Sam Eagle, DVM, a veterinary neurologist, was the deal-maker at the Great Eastern University veterinary school, a USDA-registered and NIH/OLAW-Assured institution that included all vertebrate animals, no matter the funding source for the research in which they were used, in its Assurance. Eagle had friends in all the nearby pharmaceutical companies and human hospitals, and so it was not surprising when he convinced Southedge Hospital, a tertiary care facility, to agree to carry out computed axial tomography (CAT) scans on dogs that came through the veterinary school's small animal clinic and were suspected of having had a stroke. There would be no charge to the animals' owners, as long as they also consented to have periodic functional magnetic resonance imaging (fMRI) studies on their dogs at Southedge, also at no charge to the owners. The initial CAT scan was diagnostic, but the fMRI studies were for Eagle's research and were paid for by Eagle's Everice Foundation grant.

The IACUC at Great Eastern was fully aware of Eagle's collaboration with Southedge and willingly allowed the veterinary school's Clinical Trials Committee to review and oversee Eagle's work at the human hospital. The rationale from the IACUC was that the animals were privately owned and the CAT scans were for diagnostic purposes. As for the fMRI studies, the IACUC took the position that they may have clinical utility, although Eagle proudly advertised it as his research. On the other hand, the school's veterinarians were frustrated that there was no IACUC oversight for exactly the same reason: Eagle readily stated that it was part of his research. Furthermore, the veterinarians did not consider the anesthesia needed for the fMRI studies to be innocuous; rather, they saw it as a potentially dangerous aspect of a research activity that had no direct benefit to the dogs. Eagle neither agreed nor disagreed with them. He said that it was just a matter of personal opinion and that he had no opinion at all on the issue.

What do you think? Is Eagle's work with privately owned animals a clinical study that was really designed for research purposes, or is it a pure clinical study as the Great Eastern IACUC claims? In the former instance, is IACUC approval needed? If so, should approval come from the veterinary school's IACUC, or does Southedge Hospital need to be registered with the USDA and have its own IACUC?

Response to Protocol Review Scenario: IACUC should review

Response to Protocol Review Scenario: Clinical, not research

Response to Protocol Review Scenario: A word from OLAW and USDA

Response to Protocol Review Scenario: Needs IACUC oversight