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Physical Restraint Procedures

Protocols utilizing physical restraint of animals beyond that considered ordinary animal management and care must be justified and approved by the IACUC:

Protocols are judged on a case-by case basis. Such protocols should provide justification for restraint, a full description of the restraint procedure and possible impact of restraint (when possible), post restraint monitoring (when applicable), protocol stipulations for monitoring the impact of restraint on animal health and well-being, provisions for observation of animal for deleterious signs of injury, pain, suffering and distress, appropriate veterinary care, description of intervention therapies or strategies such as acclimation designed to ameliorate, minimize, prevent or end restraint-associated pain, suffering and distress (Examples: Pre-restraint adaptive conditioning, minimization of period of restraint, acclimation to full period of restraint using sessions comprised of incremental increases in time of restraint, consideration for inter-restraint release from restraint, enrichment diversions during restraint, analgesics, tranquilization and euthanasia).

Physical Restraint Acclimation Procedures: Animals are acclimated to the confines of the testing environment two to five days before tethering or restraint. IACUC evaluates restraint on a case-by-case basis.

Physical Restraint Monitoring: Monitoring should address restraint-associated physical or psychological impact based on restraint paradigm. Such consideration may include observation for inflammation, abrasions, pressure point sores, infection and self-inflicted injuries, with limb restraint (and in addition to the foregoing) monitor should look for signs of appendage ischemia, atrophy or necrosis, change in species-specific behavior, excessive weight loss or gain, change in eating, drinking and bodily elimination frequency or pattern, etc. Current or retrospective animal health status should be ascertainable through daily health observation and record keeping by the animal care staff, researcher daily or period of restraint observation of animal based on restraint paradigm and review of researcher procedural records.

Multiple Surgical Procedures Multiple Surgical Procedures

Institutional Policy for Approval of Multiple Major Survival Surgery: Protocols utilizing multiple major surgical procedures are prohibited unless justified and approved by the IACUC. The Committee reviews multiple major surgical procedures and makes a determination based in scientific merit, scientific necessity, post-operative care plan and the availability of experienced personnel required to minimize pain and suffering and euthanasia intervention strategy to minimize or alleviate pain, distress and suffering.

Postoperative monitoring of the animal must be performed daily at an adequate frequency deemed appropriate based on the study paradigm. IACUC unannounced spot checks should be anticipated for project assessment. Critical IACUC comparative retrospective analysis of the animal health record, the surgery record and the post-operative care record serves as a key component for assessment of humane care in this category as well as all categories of operative procedures.

Food and Water Restriction

Food restriction other than short-term fasting standard for specific species required operative procedures is prohibited unless justified and approved by the IACUC. Water restriction is particularly discouraged. and must also be justified. Food and/or water restriction as well as the period of restriction must be shown to be scientifically required in order to accomplish study objectives.

Investigators may be required to monitor the following individual animal variables based on the nature and period of the restriction:

Body weight: 7 - 10% loss; lower % if over shorter period ascertained by once or twice weekly weight checks based on degree of restriction

Blood Urea Nitrogen: Reduction of normal species value: may be assessed in instances of severe restriction or as normal routine health check event for animal

Urine/fecal Output: Decreased; also lower than normal fecal moisture if ascertainable

Food/Fluid Consumption: If lower than expected consumption

Other: Species specific behavior changes, hydration assessment, etc.

Policy on Medical Device Testing

Protocols requiring device testing will be evaluated on a case-by-case basis. The IACUC refers those performing research on device testing to review the Animal Welfare Information Center Newsletter, Spring 1996, Vol. 7 No. 1 entitled “Effects of the Shift to Alternatives on Industrial Practices”. Those providing basic or applied research for industry medical device licensing may want to review Good laboratory Practices Regulations.

Policy on Transport of Animals

Transport from the Facility Within the Same Building Complex: Animals must be transported in secured primary cages at all times. Researchers and their staff are discouraged in transporting caged animals by hand. Rather, small laboratory animals should be transported in cages placed on a hand-cart and large animals should be transported in a transport cage. IN ALL CASES, ALL ANIMALS MUST BE DRAPED DURING TRANSPORT TO PREVENT VISUALIZATION BY EMPLOYEES AND VISITORS.

Transport from the Facility to Nearby Building Complex: Animals must be transported in secured primary cages at all times. Researchers and their staff are discouraged in transporting caged animals by hand. Rather, small laboratory animals should be transported in cages placed on a hand-cart and large animals should be transported in a transport cage. IN ALL CASES, ALL ANIMALS MUST BE DRAPED DURING TRANSPORT TO PREVENT VISUALIZATION BY EMPLOYEES AND VISITORS.

Transport from the Facility to Local Off-Campus Locations: Special permission must be obtained from the IACUC to have animals transported to Off-Campus Locations.   The IACUC of the receiving institution must approve the delivery beforehand. A fee-for-service may be incurred. Animals will be secured in affixed primary cages and maintained and driven in such a manner as to prevent toppling or injury and to assure adequate temperature and ventilation suitable for the species.   At the point of delivery animals will be delivered to the door only and receiving personnel will be required to receive animals in a manner stipulated by the receiving institution IACUC.

Transport from the Facility to Distant Off-Campus Locations: Special permission must be obtained from the IACUC to have animals transported to Off-Campus Locations.   The IACUC of the receiving must approve the delivery beforehand. A fee-for-service may be incurred. Animals will be health certified (if applicable) and transported in a manner consistent with the AWA, the Guide and other applicable local and federal regulations and standards.

Hazardous Drugs, Chemicals or Biohazardous Agents in Animals

Use of hazardous material (biohazards, toxic chemicals or drugs and radiation hazards) in animals is limited to that which can be safely managed within the confines, capabilities and limitations of the facility, environmental systems, engineering and technical requirements and personnel capabilities.

Investigators using such agents in animals must have demonstrated expertise and knowledge in the use of the hazardous material and do so in accordance with the Material Safety Data Sheet (MSDS) and federal and local regulations and university policies.

Before work can begin the IACUC will require the researcher to present a protocol for management of the material that prevents exposure of themselves, their personnel, our animal care and veterinary staff and prevents release of the material to the environment. A seminar may also be required at the discretion of the facility director.

Hazardous Communication must be strictly followed during conduct of the study. Ether is an example of a hazardous material that is prohibited from use in animals at the university under any circumstances.

Biohazardous Agents in Animals

The Rapid Committee Program for Biohazardous Waste Disposal prescribes procedures for university handling and disposal of biohazardous waste.

The Howard University BioSafety Committee reviews and approves protocols prescribing safe use of biohazardous agents at the university.

The IACUC, after review and approval of protocols employing biohazardous agents in animals, stipulates the requirement for BioSafety Committee approval.

Investigators using biohazardous materials in animals must have demonstrated expertise and knowledge in the use of the biohazardous material and do so in compliance with federal and local regulations and university requirements.

Veterinary Services limits biohazardous work in the facility to the BSL-2 Level and before work can begin, the investigator may be required to present a seminar to the research staff and the VS staff regarding safe use of the biohazardous agent.

In all cases the staff will be informed regarding risks, risk minimization, incident and exposure response. The college also co-sponsors an annual safety training program on chemical safety, biohazardous safety and general safety.

Radioactive Agents in Animals

The Radiation Safety Committee prescribes procedures and certifies users of radioactive materials at the university.

The office also requires annual training of users of radioactive materials.

The committee also reviews and approves protocols prescribing use of such material in animals.

The IACUC, after review and approval of protocols employing radioactive agents stipulates the requirement for Radiation Safety Committee approval.

Investigators using radioactive materials in animals must have demonstrated expertise and knowledge in the use of such material and do so in compliance with federal and local regulations and university requirements.

Before work can begin Veterinary Services may require the investigator to present a seminar to the research and VS staff regarding safe use of the radioactive agent.

In all cases the staff will be informed regarding risks, risk minimization, incident and exposure response.

Educational Programs in Occupational Safety

All animal care staff, veterinarians and researchers are required to attend the IACUC-sponsored seminar Occupational Safety for Animal Caregivers and Users.

All laboratory personnel are required to attend the University -Wide Annual Safety Seminar.

Other IACUC Policies

AWIC's USDA Employees Survey of the Effectiveness of IACUC Regulations is a must-read for anyone desiring to understand policies that the IACUC must implement to meet multiple agency mandated IACUC regulations on alternatives, preventing duplication, pain minimization, etc.

Other IACUC policies for experimental procedures comply with guidelines recommended by NIH as follows:

Antibody Production: Complete Freund's Adjuvant and Mouse Ascites Production

Guidelines for Survival Rodent Surgery

Endpoints in Animal Study Proposals provides recommendations applicable to all protocols and especially cancer and toxicology studies in animals and disease models with expected morbidity and/or mortality.

Guidelines for the Euthanasia of Mouse and Rat Fetuses and Neonates

Guidelines for Diet Control in Behavior Studies

Recommendations for LD₅₀ Testing

Definitions for Behavior/Clinical Signs of Pain

Drugs and Techniques Currently Recommended to be Used to Reduce Pain and Distress in Rodents and Rabbits

Oocyte Harvesting in Xenopus laevis

Addressing Animal Welfare Concerns

All research institutions must provide a mechanism for addressing Animal Welfare Concerns as stipulated by PHS policy. Contact the following individuals regarding your animal welfare concerns:

LaVal Cothran, D.V.M. at lcothran@howard.edu,
Doris Hughes, D.V.M. at resdeh@gwumc.edu
George Littleton, Ph.D. at glittleton@howard.edu or
Carol Winston at cwinston@howard.edu

All Animal Welfare Concerns reported to the IACUC or its membership will be treated confidentially. You may also report your animal welfare concerns anonymously.