Protocol Review Consideration of Pain and Distress and Numbers of Animals Used

Because both PHS policy and the AWRs explicitly require minimization of pain and distress of animals during research, there have been examinations of the implications and possible effectiveness of the IACUC consideration of these issues during protocol review (Dresser; Brody). Both regulations attempt to incorporate cost—benefit considerations, utilitarian theory, and some elements of a modified rights-based philosophy (Dresser). The success of PHS policy and the AWRs depends fundamentally upon the recognition that animals can experience pain and distress that can be alleviated (NRC, 1992). The USDA requires an annual report from all registered institutions that lists the numbers of animals used in research and testing, classified by the degree of pain and distress: (1) minimal, transient, or no pain or distress; (2) pain and distress relieved by anesthetics, analgesics, or tranquilizers; and (3) pain and distress not treated. A detailed statement on category 3 procedures is required, including scientific justification for withholding drugs. Another classification scheme, developed by the Scientists Center for Animal Welfare, lists six categories instead of three (Orlans, 1987). Many IACUCs use some classification scheme for pain and distress, reducing the number of animals used in research that fall into the higher categories of pain and distress by applying the "three Rs" (replacement, reduction, and refinement) of William M. S. Russell and Rex L. Burch, authors of a book first published in 1959 called The Principles of Humane Experimental Technique.

Some observers feel that IACUC review does not adequately reduce the number of animals used in research or the pain and distress of these animals. In a 1989 article, Mimi Brody suggested new legislation that would implement two oversight levels—first, a local committee; second, a national committee—to review uses of animals with "high ethical cost." Gary L. Francione argued in a 1990 article that open IACUC meetings, publicly announced and attended by interested members of the community, would improve the quality of protocol review. The two-committee approach has the disadvantage of delaying approval of certain types of research and has the potential for becoming excessively bureaucratic. The open-meetings approach presumes that the general public could comprehend the scientific details of the described procedures and would be able to judge the ethical and social justifications for the proposed procedure.

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