The University of Arizona Institutional Animal Care and Use Committee Handbook

II. THE UNIVERSITY OF ARIZONA INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE:

ROLES AND RESPONSIBILITIES

1. Doctor of Veterinary Medicine, with training or experience in laboratory animal sciences and medicine, who has direct or delegated program responsibility for activities involving animals at the institution;
2. Practicing scientist experienced in research involving animals;
3. Member whose primary concerns are in the nonscientific area;
4. Individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution. This individual should represent community interests and concerns.

The Committee can invite internal or external consultants to assist the Committee in its duties; for example in the performance of protocol review. Such consultants cannot vote, but provide their professional opinion.

B. AUTHORITY

1. Review once every six months the program for humane care and use of animals, using the ILAR Guide for the Care and Use of Laboratory Animals (Guide) and the Animal Welfare Act (Act) as bases for evaluation.
2. Inspect at least once every six months all animal facilities (including satellite facilities) and animal study areas using the Guide and Act as bases for evaluation.
3. Review concerns involving the care and use of animals.
4. Review and approve, require modifications in (to secure approval) or withhold approval of those components of activities related to the care and use of animals.
5. Make recommendations to the Institutional Official regarding any aspect of the animal care program, facilities, or personnel training.
6. Prepare reports of the IACUC evaluations conducted as required by 1. and 2. above, and submit the reports to the Institutional Official. A majority of the Committee members must sign the reports indicating their approval of the information submitted. Reports shall be maintained and made available to regulating agencies upon request. Reports must contain a description of the nature and extent of adherence to the Guide and Act and must identify specifically any departures from their provisions, and must state the reasons for each departure. Reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which is or may be a threat to the health or safety of the animals. If program of facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency. If some or all of the facilities are accredited by AAALAC, the report should identify those facilities as such.
7. Review and approve, require modification in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities.
8. Ensure that scientists, animal technicians and other personnel involved with animal care, treatment and use are provided with training in the humane practice of animal maintenance and experimentation, and the concept, availability and use of research or testing methods that limit the use of animals or animal distress.
9. The IACUC may suspend any activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provision of the Guide, Act, or NIH Assurance Statement. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.

a. If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to the NIH Office for Protection from Research Risks and APHIS.

1. Unnecessary pain or distress is avoided;
2. Anesthesia and analgesia are properly and effectively used where indicated; the only exception to this may be when agents must be withheld as a requirement of the study;
3. Painful studies requiring exemption from the use of either anesthetics or analgesia are subject to particular scrutiny, not only prior to approval, but during the experiment;
4. Postoperative care commensurate with current veterinary concepts is provided.

2. The IACUC shall establish and implement policies which will provide for a system of animal care that meet the needs of the University and include:

1. The requirement that all animal care and experimentation is conducted within the guidelines as set out in the AWA and PHS policies, and any other federal, state, or institutional regulations that may be in effect;
2. Ensuring adequate numbers of animal care personnel are present, and that animal users and animal care personnel are qualified to perform their duties. All individuals shall receive training in the humane care and use of animals;
3. Ensuring that facilities and equipment meet the standards of all applicable regulations and policies;
4. Providing standards of husbandry and veterinary medical care that meet or exceed regulatory mandates;
5. Ensuring that all activities and procedures that involve animals are carried out humanely and that analgesics, anesthetics, and tranquilizing drugs are used to minimize pain;
6. Ensuring proper methods of euthanasia, with appropriate guidelines for timely euthanasia to minimize pain and suffering.

3. The IACUC shall assure that all animal users have the opportunity to become familiar with all federal, state, city, and institutional requirements that may apply to their work.

4. The IACUC shall ensure appropriate care of animals in all stages of their life. Adequate veterinary care must be available at all times for all animal species used by the University.

5. The IACUC shall ensure the living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding and nonmedical care of the animals will 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.

6. The IACUC shall ensure that no research, testing project, teaching program, or any other study (including field studies) involving animals be commenced without prior IACUC approval of a written Animal Protocol Review Form (APRF); further, no animals shall be acquired before such approval. This includes internally-funded projects.

7. The IACUC shall review the animal care and use components of proposed research projects to ensure that procedures and practices are in compliance with the Guide, Act, NIH Assurance Statement, and any other regulations or policies which apply. When necessary, the IACUC will require further supportive information from the investigator or meet with the investigator to assure that all members of the review committee understand the procedures to be used on the animal. If there is any variance with the guidelines noted above, the IACUC will require justification for the variance on scientific grounds.

8. The animal use protocol must include the following information:

1. Project title (including course number if a teaching program.)
2. Project leader(s) (a.k.a. Principal Investigator) name.
3. Names of other Research Staff and other authorized personnel, including personnel qualifications, training, and IACUC Certification number.
4. Departmental affiliation, mailing address, phone number(s), and lab location.
5. Proposed start date, proposed end date.
6. Funding agency.
7. An indication of the use of any hazardous material including infectious agents and other biological hazards, toxic or carcinogenic chemical agents, and radioactive materials.
8. Rationale and purpose of the proposed use of animals and the scientific goals of the research.
9. Species and number of animals to be used with scientific justification; the number of animals used should be justified statistically.
10. An indication of the categories of discomfort and the classification of research based on primary use.
11. Methods of anesthesia and analgesia, including dosages and methods of use.
12. The methods of euthanasia, if necessary.
13. A description detailing the procedures that are carried out in the animals.
14. Written assurance that the activities do not unnecessarily duplicate previous experiments.
15. Assurance that procedures with animals will avoid or minimize discomfort, distress, and pain to the animals consistent with sound research design.
16. Written assurance that the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center (AWIC), used to determine that alternatives were not available.
17. Assurance that all procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator.
18. Assurance that animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanatized at the end of the procedure or, if appropriate, during the procedure.
19. Assurance that more than one major survival surgical procedure will not be performed on an animal unless justified for scientific reasons and approved by the IACUC.
20. Assurance that adequate pain relieving drugs and pre-and post-surgical care will be provided by trained personnel.
21. Assurance that the methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.
22. Description of possible clinical signs of illness or distress exhibited by the experimental animals and mode of treatment .
23. Unusual housing and husbandry requirements.
24. Any other information considered important or necessary and pertinent.
25. All information must be presented in a form that all members of the IACUC can readily understand.

9. The IACUC must be aware of all modifications to protocols. When these involve major changes in animal utilization, new protocols must be submitted.

10. The Committee shall review all protocols at least once every three years, with annual confirmation that the studies have not been changed since the commencement of the project.

11. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC.

12. Prior to Protocol review, IACUC members shall be notified of proposed research projects submitted for review. Written descriptions of research projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one member of the IACUC, designated by the IACUC Coordinator or Chairperson, and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects. If full committee review of is requested, approval of those research projects may be granted only after review at a convened, quorum meeting of the IACUC and with the approval vote of the majority present. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.

13. The IACUC shall notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

14. Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the institution. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.

15. The IACUC shall ensure that all use of animals has "scientific merit." In many instances, the Committee will primarily rely on the review process by scientific funding agencies, such as the NIH. However, for those projects that will not be subject to external peer review for scientific merit, the IACUC may require that such be obtained externally; or alternately, the Committee may choose, if qualified, to assess the protocol for scientific merit itself. In such cases, the Committee may invite other University scientists knowledgeable in the field of research indicated by the protocol to assist in the internal review.

D. MEETINGS

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Guide for the Care and Use of Laboratory Animals