Evaluation is more important than categorization

This scenario exemplifies a common debate: to what pain category does a study belong? For this study, satisfactory arguments can be made for classifying animals into either category D or E; the authors’ knee jerk reaction is to label it E for the same reasons voiced by Dr. Collins. But we suggest instead that we should argue the utility of classifying pain in non-USDA covered species. Unless assignment to a pain category dictates specific care, monitoring, or interventions, categorization is not directly relevant to the charge of the IACUC: to ensure the wellbeing of animals used in research. The IACUC should focus on helping the investigator develop plans to learn how the device will affect the animal, and for managing the animals through thorough protocol review, veterinary involvement, and post-approval monitoring¹.

This should start with information gathering during protocol review. Has the PI (or his or her staff) performed this procedure before, and are their clinical outcomes consistent with the video evidence recounted by Dr. Villanueva? Have adverse consequences occurred, including early removal from study? If personnel are not experienced, can clinical or histologic outcomes of practice animals be used to develop monitoring and intervention criteria? A veterinarian should be involved in the review of these responses with the IACUC, as well as care of the practice animals to help evaluate animal outcomes. He or she can then propose criteria for interventions, and train lab personnel in recognizing those criteria. Finally, the IACUC can employ post-approval monitoring to evaluate outcomes. Do animals exhibit signs of good welfare, and is there evidence of veterinary involvement and support? Have there been adverse outcomes? These questions illustrate the process that we propose is the crux of the issue: how to provide for the welfare of animals undergoing a procedure that may or may not cause chronic pain or distress. We believe the answer lies in a premeditated but fluid approach to evaluate and intervene based on outcomes, aims, and communication.

But at the Great Eastern University, a pain category must be named. If one relies on USDA examples by procedure, we propose the mesh insertion would fall into D, as it subjectively feels similar to survival surgery, orbital blood collection, and needle biopsy². The presence of the exiting wire could approximate the category E example of ocular or skin irritancy testing if we assume the exiting wire is irritating, though we do not know this would be painful or distressing². The case for category E could be strengthened depending on the animals’ cumulative experience. Even if the mesh insertion is the most severe procedure proposed, it alone should not dictate the pain category since factors like single housing, repeated anesthesia or restraint, or a specific phenotype can contribute to this classification.

Regardless of what categorization the IACUC agrees upon, we maintain that the more critical aspect of this scenario is the actions taken by the IACUC, the veterinary team, and the research staff to protect the welfare of the animals used in the study.