Approved - November 24, 1999
Revisions - August 1, 2005

The University of Vermont is committed to the humane care and use of animals in activities related to research, testing and teaching. The University has adopted on an institution-wide basis the principles regarding animal care as stated in the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals and is guided by the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Use in Testing, Research and Training. In order to accomplish the objectives inherent in these regulations and principles, there have been two separate organizational components designated to ensure their implementation in the overall animal care and use program.

1. The Institutional Animal Care and Use Committee (IACUC) is the University’s central review body for matters relating to the care, use and treatment of animals in these areas. The IACUC office is located within the Office of Sponsored Programs.

2. The Office of Animal Care Management/Animal Resource Center is responsible for oversight of all animal care and use and for ensuring compliance with federal, state and local regulations. The University Veterinarian is the Director of this office.

The IACUC was established in accordance with the Animal Welfare Act and the Health Research Extension Act under the authority of the Vice President for Research to ensure the humane care and use of animals for research and education at the University under optimum conditions, which, at a minimum, comply with all pertinent laws. The IACUC is staffed by the Institutional Research Compliance Administrator and the Institutional Review Boards Assistant Administrator within the Office of Sponsored Programs, which is under the authority of the Vice President for Research.

The Office of Animal Care Management (OACM)/Animal Resource Center (ARC) is administered by the University Veterinarian/Charles River Laboratory Contract Services and is charged with the veterinary care and husbandry of the animals, the occupational health and safety of personnel, and ensuring the appropriate training of personnel working with animals in accordance with all relevant regulations and guidelines governing the humane care and use of animals. The University Veterinarian and the OACM are under the authority of the Vice President for Research.

• Overview

The University of Vermont process for reviewing all research, research training, and biological testing activities involving vertebrate animals is carried out by the Institutional Animal Care and Use Committee (IACUC). The IACUC is authorized to request modifications, approve, withhold approval, or suspend animal research and teaching projects.

In addition to reviewing specific research projects, the IACUC also carries out other federally mandated functions such as: review and report on the overall animal program and inspect and evaluate all of the animal facilities at least once every six months; review and investigate legitimate concerns involving the care and use of animals at the institution; and make recommendations to the Institutional Official regarding any aspect of the research, animal program, facilities or personnel training.

All projects (with or without internal or external funding) which involve the use of vertebrate animals must undergo IACUC review and receive approval prior to initiation. Investigators are required to consult with the veterinarians about the project and submit a completed Animal Use Protocol Form (application) to the IACUC for review by the Committee (see section III below).

The Committee is comprised of non-scientific/lay/non-affiliated members as well as scientific/affiliated members, to ensure a balance of professional expertise and community perspective. All committee members participate in the review process. IACUC policies and procedures are designed to ensure that the review is conducted with thoroughness, consistency and objectivity in a manner allowing each member to exercise independent judgment. No member is assigned to serve as a primary reviewer or is permitted to vote on any matter in which that member has a conflicting interest.

Meetings are routinely held on the fourth Monday of each month. The deadline for submission of materials for review is the second Monday of the month. A reviewer(s) is assigned to each protocol. The decision as to the type of review a proposal receives (designated or full committee) is based on the expected level of animal discomfort and types of procedures. The agenda is sent to members approximately two weeks prior to a meeting. Protocols are placed on the agenda as they come in. A quorum is considered to be one more than one half the total number of regular voting members and at least one non-scientist must be present. If less than one-half the total number of regular voting members are not present, ex officio members with voting privileges may be included to constitute a quorum.

Once approved, each protocol is reviewed at least annually or more frequently if deemed appropriate or necessary by the IACUC and if active long enough, a renewal of ongoing projects is required every three years.

A research project that is identical to an already approved project in regard to specific aims, hypothesis, and animal species and use, may be given executive review and approval by the Committee Chair. This approval is reported at a regularly scheduled meeting within 30 days of such an approval.

Protocols not requiring direct use of live animals, i.e. using animal material obtained from slaughterhouses or other specified sources, receive executive review and approval. An Animal Products Use Form must be completed and submitted to the IACUC.

• Regulatory Aspects

The University of Vermont Institutional Animal Care and Use Committee (IACUC) has an Assurance on file with the Office for Protection from Research Risks in accordance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, for institutions which have research sponsored by the PHS. The Committee is governed by the USDA Animal Welfare Act as documented in the Code of Federal Regulation Title 9, Subchapter A Parts 1, 2 and 3. The IACUC applies the standards set forth in the Guide for the Care and Use of Laboratory Animals.

 

• Membership

Members shall be of varying professional and personal backgrounds and shall demonstrate a genuine interest in and commitment to the purpose of the Committee. Membership shall include one Doctor of Veterinary Medicine, one practicing scientist, one member whose primary concerns are in a nonscientific area, one individual who is not affiliated with the institution in any way other than as a member of the IACUC, an Ex Officio member (OSP staff person).

For a more detailed description of committee membership, refer to the IACUC by-laws, section 5, Membership and in the University of Vermont, Guide for the Care and Use of Animals.

• Contacting the IACUC

The IRB Administrators serve as the point of contact for information regarding the IACUC.

Nancy Stalnaker
Director
Office of Sponsored Programs/Research Protections Office
245 South Park, Suite 900
656-5040
Nancy.Stalnaker@uvm.edu

Penni Cross
Research Review Administrator
Office of Sponsored Programs/Research Protections Office
245 South Park, Suite 900
656-5040
Penni.Cross@uvm.edu

Kim Wood
Administrative Assistant
Office of Sponsored Programs/Research Protections Office
245 South Park, Suite 900
656-5040
Kim.Wood@uvm.edu

All correspondence, including that directed to the Chair or other specific members of the Committee, should be sent to the above address.

As stated above, the University Veterinarian administers the Office of Animal Care Management (OACM), which is charged with the veterinary care and husbandry of the animals, the occupational health and safety of personnel, and ensuring the appropriate training of personnel working with animals in accordance with all relevant regulations and guidelines governing the humane care and use of animals.

Further information is available at web site (http://www.uvm.edu/~oacm).

OACM/ARC is located in 116 Hills Building and the administrative personnel are as follows:

Dr. Ruth Blauwiekel, University Veterinarian 656-7881
Corey-Lyn Roberts, Facility Manager, Charles River Labs 656-1006

 

Most of the above referenced regulations, guidelines and standards are available on our web site (http://osp.uvm.edu/). For hard copies of any of these documents, contact the IACUC office at the above address or phone number.

 

A. SCOPE

The Animal Use Protocol Summary and Animal Use Protocol Form must be completed and approved for all work involving the use of vertebrate animals at the University of Vermont regardless of the source of funding or the intended use (e.g., research, teaching or testing) of the animals.

The "Information and Submission Guidelines" contain all of the specific information necessary regarding new protocol submissions, projects identical to previously reviewed and approved projects, projects in which animal use is limited to animal products, protocols for breeding or holding colonies, projects using wildlife or exotic species. (See attached, Appendix 1.)

C. PROTOCOL REVIEW PROCESS AND CRITERIA FOR REVIEW

• TYPES OF REVIEW/OVERVIEW OF THE APPLICATION PROCESS

The process for reviewing and approving programs using animals begins with the completion of an Animal Use Protocol application. Information required for the Protocol is consistent with requirements detailed in the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Animal Welfare Regulations. A consultation with the University Veterinarian is required for all proposals involving the use of animals prior to the protocol's approval.

There are three types of Committee review: full, designated or executive. Determination of the type of review is usually based upon the expected level of animal pain or discomfort and types of procedures (see Appendix 1). The following steps are involved in the review process:

 

Step 1: Submission of the Protocol. Investigators submit completed Protocols to the IACUC Office, IRB Assistant Administrator in hard copy.

Step 2: Initial Review. Following the receipt of a Protocol by the IRB Assistant Administrator, the type of review a proposal will receive (designated or full committee) based on the expected level of animal discomfort and types of procedures will be verified. Completeness of the protocol is also checked at this time.

Step 3: Review (By Type) At monthly meetings, the IACUC considers new protocols requiring full committee review, reviews the Reports of Designated Reviews and Reports of Executive Reviews. Possible outcomes of the Committee's review include unqualified approval, approval pending modification(s) and/or clarification(s), table (deferral), or disapproval.

a. FULL REVIEWS - Two reviewers are assigned. The primary reviewer is always a scientific representative of the Committee and is responsible for presenting a summary of the protocol at the meeting along with any concerns or points requiring clarification and/or stipulations. The secondary reviewer adds any additional concerns. The protocol is then open for discussion by the Committee, which includes the University Veterinarian.

b. DESIGNATED REVIEW - One reviewer is assigned. The reviewer is given 7 days to complete the review and return it to the IACUC office. The reviewer’s comments and the protocol are then forwarded to the remainder of the Committee for their review. If no further comments are received and there is no request for a full committee review, a letter requesting clarifications and/or stipulations is sent to the investigator or if a recommendation to approve outright has been made, a Verification of Approval is sent.

c. EXECUTIVE REVIEW - The chair alone (or his designee from the Committee) reviews and approves protocols falling in this category. This category includes continuing reviews, previously approved protocols that have been resubmitted or identical protocols submitted to different funding agencies, protocols with no direct animal use, e.g. funds will be used for salary support only (on a previously approved protocol), or use of shared animal products or slaughterhouse materials.

NOTE: SCIENTIFIC REVIEW - IACUC review efforts focus on the appropriateness of animal numbers, procedures and adequacy of investigator skills. Normally scientific peer review is left to outside funding agencies. In lieu of outside review, IACUC requires the department of record to certify that funds are awarded on the basis of scientific merit and periodic evaluation.

 

Step 4: Investigator Notification. If a protocol receives unqualified approval, the investigator is provided with a Verification of Approval and letter certifying the approval. In cases where the IACUC requires clarification(s) or modification(s), the investigator is notified by the IACUC Chair in a letter. In such cases, the approval is issued following receipt of an acceptable response from the investigator. In cases of a tabled or disapproved protocol, the investigator is notified by the Chair and advised as to available options.

• Criteria for Review

All proposed activities are reviewed to ensure that the following federal requirements for granting IACUC approval are met:

Activities -- All activities involving animals must be in accord with USDA Regulations/PHS Policy

Pain/Distress -- Must avoid/minimize discomfort/distress/pain. If pain/distress is caused, appropriate sedation, analgesia or anesthesia will be used. Attending veterinarian must be involved in planning. Use of paralytics is prohibited. Animals with chronic/severe unrelievable pain will be painlessly killed.

Alternatives -- The PI has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animal and has provided a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center, used to determine that alternatives were not available.

Rationale and Methods -- All proposals 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 procedures designed to assure that discomfort and pain to animals will be limited to that which is non avoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals; and

• A description of any euthanasia method to be used.

Duplication -- Assurance that activities do not unnecessarily duplicate previous efforts must be provided.

Surgery -- Requirements for sterile surgery and pre/post operative care must be met. You cannot use one animal for several major operative procedures from which it will recover, without meeting specified conditions.

Euthanasia--The euthanasia method must be consistent with USDA Regulations/AVMA recommendations

Housing/Health -- Animal living conditions must be consistent with standards of housing, feeding and care directed by veterinarian or scientist with appropriate expertise. Medical care must be provided by qualified veterinarian.

Qualifications --Personnel must be appropriately trained and qualified. Completion of all the University of Vermont's Office of Animal Care Management training program is required for all individuals working with animals or identified on a protocol.

Deviation from Requirements --Must be justified for scientific reasons, in writing.

The Committee’s review process always includes a check for compliance with all applicable IACUC or institutional policies and procedures.

D. CONTINUING REVIEW, AMENDMENTS AND TERMINATION OF PROTOCOLS

• Continuing Review and Three-Year Renewal of Ongoing Projects

Animal research protocols are approved for a three-year term, subject to continuing review at least annually.

Continuing Review Process:

A letter is sent two months prior to the anniversary date of the last review to the principal investigator indicating that the continuing review is due. The investigator must complete and return a Continuing Review Summary, which is then reviewed by a Committee member. Upon recommendation of the reviewer, the protocol is either approved outright for period of time up to an additional year or a protocol modification requested and the normal review process resumes.

Three-Year Renewal:

At the end of the third year of a protocol, the investigator must resubmit it for Committee review in order to continue research activities. A new Animal Use Protocol Form must be submitted; this form undergoes the same review process as any new protocol. The renewal should include all previous modifications or amendments made to the protocol since its original approval.

• Request for Amendment to Previously Approved Protocol

Requirements:

Review of any changes to previously approved research is required by federal regulation and is an essential element of the continuing review of research involving vertebrate animals. Federal regulations mandate that changes cannot occur until after review and approval.

The IACUC recognizes that research is a continuous process and that changes in the conduct of the research are necessary. However, no changes to an approved protocol should be implemented until the IACUC has reviewed and approved the changes.

An algorithm has been developed that categorizes amendments and shows the path of IACUC review that each category of amendment may take. The determination of whether a proposed amendment is “significant” vs “minor” falls to the IACUC chair, in consultation with the University Vetrinarian as necessary.

When to Request

Requests for approval of modifications may be submitted at any time. Complete an Animal Use Protocol Amendment form. The changes must be approved, before any changes can be implemented in the conduct of the protocol. NOTE: If the amendment involves the use of hazardous materials this requires additional review by other committees. The approval by the other committees is required prior to implementation.

How to Request an Amendment to Approved Protocol

The Animal Use Protocol Amendment form is intended to capture all of the required elements for a significant review of proposed amendments. When submitting amendments, you are required to complete this form, modify the applicable pages of the protocol form and attach all supporting documents (i.e., revised protocol form pages, literature searches, etc.) Forward two copies to the IACUC office.

Note: The necessary form is located in the forms section of our website and should be downloaded each time you need one.

Documentation:

Once approved, the IACUC will return a signed Animal Use Protocol Amendment form. Proof of the amendment/change approval must be kept by the PI (perhaps in a Research Regulatory Binder) as evidence that the IACUC has approved the change.

Note: A copy of the approval will be forwarded by IACUC to the Office of Animal Care and Use for inclusion in their protocol files.

• Termination of IACUC Protocols

It is the responsibility of the investigator to notify the IACUC when a project is completed. Projects that have been completed, withdrawn or terminated are closed immediately upon notification. The Office of Animal Care Management is notified by the IACUC Assistant Administrator of all closures. All animal use on a specified protocol is stopped. No further purchase of animals can be made under the specified protocol number. All closed projects are filed in the Office of Sponsored Programs for a 3-year period from date of closure.

IV. OTHER IACUC STANDARD OPERATING PROCEDURES

A. Semiannual Review of Program and Facilities and Protocol Monitoring

Twice each year the IACUC conducts a complete review of the University of Vermont's Animal Care and Use Program and inspects facilities where animals are housed and/or used. The NIH Guide for the Care and Use of Laboratory Animals and Animal Welfare Regulations are the principal documents used by the IACUC in its evaluations. Researchers who house animals in their laboratories over 12 hours should expect visits by the subcommittee of the IACUC at approximately 6-month intervals. In addition to looking at the research facilities during the semiannual inspection, IACUC members will conduct protocol monitoring visits at least annually. Members will meet with the investigators and their staff to discuss animal use procedures described in the applicable protocol(s), inspect drugs and materials intended for in vivo use, and inspect the research animal records.

B. Committee Training

• 4-STEP ORIENTATION PROGRAM.

Each new member is "apprenticed" to a "veteran" committee member. The apprentice and veteran will be matched and will meet each other at the first IACUC meeting. The roles of apprentice and veteran are as follows:

Apprentice's First Review

Research protocols requiring full committee review are always assigned to two reviewers. For the apprentice's first review, each veteran reviewer will be working together with an apprentice reviewer. Whether every apprentice/veteran team will actually receive a review will depend on the number of protocols submitted. Therefore, it may be the apprentice's second or third meeting before that team receives a review.

The apprentice should read the protocol and the reviewer forms and then consult with their veteran. Ideally, the veteran will promptly review the protocol and send the apprentice a copy of the review. The apprentice will not be obliged to complete a formal review the first time. The chair will invite the apprentice to comment at the time the protocol is discussed. Therefore, the apprentice should attempt to develop a point of view about the work planned in the protocol.

Apprentice's Second Review

Again, the apprentice and veteran will share observations about a protocol. For the apprentice's second review, the apprentice will present the combined views of apprentice and veteran. The veteran is expected to help the apprentice prepare for this presentation and to take part in the discussion of the protocol at the meeting.

Training Session

Staff will schedule a meeting of apprentices with staff, the University Veterinarian and the IACUC chair. The purpose of this meeting is to discuss committee functions in light of the apprentice experience. Some aspects of the committee's history, the Animal Welfare Act and the Public Health Service Guidelines will be reviewed.

Apprentice's Third Review

Depending on the number of protocols submitted, for the apprentice's third review, the apprentice will be assigned a protocol for actual review. The apprentice will be expected to complete the review and present it at the meeting. A veteran will be expected to be available for consultation and advice.

From that point on, the now "not-so-new" members will assume full committee responsibilities. Please remember that staff, the chair and the entire committee function as a team to support every member.

Orientation Materials

Basic introductory materials are provided to acquaint the new member with the Committee and its functions prior to the new member’s first meeting. Later, an additional, more detailed packet of materials is provided which is necessary for reference during reviews.

V. IACUC POLICIES AND GUIDELINES FOR USE IN REVIEW OF PROTOCOLS AND CARE OF ANIMALS  (See Appendix 2 for Individual Policies)

A. HAZARDOUS AGENTS

The Chemical Safety Office oversees policies related to the use of chemical and biological agents at the University to ensure that they are used in a safe and healthful manner and in accordance with all applicable government regulations and with University policy and procedure. The committee recommends policies to the Provost concerning the use of chemicals and biological agents. The committee is composed of faculty and staff appointed by the Vice President for Research. The members are selected based on their knowledge of the health and environmental effects of chemicals and biological agents, and the risks associated with those effects. The Chemical Safety Coordinator within the Department of Risk Management staffs the Chemical Safety Office. The Committee has the authority to require the immediate, temporary cessation of any University activity should it determine that such activity represents a substantial and immediate threat to human health or the environment. The Provost reviews such actions.

In accordance with the National Institutes of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules" revised April 2002, and other relevant federal regulation, the University of Vermont has established the Institutional Biosafety Committee (IBC). The Committee is charged with reviewing all research projects and activities involving recombinant DNA (as outlined in the "Guidelines") to assure that specific practices for constructing and handling (i) recombinant DNA molecules and (ii) organisms and viruses containing recombinant DNA molecules, as specified in the "Guidelines," are followed. The IBC was established by the authority of the Vice President for Research and define the basic policies, procedures and standards by which research involving recombinant DNA will be reviewed to provide for the safe conduct of recombinant DNA research. The authority of the IBC to disapprove, suspend or terminate a study involving recombinant DNA use may not be overridden.

All protocols involving the use of infectious agents are reviewed by an IBC member with the appropriate expertise and all chemical use is reviewed by the Chemical Safety Coordinator. The Institutional Biosafety Committee (IBC) reviews all protocols involving the use of recombinant DNA and Infectious Agents.

B. ORDERING ANIMALS

A current IACUC approval is required before animals can be purchased or housed. Contact the OACM for procedures for ordering animals or arranging for housing.

C. SURVIVAL SURGERY

D. FOOD OR FLUID RESTRICTION

E. PHYSICAL RESTRAINT

F. PAIN & DISTRESS, DETERMINATION OF LEVELS OF

G. ANTIBODY PRODUCTION

H. CONTROVERSIAL EUTHANASIA METHODS

I. DEATH AS AN ENDPOINT

J. REPORTING ANIMAL DEATHS

K. ANIMAL NUMBERS: INITIAL AND CONTINUING REVIEW

L. PROTOCOL FOLLOW-UP/MONITORING PROCESS

M. ANIMAL TISSUE USE

N. EMERGENCY OR DISASTER

O. ENSURING PROPER OCCUPATIONAL HEALTH

P. HOUSING ANIMALS OUTSIDE &/OR REMOVAL FROM CENTRAL ANIMAL FACILITY

Q. AGRICULTURAL ANIMAL USE

R. BIOLOGICAL AGENTS TO BE USED IN ANIMAL RESEARCH

S. BLOOD COLLECTION IN ANIMAL RESEARCH

T. OVERSIGHT PLAN FOR VOTEY SATELLITE FACILITY

U. BIOHAZARDOUS MATERIAL IN ANIMAL RESEARCH

V. STORAGE OF CONTROLLED DRUGS

W. AUTOCLAVE USE & STERILIZATION POLICY

X. FROG OOCYTE HARVEST POLICY

Y. TOE CLIPPING POLICY

Z. EMERGENCY EVACUATIONS DURING ANIMAL SURGERY POLICY

AA. PET POLICY

BB. RODENT CAGE DENSITY AND WEANING POLICY

CC. USE OF EXPIRED MEDICAL MATERIALS

 

VI. VETERINARY CARE (SEE UVM GUIDE – CONTACT OACM)

INCLUDES:

• PREVENTATIVE MEDICINE
• SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL OF DISEASE
• EMERGENCY CARE
• ANESTHESIA AND ANALGESIA
•SURGERY AND POSTOPERATIVE CARE
• EUTHANASIA

VII. ANIMAL HUSBANDRY (SEE UVM GUIDE – CONTACT OACM)

INCLUDES:

•ANIMAL PROCUREMENT
•FACILITIES
•HUSBANDRY

VIII. OCCUPATIONAL HEALTH AND SAFETY (SEE UVM GUIDE – CONTACT OACM)

IX. PERSONNEL QUALIFICATIONS AND TRAINING (SEE UVM GUIDE – CONTACT OACM)

Appendix 1    --   Information and Submission Guidelines

Appendix 2    --    IACUC Approved Policies and Guidelines