Information Resources for Institutional Animal Care and Use Committees 1985-1999

IACUC Administration and Program Review

• IACUC Oversight of Animal Care and Use Program
  
  
• Bibliography
  
  
• Useful World Wide Web Sites

Excerpted from the Institutional Animal Care and Use Committee Guidebook developed by Applied Research Ethics National Association and the National Institutes of Health. NIH Publication number 92-3415. The full text of this document is available at http://grants.nih.gov/grants/olaw/iacuc_guidebook/iacuc_guidebook.htm

C-1. Policies, Procedures and Responsibilities

Introduction

Under PHS Policyand USDA Regulations, the IACUC must inspect all institutional animal facilities every six months. These inspections provide an ongoing mechanism for ensuring that the institution maintains compliance with the applicable animal care and use policies guidelines and laws. They can also benefit programs for animal care by serving an educational function for the animal care personnel, research staff and IACUC members. Also, by giving the facility personnel a prior warning, the IACUC can assist an institution to prepare for subsequent visits by outside inspectors. The interaction of an IACUC and the animal care personnel at their institution should be constructive, and not adversarial, as both ultimately share the same goals of good animal care.

Staffing and Scheduling Inspection

The IACUC must schedule the inspections of facilities. This may be accomplished by assigning specific facilities to subcommittees which must contain at least two members as required by the USDA Regulations. No IACUC member should be excluded should he/she wish to attend a particular inspection, and additional ad hoc consultants may be used. The inspection team must have a working knowledge of the Guide and USDA Regulations in order to fully evaluate the facilities which are being inspected. Section C-2 of this Guidebook also provides general guidance in this regard. It is helpful for the team to have a prepared list of the categories to be inspected, such as sanitation, food and water provisions, animal identification, waste disposal, animal health records, environmental control, staff training, etc.

The IACUC may determine whether the supervisory personnel of various facilities should be notified of the date and time of an inspection. Advance notification allows individuals to be available to answer questions, but an unexpected visit shows the facility during usual operations.

Performing Inspections

An updated list of all facilities to be inspected should be maintained by the IACUC. All proposals submitted to the IACUC must contain details of all locations at which animal research is to be performed. The USDA Regulations require inspection of the centrally designated or managed animal resource facilities as well as any other animal containment facilities in which animals are kept for more than twelve hours. PHS Policy requires inspection of all surgical facilities and areas in which animals are maintained longer than 24 hours. It is helpful to keep a list of all facilities by room number, use, species and deficiencies noted in the last inspection. For satellite areas a contact person is useful. For facilities with multiple rooms, a map will assist the inspectors.

Notes should be taken throughout the visit to assist in preparation of the final report. Apparent deficiencies should be discussed with the person in charge of the facility to ensure that the team's perception of the situation is correct. In some cases an apparent deviation will be due to the experimental proposal in process, for example, withholding of food prior to surgery.

Documentation

After the visit a formal report is prepared. Any deficiencies must be categorized as minor or significant. The latter is defined, by USDA Regulations and PHS Policy, as one of significant threat to animal health or safety. A plan and timetable for correction of all deficiencies must be included in the final report. All individuals to be involved in the corrections should be consulted to ensure that the plan is realistic. If the institution is unable to meet the plan, the IACUC through the Institutional Official must inform Animal and Plant Health Inspection Service (APHIS) officials within fifteen working days of the lapsed deadline. If the activity is federally funded, the relevant agency also must be informed.

The report must be reviewed and approved by a quorum of the IACUC, and in cases involving USDA Regulations, be signed by all those who accept the report. Minority views should be included in the final document. A copy is then sent to the Institutional Official and must be kept on file for a minimum of three years. It is often useful for the report to be delivered in person in order to emphasize the findings and plans for action. Annually, the institution must notify OPRR of the dates of the semiannual inspections and the dates the report was submitted to the Institutional Official.

Program Evaluation

Both the PHS Policy and USDA Regulations include a requirement that semiannually the IACUC conduct an evaluation of the animal care and use program. Neither of these documents includes specific guidance regarding the mechanisms or procedures to employ in conducting this evaluation. OPRR has recommended that institutions use the Table of Contents of the Guide, exclusive of the facility and physical plant chapters, as an outline for program evaluation. The USDA Regulations refer institutions to other portions of those Regulations as a basis on which to conduct this program evaluation.

Key aspects of an animal care and use program that should be emphasized in the semiannual evaluation include IACUC functions and procedures, including proposal review practices, provisions for dealing with whistle blower" or other concerns regarding animal care and use, and the procedures employed to meet reporting requirements. In addition, the institution's occupational health program, veterinary care procedures and personnel qualification review process should be evaluated. Specific procedures to accomplish program evaluation may include presentations by appropriate individuals, e.g., the institutional veterinarian , occupational health personnel, etc. Written institutional policies such as standard operating procedures may be reviewed and modified if necessary.

Program evaluation deals principally with administrative aspects of the animal care and use program. In most instances these aspects will not change nor need to be modified with the same aspects of the facility or physical plant. Thus, when large changes are made in program aspects, a comprehensive evaluation by the committee should be conducted, while the review of that aspect six months later may be merely a brief evaluation of its implementation to date. Ongoing review of established practices allows the opportunity for institutions to detect a gradual change in practices from written procedures, thereby allowing modification of one or the other as appropriate. Institutions that are AAALAC accredited will find their pre-site visit package helpful in identifying areas for inclusion in the semiannual evaluation.

Occupational Health

Purpose of Occupational Health Programs

The health of individuals working in animal care Programs is an area of institutional concern. PHS Policy and the Guide identify the need for an occupational health program for all personnel who work in laboratory animal facilities or who have substantial animal contact. The emphasis of such a program is the prevention of illness, but it also includes provisions for early diagnosis and treatment when such illnesses occur.

Elements of an Occupational Health Program

An effective program will have the following components: 1) replacement medical evaluation; 2) periodic medical surveillance; 3) educational component; 4) provisions for treating illness or injury; and 5) provisions for consultation with other professional staff. The specific elements will be dictated by the extent and nature of the employee's exposure [see table].

Replacement and periodic medical evaluations: Replacement evaluations are conducted to ensure that the individual is capable of the demands and exposure of the job, and also to provide a medical reference baseline. The evaluation may include: clinical history, physical examination, spirometry, baseline tests such as TB test and serum sample collection, appropriate immunizations, educational/instructional component and appropriate feedback to the employee on all test results. Specific tests will depend on the species of animals and the nature of the procedures employed.

Periodic evaluations allow detection of early stages of disease, updating of immunizations and a re-evaluation of medical restrictions.

A uniformity in the evaluation of different individuals and the same person at different times is important to enable accurate comparisons to be made. These comparisons may allow a possible problem to be identified and corrected before it becomes a major health hazard.

Education

There are ethical and legal requirements to inform individuals of health risks and precautions which affect them. This must be part of an employee's overall orientation and job training. Some institutions rely on formal courses.

Barber, A.A (1987). University administration of animal care and use programs. Laboratory Animal Science 37(special issue): 93-96.
NAL call number: 410.9 P94
Descriptors: animal welfare, administration, policy, animal experiments.

Bascom, R. (1997). Developing and implementing personnel safety programs Part 1: Occupational health and safety program in a research animal facility. Lab Animal 26(6): 23-26.
NAL call number: QL55 A1L33
Descriptors: five key institutional activities, administration support for health and safety programs, hazard recognition, institutional trends for health and safety, who is at risk, developing and implementing a work plan, control strategies, tracking program effectiveness.

Bowman, P.J. (1991). A flexible occupational health and safety program for laboratory animal care and use programs. AALAS Bulletin 30(6): 15-17.
NAL call number: SF405.5 A23
Descriptors: zoonoses, PHS policy, factors likely to dictate type and degree of hazards, list of type of personnel that should be included in program, categories of risk, facets of an occupational health programtimelines for physical exams, TB skin tests, chest x-rays, immunizations, serum banking, allergies, injuries, Q Fever.

Bowne, G.W. (1999). Financial management in an animal research facility. Lab Animal 28(1): 33-37.
NAL call number: QL55 A1L33
Descriptors: budget development and maintenance, cost analysis, review of major costs in an animal facility, expenditures, income, equipment and amortization, tracking and monitoring costs, Circular A-2, basic points for saving money, repairing a deficit.

Carey, R. (1990). Public responsibility in medicine and research conference on administration, education and the animal care committee. Journal of Medical Primatology 19(1): 75-6.
NAL call number: QL737 P9J66
Descriptors: animal welfare, legislation and jurisprudence, laboratory animals, research, ACUC.

Donnelly, T.M. (1996). Hazardous chemicals and anesthetics in the laboratory animal facility. Lab Animal 25(4): 39-41.
NAL call number: QL55 A1L33
Descriptors: list of commonly used hazardous chemicals and anesthetics, xylene, DMSO, picric acid, formaldehyde, peracetic acid, chloroform, ether, halothane, nitrous oxide, urethane, common use of each compound in the lab, hazards associated with chemicals, recommended protective action, miscellaneous information about each chemical.

Driscoll, J.W. and T.C. Rambo (1989). Forming an IACUC at a small institution. In Animal Care and Use in Behavioral Research: Regulations, Issues, and Applications J.W. Driscoll (ed.), Beltsville, Maryland: U.S. Department of Agriculture/National Agricultural Library pp. 23-28.
NAL call number: aHV4762 A3A64
Descriptors: universities, regulatory requirements, committee responsibility, ACUC.

Ellenberger, M.A., and B.F. Corning (1999). The animal care and IACUC offices: United or divided? Lab Animal 28(1): 44-47.
NAL call number: QL55 A1L3
Descriptors: missions of an animal care program and the IACUC, animal care office, administrative support, advantages and disadvantages of separate vs combined animal care and IACUC offices, factors involved in determining the suitability of program for a facility, recommendations for an effective and efficient IACUC.

Fox, J.G. (1987). Gaining institutional support. Laboratory Animal Science 37(special issue): 115-117.
NAL call number: 410.9 P94
Descriptors: laboratory animals, animal welfare, animal experiments, ACUC.

Gordon, B (1987). Unique problems of animal care and use in small institutions. Laboratory Animal Science 37(special issue): 127-128.
NAL call number: 410.9 P94
Descriptors: animal welfare, research institutes, animal experiments.

Green, R.J. (1997). Developing and implementing personnel safety programs part II: Safety training and education in animal research. Lab Animal 26(6): 27-29.
NAL call number: QL55 A1L33
Descriptors: management responsibility, dealing with time constraints, on-site training, providing regular updates, modular courses, maximizing class time, pre-class assignments, employee interaction, distance learning, computer-based training, top 10 training tips.

Hassall, G. (1999). Committees and conflict resolution. ANZCCART News 12(1): 1-3.
NAL call number: SF405.5 A3
Descriptors: conflict resolution, definitions, disputes, conflicts, conflict resolution continuum, mediation, skills, listening, empathizing, assertiveness, timeliness, mapping, strategies for resolving conflicts.

Herscowitz, H.B. (1987). Institutional responsibilities. Laboratory Animal Science 37(special issue): 118-119.
NAL call number: 410.9 P94
Descriptors: animal welfare, laboratory animals, ACUC.

Hiiemae, K., H. Rozmiarek, J.F. Williams, J.E. LeBeau, and M. Ross (1987). Report of a panel discussion on how to run an effective Animal Care and Use Committee. Laboratory Animal Science 37(special issue): 39-44.
NAL call number: 410.9 P94
Descriptors: animal welfare, animal experiments, policy, institutions.

Hittelman, J. (1987). Operating principles for committees on animal research. Laboratory Animal Science 37(special issue): 97-100.
NAL call number: 410.9 P94
Descriptors: animal welfare, institutions, ACUC.

Holden, F. (1997). Alternatives committee established at Indiana. The Johns Hopkins Center for Alternatives to Animal Testing Newsletter 14(3): 6-7.
NAL call number: HV4701 J6
Descriptors: subcommittee to IACUC, communications between researchers and campus animal protectionists, monthly round table, institutional support at highest levels, membership includesinformation specialists, public relations/education representative, departmental representatives, IACUC liaison, animal protectionist, veterinarian, research assistant.

Holt, M.A. (1996). Institutional animal care and use issues: creativity and innovation. The Johns Hopkins Center for Alternatives to Animal Testing Newsletter 13(2): 12-13.
NAL call number: HV4701.J6
Descriptors: animal welfare, committees, innovations.

Institute of Laboratory Animal Resources (U.S.), Committee on Occupational Safety and Health in Research Animal Facilities (1997). Occupational health and safety in the care and use of research animals. Washington, DC: National Academy Press, 154 p. This document is available at http://books.nap.edu/books/0309052998/html/index.html
NAL call number: RC965.A6O23 1997
Descriptors: Laboratory animal technicians, health risk assessment, animal health technicians, occupational diseases, prevention, guidelines, program design and management, physical, chemical, and protocol-related hazards, allergens, zoonoses, principal elements of an occupational health and safety program, occupational health care services.