We have just revised Policy 12 (Table 1 and Appendix A) after a considerable amount of discussion and controversy. This policy, which requires consideration of alternatives to painful and distressful procedures, states that the database search remains the most effective and efficient method of satisfying the requirement of considering alternatives to painful and distressful procedures. At the same time, it recognizes that this method might not always be the best, or it might be one of multiple methods, used to satisfy the requirement. We believe the test should be applied by the IACUC as well as our inspectors and is two-fold. The first part of the test involves whether there is enough information for the IACUC to make a determination as to whether the principal investigator has made a good faith and reasonable effort to determine what alternatives are available. The second part of the test focuses on whether adequate consideration was given to bona fide alternatives that were identified.
Policy 11 relates to the minimization of pain and distress and reporting the same. We are in the process of revising that document. Clearly, whatever we produce is going to focus on minimizing pain and distress to the extent practical, as does the AWA and the regulations, and it will also include a definition of distress.
The draft version of this policy (Table 2 and Appendix A) recognizes that there might be other methods of relief besides anesthetics, analgesics, and tranquilizers. For example, there may be therapeutic agents (e.g., antibiotics) that in a disease process would provide some relief from pain and distress. In addition, other chemical agents or methods may provide relief from pain and distress.
The new policy will recognize that any given procedure (complete Freund's adjuvant might be an example) can be appropriately categorized in our current system under column C, D, or E, depending on the circumstances of how it is employed. On a retrospective evaluation of each animal on a case-by-case basis, it is certainly possible for some procedures to be categorized appropriately in any of the three current categories. Prospective reporting is acceptable, and retrospective reporting will clearly be allowed. As we currently have it drafted, this new Policy 11 would include descriptions of the three columns as found in our annual report. It would provide examples of what types of procedures would be categorized appropriately in each of those columns.
TABLE 1 Policy 12: Consideration of Alternatives