This scenario describes equipment failure that unfortunately lead to the death of an animal. This falls under OLAW’s Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals1, which requires reporting of “conditions that jeopardize the health or wellbeing of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals”.

However, this scenario does not state whether the study is PHS funded; the IACUC would therefore need to refer to their Animal Welfare Assurance to determine their criteria for reporting to OLAW. If the study was not funded by PHS and the institution’s Assurance states that only PHS-funded studies need be reported, then no reporting is required. However, if the Assurance is vaguely written, the institution should report this incident to OLAW. Under OLAW’s Guidance, “Reporting promptly to OLAW under IV.F.3 serves dual purposes. Foremost, it ensures that institutions deliberately address and correct situations that affect animal welfare, PHS supported research, and compliance with the Policy. In addition, it enables OLAW to monitor the institution's animal care and use program oversight under the Policy, evaluate allegations of noncompliance, and assess the effectiveness of PHS policies and procedures”.

Even though the IACUC investigation determined that this incident was not the result of a noncompliance or an animal welfare concern, there are benefits to reporting. The institution can describe how they have conscientiously addressed and corrected the issues related to this accident, including interviewing all personnel involved, having the machine re-inspected by its manufacturer, and reviewing the protocol to ensure compliance with actions taken during the surgery. By describing the investigative process, this demonstrates to OLAW that the institution is following processes outlined in their Animal Welfare Assurance and is committed to maintaining high standards in their program. Additionally, OLAW representatives can provide further guidance, if warranted, on follow up activities to prevent future issues.

Many institutions may see reporting to OLAW as a negative to their animal care and use program. They might for example worry about increased attention from activist groups or feel burdened by extra administrative work due to internal processes involved with reporting. But reporting can provide positive interactions with external regulatory agencies that are intended to assist institutions with maintaining compliance with animal welfare regulations. The veterinarians should recommend that the incident be reported to OLAW, including all the steps taken to ensure that appropriate processes were in place and functioning at the time of the event. The reporting of this incident should be discussed with the IACUC and the Institutional Officer as well.

Finally, a voluntary halt of studies is not the same as a suspension. A vote to suspend the protocol would require a convened IACUC meeting with a quorum of members. Therefore, this voluntary halt would not be reportable to the USDA.