The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Introduction The use of animals in research and teaching is a privilege that requires unique professional and moral obligations. The University of Texas at Arlington is dedicated to supporting the education and research mission of the University while maintaining compliance with federal and state animal care principles, guidelines, and regulations. The University of Texas at Arlington’s Animal Care and Use Program encompasses all animals used by the University for research, testing, and education. The purpose of the Animal Care Facility Policy and Procedure Handbook, hereafter “the Handbook,” is to provide investigators with information, resources, and guidance to appropriately conduct animal research in accordance with the federal animal welfare regulations and University policy, while continuing to promote the University’s overall research vision. An “animal facility” is any area or space subject to the oversight of the University’s Animal Care and Use Program. This includes space in the University’s centralized animal care facility or approved satellite facilities which may be used for animal procedures, surgery, housing, holding areas, animal displays, or teaching/classroom areas that utilize animals. References to the University’s “Animal Care Facility” or “ACF” include all approved facilities. The Animal Care and Use Program reports administratively to the Vice President for Research and is composed of three main branches: Research Administration, the Institutional Animal Care and Use Committee (IACUC), and members of the University community who use animals in their research. Research Administration The Animal Care and Use Program is centralized under the Office of Research Administration, reporting to the Vice President for Research. Research Administration is responsible for administrative oversight and management of the Animal Care Facility including procurement, veterinary care, facility maintenance, budgeting, per diem, and general husbandry of animals used by the University. Research Administration is also responsible for oversight, establishment, and coordination of the Animal Facility Operations Committee. IACUC The University of Texas at Arlington’s Institutional Animal Care and Use Committee (IACUC) provides oversight to the University's animal care and use programs, facilities and procedures ensuring the appropriate care, use and humane treatment of animals being used for research, testing and education. The IACUC is responsible for reviewing all requests for approval to use vertebrate animals, ensuring compliance with federal regulations. The IACUC also performs inspections of all approved animal care facilities, and oversees training and educational programs. Animal Researchers The University of Texas at Arlington is dedicated to achieving and maintaining the highest standards of excellence in its Animal Care and Use Program. The faculty and staff of the Animal Care Facility recognize 2 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 and commit to meeting their responsibilities to ensure that these high standards are translated into the provision of outstanding husbandry and medical care to all animals at the University. In turn, every person using animals, whether investigator, technician, student, or instructor, must be aware of and abide by their attendant obligations to assure that animals utilized by the University's programs are used in a humane manner. 3 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Animal Research Regulatory Requirements and the Institutional Animal Care and Use Committee 4 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 I. LAWS, POLICIES, AND STANDARDS RELATING TO THE HUMANE CARE AND USE OF ANIMALS A. Animal Welfare Act The Animal Welfare Act of 1966 and its amendments regulate the transportation, purchase, sale, housing, care, handling, and treatment of animals used in research and teaching, for exhibition, and sold by commercial enterprises as pets. The Act specifically includes dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, wild animals (excluding birds and cold-blooded), and any other warm blooded animals that the Secretary of Agriculture determines are being used or are intended for use for research, experimentation, testing, teaching, exhibition purposes, or as pets. Farm animals used in biomedical research is subject to the provisions of the Animal Welfare Act. Historically, the Secretary has not regulated rats, mice and birds; however repeated lawsuits are being heard in Federal Court which attempt to change this policy. The Act addresses such issues as exercise for dogs, obtaining dogs and cats from sources which have complied with holding periods, care of nonhuman primates to ensure their psychological well-being, the composition and duties of an institutional animal care and use committee (IACUC), adequate veterinary care and responsibilities of the attending veterinarian, record keeping and training of all personnel using laboratory animals in humane methods of animal maintenance and experimentation. The Institutional Animal Care and Use Committee (IACUC) must be composed of one (or more) veterinarian, one (or more) person unaffiliated with the institution other than by IACUC membership, and one (or more) scientific members. The IACUC is responsible for reviewing all activities using animals to make certain that they meet criteria listed in the law. In addition, the IACUC must conduct semiannual programmatic reviews and inspections of all animal study areas and animal facilities to ensure that facilities comply with standards and that there are no significant deviations of research practices from the originally approved protocols. The Animal Welfare Act is administered by the United States Department of Agriculture (USDA), specifically, the Regulatory Enforcement and Animal Care branch (REAC) of the Animal and Plant Health Inspection Service (APHIS). Research facilities are subject to unannounced inspections by USDA veterinarians and are required to furnish annual reports that include, besides other information and assurances, the common names and numbers of animals used listed by procedures involving: (a) no pain or distress (routine procedures which produce only momentary pain, such as injections are included in this category), (b) pain or distress for which appropriate anesthetic, analgesic or tranquilizing drugs were used, and (c) pain or distress for which the use of appropriate drugs would adversely affect the procedures, results, or interpretation of the research. The report must certify that anesthetic, analgesic, and tranquilizing drugs were used appropriately during research and testing and that the principal investigator has considered alternatives to painful procedures. 5 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Noncompliance with USDA standards for the humane handling, treatment, and transportation of animals may lead to substantial fines and/or suspension of animal research activities. Mailing Address: Secretary of Agriculture, U.S. Department of Agriculture, Washington, D.C. 20250, or call 1800-245-6340 (voice) or (202) 720-1127 (TDD) B. Public Health Service Policy on Humane Care and Use of Laboratory Animals The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals incorporates the changes in the Public Health Service Act (PHS Act) mandated by the Health Research Extension Act of 1985, public law 99-158. The PHS Policy requires that each institution receiving PHS funds for research involving animals submit detailed information regarding the institution's program for the care and use of animals (including farm animals, mice, and rats) to the Office of Laboratory Animal Welfare (OLAW). This information is in the form of an Animal Welfare Assurance, which is updated annually and must be resubmitted at least every five years. Significant changes in existing assurance status or problems encountered in implementing this policy must be reported immediately to the OLAW. C. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Teaching, Research, and Training The U.S. Government Principles for the utilization and Care of Vertebrate Animals Used in Testing, Research, and Training were developed by the Interagency Research Animal Committee (IRAC). These principles are consistent with guidelines that have been adopted for laboratory animal care and use at The University of Texas at Arlington. D. Guide for the Care and Use of Laboratory Animals In 1962 NIH contracted with the National Academy of Sciences Institute for Laboratory Animal Resources to develop what is now called Guide for the Care and use of Laboratory Animals (The Guide). The Guide underwent its sixth revision in 1996. The Guide’s purpose is to help scientific institutions in using and caring for laboratory animals in ways judged to be professionally appropriate. The Public Health Service requires institutions to use The Guide as a basis for developing an institutional program for activities involving animals. The Guide for the Care and Use of Laboratory Animals is also used by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) as a basis for its accreditation of institutions. E. Good Laboratory Practice Act The Good Laboratory Practice (GLP) regulations pertain to non-clinical laboratory studies done in support of applications for research or marketing permits for products regulated by the Food and Drug Administration (FDA). The GLP regulations, as they apply to the use of animals, address such issues as construction and maintenance of facilities, quarantine and isolation, disease diagnosis and treatment, animal identification, caging and routine care, sanitation, and documentation requirements. 6 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 The FDA recognizes the importance of the humane care of experimental animals. The FDA stance on animal experimentation has been published on the Non-clinical Laboratory Studies, Good Laboratory Practice Regulations, and Federal Register. Vol. 43, No. 247, pg. 60003, December 22, 1978. The following excerpt from these regulations describes the FDA policy as regards to humane care and use of experimental animals: The issue of using animals in laboratory experiments designed to establish the safety of regulated products has been raised many times in the course of agency rule making. The position of FDA has been consistent on this issue. The use of animal tests to establish the safety of FDA regulated products is necessary to minimize the risks from use of such products by humans. The humane care of test animals is a recognized and accepted scientific and ethical responsibility and is encouraged both by various agency guidelines and the Animal Welfare Act. The good laboratory practice regulations should, in fact, encourage the humane treatment of animals used in non-clinical laboratory studies by establishing minimum requirements for the husbandry of animals during the conduct of such studies. In addition, there should occur a reduction in the amount of animal testing that has to be repeated or supplemented because the original studies were inadequate or inappropriate to establish the safety of FDA regulated products. F. Controlled Substances Act Potentially addictive or habituating drugs for human or animal use are classified under this law. Examples of controlled substances include barbiturates and narcotics. The Department of Justice, Drug Enforcement Administration (DEA), enforces this law and requires appropriate security and record management of these substances. Information regarding a DEA license can be found at: http://www.deadiversion.usdoj.gov/drugreg/process.htm. G. American Veterinary Medical Association (AVMA) Panel on Euthanasia The recommendations of the AVMA Panel on Euthanasia (2000) are the prime reference for methods of euthanasia of animals. The methods of euthanasia recommended by the American Veterinary Medical Association (AVMA) Panel on Euthanasia are considered acceptable by both the NIH Policy and the Animal Welfare Act. II. INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) A. Membership By mandate of the Animal Welfare Act and PHS Policy, each institution using animals must have a committee to oversee animal care and use. The membership of these committees must include a Doctor of Veterinary Medicine with experience in laboratory animal medicine, an individual who is not otherwise affiliated with the institution, and practicing scientists who are experienced in research involving animals. The University of Texas at Arlington’s Institutional Animal Care and Use Committee (IACUC) acts as the regulatory arm of the animal care and use program. The Committee performs all duties as outlined by the PHS Policy and Animal Welfare Act including reviewing all studies, classes, and experiments which require the use of any vertebrate animal species. 7 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 B. IACUC Policy A separate and distinct UT Arlington IACUC Policy is available which details the IACUC’s functions and responsibilities. Each Investigator should obtain a copy from the Office of Research Administration website: http://www.uta.edu/ra/oric/animal/forms/UTA_IACUC_Policy_Manual.doc. C. Committee Actions The IACUC meets once a month for protocol review, and at least two meetings each year are dedicated to reviewing the Animal Care and Use Program and Animal Care Facilities. The Committee makes recommendations concerning needs for physical deficiencies, which need correction, or for reviewing any other problem or concern related to animal care and use. The Committee makes semi-annual inspections of all facilities and laboratories where animals are kept for longer than 12 hours. The Committee, or its designate, inspects research laboratories to observe surgical procedures and other studies to assure that animals are being used according to approved methods and are receiving humane treatment. In an effort to assist investigators in maintaining compliance with all laws and policies, the Institutional Animal Care and Use Committee (IACUC) has authorized UTA Animal Care Facility personnel to visit research laboratories. Animal Care personnel will examine issues such as: transport to and from the laboratory, areas for holding animals within the laboratory, surgical or procedural techniques, care during recovery, training of research staff, drug use and storage, and methods for humane euthanasia. Following the laboratory visit, Animal Care personnel may request the investigator to amend the protocol to reflect current laboratory practices and personnel. In an effort to better serve the investigator, research staff should use these visits to detail any problems or concerns they have with the Animal Care Program. D. Protocol Review Prior to initiation of any project, class, testing procedure, or any other use of animals, the IACUC must review and approve the use of the animals. The first step in this process is to obtain an Animal Care and Use Protocol Form by downloading it from the Office of Research Administration website http://www.uta.edu/ra/oric/animal/forms/AnimalSubject/IACUC_Form_2003_WD_Template.doc or by contacting Regulatory Services in the Office of Research Administration (202 E. Border, Suite 201 or 817-2723723). The form is completed by the investigator and returned to Regulatory Services. When an NIH sponsored research project is involved, Regulatory Services will obtain the PHS grant proposal form and compare it for consistency with the IACUC Protocol Application as an assurance to PHS policies. F. Reporting Deficiencies in Animal Care and Treatment Complaints or concerns regarding the care and use of research animals or charges of animal abuse should be made directly to the Office of Research Administration either verbally or in writing (817-272-3723, Box 19188). Concerns may also be addressed to the Chairperson of the Institutional Animal Care and Use Committee (iacuchair@uta.edu), an IACUC Committee member, the Animal Facility Manager/Veterinary Technician (817-272-5236 or acf@uta.edu), or to the Institutional Official (referenced in the Directory section of this handbook). 8 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 If serious allegations of abuse are being made, the Chairperson of the IACUC and the Vice President for Research should also be informed in writing of the charges. Confidentiality will be maintained if requested. The Attending Veterinarian, Office of Research Administration, and IACUC Chairperson will keep persons expressing concerns informed of actions. The Attending Veterinarian, Office of Research Administration, IACUC chairperson, or designee, shall conduct an investigation of the allegations. Investigators, or other personnel, who are the subject of a complaint shall be informed in writing as to the nature of the complaint. Documentation will be maintained, giving the complaint, the review, and action taken to clarify or rectify any problems identified. Employees who bring legitimate concerns to the attention of the University regarding animal care and use are protected under the Animal Welfare Act from retribution by their employer or the University. Contact information to report animal health concerns is posted in the central Facility. 9 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Operational Guidelines for the Animal Care Facility 10 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 III. ANIMAL CARE FACILITY The Animal Care Facility (ACF) is an important resource for UT Arlington to conduct research and teaching activities. As such, the ACF is primarily supported financially and administratively by the University as a whole. Operating as a recharge center, the ACF is secondarily supported by Animal Researchers through partial reimbursement of animal husbandry expenses (per diem). A. Operating Hours / Weekend and Holiday Care The animal facilities husbandry and staff operating hours are 8:00 A.M. to 5:00 P.M. Monday through Friday. On weekends, holidays, and ACF staff vacation / sick leave days, the husbandry will be provided by Office of Research Administration staff (GRA / student workers). The ACF staff will verify on Monday morning or the day following a holiday, vacation day or sick leave day, that the animals were taken care of by checking the husbandry log sheets at every animal room door. The Principal Investigator is responsible for monitoring animals on weekends, holidays, or ACF staff vacation days in special situations, such as after a surgical procedure. B. Training Requirements The Animal Welfare Act was revised in 1985 to include training requirements for personnel working with animals. The IACUC is to administer the training program at each institution. At UT Arlington, the IACUC, through the expertise of the Attending Veterinarian, provides training through the Office of Research Administration to all those who use or care for animals. All researchers (faculty, staff, students, etc.) who will handle animals or animal tissues are required to take the Laboratory Animal Training Association (LATA) Online Training course, specifically the Base Module, the Occupational Health and Safety module and the modules which correspond to the species which they use. In addition, anyone performing survival surgery on a vertebrate species is required to take the session on "Rodent Aseptic Surgery Techniques” and “Anesthesia and Analgesia of Rodents.” The online sessions and log-in instructions can be found on the Research Administration website: http://www.uta.edu/ra/oric/animal/training.htm. In addition to the online training, everyone is required to attend a “hands-on” training/animal facility orientation, which involves demonstrating proper handling and use of laboratory animals that will be in use, a tour of the animal care facility and review of Animal Care Facility policies. The Attending Veterinarian or the on-site ACF staff are always available to assist or instruct in any invasive or handling technique of laboratory animals. Contact ACF staff for scheduling (817-272-5236 or acf@uta.edu). Individuals will not be granted access to the ACF until evidence of training certification is provided. To become certified to enter the Animal Care Facility, you must have on file with the Office of Research Administration your required LATA Online Training Certifications, Certification from ACF staff that the hands-on training and orientation to the Animal Care Facility has been completed (Faculty are exempt from the hands-on training), and a Tetanus Immunization Record reflecting proof of Tetanus immunization within the last 10 years. C. Space Allocation in the Central Animal Care Facility 1. Overview: 11 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 The central Animal Care Facility was established by the University to appropriately meet the needs of investigators conducting animal research studies, while upholding the regulatory requirements and standards of animal care outlined in the Animal Welfare Regulations, the PHS Policy, and the Guide for Care and Use of Laboratory Animals. The central ACF is a shared University resource available to all researchers meeting the eligibility requirements. Administrative oversight and management of the ACF is provided by Research Administration. Research Administration must consider the space and capacity needs of Animal Research Protocols as they are approved by the IACUC. Additionally, department Chairs and Deans must consider ACF space needs for hiring new faculty who conduct or plan to conduct animal research at UT Arlington. It is imperative that users are accountable for efficient use of space and that space allocations are subsequently made based on this use and need. The centralized ACF has limited space and care must be taken to review the utilization, assignment and allocation of space. These guidelines provide Animal Researchers a procedure and describe the considerations given for the allocation of limited space in the ACF. 2. Eligibility: Space in the Animal Care Facility is reserved for UT Arlington researchers/faculty who are actively conducting animal research projects, directing student animal research projects, or faculty teaching courses that utilize animals. 3. Typical Space Allocation Procedures: a. Space Classification – the following classification system will be used to identify current utilization of animal research space: i. ii. iii. iv. v. 0 = Not Utilized 1 = Utilized Primarily for Storage 2 = Under Utilized 3 = Effectively Utilized 4 = Over Utilized Space classifications will be determined primarily by ACF staff who are familiar with the day-to-day operations and utilization of the Facility. b. Requesting Animal Research Space - if specific laboratory space is required for an animal research study, the following options are available: i. Option #1 – the Principal Investigator uses their existing space or makes arrangements with another PI to share existing space. For spaces shared within a department, PIs within that department should coordinate space needs with the department Chair. 12 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Option #2 – the Principal Investigator makes a space request to the ACF staff (817-272-5236 or acf@uta.edu). If possible, rearrangements or moving of animals/equipment is made to prepare available space. iii. Option #3 – the Principal Investigator seeks IACUC approval for a satellite animal facility (housing animals outside of the centralized ACF). Satellite facilities have specific requirements and standards that must be inspected and approved in advance by the IACUC. ii. If options #1 - #3 above are not feasible or appropriate for the project, a space review is initiated with the Animal Facility Operations Committee. 4. Animal Facility Operations Committee: The Animal Facility Operations Committee (AFOC) is comprised of the Vice President for Research (or designee) and Chairs of departments that conduct animal research. This committee is charged with the evaluation and prioritization of specific space requests and space allotments, annual review of ACF accounting and per diem rates, and review of ACF security measures. The AFOC will also advise the University regarding investments for facility upgrades/renovations and purchases of large equipment and instrumentation, and provide assessments of future space and user needs. D. Authorization and Access into the Animal Care Facility Any individual seeking access to the animal care facility must have a justifiable reason and must meet at least one of the following descriptions: Group A A principal investigator, co-investigator, research assistant or student listed on an IACUC-approved protocol A member of the IACUC or ACF staff Institutional Official for Animal Care Group B Federal, state, or local inspecting agencies Campus Police Designated emergency personnel Essential maintenance personnel 1. Group A Access Authorization: a. New faculty must have an approved IACUC protocol to obtain access to the facility. Students must be listed on a faculty-sponsored IACUC protocol under the "Personnel" section. If they are not, the student must be added to the protocol via an Amendment. The Amendment must be signed and submitted by the faculty Principal Investigator. b. Faculty and students seeking access to the Animal Facility must complete all training and immunization requirements (online training requirements, hands-on training and facility orientation, and tetanus immunization). For full instructions, please view the Research Administration website: 13 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 http://www.uta.edu/ra/oric/animal/training.htm. Please note that new protocols and amendments cannot be approved until training requirements have been met. c. Once an individual is listed on an IACUC-approved protocol (or has been added via an amendment) and has completed all training and immunization requirements, they may contact ACF Staff (acf@uta.edu, 817-272-3723) to schedule an appointment. During this appointment, a photo ID badge will be created (this is different than the MavCard) and the individual's MavCard will be activated for access to the animal facility. d. When a student or project personnel completes work, the Principal Investigator should formally delete the individual from their protocol through submission of an Amendment. This will trigger Research Administration to delete the individual’s card access to the Facility. e. Students enrolled in Animal Use Courses will only be permitted into the outer corridor and can only enter into the Student Animal Laboratory. The Faculty Instructor must notify Research Administration of the class to take place and provide a list of students. Research Administration will activate access and issue the students a special classroom badge that indicates their access is for the outer corridor only. Students participating in an animal use course will have card access terminated at the close of the semester. 2. Group B Access Authorization: a. University staff providing safety measures, security, and essential maintenance/construction may require access to the Animal Care Facility. This may include maintenance personnel (Facilities Management or contractors through Facilities Management), emergency/safety personnel (Environmental Health & Safety), and Campus Police. Essential personnel may be granted card access to the Animal Care Facility only by request from the staff member’s supervisor to the Office of Research Administration (acf@uta.edu or 817-272-3723). Access requests should be limited to only essential employees who may be required to perform work/services or provide emergency/security response to the Facility. Upon receiving the supervisor’s request, the Office of Research Administration will activate their MavCard access and add the individual to the authorized access list. b. Maintenance and EH&S personnel should limit non-emergency work/services performed in the Facility to normal business hours, 8:00 am – 5:00 pm. For these non-emergency work/services, maintenance and EH&S personnel must contact the Animal Facility Manager or staff in advance (817-272-5236 or acf@uta.edu). The ACF staff will first notify the appropriate Investigator if work or services is necessary inside their personal laboratory/work space, or if it will have an affect on the Investigator’s lab/work space or animals (noise, vibration, dust, etc.). Once the Investigator approves the visit or time of work, the ACF staff will coordinate the visit with the maintenance or EH&S personnel. ACF staff will escort visiting personnel into the Facility and monitor the work performed. c. Non-emergency work/services performed after normal business hours should be avoided, but if necessary, should follow the same procedures as item 2 above for notifying ACF staff so Investigators can be notified in advance. 14 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 d. In the event that emergency work/services are performed without prior notification to ACF staff and Investigators, a summary of the response and services performed will be sent to ACF staff (acf@uta.edu) as soon as possible after the event. ACF staff will notify the appropriate or affected individuals. e. Federal, state, or local inspecting agencies will be asked to present photo and agency identification before entrance into the Animal Care Facility. The inspection agency personnel will be signed in as a Visitor by ACF staff and issued a temporary visitor pass. ACF staff will escort the inspector(s) into the Facility and accompany the inspector(s) throughout the Facility. At the conclusion of the inspection, the visitors will sign-out and return the temporary visitor passes to ACF staff. E. Security The University is dedicated to the progress and enhancement of knowledge that is obtained through humane animal research. To preserve this goal, UT Arlington is fully committed to the protection of the entire animal research program and ensuring the safety and well-being of all faculty, staff, and students participating in this research. Animal rights groups that oppose animal research have long used peaceful demonstration to voice their opinion. Unfortunately, some animal rights groups have become extremists resorting to harassment, intimidation, violence, or other illegal activity to threaten animal researchers, facilities and research programs. The use of animals in research is a privilege that comes with a great deal of responsibility. As participants in the animal research program, we must maintain our vigilance and increase awareness in order to protect ourselves, the facility, and our resources. 1. Animal Facility Security Measures a. b. c. d. e. f. g. h. i. j. Card Access – the animal facility is protected by card access which can only be initiated by Research Administration after meeting criteria requirements. Criteria Requirements for Access – personnel must go through the IACUC approval process to be added to a protocol under faculty sponsorship (UTA staff requires authorization from their supervisor), complete in-person orientation, obtain immunization, and meet in-person with Research Administration to obtain a photo identification badge. Monitoring Access – Research Administration regularly audits the MavCard authorized access list to ensure that it is consistent with the approved list and access criteria. Alarm System – facility doors are armed with silent alarms that notify Campus Police if they are propped or left open. Police Monitoring - Campus Police monitors the facilities regularly, especially after-hours. Security Assessment – Campus Police has conducted a security assessment of the Facility and will continue to conduct routine security assessments, upon request by Research Administration. The contact person is the Crime Prevention Specialist in the Campus Police department, 817-272-3003. Video Monitoring – a video monitoring system allows staff to monitor halls and doorways during business hours; after hours the video-feed is recorded. Emergency Information – emergency contact lists are posted throughout the facility. Secure Storage – lockers are available in facility breakroom for secure storage of personal items. Alert Buttons – alert buttons are installed in the hallways and teaching area of the facility; button activation will silently alert Campus Police to immediately respond. 15 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 k. Disaster Plan – the facility Disaster Plan provides guidance on handling and reacting to threats: http://www.uta.edu/ra/oric/animal/animalcaredisasterplan.htm 2. Investigator Security Responsibilities a. b. c. d. e. f. g. h. i. j. Faculty should carefully consider adding new project personnel and the access they will obtain. Personnel must wear their photo ID badges at all times within the facilities. If you notice an individual without a photo ID badge, ask to see it or report it immediately to animal facility staff (or Campus Police if after-hours). Do not allow tailgating into the facility. If an individual does not display a photo ID badge and attempts to follow you into the facility, do not allow them inside. Report it to animal facility staff. Faculty should monitor their students as much as possible, and be aware of the hours they will be working in the facility. Everyone is encouraged to work in the facility during normal business hours. Visitors are strongly discouraged. If a visitor is necessary, he/she must be approved in advance by animal facility staff, and visits can take place only during normal business hours. Visitors will sign in and receive a temporary pass. Individuals that fail to adhere to this rule will jeopardize their own access privileges. Be aware of your surroundings at all times - if you witness any suspicious activity or receive any suspicious or threatening emails, phone calls, or mail, immediately notify Campus Police at ext. 23003. If any suspicious activities or incidents take place at your home, call the local police department immediately, then contact Research Administration as soon as possible for follow-up or resulting communication to other staff/researchers. Warn personnel not to give out sensitive information over the phone, to a visitor, or via e-mail — this includes the names of scientists and others working with animals, location of animal facilities, and the species and number of animals on the premises. If you are threatened or arrive during a disturbance, do not confront the individuals directly. Remain calm and courteous, but leave the area at once. Report it immediately to Campus Police, ext. 2-3003. Frequently review (involve your personnel) the guidance in the facility Disaster Plan: http://www.uta.edu/ra/oric/animal/animalcaredisasterplan.htm. 3. Visitors In an effort to protect research animals and minimize any possibility of disease transmission, visitors (including family members and especially children) are not allowed in the animal facilities without prior approval of the Office of Research Administration/ACF Staff. Visitors are only allowed under special circumstances and must adhere to the following procedures: a. b. c. d. The faculty sponsor must approve of the visit and escort the visitor to the facility. The visit must be for a justifiable reason. The Animal Facility Manager (817-272-5236 or acf@uta.edu) must be contacted in advance for approval. The Visitor is required to sign-in with the ACF Manager and be issued a special Visitor Pass. Visitors must be accompanied by ACF staff into the facility unless the guest will be accompanied by an authorized Principal Investigator for the length of the visit. A Visitor may not be left alone at any time without the Principal Investigator or ACF staff. 16 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 e. f. g. h. i. The visit must be for a brief time period and the visitor must not appear as if they are collaborating or working on any animal research protocol (individuals conducting work with animals must be listed as personnel on a UTA IACUC-approved protocol). The visit must take place during normal business hours, between 8:00 am - 5:00 pm. The visitor must wear the Visitor Pass at all times inside the Facility. The Visitor Pass must be returned to the ACF Manager at the end of the visit. These passes are numbered and individuals will be contacted if a pass is not returned. Any unauthorized personnel found in the Animal Care Facility will be escorted out by Campus Police. 4. Photographs or Videotapes of Research Animals Photographic equipment and personnel entering animal rooms can be detrimental to the animals' health and well being. Bright lights can affect the animals' photoperiod and cause retinal damage in some species. Noise from personnel and equipment can disturb the animals and cause stress-related reactions. For all of these reasons, the use of still and video cameras is not allowed in the animal rooms except in certain circumstances. These exceptions are: a. For research purposes. Research staff is urged to carefully consider all possible interpretations of pictures of research animals taken for documentation or publication. b. Documentation requirements by USDA representatives. c. Documentation by Animal Care Facility personnel. d. Public or University media representatives may, on occasion, be allowed access to facilities for photographic purposes. The UTA Animal Care Facility reserves the right to select animal rooms and specific animals for photography purposes to minimize contamination of clean facilities and disruption of research protocols. ALL PHOTOGRAPHS OR VIDEOTAPES TAKEN IN THE ANIMAL HOLDING FACILITY MUST BE APPROVED BY THE OFFICE OF RESEARCH ADMINISTRATION AND THE PRINCIPAL INVESTIGATOR. 5. Threats Related to Animal Use a. Threats from Individuals: Threats, whether written or verbal, should be immediately reported to UTA Campus Police (817-2723003). If the threat indicates a bomb or is a direct threat to your life or the life of others, call Campus Police immediately. In cases of bomb threats, all individuals should leave the building. Be sure to secure doors to offices, laboratories, and animal facilities. Please refer to the Animal Care Facility Disaster Plan. If you are approached by an individual(s) who appears to be confrontational concerning animal use, you should not try to have a conversation with them. Be polite, but do not argue your case for animal research. Walk away from the individual, go to the nearest building, office, or laboratory and call the 17 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Campus Police. If the individual attempts to follow you or is belligerent, get to the nearest phone, dial 23003 and leave the receiver off the hook. This indicates to the police that it is a serious emergency and the response will be faster. The police can locate you from the telephone call alone. If you are moving animals through the building or outside and someone confronts you, move to a secure area and call campus police. Always remember to look carefully at the individual so that you can give a description to the police. If the individual has a vehicle, try to remember the make, model, color, and license plate number. If you see suspicious individuals near your office, laboratory, or facility, or see suspicious vehicles outside of research buildings or animal facilities, you should call security or the police and notify them of your observations. Office, laboratories, and animal room doors should be immediately secured. Police personnel will inform threatened individuals as to what they should do, and the police will take action as needed. In addition, once police have arrived, the Office of Research Administration and the IACUC Chair should also be informed. b. Demonstrations: In the event of a demonstration related to animal use at the University, employees should avoid the area where the demonstration is being conducted, avoid confrontation with the demonstrators, and follow the directions of Security or other personnel in charge of the area. Communications with the media will be coordinated by the Institutional Official. c. Break-ins: Anyone discovering a break-in of animal housing or use areas will immediately inform the security or police unit in charge, and inform the Office of Research Administration. The area should not be cleaned or otherwise disturbed without the permission of the Campus Police personnel in charge of investigation of the incident. F. Facility Maintenance ACF staff monitors any physical problems with the building (HVAC, water system, piping, rooms, equipment and etc.). If any investigator notes a problem with cages, needed room repairs, or other facility maintenance problems, please report to ACF staff (acf@uta.edu or 817-272-5236) and appropriate repair personnel will be notified. G. Shared Space, Equipment, and Storage in the ACF 1. Overview: In the spirit of the Institution’s research endeavor and for optimized efficiency, animal researchers are encouraged to share space and equipment within the ACF. Please refer to section III. A. within this Handbook, 18 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 “Space Allocation in the Central Animal Care Facility,” for more information regarding space requests and allocation. 2. Designated Shared Space and Reservation Procedures: a. Certain spaces in the ACF are currently designated as shared-use areas – i. Surgical Suites – rooms 582, 583, and 584. These rooms are specialized areas for performing surgical procedures. These suites and all ACF-owned equipment within are to be shared among all researchers in the ACF. A sign-up sheet is posted on the doorway of each surgical suite. Researchers should sign up for desired blocks of time with respect to the needs of other individuals. If the suite is not occupied within 30 minutes of the reservation start-time, another user may sign-up and begin using the space. ii. Histology Room – room 581. This room is a specialized area for performing histology and is to be shared among all researchers in the ACF. A sign-up sheet is posted on the door for long-term (> 2 hours) use. Otherwise, the histology room can be utilized as needed. iii. Tech Offices – rooms 567, 569, 571, 572, and 573. These rooms are provided as office/work space for individuals in the Facility. These offices are to be shared among all researchers/students in the ACF. A sign-up sheet is posted on the doorway of office. Users should sign up for desired blocks of time with respect to the needs of other individuals. If the office is not occupied within 30 minutes of the reservation start-time, another user may sign-up and begin using the space. iv. Lab Space – several departments have shared space(s) used among their departmental PIs. Contact the department Chair to request use of shared departmental space. v. Instructional Space – Courses utilizing live animals must be reviewed and approved by the IACUC. As soon as a course is planned, the department Chair should notify Research Administration to assess availability of instructional areas. The instructional space request may be referred to the ARSC, if necessary. 3. Shared Equipment: The ACF supplies several pieces of commonly used equipment for shared use by animal researchers: a. Heating pad b. Room 580 Fume Hood c. Room 581 Fume Hood d. Portable Fume Hood e. Centrifuge f. Steam Sterilizer g. Euthanization Equipment h. Small Animal Anesthesia Machine i. Digital Scale j. Housing equipment (tubs, racks, bottles etc) 4. Procedures for Shared Equipment: 19 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 a. b. c. Shared equipment must be reserved by submitting a request to the Animal Care Facility Manager at least 24 hours in advance: acf@uta.edu, 817-272-5236, or 817-272-3723. ACF staff will respond to the request confirming availability of the requested equipment. A specific time and duration of use must be given at the time of the request. If the equipment is not being used during the time requested, the use of the equipment will be forfeited and made available to other users. 5. Storage and PI-Owned Equipment: During routine IACUC self-assessment process, site visitors frequently note improper storage of items in the animal facilities. The following guidelines are provided to help clarify what items can be stored in the animal facility and under what circumstances they are to be stored. These guidelines are intended for use by animal care personnel as well as research personnel. This policy applies to all supplies or PI owned equipment stored in the ACF. a. Animal holding rooms and laboratory spaces must not be used simply for storage purposes. The ACF Warehouse is a large space dedicated for storage. If feasible, items may be temporarily stored in the Warehouse upon making arrangements with the Animal Care Facility Manager. b. Items stored in animal holding rooms must be sanitizable or stored in sealed plastic containers. c. Only items required for the daily maintenance of the animals are allowed to be stored in the animal holding rooms. Examples of required items include: i. Blank cage cards, ii. Gloves, Caps, Masks, iii. Cage tags for health reports, special diets, etc., iv. Enrichment Items, v. Extra water bottles, vi. Food, vii. Bedding, viii. Non-wooden step stools, ix. Biosafety Cabinet or Fume Hood d. Supplies and Signage - No bulk storage is permitted. The amount or volume of the following items should be kept at a minimum: i. Ladders are not to be stored in the animal use areas because of safety and space issues. ii. Extra, clean air filters must not be stored in the animal use areas. iii. Small research supplies such as electric cautery units, pipettes, and gauze sponges may be kept in the animal holding rooms only if they are stored in sealed, plastic type containers that may be easily moved and sanitized. iv. Small numbers of office supplies such as pens, pencils, note pads, and notebooks may be kept in the animal holding rooms only if they are stored in sealed, plastic type boxes that may be easily moved and sanitized. v. No containers that are made of porous materials such as cardboard are to be used for storage in the animal holding rooms. The exceptions to this are the mask, glove, and cap containers that are provided by the vendors. vi. Notices that are posted on the walls, doors, or cabinets in the animal holding rooms must be relevant and critical to animal care or personnel safety issues. All paper notices must be covered in 20 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 plastic that can be easily sanitized. Notices should be no larger than a sheet of standard copy paper (8 ½ x 11inches). vii. Animal holding rooms must not be used for long-term storage of special research equipment. If equipment will not be used for at least a 3 week period, it must be moved out of the animal holding room and stored in the investigator’s storage space. viii. The number of carts in an animal holding room should be limited to only those necessary to carry out daily animal care routines (i.e. record keeping work surface, supply access, etc.). Carts must not be used as routine racks for cages of animals. e. PI Owned Equipment and Items – i. Researchers are responsible for their own equipment used in shared spaces. Moveable pieces of equipment should be placed back in the researcher’s personal assigned space and not be stored in the shared areas. Please respect the equipment of other researchers and ask permission before moving or using another’s equipment. ii. Individuals are responsible for their own items used or left in the shared areas. Personal items should not be left unattended or overnight. Lockers are available in the ACF breakroom for storage of personal items. If there is not a locker available, arrangements may be made with the Animal Care Facility Manager (817-272-5236 or acf@uta.edu) for secured storage. H. Use of Biohazardous Materials / Radioisotopes in the ACF Special procedures must be followed when using radioisotopes, hazardous substances, or biohazards. In order to use radioactive substances in the animal facilities, the user must be a current approval holder, licensed by the UTA Radiation Safety Committee and by the Radiation Safety Officer in the Environmental Health & Safety Office. Approval holders who wish to use radioisotopes in animals must also have IACUC approval for animal use and radioactive substances. In advance of the work, the user should contact ACF staff to ascertain if room and cage space is available for the study. A radioactivity sign will be posted for special handling and safety equipment if necessary. For biohazards in animal research, the user must register the pathogenic/infectious material with Environmental Health & Safety (817-272-2185 or ehsafety@uta.edu): http://www.uta.edu/policy/forms/ehs/8-30.pdf. It is advisable for all studies with special requirements, such as access to radioisotope rooms, fume hoods, or biocontainment facilities, to contact the Office of Research Administration to discuss needs even before submitting protocols to the IACUC or other committees. In this way, the user can ensure that the needed space, rooms, or equipment will be available. For assistance at the Animal Care Facility, contact the Office of Research Administration at 817-272-3723 or ACF staff at 817-272-5236 or acf@uta.edu. The rooms and procedures utilizing hazardous materials are overseen by the Office of Research Administration and appropriate Environmental Health and Safety Office personnel. Protocols and precautionary measures for each study must be provided by the Principal Investigator and are posted outside of each animal room. I. Occupational Health in the Animal Facility There are a number of diseases which can be transmitted from laboratory animals to humans. When considering a research project involving animals, you should discuss these possibilities with the Attending Veterinarian. 21 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 1. Immunization Requirements Persons who will be handling any laboratory animal or animal tissues are required to receive tetanus immunizations. Those individuals who have received a tetanus immunization within the last 10 years must provide documentation of that vaccination. Otherwise, the individual must receive the immunization at their expense. This is an additional requirement to training to obtain access to the ACF. 2. Animal Bites All animal bites must be reported to ACF staff (817-272-5236 or acf@uta.edu) and Environmental Health & Safety (ehsafety@uta.edu or 817-272-2185) as soon as possible. If necessary, the individual should first seek medical attention. Quarantines of the animal for a specified period of time may be recommended. At the end of the quarantine period, Office of Research Administration sends a report to the bite victim, informing them whether the animal passed the quarantine. 3. Clothing Lab coats are provided (located near ACF staff office). If working with known biological or other hazards, investigators should check with EH&S personnel for additional precautions. 4. Smoking No smoking is allowed in the ACF. This includes all animal facilities, offices, break rooms, and hallways. 5. Eating No food or drink is allowed in the animal rooms, laboratories, or hallways. Food may only be taken or consumed in the Facility breakroom/lounge area. J. Supplies The Office of Research Administration provides shoe covers when needed and gloves for use while in the animal facility. Food and bedding are provided for animals under the care of the ACF staff. Animals housed in satellite facilities, which are cared for by individual investigators, must be recharged for animal-related supplies, as they are not being inventoried. At no time are investigators allowed to take containers of food and bedding from the main animal facilities unless it has been cleared through the Office of Research Administration. All bedding and food are accounted for and factored into per diem costs. Investigators while in the animal facility may use stainless steel carts or rubber carts belonging to the ACF. At no time shall this equipment leave the facility. The Office of Research Administration does not provide sheets to cover animals, clothing (other than special clothing required by specific animal rooms), drugs, reagents, chemicals, blood collection and microbiological supplies for free. The Office of Research Administration also does not provide cages, bedding, food, water bottles and containers to private animals. K. Animal Care Per Diem – Recovering Costs for Unsubsidized Animal Care 22 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Historically, the University has subsidized total costs of employee salaries and benefits directly associated with the Animal Care Facility and has contributed to cover more than 50% of the total expenses of the Facility. This University subsidy has eased financial burden on researchers by allowing the animal care per diem costs to remain low, even when compared to similar institutions. The Animal Care Facility is obligated to recover the unsubsidized costs associated with the procurement, care and support of animals used in research or teaching at the University. To recover these costs, the ACF has established per diem rates. Per diem charges are the charges based on units of animal care service provided and are tallied by the number of days of service. Units of animal care service are accounted for by individual animal, such as a rat, mouse, rabbit, etc. Per diem charges include: daily observation and husbandry of every animal, veterinary care, health surveillance program, water and one or two feedings per day of a standard ration, general ACF supplies, facility maintenance, and appropriate sanitation of rooms and cages according to the Guide for the Care and Use of Laboratory Animals and ACF SOPs. The rate does not cover special diet or special caging not already available in the daily operation of the ACF. Investigators are billed on a quarterly basis for animal care per diem expenses. The ACF per diem rates are determined using detailed cost accounting and a survey of the per diem rates charged by many other universities. Per diem charges for species and/or housing systems for which the ACF has no recent cost experience are initially estimated based on similar species/housing or estimates from other institutions that have applicable experience. Per diem rates are reviewed annually by Research Administration and the Animal Facility Operations Committee. Changes in populations, cost of husbandry supplies, maintenance fees, new regulatory requirements or other factors may result in increases. Investigators should plan and budget for a 5% - 10% increase annually. The current ACF per diem rates can be found on the Research Administration website in the Animal Subjects – Animal Care Facility section. www.uta.edu/ra 23 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 Animal Care Facility Procedures for Animal Care, Husbandry, and Surgery 24 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 IV. UNIVERSITY ANIMAL CARE PROGRAM A. Animal Health Care Program The animal health program is administered by the Attending Veterinarian. ACF staff will make daily rounds of all animal rooms. These rounds, in conjunction with observations and reports ensure adequate veterinary care and health monitoring for all animals. ACF staff, under the direction of the Attending Veterinarian, examines all incoming animals, and performs initial and follow-up treatments for health problems. ACF staff is responsible for checking assigned rooms daily for animals in need of veterinary care. In emergency situations ACF staff will seek immediate veterinary assistance. Medical records are retained on file within the ACF. Laboratory records become a part of the medical record of the animal - one copy will go to the investigator to be maintained in the diagnostic laboratory file. Certain results, such as positive viral serology, are noted in room status cards mounted on each door. Surgical, post operative and treatment records are kept for most animals. These remain in the ACF Staff Office. B. Standard Operating Procedures for Animal Care Standard Operating Procedures for husbandry practices are available for investigators to review. Investigator may request copies of specific SOPs by contacting ACF staff at 817-272-5236 or acf@uta.edu. SOPs detail such things as cage changing frequency, types of bedding used for individual species, food variety, sanitation methods, etc. SOPs are written for adult animals maintaining a steady weight. Investigators may be required to write SOPs for their specific protocol. An investigator's SOP will always supersede the ACF SOPs. All investigator-generated SOPs must be given to the ACF staff. C. Health Surveillance and Quality Assurance Program 1. Vendor Surveillance/Quarantine Procedures In order to obtain healthy animals and maintain the health of animals held in its facilities, UTA Animal Care Facility monitors the quality and health status of all animals received. Vendor lists can be obtained from ACF staff (817-272-5236 or acf@uta.edu). Selection is as follows: a. Rabbits - All rabbits are obtained from an approved vendor and arrive in healthy condition and with a health report. b. Mice/rats - Only certified viral antibody free/mycoplasma free vendors are used (Harlan, Jackson). Animals are shipped in filtered cartons and delivered to the animal receiving room where the shipping containers are wiped down with sporklenz then moved to the quarantine room. ACF staff will distribute the animals to the appropriate rooms. Incoming animals, which are used as sentinels, are tested for Sendai, corona virus, PVM, parvo virus, Mycoplasma pulmonis, and pinworms after a 21 day quarantine period. If positives are found for any of these infectious agents, the shipment is rejected or, in the case of valuable animals, rederivation is considered. c. Other Species - Appropriate diagnostic tests and examinations are performed as needed. 2. Health Surveillance of Colonies 25 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 a. Rodents - Sentinel animals are housed in each rodent room and tested semi-annually for common viruses, Mycoplasma pulmonis, parasites, corona virus, mouse parvo virus, and pinworms. Comprehensive necropsies are performed and include comprehensive serology screens, parasitology, and histology of selected target tissues. Sentinels are screened for respiratory and enteric bacterial pathogens. Reports of all test results are maintained by ACF staff. Positive results are immediately reported to the Attending Veterinarian, investigators are notified, and appropriate steps are taken to quarantine the animals and eliminate the disease. Follow-up testing is performed and posted. b. Other Species - For all other species health monitoring is performed through the Animal Health Program. 3. Isolation Procedures Rooms where outbreaks of highly contagious disease occur are individually isolated and access limited. Positive viral serology occurs in designated viral-free rooms, or if conventional rooms seroconvert to unacceptable viruses, animals are isolated and a burnout is performed. Investigators with animals in contaminated rooms are not allowed to order new animals during the burnout (three months). Viral infected rooms are designated with signage and access restrictions are posted. 4. Environmental Monitoring A log sheet is kept for each room, and the temperature is recorded daily. Humidity and lumens of light are checked quarterly and recorded. Any deviation from the normal is reported to Facilities Management to adjust the temperature, humidity, or lights. Light timers are also checked daily to assure proper function. Room logs are also used to record any other environmental problem, such as insects, broken equipment, etc. Problems are reported to Facilities Management for correction or repair. D. Animal Care Inventory Procedures Inventories of animals currently in-house are maintained on a daily basis by use of a standard count sheet. One count sheet is prepared for each animal room, separated by investigator. The inventory count sheet is updated each day for all activity on each account, recording receipts, deaths, room transfers, usage by investigators, and other necessary adjustments. For purposes of calculating per diem charges, if an animal leaves the facility before the inventory count is updated for the day (usually in the morning), the investigator is not charged per diem for the animal for that day. Similarly, if the animal is not removed until after the inventory is taken for that day, per diem will be charged for that animal. Once a study is completed, it is the investigator’s responsibility to dispose of the animals as documented in the IACUC-approved protocol. If animals remain in the Facility, even after a study is complete, these animals take up valuable space and the investigator will continue to accrue daily per diem charges. E. Feeding and Food Monitoring All feed is checked upon arrival to assure that no outdated feed is received. The oldest milling date is always used first, and in no instance can feed with a milling date greater than 90 days be used. Feed infested with vermin is immediately disposed of and all containers cleaned and washed. Feed barrel fill, sanitation and change 26 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 of liner is recorded on the room sheet. Feed companies are required to furnish data on nutrient content, chemical contaminates, etc. a. Mice and rats are fed pelleted feed ad libitum. The cage hopper has food in it at all times, but only contains enough food to last until the next day. b. Rabbits receive 100 grams of Laboratory Rabbit Chow daily. c. Xenopus are fed frog diet twice a week with a dry commercially available dry food obtained thru Xenopus Express. d. IF ANIMALS ARE YOUNG AND NEED TO GROW, THE INVESTIGATOR MUST WRITE AN SOP DETAILING THE NEW FEED REGIME. ALL ANIMALS ARE FED A MAINTENANCE DIET UNLESS OTHERWISE DIRECTED. F. Water Quality Water is provided to the facility by the City of Arlington. City water is treated and certified by the State Water Control Board. Automatic watering (Edstrom) is provided for most animals within the Facility. Other animals are provided with water in bottles with sipper tubes. Rabbits are provided with an (Edstrom) automatic watering system. G. Ordering Animals Only ACF staff and the Office of Research Administration are authorized to purchase live vertebrate animals (by UTA IACUC Policy and UTA Accounting Policies). Prior to placing an order, it is advisable to call ACF staff to discuss the strain of animals needed, and the choice of vendors. As discussed earlier, only approved vendors may be used. A list is maintained of approved vendors for each species, and a selection can be made from any of these. NO ORDERS CAN BE PLACED UNTIL THE PROTOCOL HAS BEEN APPROVED BY THE IACUC. Harlan, Charles River, and Jackson Labs are the primary sources of rats and mice. There may be shipping charges associated with animal delivery. Carton charges are also levied by all vendors. Some vendors charge for water kits or water substitutes as well. ACF staff can usually provide you with an estimate of cost for delivery, but will not know the actual costs until the bill from the vendor is received. With regards to price estimates for animals, ACF staff receives price lists from vendors, which state, "Prices are subject to change without notice." Therefore, it cannot be guaranteed that any estimated price is what will in fact be charged by the vendor. Anyone is welcome to contact the vendor directly regarding prices. However, it is suggested that if you are able to commit a vendor to a firm price that you note the name of the vendor contact that confirmed the price on your Animal Purchase Order Form for future reference. When an order clearly states a preference for a particular vendor, ACF staff will abide by the preference. ACF staff cannot take the responsibility for ordering from a different vendor, even for a lower price, if it is against the investigator’s wishes on the animal request form. INVESTIGATORS WHO DO NOT FOLLOW PROPER ORDERING PROCEDURES MAY BE LEVIED SUBSTANTIAL PENALTIES. ANIMALS ARRIVING WITHOUT PROPER PAPERWORK MAY BE HELD, EUTHANIZED, OR RETURNED TO THE VENDOR. 27 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 1. Procedures for Ordering Animals: i. Animal requests and purchases can only be made under an active, IACUC-approved protocol. ii. Authorization to purchase animals at UTA is granted solely to the Office of Research Administration. Animals cannot be ordered from an outside vendor either by PIs or their departments. iii. To make an animal purchase from a vendor, the PI must complete the “Request for Animals” form to be submitted to the ACF staff. Blank forms are available from ACF staff or outside the breakroom area of the central Facility. The Form may be submitted in person to ACF staff (Room 545 of the Animal Facility) or e-mailed (acf@uta.edu) to the ACF staff directly from the PI of the research protocol (email requests by students will not be accepted). iv. The Request for Animals Form contains the following information: v. PI and Protocol Information – Date, PI, Department, Contact Information, Protocol Title, and PI’s Signature (not required if the form is submitted via e-mail by the PI). vi. Animal Order Information – Species, Sex, Strain, Quantity, Account Number to Be Charged, and Special Instructions. vii. The PI will be charged for the animals via an Interdepartmental Transfer (IDT). The account number provided on the Request for Animals form will be verified as active with the appropriate amount of funds before the animal purchase is made. viii. The ACF staff will review the Request for Animals Form. If appropriate funding is available in the account number provided, ACF staff will then verify protocol approval and the number of animals allowable under the approved protocol. ix. If the requested animal numbers do not exceed the maximum allowable number as indicated in the IACUC-approved protocol, the request will be accepted and the order will be fulfilled. If the requested number of animals exceeds the maximum allowable number as indicated in the IACUC-approved protocol, the request will be denied. The PI must then submit an amendment to the existing protocol for IACUC approval of additional animals. The ACF staff’s approval/disapproval will be documented by signature on the Request for Animals Form and filed for recordkeeping purposes. x. For animals ordered/transferred from a breeding colony, the Principal Investigator will be required to keep a log to record the date which an animal is transferred from a breeding colony to an active research protocol. Animals from a breeding colony will be billed to the PI in addition to the regular animal care per diem charges. xi. For animals purchased from an outside vendor, ACF staff will create an IDT for the purchase charges and the transfer will be made immediately from the PI’s provided account, to the ACF account. 28 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 H. Transporting Animals: Moving Animals In/Out of Animal Facilities All transportation of animals outside of their approved facilities, including on-campus transfers, must be approved in advance by the IACUC. Investigators must contact Research Administration (817-272-3723 or iacuc@uta.edu) for more information and to submit the appropriate IACUC paperwork. Transportation should be planned to minimize transit time and the risk of zoonoses, protect against environmental extremes, avoid overcrowding, provide food and water when indicated, and protect against physical trauma. Due to occupational exposure and public concerns, all cages must be completely covered with a clean cloth sheet or large towel. Larger animals should be moved in transport cages. Sheets and towels used for this purpose are not provided by the Animal Care Facility and must be supplied by the investigator. In addition, animals slated to return to the animal facilities should be transported in micro isolator cages to prevent unnecessary exposure to potential pathogens. Unless specific IACUC approval has been granted, animals cannot remain outside the animal facilities for longer than 12 hours. Do not move animals using the public elevators. Only use the freight elevators. If animals must be transported in cages by hand or on carts, this should be done as unobtrusively as possible. Animal cages should be covered. If possible, animals should be moved at low activity times of day, such as before 8:00 A.M. and after 5:00 P.M. I. Removal of Animals from the ACF Federal law has strict accounting standards, which require records of final disposition of animals used by an institution. Even when a research protocol has completed and the animal is no longer needed for that project, animals may not be removed from the University without clearance through the IACUC and the Office of Research Administration. J. Housing of Animals in Research Laboratories Unless specific IACUC approval has been granted, animals cannot remain longer than 12 hours outside the animal facilities (any transportation of an animal outside of the animal facilities must be approved in advance by the IACUC). When approval for long-term holding (> 12 hours) outside the ACF has been granted, animals must be housed and cared for in accordance with standards as propagated in the Guide for Care and Use of Laboratory Animals. For animals housed in laboratories under IACUC approval, food and bedding can be purchased from the Animal Care Facility, and arrangements can be made to obtain clean cages, and water bottles, etc. Arrangements for purchase may be made by contacting ACF staff (acf@uta.edu or 817-272-5236). Food and supplies are not to be taken from the Animal Care Facility without permission. Doing so leads to increases in your per diem rates the following year (indirect costs rise). K. Experimental Procedures in Animal Housing Areas Painful or stressful procedures may not be conducted in animal housing areas. Special procedure rooms are available in the facility and animals must be taken to these rooms or to research laboratories. L. Survival Surgery 29 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 1. Overview: All survival surgery performed in animals must be done under aseptic conditions. For rodents, this includes use of sterile instruments sterilized by autoclave or chemical/gas sterilants. Agents, such as alcohol or iodine compounds, are not adequate for sterilization. The surgeon must wear sterile gloves, a mask and cap, clean lab coat or scrub top; the surgery site must be clipped and prepped using an antiseptic and the surgical procedure should be performed in a separate room or separate area of the laboratory which has been set aside for survival surgical procedures. Non-rodent survival surgeries are to be performed in the UTA Animal Care Facility Surgical Suite (Room 582584). ACF staff can be contacted for scheduling or questions about university policies concerning surgery (acf@uta.edu or 817-272-5236). 2. Investigators' Responsibilities: Good practice and regulations require that the surgical team initiate Surgery Records and Animal Treatment Forms. Completion of an Anesthesia Record is required. 3. Post-Operative Care: Prior to surgical procedures, the investigator should discuss the surgical program and postoperative care with the Attending Veterinarian and ACF staff. Assistance with post-op care is available upon request, but the establishment of post-op care and record keeping should be initiated by the investigator. The following post-op guidelines are recommended by the Attending Veterinarian: a. Place animal on towel and covered in a clean, dry cage without bedding. Animals can get bedding in their mouths while recovering from anesthesia and run the risk of aspirating it. b. Covering with a towel as well as being in a warm environment (i.e., warm room or supplemental heat) are very important as the animal loses body heat from surgical procedures and from anesthesia. There should be NO DRAFTS on the animal. c. Remove food and water bowls from cages that the animal could fall into or injure itself on while going through the unsteadiness of recovery. d. Under no circumstances should an animal recovering from anesthesia and surgery be placed with awake animals or animals recovering from an earlier surgery. Cannibalism could occur. e. Small animals that have gone through surgery at the same time and will recover in the same time frame can recover in pans together but in reduced numbers. f. Rabbits and larger animals should recover in a clean, dry cage by themselves with a towel beneath them and one to cover them (if not already mobile). g. Check post-op animals frequently and turn them from one side to the other keeping them covered until they regain their righting reflex and ambulation. 30 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 h. Check incision periodically and assess need for analgesics and administer if indicated. i. When recovered make usual food and water available and return to normal bedding. j. Continue to check incision site, sutures and healing. k. Information and blank record sheets can be obtained from ACF staff. For assistance with post-op care problems contact ACF staff immediately. 4. Surgical Training: Investigators must also familiarize themselves with and be knowledgeable about proper attire for the surgery area and understand aseptic and surgical techniques in the animal species to be utilized. This information can be obtained from ACF staff or the Attending Veterinarian, and is also provided in the IACUC LATA online training sessions. 5. Monitoring Animals Receiving Anesthesia: Pursuant to 9 CFR and the National Research Council’s Guide for the Care and Use of Laboratory Animals the following policy will pertain to all animals before, during and after all anesthetic procedures until the animal is fully recovered or humanely euthanized as the IACUC approved protocol details (CFR Section 2.33 b 5): a. Adequate veterinary medical care consists of carefully and closely monitoring all animals before, during and after all anesthetic procedures. b. Animals which are left unattended for any reason before the animal is fully recovered or humanely euthanized would be a violation of CFR Section 2.33 b 5 and UTA policy. 6. Major Surgery and Multiple Survival Surgeries: Major surgery is defined as surgery which invades a body cavity or results in physiological or anatomical alteration of the surgical subject. All major surgery in rabbits and species higher on the phylogenetic scale is to be performed in the dedicated surgery areas within animal care facility. The Public Health Service Policy and the Animal Welfare Act prohibit the performance of more than one major surgery on an animal with the animal surviving. This is known as Major Multiple Survival Surgery. There is provision for these surgeries with adequate scientific justification and approval by the Institutional Animal Care and Use Committee (IACUC). 7. Aseptic Surgery in Laboratories - Rodents Only: Survival surgery on rodents may be carried out in investigator ACF laboratories if aseptic techniques are followed. Caps, masks, and sterile gloves must be worn and sterile instruments, supplies and drapes must be used. In addition, in accordance with NIH guidelines, there must be an animal prep area separate from the surgery area. This is to keep hair and dirt from clipping and prepping the animal away from the area in which a 31 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 sterile procedure is to be performed. Generally, the surgery area should be in a separate room, or hood dedicated to surgery. If these are not available, an individual area of a room may be dedicated to surgery, but must not be used for other purposes. All instruments must be sterilized, either by heat, gas, or chemical means. Use of only disinfecting agents such as alcohol, povidone iodine, etc., is not acceptable. Sterilants kill all microorganisms with the possible exception of some parasitic life forms. Disinfectants have a much lower level of effectiveness. Acceptable methods of sterilization include steam, gas, glass bead, and chemical agents. Chemical agents include phenols, glutaraldehyde, and chlorine dioxide. Glutaraldehyde is mutagenic, phenols are corrosive and both require special disposal procedures. Chlorine dioxide has a short sterilizing useful life (one day) and is corrosive to metals. All agents require rinsing with sterile solutions prior to tissue contact. Glass bead sterilizers will sterilize only the portion of the instrument placed in the beads. The ACF has adopted the following policy in regards to instrument sterilization for rodent surgeries: a. All instruments used in survival rodent surgeries must be steam or gas sterilized (this is the PI’s responsibility) prior to each surgery or group of surgeries (biological indicators monitoring sterilizer efficiency are advisable). b. Instruments must be kept on sterile nonporous towels during use. c. Instruments must be cleaned of blood and debris by brushing or wiping with sterile water and gauze sponges between surgeries. d. If contamination has occurred, instruments must be placed in a chemical agent or a glass bead sterilizer for the appropriate period of time for the method used to be effective (or the pack replaced by a new one). e. If a chemical agent is used, instruments must be rinsed with sterile water or saline before being used on the next animal. f. Surgical gloves and blades should be changed between each animal and/or after contamination. g. The Investigator is required to monitor the animal at all times during surgical procedures. h. Following surgery, all instruments must be thoroughly cleaned and preferably placed in an ultrasonic cleaner and rinsed. 8. Major Surgical Procedures on Weekends and / or Holidays: Major surgical procedures should not be done on weekends and / or holidays, with the following exceptions: a. The procedure is an emergency needed to save the animal’s life. b. The PI notifies the Veterinarian and ACF staff in advance to have them available if there are complications. The Veterinarian or ACF staff must agree to be available. 32 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 9. Euthanasia, Anesthesia, Analgesia: In order to determine the best agent to be used in individual studies, the Attending Veterinarian will discuss with the investigator the nature of the study, the species to be used, the invasiveness of any procedures, and the degree of sedation required. Background information available in published literature is also reviewed. With this information, and with consideration of the users’ training and experience, the Attending Veterinarian will help the investigator decide which agent or agents are suitable. The use of anesthetics and analgesics is monitored by the Attending Veterinarian and ACF staff. Observation of anesthetic technique, depth of anesthesia, apparent level of pain, as well as physiological parameters, are the means by which anesthesia and analgesia are monitored. If animals are observed to be in pain at any time, the investigator will be contacted and the use of analgesics discussed. If the investigator determines that analgesics cannot be used, the Attending Veterinarian will decide whether the animal can continue in the study, or if it must be euthanized. In a similar manner, the Attending Veterinarian will assist investigators in choosing euthanasia methods. All methods must be according to the recommendations of the American Veterinary Medical Association Panel on Euthanasia, unless alternate methods were approved in the IACUC review process. 10. Paralytic Agents: Paralytic agents are no longer considered a “best practice” procedure because many signs of anesthetic depth are eliminated (NRC “Guide” page 65). There are more appropriate drug protocols available in veterinary medicine today, which eliminate the need for paralytic agents in IACUC protocols. It is the responsibility of the IACUC to carefully and extensively review all protocols involving paralytic agents to assure they are consistent with current “best practice” methods to meet the intent of the National Research Council “Guide” and the Animal Welfare Act regulations. M. Treatment of Animals: ACF staff makes daily rounds of all facilities to assure the continued maintenance of good health in all animal colonies. If sick or injured animals are found, ACF staff or the Attending Veterinarian will attempt to reach the investigator, prior to initiating treatment. In emergency situations, the Animal Care Facility Staff will provide immediate care to stabilize the animal, and then notify the investigator. Treatment programs for animals are worked out between the investigator and the Attending Veterinarian. Advice is provided to the investigator on whether the condition or treatment of a condition could impact the research results. In cases when treatment will alter the results, the Attending Veterinarian and investigator will make a determination whether the animal can be left untreated. If the animal is in significant pain or distress, the Attending Veterinarian or ACF staff under the direction of the Attending Veterinarian, will recommend immediate use or euthanasia. N. Euthanasia of Animals in Pain or Distress 33 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 ACF staff makes every attempt to work with the investigator to assure that experimental results are not affected by treatment of an animal. Federal law mandates, however, that the Attending Veterinarian has the responsibility to provide humane care and alleviate suffering. In some instances, this will mean that animals must be euthanized despite the effect on the outcome of the research. O. Use of Adjuvants in Antibody Production The use of complete Freund's adjuvant is discouraged. There are many alternative Adjuvants, such as the RIBI system, which provide equal or improved stimulation without the side effects of Freund's. When Freund's must be used, there are methods to reduce inflammation and pain. The IACUC has established policy on the use of Adjuvants, including the proper use of Freund's. Copies of the policy and sources for alternative Adjuvants can be obtained by contacting ACF staff (acf@uta.edu or 817-272-5236). 34 The University of Texas at Arlington Office of Research Administration ACF Policy and Procedure Handbook Updated September 2015 APPENDIX A UTA Animal Care Facility Contact List Institutional Official Duane B. Dimos, Ph.D., Vice President for Research…………………………………….……………………….817-272-1021 IACUC Chair Michael Roner, Ph.D., Assistant Professor, Biology…………………………………………………………….817-272-1302 Office of Research Administration Joe Barrera, Ph.D., Director of Shimadzu Institute for Research Technologies….…….817-272-2156 Kirstin Morningstar, Director of Regulatory Services………………..…………..……..817-272-1234 Animal Care Facility Alphas Wicker, Animal Facility Manager………………………………817-272-5236 Nathan Moore, Animal Technician………………………………..…….817-272-9612 Attending Veterinarians Egeenee Daniels, D.V.M, Attending Veterinarian………………………817-735-2017 Tony Myers, D.V.M., Back-Up Veterinarian…………………………...214-341-8392 Facilities Management Main Number............................................................................................817-272-3571 Bill Poole (Asst. Vice President, Facilities Management)........................817-272-3571 Jeff Johnson (Assoc. Director, Facilities Management)............................817-272-3232 Robb Chock (Fac. Engineer, Fac. Management)......................................817-272-3458 John Hall (VP for Administration & Campus Operations)……………......817-272-2102 An Emergency Contact List is posted through out the Facility. Animal / Animal Supplies / Equipment Vendors Harlan Sprague Dawley...........................................................................800-793-7287 Charles River Laboratories……………………………………………...800-522-7287 Jackson Laboratory……………………………………………….….…..800-288-6000 Miller Vet Supply………………………………………………...…..…817-335-5487 Pharmacal……………………………………………………….….…...800-243-5350 Lab Products……………………………………………………….…....800-526-0469 Allentown Caging…………………………………………………......…609-259-7951 Ancare………………………………………………………………........516-781-0755 Edstrom (Auto Watering System)…………………………………...…...800-558-5913 35