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IACUC GUIDELINES FOR ANTIBODY PRODUCTION IN LABORATORY ANIMALSThe production of either monoclonal or polyclonal antibodies through animal immunization is an inexact science due to the incompleteness of our understanding of the immune response. The use of live animals necessitates the refinement of the technique such that it causes minimal impact on the animals. With this in mind, the IACUC has adopted recommendations concerning the use of animals for antibody production. (See attached). Animal Use Protocols. Due to the sensitive nature of antibody production from the animal welfare standpoint, it is important that critical aspects of the procedure be done appropriately as documented in the animal use protocol. Answers to the following questions should be provided as part of the protocol.
Pertinent information is contained within the attached guidelines. The nature of the antigen will influence the need for and the selection of an adjuvant. The undesirable effects of adjuvant use include tissue damage, pyrogenicity, and adjuvant-induced uveitis or arthritis. Improper or unnecessary use of Freund's adjuvant may cause inflammation, induration, or necrosis. The IACUC would like to encourage investigators to consider the use of adjuvants such as the Ribi system (l) or Hunter's TiterMax (2), which have fewer side effects, before using Freund's.The IACUC has developed the following guidelines to minimize the animal discomfort associated with the use of adjuvant. Departures from these guidelines require that adequate justification be given to the IACUC. A. Use of Adjuvant
B. Injection of Adjuvant
(1) Ribi Immunochern Research Inc., P.O. Box 409, Hamilton, MT 59840 (800-548-7424) (2) CytRx Corp., 150 Technology Parkway, Norcross, GA 30092 (800-345-2987) _________________________________________ Injection of one rear footpad in mice or intradermal injections in rabbits may be permitted only if documentation is presented to the IACUC showing that injections in other sites do not produce significant antibody titers to the antigen under study. C. Monoclonal Antibody Production in Mice
Animals should be observed daily, and the fluid drained as needed to prevent excessive pain and distress. Ascitic fluid should be collected when the abdomen is the size of a near term, pregnant mouse. Animals should be euthanized if their condition begins to deteriorate. Usually this means one tap and a second one as a terminal procedure.
IACUC GUIDELINES FOR BLEEDING RODENTS AND RABBITSThe IACUC has developed the following guidelines for bleeding rodents and rabbits. Deviations from these techniques must be approved by the IACUC. Instruction in these techniques can be scheduled through the Campus Veterinarian. Videotapes are also available.
Innovar-Vet (Droperidol and Fentanyl) (0.15-0.2 ml/kg, IM) - Some rabbits appear to have better vasodilation with this drug than with acepromazine. Acepromazine maleate (1.0 mg/kg, IM) - Is a good tranquilizer for use in rabbits. It also promotes vasodilation. Xylazine (3-10 mg/kg IM) can be used in rats and mice to provide sedation with some analgesia. Carbon dioxide - This is an extremely useful agent for use in rodents. It induces a short-term coma in the animal and is relatively non-toxic to the user. It can be used for euthanasia when given as an overdose. Metofane (Methoxyflurane) - May be used as a short-term anesthetic in mice and rats. It must be used under a hood due to its potential for causing nephrotoxicity in people. Torbugesic (Butorphanol tartrate, 10mg/ml): Acepromazine maleate (10mg/ml) Mix 1:1 by volume. Give 0. 1 ml/kg, IM or SC. This combination is a good alternative for bleeding rabbits when InnovarVet is not available.
IACUC GUIDELINES FOR ANIMAL SURGERYRODENT SURGERY According to PHS Policy and the Animal Welfare Act, survival surgery on rodents does not require special facilities but may be done in a laboratory under appropriate conditions. The area must be easily sanitized, clean and uncluttered and not used for any other purpose during the time of surgery. Aseptic technique must be used. This includes the use of sterile instruments, surgical gloves and masks. A clean lab coat is recommended. The surgical area should be clipped and scrubbed with a povidone-iodine scrub (e.g., Betadine),working from the center to the periphery of the site. The site should then be rinsed with 70% alcohol. At least three alternating preparations of germicidal scrub and rinse are considered adequate. . Surgical drapes are optional for short procedures, but should be used for prolonged procedures that require exteriorization of the viscera or for those procedures that are performed on immune-suppressed rodents. Instruments can best be sterilized in an autoclave but a chemical sterilant such as Cidex can also be used.During recovery, animals should be placed in a clean dry area with a supplemental heat source or covered with a towel to prevent excessive heat loss and hypothermia. If they are placed close to each other to conserve body heat they must be watched carefully until recovered from anesthesia to prevent any cannibalism that might occur. Appropriate medical records should be maintained. A minimum appropriate record consists of recording on the cage card the type of surgical procedure performed, the date of the procedure, and the initials of the person who performed the procedure. OTHER SPECIES Major survival surgery, as defined as penetration of a body cavity or having the potential to create a permanent handicap, on most other laboratory animals, including rabbits, requires a dedicated suite of 3 rooms and aseptic technique. Any such surgery will need to be discussed with the Campus Veterinarian before it is permitted as the campus' capabilities in this area are somewhat limited. Minor surgical procedures can be performed under less stringent conditions if they are performed in accordance with standard veterinary practices.
IACUC POLICY ON DECAPITATION WITHOUT SEDATIONThe PHS Policy and the Animal Welfare Act requires that euthanasia procedures follow the 1993 Report of the AVMA Panel on Euthanasia. This report recommends that decapitation should be used only after the animal has been sedated or lightly anesthetized. At its January 17, 1991 meeting, the IACUC recommended that this guideline be followed unless the investigator submits written justification that adherence to this recommendation will jeopardize the successful outcome of the study. If you want to continue to use this method, please provide written justification for its use, and a statement that it will be done only be personnel that are skilled in the procedure. Otherwise, please give the name of the sedative/anesthetic or an acceptable method of euthanasia that will be used.
IACUC GUIDELINES FOR BIOHAZARD USE IN LABORATORY ANIMALSCopies of all animal use protocols that indicate that biohazards will be used in laboratory animals will be sent by the Committee Coordinator to the Environmental Health and Safety (EH&S) representative on the Chancellor's Committee on Laboratory Animal Care. This will include an Animal Handler Precaution form if contaminated animals will be housed in the vivaria. It will be the responsibility of EMS to review and give written approval to the proposed biohazard use relative to human safety before the animal use protocol is given final approval. This review will include any precautions that need to be taken while the animals are housed in the vivaria. These precautions will be documented on the Animal Handler Precaution form. Biohazards to be covered in this manner include infectious agents, carcinogens, toxic chemicals, noxious gases including volatile anesthetics, radioisotope materials, tumor cells and tissues, sera or other biologics that may contain infectious agents. When such agents are to be used in/on animals while they are housed in the vivaria, it will be the responsibility of the investigator to notify the Campus Veterinarian and the Principle Animal Technician for the vivarium involved when the agents are in use. The Animal Handler Precaution form will be posted on the animal room door describing the agent(s) used and any precautions that need to be taken.
IACUC GUIDELINES FOR THE USE OF ANIMALS IN TEACHINGThe following guidelines, adopted by the IACUC after consultation with faculty who use animals in teaching, are meant to clarify the legal requirements that must be met when animals are used in teaching and to identify areas where students should be informed of possible risks associated with animal experiments. Federal regulations mandate the following:
Informing student of risks Students who are using live or dead animals should be informed of risks associated with the procedure, including those of developing allergic responses or of exposure to zoonotic diseases. On request, the Campus Veterinarian will provide data on risks associated with specific teaching protocols. In particular, the IACUC is concerned students understand that exposure to animal dander or urine has a risk of producing allergies. Some people may develop allergic responses to animal dander or urine proteins. Individuals with AIDS or weakened immune systems are at greater risk. Also, animals can be the vector for zoonotic diseases. Although animals purchased from approved vendors may have a small risk of transmitting zoonotic diseases, instructors should inform students when a significant risk is present. The students should be aware that allergens and infectious organisms have the potential of being transmitted on clothing to humans outside the laboratory setting. The instructor is also responsible for informing students when chemicals from embalmed or treated animals may present a hazard. The IACUC recommends that disposable gloves be available for students in all laboratory sessions using animals. Instructors may wish to provide disposable facemasks and/or eye protection for some laboratory sessions and should inform the students that lab coats are available for purchase in the bookstore.
UCR VIVARIA TREATMENT AND REPORTING OF ANIMAL BITESThe following procedures should be followed by all animal users:
- the date - a description of the bite and its circumstances - the identification of the animal and its location - the treatment you received for the wound With the exception of bats, rabies is not a significant hazard with the species (and their sources) currently housed in the vivaria. Although the risk with bats is minimal, it should be discussed with a physician.
REVISED IACUC POLICY MEMBER 19, 1993 USE OF VOLATILE ANESTHETICS IN LABORATORY ANIMAL RESEARCHOn October 20, 1993, the Chancellor's Committee on Laboratory Animal Care developed policies concerning the use of volatile anesthetics in conjunction with procedures involving laboratory animal. The Investigator is to follow one of the following procedures:
Any questions regarding this should be directed to the Chair of the Committee (x5535).
IACUC POLICY ANIMAL ADOPTION POLICYCATS: Healthy cats, used as hosts for fleas in Dr. Michael Rust's research program, can be adopted by people known directly by the animal technicians or other staff and faculty. The adopting party will sign a form acknowledging that the cat had been used for research/teaching purposes and releasing UCR from any responsibility and that they plan to keep the animal as their personal pet. In addition, information on the adopting person's full name, address, Social Security number, drivers license number, and a description of the animal(s) will be obtained. OTHER ANIMALS: The adoption of other animals must be approved by the IACUC on a case by case basis. Any questions regarding this should be directed to the Chair of the Committee (x5535).
IACUC POLICY RESEARCH ANIMALS DONATED BY PRIVATE INDIVIDUALSCATS: Cats can be donated for use in Dr. Michael Rust’s flea research program only by people that are well known to the animal technicians or other staff or faculty. The donor of the animal(s) will sign a statement acknowledging current ownership, relinquishing ownership to UCR, and consenting to the Use of the cat for research purposes. In addition, the providers full name, address, Social Security number, driver's license number, and a description of the donated cat, its original source and the reason for donation; and signatures of the animal technician and investigator Involved will be obtained. OTHER ANIMALS: Acceptance of any other animal from a private individual for research use will be decided by the IACUC on a case by case basis. Any questions regarding this should be directed to the Chair of -the Committee (x5535).
UNIVERSITY OF CALIFORNIA, RIVERSIDE ANIMAL ADOPTION FORM (READ ONLY)
I am aware that the following described animal(s) was used for research/teaching purposes, and I hereby release the University of California, Riverside from any responsibilities in connection with such animal(s). I am willing to adopt said animal(s) as is. I plan to keep this animal(s) as my persona1 pet. (IACUC Policy 516194) Description of Animal(s)______________________________________________________
Adopting Party: Date: __________________________ Name: _________________________ Address: ________________________________________________________ _________________________________________________________ City State Zip SSN: __________________________ Driver's License Number: ______________________
Technician's Signature: ___________________________________________________________ Date Adopting Party's Signature: ________________________________________________________ Date:
Cc: United States Department of Agriculture (USDA) files
UNIVERSITY OF CALIFORNIA RIVERSIDE OFFICIAL ANIMAL RELEASE FORM (READ ONLY)Date:
Owner's Name: Owner's Address: City: State: Zip:
USDA License Number: SSN: Driver’s License Number: Description of Animal(s) (name, sex, age, breed, color, identification number):
Owner’s source of animal: Reason for relinquishing animal: I am the owner of the above described animal(s), and I hereby release ownership to the University of California, Riverside for use as a research animal(s), thereby giving consent for the animal(s) to be used as needed for the purpose of research or teaching labs. (IACUC Policy 516194) Donor Signature: Vivarium Signature: Investigator Signature: Department:
IACUC GUIDELINES FOR TUMOR PRODUCTION IN RODENTSPurpose The purpose of this document is to provide general guidelines to be used for experimentally induced neoplasia in rodents. Investigators producing tumors in rodents should use this document as a reference in preparing their Animal Use Protocols. The IACUC recognizes the difficulty in establishing specific limits on tumor burdens for rodents and that these general guidelines may not be applicable in all cases. However, the IACUC assumes that all projects will be in compliance with these guidelines unless alternate procedures are clearly described and justified In the AUP. Guidelines Each AUP Involving tumor production in rodents must define a set of conditions under which the affected animals will be euthanized. Animals should be euthanized before their tumor burden becomes excessive and before the animals become debilitated Use of survival time as an end point is rarely justifiable and should be avoided. The following general criteria for euthanasia should be used: SOLID TUMORS 1. Tumor burden in rodents should not exceed 10% of the animal’s body weight. In the case of a twenty-five gram mouse, this would represent a single nodule approximately 1.5 cm in diameter or multiple smaller tumors with a total volume equal to this. Animals should be euthanized before tumors reach this size or if a subcutaneous tumor ulcerates prior to reaching this size. Some ulceration of intradermal tumors may be allowed as long as the animal remains in good condition. 2. In some studies, either the tumor itself or anti-tumor therapies may cause the animal to lose condition. In these cases, adult animals should be euthanized if they lose 20% of their body weight, corrected for the weight of the tumor, or if growing animals fail to attain a weight 80% of non-tumor bearing animals. 3. Some tumors, depending on their type and location, may interfere with the function of vital organs or motor function. If animals show evidence of distress due to systemic illness (rough hair coat, dehydration, depression, severe diarrhea, anemia etc.) or problems with motor function (ambulation, eating, grooming, etc.) they should be euthanized regardless of the size of the tumor or body weight. HEMATOLOGIC TUMORS 1. The same guidelines as given in #2 and #3 above should be followed to ensure the adequacy of the animal's general condition.
In addition to the daily health checks performed by the animal care staff, the Principal Investigator/research staff must be continually aware of the condition of the animals in which tumors have been induced. In the case of very rapidly growing tumors or other situations in which the progression of clinical signs is likely to be rapid, the P.I. or research staff must examine the animals daily. Any animal that falls into one of the above categories should be reported to the PI who must examine and euthanize the animal within 24 hours unless such a condition is part of the approved Animal Use Protocol. If the PI is not responsive, the Campus Veterinarian may euthanize animal deemed to be debilitated.
OTHER TUMORS
Guidelines for animals bearing ascites tumors are addressed in a separate guideline.
IACUC POLICY TRAINING OF ANIMAL USERSBackground: PHS Policy and the Animal Welfare Act require that all people that use animals in research and teaching be trained in the proper care and use of research/teaching animals prior to beginning the project. To partially fulfill this requirement, the IACUC offers semi-annual didactic sessions, discussing the animal care and use program at UCR, and hands-on laboratories on basic animal procedures. Policy: Didactic sessions will be offered twice in each calendar year. All PIs must attend a didactic session within a year of the approval of an initial AUP and animal users must attend within a year of their being enrolled in the project. The Chair may grant an extension in either case. Noncompliance will result in the failure being discussed by the IACUC and risks suspension of the AUP and mention in the semi-annual program review as a specific institutional deficiency. Hands-on sessions may be attended on an "as needed" or desired basis. The IACUC suggests that the didactic training session be repeated within five years, barring any significant changes in the PHS Policy or Animal Welfare Act.
HOUSING OF ANIMALS OUTSIDE THE VIVARIA: IACUC POLICYThe IACUC has adopted the following policy for situations where animals are housed outside the vivarium: all animals housed outside the vivarium for over 12 hours must be scientifically justified and approved by the committee on an individual basis. All appropriate record keeping and monitoring of the animal's health will be conducted in the same manner as if the animal is housed in the vivarium. A description of the husbandry procedures to be followed must be approved before animals can be ordered.
INTRODUCING ANIMALS INTO THE VIVARIAIACUC Policy INTRODUCING ANIMALS INTO THE VIVARIA June 25,2001 Background: Traditionally, all research animals have
come from commercial vendors approved by the IACUC. It has been a long-standing policy that
these animals be ordered through the animal technician in the vivarium.
This allows the animal technician to plan for the animals’ arrival and to
ensure that their health status meets our standards and that there is adequate
space and caging for their housing. More recently however, animals,
especially genetically altered ones, have been coming from other institutions or
other non-approved sources. Nevertheless, it is still necessary that
orders go through the animal technician so that the technician can plan
appropriately and determine the animals’ health status. The latter is
particularly important to prevent the introduction and spread of disease through
the vivaria. Even if incoming animals are contaminated, that knowledge
will allow appropriate isolation precautions to be taken. Recognizing the
importance of these needs, the Guide for the Care and Use of Laboratory Animals,
when addressing the information supplied by commercial vendors on the genetic
and pathogen status of their animals, notes that “similar data should be
obtained on animals received by interinstitutional or intrainstitutional
transfer (such as transgenic mice).” The Guide also states “Coordination of
ordering and receiving with animal-care personnel is important to ensure that
animals are received properly and that appropriate facilities are available for
housing.” To help investigators be aware of the required ordering
procedures and to help ensure that procedures are followed, the IACUC has
adopted the following policy. Policy: All animals coming into a vivarium from any
source (e.g., commercial sources, other institutions, colonies in other UCR
vivaria) must be ordered or requested through the principal animal technician in
the vivarium in writing. Any special housing or husbandry needs of these
animals must be indicated at this time. With the exception of animals from
approved commercial sources, the arrival of all animals must be preceded by a
health certificate that is no more than three months old. The certificate
should show, at minimum, the results of a serological survey of the colony the
animals are coming from. It should also include a descriptive statement of
any known or suspected infectious health problems in that colony and that
facility within the last year. The requirement for a health certificate is
absolutely necessary to protect the health of the other animals in the vivaria
and will require the investigator to plan ahead. The acceptance of animals from
infected colonies must be approved by the individual vivarium (whoever is
designated to make such decisions for the vivarium) and the campus veterinarian.
Under exceptional circumstances, animals without health certificates may be
admitted to a vivarium with the approval of that vivarium (whoever is designated
to make such decisions for the vivarium) and the campus veterinarian, provided
there is quarantine space available. To ensure proper record keeping, the
campus veterinarian will inform the Compliance Officer when such exceptions are
made.
PI CARE OF ANIMALS INSIDE THE VIVARIA: IACUC POLICYThe IACUC has adopted the following policy on the P1 care of animals and record keeping: * Pl's who care for their animals inside the vivarium are required to have the same documentation for that care that the outside Pls are required to keep.
IACUC POLICY: MONITORING OF ANIMAL USE BY IACUCOn October 20, 1993, the Chancellor's Committee on Laboratory Animal Care developed the following policy concerning the monitoring of animal use at UCR: "Interviews with the PI and his group at the work site will be conducted by at least two members of the IACUC working as a team The interview will include, but is not limited to, inspection of surgical areas, procedures, and review of protocol(s). After each interview, the interview team will submit a report to be included as part of the appropriate protocol file(s). If a situation is discovered which needs correction or further review, the interview team will inform the Chair of the Committee, the Campus Veterinarian, and the Pl." Any questions regarding this should be directed to the Chair of the Committee (x5535)
IACUC POLICY: TRAINING OF INVESTIGATORS AT OTHER INSTITUTIONSOn October 20, 1993, the Chancellor's Committee on Laboratory Animal Care developed the following policy concerning the use of laboratory animals at UCR by PIs trained at other institutions: "Whenever a P1 is trained in the use of laboratory animals at another institution, a letter of qualification should be obtained from that institution that states the individual has his/her local IACUC's* approval for such procedures. This letter should accompany the protocol whenever the PI applies for approval to use laboratory animals at UCR." Any questions regarding this should be directed to the Chair of the Committee (x5535) (*IACUC: Institutional Animal Care and Use Committee)
IACUC GUIDELINES ON DEATH AS AN END POINT STUDIES IN RODENTS1,2,3Contemporary legal, regulatory arid moral guidelines require that animal pain, distress and suffering be minimized in laboratory animals. Investigators should use their experience with the animal model to identify signs particular to their study that indicate that the rodent is dying and to administer euthanasia at that time. Otherwise, the general signs given below can be used. If death itself is absolutely required as the end point, the investigator may receive approval to conduct such studies by providing appropriate, scientific justification to the IACUC. Otherwise, investigators are expected to agree with the guidelines below and that they or the animal staff, following notification of the PI, will euthanize any animal found moribund. A further requirement of such studies is to minimize animal numbers within the statistical constraints of the project. Thus, in studies using death as an endpoint, investigators are encouraged to administer euthanasia prior to the actual death of an animal if the experimental validity will not be compromised. GUIDELINES
As in all protocols, all animals will be monitored daily by the animal care staff. If signs of illness or disease are noted (see below), the cage will be tagged, and the date and abnormality described on the back of the card. The investigator and the Campus Veterinarian will be notified and the animal care staff will continue daily observations. If the abnormality is expected to lead to death of the animal but the animal is not yet moribund (see below), or if the animal has reached a known critical period with respect to impairment, the investigator must institute twice daily observations of the animal, early AM and late PM, including weekends and holidays, and euthanize the animal once it becomes moribund. If a moribund animal is found by the animal care staff or the Campus Veterinarian, attempts will be made to alert the investigator or his staff, but N this is not possible or N the animal has not been euthanized within two hours, the animal will be euthanized by the animal care staff or the Campus Veterinarian. Signs of Disease/Illness in Rodents - Ruffled fur - Slow, shallow and labored breathing - Hunched posture – lethargy - Rapid breathing - Poor appetite - Hypo- or hyperthermia - Diarrhea or constipation - Ulcerative dermatitis or infected tumors - Rapid weight loss Signs of the Moribund Condition in Rodents That Require Euthanasia Signs of disease/illness plus any of the following:
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SOP FOR MONITORING NUMBERS OF RESEARCH ANIMALS USEDINTRODUCTION As part of UCR's Animal Welfare Assurance statement to the Public Health Service, we must provide assurance that we adhere to the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. Principle III requires that "The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results." To document that minimal numbers of animals are used, we need to begin to track the actual number of animals involved or used in the performance of a protocol. The following is the method we will use to do this. GUIDELINES All breeding colonies will be covered under an Animal Use Protocol specific for the colony. I. What will be counted:
II. Breeding colonies for:
III. PIs will be notified by the Chair of IACUC when they have used 80% and 100% of the approved number. IV. An AUP year is defined as one year from the date the Chair, IACUC, signs final approval on the AUP. Thus, the anniversary date for each AUP will be the date of final approval of the original protocol. IMPLEMENTATIQN
11. For PI cared for animals.
MONITORING NUMBERS LETTER (READ ONLY)Date: XXXXXXXXXXX
To: XXXXXXXXXXXX Principal Investigator
Fm: XXXXXXXXXXXX Chair, IACUC
Re: AUP - A-XXXXXXXX
This is to inform you that you have bred and/or obtained from outside sources 80/100%of your approved number of ______(number) _____(species) ______ for the current year of your AUP which is renewable on ________ and ends on ________. If you need more than 110% of the approved number of animals before the anniversary of your AUP, you must file an amendment to your protocol stating the number of additional animals you will need and justifying this need. This request will have to be approved by the IACUC before you will be allowed to order or use additional animals.
Cc XXXXXXXX, MS0 XXXXXXXX, Animal Technician XXXXXXXX, Campus Veterinarian XXXXXXXX, AUP file
IACUC POLICY "To Be Named" Personnel PolicyIt is the responsibility of the PI to notify the Research Office (ORA) and/or the Office of the Campus Veterinarian (OCV), within one week of the appointment of a previously unnamed person to a position that will involve animal handling or use. The person's past training/experience should be described relative to the tasks the person will be performing. If additional training is needed, the training and how it will be achieved should also be mentioned. Once the training is complete, the PI must provide the ORA or OCV with the person's name and a brief description of the training and how it was obtained. Attached is a suggested reporting form that can be used for this purpose.
TRAINING IN ANIMAL PROCEDURES (READ ONLY)UNIVERSITY OF CALIFORNIA – RIVERSIDE
DATE: ______________________ PERSON RECEIVING TRAINING: ____________________________ DEPARTMENT: _____________________________ AUP NUMBER: ______________________________ PROCEDURE:
COMMENTS:
I certify that this person has been trained in and that he/she can adequately perform the procedure described above.
______________________________________ ______________________________ Print Name of Person Providing Training Signature of Person Providing Training
IACUC POLICY DOCUMENTATION OF TRAININGBackground: On January 8, 1997, we were inspected by the Veterinary Medical Officer from the USDA. In looking through our Animal Use Protocols, he was concerned about a particular statement under section #13, 'Animal Procedures'. This statement (#c) reads... "Identify the individuals who will conduct the procedures, and list their qualifications (experience, training classes attended, etc.) to perform such procedures on the species to be used in this project." When the PI states that……."if Ms/Mr. Doe does this procedure, they will be trained by (person doing the training).", do we (the compliance committee) know for sure that if that person does the procedure, that they have actually gotten the training required. Policy: If the AUP states the person (trainee) who will be doing the procedure(s) specified will be trained by the person named in Section 13, letter c., the PI is responsible for supplying the IACUC with written confirmation that this training has taken place before the trainee actually performs the procedure in question, by filling out and returning the attached "Training in Animal Procedures" form.
TRAINING IN ANIMAL PROCEDURES (READ ONLY)UNIVERSITY OF CALIFORNIA – RIVERSIDE
DATE: ______________________ PERSON RECEIVING TRAINING: ____________________________ DEPARTMENT: _____________________________ AUP NUMBER: ______________________________ PROCEDURE:
COMMENTS:
I certify that this person has been trained in and that he/she can adequately perform the procedure described above.
______________________________________ ______________________________ Print Name of Person Providing Training Signature of Person Providing Training
FULL COMMITTEE REVIEW OF PAIN AND/OR DISTRESSBack-ground: PHS Policy and the Animal Welfare Act require animal use protocols to be reviewed by the IACUC for the scientific justification of any unalleviated pain or distress to animals. To insure full attention to these questions, the IACUC will discuss at a formal meeting any protocol that involves major surgery or unalleviated pain or distress. Policy: IACUC REVIEW OF PAIN AND/OR DISTRESS The IACUC will discuss at a formal meeting* any AUP application which involves any of the following:
*A formal meeting is an announced meeting at which a quorum of members is in attendance.
IACUC POLICY WEARING OF PROTECTIVE CLOTHING IN ANIMAL ROOMSBack-ground: The Guide of the Care and Use of Laboratory Animals and Occupational Health and Safety in the Care and Use of Research Animals recommend all animal using personnel maintain a high standard of personal cleanliness and hygiene. The use of dedicated, protective clothing is recommended as an integral part of such a program. This is to help provide protection from, and to help prevent the spread of, allergens, as well as infectious and hazardous agents. Policy: All animal technicians must wear protective clothing, consisting of a shirt and pants or coveralls and shoes, while in the vivarium. This protective clothing should not be worn outside of the vivarium. The use of gloves and suitable respiratory protection is recommended when dumping cages and working with hazardous agents. The department is responsible for providing appropriate and adequate clothing and laundering facilities. Pis and laboratory technicians should wear dedicated protective outer garments while in animal rooms. Additional clothing such as shoe covers, masks, hair bonnets, and full body outer garments may be required in some situations. All personnel should wash their hands frequently, especially after leaving an animal room.
IACUC POLICY ALTERNATIVES TO PAINFUL PROCEDURES (USDA POLICY #12)Background: USDA policy #12 (AWA Section 13(a)(3)(B) - 9 CFR, Part 2. Section 2.31 (d)(1)(ii)) on painful or distressful procedures requires specific documentation of the search for alternatives to such procedures. Policy: All Pis who plan to conduct experiments involving painful or distressful procedures and use animals covered under USDA guidelines" must provide specific documentation of their consideration of alternatives to such procedures, as specified in USDA policy #12. The minimal written narrative should include: the databases searched or other sources consulted, the date of the search and the years covered by the search, and the key words and/or search strategy used by the Principal Investigator when considering alternatives or descriptions of other methods and sources used to determine that no alternatives were available to painful or distressful procedure. The narrative should be such that the IACUC can readily assess whether the search topics were appropriate and whether the search was sufficiently thorough. Reduction, replacement and refinement (the three R's) must be addressed, not just animal replacement.
**Any warm blooded animal other than rodents of the genus Mus or Rattus bred for use in research, birds, or livestock for use in agriculture research.
IACUC POLICY PRODUCTION OF MONOCLONAL ANTIBODIES USING MOUSE ASCITES METHODBack-ground: During the September 8, 1998 IACUC meeting, the Chair informed the Committee that we were in receipt of a letter from OPRR (attached) detailing specific new requirements for evaluation of proposals to use the mouse ascites method of antibody production. The ascites method is still acceptable, but investigators need to document their consideration of alternative methods. Policy: IACUC will critically evaluate any proposed use of the mouse ascites method to produce monoclonal antibodies. Prior to approval of proposals that involve this method, the IACUC must determine that: (1) the proposed use is scientifically justified, (2) methods that avoid or minimize discomfort, distress, and pain (including in vitro methods) have been considered, and (3) the latter have been found unsuitable. Fulfillment of this three-part requirement must include appropriate documentation in the AUP application.
REPORTING THE MISTREATMENT OF ANIMALS AND DEFICIENCIES IN THEIR CARE AT THE UNIVERSITY OF CALIFORNIA, RIVERSIDE
DEFINITION: Allegations of animal mistreatment and deficiencies in care include the following: (1) the wrongful or abusive physical or psychological treatment of an animal and (2) Noncompliance with approved procedures, policies or protocols. PROCEDURES: Any person with knowledge of deficiencies or with reasonable suspicions of deficiencies or mistreatment involving animals should report them directly to the Chair of the Chancellor's Committee on Laboratory Animal Care (IACUC), to the Campus Veterinarian (787-5845), to any member of the IACUC, to the Chair of the department or program supervising the site where the observed actions have occurred, to the Campus Compliance Officer (787-5535) or to the Institutional Official, i.e. the Vice Chancellor for Research and Graduate Affairs (787-5535). Timely reporting is essential to protect the animals involved and to aid the investigation of the allegations. Neither administrative action nor retribution of any kind may be taken against a person making a good faith report of deficiencies. This is in accordance with the UC Policy and Procedures for Reporting Improper Governmental Activities and Protection Against Retaliation for Reporting Improper Activities (Whistle Blower Policy), July 1, 1992. Reports of suspected deficiencies should be made in writing whenever possible and should include, but need not be limited to, the nature and the place of the occurrence, the person or persons alleged to be delinquent, the date, the time, and any supporting facts. If a person actually witnesses mistreatment or abuse, the witness should immediately notify the Campus Veterinarian so that the animal or animals involved can be evaluated and receive medical treatment if necessary. The person should then report the incident as described above. If the Campus Veterinarian is not available, one of the individuals listed above should be contacted to arrange the appropriate care. The Chancellor's Committee on Laboratory Animal Care will investigate allegations and report its findings and recommendations to the Institutional Official in a timely fashion. Details of any reports or allegations of deficiencies, findings or recommendations of the IACUC, as well as administrative or legal actions taken by the committee or the Institutional Official, are considered privileged information and may be released only through official channels, or as required by law. Willful mistreatment or abuse of animals may be grounds for suspension of all animal use activities or protocols involved, or other disciplinary actions. Disciplinary action may be appealed through existing procedures. This policy will be distributed to all personnel involved in animal research and will be posted in vivaria, in departments where animals are used, and in public areas where animals are transported. Statutory authority for this instruction is found in the 1985
Amendment to the Animal Welfare Act Title 7, United States Code, Section
21312156, PL99198. The act requires that "...training for scientists,
animal technicians, and other personnel involved with animal care ... shall
include ... methods whereby deficiencies in animal care and treatment should be
reported." *University Policy on the Use of Animals in Research and Teaching (October 15, 1984), University Policy on Integrity in Research (June 26, 1990), and UCR Policy on Integrity in Research (October 15, 1990).
SEPARATE ANIMAL USE PROTOCOLS (AUPs) FOR BREEDING COLONIESBackground:
According to federal regulations, all breeding colonies* at UCR must be covered
by an AUP. However, there is often confusion related to filling out the
AUP when the breeding colony and the animals to be used in actual experiments
are discussed in the same document. This is due to the different answers
required by some of the questions depending on whether breeding or research
animals are being discussed. Policy:
Unless otherwise justified by the investigator, separate AUPs will be required
for breeding colonies and for the animals actually used in the research project.
The AUP for the breeding colony should cover all breeders and all animals
produced by the colony regardless of whether the animals are used for research
or not. The instructions and AUP form for breeding colonies will be
modified as appropriate. *A breeding colony is a group of organisms that are producing progeny
for research projects without being part of a research project themselves. Adopted January 22, 2001
OCCUPATIONAL HEALTH PROGRAM - POLICY ON ENROLLMENT
Background:
The Chancellor’s Committee on Laboratory Animal Care (IACUC) review of Animal
Use Protocols (AUPs) includes a mandatory assessment of occupational and
environmental health risks. In some cases, enrollment in the Occupational
Health Program (OHP) may be recommended or required for some AUP participants. 12/8/00
Mouse Antibody Production (MAP), Rat Antibody Production (RAP) or
Guidelines for Aseptic Rodent SurgeryThe guidelines for rodent surgery are based on the Guide for the Care and Use of Laboratory Animals and 9 CFR, the Animal Welfare Act (AWA). 1,2 Part 2 of the AWA states that all survival surgery on rodents must be performed using aseptic procedures. This means that survival surgery on rodents should be performed using sterile instruments, surgical gloves, masks and aseptic procedures. The goal of this requirement is to reduce the microbial contamination of exposed tissues to the lowest practical level. Minor surgical procedures such as wound suturing and peripheral vessel cannulation should be performed in accordance with standard veterinary practices.1 In most instances, this will require aseptic technique, sterile instruments and appropriate anesthesia. A separate room for rodent surgery is not necessary. PROCEDURES 1,3,4,5 Pre-Operative 1. Surgery may be performed in the laboratory but should be done in an uncluttered area dedicated to the procedure while it is being performed. The area should be disinfected before use. (Table 1) 2. Withholding food prior to surgery is not necessary in rodents unless the protocol or the surgical procedure requires it. 3. The animal should be anesthetized using an appropriate inhalant or injectable anesthetic. The use of a local anesthetic such as bupivicaine at incision sites should be considered. The use of analgesics is encouraged. Administration of analgesics and antibiotics prior to the beginning of surgery can enhance their effectiveness. Contact the Campus Veterinarian or the Laboratory Animal Training Manual for more information on the use of various anesthetics and analgesics. 4. As soon as the animal is anesthetized ophthalmic ointment should be applied to the eyes to protect the corneas. 5. The area of the incision should be prepared aseptically. The animal's fur should be removed from the area where the incision will be made leaving a clear border of at least 1 cm around the incision site. The clipping should be done in an area separate from where the surgery is to be conducted. Fine bladed clippers, a razor blade or plucking may be used. Loose fur should be removed with a vacuum or damp towel. 6. The skin in the area of the incision should be scrubbed with a povidone-iodine scrub (e.g., Betadine),working from the center to the periphery of the site. The site should then be rinsed with 70% alcohol. At least three alternating preparations of germicidal scrub and rinse are considered adequate. The area should be draped with sterile drapes. 7. Surgeons should scrub their hands with a surgical soap before aseptically donning sterile surgical gloves. Operative 1. The animal must be maintained in a surgical plane of anesthesia throughout the surgery. Procedures should be in place to maintain the animal's body temperature with supplemental heat. This can be supplied with warm water blankets or bottles. Bubble wrap can also be used to maintain body heat but is not very effective in warming an animal up. 2. Surgery must begin with sterile instruments (Table 2) which are then handled aseptically. 3. The animal's vital signs should be monitored and maintained on an ongoing basis. 4. Tissues exposed for long periods of time should be kept moist with warm saline or lactated Ringers solution. If the surgery is prolonged or the animal has lost more than a small amount of blood, these same fluids should be administered subcutaneously or intraperitoneally to prevent dehydration and volume depletion. 5. The surgical incision should be closed using appropriate technique and sterile absorbable or non-absorbable material as appropriate. (Table 4) Post-Operative 1. After the surgery is completed, move the animal to a warm, dry area and monitor it during recovery. Supplemental heat, again with warm water blankets, bottles, or bubble wrap to maintain body heat, should be provided until the animal has recovered from anesthesia. Only at this time should the animal be returned to its routine housing. Heat lamps or electric blankets are discouraged as they may become too hot. If they must be used, a somnolent animal must be turned frequently to prevent over heating or burns. Space should be available so that an awake animal can escape the heat if it becomes too hot. 2. The animal should be watched until it can maintain sternal recumbancy and can hold its head up. 3. Provide analgesics as appropriate. 4. Generally, remove skin closures 7 to 14 days post-operatively. 5. Observe the animal daily for at least the first 5 days. Maintain a surgical record (e.g., annotate cagecard with procedure and date. Record anesthetic, analgesic, antibiotic administration and animal's condition on cage card or in lab notebook). References 1. Guide for the Care and Use of Laboratory Animals, National Research Council, National Academy Press, 1996. 2. Animal Welfare Act, 9 CFR Part 2. 3. Laboratory Animal Anesthesia, Second Edition. P.A. Flecknell. Academic Press, 1996. 4. Anesthesia and Analgesia in Laboratory Animals. D.F. Kohn, et al Eds. Academic Press, 1997. 5. Experimental and Surgical Technique in the Rat, Second Edition. H.B. Waynforth, P.A. Flecknell. Academic Press, 1992.
TABLES Table 1. Recommended hard surface disinfectants.
Table 2. Recommended instrument sterilants
All instruments must be rinsed thoroughly with sterile water or saline to remove chemical sterilants before being used. Always follow manufacturer's directions. Table 3. Recommended Instrument Disinfectants
Instruments must be rinsed well with sterile water or saline to remove chemical sterilant before being used. Always follow manufacturer's instructions. Table 4. Suture selection
Note that some synthetic sutures are absorbable. Use the smallest gauge suture material that will perform adequately. For rodents, this is usually 3-0 or higher. Use suture that is attached directly to the needle, swedged on. Use cutting, or reverse cutting needles with sharp edges for dense, tough tissue such as skin. Use non-cutting taper point or round needles for soft tissue such as muscle or intestine.
WIRE BOTTOM CAGES FOR HOUSING
RODENTS
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