the rabbit model was both scientifically justified and appropriate for Hampton's studies during the preceding two decades, the IACUC's deliberation of the pilot study request seems to be incomplete.

Irrespective of Hampton's incentive for developing a new model, the IACUC must require him to present a logical rationale for doing so, even for a pilot study1,2,3. Pilot studies are often discrete feasibility studies that are limited in animal number. Nevertheless, a proposed pilot study must be accompanied by a scientific rationale and a confirmation that it does not unnecessarily duplicate known work. Hampton's request should have included the intellectual basis for proposing that development of an alternative model is a logical approach to advancing the project in the face of limited resources and an adequate justification for the number of animals proposed to be included in the pilot study. The rationale could include physiological, anatomical or mechanical features of rodents; advantages and disadvantages of a rodent model; or the homologous and analogous characteristics of the relevant tissues and systems in rodents compared with rabbits, but it must provide enough information for the IACUC to determine whether the pilot study is justified. If the focus of the discussion was on the factors of cost and research program sustainability, then the IACUC's deliberations were not in keeping with its responsibilities.

If the pilot study is approved and Hampton later submits another protocol proposing to use additional animals to advance the model, then that request should include additional justification based on the pilot study results, with some indication as to whether the surgical manipulation of the femur could be duplicated and remain effective in the smaller animal. Such justification could include the potential for the rodent model to meet some or all of the project goals, including species-specific requirements; a discussion of the impact of combining data from different species on the interpretation, validity and quality of the data; and a description of the model's value toward advancing scientific knowledge and to society in the context of the principles of the 3Rs4.

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