Dr. John Smith, a distinguished investigator at Great Eastern University, had spent his career searching for a treatment for hearing loss. After 20 years of research, he developed a drug that could potentially improve auditory function after damage to the inner ear. The drug was administered by injection into the middle ear with the use of a fine needle inserted through the eardrum.

Smith submitted a protocol to the IACUC describing a small study on cats in which he would treat one group of animals with the drug and another with saline to determine whether the drug prevented the changes in the anatomy of the inner ear that normally occur with aging. After a discussion, the IACUC asked Smith to modify his experimental design such that each animal would act as its own control by injecting the drug into one ear and saline into the other. This design would reduce the number of animals required by 50%. To avoid controversy and lost time, Smith accepted the opinion of the IACUC and carried out the experiment subsequent to protocol approval.

The result of the initial study was quite promising, and Smith submitted a grant application to the National Institutes of Health (NIH) to fund a more complete examination of the effectiveness of his new drug. He proposed the same experimental design suggested by the IACUC, with each animal serving as its own control. The NIH reviewers were impressed by Smith's preliminary data but were seriously concerned about each animal serving as its own control. Because the drug was lipophilic, they argued that it was likely that some of the drug would be absorbed into the bloodstream and would indirectly affect the untreated ear. Still, the grant application received a very good score, but not quite good enough to be funded. Smith revised his grant according to the suggestions of the NIH reviewers and received an exceptional score when the application was reconsidered.

During the 'just-in-time' period, Smith submitted to the IACUC the protocol that related to his grant. Once again, the IACUC indicated he could eliminate 50% of the animals he proposed to use by using each animal as its own control. Smith stated in his communications to the IACUC that the design of the study was demanded by the NIH scientific review group that considered the grant and whose membership included leading experts in the field. He said that the review group raised a significant scientific concern about the experimental design stipulated by the IACUC in its effort to reduce animal usage. Smith received the same reply to all the arguments he made: “The IACUC has no obligation to consider the opinions of peer review panels, including NIH review groups, during its deliberations.”

Should Smith persevere, arguing that good science, not reduction of animal numbers, should prevail? Or should Smith capitulate to the wishes of the IACUC? Do you think that the IACUC should consider the opinions of an external review panel during its deliberations?

Response to Protocol Review: Study section's opinion matters

Response to Protocol Review: IACUC overstepping its bounds

Response to Protocol Review: Help IACUC understand the science