other activities as stated herein and as required by federal, state, or local regulations and policies. Protocols should be reviewed in accord with the AWRs, the PHS Policy, U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (IRAC 1985; see Appendix D), and this Guide (see footnote, p.2).
The following topics should be considered in the preparation and review of animal care and use protocols:
Rationale and purpose of the proposed use of animals.
Justification of the species and number of animals requested. Whenever possible, the number of animals requested should be justified statistically.
Availability or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation (see Appendix A, "Alternatives").
Adequacy of training and experience of personnel in the procedures used.
Unusual housing and husbandry requirements.
Appropriate sedation, analgesia, and anesthesia. (Scales of pain or invasiveness might aid in the preparation and review of protocols; see Appendix A, "Anesthesia, Pain and Surgery.")
Unnecessary duplication of experiments.
Conduct of multiple major operative procedures.
Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated.
Method of euthanasia or disposition of animal.
Safety of working environment for personnel.
Occasionally, protocols include procedures that have not been previously encountered or that have the potential to cause pain or distress that cannot be reliably controlled. Such procedures might include physical restraint, multiple major survival surgery, food or fluid restriction, use of adjuvants, use of death as an end point, use of noxious stimuli, skin or corneal irritancy testing, allowance of excessive tumor burden, intracardiac or orbital-sinus blood sampling, or the use of abnormal environmental conditions. Relevant objective information regarding the procedures and the purpose of the study should be sought from the literature, veterinarians, investigators, and others knowledgeable about the effects on animals. If little is known regarding a specific procedure, limited pilot studies designed to assess the effects of the procedure on the animals, conducted under IACUC oversight, might be appropriate. General guidelines for evaluation