Policy #2202
Care and Use of Laboratory Animals

Date of Current Revision: November 2002
Responsible Office: Provost and Vice President for Academic Affairs
  1. PURPOSE

    This policy provides the university community with procedures for the appropriate care and use of laboratory animals at the university.

  2. AUTHORITY

    According to the Assurance of Compliance with Public Health Service Policy on the Humane Care and Use of Laboratory Animals, it is the responsibility of the university to provide direction and oversight for the use and care of live vertebrate animals in the conduct of scholarly research or other academic activities.

    In compliance with the PHS policy, "The chief executive officer shall appoint an Institutional Animal Care and Use Committee, qualified through the experience and expertise of its members to oversee the institution's animal program, facilities and procedures."

  3. DEFINITIONS

    Animal:
    Any live, vertebrate animal used or intended for use in biological testing, experimentation, or instructional, research, research training or related purposes.

    Animal Facility:
    Any and all areas, buildings, enclosures, rooms or vehicles, including satellite facilities used for animal confinement, breeding, experiments inclusive of surgical manipulation, maintenance or transport. A satellite facility is any containment outside of a core facility or a centrally designated or managed area in which animals are housed for more than 24 hours.

    Animal Welfare Act:
    Public Law 89-544, 1966, as amended, (P.L. 91-579, P.L. 94-279 and P.L. 99-198) 7 U.S.C. 2131 etc. seq. Implementing regulations Subchapter A, Parts 1, 2, 3 and 4, and are administered by the U.S. Department of Agriculture.

    Animal Welfare Assurance or Assurance:
    The documentation from an institution assuring institutional compliance with the PHS policy, Appendix D of the Guide.

    Guide:
    Guide for the Care and Use of Laboratory Animals, HHS, NIH Pub. No. 86-23, 1985 edition or succeeding revised editions.

    IACUC:
    Institutional Animal Care and Use Committee

    Institutional Official:
    An individual who has the authority to sign the university's Assurance, making a commitment on behalf of the university that the requirements of the Public Health Service policy will be met.

    Public Health Service or PHS:
    The Public Health Service 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.

  4. APPLICABILITY

    The policy applies to all student/faculty research and teaching whether funded from external or internal sources.

  5. POLICY

    It is university policy that the care, housing, use and procurement of animals should conform to the National Institutes of Health Guide for the Care and Use of Laboratory Animals NIH 86-23 or succeeding editions and other relevant federal policies and procedures.

  6. PROCEDURES

    6.1 Institutional Animal Care and Use Committee or IACUC
    Membership or Composition - See IACUC Membership Requirements at the following URL: http://grants.nih.gov/grants/olaw/tutorial/iacuc.htm
    The IACUC will consist of not fewer than five members who shall include the following:
    • A doctor of veterinary medicine
    • A member whose primary concern is a nonscientific area
    • Practicing scientists experienced in research involving the use and care of animals
    • One individual not affiliated with the university other than as a member of this committee

    6.2 Categories of Animal Use Subject to Review
    The IACUC reviews all classroom and research projects involving the use of living non-human vertebrate animals to ensure the humane care and use of animals including, but not limited to the following:
    • Classroom exercises, demonstrations and lab projects
    • Faculty or staff research projects (including those that are funded)
    • Graduate student projects
    • Undergraduate student honor projects
    • University-approved research by investigators not affiliated with the university who propose to involve university students, staff or faculty members as part of a proposed research project

    6.3 Criteria Used for Review of Proposals
    Review Criteria
    The JMU IACUC in its review of proposed animal use protocols involving animals will determine that the proposed activity meets the following requirements as spelled out in JMU's institutional assurance to the U.S. Public Health Service Office of Laboratory Animal Welfare:
    • Procedures involving animals must be designed and performed with due consideration of their relevance to human or animal physical or mental health, the advancement of knowledge, or the good of society.
    • Animals selected for a procedure must be of an appropriate species and quality, and the number of animals used must be the minimum required to obtain valid results. Alternate approaches such as mathematical models, computer simulation and in vitro biological systems should be considered whenever possible.
    • Consistent with sound research design, procedures with animals must avoid or minimize discomfort, distress and pain to the animals.
    • Procedures that may cause more than momentary or slight pain or distress to the animals must be performed with appropriate analgesia, anesthesia or sedation; animals to undergo surgery or other painful procedures must always be properly anesthetized. Any variation from this requirement must be justified for scientific reasons in writing and must be reviewed and approved by the IACUC.
    • Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved must be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure.
    • Multiple major surgical procedures on the same animal are discouraged and may be justified only when the procedures are related components of a research protocol. Such multiple surgical procedures require written justification and IACUC approval; approval will not be granted on the basis of cost savings alone.
    • 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 animals will be directed by a scientist trained and experienced in the proper care, handling and use of the species being maintained or studied.
    • Medical care for animals will be available and provided as necessary by a qualified veterinarian.
    • Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
    • All animals must be held in IACU-inspected and -approved facilities. Surgical procedures must be performed only in facilities that have been approved by the IACUC for that purpose.
    • Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia. Any variation from this requirement must be justified for scientific reasons in writing and must be reviewed and approved by the IACUC.

    6.4 Procedures for Submitting Proposed Animal Use Protocols to the IACUC
    • Submit an electronic copy and forward one signed original of the completed protocol package - Attachment A (including the description of the methodology involving animals and abstract) to the Office of Sponsored Programs for review, approval and distribution. The electronic version can be submitted at: http://www.jmu.edu/sponsprog/iacucsubmit.html or e-mailed to jmu_grants@jmu.edu.
    • Protocols will not be accepted for review unless the hard copy of the protocol cover page provided to the Office of Sponsored Programs contains signatures of the instructor or principal investigator, each co-investigator named and the appropriate director or unit head.
    • Protocols to be reviewed should be received by the IACUC not less than 30 days prior to the date approval is required.
    • IACUC approval must be received before starting the project.
    • On approval, commencement and expiration dates will be assigned for the project, and a copy of the Action of the Board Form will be returned to the principal investigator or instructor.

    Post-Approval IACUC Procedures
    • Application approval will be valid for a maximum of three years.
    • The principal investigator or instructor will contact the IACUC chairperson annually to verify the status of the project.
    • If no significant change in the protocol has occurred, approval may be extended for a year.
    • Any significant change in the protocol requires a new application and approval.
    • Approval will be canceled for discontinued projects.
    • Significant departure from the original protocol requires prior approval from the IACUC.

    6.5 Statement of Concern/Complaint Concerns about animal abuse or infractions of animal care and user regulations, use the following chain of command to report the situation:

    Principal Investigator or → Attending Veterinarian
    ↓   ↓
    Department Head or → IACUC Chairperson


    Should circumstances exist that prevent the use or implementation of this chain of command, concerns may be directed to the IACUC chairperson or a member of IACUC.

    In grievous matters, the university, after verification of the report and the situation, will take appropriate actions to ensure the humane care and use of animals and will report the matter to the appropriate authorities. No committee member, facility employee, laboratory personnel or student shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standard.

  7. RESPONSIBILITIES

    7.1 The IACUC reviews research applications proposing the use of vertebrate animals to ensure that the described care and use of animals are in compliance with federal rules and regulations and university policy. The IACUC is responsible for the following:
    • Reviewing the institution's program for the humane care and use of animals at least once every six months using the Guide as a basis for evaluation.
    • Inspecting all of the institution's animal facilities at least once every six months using the Guide as a basis for evaluation.
    • Preparing reports of IACUC evaluations as set forth in the PHS policy and submitting the reports to the provost.
    • Reviewing concerns involving the care and use of animals at the institution.
    • Making written recommendations to the provost regarding any aspect of the institution's animal program, facilities or personnel training.
      The provost will apprise the appropriate university offices of the committee's recommendations and concerns. In addition, the provost will provide the Office of Facilities Planning with an up-to-date list of approved animal facilities and a separate list of facilities where vertebrate animal research is currently taking place.
    • Reviewing and approve, require modifications (to secure approval or withhold approval) of those activities related to the care and use of animals as set forth in the PHS policy.
    • Reviewing and approving, require modifications in (to secure approval or withhold approval) proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS policy.
    • Notifying investigators and the university in writing 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 as set forth in the PHS policy.
    • Authorizing the suspension of an activity involving animals as set forth in the PHS policy.
    • Overseeing lawful procurement of vertebrate animals.
    • Reviewing and approving all new, continuing or revised protocols involving use of animals in university-supported and/or externally funded research or instructional activities.

    7.2 The principal investigator or instructor is responsible for the following:
    • Submitting a properly executed application for Use of Animals in Research and Teaching for each project to the Office of Sponsored Programs, the administrative arm for IACUC. OSP will distribute the protocol for review and approval to the IACUC. No work may commence until IACUC approval has been obtained.
    • Ensuring that all animals are obtained lawfully.
    • Ensuring that arrangements are made for obtaining any special permits necessary for the acquisition of certain exotic, wild and restricted species.
    • Establishing proper procedures in their laboratory or study area for all aspects of animal care and use such as anesthesia, postoperative care, preoperative care, sampling techniques and euthanasia, as well as disposing of animal carcasses and waste. The principal investigator or instructor is not responsible for the physical removal of animal carcasses and waste. However, the principal investigator or instructor is responsible for implementing procedures for preparation of wastes according to the Guide for collection and disposal. Waste disposal will be collected and disposed of in a safe and sanitary manner under the auspices of the physical plant.
    • Ensuring that personnel are adequately trained in the care, handling and restraining of all animals used in relevant experimental procedures.
    • Ensuring that instructions to laboratory personnel are implemented, including the health-care program.
    • Ensuring that aseptic surgery is performed in a facility designed in accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 86-23 or succeeding editions).
    • Ensuring that procedures are in compliance with all campus policies, including regulations concerning the use of agents such as radionculides, biohazardous agents, etc., as well as those involving the use of vertebrate animals. Experimentation with such agents may require registration with or approval by other campus committees or offices.

  8. SANCTIONS

    Sanctions will be commensurate with the severity and/or frequency of the offense and may include termination of employment.

  9. EXCLUSIONS

    None.

  10. INTERPRETATION

    The authority to interpret this policy rests with the president and is generally delegated to the provost.
Approval:

November 20, 2002
Linwood H. Rose, President


Index Terms:

Animal care
IACUC
Laboratory animals
OSP
Research
Appendices
Action of the Committee
Animal Use Protocol
Instructions for Submitting Animal Use Protocols for Review

ANIMAL USE PROTOCOL JAMES MADISON UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

PROTOCOL TITLE: (Limit to 200 spaces)____________________________________

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

COURSE TITLE AND NUMBER (if appropriate):________________________________

REVIEW STATUS: Initial Review_____Continuation Continuation No Change_____Major Change_______

PROTOCOL PERIOD: (Not to exceed three years) From / / to / / .

PRINCIPAL INVESTIGATOR OR INSTRUCTOR: (Must be a JMU faculty member)

--------------------------------------------------------------------------------

Typed Name Signature Date
Academic Title:___________________________Work Phone No:_________________

Department:______________________________Emergency Phone No:____________

CO-INVESTIGATORS (if any): Typed Names Signatures
________________________ ___________________
________________________ ___________________
________________________ ___________________

FACILITIES: The animal care and use will be conducted in the following IACUC inspected and approved facilities:
Locations Dates Approved

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

DEPARTMENT OR UNIT HEAD ENDORSEMENT: I have reviewed the proposal that is the basis of this Animal Use Protocol and endorse its submission.

Comments:______________________________________________________________

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Typed Name Signature Date

ATTENDING VETERINARIAN: I have reviewed this protocol in the context of provisions of the Animal Welfare Act, the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, and other statutes and regulations relating to animals.

Comments:______________________________________________________________

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Typed Name Signature Date

ANIMALS TO BE USED:

ANIMALS TO BE USED:


Species    Number    Age    Sex    Weight    Housing Location

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

(1) SURGERY: Will surgery be conducted on animals? Yes_____ No________

If no, continue with No. 2 below.

Nonrecovery Surgery____ Recovery Surgery____ Multiple Surgeries____

Fully describe surgical procedures including the surgeon's name(s), job titles and locations in protocol.

(2) INFECTIOUS OR TOXIC AGENT: Will infectious or toxic agents be used? Yes____ No____

If no, continue with No. 3 below.

Fully describe infectious or toxic agents in protocol.

(3) RESTRAINT: Will prolonged restraint be used? Yes____ No____

If no, continue with No. 4 below.

Describe the type and duration of restraints used in the protocol.

(4) PAIN OR DISTRESS: Does this procedure have the potential to inflict pain or distress? Yes____ No____

If no, continue with No. 5 below.

Describe the measures taken to alleviate or minimize pain or distress in the protocol.

(5) ANESTHESIA, ANALGESIA, TRANQUILIZERS: Will anesthetic, analgesic or tranquilizing agents be administered? Yes____ No____

If no, continue with No. 6 below.

Describe use of anesthetic, analgesic or tranquilizing agents in protocol, including species, agents, dose, route of administration and personnel performing procedures.

(6) EUTHANASIA: Will euthanasia be carried out? Yes____ No____

In protocol describe disposition of animal(s) at the conclusion of the study or the method of euthanasia including agent/procedure, dose, route of administration and personnel.

PROTOCOL

Provide a complete description of the purpose of the procedure and the methodology. (DO NOT EXCEED THREE PAGES).

Every proposal must also include these subsections:

RATIONALE FOR USING ANIMALS: Briefly describe the rationale for using animals (include consideration given to alternative methods to use of animals) and for use of the species selected.

NUMBERS OF ANIMALS: Justify the number of animals to be used.

DISPOSITION OF ANIMALS AT THE CONCLUSION OF THE PROCEDURE: Describe what will happen to your animals at the conclusion of the project.

If items No. 1-5 were answered yes, the protocol should include the following relevant subsections:

SURGICAL PROCEDURES

INFECTIOUS or TOXIC AGENTS

RESTRAINT

PAIN OR DISTRESS

ANESTHESIA, ANALGESIA or USE OF TRANQUILIZERS

ABSTRACT (for research projects only)
Prepare a typed abstract of this project and its significance and rationale in lay terms. (NOTE: This information may be used by JMU in official communications with the public and news media.) DO NOT EXCEED ONE DOUBLE-SPACED, TYPED PAGE.

PROJECT PROPOSAL
Submit one copy of the completed project proposal.


JAMES MADISON UNIVERSITY
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

ACTION OF THE COMMITTEE

REVIEW STATUS:

Date Submitted:_______________ _____Initial Review
Code Number:__________________ _____Continuation No Change
_____Continuation Major Change

TITLE OF PROTOCOL:

The Institutional Animal Care and Use Committee took the following action on the protocol cited above:

____Approved ____Disapproved

____Approved with Modifications*

*Modifications requested by the IACUC have been accepted by the investigator(s) and, therefore, the protocol has been APPROVED.

Approval of the protocol is for the period / / through / / . The IACUC will periodically contact investigators to seek information about approved protocols.

The investigator(s) shall immediately bring any changes proposed for the approved protocol as they relate to the care or use of laboratory animals to the attention of the IACUC. The IACUC will decide whether the extent or type of changes proposed warrant formal IACUC review. If such a review is deemed necessary, the chairperson shall schedule the review for the earliest feasible time.

FOR EXTERNALLY FUNDED PROJECTS, INVESTIGATORS ARE RESPONSIBLE FOR CONVEYING A COPY OF THIS DOCUMENT TO THE OFFICE OF SPONSORED PROGRAMS TO BE FORWARDED TO THE APPROPRIATE SPONSORING AGENCY.

Date____________________Signed_______________________________ (Chairperson)
JAMES MADISON UNIVERSITY

INSTRUCTIONS FOR SUBMITTING ANIMAL USE PROTOCOLS FOR REVIEW

TO

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE


Research Protocol
  1. Submit an electronic copy and forward one signed original of the completed protocol package - Attachment A (including the description of the methodology involving animals and abstract) to the Office of Sponsored Programs for review, approval and distribution. The electronic version can be submitted at: http://www.jmu.edu/sponsprog/iacucsubmit.html or e-mailed to jmu_grants@jmu.edu.
  2. Protocols will not be accepted for review unless the hard copy of the protocol cover page provided to the Office of Sponsored Programs contains signatures of the instructor or principal investigator, each co-investigator named and the appropriate director or unit head.
  3. Protocols to be reviewed should be received by the IACUC not less than 30 days prior to the date approval is required.
  4. Receive notification of approval from the IACUC prior to starting the project.
  5. On approval, commencement and expiration dates will be assigned for the project, and a copy of the Action of the Board Form will be returned to the instructor or principal investigator.
Review Criteria:
In its review of proposed animal use protocols involving animals, the JMU Institutional Animal Care and Use Committee will determine that the proposed activity meets the following requirements as spelled out in JMU's institutional assurance to the U.S. Public Health Service Office of Laboratory Animal Welfare:
  • Procedures involving animals must be designed and performed with due consideration of their relevance to human or animal physical or mental health, the advancement of knowledge or the good of society.o Animals selected for a procedure must be of an appropriate species and quality, and the number used must be the minimum required to obtain valid results. Alternate approaches such as mathematical models, computer simulation and in vitro biological systems should be considered whenever possible.
  • Consistent with sound research design, procedures with animals must avoid or minimize discomfort, distress and pain to the animals.
  • Procedures that may cause more than momentary or slight pain or distress to the animals must be performed with appropriate sedation, analgesia or anesthesia; animals to undergo surgery or other painful procedures must always be properly anesthetized. Any variation from this requirement must be justified for scientific reasons in writing and must be reviewed and approved by the IACUC.
  • Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved must be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure.
  • Multiple major surgical procedures on the same animal are discouraged and may be justified only when the procedures are related components of a research protocol. Such multiple surgical procedures require written justification and approval of the IACUC; approval will not be granted on the basis of cost savings alone.
  • The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding and nonmedical care of the animals will be directed by a scientist trained and experienced in the proper care, handling and use of the species being maintained or studied.
  • Medical care for animals will be available and provided as necessary by a qualified veterinarian.
  • Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
  • All animals must be held in IACUC inspected and approved facilities. Surgical procedures must be performed only in facilities that have been approved by the IACUC for that purpose.
  • Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia. Any variation from this requirement must be justified for scientific reasons in writing and must be reviewed and approved by the IACUC.