SECTION I: Use of Animals
in Research and Teaching
SECTION II: Specific Issues in the Care of Animals
Bloomington Institutional Animal Care and Use Committee
Research and the University Graduate School
IACUC Administration
819 N. Forrest Ave., Room 101
2003
SECTION I
Use of Animals in Research and Teaching
- Introduction
- Public Health Service Guidelines and Regulations
- The Animal Welfare Act
- The Composition and Operation of BIACUC
- The Bloomington Campus Implementation
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I. Introduction
Fulfillment of the teaching and research missions at Indiana
University requires a variety of approaches, among which is the
use of animals. It is the policy of the university that living
animals are to be used only when there is no suitable and valid
alternative. Further, all animals must be healthy and well-cared
for in order for the results of experiments or demonstrations
to be valid and reliable. For these reasons, it is the policy
of Indiana University that animals shall be housed, cared for
and used in accordance with the highest standards of comfort,
cleanliness, and humaneness as specified by the guidelines and
regulations of the Animal Welfare Act, The National Institutes
of Health, and the Public Health Service. To further this policy,
the present document outlines the nature of these guidelines and
regulations and their implementation at Indiana University.
The Public Health Service (PHS), in response to increasing
public and private pressure to monitor and control animal research
and demands for accountability in the spending of research dollars,
revised its requirements concerning the humane care and use of
laboratory animals by awardee institutions. This revised policy
became effective November 1, 1986, and markedly affects several
aspects of animal research at Indiana University. The basis for
implementation of the PHS policy is a relationship between Bloomington
Campus and the Public Health Service confirmed by a Letter
of Assurance, filed by Bloomington Campus, that sets forth
an agreement to comply with the PHS policy. In areas of noncompliance
the campus must state the steps being taken to assure compliance
and a time table for their accomplishment. The assurance is guaranteed
by a responsible institutional official and is based on information
provided by the Bloomington Institutional Animal Care and Use
Committee (BIACUC), the attending veterinarian, the Director of
Laboratory Animal Resources, animal care staff, and researchers.
The assurance is central to the contract between Bloomington Campus
and PHS and OPRR (Office for Protection From Research Risks).
If an assurance is not filed within 60 days after the application
date of the proposal, federal agencies may and have denied review
of new and/or continuation applications. Further, violations of
the terms of the assurance can result in suspension or removal
of grant funds to the university. Finally, the PHS expects awardee
institutions to move rapidly toward complete compliance with PHS
policy, and strongly encourages compliance with the accreditation
standards outlined by the American Association for the Accreditation
of Laboratory Animal Care (AAALAC).
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II. Public Health Service Guidelines and Regulations
The PHS guidelines and regulations are stated in the Guide for the Care and Use of Laboratory Animals and the Public Health Service Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions and reaffirmed by the Animal Welfare Act. Important aspects of the policy are summarized in this document and in other information you will receive. Among the requirements of the PHS policy are:
- The formulation and administration of an institutional program for animal care and use, including the establishment of lines of authority and responsibility for administration of the program.
- The appointment of a qualified Veterinarian with considerable responsibility for animal care.
- The formation of a committee (the Bloomington Institutional Animal Care and Use Committee--BIACUC) whose function is to ensure that the care and use of animals is appropriate and humane in accordance with PHS policy and the Animal Welfare Act.
- The establishment of procedures which the BIACUC must follow to fulfill these requirements.
- The establishment of health monitoring and training programs for personnel who work with animals in laboratory animal facilities or have frequent contact with animals.
- The filing of a semiannual report concerning the nature and extent of the institution's adherence to the Guide for the Care and Use of Laboratory Animals. In particular, the report must specify any departures from the provisions of the Guide and the PHS policy and state the reasons for the departure. If program or facility deficiencies are noted, the report must contain a reasonable and specific plan and time-table for correcting each deficiency.
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III. The Animal Welfare Act
The Animal Welfare Act was first passed on August 24, 1966, as PL-89-544. It was entitled the Laboratory Animal Welfare Act and authorized, "The Secretary of Agriculture to promulgate such rules and regulations, and orders as he may deem necessary to effectuate the purpose of this Act." The purposes of the original act were to:
- Protect the owners of dogs and cats from theft of such pets.
- Prevent the sale or use of dogs and cats which have been stolen.
- Insure that certain animals intended for use in research facilities were provided humane care and treatment.
The original Act covered non-human primates, guinea pigs, hamsters, rabbits, dogs and cats. Humane treatment was required while they were at the dealers or research facility and while being transported by dealers. Dealers were required to be licensed. Research facilities, which used, or intended to use, dogs or cats, and either purchased them in commerce or received any federal funds, were required to be registered.
In 1970 the original Act was amended (PL-91-579) and renamed
the Animal Welfare Act. The amended Act covered broader classes
of animals and included those used in exhibitions and sold at
auction and regulated anyone involved in these activities. The
definition of an animal was expanded to include all warmblooded
animals. The definition of a research facility was expanded to
include those institutions using covered live animals and not
just dogs and cats. These facilities were required to file an
annual report. Civil penalties were also added for refusing to
obey a valid cease and desist order from the Secretary. The term
"handling" was added to the basic categories for which
standards were to be created and the phrase "adequate veterinary
care" was broadened to include the appropriate use of anesthetics,
analgesics and tranquilizers.
In 1976, the Animal Welfare Act was further amended to
enlarge and redefine the regulation of animals during transportation.
The Secretary also promulgated regulations which specifically
excluded rats, mice, birds, horses and farm animals from the definition
of an animal. This exclusionary language effectively excludes
over 80 percent of the animals currently used in research, teaching
and testing from coverage under the Animal Welfare Act.
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In 1985 the Act was further amended with the passage of the Food Security Act of 1985 (PL-99-198) which contained an amendment entitled the Improved Standards for Laboratory Animals Act. This amendment when fully implemented will strengthen the standards for providing laboratory animal care, increase enforcement of the Act, provide for collection and dissemination of information to reduce unintended duplication of experiments using animals and mandate training for those who handle animals.
The most recent amendment to the AWA also includes development of standards: for the "exercise of dogs," for "provision of a physical environment which promotes the psychological well-being of primates," for "limitation of multiple survival surgeries", and to "require the investigator to consult with a veterinarian in the design of experiments which have the potential for causing pain to insure the proper use of anesthetics, analgesics and tranquilizers". Each research facility will have to show upon inspection, and include in their annual report, assurances that professionally acceptable standards for the care, treatment and use of animals are being used during the actual research or experimentation. As part of these standards, the investigator is required to consider alternative techniques to those which might cause pain or distress in the experimental animals.
The 1985 amendment requires the Chief Executive Officer
of each research facility to appoint an Institutional Animal Committee
consisting of at least three members including a doctor of veterinary
medicine and one member who is not affiliated with the institution.
The regulations promulgated to implement the amendment designate
this committee as the Institutional Animal Care and Use Committee
(IACUC) and charge it to act as an agent of the research facility
in assuring compliance with the Act. The Committee is required
to inspect all animal facilities and study areas at least once
every six months, and to review the condition of the animals and
the practices involving pain to the animals to insure compliance
with the regulations and standards promulgated under the Act.
The Committee is also required to review once every six months
the research facility's program to assure that the care and use
of the animals conforms with the regulations and standards. The
Committee must file a report of its inspection with the Institutional
Official of the research facility. If significant deficiencies
or deviations are not corrected in accordance with the specific
plan approved by the Committee, the USDA and any federal funding
agencies must be notified in writing.
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The Committee must also review and approve all proposed activities involving the care and use of animals in research, testing or teaching procedures and all subsequent significant changes of ongoing activities. As part of this review, the Committee must evaluate procedures that minimize discomfort, distress and pain. When an activity is likely to cause pain, the veterinarian must be consulted in planning for the administration of anesthetics, analgesics and tranquilizers. The committee must also assure that paralytic agents are not employed except in the anesthetized animal. The BIACUC must also determine that animals which experience severe or chronic pain are euthanized consistent with the design of study, that the living conditions meet the species needs, that necessary medical care will be provided, that all procedures will be performed aseptically and that no animal will undergo more than one operative procedure that is not justified and approved. Methods of euthanasia must be consistent with the definition contained in the AVMA: Panel on Euthanasia.
The BIACUC must also assure on behalf of the research facility that the principal investigator considered alternatives to a painful procedure and that the work being proposed does not unnecessarily duplicate previous experiments. To provide this assurance, the Committee must review the written narrative description provided by the investigator. This description must include the methods and sources used in determining that alternatives were or were not available.
In reviewing proposed activities and modifications, the BIACUC can grant exceptions to the regulations and standards, if they have been justified in writing by the principal investigator and are approved by the BIACUC.
In addition to the above requirements, the research facility is required to provide training in the following areas to scientists, animal technicians and other personnel involved with animal care and treatment:
- Humane practice of animal care, handling, and experimentation.
- Research or testing methods that minimize or eliminate the use of animals or limit pain or distress.
- Utilization of the information service of the National Agricultural Library.
- Methods whereby deficiencies in animal care and treatment should be reported.
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The regulations require that each research facility establish
a program of adequate veterinary care that includes: appropriate
facilities, personnel and equipment; methods to control, diagnosis
and treat diseases; daily observation and provision of care; guidance
to personnel on the use of anesthetic, analgesic and euthanasia
procedures and pre- and post-procedural care. Specific requirements
for maintaining records and filing annual reports are included
in the regulations along with a miscellaneous section containing
a variety of requirements to which a research facility must adhere.
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IV. The Composition and Operation of the BIACUC
At Indiana University-Bloomington, the BIACUC (Bloomington Institutional Animal Care and Use Committee) is appointed by and reports to the Vice-President for Research and the University Graduate School. BIACUC is responsible for and oversees the total animal program, procedures, and facilities of Indiana University-Bloomington.
The composition of the BIACUC is mandated by PHS to include a scientist working with animals, a qualified veterinarian, an individual whose primary field of expertise is not science, and an individual from the community who is not affiliated with the institution (and is not a member of the immediate family of a person affiliated with the institution).
The duties of an IACUC are mandated by the PHS (Guide for grants and contracts) and are:
- Review and inspect the institution's program for humane care and use of animals and facilities semi-annually and report to the Bloomington Campus Vice-President.
- Review all concerns involving the care and use of animals on the Bloomington Campus.
- Recommend action to the responsible institutional official concerning the program, facilities, personnel training, and any other relevant concerns.
- Review, approve, require modifications in, or withhold approval of applications for animal use.
- Review, approve, require modifications in, or withhold approval of proposed signficant changes regarding the use of animals in ongoing activities.
- Suspend any activity involving animals that is not being conducted in accordance with the Animal Welfare Act, The Guide, the institution's Letter of Assurance, or the PHS Guide Supplement.
The mandated basis for the BIACUC review of Animal Care and Use Applications, Annual Reviews and Amendments includes:
Basic Information:
- Specification of the species and approximate number of animals to be used.
- The rationale for involving animals, and for the appropriateness of the species and numbers to be used.
- A lay description of the proposed use of the animals.
- Assurance that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research.
- Assurance that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals.
- Assurance that journals for this type of research have been reviewed and the proposed research does not unnecessarily duplicate previous work.
Specific considerations derived from Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training:
- Evidence of the minimization of discomfort, distress, and pain to the animals consistent with sound research design. It is the conclusion of The Guide that in the absence of evidence to the contrary, the use of human feelings is an appropriate guide.
- Convincing justification of procedures that may cause more than momentary or slight pain or distress without appropriate sedation, analgesia, or anesthesia.
- Painless killing of animals that would otherwise experience severe or chronic pain or distress that cannot be relieved.
- Use of housing, feeding, and nonmedical care directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.
- The provision of necessary medical care for the animals by
a qualified veterinarian. Also required is appropriate care
for animals recovering from surgical
procedures. - Appropriate qualifications and training of personnel conducting procedures.
- Methods of euthanasia consistent with the recommendation of the American Veterinary Medical Association Panel on Euthanasia, unless a deviation is justified for scientific reasons by the investigator.
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V. The Bloomington Implementation
Indiana University has campus-specific animal care and use committees serving the needs of each particular campus. The Bloomington committee is named the Bloomington Institutional Animal Care and Use Committee (BIACUC). The BIACUC oversees and is responsible for approving animal care and use on the Bloomington campus. The Committee is appointed by and reports to the Vice President for Research and Dean of the University Graduate School.
A critical aspect of the PHS guidelines is the requirement that all campuses develop and maintain a consistent animal care and use program. The Bloomington program begins with the relation between the animal user and BIACUC. BIACUC treats this relation in much the same way as the PHS treats its relation to the university. The basis of the relation between the investigator and BIACUC is an assurance, which takes the form of a description of the proposed use of animals submitted to the BIACUC for its approval. BIACUC views these applications as a statement that the investigator has read and understood the relevant aspects of the PHS policy as outlined in the present guide, is in compliance with them, and that the application describes the procedures actually used.
Like the PHS, the BIACUC has no desire to become a policing
agency. Investigators are assumed to be capable and responsible.
The point of our procedures is to bring the investigator in contact
with the relevant portions of PHS and university policy, to produce
a record of the justification of the selection and use of animal
subjects, and to ensure that the proposed use of animal species,
numbers, and procedures are consistent with the PHS guidelines.
The purpose of this policy is to produce excellent and appropriate
care and use of animals, and to provide documentation of this
care to authorized responsible inquiring agencies. Such inquiries
are usually directed to the university by the PHS acting on the
basis of complaints received,
information provided by the institution, requests from congress,
or periodic review by the USDA and the BIACUC, itself. The PHS
has shown itself ready to suspend all research on a campus if
care and use practices are not appropriate, and/or if the institution
is unable to provide convincing evidence that a consistent and
appropriate animal care and use program is in effect. The USDA
is ready to suspend activities if the animal facilities are not
in compliance with PHS, the Animal Welfare Act, and the US Department
of Agriculture.
The USDA also conducts inspections at least annually, and
frequently semiannually, of the animal care and use program and
facilities.
B. The Bloomington Instutitional Animal Care and Use Committee (BIACUC)
As part of the campus-wide policy for animal care and use, BIACUC has mandated some important extensions to government policy. Though these extensions are not directly required by the PHS, most have been implicitly favored by PHS and approved in the original Letter of Assurance dated 2/2/87 and subsequently on 6/1/94. The current Letter of Assurance for Bloomington Campus was approved on 12/1/95.
- All use of animals in research and teaching on the Bloomington campus will follow the same set of approval requirements, not just research supported by PHS. The PHS guidelines extend the animal care policy of the USDA to all animals on campus. Further, many public and private research foundations have adopted the PHS guidelines for research and housing. Finally, PHS officials have indicated their approval of such a step as representing the implementation of a clear animal care policy by the university.
- All animal care and use on the Bloomington campus includes the different schools as well as the College of Arts and Sciences, and includes animal use contracted by principal investigators from external sources.
- The composition of BIACUC includes (in addition to the attending veterinarian, the outside member, and the nonscientist), a representative of each major department-like entity that uses animals in research or teaching, a graduate student representative knowledgeable in animal research, and the Director of Laboratory Animal Resources. This requirement ensures adequate representation of the constituencies using animals as well as providing a channel of communication to each department. The committee also includes an appropriate member from the Office of the Vice Provost for Research and Dean of the University Graduate School.
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C. The Departmental Animal Resources Committee
- Each department or department-like entity using animals should have an animal resources committee, typically drawn only from members of the department. The department's representative on BIACUC should be the chairperson or co-chairperson of the department's committee.
- The department's animal resources committee is responsible for the initial approval of the individual investigator's proposal. It is assumed that there will be screening at this level for the appropriateness of the content of the proposal as well as more general care and use issues.
- The department's animal resources committee is responsible, in combination with the attending veterinarian, the director of Laboratory Animal Resources and the department chairperson, for the oversight of animal care within the department.
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D. The Responsibilities of the Investigator
As indicated above, BIACUC views its relation with the individual investigator much as the PHS views its relation to the university. The relation is primarily one of trust with a focus on the common gain of responsible animal care and use. BIACUC anticipates that individual investigators will be motivated to comply with the guidelines of relevant government agencies and their specific campus-wide implementation. Part of this confidence stems from the fact that BIACUC includes full-time researchers interested in producing responsible animal care and use while preserving the flexibility necessary to good research.
Any specific complaints, recommendations, and points of information
will be welcomed, along with any desire to serve on the committee.
It is important to remember that the basic aim of BIACUC and the
PHS is to facilitate responsible research and training. It is
also important to reiterate that PHS reviews will occur, and the
lack of good records, or inconsistencies among records, statements
of procedure, and actual procedures are grounds for considerable
concern on the part of the PHS.
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Knowledge. Each investigator and teacher using animals must be knowledgeable about the pertinent external guidelines and regulations, and about relevant Indiana University policies. The sources of information include: (a) The Animal Welfare Act; (b) The PHS Guide for the Care and Use of Laboratory Animals; (c) the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions; and (d) these guidelines, appendices, and supplements. Copies of these can be obtained by contacting IACUC Administration, 819 N. Forrest Ave., Room 101.
Investigators and teachers should also seek information and assistance from Laboratory Animal Resources (LAR) and BIACUC concerning new procedures and guidelines. BIACUC and LAR will make periodic mailings of relevant material. LAR will be a source of up-to-date information and guidance concerning medical techniques and procedures, euthanasia, and general animal care and husbandry. If an investigator or teacher has a question about the care or handling of animals, it is most important that they refer the question to animal care staff in the department, and at LAR. Also, if appropriate, contact the attending veterinarian, the Departmental Animal Resources Committee and/or BIACUC. Examples of typical questions will include queries about euthanasia, current assumptions about the degree of pain or discomfort inherent in various procedures, housing, surgical techniques, etc. It is important that the information flow on campus be excellent. To achieve this end, it is critical that adequate records of the use of animals be maintained at all times.
Representation of the University. The investigator or teacher represents both his/her own line of research and training and the scholarly community at Indiana University. Laboratory assistants and classes should be informed as to the rationale for the use of animals with emphasis on the potential theoretical and practical gain from such research. Animals should be treated with care and respect. It is important that the public and the remainder of the university be acquainted with our policy of humane care and use of animals and the potential contribution of experiments and training using laboratory animals to human and animal welfare.
Pain and Well-Being of Animals. Perhaps no other
area is as difficult to deal with as the goal of minimizing pain
and providing for the well-being of animals. In general, it is
expected that investigators and teachers will strive to eliminate
unnecessary pain. Invasive and painful techniques should be clearly
justifed and closely monitored. There are often individual differences
in their implementation and receipt. Alternatives to the use of
live animals should be considered where possible. Recent guidelines
have emphasized the undesirability of procedures such as multiple
survival surgeries, and decapitation of animals above certain
weights without anesthesia. Specific guidelines have been proposed
for exercise and social treatment of dogs and primates and also
the psychological well-being of primates. When in doubt about
the existence of alternatives to particular procedures, please
consult LAR or BIACUC.
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3. Specific Duties and Relevant Information
a) The Animal Care and Use Application
The investigator or teacher must fill out a BIACUC Animal Care and Use Application for each project (see definition below) using animals and submit it to the Departmental Animal Care Committee. The application must supply the following information:
- The species and number of animals used along with a rationale for using animals, and for the appropriateness of the species and numbers to be used.
- The anticipated source of the animals (e.g., commercial breeder, live trapping, local breeding colony), whether quarantine will be required, the location(s) of housing and use, and the dates of proposed use.
- A description of the relevant details of all procedures involving the animals. Be sure to list methods of anesthesia including drug(s), dosage, and route of administration, any requirements for analgesia and post-operative care, and the method of euthanasia for each species, again including name of agent, dosage, and route of administration. It is acceptable to submit a copy of relevant parts of the grant proposal, but in most cases it will be more appropriate to assemble the relevant details for the committee on a summary sheet.
- In addition the Animal Care and Use Application should include information concerning deadlines that the committee should know, any granting agencies and grant titles, and a way to reach the investigator.
The departmental committee is responsible for acting within no more than one week and sending the Animal Care and Use application on to BIACUC (in care of IACUC Administration, 819 N. Forrest Ave., Room 101, Indiana University, Bloomington), or back to the investigator for revision. The IACUC Administrator will assign a protocol number, log the proposal, place it on the agenda for the next BIACUC meeting, and send a copy to LAR for screening. LAR has been directed to mark all potential approval problems and contact the investigator concerning possible revision and/or justification. Revisions by the investigator should be sent to the IACUC Administrator of BIACUC. The agenda for the committee will be sent to all members of BIACUC prior to each scheduled meeting.
At a BIACUC meeting, proposals on the agenda can be approved, approved pending further information, declined with explanation, or tabled. The investigator will be informed by mail (or e-mail when pending further information) of BIACUC's action within a few days. In the case of an externally funded application which has already been submitted, the Compliance Officer will inform the appropriate agency of BIACUC approval. If the protocol is declined, the investigator must begin the submission process again. If the protocol is approved subject to amendment, the Chairperson of BIACUC or an appropriate substitute committee member selected by the Chair, may approve an appropriately amended protocol prior to the next meeting, or place it on the agenda again if some question of appropriateness remains. If the protocol is tabled, either the veterinarian, the chairperson, or an appropriate committee member selected by the chair, will contact the investigator for further information, and the item will be placed on the agenda for the next meeting of BIACUC.
There are a number of important terms related to the information above that require further specification. A project is defined as a single academic course, or as a set of similar experiments such as might be found in a grant proposal. The critical aspect of defining a set of experiments as a project is that all of the sensitive aspects of procedures, care, justification of species and number, and euthanasia are readily dealt with on a single Animal Care and Use application. Any alteration in responses to the check list on the application form, or significant change in the justification or approximate number of animals used requires the filing of an amendment, or if there is substantial alteration, the filing of a new application. It should be clear that the more similar the experiments are in basic scientific procedures, the more reasonable it will be to include them in a project application. However, with appropriate justification, diverse procedures can be included in the same project. Amendments may be submitted directly to the Department's Animal Resources Committee.
Each application will be assigned a Protocol Number. This number should be retained and referred to in correspondence with the committee. In addition this number should be used in reporting animals ordered.
Animal Care and Use Applications should be filed in good time prior to the anticipated start of a teaching or research activity. In order for an Application to be reviewed during a specific monthly meeting, it must be received by the departmental committee by the tenth (10th) of the month and by the BIACUC by the fifteenth (15th) of the month. The PHS currently allows 60 days following submission of a research proposal for the investigator to obtain an approval, but they strongly recommend this as more the exception than the rule. They prefer that the approval goes in with the proposal. Other sources of research funds (such as the American Heart Association) require approval with the grant application for the proposal to be reviewed by that agency. The Bloomington campus internal review process is currently set-up so that it takes a minimum of about two weeks and a maximum of about six weeks for approval to be secured, provided there are relatively few and minor problems. The exception is with the Medical Sciences Program, which may require more time because of the interface with Indianapolis. Please be sure to allow sufficient time to process your paperwork.
Animal Care and Use approvals must be kept current. A change in procedures, species, or number of animals must be accompanied by an amendment or a new Animal Care and Use application depending on the degree of change.
Amendments may be initiated by the investigator, suggested by the veterinarian, the Chairperson of BIACUC, IACUC Administrator, an appropriate person or committee selected by the Chair, or the BIACUC itself. These amendments once again, go to the departmental committee , if appropriate, for review. Amendments flow from the departmental committee directly to the IACUC Administrator for further action. Amendments may also be required by a change in the Animal Care and Use Application for a particular project. Amendments may be made by submitting an appropriately altered Animal Care and Use Application and/or additional pages specifying the changes. The Committee recommends that when possible the investigator submit amendments as additional pages rather than a new form.
BIACUC is mandated to give continuing protocols an annual review. BIACUC will remind the investigator that a review is forthcoming, and the investigator is expected to inform BIACUC promptly either that the same protocol is still in effect, or submit to BIACUC appropriate amendments, cancellations, or new protocols.
In order to ensure a high probability that your vertebrate animal care and use approval will go in with your grant, BIACUC has the following recommendations:
When submitting a new grant or a competing renewal, you are urged to submit a BIACUC Application to your departmental committee 45 days ahead of the due date. Provided the form clears the departmental committee within several days, typically two BIACUC meetings will be held prior to the date your grant must be mailed. We have tried to ensure that one BIACUC meeting is sufficient for evaluating most forms by having the LAR Director review the application and consult with the PI prior to the meeting. The interests of the PI are best served by allowing time for two meetings, and quickly replying to all BIACUC requests for information.
BIACUC approval may be obtained if a quorum of the membership is present. BIACUC may invite consultants to present views and information. The consultants may not remain during deliberations or any other part of the meetings.
Research and teaching involving animals on the Bloomington
Campus should not take place until BIACUC approval has
been secured. BIACUC has no choice but to suspend ongoing
research and teaching without an Animal Care and Use Application
on file and refer the matter to the appropriate institutional
official for permanent disposition and any sanctions.
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b) Personnel working with animals
A considerable portion of the PHS mandate concerns the health and training of laboratory personnel. PHS guidelines refer to animal care personnel, and all laboratory personnel that work with animals, including technicians, faculty, graduate students, and undergraduates. Each investigator should be aware of the PHS and university guidelines for personnel having contact with animals.
The university approved health program for personnel who work in laboratory animal care facilities or have substantial contact with animals involves three areas of concern:
- Pre-employment. Physical examination and counseling on health hazards associated with working with animals. The physical examination may include a TB test, and a review of the immunization record. Tetanus prophylaxis is recommended for all, and rabies prophylaxis is recommended for those working with dogs, cats and bats.
- On the job. Annual review of immunization and TB tests. In-service training on safety and disease control. Annual tuberculin tests for those handling nonhuman primates. The use of distinctive protective garments and devices must be provided and maintained by the university. A record of daily animal contact must be maintained.
- Health record. A central directory of all covered persons should include date of physical examination, immunization record, updated details of allergies and health problems, Indiana University work history and on-the-job injuries, and a physician and contact person in case of emergency.
In addition to developing broad health policies for personnel working with animals, all personnel are required to complete Continuing Education materials annually or take classes. We emphasize that graduate students and faculty must spend the time to become acquainted with animal care issues and regulations.
BIACUC does hold the investigator responsible for the training
of all personnel working in a laboratory on the specific procedures
used on the project and the general rules and practices of sound
animal care as outlined in the various PHS documents. These latter
include the care of sick animals and the disposal of dead animals,
as well as appropriate hygiene and medical procedures for protecting
both the researcher and the animals. When such a practice is useful
and feasible, BIACUC strongly endorses the use of special laboratory
apparel that is left in the laboratory and cleaned professionally
at appropriate intervals. BIACUC/LAR/Departmental Animal Care
and Use Committees will attempt to facilitate the training of
personnel by holding general orientation and information sessions
at least once a year. In addition LAR will provide training and
information on a request basis.
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The major point to be stressed in ordering animals is that the investigator must provide the protocol number of his/her returned Animal Care and Use Application form. Except for wild-caught species, all animals must be purchased from approved vendors. A list of vendors is available from LAR. Provided investigators have BIACUC approval and permits (such as U.S. Fish and Wildlife) where applicable, wild species may be obtained by the investigators but, may need to be quarantined prior to use (see below).
The investigator should order all animals through their
own
department. These orders are then forwarded to LAR for verification
of an approved protocol. In all cases the investigator must obtain
approval from the animal care personnel in charge of space at
the housing facility, and from LAR if quarantine is required.
In addition the investigator must report to LAR information as
to species, number, and the Animal Care and Use Application number
assigned by BIACUC in its approval as a regular part of the ordering
procedure. It is absolutely critical that LAR have this information
in an up-to-date form for access by appropriate university officials
and outside agencies, such as PHS.
Quarantine is required for many animals received at IUB except pigeons and commercially raised rats and mice. The quarantine is imposed to allow detection and treatment of parasitic and infectious diseases that may be communicated to other animals or to humans. The quarantine also allows the discovery of physical defects, travel-related injuries, and obvious behavioral shortcomings. At the completion of the quarantine period, LAR will deliver the animals to the appropriate department facility. Per diem fees will be charged for quarantine to recover the cost of housing and care.
Transportation of most animals occurs in the supplier's
vehicle, which must be appropriately climate controlled. For those
few animals shipped by common carrier, arrangements must be made
to transport the animals immediately from receiving to appropriate
housing or holding areas. The LAR has a climate controlled van
suitable for transportation of animals around the university campus,
and for necessary pick-up of species such as primates at the Indianapolis
airport.
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E. Laboratory Animal Resources
Laboratory Animal Resources consists of the director, the attending veterinarian, support staff, housing, and equipment necessary to provide veterinary care and information to all campus animal facilities research projects. Their services include:
- Receipt, examination, and any necessary quarantine of newly arrived animals.
- Veterinary medical care and husbandry for all animals used in research and training on the Bloomington campus.
- Assistance with procurement, housing, husbandry, disease control, species or model selection, procedures, anesthesia, euthanasia, and transportation of animals.
- Assistance with compliance with PHS, USDA and Bloomington guidelines for the care and use of animals.
- Ordering of feed, bedding, and other husbandry supplies.
- Training of scientific and technical personnel in techniques and manipulations with most laboratory species.
- Assist in development and design of all animal room renovations or new facility construction.
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SECTION
II
Specific Issues in the Care of Animals
What follows is specific information concerning the care and
use of animals on the Bloomington Campus. All researchers and
teachers should be familiar with this material.
- Indiana University Policies
- Regulations and Guidelines
- Anesthetics, Analgesics and Tranquilizers
- Animal Surgery
- Safety Committees
- Animal Disposal
- Campus Animal Facilities
- Husbandry
- Veterinary Care
Appendices
I. Indiana University Policies
A. Indiana University Systemwide Statement on Animal Care and Use (11/13/84)
Fulfillment of Indiana University teaching and research missions requires a variety of approaches, among which is the use of animals. Living animals are used only when there is no valid alternative to their use, or when their use may be required by law in a particular experiment or test.
Animals, in order to yield valid results, must be healthy and comfortable. For this reason, as well as for humaneness, it is the policy of Indiana University that animals required for teaching and research shall be housed, cared for and used in accordance with the highest standards of comfort and cleanliness, as required by regulations and guidelines of the Animal Welfare Act, the National Institutes of Health, and Public Health Service.
B. Bloomington Statement on Animal Care and Use (2/5/85)
Fulfillment of the teaching and research missions of Indiana University requires the use of research animals. It is the policy of Indiana University that animals are used only when there is no reasonable alternative or when their use may be required by law in a particular experiment or test. In order that the results of their use be reliable and valid, animals must be maintained in a healthy and comfortable condition. Therefore, Indiana University requires that animals be housed, cared for, and used in accordance with appropriate standards of comfort, cleanliness, and humaneness.
Indiana University adheres to appropriate federal, state and local acts, statutes, and regulations governing the acquisition, transportation, housing, care, use, and disposition of animals. An Assurance of Compliance, on file with the Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), states that Indiana University-Bloomington is committed to compliance with the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, the Public Health Service Principles for the Use of Animals, and all other applicable laws and regulations.
The University has taken several specific steps to guarantee
compliance with both the spirit and the letter of these laws,
regulations and standards. They include the establishment of a
Bloomington Institutional Animal Care and Use Committee (BIACUC).
Convened by the Associate Dean of Research and Dean of the University
Graduate School and operating under the authority of the Vice-President
of Research and Dean of the University Graduate School, in accordance
with the regulations of the National Institute of Health, this
committee is charged with developing policy and implementing guidelines
governing animal research on the Bloomington Campus, in keeping
with current and future standards. Decisions relating to implementation
of the Indiana University-Bloomington Policy on Animal Care and
Use are the responsibility of the Vice-President for Research
and Dean of the Graduate School. Oversight responsibility is vested
in the Campus Animal Care and Use Committee, composed of scientists,
a non-scientist faculty member, a graduate student, a person from
outside the university, and an attending veterinarian. The BIACUC
is required to oversee all aspects of animal research, including
the establishment of uniform and comprehensive training standards
for animal technicians; the maintenance of high levels of care,
use, and disposal of animals; and the approval of all research
and teaching applications involving animals.
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C. Indiana University Policy on Access to Laboratory Animal Facilities (3/27/84)
The laboratory animal facilities within the Indiana University system are critically important education and research support facilities. As such, it is essential that the University maintain the best conditions of health and tranquility for the animals, and protect the public from possible health hazards. Therefore, access to laboratory animal care facilities is generally limited to University personnel and students who are qualified in the use, care and maintenance of laboratory animals and currently engaged in university-sponsored research or instruction involving the use of animals. There may be occasions when other persons desire to visit specific laboratory animal care facilities. Indiana University will act responsibly as a state-sponsored institution in responding to such requests. In doing so, the following guidelines shall be applied:
- Persons requesting to visit facilities should be informed
that Indiana University and its laboratory animal care facilities
are in compliance with the Animal Welfare Act, the NIH Guide
for the Care and Use of Laboratory
Animals, and the Public Health Service Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions. - Persons seeking to visit laboratory animal facilities shall forward their requests, in writing on Visitation Request forms to the Investigator who will approve/dissapprove and forward to the departmental committee to review and they will forward BIACUC, who is directly responsible for granting requests along with the specific investigators whose facilities are involved and the respective departmental animal care and use committee. The written request shall state the particular facility to be visited, the species to be observed, and the purpose of the visit. It shall also identify the specific individuals who desire to participate in the visit.
The University recognizes that the use of animals for biomedical
research and teaching will continue to be required, if it is to
advance in knowledge, and if it is to continue properly to educate
and train tomorrow's physicians, dentists, and scientists. The
University also recognizes its responsibility to insure that biomedical
research models be maintained for the ultimate benefit of all
mankind. Further, the University is committed to support fully
such activities, consistent with legal and ethical standards,
and with scientific and humanistic concern.
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II. Regulations and
Guidelines
- Animal Welfare Act
Regulated by this legislation are:- Licensing of laboratory animal dealers,
- Registration of research facilities,
- Identification of animals,
- Records of care and use,
- Humane handling, care, treatment and transportation of dogs, cats, mice, rats, guinea pigs, hamsters, rabbits, nonhuman primates, marine mammals, and other warm-blooded animals.
- Veterinary care of all covered species, and
- The use of anesthetics, analgesics, and tranquilizers for experiments causing pain or distress,
- Institutional Animal Care and Use Committee make- up and function,
- Exercise for dogs, and
- Psychological well-being of primates.
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Coverage of the Animal Welfare Act specifically excludes rats of the genus, Rattus; mice of the genus, Mus; birds; horses; and farm animals. Provisions of the Act are administered by the U.S.D.A., through periodic unannounced inspections by veterinarians on the U.S.D.A. staff. A copy of PL89-544 is available from Laboratory Animal Resources (LAR) or BIACUC.
- Guide for the Care and Use of Laboratory Animals
- Institutional policies,
- Laboratory animal husbandry,
- Veterinary care,
- Physical plant, including space recommendations for commonly used species, and
- Special considerations.
The Guide is written in general terms to cover various situations, and to allow for professional and scientific judgement in interpretation and implementation.
The Guide covers specifically all warm-blooded species used in all situations of instruction or research. Although marine mammals and cold-blooded animals are not discussed specifically, the humane principles stated are applicable to their care and use.
- Principles for the Utilization and Care of Vertebrate Animals
Used in Testing, Research and Training, (U.S. Interagency Research
Animal Committee - I.R.A.C.)
The Interagency Research Animal Committee Principles govern all vertebrate animals, and are included in this manual as Appendix C.
- Public Health Service Policy on Humane Care and Use of Laboratory
Animals by Awardee Institutions
This Policy covers all live vertebrate animals, in all facilities and field research used in activities supported by the Public Health Service. Institutions are required to:- Provide an Animal Welfare Assurance setting forth plans for complying with the Policy,
- Establish a committee to oversee the institution's animal program, facilities, and procedures,
- Review sections of research proposals related to the care and use of laboratory animals,
- Maintain certain records, and
- Report status periodically, including changes in programs, procedures, committee membership, and results of committee inspections and facilities.
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III. Anesthetics, Analgesics, and Tranquilizers
The proper use of anesthetics, analgesics and tranquilizers in laboratory animals is necessary for both humane and scientific reasons. The choice and use of appropriate drugs are subject to the professional judgement of the Attending Veterinarian, LAR, the departmental animal care and use committee and BIACUC.
Consultation regarding choice and use of pain and stress relieving drugs is available from LAR and the Attending Veterinarian. A list of common anesthetics for common species appears as Appendix A. Equipment for inhalation anesthesia, and assistance with its use, are available from LAR.
Muscle relaxants and paralytic drugs (curariform) are not anesthetics, and are NOT to be used alone for surgical restraint. They may be used for surgery in conjunction with analgesics and either machine or manually assisted respiration.
The Animal Welfare Act requires, from each research facility using live animals, an annual report showing that professionally acceptable standards of care and use were met. The report includes appropriate use of anesthetics, analgesics, and tranquilizers, and is divided into three categories:
- Research, experiments, or tests involving no pain, distress, or pain relieving drugs, (routine procedures such as injections, tattooing and blood sampling need not be reported).
- Research, experiments, or tests involving accompanying pain or distress and for which appropriate anesthetics, or tranquilizers were used, and,
- As in B, except for which the use of anesthetics, analgesics, or tranquilizers would adversely affect the procedure, results, or interpretation. A brief explanatory statement is required for each such use.
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Many animal research projects involve surgery, and this may vary dramatically in complexity. Many P.I.'s and their graduate students and technicians have become highly proficient at techniques which are repetitious. Assuming compliance with regulations on pain and distress relief, this is certainly acceptable. Consultation on procedures, instrumentation, recovery, etc. is available from LAR.
The Guide requires that surgery on all warm-blooded animals (except rats, mice, guinea pigs and hamsters) be conducted only in areas specifically equipped and maintained for that purpose, and that only surgery be performed in those areas. Aseptic technique must be used on all animals including rabbits.
Survival surgery on rodents (except lagomorphs) does not require a special surgical facility, but should be performed using sterile instruments, gloves, and aseptic procedures. Any room or enclosure used for surgical manipulations, regardless of location, is considered part of the animal facility (PHS Policy). As such, these areas must meet the same standards of construction, sanitation, and equipment as does an animal room.
Surgical services are routinely provided at LAR by the
Director. This includes sterilization, anesthesia, and recovery
room, in addition to the surgical procedure. Principal Investigators
may arrange for use of the LAR surgical area to perform their
own manipulations.
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Under usual circumstances, work with animals poses no greater
risk than does other research occupations. However, research with
hazardous biological, chemical or radioactive agents requires
procedures and equipment to protect people, animals, and the environment.
Numerous degrees and types of containment can be used. Employee
health surveillance, tailored to the particular case, may be instituted.
Hazardous agents and procedures are so varied as to prevent formulation
of absolute
rules. However, the following are general principles concerning
potentially hazardous situations.
- The PI is responsible for minimizing biohazards. This involves anticipation of problems, responsible preventive measures, and appropriate reaction in case of contamination.
- All animal experiments involving potential danger to humans or animals must be approved in advance by the appropriate safety committee in addition to the BIACUC. In addition, it is essential that allowed work with animals comply with the guidelines and regulations and approval of the committees listed in Appendix B. Animals and animal waste from these projects present special problems. Infectious agents may persist for months, indeed spore-forming bacteria and some parasite ova persist for years. Decay times of implanted radioactive substances may be measured in dozens of years. Poisonous chemicals may be highly persistent in water and soil, and certain breakdown compounds may be more toxic than their precursors. Therefore, disposal of any potentially hazardous material may occur only after clearance has been obtained from the Committees involved. Storage and calculation of safe disposal dates for radioactive waste will be supervised by the Campus Radiation Safety Officer. An autoclave (capacity 2.5 cu. ft.) is available at LAR for decontaminating items harboring infectious organisms. When possible decontamination (autoclaving, dry heat, chemical) should occur at the site of use.
- Any potentially dangerous situation should be brought to the attention of LAR and the BIACUC.
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- Disposition of unneeded animals can take several forms.
Principal among these are:
- Use in another research or instruction situation at I.U.
- Transfer to another I.U. installation, or to another educational or research institution or rehabilitation facility.
- Euthanasia
- Healthy surplus animals may be used in further research
or instruction only if:- They are NOT destined to be subject to major survival surgery, having already survived one major surgical procedure.
- They have not received, by any route, any radioactive or other toxic substances, and,
- They have not been inoculated with disease organisms with substantial public health significance.
- Animals destined for other institutions shall be examined
by LAR, and if found to be healthy, shall have appropriate certification
issued. Primates shall be tuberculin tested and found to be
negative. In no case whatsoever shall a primate be transferred
for use as a pet, or for exhibition at other than AAZPA institutions.
- All Euthanasia must be performed by trained personnel and
conform to the "Report of the AVMA Panel on Euthanasia",
found in the Journal of the American Veterinary Medical Association,
202 (Jan. 15, 1993). LAR staff is available at any time to assist
with selection of agents and methods, proficiency of technique,
and sanitary disposal of carcasses. Choice of method is dependent
upon considerations such as species, research nature, need for
tissues, and safety of the euthanasia agent for humans. Animals
of most species can be killed quickly and humanely by intravenous
or intraperitoneal injections of concentrated barbiturate solutions,
or intravenous injections of non-barbiturate euthanasia solutions.
Decapitation and cervical dislocation are acceptable in mice,
rats, and hamsters after sedation or tranquilization.
Under no circumstances should the following methods be used: - Chloroform - A proven carcinogen to humans
- Succinyl Choline/Magnesium Sulfate - These two drugs paralyze voluntary muscles, but have no anesthetic or sedative properties. Therefore, the animal dies of asphyxiation while still fully awake and able to feel pain and distress.
- Strychnine - Has no anesthetic or analgesic properties. Causes violent, painful tetanic convulsions, causing the animal to die of asphyxiation due to inability to control chest muscles.
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All quarters in which animals are housed for any reason
must be inspected by BIACUC and have the committee's written approval.
This includes satellite facilities, which are defined as areas
of containment outside a core facility or centrally designated
or managed area, in which animals are housed for more than 12
hours. Additions or exceptions can be sought through the BIACUC.
- Housing
- Type - Impervious, easy to clean materials, designed with regard to the animals' comfort, ease of care, and maintenance, and compatibility. Stainless steel, hard aluminum, and clear plastic are best, galvanized steel and opaque plastic are acceptable, untreated wood is normally unacceptable.
- Size - Minimum linear dimensions and volumes for most sizes of most species are found in a table in the Guide. Deviations from these values are discouraged and must be satisfactorily justified.
- Exercise - Need for exercise is still a matter of professional judgement. Cage confinement cannot be equated with lack of exercise or lack of well-being. However, extra exercise is encouraged, particularly in the case of dogs and primates. Primates will also be provided with varying environmental enrichment items.
- Climate - General recommendations are located in the Guide.
Specific temperature and relative humidity limits can be
found in the Animal Welfare Act. The following are general:
Temperature - 64° < 84° F (18° - 29°C) ± 2° F (1° C)
Rel. Hum. - 30 < 70%Air changes - 12 < 15 per hour at the primary enclosure (cage, etc.)
Lighting - 75 < 125 foot candles for observation and cleaning. < 30 adequate other times. Automatic timers preferred.
- Nutrition
- Diet selection
In general, commercial diets are preferred over home-formulated diets. These diets, delivered fresh, are available for most mammals and birds, and numerous fish, amphibians, and reptiles. There is no objection to moderate supplementation with foods particularly liked by a certain species. However, in almost all cases the supplements are more beneficial to the feeder than to the subject. Custom formulated diets can be obtained. These are used for exotic species, to create nutrient imbalances, or to act as a carrier for an experimental compound. - Method and Schedule
Self-feeding is normally the method of choice for rodents and rabbits. Restricted food availability may be indicated for:- dogs and cats which tend to eat everything immediately,
- old rodents and rabbits which tend to become obese if fed ad lib,
- fresh diets which spoil if not refrigerated, and
- the experimental protocol, in which case the level of restriction must be justified.
- Water
Water must be available at all times, unless water deprivation is integral to the research.
Water should be presented in a manner both acceptable to the species and capable of minimizing waste and contamination. Automatic watering devices are reliable, sanitary, and readily accepted by most species, although brief training may be necessary with an occasional animal. Drinking water may be used to distribute medication through a rack, room, or colony. However this dictates particular attention to water system monitoring and cleanliness.
Some rodents from an arid natural habitat, particularly Mongolian Gerbils can exist on very low water intake. However, with constant water supply they drink and urinate similarly to the other rodents.
- Sanitization
Clean living conditions- Reduce disease propagation and transmission,
- Reduce unwanted variables in the experiment,
- Are aesthetically acceptable to technicians and scientists, and
- Add to the useful life of cages and equipment.
Requirements
- Hot Water - With rare exceptions, dirty surfaces cannot be sanitized with hot water alone. Hot water, with appropriate detergents, is absolutely vital to any sanitation program.
- Scrubbing - Preferably in an automatic washer with water Æ 150%F(60%C). If not, by hand with 150%F(60%C) water.
- Sanitizing - Machine rinse with 180%F water. If not feasible, use disinfectant chemical, then rinse.
- Litter change - Primates, dogs, cats - Daily; Livestock - daily; Others - 1 to 2 times weekly
- Vermin and rodent control
- Deny sanctuary - Seal all cracks, eliminate all possible places of harbor.
- Eliminate food sources - Seal all containers, clean up spills, keep feeders in good condition.
- Physical, chemical, biological control methods.
- Seldom necessary,
- May confound experimental results,
- May be dangerous to humans or animals,
- Always consult with principal investigator prior to use, and
- Contact LAR for assistance with selection of material and method
- Waste and disposal
- Waste receptacles must be covered, plastic lined, and light enough to be handled readily.
- Waste storage area must be separate from feed, bedding, and equipment storage. Cold storage is necessary for carcasses.
- Non-infectious bedding can be incinerated or put in a land-fill. Biohazardous waste of any kind may be disposed of only in accordance with rules established by the campus Biosafety Committee.
- The I.U. Bloomington Student Health Center houses the only Indiana Air Pollution Control Board approved incinerator on the campus. Therefore incineration of carcasses or litter considered biohazardous is to be picked up by LAR and incinerated at the Student Health Center.
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- Transportation
- Off campus - Most animals arrive by common carrier or by vendor's truck. Shipping regulations are their concern, and by and large both do a good job. One regulation of interest to us concerns temperature. At no time shall the air temperature around any live warm-blooded animal be allowed to fall below 45°F (7°C), or rise above 85°F (29.5°C). The minimum is rarely of concern, since most such warehouses are heated. The maximum may be of concern, since many shipping and receiving warehouses are not air conditioned. As a general rule, if the temperature at any handling point on the route is predicted to exceed 85°F during the trip, the airline or truck line will refuse the shipment. From June 1 to October 1, check first.
- On Campus - LAR maintains a vehicle which satisfies
requirements of cleanliness, construction and temperature
control. Except in extreme urgency, no other vehicle
should be used for intra-campus animal transportation.
Off Campus - Primates are normally shipped, by the vendor, by means of a freight forwarder such as Emery. The cost is usually the same for delivery to campus or pick-up at the Indianapolis airport. If this is not the case, the LAR vehicle can pick up animals at the airport. The same is true for pick-up or delivery to regional campuses. Check with LAR for costs.
- Diet selection
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Provision of adequate veterinary care is mandatory under the Animal Welfare Act, The Guide, the Interagency Research Animal Committee Principles, and the PHS Policy.
Veterinary Care is provided by, or under the guidance of
the Attending Veterinarian and the Director of LAR. Isolation
facilities are available at LAR when contagious diseases are
detected.
Clinical laboratory and pathology services are available
from LAR and from external laboratories. Access to external services
is available by referral from LAR.
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APPENDICES
Recombinant DNA and other Infectious Agents, Contact the Biosafety Compliance Officer, Research and the University Graduate School for the most recent federal and state guidelines and University Policy.
Human Tissues and Fluid, contact the Biosafety Compliance Officer, Research and the University Graduate School for the most recent federal and state guidelines and University Policy.
Chemical Safety, contact the Chemical Safety Officer, Environmental Health and Safety for the most recent federal and state guidelines and University Policy.
Radiation Safety, contact the Radiation Safety Officer,
Environmental Health and Safety for the most recent federal and
state guidelines and University Policy.
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Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research
and Training - (U.S. Interagency Research
Animal Committee)
The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. When U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered to:
- The transportation, care, and use of animals should be in accordance with the Animal Welfare Act and other applicable federal laws, guidelines, and policies.
- Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
- The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
- Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
- Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
- Animals that would otherwise suffer severe or chronic pain
or distress that cannot be relieved should be
painlessly killed at the end of the procedure or, if appropriate, during the procedure. - The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
- Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
- Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made with due regard to Principle 2, by an appropriate review group such as an institutional animal research committee. Such exceptions should not be made solely for the purpose of teaching or demonstration.
For guidance throughout these Principles the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences for the Public Health Service, National Institutes of Health.
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