The
Institutional Animal Care and Use Committee
Serving The University of Vermont
12/17/07
|
MANUAL
FOR
VERTEBRATE
ANIMAL
RESEARCH
|
245 South Park,
Tel: (802) 656-5040 Fax: (802) 656-5041
RESEARCH MANUAL FOR VERTEBRATE ANIMAL RESEARCH:
[Click here for a printer friendly PDF version.]
The
The
Assuring laboratory animal welfare necessitates a partnership among the Institutional Official (IO), the IACUC, the University veterinarian and the investigators. Ultimately, accountability for assuring humane care and use of the animals resides with the institution, but this may only be achieved when all the constituents contribute to this shared goal. The following organizational chart clearly outlines the direct lines of responsibility and corresponding authority.

In order to accomplish the objectives inherent in these regulations and principles, there are primarily two 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 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.
3.
Charles River Labs is the contract manager for the
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 and Graduate Studies 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 Office of Animal Care Management (OACM)/Animal Resources 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 and Graduate Studies.
1. Review and report at least once every six months, on the evaluation of the research facility’s program for the humane care and use of animals.
2. Inspect, evaluate and report to the institutional official, at least once every six months, inspection findings of the animal facilities.
3. Review and investigate legitimate concerns involving the care and use of animals at the institution.
4. Make recommendations to the Institutional Official regarding any aspect of the research, animal program, facilities or personnel training.
5. Review and have authority to approve, require modifications in, withhold approval, or suspend animal research and teaching projects.
6. Notify investigators and the institution 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 at IV.C.4.
7. Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy at IV.C. 1-4. at least once every three years.
8. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.
Committee membership is comprised of members with varying professional and personal backgrounds and who have demonstrated a genuine interest in and commitment to the purpose of the Committee. Membership includes 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.
The
administrative office of the IACUC is located in 245 South Park,
Nancy Stalnaker
Program Director
Donna Silver
Assistant Program Director
Penni Cross
Research Review Administrator
Kim Wood
Research Review Assistant
All correspondence, including that directed to the Chair or other specific members of the Committee should be sent to the above address.
Committee Chairs:
Margaret Vizzard, Ph.D., Chair
William Falls, Ph.D. Associate Chair
University Vetrinarian:
Ruth Blauwiekel, DVM, Ph.D.
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/
The main OACM office is located in 116 Hills Building. Administrative personnel are as follows:
Dr. Ruth Blauwiekel, University Veterinarian 656-0459 drruth@uvm.edu
Kathryn Yager, MBA, Business Manager 656-2206
Project Manager, Charles River Laboratories, 656-1006 facmgr@med.uvm.edu
Appropriate level training must be complete for all key personnel prior to protocol or amendment approval release. The various training requirements are listed below
A formal program for training and education about the use of animals in research is established along the guidelines of the Guide, OLAW Assurance, USDA Regulations & the “Education and Training in the Care and Use of Laboratory Animals” National Research Council publication. General training is required for all persons working with animals prior to using animals.
A web-based program referred to as “General” training course for all individuals has been developed. The program includes a short on-line exam. Participation in the “General” training program is required and is documented.
Persons identified as requiring further training by the veterinarians are encouraged to enroll in a hands-on research rodent training session which is given by the veterinary technicians. This practicum focuses on restraint, biology of mice and rats, colony management, sample collection, injection techniques and other methods.
The general course discusses occupational health risks of dealing with animals. In addition, basic precautions to avoid exposure to animal pathogens and allergens are emphasized in the training session with the veterinarian. See Section 5.E. for additional information regarding the Occupational Health and Safety Program.
Didactic training is provided on a regular basis, covering topics such as record-keeping, anesthesia, surgical techniques, post-operative analgesia, and euthanasia.
Those involved with the use of hazardous agents/organisms are primarily trained for working with those agents/organisms in their research laboratories by the PI. The Office of Environmental Safety (OES) monitors the use of chemical and biohazardous agents and the Radiation Safety Office (RSO) monitors radiation exposure.
NOTE: All projects proposing to utilize recombinant DNA or
infectious agents require review and approval from the The Institutional
Biosafety Committee (IBC) prior to IACUC submission. The IBC is charged
with reviewing all research projects and activities involving recombinant DNA
(as outlined in the “Guidelines for Research Involving Recombinant DNA
Molecules”) to assure that specific practices for constructing and handling (i)
recombinant DNA molecules and (ii) organisms and viruses containing recombinant
DNA molecules are followed. The IBC is also charged with responsibility for
reviewing the use of infectious agents in research at UVM. A representative of
the Office of Environmental Safety serves on the IBC, as does the Director of
the Department of Risk Management, the University Veterinarian, the Radiation
Safety Director, and two faculty of the
The OES offers Chemical Safety Training which covers general laboratory safety and an overview of regulations, OSHA laboratory standards and the UVM Chemical Hygiene plan. Training may also be provided by the person’s laboratory supervisor, provided that training is adequately documented. Chemical labeling and storage requirements and a copy of the UVM Laboratory Safety Audit are available on the OES website http://esf.uvm.edu/
The RSO requires that a person complete Radiation Safety Training prior to using radioisotopes or radiography in the laboratory. A certification exam is required at the completion of the course. The Radiation Safety Handbook is available online.
All animal caretakers are instructed and trained by the ARC Facility Manager in the husbandry, sanitation procedures and precautions to be followed when working in any biohazard area. Each protocol utilizing hazardous agents requires an instruction sheet which is reviewed by the Facility Manager with the caretakers and is posted on the animal room door. The instructions on the sheet include animal and personnel safety.
Refer also to the “Biohazardous Materials” policy.
There is a web-based surgery training course that must be completed. After completing the web portion and submitting the test to ARC, the researcher wishing to perform surgery must meet with one of the veterinarians to review the protocol surgical procedures in detail.
Protocol procedures include drug usage, anesthesia procedures, pre-surgical care, surgical procedures, and post-surgical care. Discussions include proper animal preparation, preparation and use of instruments and other surgical materials. Also included are requirements for gowning and gloving, proper sterile technique when operating on animals, locations for performing the surgery, and tissue handling during surgery.
Anesthetic agents are discussed in the surgery web-based training (above). Anesthetic monitoring, recovery and record-keeping are discussed in the one-on-one surgical training given by the veterinarians. Personnel who do not have prior experience with rodent procedures are also encouraged to enroll in a biomethods training offered by the veterinary technicians, in which each participant anesthetizes their own animal using injectable agents.
Again, web-based training is required for personnel performing euthanasia, in addition to a meeting with one of the veterinarians. For protocols utilizing a conditional form of euthanasia, personnel must be observed by a member of the veterinary staff while performing the procedure to certify that the person is proficient in the technique.
Ongoing “hands-on” training for present and incoming research personnel is provided by the veterinary staff. Regularly scheduled small group sessions cover restraint, injection and sampling techniques, recognition of common health problems, aseptic technique, anesthesia and euthanasia. This training is provided to individuals on an as-needed basis following consultation with the University Veterinarian.
Workshops, guest speakers and/or consultation on various relevant topics such as research models and mouse colony management are provided to the research community.
Library support for searches for alternatives to animal use and/or procedures which cause more than momentary or slight pain and distress to animals is available through the University Library Services. The Office of Animal Care Management and the Research Protections Office have numerous reference materials available.
Information on the following topics is also available: Levels of discomfort/distress in animal experimentation; anesthetic and analgesic drug formulary for different species; AVMA Guidelines for Euthanasia.
Self-study materials on handling and basic manipulative procedures for commonly used laboratory animals are available.
Video tapes are available on ethics, animal uses, handling techniques, and surgery both in the library and the OACM office. The Northern Mountain Branch of AALAS meets three times a year and is open to all involved in the use of animals.
An
occupational health and safety program is a required part of the overall animal
care and use program. The focus is maintaining a safe and healthy
workplace. The Department of Risk Management has contracted with an
outside firm to provide occupational health monitoring for all UVM personnel
who work with animals. This firm, Concentra, Inc., is located at
All personnel working with animals are requested to complete a baseline risk assessment form prior to working with animals. The form is available on OACM's web page. As the assessments are received at Concentra, each person’s responses are evaluated by an occupational health physician. Those persons who are designated to be at risk for work-related disease will be contacted by Concentra to make an appointment for a physical examination by Concentra. Physicals typically include but are not limited to a medical history, physical exam, hearing and eye exams, CBC and chemistries, urinalysis, and vaccinations. The program will cover the cost of the initial and annual occupational health screening; UVM does not reimburse for ongoing care or prescriptions that may arise from Concentra’s patient referrals for a particular condition. This expense is the responsibility of the employee/student and/or his/her health insurer.
Concentra will notify the RPO when an individual has been cleared to work with animals. Failure to complete and submit the required form or failure to followup with Concentra as necessary may result in denial of access to the animal facility and/or protocol approvals may be held.
Subsequent health reviews are required annually utilizing an annual update form which is available on OACM's web page. If, however, you have health concerns prior to any review you should contact Concentra immediately.
Exceptions:
Undergraduate students whose exposure is limited to one hour per week per
semester, research involving aquatic animals, or personnel who work only with
animal products are not required to enroll in the program. Undergraduate
students are made aware of the program and are provided with information about
risks. Students in need of attention should contact the
Any other exceptions to required program enrollment are considered on a case-by-case basis by the UVM veterinarian.
Department of Animal Science students, with assistance from faculty advisors, develop individualized programs that lead to rewarding careers in a wide variety of occupations. These programs apply to farm, laboratory, zoo, and companion animals; their interaction with human society; and the contribution of animal products, such as milk and meat, to the world food supply. For these classes a web-based training has been developed which can be found at http://asci.uvm.edu/animal_testing/index.html.
This training is appropriate for the required classes. If the role of the student, however, involves responsibilities not typically required of the class, such as husbandry or procedures with the animals, the student would be required to take additional training as appropriate. The University Vetrinarian should be contacted by the instructors for guidance.
Fellows, residents, post-doctoral fellows, post-doctoral associates, post-doctoral trainees, and students (graduate or undergraduate) cannot conduct vertebrate animal research without having a faculty sponsor/instructor who is responsible for overseeing the research activities.
The faculty sponsor is responsible for:
a) reviewing the materials for submission to the IACUC for accuracy and completeness;
b) assisting and supporting the student in his/her interaction with the IACUC and for overseeing the resolution of any issues arising during the review process; and
c) oversight of the student's research to ensure that the protocol is followed as approved.
Students who are principal investigators have responsibilities as listed in Investigator Responsibilities.
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 veterinarian about the project prior to submitting the project to the Committee. 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. For pain levels see policy “Determination of Levels of Pain & Distress.”
NOTE: Any projects proposing to utilize recombinant DNA or
infectious agents, requires review and approval from the The Institutional
Biosafety Committee (IBC) prior to IACUC submission. The IBC is charged
with reviewing all research projects and activities involving recombinant DNA
(as outlined in the “Guidelines for Research Involving Recombinant DNA
Molecules”) to assure that specific practices for constructing and handling (i)
recombinant DNA molecules and (ii) organisms and viruses containing recombinant
DNA molecules are followed. The IBC is also charged with responsibility for
reviewing the use of infectious agents in research at UVM. A representative of
the Office of Environmental Safety serves on the IBC, as does the Director of
the Department of Risk Management, the University Veterinarian, the Radiation
Safety Director, and two faculty of the
Any project with USDA pain level D or above requires a “full” review. Two Committee member(s) are assigned to review the complete protocol or amendment. The primary reviewer is always a scientific representative of the Committee and is responsible for presenting a summary of the protocol at a fully convened 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. All Committee members are provided the protocol or amendment materials and have access to all other documentation related to the study.
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.
Any project with USDA pain level C or below may qualify for a “designated” review. One Committee member is assigned to review the complete protocol or amendment. This review occurs outside a convened meeting. The reviewer’s comments and the protocol are then forwarded to the remainder of the Committee for their further review. Any member may request that the project be brought forward to the full committee for review. If no additional comments are received and there is no request for a full committee review, either a letter requesting clarifications and/or stipulations is sent to the investigator or a final Verification of Approval is sent.
The chair alone (or his/her designee from the Committee) reviews and approves protocols or amendments falling into this category. This category includes some 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.
What is "Just-In-Time" Review?
Many sponsors require protocol approval before accepting new grant applications or within a specified period of time after grant submission. Some sponsors, however, will now accept new grant proposals with the understanding that the researcher will proceed with the protocol review process upon receiving notification of a score in the fundable range. This is called the "Just-In-Time" review process. Many sponsors, (e.g., NIH, NSF, AHA, et al) will accept Just-In-Time review. You should check with the Pre-Award Services Office in Sponsored Programs to determine your funding agency's IACUC approval requirements.
Process for "Just-In-Time" Review
If your sponsor accepts Just-In-Time protocol review, as soon as you are notified that your proposal received a score in the fundable range, you should begin preparation of your IACUC submission IMMEDIATELY! You should check the IACUC submission deadlines in order to get your protocol submitted for the next available IACUC meeting, as special requests for insertion onto an agenda after the scheduled deadline may not be possible.
The submission of your IACUC approval may delay the award of your proposal but should not affect whether you actually receive an award, just when you receive the award.
This would include resubmissions of unfunded projects, the submission of the same project to another funding agency, or an application for fellowships, salary support or career development award to work on an already funded project.
The Committee treats identical protocols as new applications, however, full committee review may not be required if the project is the same as a previously approved project. See submission guidelines for further information on submission requirements in these cases.
NOTE: Please notify the Committee office in a timely fashion if grants have not been funded to allow the IACUC to close the file.
Animal product is defined as material obtained from a USDA slaughterhouse, animal byproducts, or shared animal products from other investigators. These projects do not involve live animals and thus do not require IACUC review. For additional information see the Animal Tissue policy.
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. Protocols are placed on the agenda as they come in.
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.
Step 1: Submission of the Protocol. The process for reviewing and approving proposals 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 Act. A consultation with the University Veterinarian is required for all proposals involving the use of animals prior to the protocol's submission to the Committee.
Step 2: Initial Review. Following the receipt of a Protocol by the Research Review Administrator, the type of review a proposal will receive is based on the expected level of animal discomfort and types of procedures. 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 and reviews the Reports of Designated Reviews and Reports of Executive Reviews. Possible outcomes of the Committee's review include unqualified approval, approval pending stipulations, clarification(s), and/or modification(s), table (deferral), or disapproval.
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 stipulations, 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.
Step 5: Documentation. The PI should be able to provide a copy of all versions of approved protocols, IACUC amendments and any documents submitted to the IACUC (perhaps in a Research Regulatory Binder) as evidence of IACUC submissions and approval record.
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 accordance with USDA Regulations/PHS Policy.
Pain/Distress – All activity must avoid or minimize discomfort, distress, and/or pain. If pain and/or distress is caused, appropriate sedation, analgesia or anesthesia will be used. The attending veterinarian must be involved in planning. The use of paralytic agents is prohibited without concurrent anesthesia and appropriate monitoring. 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 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 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. An animal may not be used for several major operative procedures from which it will recover, without meeting specified conditions.
Euthanasia--The euthanasia method must be consistent with the recommendations of the current AVMA Panel on Euthanasia (2000 edition or later).
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
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.
Animal welfare regulations require a continuing review at least annually and PHS policy requires that a protocol undergo complete IACUC review at least once every three years.
It is the policy of the IACUC to review vertebrate animal research appropriate to the degree of pain involved, but not less than once per year.
The purpose of continuing review is to monitor:
1) the status of the protocol
2) verify that completed activities were conducted in accordance with the approved protocols, and;
3) solicit information about activities projected for the coming year;
4) changes in key personnel and whether mandatory training is complete;
The Committee will forward a Continuing Review Summary form to the PI approximately two months before the approval is due to expire. Reminders will be sent at one month and two weeks prior to expiration.
Expired Approvals: Extensions beyond the expiration date cannot be granted. If the expiration date has passed, or is in jeopardy of passing, the Committee must be notified as soon as possible.
a. If the Committee does not provide continued approval of the research by the specified expiration date, research activities are suspended pending continued approval of the research by the Committee.
b. Researchers found to be conducting research activities without a current IACUC approval are in non-compliance with the regulations.
As part of the continuing review process, the Committee may require that the research be restricted, modified, reviewed more frequently or terminated/suspended. Alternatively, special precautions or Committee-imposed restrictions, or shortened review periods, may be modified if current data support such actions.
The most visible element of the continuing review process approval is the Verification of Approval (VOA) form. This form indicates an expiration date which can only be extended through the Continuing Review process.
Once approved, the Committee will return a signed Verification of Approval form to the PI via interoffice mail and provide a copy of the approved protocol to the Office of Animal Care and Use Management. A copy of the VOA should be kept by the PI as documentation of continuing review completion.
8.B.1.a. In accordance with the Animal Welfare Act, (9 CFR Ch.1), Part 2 – Subpart C), 2.32. Training and instruction of personnel include methods whereby deficiences in animal care and treatment are reported, including deficiences in animal care and treatment reported by any employee of the facility. No faculty employee, Committee members, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations or standards under the Act.
8.B.1.b. Local Policy: CRL-UVM SOP #1.1.3 Reporting Animal Welfare Concerns
All procedures performed at the CRL facilities and contract staffing services locations must comply with all applicable regulations governing the care and use of animals. Non-compliance will result in corrective action for the person(s) involved. Any concern regarding animal welfare will be taken seriously and investigated. Corrective action, if indicated will be taken and the individual(s) expressing the concern will be informed.
Any time there are concerns about animal welfare or non-compliance, those concerns should be communicated to OACM and IACUC. Non-compliant incidents of a serious nature (those which harm animals or threaten their health) should be reported immediately.
We recommend contacting the University veterinari