Review of experimental protocols: classifying animal harm and applying "refinements"

ACUCs and investigators are challenged by the new federal policies requiring review of experimental protocols. They are also challenged by the requirements to consider alternatives and to reduce animal pain wherever possible. Use of a classification system based on degrees of ethical concern for the animals, (e.g. Table 1 page 12) can help in the selection of projects for expedited review. Knowing how to categorize animal experiments according to their degree of invasiveness can also help conceptualize the bioethical issues involving in justifying animal experiments. Scientists are becoming increasingly familiar with the broad concept of alternatives espoused by the three R's of refinement, reduction, and replacement. Expertise in reviewing experimental protocols for animal welfare concerns and actively applying the concept of alternatives is increasing rapidly. This paper describes some alternative refinements which can lessen the ethical costs if introduced into the experimental design. As experience is gained by ACUCs, more refinements will be identified and applied. The Committee's negotiations with investigators can be constructive in improving the welfare of the laboratory animals and also in enhancing the scientific validity of the results. The experience of ACUCs is that investigators generally support this process and are cooperative in incorporating relevant suggestions into their research protocol.