Clearly, officials at Great Eastern are within their charge to refuse to approve the protocol if scientific merit is lacking. It is more difficult, however, actually to evaluate scientific merit.

The IACUC's merit review and approval of animal use, which is mandated by public policy, differs from merit studies done by funding agencies. One key consideration in IACUC review is whether or not the proposed work has sufficient scientific merit so that its cost in terms of animal use is outweighed by the value of knowledge potentially gained. The IACUC must remain cognizant of principles of humane animal use known as the 3 Rs1: replacement, reduction, and refinement. Furthermore, the Committee must evaluate each proposal reasonably on its own, without being unduly biased by a researcher's past successes or failures.

Does Vogelman's work have merit? Experts in the field have concluded that his research does not justify external funding and that it is not of publishable quality. Although he may be asking pertinent scientific questions, his methods cannot, according to colleagues and journal editors, provide any useful answer to those questions. Therefore, he has wasted the animals that he has used, even though he has been careful, flawless, humane, and meticulous. Because his work is not published, any results that he might obtain will not be disseminated to others in the field—necessitating repetition of the work that would violate the principleof reduction.

Does Vogelman's work have any redeeming value? His work could be significantly useful in training students on research models, experimental design, techniques, and animal care. However, the issue of using passé techniques then arises. Outmoded methods may not be accurate or sensitive enough to obtain reliable, reproducible data. It is the investigator's responsibility to seek current procedures that improve or replace those that are outdated, always with the goal of refinement. If students are trained with passé techniques, they then have the disadvantage of that limitation; this subverts the credibility of the training argument and detracts from the benefit side of the cost-to-benefit ratio.

Is it time for Vogelman's experiments to end? Because Vogelman's colleagues consider his techniques to be outmoded and because his research is not being published, the work does not seem to have adequate merit to justify continued IACUC approval for animal use. His questions about drug dependency may be scientifically valid, but if there is no realistic expectation that he will obtain answers to that question, then the costs of his work seem to outweigh the benefits.

The IACUC has a duty to end its sanction of Vogelman's work because of insufficient refinement as well as the lack of merit.