A clinical trial is usually done to determine the safety or efficacy of a diagnostic tool or treatment designed to be of benefit for a clinical condition in the research subject. Ideally, the procedure or drug should address the specific medical condition of and have some direct benefit to the animals enrolled. In this scenario, the dogs were chosen to participate in this study on the basis of clinical indications that they had suffered a stroke. As CAT scans are diagnostically useful in this scenario, this portion of the work could legitimately be considered a clinical procedure and be covered by the Clinical Trials Committee.
The subsequent fMRIs do not have any diagnostic or therapeutic merit, however, and the associated anesthesia poses a real risk to the dogs. The fMRI portion of this study should be considered research, just as Eagle has advertised. Although the Animal Welfare Act1 does not explicitly address the use of privately owned animals in research, the dogs in this study would meet the Animal Welfare Regulations' definition of “animal.” The Public Health Service requires research studies using species listed in the university's Animal Welfare Assurance to have IACUC approval; therefore, regardless of the USDA's position in this situation, Great Eastern's Public Health Service Assurance would dictate that this research be covered by an IACUC protocol2. A detailed informed consent document explaining the risks to the owners should also be evaluated during the IACUC review process.
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