ABSTRACT

For example, regulations and policies require humane end points for animals that, when reached, necessitate an action. The animal(s) must be removed from the study or a procedure must be undertaken to alleviate the pain and distress of the animal(s). Many organizations have established programs with well-defined and effective policies on humane procedural end points, while others have not considered the issue and will await a troublesome situation before establishing a process or effecting a solution. In some cases, there are variations in selected end points among organizations, which can lead to variable outcomes. Some organizations may choose a conservative approach and prematurely remove animals from a study, thus assuring that no animal reaches a humane end point. This approach may compromise the research by preventing the accumulation of data that would occur just prior to reaching an end point. Conversely, other programs using a less stringent approach may allow animals to achieve or exceed the humane end point, and in doing so may inadvertently allow some animals to experience pain or distress beyond that approved by the IACUC. Assuming the IACUC has appropriately selected end points, animals should not exceed defined end points and thus not experience unnecessary unrelieved pain and distress. If an IACUC humane end point is exceeded, this operation is not compliant

with the committee-approved animal activity. If the IACUC has approved an end point that exceeds the humane end point, without scientific justification, then the IACUC is noncompliant. This diversity in procedures will lead to varying outcomes in identical or similar studies.