In response to the issues posed in this scenario, the U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS) and the National Institutes of Health Office of Laboratory Animal Welfare (NIH-OLAW) provide the following clarifications.

In this scenario, a veterinary resident found a cat abandoned on the premises of the veterinary school and placed it on a clinical trial to study a new cardiomyopathy treatment without the facility’s or the principal investigator’s knowledge. The resident also implemented a treatment regimen that was not in accordance with the protocol of the clinical trial and left the animal housed in its original carrier overnight.

Response from USDA-APHIS

Under the AWA regulations, a research facility that obtains dogs and cats from sources other than dealers, exhibitors, and exempt persons shall hold the animal for 5 full days, which does not include the day of acquisition and the time in transit before use in the facility1. In addition, research facilities are required to create and maintain accurate acquisition and disposition records on dogs and cats2. In this scenario, the resident should have informed the facility of the abandoned animal so the date of acquisition could be recorded and the 5 day holding period implemented. The holding period is especially important in this scenario because there was no verification of abandonment. If the cat remained unclaimed after holding, it would become property of the institution and therefore receive an official USDA tag or tattoo in accordance with the regulations3. Placing the animal on study without implementing a holding period is out of compliance with the regulatory requirements. In addition, leaving the cat in the carrier overnight, when the cat is not in transit, is not in compliance with the regulatory requirements for primary enclosures4.

After review and investigation of the concerns involving the care of this animal and the conduct of this activity, the IACUC must determine the appropriate actions to correct the non-compliance and prevent further recurrence. Reporting the action to USDA is required if the IACUC elects to suspend the activity.

Response from NIH-OLAW

Institutions must implement the PHS Policy for all activities involving animals supported by Department of Health and Human Services (HHS) agencies and must ensure that other activities with animals do not affect or pose risks to PHS supported activities5. In addition to HHS agencies, the National Science Foundation (NSF), the Department of Veterans Affairs (DVA) and the National Aeronautics and Space Administration (NASA) have agreements for OLAW to provide oversight of their funded activities involving animals.

In this incident, the clinical trial is not federally funded. However, the behavior of the resident indicates a serious programmatic training failure at the veterinary school and is thus reportable to OLAW6. Under the Memorandum of Understanding between NIH and USDA, OLAW would inform the USDA of the reported noncompliance related to cats, whether the activity is covered under the AWA regulations or not7. The suspension by the IACUC of an individual’s privileges to conduct animal research is not always reportable to OLAW. It is reportable if the reason for the suspension involves serious noncompliance6. If in doubt about whether an incident must be reported, institutions are encouraged to contact OLAW to discuss the details and receive guidance on what and whether to report.