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Academics and Research – Research
EWU Policy 302-03 Authority: EWU Board of Trustees
Effective June 22, 2011 Proponent: Provost and Vice President for Academic Affairs
Purpose: This policy prescribes standards for the care, treatment, and use of animals in teaching and research activities at Eastern Washington University.
History: This policy revises and supersedes UGS Policy 435-060, Animal Research, et seq. It was adopted by the EWU Board of Trustees on June 22, 2011.
Applicability: This policy pertains to all persons involved in teaching and research that is conducted using facilities, equipment, or personnel of Eastern Washington University.
CHAPTER 1 – ANIMAL CARE AND USE
a. Eastern Washington University is committed to the humane treatment of animals used in teaching and research.
b. Eastern Washington University supports the use of live animals for teaching and research when such activities are considered to yield fruitful results for the good of society and are not random, duplicative, or otherwise unnecessary in nature; are based on knowledge of the problem under study and so designed that the anticipated results will justify the performance; and cannot be carried out using alternative methods without compromising the integrity of the teaching or research.
c. Eastern Washington University follows the provisions of the Animal Welfare Act and the regulations of the U.S. Department of Agriculture for the care and use of animals. In addition, grant-funded activities abide by specific regulations of the granting agency.
d. The Institutional Animal Care and Use Committee (IACUC) at Eastern Washington University is responsible for ensuring that animal care , treatment, housing, and use are in accordance with the Animal Welfare Act, the regulations of the U.S. Department of Agriculture, and any other applicable regulations.
e. The IACUC has authority to approve, require modifications in, withhold approval or suspend any laboratory project using live vertebrate animals and any field project using vertebrate animals which involves invasive procedures, harms the animals, or materially alters the animals’ behavior. Such projects may be conducted only with current IACUC approval.
f. The housing, care, and feeding of animals are supervised by a properly qualified veterinarian.
g. All individuals involved in the care, treatment, and use of live vertebrate animals must be adequately qualified and trained to perform their duties.
1-2. Humane Treatment of Animals
a. Projects using live animals must be conducted to avoid or minimize discomfort, stress and pain to the animals.
b. If a procedure is likely to cause more than momentary or slight pain or distress to the animal, the animals must first be rendered incapable of perceiving pain and be maintained in that condition until the work is ended.
c. The only exception regarding discomfort, stress, and pain is in those cases where withholding sedatives, analgesics or anesthetics is justified by the principal investigator for scientific reasons, in that it would defeat the purpose of the project and data cannot be obtained by any other innocuous procedure. In these cases, the principal investigator must include a consultation with the attending veterinarian or his/her designee as part of the planning process and the procedures will only continue for the necessary period of time. Such procedures must be carefully supervised by a qualified scientist or veterinarian. Medical care for the animals must be available and provided as necessary by a qualified veterinarian.
d. Users of animals must be prepared to terminate work when continuation of the work may result in severe or chronic pain or distress for the animals that cannot be relieved.
e. If it is necessary to kill an animal, the animal must be killed in a humane manner, in such a way as to ensure rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death. Methods of euthanasia must be in accordance with the guidelines of the American Veterinary Medical Association Panel on Euthanasia. No animal may be discarded until after it is dead.
1-3. Use of Animals for Teaching
a. Students at any level are permitted to perform procedures on dead animals.
b. Use of live vertebrate animals by undergraduate students is under the direct supervision of the course instructor. If procedures are to be done outside regularly scheduled class times, the instructor must provide assurance that students are adequately trained consistent with Section 1-5 of this Policy.
c. Graduate students may work with live vertebrate animals independently and with indirect faculty supervision after they have received training consistent with Section 1-5 of this Policy.
1-4. Use of Animals for Research
a. Research using live animals must be expected to yield fruitful results relevant to human or animal health, the advancement of knowledge or for the good of society and must not be random or unnecessary in nature. It must be based on knowledge of the problem under study and designed so that the anticipated results justify its performance. It must not unnecessarily duplicate previous work.
b. Research projects may use live animals only when the use of alternative methods would compromise the quality of the research. Research projects will be designed to use the appropriate species, quality and the minimum number of animals to obtain valid results.
c, Research projects using live animals must be performed by or under the supervision of a qualified scientist or veterinarian.
a. All individuals involved in the care, treatment, and use of live vertebrate animals must be qualified to perform their duties.
b. Training must be made available with sufficient frequency to ensure that individuals are adequately trained.
c. Training must include guidance in at least the following areas: humane methods of animal maintenance and experimentation; methods for limiting animal use and minimizing animal distress; proper use of anesthetics, analgesics, and tranquilizers; methods for reporting deficiencies in animal care and treatment; and utilization of library resources on methods of animal care and use, alternatives to the use of live animals that could prevent unintended and unnecessary duplication of research involving animals (e.g. previous experimental results with live animals), and the requirements of the Animal Welfare Act. The specific components of the training program presented to each individual are dependent on the nature of that individual’s activities.
CHAPTER 2 – INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
a. At least once every 6 months, the IACUC shall: review the humane care and use of animals; inspect animal facilities; and prepare reports of its evaluations and submit them to the president of Eastern Washington University; investigate concerns involving the care and use of animals; make recommendations regarding the animal program, facilities, or personnel training. Additional functions of the IACUC are to review and approve, require modifications in, or withhold approval of proposed activities related to the care and use of animals; review and approve, require modifications in, or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; suspend ongoing activities involving animals if the activities are not being conducted in accordance with the description of that activity provided by the user and approved by the IACUC.
b. Except as specifically authorized by the Animal Welfare Act, the IACUC is not permitted to prescribe methods or set standards for the design, performance, or conduct of actual instruction, research, or experimentation.
c. The IACUC is composed of at least five members, including one veterinarian with training or experience in laboratory animal science and medicine with direct or delectated program responsibility for activities involving research animals at the University; one practicing scientist; one nonscientist; and one person not affiliated with the institution and not an immediate family member of a person who is affiliated with the facility. In no case shall more than three members of the Committee be from the same administrative unit of the University. Members should be qualified through experience and expertise to assess the animal program, facilities, and procedures.
d. The president of Eastern Washington University appoints members to the IACUC.
e. The IACUC reports directly to the president of Eastern Washington University.
f. The IACUC members elect a chairperson at the beginning of each academic year. The chairperson must be an employee of Eastern Washington University. The term of office is one year.
g. A secretary to the IACUC may be appointed by either the Eastern Washington University president or the IACUC chairperson. Duties of the secretary include scheduling meetings, notifying members of meetings, writing and distributing minutes of the meetings which include records of attendance, activities of Committee, and Committee deliberations; typing and distributing IACUC documents, receiving and distributing Protocol Review Forms, recording approval dates for protocols, and notifying users one month prior to renewal dates.
2-2. Review of Protocols by the Institutional Animal
Care and Use Committee
a. IACUC approval must be obtained before the start of any laboratory project using live vertebrate animals for research, teaching, or testing, and for any field project using vertebrate animals which involves invasive procedures, which may harm the animals, or materially alter the animals’ behavior. This applies to teaching, research, and testing projects which are conducted through or on the Eastern Washington University campus, associated with any teaching degree program at EWU, or financed by any internal or external funding administered by Eastern Washington University.
b. A Protocol Review Form must be submitted to the IACUC for each such project. The Protocol Review Form must address the criteria in Section g below and include justification for the selection of the methods used on animals, and the method of euthanasia if applicable.
c. Protocol Review Forms are posted on the IACUC web site by an authorized faculty member. The IACUC secretary notifies IACUC members that the protocol has been posted. IACUC members review the protocol within five business days if it is a class research project or within 10 business days otherwise.
d. IACUC members post questions or concerns about the protocol on the IACUC web site, and the authorized faculty member responds to questions and concerns on the web site. Modifications to the protocol are negotiated among the authorized faculty member, veterinarian, and IACUC members. If concerns remain, any IACUC member may request a full committee review at a convened IACUC meeting.
e. If a majority of IACUC members has approved a protocol, with or without modifications, and no one has requested a full committee review, the veterinarian may approve the project. A final Protocol Review Form, with modifications as necessary, is posted on the web site.
f. If a full committee review is requested, a quorum of the committee must be present at a convened meeting in order to vote. A protocol may be approved if a majority of members present at the meeting vote to approve it. If an IACUC member is involved in a protocol or has a conflicting interest, that member may not count toward the quorum and may not vote. The quorum in the event of a conflict is a majority of those eligible to vote. The IACUC may invite consultants to assist in the review of complex issues arising out of its review of proposed activities. Consultants may not approve or withhold approval of an activity, and may not vote with the IACUC unless they are also members of the IACUC.
g. Criteria for Evaluation of Protocol Reviews Forms
- The IACUC reviews those components of projects related to the care and use of animals.
- Projects must avoid or minimize unnecessary discomfort, distress, or pain to animals.
- Procedures that may cause more than momentary or slight pain or distress to animals must: continue only for the necessary period of time, be performed with appropriate sedatives, analgesics, or anesthetics unless withholding such agents is justified for scientific reasons; involve consultation with the attending veterinarian; not include the use of paralytics without anesthesia; and allow euthanasia to avoid severe or chronic pain or distress.
- Projects must not unnecessarily duplicate previous work. Necessary duplication may include teaching lab activities, student research projects that provide significant opportunities for learning, and research projects where duplication is an essential part of the project.
- Animals’ living conditions must be appropriate for their species.
- Medical care for animals must be available and provided as necessary by a qualified veterinarian.
- Individuals conducting procedures on animals must be appropriately qualified and trained in those procedures.
- Projects involving surgery must include provision for pre-operative and post-operative care of the animals in accordance with established veterinary practices.
- No animal may be used in more than one major operative procedure from which it is allowed to recover, unless: it is justified for scientific reasons; it is required as routine veterinary procedure or to protect the health or well-being of the animal; or in other special circumstances.
- Euthanasia must involve humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death.
h. After IACUC approval, the final Protocol Review Form is maintained on the IACUC web site for the duration of the project so that it is available for review. After the project is completed, the Protocol Review Form is archived on the web site for at least three years after the most recent approval date.
i. If the IACUC decides to withhold approval of a project, it must send written notification to the instructor or principal investigator which includes a statement of the reasons for the decision, and gives the user an opportunity to respond in person or in writing. The IACUC may reconsider its decision, with documentation in IACUC minutes, in light of the information provided by the instructor/investigator.
j. The IACUC may suspend a project that it previously approved if it determines that the project is not being conducted in accordance with the description of that project provided by the user and approved by the IACUC. The IACUC may suspend a project only after review at a convened meeting of a quorum of the IACUC and with a majority vote of the quorum present. If the IACUC suspends a project, the Eastern Washington University president, in consultation with the IACUC, must review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation to the APHIS and any federal agency funding the project.
k. Significant changes to a protocol must be submitted to the IACUC as an addendum to the original Protocol Review Form. The proposal must include: identification of the species and the approximate number of animals to be used; a rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used; a complete description of the proposed use of the animals; a description of the procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize the discomfort and pain to animals; and a description of any euthanasia method to be used. The changes must be approved by the IACUC, as provided by Subsection 2-2 a-f above, before they may be implemented.
l. Annual review is required for teaching projects which are repeated yearly and for research projects which last more than one year. The IACUC secretary keeps a record of approval dates for protocols and sends e-mails to users one month prior to the renewal date. If there are no changes in a project, a user may request renewal of the original Protocol Review Form, without completing a new Protocol Review Form. The IACUC secretary notifies IACUC members that the protocol is available for re- review. The approval procedure is the same as for new protocols. Projects may not continue beyond the renewal date without IACUC approval for continuation.
m. The Science Instructional Technician or animal caretaker may not provide live vertebrate animals to instructors or investigators unless a currently approved Protocol Review Form is posted on the IACUC web site.
n. Faculty sponsors have the responsibility of ensuring that student projects are conducted in accordance with the Protocol Review Form and in accordance with federal regulations
o. Projects conducted at an institution assured under the Public Health Service Policy and receiving IACUC approval from that institution need not be reviewed by the IACUC at Eastern Washington University.
2-3. Reporting Deficiencies in Animal Care and Treatment
a. Deficiencies in animal care and treatment may be reported to any IACUC member or to the president of Eastern Washington University.
b. The IACUC is obligated to investigate all reported concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees.
c. No individual may be discriminated against or be subject to any reprisal for reporting violations of any regulations or standards. d. Methods for reporting deficiencies in animal care and treatment must be included in the training program for all individuals receiving training on animal care and use through EWU.
2-4. Institutional Animal Care and Use Committee Files
a. There are two official IACUC files, one in the office of the president of Eastern Washington University and one in the office of the Instruction & Classroom Support Technician.
b. The Instruction & Classroom Support Technician’s file must include the Eastern Washington University president’s formal letters of appointment; Protocol Review Forms detailing proposed activities involving animals and proposed significant changes in activities involving animals whether approved or disapproved minutes of IACUC meetings, including records of attendance, activities of Committee, and Committee deliberations; IACUC inspection reports and recommendations (including minority views).
c. The Instruction & Classroom Support Technician’s file must be accessible to the APHIS or funding Federal agency representatives at reasonable times
d. All records must be kept for a minimum of three years. Records that directly relate to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after the completion of the activity. Whenever the Administrator of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture or any other official of the Animal and Plant Health Inspection Service to whom authority has been delegated in his/her stead notifies Eastern Washington University in writing that specified records shall be retained pending completion of an investigation or proceeding under the Animal Welfare Act, those records shall be retained until their destruction is authorized in writing by the Administrator.
a. An inspection of all vertebrate animal facilities must be conducted by at least two IACUC members at least twice annually.
b. If a deficiency is found during an inspection, the IACUC must specifically identify it and set a specific compliance date. The deficiency must be designated as major or minor. The IACUC will decide by a majority vote if the deficiency is significant (affecting the health and safety of animals). A second inspection must be conducted soon after the compliance date. If the deficiency has not been corrected by the compliance date the IACUC must notify, through the Institutional Official, both the APHIS and any federal agency which is funding the project in writing within 15 business days.
c. An inspection report must be signed by a majority of IACUC members. Copies of the inspection report are placed in the files of the Eastern Washington University president and the Instruction & Classroom Support Technician.
d. Any IACUC member may add a minority view to the inspection report.