Institutional Animal Care and Use Committee Policies, Regulations and Rules General Information West Texas A&M University (WTAMU) policy requires an approved Application for Vertebrate Animal Use (AVAU) for all activities involving the use of animals (research, teaching, public service; intramurally or extramurally funded regardless of source or amount; and including animals being bred, conditioned, or held for future use). The AVAU is a form that allows the investigator to communicate to the Institutional Animal Care and Use Committee (IACUC) their reasons for and methods of animal use. The IACUC is charged with overseeing all aspects of animal care and use at WTAMU. The IACUC may approve, require modification of, or withhold approval from a project. Animal use in the absence of IACUC approval is a serious violation of University policy and a violation of federal law. The person submitting an AVAU must be the principal investigator (PI) and must have faculty rank. PIs are responsible for animal use by their students and staff. The PI heading a research group or teaching a course must have an approved application on file for each project or course under his/her supervision. Collaborators, technicians, and students must care for and use animals according to the protocols described in the approved applications. Deviations should be reported to the IACUC. PIs must become familiar with laws, rules and regulations governing animal care and use as well as policies governing the review of animal care and use. Most Applications for Vertebrate Animal Use, AVAU, are processed in about six weeks. On occasion, an individual protocol may require a longer period of time because of the nature of the proposed use or other complicating factors. Therefore, it is prudent to submit the forms to the IACUC as soon as the need is anticipated. The IACUC cannot expedite the review of an application because the investigator failed to submit it in time to meet various deadlines. It is the responsibility of the principal investigator to submit an AVAU with sufficient lead-time to meet all University and agency deadlines. Under certain circumstances, it may be possible to cover vertebrate animal use for more than one project under a single AVAU. For example, resubmission of a grant within one year of approval of an AVAU to the same or another funding agency which may involve changes in title, size of project, or contain other changes, but for which the scope of animal use (procedures, numbers, duration) does not significantly change. Co-submission of the same proposal to two or more granting agencies requires only one Application for Vertebrate Animal Use and a copy of each proposal. Resubmission of an unfunded proposal will not require re-review as long as it is not significantly revised over the previous submission and as long as the previous submission was within the last 12 months. A renewal of a previously funded project does not require animal use re-review as long as it has not been significantly revised and has been reviewed by the Committee within the last three years. While the IACUC does not conduct inspections of field and overseas research sites, the use of vertebrate animals at those sites by PIs is expected to be in accordance with University policy. That portion of vertebrate animal use conducted at WTAMU in collaboration with outside researchers must be reviewed by the WTAMU IACUC, even if it has already been reviewed by an IACUC or similar committee at the collaborating institution. WTAMU investigators participating in vertebrate animal research conducted at other sites which has been reviewed and approved by IACUCs at other institutions may not be required to submit an application to the WTAMU IACUC. However, the WTAMU IACUC requires investigators to submit a copy of the IACUC approval from the other reviewing institution. The WTAMU IACUC must be allowed to assess whether or not an application should be submitted to our office under these circumstances. With regard to collection of tissue samples (i.e. biopsies, blood, etc.), if samples are being collected expressly for the purposes of an WTAMU investigator's research or teaching projects, that investigator must file an application for vertebrate animal use with the WTAMU IACUC. For example, clinically necessary biopsies and blood samples may be split for research purposes without IACUC review, but no clinically unnecessary sample maybe taken without IACUC review and approval. This policy also applies to field studies in which samples are being collected expressly for the purposes of an investigator's research or teaching projects and to studies covered by government permits. The IACUC must review these projects. The AVAU is approved for three years. The PI is required to submit an annual report updating any changes that may have occurred during the year. The IACUC administrator distributes the form for updates at the appropriate time. After three years, the AVAU must be re-written and undergo the entire review process again. If significant changes are anticipated in an on-going project, a Protocol Amendment Form must be submitted to the Killgore Research Center office prior to initiation of these changes. However, total approval time for a single Application for Vertebrate Animal Use may not exceed three years. Consult the Killgore Research Center office (phone 651-2270, e-mail iacuc@mail.wtamu.edu for information. Applications can be obtained from the IACUC website. The application form must be TYPED . Each section must be answered in specific detail or noted "not applicable". It is not sufficient to answer a question by simply referring to a more detailed paper or reference or attached document. All applications require an original signed application form. Syllabi are needed for teaching activities. Submit all applications through the Killgore Research Center office (Box 60215, Canyon, TX 79016, phone 651-2270, e-mail iacuc@mail.wtamu.edu). After review and approval, the Chair of the IACUC will send the approval information to the Principal Investigator for submission to the appropriate offices or federal agencies. GENERAL REFERENCES ON ANIMAL CARE AND USE Animal Welfare Act , 7 U.S.C. 2131-2159; 7CFR 2.22,2.80, and 37102(g). The Guide for the Care and Use of Laboratory Animals. Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council, National Academy Press, Washington, D.C. 1996. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. Federation of Animal Science Societies, Savoy, IL, 1999. 1993 Report of the AVMA Panel on Euthanasia. J Amer Vet Med Assoc, 202(2): 230-249. Jan 15, 1993. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Office of Laboratory Animal Welfare, National Institutes of Health, Office of the Director, Rockville, MD, 1996. Guidelines on Activities Requiring IACUC Approval According to policy set by the WTAMU Board of Trustees, “All research projects and educational or extension activities using vertebrate animals under the jurisdiction or control of WTAMU shall be reviewed and approved by the Institutional Animal Care and Use Committee.” (IACUC) The following provides additional clarification of Board of Trustees policy. Animal use activities that require IACUC approval: - activities using animals owned by WTAMU;
- activities in which an employee of WTAMU assumes responsibility for a non-WTAMU-owned animal in a teaching or research capacity;
- clinical trials involving non-WTAMU-owned animals;
- activities using wild animals for teaching or research, when animals are manipulated in any way.
Animal use activities that do NOT require IACUC approval: - activities in which the animal is under the control of the owner or an owner-designated handler (except in the case of clinical trials);
- activities in which a veterinarian is providing routine clinical services to a privately owned animal/herd/farm or to wild animals;
- field studies, as defined in Animal Welfare Act regulations (“…any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study.”).
- Although IACUC review and approval are not required for these activities, the IACUC is willing to conduct standard review as requested. The IACUC recommends that these activities receive some type of administrative review for potential legal, liability, and public relations concerns.
Policy on Use of Animals and Lab Animal Care Facilities PREAMBLE: The use of animals is essential to the teaching, extension, and research missions of West Texas A&M University. Significant benefits to the health and welfare of both animals and humans have resulted from animal use in research, and continued use is crucial to future advancements. Without the use of animals, adequate instruction of students in many programs such as agriculture, the biological sciences, and veterinary medicine would not be possible. However, those who utilize animals are morally and legally obligated to care for them properly and use them humanely. Each faculty member, staff member, or student involved in the use of animals is directly responsible for promoting and protecting their welfare within the instructional, extension, and research programs of the University. Those who use animals should assume this responsibility through precept and example. The following policy provides guidance for the proper care and humane use of animals within University programs. POLICY: - Animals should be used in teaching, research, and extension programs only as required to demonstrate principles, to obtain new information, and achieve results which will ultimately benefit society. Whenever feasible, mathematical models, in vitro biological systems, demonstrations, and computer and audiovisual aids should augment, complement, or possibly replace animal use entirely, thereby reducing the number of animals needed.
The procurement, care, and use of animals shall be in accordance with the regulations and terms of the federal Animal Welfare Act and the Health Research Extension Act of 1985, and subsequent revisions. - All research projects and educational or extension activities using vertebrate animals under the jurisdiction or control of WTAMU shall be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). In its reviews, the Committee will apply standards and guidelines set forth in the Animal Welfare Act and the Health Research Extension Act of 1985, and subsequent revisions.
- The housing, care, feeding and observation of all animals must be supervised by individuals trained in such matters. Managers of animal care facilities are expected to meet the guidelines set forth in the Guide for the Care and Use of Laboratory Animals (for biomedical research projects) or the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (for agricultural research projects), or other guides as adopted by the Institutional Animal Care and Use Committee. These guides are available from the Killgore Research Center.
- Animal use shall be planned and conducted so as to avoid or minimize pain and distress to the animals. Procedures involving animals must be performed by, or be closely supervised by a faculty or staff member who is skilled in the procedure. Students taking part in such procedures must be appropriately instructed and supervised. If any experimental or demonstrative procedure, or its consequences, have the potential to induce significant and/or lasting pain, distress or suffering, appropriate methods of tranquilization, anesthesia and analgesia must be used. Any painful or distressful procedure, regardless of whether it can or cannot be obviated, must be reviewed and approved in advance by the Institutional Animal Care and Use Committee.
- Procedures for euthanasia must be performed in a manner consistent with the latest recommendations of the American Veterinary Medical Association Panel on Euthanasia and all proposed methods must be approved in advance by the Institutional Animal Care and Use Committee.
- Any faculty member, staff member, or student of the University who has reason to know or believe that this policy is being violated may submit a written request to the Chairman of the Institutional Animal Care and Use Committee for review of the procedure or situation in question. The Committee will examine all pertinent facts regarding the alleged policy violation. If the allegation is substantiated, the Committee will report the violation to the appropriate administrative officials. The University will take all steps possible to prevent retaliation against the person requesting the review.
Preparation and Review of Blanket Protocols Principal Investigators (PIs) may wish to seek “blanket” approval for animal use where procedures can be described, but specific treatments and/or animal numbers are not yet determined. The potential advantage of this approach is that only an amendment would need to be filed, as these additional details are known. However, the process for approving amendments that involve significant changes requires essentially the same steps as a new submission; therefore, there may not ultimately be significant time savings in review. On the other hand, if amendments include only non-significant changes, then those changes would generally be approved quickly. If a PI has special need for rapid turnaround time on review of an Application for Vertebrate Animal Use (AVAU), s/he should contact the Killgore Research Office. The Institutional Animal Care Use Committee requires a complete description of the animal-use activity. This description includes not only the procedures performed with/on animals, but also details of the experimental treatments: specific drugs, dosages (volume and mg/kg), and routes of administration; dietary manipulations; justification of animal numbers based on the experimental design; etc. The above information may be supplied in some combination of AVAU and amendment form, and must be reviewed and approved by the IACUC before an animal activity begins. If details of animal use are not available at the time of initial AVAU submission, then the AVAU should indicate specifically what additional information will be provided as an amendment. For each amendment submitted, the IACUC Chair decides whether the proposed changes are “significant.” This decision is based on the IACUC Guideline, “Review Procedures for Significant Changes in an Approved AVAU.” Tracking of IACUC Approval and Approved Animal Numbers All use of vertebrate animals at WTAMU requires prior IACUC approval of the Application for Vertebrate Animal Use (AVAU). All animals must be accounted for in the AVAU, including all neonates; e.g., pre-weanling animals euthanized to standardize litter size or to cull unwanted genotypes or sex, and animals that are expected to die as a result of a harmful genotype. Use of prenatal, pre-hatch, embryonic or larval stage animals does not require listing in the AVAU. In accordance with federal regulations and university policy, the AVAU requires the Principal Investigator to provide a rationale for the numbers of animals to be used. It is implicit from these requirements that there be an institutional mechanism to ensure that the animal use is approved, and that the number of animals used is consistent with information in the approved protocol. Each department must have written procedures in place for monitoring and documenting animal use. Procedures must include methods to ensure that animal use is covered by an active IACUC-approved protocol, and that the numbers of animals used do not substantially exceed those approved in the protocol. Animal resource units also should have procedures that allow retrieval of animal use numbers, by category of use, for completion of the Annual Reports. |
