Part II:
The Use of Animals in Research & Teaching at the U of M
To use animals at the University of Minnesota you must:
- have an approved and up to date (active) animal use protocol
- be certified by the IACUC to use animals in research or teaching
- complete any additional training needed
- be enrolled in the Occupational Health program for animal handlers
- ensure the humane care and treatment of animals
Animal Usage Form
To complete an Animal Usage Form always download the most recent version of the animal use protocol from the IACUC web site, www.iacuc.umn.edu.
Answer all the questions in Part A and Part B completely and attach relevant appendices. (A separate Part B must be filled out for each species used.)
 Once the protocol is completed, submit 12 copies to the IACUC office by the meeting deadline date and the protocol will be reviewed at the next meeting. Meeting dates and deadlines are on the IACUC web site.
At the meeting IACUC will review and discuss the protocol and will do one of the following:
- Approve the protocol, as is.
- IACUC will send you a letter saying that the protocol was approved and you may begin work.
- Approve with stipulations.
- This means that IACUC had a few minor questions that need clarification before final approval, other offices or committees need to review and approve some aspect of the protocol, or personnel involved in the project need to complete required training. If this is the case, you will receive a letter outlining the questions that need clarification, or steps that need to be taken before final approval is granted. You respond to the committee in writing and once the stipulations have been met, you will receive a final approval letter. You may not begin work or order animals until you receive final approval.
- Defer the protocol.
- If your protocol is deferred, this means that IACUC did not have enough information to approve or not approve your protocol. Again, IACUC will write you a letter outlining the questions they had and request further information. You respond to the questions in writing. If your protocol is deferred, it will need to go back to the full committee for review again. This process can take longer than responding to stipulations.
- Not approve the protocol.
- While this is rare, if a protocol is not approved, IACUC will require you to submit an entirely new protocol. IACUC will identify animal welfare concerns and provide policy requirements for a new submission.
Committee decisions are also available on the web site within 24 hours after the meetings.
Protocol Number (example) 0305A12345
 Once your protocol is approved, that approval is valid for 3 years pending annual renewal. The protocol will receive a number. The first four numbers of the protocol refer to the year and month that the protocol was submitted to the IACUC office. For example 0305 means that the protocol was submitted in May (05) of 2003 (03). This provides an "at a glance" idea of approximately how long the protocol approval is valid.
The protocol number is used to order animals. You must use the appropriate approved and active animal use protocol number to order the animals from RAR. Protocols are approved for a limited and specific number of animals - the IACUC does not typically approve ranges of animal numbers.
The protocol number is also used to identify animals. It should be on the cage cards for all animals. A copy of the protocol, or the protocol number should be available in any areas where animals are taken or used.
Continuing Review
Once your protocol is approved, the IACUC will request a report for an annual continuing review and renewal of approval. You will receive correspondence from the IACUC office regarding this continuing review and your response is required in order for your animal use protocol to remain active.
Three-year renewal
Based on federal regulations, the protocol approval is valid for three years. You must submit a new application at the end of the three years in order to continue the work. Extensions to protocol approvals can not be granted. The new animal use protocol will receive a new number and the old number will no longer be valid.
Keep in mind that the composition of the committee, federal regulations, and University policies can evolve and change in three years, so even if your work has remained the same, the information needed for approval of an animal use protocol may be different. It is also recommended that you begin the application process at least 3 months in anticipation of expiration, in order to ensure that your work is not interrupted.
Changes to protocols
All changes to animal use protocols must be approved by the IACUC before they are initiated. Submit all changes in protocol to the IACUC office in writing and be sure to include the signature of the Principal Investigator. Very minor changes (such as addition of a grant title) may be handled administratively by the IACUC office. Major changes, such as a change in animal numbers, a change in animal species or changes in objectives or procedures will be reviewed by the full committee.
It is recommended that you review your original protocol and answer all questions that are relevant to the requested change. For example if you are requesting additional animals, state the statistical justification for the increased numbers. If you are changing the species used, you will need to submit a new Part B of the application form. Include any relevant appendices.
Changes to protocols that are reviewed by the committee will be approved, approved with stipulations, deferred or not approved. Once again, changes may not begin until final approval is received.
Closing a Study
If you are closing your study, inform the IACUC of this action.
Inspections
The IACUC and/or the Office of Regulatory Affairs conducts announced or unannounced inspections of animal care and use areas on a regular basis. Be prepared to state the protocol you are working on and answer questions about animal use in your research.
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Certification for animal use
Everyone who uses animals in research or teaching must be certified by the IACUC. This certification is accomplished through attendance at an orientation seminar and /or through completion of this on-line tutorial. All personnel must obtain this certification before beginning work with animals or obtaining access to animal housing areas.
Protocols will not be approved by the IACUC until all personnel have completed this certification process. If you have questions about your certification status or that of your staff, please contact the IACUC office.
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 Additional Training
Before you can work with Specific Pathogen Free (SPF) rodents, there is additional training that is required by RAR. Also, before you can work with non-human primates you must attend a specialized training conducted by RAR.
The Department of Environmental Health and Safety (DEHS) requires laboratory safety training for anyone working in a laboratory. Additional training may also be required for people working with or around radiation or other hazardous substances.
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Occupational Health Program
Enrollment in the Occupational Health program is required for all personnel who use animals. The Occupational Health Program consists of education on zoonotic disease and other occupational health issues, and a preventative medicine program.
Boynton Health Service administers the preventive health portion of the occupational health program. When you complete the animal certification process, your name and contact information will be sent to Boynton Health Service and they will contact you regarding preventive health services.
Tetanus vaccination
It is required that all personnel who work with animals be vaccinated for tetanus. Exceptions to this requirement may be made for religious or health reasons. The tetanus vaccination is given every 10 years as a preventive measure. Vaccination for tetanus should be covered by most health plans, including the student health coverage. If you are bitten or scratched by an animal or otherwise receive a wound, Boynton Health Service may want to booster your tetanus if you have not had a shot within the last 5 years or if you are not sure when you last had your shot. Costs for this booster would be covered by the Occupational Health Program.
Rabies vaccination
If you are working with dogs, cats, bats or other flesh-eating carnivores, you have an option to receive the pre-exposure rabies vaccination. This is a series or three shots. If you have already been vaccinated for rabies, you may have your titer checked every two years through the Occupational Health Program. If your titer is no longer protective, you may receive a booster for the rabies vaccine.
Rodents and rabbits do not normally carry the rabies virus. The rabies vaccination is not recommended for those who are only working with rodents and rabbits.
Toxoplasmosis testing
Toxoplasmosis is a protozoan parasite that can be present in the feces of cats. It can cause birth defects and spontaneous abortions in pregnant women. Women of childbearing age who are working with cats have the option of being tested for toxoplasmosis. Boynton Health Service will provide further information and/or counseling to those personnel who use this service.
Tuberculosis testing
All personnel who work with non-human primates must be tested every 6 months for tuberculosis. Because the non-human primates are actually more susceptible to tuberculosis than humans, this is actually a protective measure for the non-human primate colony. Clinics are held every 6 months through RAR or you may arrange the test through Boynton Health Service. If you have been vaccinated for tuberculosis, you must have an annual chest x-ray.
Herpes B virus
The macaque species of monkeys can carry the Herpes B virus. The non-human primates infected with Herpes B may have a cold sore in their mouth or not show any visible signs at all, but the virus can be highly fatal to humans who may become infected. An exposure is considered to be:
- a bite, a scratch,
- a scratch from a cage,
- a needle stick from a needle that has been in a monkey, or
- splashing of any monkey body fluid into an eye or other mucous membrane.
There are BITE KITs present in the anterooms to the monkey housing areas that contain instructions about what to do if you are exposed. If you work with non-human primates, become familiar with the location of these BITE KITs. If you are exposed, follow the instructions in the BITE KIT and then go to Boynton Health Services or Fairview University Emergency after hours. Bring the instruction card for the health care provider with you. Notify RAR that you have been exposed as soon as possible.
Allergies
Allergies to laboratory animals can be common. These allergies can develop over time and pre-existing allergies can predispose a person to developing allergies to laboratory animals. Allergies to the dander of dogs and cats can occur and the urine of rodents causes allergic reactions. The use of personal protective equipment such as masks and gloves, especially when handling animals or cleaning cages, can reduce the amount of exposure to allergens.
Handling injuries
Treat any injuries with standard first aid. Go to Boynton Health Services or Fairview University Emergency after hours if the injury requires medical attention. Report any bites from a dog, cat, or non-human primate to RAR as soon as possible.
Zoonotic Disease
Zoonoses are diseases that can be passed between humans and other animals. You should be aware of some of the zoonotic diseases carried by the species that you are working with. Specific zoonotic diseases will be discussed in Part 3 of this tutorial.
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Ensure the Humane Treatment of Animals
Concerns about lab housing, transport, or general condition/treatment of animals can be reported to IACUC. Any concerns, no matter how "trivial" should be reported.
IACUC is required to make reasonable inquiry into all complaints and/or concerns. In some instances investigation and corrective action will result.
Please report any animal welfare concerns to
Research Subjects Protection Program
612-626-5456
iacuc@umn.edu
An anonymous email form is also available on the IACUC web site.
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Research Animal Resources
 Research Animal Resources (RAR) provides the husbandry, housing and veterinary care for the animals at the University. There are six laboratory animal veterinarians and twelve laboratory animal technicians on the Twin Cities Campus. There are also approximately 85 specially trained animal care staff who provide the day to day care for the animals.
RAR veterinarians monitor the health and welfare of the research animals and assist the IACUC with protocol review and facility inspections. They provide a consultation resource to researchers for experimental model development, the minimization of pain and distress in research animals and other aspects of animal care and use.
RAR Services:
- Ordering
- Animals can now be ordered on line through RAR. See the RAR web site.
- Training
- RAR conducts required training for persons working with Specific Pathogen Free (SPF) rodents and non-human primates
- Resources
- RAR has an extensive library, training videos and an excellent web site including a veterinary drug formulary for common drugs used in research animals.
- Animal care
- RAR provides the routine care and feeding for the research animals. Special requests including special diets, increased observation or transportation of animals to the laboratory can be arranged. Special veterinary technical services can also be arranged. Special coolers for disposal of animal carcasses are available on campus.
- Enrichment
- All research animals are provided with an enrichment program to allow for the expression of some natural behavior in their environment. If the enrichment program interferes with the goals of an experiment, a special request must be made to remove the enrichment following approval for withholding enrichment by IACUC
- Identification
- All animals must be identified. Cage cards including the protocol number and contact information provide identification. Dogs, cats, non-human primates and farm animals must have additional individual identification such as a tattoo or microchip.
- Veterinary services
- RAR can provide diagnostic services including hematology, serum chemistry, microbiology and parasitology. RAR monitors the diseases present in the animal areas. There are sentinel animals present in the rodent rooms that are tested on a regular basis for specific rodent diseases. RAR is also available for emergencies. A veterinarian is on call after hours and on the weekends. Page the emergency vet at (8) 899-6285 or call 612-624-9100 in the event of an emergency.
- Post-operative care program
- All non-human primates, dogs, cats and farm animals used in biomedical research that undergo survival surgery must be enrolled in RAR’s post-operative program. RAR veterinarians and technicians provide monitoring and post op care in a central area for dogs, cats, sheep, goats, and pigs. The other animals are cared for in their housing areas.
- Guidelines
- The RAR web site contains many of the experimental and surgical guidelines that must be followed by researchers at the University of Minnesota.
See the RAR web site for more information on these topics.
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Other University Policies and Groups
The Department of Environmental Health and Safety
- Hazardous chemicals
- The use of hazardous chemicals requires a Chemical Hygiene Plan in the laboratory. The chemical hygiene officer can provide assistance (Dawn Errede, 612-626-2330, erred001@umn.edu).
- Radiation
- The Radiation Protection division of DEHS requires an application to use radioactive materials in research. Additional training is needed to work with radioactive materials and special radiation training is also required to access the BSBE and MCB building laboratories.
- Human tissues or blood
- Standard/Universal Precautions are required to work with human blood, body fluids, or unfixed tissue and must be followed. Yearly blood-borne pathogen training is also required.
- Sharps
- Special sharps containers must be used to dispose of all needles, glass pipettes or other sharp objects. Needles must not be recapped except in certain situtations when a one-handed technique is used..
- Ergonomics
- Workstation evaluations and training in ergonomics is available through DEHS.
- Hazardous Waste
- DEHS has special procedures and training for hazardous waste disposal.
See the DEHS web site for more information.
Institutional Biosafety Committee
The use or storage of infectious agents, biological toxins or recombinant DNA requires approval from the Institutional Biosafety Committee. There are additional procedures that must be followed for the use or storage of Select Agents.
See the IBC web site for forms, more information and contacts.
Contact the Office of Regulatory Affairs or a Biosafety Officer for more information on the policy.
Office of Regulatory Affairs/ DEHS
 Controlled Substances
The use of controlled substances in research requires special registrations with the DEA and the Minnesota Board of Pharmacy. The University of Minnesota Policy 2.1.4 “Using Controlled Substances for Research” must be followed. Controlled substances must be stored in a safe approved by DEHS and access must be limited.
There are also special record keeping and auditing requirements. Training sessions on the revised policy are currently being conducted. Contact the Office of Regulatory Affairs (612-625-9624) for more information.
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