In response to the issues posed in this scenario, the US 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 dog unexpectedly dies while undergoing an experimental cardiac surgical procedure and the institution’s IACUC must decide if the incident is reportable to USDA and NIH.

USDA-APHIS response

The issue in this scenario is whether the research facility is obligated to report to USDA an event involving a dog that died unexpectedly while undergoing an experimental cardiac surgical procedure.

There are four items research facilities are required to report to APHIS under the Animal Welfare Act (AWA) regulations: an annual report on animal usage1, a change of operation affecting its status as a research facility2, an animal activity suspension by the IACUC during a convened meeting with a quorum present3, and a failure to correct a significant deficiency identified by the IACUC during a semiannual inspection4. Here, the investigator voluntarily halted the study following the animal’s death to allow for review. The review determined that the veterinary technician followed the approved protocol for anesthetizing the animal, and that a properly serviced anesthetic vaporizer machine malfunctioned, leading to the animal’s death. Although there was some question about whether the veterinary technician independently monitored the animal’s depth of anesthesia beyond relying on the machine’s reported levels, under these circumstances, there is not a regulatory obligation to report the event.

However, a facility may elect to voluntarily report an incident to USDA. Voluntary reporting allows proactive identification, correction, and prevention of issues that may negatively impact animal welfare, and provides an opportunity for a research facility to keep its USDA inspector up-to-date on activities at the facility.

NIH-OLAW response

The IACUC conducted an investigation of the incident and found that the surgical procedures, anesthetic monitoring, and routine maintenance of the anesthetic equipment were all appropriate. They determined that the cause of death was due to a faulty anesthetic vaporizer. Adverse events such as this where an animal is harmed or dies as the result of equipment malfunction are considered reportable to OLAW5. If institutions with an OLAW-approved Animal Welfare Assurance are in doubt about whether an incident is reportable, OLAW encourages a preliminary call from an authorized institutional representative and will provide guidance on the specific circumstances. The incident does not meet the requirements for a suspension because Public Health Service Policy (IV.C.6) states that: “The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present”6.