Maybe it was because of his years in the military, but whatever the reason, Dr. John Allington was a straight shooter. He expected that his research would be performed according to his IACUC-approved protocol, without any deviations. So, when one of Allington's technicians made an error that resulted in about an hour of moderate-intensity pain to a dog, Allington went directly to the Great Eastern University IACUC with a full explanation of what happened. Either the technician, who had performed epidural analgesia many times before, had not placed the catheter quite properly, or the catheter had migrated after its placement, but within an hour after surgery (which was performed under propofol anesthesia), the technician recognized that something was wrong and that the animal was experiencing far more pain than anticipated. The technician informed Allington and the veterinary staff of the problem, and then administered supplemental analgesia.

Although the study, as approved by the IACUC, had been placed in USDA annual report category D (alleviated pain or distress), all concerned parties agreed that, in view of the problem that had occurred, a change to USDA category E (unalleviated pain or distress) was appropriate because of the “more than momentary” unalleviated pain or distress. An investigation by the IACUC revealed that the entire experiment had been carried out according to the protocol, that personnel were properly trained, and that the animal had been properly observed postoperatively. Nevertheless, the recognition of the problem took a little time, because the general process of recovery from the general anesthetic had masked some of the early signs of postoperative pain. The IACUC decided that this incident was simply an unfortunate aberration and that no further action was required.

Some months later, during a routine USDA inspection, Dr. Shana Madela, the USDA Veterinary Medical Officer (VMO), was reading Allington's protocol and discovered what had happened. She confirmed the facts with the IACUC office, took issue with the IACUC's conclusion, and on her report stated that Section 2.32(a) of the Animal Welfare Act Regulations had been violated because Allington's technician had not been properly trained in epidural analgesia techniques. The Attending Veterinarian (AV) strongly objected and produced training records to document that the technician had been adequately trained. Furthermore, the AV noted that many other animals had undergone the same procedure with the same technician providing the epidural analgesia, and there were no adverse incidents reported. Madela was unimpressed, claiming that the proof of the problem was in the clinical record and the IACUC's decision to investigate the incident. The school, she said, could always write a rebuttal letter explaining its position. Madela's supervisor subsequently upheld her actions.

Not only were the administrators at Great Eastern University annoyed at Madela's actions, but they also believed that this incident might lead to public scrutiny of the inspection report but not of any rebuttal that might be sent. Do you think that Great Eastern made the right decisions along the way? Would Great Eastern be wiser to accept the citation without any further comment, or would it be better for the school to pursue the issue to whatever conclusion was reached?

Response to Protocol Review Scenario: Training opportunity missed

Response to Protocol Review Scenario: Stand your ground

Response to Protocol Review Scenario: Agree to disagree

Response to Protocol Review Scenario: A word from USDA