PROTOCOL FOR USE OF LIVE VERTEBRATES
THE UNIVERSITY OF THE SOUTH
The cover page, part I, General Information and all applicable sections of part II, Detailed Information must be completed for all research and teaching activities.
Submit 6 typed copies to:
Richard G. Summers, Ph.D.
Chair, Institutional Animal Care and Use Committee
Spencer Hall 176A
Phone # 931-598-1917
email:
Title of Project/Course (and number)
Principal Investigator/Instructor
Wk. PhoneDepartment
Signature of P. I./InstructorDate
Signature of Co-investigatorDate
Your signature as P. I. or Co-investigator on this application verifies that: (1) the information herein is true and correct and that you are familiar with and will comply with the legal standards of animal care and use established under federal and state laws and policies as well as university policies; and (2) the activities do not unnecessarily duplicate previous experiments.
FOR IACUC USE ONLYRevised 2/10
IACUC Number ______Ethical Concern Category: A BCDE
Distributed To IACUC, Date: ______
SUSPENSION OF ANIMAL ACTIVITIES
PLEASE NOTE THE FOLLOWING GUIDELINES OUTLINING WHEN ANIMAL USE IN AN APPROVED PROTOCOL MUST BE TERMINATED. IN THE EVENT OF SUCH TERMINATION CONTACT THE CHAIR OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE IMMEDIATELY.
The use of animals in an approved protocol should be suspended, and the Chair of the Institutional Animal Care and Use Committee should be notified if any of the following occur:
a) Animals are noticed to be experiencing unanticipated and/or unplanned for pain or distress while being used in research or teaching activities. Pain or distress may be immediately recognized during work with the animals or it may be revealed by subtle changes in the animal’s behavior. Please consult Table 1 in the guide to “Pain and Distress in Mice, Rats, and Rabbits” that has been provided to all professor/investigators using animals at Sewanee. Additional copies of this guide can be obtained from the Chair of the Institutional Animal Care and Use Committee.
b) More than one animal becomes sick or dies of unexplained causes while being housed at Sewanee or while being used at sites other than Sewanee. In cases where a single animal becomes sick or dies while being housed at Sewanee, the responsible professor/investigator should immediately contact the institution’s veterinarian. With input from the veterinarian, an assessment of the threat to the health of other animals being housed in the same facility should be made and a plan of action should be devised, which may include suspension of the teaching or research activity until the threat is eliminated.
c) It becomes impossible for any reason to maintain daily monitoring and care for the animals. In this case, the research/teaching project must be terminated immediately and the animals must be disposed of as indicated in the appropriate protocol.
d) The facility housing the animals ceases to function adequately due to mechanical failure or any other problem that threatens the health of the animals being housed there. If alternative housing facilities cannot be provided, the research/teaching project must be terminated immediately and the animals must be disposed of as indicated in the appropriate protocol.
ISOLATION OF SICK ANIMALS
Animals that appear sick (listless or unusual behavior, abnormal eating or drinking, coughing, sneezing, mucus secretions around eyes or nose, unusual sensitivity to touch, etc) must be moved at least 5 feet away from all other healthy animals, water sources, food sources, and bedding sources while waiting for or recovering from veterinary treatment. If this level of quarantine cannot be achieved, then the animal must be removed from the animal room and taken to the veterinarian’s office for quarantine and treatment.
INSTRUCTIONS FOR COMPLETING
“PROTOCOL FOR USE OF LIVE VERTEBRATES”
1.Submit 5 copies of the completed protocol form to the Chair of the Institutional Animal Care and Use Committee (IACUC) (Dr. Richard G. Summers, WE 116). Generally, the IACUC rules on a proposal within 10 working days of receipt, but PLEASE NOTE: Any member of the IACUC can request a full meeting of the IACUC to discuss concerns about a protocol. These meetings take time to schedule. Thus, it can take more than 10 working days to rule on a protocol (and there is a good chance that amendments to the protocol may be required before approval). Consequently, please submit proposals as early as is possible to ensure their timely approval.
2.Federal Regulations require that all uses of living vertebrate animals that are regulated by the USDA or that are being used in NSF or NIH funded research within the Institution be reviewed and approved for their compliance by the Committee before any use of the animals commences.
3.For general reference, all of the information requested in the “Protocol for Use of Live Vertebrates” is based on:
a.Public Health Service Policy on Humane Care and Use of Laboratory Animals.
b.NIH Guide for the Care and Use of Laboratory Animals.
c.The Animal Welfare Act.
All of the above can be accessed via the internet. Departures from these published regulations and guidelines require written scientific justification.
4.An additional use of these protocols is to associate each individual animal with its proper protocol at the request of the USDA inspector. Different groups or species of animals associated with the same study may be listed on one protocol; please take care to indicate to which group or species of animals any of the procedures will apply.
5.The information provided in this protocol will be reviewed by members of the Committee, including a non-scientist, therefore, every attempt should be made to use terminology understandable to all reviewers.
6.Please inform the Chair of the Institutional Animal Care and Use Committee immediately if a project is terminated or a course discontinued.
7.If a project lasts more than one calendar year, a new protocol must be submitted each year for review and reapproval.
8.If a course is taught each year a new protocol must be submitted each year for re-evaluation and reapproval.
REVIEW PROCEDURE
1.Protocols first receive a clerical review by the IACUC Chair who will assign the protocol to the appropriate ethical concern categories. If, at this stage, the chair notes any obvious omissions of required information, the protocol may be immediately returned to the submitter for revision. Once a protocol is deemed complete it will be distributed to all members of the IACUC. Any Committee member having concerns about a protocol may request a full Committee review of the protocol at a convened meeting of the Committee. If a full Committee review is not requested within 10 working days from the receipt of the protocol, the chair will review the protocol and either: 1) approve, 2) require modifications to secure approval, or 3) request a full Committee review of the protocol at a convened meeting of the Committee. Whenever a full review is requested, the Committee will, based on a majority vote of the quorum present: 1) approve, 2) require modifications to secure approval, or 3) deny approval of the protocol. Animals are not to be purchased, transferred or accepted for a project until notification of full approval from the IACUC through the Chair.
2.If, as research proceeds, it becomes necessary to make significant changes in a protocol, the principal investigator should contact the IACUC Chair for advice on whether an amendment would suffice or if the entire protocol should be resubmitted (call 598-1917 for advice).
ANIMAL HOUSING FACILITIES
In order to provide assurance of humane care and use of laboratory animals, all animal housing facilities on the University of the South campus will be operated according to federal laws and NIH Guidelines, as appropriate. Housing of animals, including those actively on experiment, for periods longer than 12 hours, is restricted to facilities meeting such guidelines and laws.
Please note the following additional guidelines:
1)Animals housed in the same primary enclosure will be maintained in compatible groups.
2)Animals will not be housed in the same primary enclosure with other species of animals unless required for scientific reasons.
3)Animals will not be housed near other animals that interfere with their health or cause them discomfort.
4)Animals from separate sources or deliveries will not be housed in the same primary enclosure unless required for scientific reasons.
5)Sick animals will be quarantined as outlined on page 2 of this protocol.
Please check your housing location.
[]Department of Biology Facility in WL129b.
[]Department of Biology Facility in WL129c.
[]Department of Psychology Facility in WL322.
[]*Other List: ______.
*Any newly established facility must be approved.
In accordance with NIH Guidelines and Federal Law, the IACUC formally reviews all animal housing facilities and satellites semi-annually and files a report to the Office of the Dean of the College of Arts and Sciences and the United States Department of Agriculture (USDA).
PART I.
GENERAL INFORMATION
To be completed for all covered Research and Teaching Activities.
A.Identification
1.This is a [ ] New [ ] Continuation [ ] Supplemental application. If this is a Supplement or Continuation of a project previously approved by the Committee, please indicate the IACUC number and title of the previous application:
2.Check one: [ ] Research [ ] Teaching
3.[ ] Yes [ ] No This protocol includes the use of farm animals used or intended for use as food or fiber, or livestock or poultry used or for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber.
4.Veterinarian responsible for clinical care (other than PI) ______
*The Animal Welfare Act requires consultation with the attending veterinarian during planning of all studies that may cause more than momentary pain or distress (e.g., all surgical procedures and use of Freund’s adjuvant). The attending Veterinarian used by the IACUC is Dr. George Bowers of the Animal Care Center in Winchester, TN (931-967-6345). Dr. Bower’s emergency telephone number is 931-312-9372.
5.Funding Source:
6.Course Number and title:
7.Anticipated:start date______end date______
B.Description of Animals
1.Species Breed/StrainMaximum #Total #
maintained atneeded for
any given timethis project
2.Source
[ ] Purchased from: ______.
[ ] Bred or reared at the University of the South.
[ ] Captured from wild: if yes, give agency and permit #(s) and attach copy(ies).
[ ] Donated to become the University of the South property.
[ ] Client owned.
[ ] Transferred from another study (if yes, provide title and PI of previous study).
______
[ ] Other (Please Describe): ______
3.______
SexAge/Weight
4.______
Single or group housing (provide numbers per cage or pen)
5.How will individual animals be identified? (circle all that apply) collar; ear tag; ear notch; cage card (small animals only); freeze brand; list other:
______
6.Disposal of animals after completion of activity:
[ ] Return to production/breeding unit/facility inventory.
[ ] Sold.
[ ] Transfer to another research project (if yes, project title and investigator).
[ ] Euthanized.
[ ] Returned to owner.
[ ] Other (Please describe) ______
C.Non-Technical Summary
(A complete non-technical summary is required for conformance with PHS Policy)Non-technical summary must be submitted as an attachment and should not exceed two (2) pages. Non-technical summary must be written to ensure comprehension by non-scientists. It must contain the following: 1) objectives of the research or teaching activity; 2) species and number of animals; 3) schedule of the course or the study procedures performed during each phase; and procedures or methods used to reduce any experimental stress or discomfort; 4) benefits, outcome and results expected in non-technical terms.
D.Flow Sheet
Pertinent information (i.e., numbers of animals, experimental manipulations) should be provided on a flow sheet. The Committee members should be able to follow every manipulation of the animal from experiment initiation to completion (e.g., day one, group one, treatment; day two. etc.)
E.Qualifications of Personnel
The Animal Welfare Act places responsibility with the Institutional Animal Care and Use Committee (IACUC) for determining qualifications of individuals involved in animal research, teaching, and testing activities. Qualifications to perform specific procedures will be based upon information provided in this section.
Investigators are responsible for ensuring that all their personnel including students are trained and that employees and students perform proper animal procedures.
Please indicate how the people who will conduct procedures using animals (especially surgery, anesthesia, pre- or post-operative care, or euthanasia) are to be trained.
F.Duplication of Research
The Animal Welfare Act requires that the principal investigator give written assurance that the proposed research is not unnecessarily duplicative.
1.Does the proposed research duplicate any previous work? [ ] yes [ ] no
2.If no, what procedures and sources did you use to determine that the proposed research does not duplicate previous work?
[ ] Medline [ ] CAB [ ] Agricola [ ] Other (describe)
3.If yes, provide justification for the need to duplicate previous work.
G.Alternatives to the use of Animals.
The Animal Welfare Act requires that the Principal Investigator must consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and provided a written narrative description of the methods and sources.
1.What is the justification for using live animals rather than alternative means for achieving the research goals?
2.What procedures and sources did you use to determine that non-painful alternatives were not available or appropriate? (e.g., Animal Welfare Information Center, National Agricultural Library 301-504-6212)
3.Why have you selected the particular species proposed in this project?
4.Provide an explanation of how the numbers of animals to be used were derived. If used in an experiment (test a hypothesis) numbers should be based on scientific and statistical requirements (power tests) to achieve objectives.
PART II.
DETAILED INFORMATION
Check and complete those sections A - E that are relevant to your project.
REMOVEALLSECTIONSNOTAPPLICABLETOYOURPROPOSAL.
A.Non-Surgical Procedures (Pertains to any experimental procedure - including non-surgical, pre-surgical and post-surgical procedures using animals).
[ ] NO [ ] YES: COMPLETE SECTION A
B.Surgical Procedures (Pertains to any surgical procedure, including non-survival surgery. If other procedures are done on animals prior to or after surgery, complete section A and other applicable sections.)
[ ] NO [ ] YES: COMPLETE SECTION B
C.Field Studies Involving Wild Animals
[ ] NO [ ] YES: COMPLETE SECTION C
D.Hazardous Agents
[ ] NO [ ] YES: COMPLETE SECTION D
E.Euthanasia
[ ] NO [ ] YES: COMPLETE SECTION E
Part II
Section A
Non-Surgical Procedures
1.Sites of Study
a.Site of housing prior to study:
Bldg.Room/pen
b.Site of experimental work:
Bldg.Room/pen
2.Please check the following items that apply and fill out appropriate parts of this section.
[ ] Antibody production*
[ ] Blood or other body fluid withdrawal, tissue collection
[ ] Restraint with mechanical devices
[ ] Projects involving nutritional studies, tumor and disease models or toxicity testing
[ ] Anesthesia or analgesia (for non-surgical procedures)
Antibody production
Describe procedure, antigen and adjuvants used, the ratio of antigen to adjuvant and routes of injection: (Vol. should be <0.2 ml per injection site; subcutaneous route is recommended)
Blood or body fluid withdrawal/tissue collection
Describe method(s), volume(s) collected and frequency of collection:
Restraint with mechanical devices
Describe device, duration of restraint, conditioning procedures and steps to assure comfort and well-being:
Nutritional deficiencies/Ascites tumor, monoclonal antibody production/Disease, neoplasia models/Toxicity testing
Describe methodology. State objective criteria used to assess physical condition and pain and distress during course of study. Include clinical signs or manifestations expected from the procedure. What criteria will be used to determine a humane endpoint before severe morbidity and death?
Anesthesia/Analgesia/Tranquilization (Other than Surgery Section B)
List procedures for which anesthetics, analgesic or tranquilizers are required, including the name, dose, route, and frequency of treatment with drugs or other medications.
DRUGDOSEFREQUENCYROUTE
3.Health Assessment:
How often will the clinical condition of animal subjects be assessed during experimental investigation? (e.g., how frequently will animals be observed? How often will weight, body temperature, and behavior be assessed?)
Describe methods used to minimize degree and duration of discomfort. If drugs which might alleviate pain or distress will be withheld, provide humane endpoints (e.g., animals to be euthanatized if weight loss exceeds 20% of normal weight; mice euthanatized when tumors reach 1 cm. in diameter or tumor ulcerates).
Part II
Section B
Surgical Procedures
The attending veterinarian must be consulted on anesthetic regimens, surgical procedures and post-surgical care.
Adequate records describing surgical procedures, anesthetic monitoring and postoperative care must be maintained and available to the attending veterinarian and animal care staff.
Survival Surgery [ ] Yes [ ] No
Survival surgical procedures (Pertains to any surgical procedure, including biopsies, where an animal is allowed to recover from anesthesia, however short the survival period.) In non-survival surgery, the animal is euthanized while still anesthetized.
Multiple survival surgery? [ ] Yes [ ] No
If yes, provide justification for multiple survival surgical procedures:
1.Surgeon: ______
2.Describe surgeon’s experience with procedures to be performed.
3.Location of housing and procedural areas: (Be as specific as possible, including building, room and location of off-campus sites.)
Housing prior to and after surgery
Surgery RoomRecovery
4.Briefly describe surgical procedure. (Include anticipated duration of procedure from start of anesthesia to recovery.)
5.Statement on health status of animals:
a.How will health status of animals be assessed before initiation of procedure?
b.Will animals be fasted prior to surgery? [ ] Yes [ ] No
If yes, for how long?
c.Will water be withheld prior to surgery? [ ] Yes [ ] No
If yes, for how long?
Water should not be withheld from rodents and should not be withheld for more than 12 hours from non-rodents.
6.Anesthetic Protocol
a.______
Anesthetist
b.______
Pre-anesthetic Agent(s)Dose/Route
c.______
Anesthetic AgentDose/Route