This scenario raises two main questions: was Ballantine's method of castration humane, and why was Ballantine, as a swine consultant, not more involved in the development of the protocol?

There are several points to consider in answering the first question. First, the position statement of the Association for Assessment and Accreditation of Laboratory Animal Care International (http://www.aaalac.org/accreditation/positionstatements.cfm#ag) that the IACUC member quoted refers to husbandry and housing standards, not to veterinary procedures and is not relevant in determining how castration should be done by the veterinarian. Second, Ballantine alluded to the Guide for the Care and Use of Laboratory Animals1 (the Guide) as stating that castration “usually doesn't cause much pain” because it is a minor procedure. However, the Guide does not specifically say that castration does not cause pain but rather states that animals do not show significant signs of post-operative pain with minor procedures like castrations1. Furthermore, the Guide for the Care and Use of Agricultural Animals in Research and Teaching indicates that castration is considered to cause clear signs of pain and discomfort in pigs that can result in behavior changes2. Finally, Ballantine would have been willing to provide additional anesthesia, as he himself stated, “If you wanted me to use an anesthetic you should have said so.” His statements tell us more about what he is used to doing rather than what is humane. So, was his method humane? Administration of local anesthetics can reduce both behavioral and physiological responses of piglets to castration3. If a refinement to an existing method is able to reduce pain and distress, then the old method would not be considered humane. Proper justification would be needed in order for the IACUC to approve a study in which piglets are castrated without administration of a local anesthetic. Such justification should ideally be determined in collaboration with Ballantine.

That brings up the second question of why Ballantine was not involved in this veterinary decision in the first place. Because Conquer Pharmaceuticals is not an NIH Assured institution, its IACUC needs only three members, as defined by the Animal Welfare Act regulations, one of them being a veterinarian trained in laboratory animal medicine4. Perhaps a different veterinarian was in charge of developing this protocol, explaining why Ballantine was not legally required to be a part of the process.

The Guide makes it very clear that all personnel, including consulting veterinarians, must have adequate training in laboratory animal science1, which should include information regarding IACUC protocol review. It is the IACUC's responsibility to ensure that Ballantine understands what is expected to take place in an approved procedure. His failure to follow the protocol constitutes an oversight on the part of the IACUC as well as on his part. Ballantine should have followed the protocol or requested an amendment.

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