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U.S. Government (PHS and USDA) Principles for Protocol Review


  1. Transportation, care, and use of animals should be in accordance with the AWA, and other federal laws, guidelines and policies.
  2. Scientific relevance.  Procedures involving animals should be designed and performed with due consideration of their scientific relevance to human or animal health, the advancement of knowledge, or the good of society.
  3. Appropriate type and number of animal subject.  The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Other alternatives, (e.g., computer or mathematical models, en vitro biological systems) should be considered.
  4. Minimization of Pain.  Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices is imperative.
  5. Anesthesia, analgesia.  Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia.  Surgical or other painful procedures should not be performed on anaesthetized animals paralyzed by chemical agents.
  6. Animals with chronic pain.  Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
  7. Animal health and comfort.  The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
  8. Investigator qualifications.  Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals.  Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
  9. Exceptions to principles.  Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made with due regard to Principle 2, by an appropriate review group such as an institutional animal care and use committee.  Such exceptions should not be made solely for the purposes of teaching or demonstration.

(Principles extracted from the Institutional Care and Use Committee Guidebook, 2nd ed., ARENA/OLAW, 2002, C.I. Table A, Regulatory Criteria Applicable to Protocol Review as Defined in PHS Policy and USDA Regulations.)

PHS USDA principles for animal use.

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