Animal Care and Use Policy                                             UPPS No. 02.02.05

                                                                                                Issue No. 4

                                                                                                Effective Date: 09/12/2011

                                                                                                Review: January 1 E3Y

 

 

01.       POLICY STATEMENTS

01.01  Texas State University-San Marcos recognizes the importance of the use of animals in its education and research programs. The use of animals is vital both for understanding basic biological, agricultural, and ecosystem processes, as well as, in developing diagnostic, therapeutic, and preventive approaches for human and animal diseases. It is Texas State’s policy to provide all animals used in education and research with humane care and treatment.

 

01.02  Texas State is committed to maintaining the highest possible standards for the care and use of animals. Texas State endorses as its own, the "United States Government's Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training." Texas State, including its investigators, researchers, teachers, students and staff, accepts responsibility for determining that research and education involving the use of animals fulfill the principles outlined in the aforementioned document.

 

01.03  The purpose of this policy statement is to establish and standardize procedures and regulations concerning the procurement, maintenance, handling, and disposal of all live animals for education and research purposes by Texas State.

 

01.04  Specifically, adherence to the policy set forth in this document will insure that Texas State is in compliance with regulations established by the federal government under the Animal Welfare Act, as described in Section 01.05 and with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, whether or not federal funding is involved.

 

01.05  The U.S. Department of Agriculture administers the Animal Welfare Act (7 U.S.C. Sections 2131-2159) and its implementing regulations, published in 9 C.F.R., Title 9, Subchapter A, Parts 1-4. The Animal Welfare Act regulates the transportation, purchase, sale, housing, care, handling, and treatment of animals used in research, for exhibition, and sold as pets. The Act specifically includes dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, wild animal species, and any other warm blooded animals that the Secretary of Agriculture determines are being used or intended for use for research, testing, experimentation, exhibition purposes, or as pets. Beginning June, 1990, farm animals used in biomedical research were subject to inspection under the Act.

 

The Animal Welfare Act is administered by the U.S. Department of Agriculture (USDA), specifically, the Regulatory Enforcement and Animal Care Branch of the Animal and Plant Health Inspection Service (APHIS). Research facilities are subject to unannounced inspections by USDA personnel and are required to furnish annual reports that include, in addition to other information and assurances, the common names and numbers of animals used listed by procedures involving (a) no pain or distress, (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. Routine procedures such as injections are exempt from the reporting requirements. 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. Non-compliance with USDA standards for the humane handling, treatment, and transportation of animals may lead to substantial fines or suspension of animal research activities.

 

The PHS Policy on Humane Care and Use of Laboratory Animals incorporates the changes in the PHS Act mandated by the Health Research Extension Act of 1985, Public Law 99-158, as amended in 2002. The PHS policy, frequently referred to as National Institute of Health (NIH) 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 all vertebrate animals) to the Office of Laboratory Animal Welfare (OLAW). At least every five years, the university must resubmit this information in the form of an Animal Welfare Assurance. The university must report significant changes in existing assurance status or problems encountered in implementing this policy to the OLAW immediately. The PHS requires institutions to use "The Guide for the Care and Use of Laboratory Animals" (the Guide) as a basis for developing an institutional program for activities involving laboratory animals. In 1962, the National Academy of Sciences Institute for Laboratory Animal Resources (ILAR) developed the Guide under contract with NIH. Its purpose is to assist scientific institutions in using and caring for laboratory animals in ways judged to be professionally appropriate. NIH policy dictates that grantees and contractors using live vertebrate animals in projects or activities supported by NIH use the recommendations in this publication for guidance.

 

01.06  The policy set forth in this document will be changed as required by future changes in federal law.

 

02.       INSTITUTIONAL POLICY FOR CARE AND USE OF ANIMALS IN TEACHING AND RESEARCH

 

02.01  Definitions

 

a.   Animal – Any live, vertebrate animal used or intended for use in education, research, research training, experimentation, biological testing, exhibition, or for related purposes. Control of feral animals, nuisance species, exotics, or other uses outside of the above uses do not require Institutional Animal Care & Use Committee (IACUC) approval, but may require permitting by other agencies as appropriate to the taxa.

     

b.   Animal Facility – Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. A satellite facility is a containment outside a core facility or centrally-designated or managed area that houses animals for more than 24 hours. This includes all buildings, structures, farms, fish tanks, and other facilities owned or used by Texas State, such as federal and state fish hatcheries.

 

c.   Animal Welfare Assurance or Assurance – The documentation from an institution assuring institutional compliance with PHS policy.

 

d.   Guide – Guide for the Care and Use of Laboratory Animals, PHS, 1996 edition or succeeding revised editions.

 

e.   Ag Guide – Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, First Edition, 1988, developed by the Consortium for Developing a Guide for the Care and Use of Agricultural Animals.

 

f.    IACUC – A quorum of the Institutional Animal Care and Use Committee.

 

g.   Institution – Texas State University-San Marcos.

 

h.   Institutional Official – An individual who signs, and has the authority to sign, Texas State's Assurance, making a commitment on behalf of Texas State that the requirements of PHS and USDA policy are met.

 

i.    Public Health Service – The Public Health Service or PHS includes the Alcohol, Drug Abuse, and Mental Health Administration; the Centers for Disease Control; the Food and Drug Administration; the Health Resources and Services Administration; the National Institutes of Health; and the Office of the Assistant Secretary for Health, Department of Health and Human Services.

 

j.    U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, 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 Inter-agency Research Animal Committee (IRAC). These principles are consistent with the guidelines Texas State has adopted for laboratory animal care.

 

k.   American Association for Accreditation of Laboratory Animal Care – The American Association for Accreditation of Laboratory Animal Care (AAALAC) provides voluntary peer review and awards accreditation of laboratory animal care facilities and programs which meet its rigid standards. Representatives of this organization make periodic visits and inspections to assure the institution meets the standards. Representatives of this organization make periodic visits and inspections to assure the institution meets the standards. The NIH, in its current policies, accepts AAALAC accreditation as the best means of demonstrating conformance with NIH requirements for animal care and use.

 

l.    Good Laboratory Practice Act – The Good Laboratory Practice (GLP) regulations pertain to nonclinical laboratory studies done in support of applications 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 and diagnosis and treatment, animal identification, caging and routine care, sanitation, and documentation requirements.

 

m.  American Veterinary Medical Association Panel of Euthanasia (AVMA) – The recommendations of the AVMA Panel on Euthanasia are the prime reference for methods of euthanasia of animals. The methods of euthanasia by the AVMA Panel on Euthanasia are considered acceptable by both the NIH Policy and the Animal Welfare Act.

 

n.   Quorum – A majority (more than half) of the members of the Institutional Animal Care and Use Committee (IACUC).

 

02.02  Implementation of Animal Welfare by Texas State University-San Marcos

 

a.   The AAALAC provides voluntary peer review and awards accreditation of laboratory animal care facilities and programs meeting its rigid standards.

 

1)   Space Requirements – Generally, animals shall receive adequate space for normal movement, changing position (standing, lying down, turning around, and other physical activities), and body maintenance (grooming, etc.) with respect to their size, age, condition, and expected confinement duration. Subject to justification and committee review, the institution may approve modifications for specific experiments, such as metabolism studies involving a limited number of animals. The institution will ensure working pens, fencing, and other retention or holding facilities are free of harmful objects or protrusions to avoid unnecessary pain, harm, or fear to the animal.

2)   Transportation – The institution will ensure loading equipment and transport vehicles are built and maintained to prevent animal and personnel injuries, and protect animals against extreme heat or cold conditions as the Livestock Conservation Institute guidelines (trucking guide and poultry handling) recommend, considering intensity, trip length, and weather conditions.

3)   Outdoor Maintenance and Protection – Animals should be maintained under conditions compatible with general comfort, health and well being. To help protect animals from weather extremes, the institution will provide appropriate shelter and shade and a thermo neutrality comfort range to a reasonable extent. Outdoor protection considerations may include breed background or adaptation, accessible natural protection, and other factors.

4)   Nutrition – Minimal animal nutritional requirements are provided as outlined in the National Academy of Sciences publications of nutrient requirements for domestic animals. As part of research objectives, the institution may justify significant deviations from published requirements. In extreme cases (such as prolonged withholding of essential nutrients), a full justification and review will be required.

5)   Sanitation – The institution will keep animal facilities clean and will remove animal excrement on a reasonable periodic basis. It will not force animals to lie in their own excrement or that of other animals. When areas become excessively wet and boggy (to the degree that jeopardizes health or significantly inhibits normal movement) due to precipitation or feces or urine accumulation, the institution will remove the animals. In instances where animals are not in direct contact with excrement (pits or litter-drop systems), some excrement accumulation is acceptable. The accumulation of harmful odors and gases (such as ammonia) should be minimized.

6)   Animal Identification – During research studies, the institution will identify each animal individually and retain its identity, using ear tags, neck chains, and other methods. When branding is merited or essential for identification, freeze branding is recommended.

7)   Maintenance and Treatment – Animal care procedures shall meet or exceed those in commercial practices with major consideration given to humane and sanitary care in handling and treating animals, including castration, dehorning, and other cultural practices.

8)   Standard Agricultural Practices – Long-term animal welfare may necessitate certain commercial husbandry procedures that may cause temporary discomfort or pain. The Act accepts these practices as standard procedures provided they are a) warranted in agricultural production; b) performed by or under the supervision of capable personnel; and c) performed with precautions to reduce pain, stress, and infection.

9)   Protocols – The research investigator or instructor must design animal experiments or activities that comply with the Ethics of Animal Experimentation and Use and Biologically Sound Experimental practices for the reasonable care and use of agricultural animals.

10)Surgery – The institution will conduct surgical, metabolic and other physiological and biological studies with appropriate facilities, adequate equipment, and under the direction and supervision of qualified personnel for animal sanitation and protection, including both operative and post-operative recovery.

11)Posted Information and Emergency Procedures – The institution will display a list of names and points of contact (i.e., responsible animal caretaker or ranch manager, key researchers, emergency or weekend telephone numbers, and feeding and inspection schedules) near the entrance to each livestock facility, building or pasture. It will provide instructions regarding which personnel to notify in the event of an emergency (i.e., escaped animals, power failure, fire sick animals, or animals in extreme pain) and reporting procedures regarding animal welfare concerns. The institution expects employees to conduct themselves according to the IACUC code of ethics that it will post near the entrance to each livestock center or unit.

12)Concerns Regarding Animal Care or Abuse – People who observe or are informed of substandard, inhumane, or detrimental animal care must immediately report their concern to the IACUC chair or a designated representative (24 hours a day), who will investigate the concern immediately. The IACUC chair or designated representative will then notify the animal caretaker, principal investigator, and the appropriate departmental chair, who will take corrective action if a legitimate concern exists. If an animal is found in significant pain due to injury or other cause, and after a reasonable effort to notify the person responsible for the animal has failed, or those responsible fail to take immediate action, the IACUC chair or a designated representative has the authority to immediately direct alternative care, administer analgesics, or euthanize the animal as appropriate. The IACUC will review such cases and issue a report to the appropriate departmental chair.

13)Agricultural Animals for Market – The operation of the Freeman Ranch includes animals not used in research, education, or outreach with the primary purpose of market production. Care of these livestock will meet all above guidelines and inspections will be done alongside IACUC protocol animals. As market production is not an IACUC activity, per se, Freeman Ranch will use the best management practices (BMPs) for the annual activities with inspections and any necessary modifications by the IACUC in the absence of a specific IACUC protocol for these market livestock activities.

 

b.   The institution will implement policies that will enable it to maintain approved OLAW Animal Welfare Assurance in the event that PHS funding is applied for or ongoing. The institutional official will type the Assurance on Texas State’s letterhead, sign it, and submit it to the PHS for OLAW evaluation to determine the adequacy of the university’s proposed animal care and use program. All Assurances submitted to the PHS will be evaluated by OLAW to determine the adequacy of Texas State's proposed program for the care and use of animals. An Assurance is approved for a specified period, not longer than five years, after which time Texas State must submit a new Assurance to OLAW. On the basis of this evaluation, OLAW may approve or disapprove the Assurance, or negotiate an Assurance with Texas State. An Assurance is approved for a specified period, not longer than five years, after which time Texas State will submit a new Assurance to OLAW. OLAW may limit the period during which any approved Assurance shall remain effective.

 

1)   Institutional Program for Laboratory Animal Care and Use – The Assurance shall fully describe Texas State's program for the care and use of laboratory animals. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing an institutional program for activities involving laboratory animals. The program description will include the following:

 

a)   a list of every branch and major component of Texas State, as well as of any other institution included under the Assurance;

b)   the lines of authority and responsibility for administering the program and ensuring compliance with institutional policy;

c)   the qualifications, authority, and responsibility of the veterinarian who will participate in the program and the percent of time each will contribute to the program;

d)   the membership list of the IACUC established in accordance with the requirements set forth in Section 02.04 b. of this policy;

e)   the procedures which the IACUC will follow to fulfill the requirements set forth in this policy;

f)    the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;

g)   a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;

h)  the gross square footage of each animal facility (including satellite facilities), the species housed therein and the average daily inventory, by species, of animals in each facility; and

i)     any other pertinent information requested by OLAW.

 

02.03  Institutional Status: Texas State will assure that its program and facilities are in one of the following categories:

 

a.    Category 1 – Accredited by the AAALAC. The institution will evaluate all of its programs and facilities (including satellite facilities) for activities involving animals under guidelines applicable for AAALC accreditation or another accrediting body recognized by PHS. The IACUC will evaluate all of the institution’s programs and facilities (including satellite facilities) for activities involving animals and will re-evaluate these same programs at least once every six months, in accordance with Section 02.04 d. and reports prepared in accordance with Section 02.08; or

 

b.    Category 2 – Evaluated by the Institution. The IACUC will evaluate all of the institution’s programs and facilities (including satellite facilities) and will re-evaluate them at least once every six months, in accordance with Section 02.04 d. and prepare reports in accordance with Section 02.08. The IACUC will submit the evaluation’s initial report, along with the Assurance, to the OLAW.

 

02.04  Institutional Animal Care and Use Committee (IACUC)

 

a.   The chief executive officer (Texas State president) shall appoint an IACUC, as described in Section 03 of this document.

 

b.   The committee shall consist of no fewer than six members, and shall include at least:

 

1)   one doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving laboratory animals at Texas State; or one doctor of Veterinary Medicine experienced in disease prevention and animal health procedures associated with farm animals;

2)   one practicing scientist experienced in research involving field studies of vertebrates;

3)   one practicing scientist experienced in large animal nutrition and growth requirements;

4)   one practicing scientist experienced in research involving laboratory animals;

5)   one member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy); and

6)   one individual who is not affiliated with Texas State in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with Texas State.

 

c.   An individual who meets the requirements of more than one of the categories may fulfill more than one requirement. However, no committee will consist of fewer than six members.

 

d.   Functions of the IACUC. As an agent of Texas State, the IACUC shall, with respect to teaching and research activities involving animals:

 

1)   review at least once every six months Texas State's program for humane care and use of animals, using the appropriate Guide as a basis for evaluation;

2)   inspect at least once every six months all of Texas State's animal facilities (including satellite facilities) using the appropriate Guide as a basis for evaluation;

3)   prepare reports of the IACUC evaluations conducted as required by PHS policy, and submit the reports to the institutional official. At least every six months, upon completion of the required semi-annual evaluations, the IACUC will update the reports, making certain to maintain the reports and make them available to OLAW upon request. The reports will contain a description of the nature and extent of Texas State's adherence to the appropriate guides and will identify specifically any departures from the provisions of the appropriate guides and PHS policy, and will state the reasons for each departure. The reports will distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which in the judgment of the IACUC and the institutional official is or may constitute a threat to the animals’ health and safety. When program or facility deficiencies are noted, the reports will contain a reasonable and specific plan and schedule for correcting each deficiency;

4)   review concerns involving the care and use of animals at Texas State;

5)   make recommendations to the institutional official regarding any aspect of Texas State's animal program, facilities, or personnel training;

6)   review and approve, require modifications in (to secure approval) or withhold approval of those components of activities related to the care and use of animals as specified in this document;

7)   review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and

8)   have authorization to suspend any activity involving animals in accordance with specifications set forth in this document.

 

02.05  Review of Educational and Research Projects

 

a.   In order to approve proposed projects or proposed significant changes in ongoing projects, the IACUC shall review those components related to animal care and use, and determine whether the proposed projects agree with this document. In making this determination, the IACUC shall confirm that the institution will conduct the project in accordance with the Animal Welfare Act insofar as it applies to the project, and that the project complies with the appropriate Guide unless the institution presents acceptable justification for a departure. Further, the IACUC shall determine that the project meets the following requirements:

 

1)   Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals.

2)   Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the absence of sedative, analgesia or anesthesia is justified for scientific reasons in writing by the investigator.

3)   Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure.

4)   The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non-medical care of the animals will 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.

5)   Medical care for animals will be available and provided as necessary by a qualified veterinarian.

6)   Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.

7)   Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator (Journal of the American Veterinary Medical Association, 1986, Vol. 188, No. 3, pp. 252-268, or succeeding revised editions). Copies of these recommendations are available from the IACUC chair or from APHIS.

 

b.   Prior to the review, each IACUC member will receive a list of proposed projects to review. All IACUC members will have access to written descriptions of projects that involve the care and use of animals, and any IACUC member may obtain, upon request, full committee reviews of those research projects. If full committee review is not requested, at least one member of the IACUC, designated by the chair and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects. If full committee review is requested, the IACUC may grant approval of those research projects only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest (e. g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.

 

c.   The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC.

 

d.   The IACUC shall notify investigators in writing or electronically of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

 

e.   The IACUC shall conduct continuing review of activities covered by this document at appropriate intervals as determined by the IACUC, but not less than once each year. The IACUC will review this document every three years as described in Section 07.

 

f.    The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, The Ag. Guide, Texas State’s Assurance, or this document. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present. The chair of the IACUC may intervene in the event of existing threats to animal welfare, departure from protocol, or other extraordinary circumstances to immediately rectify the situation prior to the quorum meeting of the IACUC for review.

 

g.   If the IACUC suspends an activity involving animals, the institutional official, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report such action with a full explanation to OLAW.

 

h.   Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of Texas State. However, those officials may not approve an activity involving the care and use of animals if that protocol has not been approved by the IACUC.

 

02.06  Information Required in Applications and Proposals for Awards. Applications and proposals for awards submitted to external funding sources that involve the care and use of animals shall contain the following information:

 

a.   identification of the species and approximate number of animals to be used;

 

b.   rationale for involving animals, and for the appropriateness of the species and numbers to be used;

 

c.   a complete description of the proposed use of the animals;

 

d.   a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and

 

e.   a description of any euthanasia method used.

 

02.07  Record Keeping Requirements

 

a.   The institutional official of Texas State shall maintain:

 

1)   an Assurance that OLAW has either approved or deemed provisionally acceptable;

2)   minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations;

3)   records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld; and

4)   records of semi-annual IACUC reports and recommendations (including minority views); and records of accrediting body determinations.

 

b.   The institution will maintain all records for at least three years. Records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the IACUC will be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

 

02.08  Reporting Requirements During Times of PHS Funding

 

a.   At least twice every twelve months, the IACUC, through the institutional official, shall report in writing to OLAW:

 

1)   any change in Texas State's program or facilities that would place Texas State in a different category than specified in its Assurance;

2)   any change in the description of Texas State's program for animal care and use as required by Section 02.03 of this document;

3)   any changes in the IACUC membership; and

4)   notice of the dates that the IACUC conducted its semi-annual evaluations of Texas State's program and facilities and submitted the evaluations to the institutional official.

 

b.   At least two times every twelve months, the IACUC, if it has no changes to report, shall submit a letter, through the institutional official, to OLAW stating that there are no changes and informing OLAW of the dates of the required IACUC evaluations and submissions to the institutional official.

 

c.   The IACUC, through the institutional official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

 

1)   serious or continuing non-compliance with this document;

2)   any serious deviation from the provisions of the appropriate Guide;

3)   any suspension of an activity by the IACUC; and

4)   reports filed under Section 02.08 of this document shall include any minority views filed by members of the IACUC.

 

02.09  Recognition of the Authority of the Office for Laboratory Animal Welfare (OLAW). Texas State recognizes that OLAW has the authority to:

 

a.   request and negotiate, approve or disapprove, and, as necessary, restrict or withdraw approval of Assurances;

 

b.   distribute to executive secretaries of initial review and technical evaluation groups and to PHS awarding units lists of institutions that have an approved Assurance;

 

c.   advise awarding units and awardee institutions concerning the implementation of animal care policy;

 

d.   evaluate allegations of non-compliance with PHS policy;

 

e.   review and approve or disapprove waivers to PHS policy; and

 

f.    conduct site visits to Texas State.

03.       PROCEDURE FOR APPOINTMENT OF THE INSTITUTIONAL OFFICIAL AND THE IACUC

03.01  Appointment of the Institutional Official. The president of Texas State will designate the assistant vice president for Research as the institutional official with the authority to sign assurances and documents required for Texas State.

03.02  Appointment and Responsibilities of the chair of the IACUC.

 

a.   The institutional official will appoint the IACUC chair from existing Texas State faculty. The chair must have a Ph.D., D.V.M. or M.D. degree in a scientific discipline and have experience in animal research and with federal regulations concerning animal research.

 

b.   The IACUC chair will implement the policy as described in Section 05.

 

c.    The IACUC chair will report to the institutional official named in Section 03.01 and will serve in this capacity for a renewable three-year term.

 

03.03  Appointment of the IACUC: Upon the recommendation of the IACUC chair, the institutional official will appoint the members of the IACUC committee in accordance with Section 02.04 b. The members of the committee will serve for a renewable three-year term.

 

03.04  Compensation for the chair of the IACUC. Compensation for the duties of the IACUC chair shall consist of appropriate release time for the faculty person usually equivalent to the teaching of one course during the fall or spring semesters or during one summer session or salary compensation equivalent to that of one summer session.

04.       PROCEDURES FOR APPLICATION FOR APPROVAL TO USE ANIMALS, MEETINGS, AND VOTING OF THE IACUC

04.01  Application for Approval to Use Animals: Individuals seeking approval for use of animals shall provide the IACUC chair with a written or electronic proposal indicating in detail the planned use of animals, and will provide evidence to their competence in the handling and use of animals (see Section 05.03 b.). The IACUC chair will provide a form for this application.

 

04.02  Application for Extramural or Intramural Funds for Activities Involving Animals. In addition to the requirements in Section 04.01, individuals seeking extramural or intramural funding for activities involving animals shall include in their proposals the specific information required in Section 02.06 above. These individuals will also provide a completed form as indicated in Section 04.01.

 

a.   The assistant vice president for Research shall require approval of the proposal by the IACUC to be obtained prior to the submission of the proposal to the funding agency. The routing cover sheet for proposals shall allow for the signature of the chair of the IACUC, indicating approval of the IACUC.

 

b.   The budget for grant funds to cover procurement and per diem costs of animals will include labor costs associated with animal maintenance.

 

c.   Upon approval of the proposal by the IACUC, the IACUC chair will provide confirmation of approval for submission to the funding agency indicating approval of the proposal by the IACUC.

 

04.03  Meetings of the IACUC. The IACUC will hold meetings semi-annually and as required to approve proposals or review programs already in progress. The IACUC chair will provide each committee member with written descriptions of the projects prior to the meetings as described in Section 02.05. The IACUC chair will convene these meetings.

 

04.04  Voting Policy of the IACUC: Voting policy is described above in Section 02.05.

05.       PROCEDURES FOR INSPECTION, PROCUREMENT, TRAINING & MAINTENANCE, PREVENTION OF BIO-POLLUTION, AND DISPOSAL OF CARCASSES

05.01  Inspection

 

a.    At least every six months, the IACUC or its delegate will inspect all Texas State animal housing facilities, as defined in Section 02.01 b. The IACUC will use the appropriate Guide to determine compliance with Texas State policy, with written notice of non-compliance given to the responsible person and the institutional official.

 

b.    Every six months, the IACUC chair or an assistant will inspect all animal handling facilities, including surgeries, restraining devices, and any structure or device used for the temporary restraint or manipulation of animals. The IACUC, the IACUC chair or an assistant will use the appropriate Guide to determine compliance with Texas State policy, with written notice of non-compliance given to the responsible person and the institutional official.

 

05.02  Procurement

 

a.   Application for approval to use animals must be made prior to procurement of animals for use at Texas State, as described in Sections 04.01 and 04.02. Upon approval, the chair of the IACUC will assign the applicant an approval number. All procurement procedures will comply with the appropriate Guide.

 

b.    The Texas State director of Procurement Services will not approve any purchase order for animals, as defined in Section 02.01 a., that does not include an IACUC approval number.

 

05.03  Training of persons involved in care and use of animals. Qualified Texas State faculty and consultants from nearby facilities such as the University of Texas at Austin that have approved animal care programs will provide training of all persons involved in the care and use of laboratory animals at Texas State. Other training options include written, video, or audio programs prepared for this use. The chair of the IACUC will have the authority to administer tests to determine knowledge of animal care and to deny access to and use of animals to persons that have not shown proficiency in animal care. This training will include:

 

a.   Diagnostic testing to determine knowledge of animal care and use;

 

b.   Provision of materials to remediate areas of deficiency in the knowledge of animal care; and

 

c.   Further examination until proficiency in animal care and knowledge of regulations regarding animal care is demonstrated.

 

05.04  Texas State is committed to best management practices that seek to prevent the spread or introduction of invasive or non-native organisms, hereafter, bio-pollution. Researchers utilizing vehicles, equipment, or other potential vectors of bio-pollution in their research or investigations will act in accordance with Hazard Analysis and Critical Control Point (HACCP) Natural Resource Management (NRM). The HACCP-NRM methods for preventing the spread or introduction of nuisance species provide a long-term benefit to the systems in which our research, education, and outreach activities are conducted.

 

05.05  Disposal: The Guide contains recommendations for disposal of animal carcasses. Prior to disposal, the institution may store carcasses in dedicated cool rooms, refrigerators or freezers. The institution will place animal carcasses in plastic bags and transport to containment facilities by licensed, commercial-waste-disposal firms. Animals exposed to radioactive materials are disposed of with radioactive waste.

06.       POSSIBLE INTERFERENCE

06.01  Awareness by Administration of Possible Interference with Texas State’s Animal Care and Use

 

a.   The institutional official shall maintain awareness of people or organizations that may illegally interfere with legitimate institution activities involving the care and use of animals. This official should be informed of such activities elsewhere and be prepared to act in the event of such an occurrence at Texas State.

07.       REVIEWERS OF THIS UPPS

07.01  Reviewers of this UPPS include the following:

 

Position                                                         Date

 

IACUC Chair                                                January 1 E3Y

 

Assistant Vice President for Research    January 1 E3Y

and Federal Relations

08.       CERTIFICATION STATEMENT

This UPPS has been approved by the following individuals in their official capacities and represents Texas State policy and procedure from the date of this document until superseded.

Chair, Institutional Animal Care and Use Committee; senior reviewer of this UPPS

Assistant Vice President for Research & Federal Relations

Associate Vice President for Research & Federal Relations

Provost and Vice President for Academic Affairs

President