Gradual adaptation of her rats to a restraint device seemed a logical and obvious strategy to Dr. Julia Marshall, a neurophysiologist at Great Eastern University. Her research focused on ocular responses to external stimuli, and her methodology required that the head of each rat that she used be immobile, although the remainder of the torso did not require full restraint. Her IACUC-approved adaptation protocol had three steps: first, a rat was placed into an empty plastic restraint tube once a day for three days; second, the rat was anesthetized and allowed to awaken in the tube once a day for three days; finally, the rat was lightly anesthetized, its head placed in a special restrainer within the plastic tube, and again allowed to awaken in the restrained position once a day for three days. The rat would remain in the tube for 30 minutes during the first session, then 45 minutes for the second session and finally for 60 minutes at the last session. After the conditioning was completed, the study, which lasted five consecutive days, would begin. A total of 15 rats would be tested, all requiring head restraint.

Marshall had used the same basic protocol for many years without a problem. The occasional rat that did not adapt to the restraint device was excluded from her study. But just before the most recent testing session, Marshall's long-time research associate took ill, and the testing had to be delayed for a little over a week. The delay was quite obvious to the vivarium staff because the testing room was ready but unused. The attending veterinarian asked Marshall about her plans to 'readapt' the animals before the testing started, but Marshall said that wasn't necessary because the rats had already been adapted to the restraint procedure. The veterinarian could not find any literature about the length of time a rat could remain adapted to a restraint procedure after a break in a testing protocol. When Marshall also could not produce any documentation relative to her model, the issue was quickly given to the IACUC. Unfortunately, the IACUC could not locate an expert who could confirm or refute Marshall's opinion, and so the issue seemed to be headed for a stalemate.

What steps do you think the IACUC could or should take to resolve this problem?

Response to Protocol Review Scenario: Pilot study

Response to Protocol Review Scenario: Is the change significant?

Response to Protocol Review Scenario: IACUC observation team