In response to the issues posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) provides the following clarifications:

In this scenario, a PI proposes to test a drug to treat osteosarcoma in canines in an NIH-funded study. The study proposal describes in detail all aspects of the experiment that will be conducted after amputation of the affected limb. However, it does not describe the amputation procedure. When asked to include the amputation procedure during administrative pre-review by the IACUC office, the investigator declines, replying that this request exceeds IACUC authority, as the standard of care SOP will be followed. The scenario asks, “How should the IACUC handle the situation?” However, the key question is whether the amputation procedure must be included in the protocol.

The IACUC is responsible for the welfare of each animal in the research study.1 Amputation is an integral part of the study and the IACUC must have all the information on procedures to be performed on the animal to evaluate animal welfare. Additionally, it would be necessary to know which anesthetics, analgesics, and fluids were used as well as physiological parameters assessed during surgery, if unexpected complications occur during the research study.

The PI may provide details of the amputation procedure within the protocol or may simply reference the veterinary school SOP for details of the procedure. As described by reviewers, this “helps reduce regulatory burden for investigators, while providing the IACUC the necessary details of the procedures performed.” The IACUC may review and accept the established written standard of veterinary care for the surgery and incorporate it in the protocol.