Definitions and Categories

We have heard considerable discussion today about the current USDA definition and protocol categorization based on anticipated pain and distress. I agree with speakers who have argued that the current definitions are flawed. I believe part of the flaw is the focus on process rather than outcome. For example, the categorization includes such variables as the use of analgesia or anesthesia, rather than simply asking the more simple (and important) question of whether a proposed protocol would involve an element of animal pain and distress. In this respect, I believe the approach of the Humane Society of the United States, simply to classify pain and distress according to three categories of outcome, represents an improvement. It is important to have a process whereby investigators, veterinarians, and IACUCs assess protocols and monitor research in an effort to minimize pain and distress.

Dr. Haywood admonished us earlier today to keep it simple. I agree completely. Laboratory animals are best served by a simple classification that speaks exclusively to the outcome. We need to use simple words that all of us generally understand and can apply in global assessment, as opposed to overdefining or overquantifying such variables as temporal and intensity issues. I believe a more simple clinical judgment would focus more appropriately and consistently on qualitatively minimizing animal pain and distress and would use the practical experience and intuitive judgment of trained veterinarians and investigators. In fact, I am not truly convinced that it is useful to have distinct definitions of pain and distress. We know what those words mean. The issue is simply whether they are absent (or minimal), moderate, or severe.


I believe that exemplary procedures generally associated with moderate or severe pain are useful as guides to investigators and to IACUCs. I would argue, however, that such exemplars should not be codified in regulation or policy, which risks replacing good judgment with a “check-off” mentality. I believe the more simple notion of global assessment, as I interpret the Humane Society categorization, serves animals well and provides a regulatory framework that can be applied and enforced with greater consistency. Simplifying the process of protocol preparation and review, and elimination (to the extent possible) of the “hassle factors” that promote investigator cynicism and reluctant cooperation, would also contribute significantly to realization of our shared goal of minimizing pain and distress.

Replication of Human Diseases

Nevertheless, I want to reemphasize that just as human disease inherently involves pain and distress, it will not be possible to eliminate these conditions in

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