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Note - All Faculty, students and research or
technical staff who wish to engage in research involving the use of
vertebrate animals, must satisfactorily complete the orientation and
have their role identified on a IACUC approved protocol PRIOR to
participating in any animal-related activities and PRIOR to obtaining
access to the animal facility. No exceptions will be made and
until orientation is completed, work with animals is prohibited.
Non-faculty members must be sponsored for orientation by a faculty
researcher, preferably the project principal investigator.
This tutorial will discuss several aspects of humane care and use of animals in research. It will also provide a set of general guidelines for the facilities comprising the MMC animal research program. When this tutorial is completed, follow the instructions for completing the orientation process and taking the facility orientation. Further and/or specific information about facility functions and standard operating procedures (SOPs) are available through the Animal Care Office. |
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Ethical Treatment of Animals - Different members of our society hold widely diverging views about the relative value of animals compared to humans. These views may be held on moralistic, emotional or practical grounds. A majority of people value the emotional and practical aspects of using animals to benefit humans. These uses include food, clothing, companionship, work, sport, and the investigation of the basic processes of life, disease and death. People also recognize that any of these uses may cause pain or distress to animals, and feel that humans have a moral obligation to minimize the consequences of their activities. Thus, the humane care and use of animals used for research, testing and training is considered a moral obligation. There are also compelling scientific reasons why animals used for research should be treated humanely. Pain and stress can drastically alter the physiologic state of animals. Distress results when animals are no longer able to adapt to changes in their environment or physiological condition and display maladaptive or abnormal responses. These responses are not predictable and thus represent an uncontrolled experimental variable. Numerous studies have shown that prevention of pain or distress results in improved experimental results. Simply said, good animal care and use is good science.
Committee Review Process - Copies of final protocols are distributed to IACUC members by the IACUC secretary in advance of the meeting. At the meeting, IACUC members discuss each individual protocol and evaluate it for adherence to animal welfare laws, regulations, and policies. IACUC approval voting is by consensus. The possible actions taken by the IACUC are: Approved (self explanatory), Conditionally Approved (minor points require clarification or correction but the protocol is generally satisfactory), Deferred (there are some major areas of concern that may require in-depth discussion and resolution), and Disapproved (the protocol, as submitted, is not acceptable and must be extensively revised and resubmitted as a new application). After a convened meeting is held, committee actions are recorded in the IACUC minutes. The secretary of the IACUC sends written notification to the investigator of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure approval. When approval is granted, a copy of the notification letter in addition to all IACUC records, are placed on file in the Office of Sponsored Programs for review by Federal and State agencies responsible for animal welfare . If the IACUC decides to withhold approval of an activity, the notification includes a written statement of the reasons for its decision. The investigator is given an opportunity to respond in person or in writing prior to/or at the next convened meeting. Investigators may be contacted by committee members to clarify points and/or negotiate changes in the protocol. For Conditional Approvals, once the IACUC secretary has received the investigator's response to the IACUC, approval may be granted before the next convened meeting. Research may not be initated or continued until full approval is granted. For Deferred protocols, the investigator's response must be reviewed by all members at the next committee meeting. It is important to remember that the approval process is one of discussion and negotiation between the IACUC and investigators in order to promote research while maintaining high standards for animal welfare. Protocol
Approval and Expiration - Approval is for a period of
ONE YEAR. An annual protocol review consists of review of an IACUC
protocol that is methodologically identical to the protocol previously
approved within the last 12 months.These protocols are reviewed as a
"continuing submission". Principal investigators must complete an annual review form which
indicates that no substantive changes have taken place and provides the
following information: IACUC approval number, IACUC approval date,
title of the project, species used, number of animals to be used in the
current year, number of animals to be used in the overall project,
identify any changes in personnel ( including qualifications) whose
activities on the project involve contact with animals. The annual protocol review process is initiated by submitting an Annual Review Form to the IACUC office. This form is sent to Scientists by the IACUC Secretary approximately three months prior to the anniversary of the last approval. Ten copies of the completed form should be submitted to the IACUC Office two weeks before a regularly scheduled meeting. As PHS policy requires, a complete (de novo) protocol review and approval by a convened IACUC meeting is conducted for all protocols every 3 years from date of initial approval. Conditions of review and information required is the same as that for new submissions for IACUC approval. Investigators must secure prior approval from the IACUC before making any substantive revisions to the experimental procedures. Substantive procedures are those which effect animal health or welfare. Guidelines for reporting changes are available. Searching
for Alternatives- Federal policy requires that
scientists conduct a search for alternatives for any procedure that
causes more than momentary pain or distress. Searching
for Alternatives in Animal Research reviews the principles involved
in conducting a search which fulfills the regulatory requirements.
VETERINARY OVERSIGHT The IACUC is
responsible for supervising the use of animals at MMC and has
authorized the attending veterinarian to oversee all procedures.
Immediate veterinary supervision is provided by the Animal Care
Manager. Animal
Care technicians conduct daily husbandry rounds at which time any
abnormalities are noted and entered in a facility daily observation
journal in addition to being reported to the Institutional Veterinarian
and Manager.
All problems are addressed immediately. Inspection of physical plant
and clinical rounds of all animals is carried out weekly by the
Manager. Routine inspections are made of sites where surgical
procedures are conducted. The Institutional Veterinarian must have
access to all
animals to ensure that daily observations of the animals are performed
by qualified individuals. The IACUC is required to stop any research
project wherein non-compliance is suspected. After regular work hours,
the Veterinarian, and Manager are available by cell phone for
emergencies.
RECORD KEEPING Daily activity sheets are posted in each room and include all husbandry activities, and environmental parameters. At the end of each month, the daily activity sheets and census sheets are filed in the facility office. Individual clinical records are maintained in the facility office for all USDA covered species. Observations, clinical laboratory findings, diagnosis, treatment and progress notes are entered by the Animal Care staff, and research staff. The date and name of any procedure performed on rodents is noted on the front of the cage cards. The USDA requires that a log of intra- and post-operative monitoring be maintained for all USDA covered species and that these records be available for review during unannounced government inspections and during semi-annual IACUC inspections. Forms to be used for intra-operative monitoring are also available from the Animal Care technicians. The Veterinarian routinely monitors these records for adequacy of anesthesia/analgesia and post-operative practices. ANESTHESIA MONITORING FORM The USDA and IACUC require that intra-operative records are kept for all covered species (lagomorphs and above) undergoing either survival or non-survival surgery. These records are used to document an adequate plane of anesthesia for the surgery being performed and to provide evidence that the support procedures are consistent with "current veterinary practice." Corneal or palpebral reflexes should be obtained prior to beginning the procedure and baseline HR and/or RR should be recorded. Redosing of anesthetic agents may be required during prolonged procedures. Overdosage may lead to cardiopulmonary arrest. Thus, the depth of anesthesia must be monitored frequently, approximately every 15 minutes, using appropriate methods, during the entire course of the procedure. The data from this monitoring must be entered on the anesthesia monitoring form. Records of the pre-anesthetics and anesthetics employed, the use of IV therapy, respirator use, extubation time, etc., would assist the Veterinarian in determining appropriate therapy in the event of a problem with the animal. It is important to remember that this form is subject to Federal, State, and institutional review during an unannounced inspection. For some types of non-survival surgery the recording interval may be longer than the 15 minutes noted above. Deviations from the 15 minute rule must be approved by the IACUC. POST-OPERATIVE RECORD KEEPING Post-operative care as specified in the research protocol must be documented on the Post-operative Record Form. It is important that each aspect of post-operative care be adequately recorded. Thus, for example, if the protocol specifies three days of post-operative analgesia, then the administration of at least three days of analgesics must be documented. Likewise, general observations, special tests, wound care, etc., must be recorded. On covered species, these records are subject to review during unannounced inspections by Federal, State, and institutional inspectors. It is important to remember the rule used by most inspectors, "if it is not written down, it was never done." In addition, the Veterinarian and veterinary technicians are better able to evaluate the status of an animal if they are aware of treatments that have been provided by the investigator or his/her staff. The Animal Care Post-operative Record Keeping Form should be used to record treatments. SCHEDULED DRUGS It is the responsibility of the Principle Investigator to provide and maintain records of use for all scheduled drugs in accordance with DEA requirements. Animal Care does not provide scheduled drugs for investigator use. MUSCLE RELAXANTS Muscle relaxants (e.g., succinylcholine or other curariform drugs) are not anesthetics. They must never be used alone for surgical restraint, although they can be used in conjunction with drugs known to produce anesthesia and analgesia. It is strongly recommended that the investigator consult the Veterinarian prior to initiation of a study employing muscle relaxants. ANESTHETIC, ANALGESIC, AND TRANQUILIZER REQUIREMENTS Federal law requires that appropriate anesthetics or analgesic drugs be used in animal experiments involving more than momentary pain and distress. Each proposed animal project is reviewed by the IACUC and the description of the project must list the analgesic and anesthetic agent, including the method for inducing and maintaining anesthesia. There are specific record keeping and monitoring requirements when anesthetics are employed in a study. Investigators are referred to the publications of the American Veterinary Medical Association for anesthesia guidelines. These documents are available on request from Animal Care. The Veterinarian is available to assist in the determination of appropriate anesthesia or analgesia. Reporting Violations or Abuse (Whistleblower
Policy) OFFICE HOURS The Animal Care Office and the Animal Facility are open from 8:30 am - 4:30 pm, Monday through Friday. You may contact the Animal Care Manager at fblanco@montefiore.org. During these hours Animal Care Technicians will be on site to provide animal care and technical assistance. Technical assistance may be arranged in advance by submission of the technical services request form to the facility supervisor. Any assistance that is required beyond these times can be scheduled through the central office. STANDARDIZED FORMS FOR USE IN THE ANIMAL FACILITY
PER DIEMS AND FEE FOR SERVICE To defray the expenses for animal care, a system of per diem charges for the maintenance of all experimental animals housed in the MMC Animal Facilities has been instituted. The rates reflect the direct costs related to keeping animals, including: food and bedding, but do not offset the cost of diagnostic work, technical supplies and procedures which are charged on a fee for service basis. Census records of all animals on a protocol are kept by Animal Care staff. Charges are based on the deduct system in which a valid count will be conducted weekly and at the end of each month by the Animal Care technician. When Investigators and/or their staff remove animals, they will are responsible for indicating this on the appropriate housing record in the housing room; Animal Care staff will add this information to the census records. Bills are distributed monthly and are calculated as the total number of care days multiplied by that species per diem rate. SECURITY The animal facilities are protected and monitored 24 hours a day, seven days a week. Access can be obtained only after completion of the Animal Welfare Orientation process has been completed. VISITORS Visitors to the animal facilities who have not completed the Animal Welfare orientation process are not permitted in the facilities unless they have received prior approval from the Animal Care Director. The health and TB test status of any potential visitors must be reviewed to protect the visitor and to prevent the exposure of research animals and personnel to adventitious agents from the outside environment. Approved visitors must be escorted at all times.Top FACILITY INSPECTIONS The facility is subject to unannounced inspections by the USDA and by the New York State Department of Health. Upon arrival, regulatory personnel should be taken directly to an Animal Care representative according to the following priority list:
Do not allow a person who introduces themselves as an inspector to move about the floor unescorted or to enter any animal or laboratory area until he/she has been identified by one of the above. By law, inspectors may enter any animal housing area or laboratory where animal studies are conducted. While access to an area cannot be denied if the inspector requests entry, the inspectors usually are sensitive to the needs of investigators regarding disruption of an on-going experiment. LABORATORY INSPECTIONS Both the Office of Laboratory Animal Welfare (NIH) and the United States Department of Agriculture policies and regulations require that every animal study area be inspected twice a year by the MMC IACUC. Animal study areas are defined as any area where animal research activities are conducted. At intervals of no more than six months, a sub-committee of the IACUC will inspect all laboratories using the NIH Guide and the USDA regulations as standards. Deficiencies will be given an adequate period of time for correction. The results of these inspections will be included in the IACUC's mandated semi-annual inspection report and kept on file at Animal Care and the Office of the Institutional Official for review by Federal and State Regulators during their unannounced inspections. HAZARDOUS MATERIALS Approval for use of any hazardous agent must be obtained from the MMC Office of Environmental Safety. In addition, consultation with the Animal Care Manager is required to establish operating procedures for work with the specific biohazardous agent within an animal facility. Disposal of hazardous materials must be done according to guidelines from the Office of Environmental Safety. ETHER The use of ether for animal anesthesia is prohibited due to its explosive nature. Inhalant alternatives that can be used for rodents are isoflurane, halothane and CO2 gas narcosis. All volatile anesthesia must be used in ventilated hoods or with an appropriate scavaging device. SHARPS Hypodermic needles and scalpel blades are to be place in red plastic sharp boxes in animal facilities. Hypodermic needles are to be placed UNCAPPED into the receptacle. Animal Care technicians dispose of filled sharps containers. VERMIN CONTROL The control of vermin (arthropods and wild rodents) is essential to the maintenance of a healthful research environment. The vermin control program is maintained on an outsourced basis from a company determined to be experienced in AAALAC accredited facilities. You are requested to report the sighting of any vermin to an Animal Care technician. SURGICAL WASTE All surgical waste including hair clippings, masks, gauze, gloves, etc. should be accumulated in a red medical waste plastic bag at the site and placed in a medical waste box immediately upon completion of the procedure. Under no circumstances is animal waste or procedural material to be placed in regular waste-paper baskets, or in the carcass freezer. Top IACUC PROTOCOL REVIEW Every research project involving animals must have received prior IACUC review and approval. How to apply for approval of a study using vertebrate animals can be found on the Institutional Animal Care & Use Committee page. The IACUC site contains the details of the submission process, and links to: the Animal Care and Use Form, various regulatory and information sources, information on how to report animal abuse, and a description of the required search for alternatives. It is the responsibility of the IACUC to determine that the proposed research is consistent with and federal and state guidelines on the care and use of animals in research. Approval usually takes a minimum of one month. New protocols must be reviewed by the Animal Care Manager and the Veterinarian prior to submission. ANIMAL SOURCES Purchase of rodents is limited to specific pathogen free (SPF) sources to maintain virus antibody free (VAF) colonies. The animal facility maintains a list of approved animal vendors. VAF rodents with accompanied detailed health screens are added to the colony. Scientists wishing to receive rodents from non-commercial colonies (e.g., transgenic, knock-out) must obtain a current animal health report from the source institution and submit it along with the animal order form. Animals must be free from all pathogens that would potentially threaten the health of the MMC colony. This determination is made by the Director of Animal Care and if accepted, these animals will be subsequently quarantined for a minimum of 3 weeks. Scientists may not come in contact with any animals in quarantine. ANIMAL PURCHASE REQUESTS The
purchase of all research animals is coordinated by the Animal Care
office. This ensures regulatory compliance, availability of space, and
maintenance of existing animal colony health. Animal purchase requests
are to be submitted to the animal facility office (blank forms are
available) at least 14 days in advance of the desired delivery date.
The requests should be completely filled out and signed by the
Principal Investigator; the project title and protocol number assigned
by the IACUC must appear on all requests. Only requests with currently
approved IACUC protocol numbers will be accepted. An Animal Care
technician will be able to advise on vendors and terms of delivery. To
order species other than rodents and rabbits, contact the Animal Care
Manager directly. Requests which would raise the total
number of animals ordered (cumulative) above the number approved
by the IACUC will not be honored. ANIMAL CAGE ASSIGNMENTS Upon arrival, Animal Care technicians will house animals in appropriate holding rooms. Investigators may find the location of their animals within the facility by checking cage animal identification cards. The I.D. cards are also medical records for rodents. Higher phylogenetic species have individual charts. Cage I.D. cards contain the investigator's name, IACUC approved protocol number, species, unique animal ID number, vendor source, arrival date, and a running log of all activities and procedures performed on the animals housed in the designated cage. These activities and procedures must be listed by date and title (i.e., 5/20/05 - blood collection 0.5mls). All procedures must be in accordance with those stated in the protocol designated on the cage card. Any deviation from use of animals as identified in the approved protocol will be grounds for termination of the project and removal of the animal. Alterations in animal use can be made through a protocol amendment submitted to and approved by the IACUC. ANIMAL HEALTH PROGRAM Animal technicians will check the health status of all animals on a daily basis 365 days a year. When indicated by monitoring schedules in IACUC approved protocols, investigators and research technicians are also responsible for checking the animals health status and for reporting any animals showing signs of illness to the Animal Care Technician immediately. The Animal Care Technician will place a "red flag" card on the cage and will notify the Veterinarian. Animal Care maintains individual records for all animals. A sentinel program, conducted quarterly, is implemented for rodent species. The sentinels are examined for ecto- or endo-parasites and for seroconversion to a panel of selected viruses. Microbiology panels are evaluated when warranted in animals with clinical disease. ANIMAL REMOVAL When an animal is removed from the housing facility for any reason, its animal identification cage card must accompany the cage at all times. Upon return of the animal and the cage to the facility, the cage card must be present; no other form of identification will be accepted. When an animal is euthanized by the research staff, its cage card must be marked accordingly and submitted to the facility office. If a scientist is granted IACUC approval to transfer an animal to a different owner, an animal transfer form must be completed and submitted to the Animal Care office. Animal Care staff will implement the transfer and will create a new cage card. EUTHANASIA When an animal's use has ended, it must be humanely euthanized in accordance with guidelines established by the Report of the AVMA Panel on Euthanasia in the manner indicated in the IACUC approved protocol. Requests for Animal Care assistance for animal euthanasia must be submitted in writing on technical service request forms to the facility office at least 2 days prior to the date needed. Technical request forms may be obtained from the facility office. SPECIAL CARE In general, it is the responsibility of the facility staff to provide for the daily routine care of all animals. When it is necessary to temporarily withhold food or water, the Animal Care staff must be notified in advance so that special instructions can be posted. Special care procedures are generally the responsibility of the researcher.The Animal Care staff may be requested by the researcher to perform technical services on a fee-for-service basis. Technical requests must be submitted in writing on an Animal Care "technical request" form at least one week in advance, the exception being requests for euthanasia which is to be submitted 2 days in advance. SURGERY Both the Animal Welfare Act and the Department of Health and Human Services have written, minimum "standards" for providing care before, during and after surgical procedures. A project that involves more than momentary or slight pain or distress must involve the veterinarian in the planning stage. Once a research project has begun, all surgical techniques (rodent and non-rodent species) are monitored by the Veterinarian at least once a year. Surgery on non-rodent USDA covered species cannot be independently conducted by the investigator until the Institutional Veterinarian has observed and approved the surgical technique at its initiation. On-line training modules and personalized training or assistance is available through Animal Care. A dedicated surgical facility is available through Animal Care for non-rodent species. Rodent surgery may be performed in a IACUC approved laboratory area. Aseptic surgical technique must be followed for all survival surgical procedures. EMERGENCIES-PROBLEMS All reports of problems such as sick animals, unsanitary or dangerous conditions, or any other irregularities in the facility should be reported to the Animal Care Manager and Veterinarian as soon as possible. Since these condition have the potential to disrupt research, the appropriate researchers are also notified by Animal Care Technicians. An Animal Care contact sheet with emergency pager numbers are posted in each animal facility, security and engineering offices. For physical plant emergencies, all relevant building personnel are trained in procedures to be implemented in the event of a emergency in the facility. Praise or complaints about the general operation of the facility and requests for additional space or services should be directed to the Animal Care Manager or Director. Top This site has been established to provide access to all Federal, State, and Institutional animal welfare laws, regulations, policy and guidelines concerning vertebrate animals used in research and teaching. In addition, the latest versions of Animal Care record keeping and IACUC protocol review forms are available for downloading. Finally, information on alternatives searching and links to other animal welfare-related informational sites have been provided. For comments or questions regarding this site contact the Webmaster |