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Conflict of Interest

• The AWARs and PHS Policy mandate that no IACUC member “may partictipate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC.”
• If the investigator submitting a protocol believes that an IACUC member has a potential conflict, the investigator may request that the member be excluded. When a member has a conflict of interest, the member should notify the IACUC chair and may not participate in the IACUC review or approval except to provide information. Members who have a conflict of interest may not be counted toward a quorum and may not vote.

Principles for the Utilization and Care of Vertebrate Animals

U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Research, Teaching and Training

The development of knowledge necessary for the improvement of the health and well being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible institutional officer shall ensure that these principles are adhered to:

1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. et. seq.) and other applicable Federal laws, guidelines, and policies.
2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
5. 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 unanesthetized animals paralyzed by chemical agents.
6. 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. 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. 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. 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 II, by an appropriate review group such as an institutional animal research committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

Published in the Federal Register, 5/20/85, Vol. 50, No. 9

Federally Mandated Functions of the IACUC

1. Review, at least once every six months, the research facilities program for the humane care and use of animals using The Guide for the Care and Use of Laboratory Animals (PHS Policy, also referred to as “The Guide”) and Title 9, Chapter 1, Subchapter A-Animal Welfare of the Code of Federal Regulations (CFR) as a basis for evaluation.
2. Inspect, at least once every six months, all of the institution’s animal facilities. PHS Policy requires the inspection of satellite holding facilities (areas outside the core facility in which animals are held for more than 24 hours) and areas in which surgical manipulations are performed. USDA Regulations require the inspection of animal study areas where animals are housed for more than 12 hours (for USDA regulated species).
3. Prepare reports of the IACUC evaluations and submit reports to the Institutional Official (IO). Reports must distinguish significant deficiencies from minor deficiencies and must contain a reasonable and specific plan and schedule for correcting each deficiency. A significant deficiency is one that is or may be a threat to the health and safety of animals. For USDA regulated species, a significant deficiency remaining uncorrected beyond the scheduled correction date shall be reported in writing to the Animal and Plant Health Inspection Service ( APHIS) and any federal agency funding that activity. The reports shall be made available to the Office of Laboratory Animal Welfare (OLAW) upon request.
4. Review, and if warranted, investigate concerns involving the care and use of animals at the institution. This includes public complaints and reports of noncompliance received from laboratory of research facility personnel or employees.
5. Make recommendations to the IO regarding any aspects of the animal program, facilities, or personnel training.
6. Review and approve, require modifications in, or withhold approval of those components of proposed activities related to the care and use of animals.
7. Review and approve, require modifications in, or withhold approval of proposed significant changes regarding the care and use of animals in on-going activities.
8. Be authorized to suspend an activity involving animals if it determines that the activity is not being conducted in accordance with the description provided by the investigator and approved by the IACUC (USDA Regulations), or if the activity is not being conducted in accordance with PHS Policy.

The functions listed above are granted to the IACUC by federal law. The institution, however, may grant additional powers to the committee as long as these do not conflict with federal regulations.