University of Vermont

Institutional Animal Care and Use Committee - IACUC

THE UNIVERSITY OF VERMONT

 



MANUAL

 

FOR

 

VERTEBRATE

 

ANIMAL

 

RESEARCH

10/24/12

Research Protections Office

213 Waterman Building, 85 South Prospect Street

Burlington, VT 05405

Tel: (802) 656-5040

 



 

RESEARCH MANUAL FOR VERTEBRATE ANIMAL RESEARCH

 

[Click here for a printer friendly PDF version.]

 

1. COMMITTEE’S MISSION.. 4

2. COMMITTEE’S RESPONSIBILITIES/AUTHORITY/COMPOSITION.. 5

2.A.   Responsibilities and Authority.. 5

2.B.   Composition.. 5

3. CONTACTS. 6

4. OFFICE OF ANIMAL CARE MANAGEMENT (OACM) 6

5. TRAINING REQUIREMENTS AND OCCUPATIONAL HEALTH.. 7

5.A.  General Training.. 7

5.B.  Specific Training.. 7

5.B.1.a.  Working With Hazardous Agents in Animals. 7

5.B.1.b.  Personnel Performing Surgery. 8

5.B.1.c.  Personnel Performing Anesthesia. 8

5.B.1.d.  Personnel Carrying Out Euthanasia Procedures. 8

5.C.  Continuing Training.. 8

5.D.  Other Resources. 8

5.E.  Occupational Health and Safety Program (revised 05/01/11) 9

5.F.  Animal Science Student Training.. 10

6. FELLOWS, RESIDENTS, POST-DOCTORAL FELLOWS, ASSOCIATES, TRAINEES, AND STUDENTS CONDUCTING VERTEBRATE ANIMAL RESEARCH.. 10

7.  COMMITTEE REVIEW AND SUBMISSION PROCESS. 10

7.A.  Types of Review... 10

7.A.1.  Full Committee Review.. 11

7.A.2.  Designated Review.. 11

7.A.3.  Administrative Review.. 11

7.A.4.  Projects in which Animal Use is Limited to Animal Products. 11

7.B.  Criteria for Review... 11

7.C.  Initial New Protocol Review and Submission Process. 12

7.C.1.  Initial New Protocol Review.. 12

7.C.2.  Initial New Protocol Submission. 13

7.C.3.  Review of Grants. 13

7.D.  Continuing Review... 15

7.D.1.  Requirements. 15

7.D.2.  When to and How to Report on Continuing Protocols. 15

7.D.3.  Documentation. 16

7.E.  Request for Modification/Amendment to Previously Approved Protocol.. 16

7.E.1. Requirements. 16

7.E.2. When to Request 17

7.E.3. How to Request an Amendment to Approved Protocol and Review Process. 17

7.E.4. Documentation. 17

7.F.  Notice of Termination.. 17

8. PRINCIPAL INVESTIGATOR RESPONSIBILITIES. 18

8.A.  Expectations of a Principal Investigator.. 18

8.B.  Requirements of the Principal Investigator.. 18

8.B.1.  Ensure Proper Training of the Research Team.. 19

8.B.2.  Ensure Protocol Adherence. 19

8.B.3.  Provide Reports on the Progress of the Study. 19

8.B.4.  Coverage for PI 20

8.C.  Guidance for the Investigator.. 20

8.C.1.  Communication with the IACUC.. 20

8.C.2.  Written Communication of IACUC Decisions. 21

8.C.3.  Accessibility of Records. 21

9.  Animal Welfare Incident Reporting.. 21

9.A.  Policies. 22

9.B.  Determining When and How to Report Incidents. 22

10. OVERSIGHT AND MONITORING.. 22

10.A.  Internal.. 22

10.B.  External.. 23

 

 

Attachments

 

A: Committee Policies, Procedures and Guidance Documents. 24

B: Committee Forms. 25

 


1. COMMITTEE’S MISSION

 

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 the animal care principles in accordance with the Guide for the Care and Use of Laboratory Animals (“the Guide”), and in compliance with applicable federal, state, and local laws and regulations, such as the federal Animal Welfare Act, and Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS).  

 

The University of Vermont Institutional Animal Care and Use Committee (IACUC) has an Assurance on file with the Office of Laboratory Animal Welfare in accordance with the PHS Policy. The Committee is regulated by the USDA under the Animal Welfare Act as documented in the Code of Federal Regulation Title 9, Subchapter A Parts 1, 2 and 3.   The University’s Animal Care and Use Program is fully accredited by AAALAC International.

 

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.

Organizational ChartIn 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.  Priority One Services, Inc. is the contract manager for the Animal Resources Center.

 

 

2. COMMITTEE’S RESPONSIBILITIES/AUTHORITY/COMPOSITION

 

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 Dean of the Graduate College 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/Priority One Services, Inc. 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 Dean of the Graduate College.

 

2.A.   Responsibilities and Authority 

 

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. 

 

2.B.   Composition

 

          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.  

 

3. CONTACTS

 

The administrative office of the IACUC is located in 245 South Park, Suite 900, 656-5040. 

 

Nancy Stalnaker

Director, Research Protections Office

Nancy.Stalnaker@uvm.edu

 

Donna Silver

Assistant Director, Research Protections Office

Donna.Silver@uvm.edu

 

Penni Cross

Research Review Administrator

Penni.Cross@uvm.edu

 

Kim Rayl

Research Review Assistant

Kim.Rayl@uvm.edu

 

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

 

Committee Chairs:

 

William Falls, Ph.D. Chair

William.Falls@uvm.edu

 

Margaret Vizzard, Ph.D., Associate Chair

Margaret.Vizzard@uvm.edu

 

 

University Veterinarian:

 

Ruth Blauwiekel, DVM, Ph.D.

DrRuth@uvm.edu

 

4. OFFICE OF ANIMAL CARE MANAGEMENT (OACM)

 

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

 

Suzanne Snyder, Business Manager 656-2206

 

Project Manager, Priority One Services, Inc., 656-1006 facmgr@med.uvm.edu

 

 

5. TRAINING REQUIREMENTS AND OCCUPATIONAL HEALTH

 

Appropriate level training must be complete for all key personnel prior to protocol or amendment approval release.  The various training requirements are listed below

 

5.A.  General Training

 

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.

 

5.B.  Specific Training

            5.B.1.a.  Working With Hazardous Agents in Animals

 

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 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 faculty of the College of Medicine with particular expertise in infectious agents.   For more information go to http://www.uvm.edu/ibc/ and http://www.uvm.edu/~radsafe/.

 

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.

 

            5.B.1.b.  Personnel Performing Surgery

 

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.

 

            5.B.1.c.  Personnel Performing Anesthesia

 

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.

 

            5.B.1.d.  Personnel Carrying Out Euthanasia Procedures

 

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.

 

5.C.  Continuing Training

 

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.

 

5.D.  Other Resources

 

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.

 

5.E.  Occupational Health and Safety Program (revised 05/01/11)

 

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 7 Fayette Road, South Burlington, VT 05403, phone, 658-5756. 

       

All personnel working with animals are required 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.

 

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.

 

Persons working with animals and their respective protocol PIs will be notified well in advance of expiration of their current clearance to work with animals.  Failure to complete and submit the required annual form will result in protocol suspension. 

 

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 Student Health Center. 

 

Any other exceptions to required program enrollment are considered on a case-by-case basis by the UVM veterinarian.

 

5.F.  Animal Science Student Training

 

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 Veterinarian should be contacted by the instructors for guidance.

 

           

6. FELLOWS, RESIDENTS, POST-DOCTORAL FELLOWS, ASSOCIATES, TRAINEES, AND STUDENTS CONDUCTING VERTEBRATE ANIMAL RESEARCH

 

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.

 

7.  COMMITTEE REVIEW AND SUBMISSION PROCESS

 

7.A.  Types of Review

 

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 and obtain her signature on the final protocol form prior to submitting the protocol form to the Committee.  There are three types of Committee review: full, designated or administrative 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 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 faculty in the College of Medicine with particular expertise in infectious agents.   For more information go to http://www.uvm.edu/ibc/ and http://www.uvm.edu/~radsafe/.

 

 

7.A.1.  Full Committee Review

 

  A full committee review is required for all protocols with pain levels of D or higher.  The IACUC uses a primary/secondary reviewer method for full Committee reviews.   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. A secondary reviewer is usually assigned by the IACUC Chair.  The secondary reviewer adds any additional concerns. The University Veterinarian then outlines any additional issues and then the review is opened for discussion by the Committee.  All Committee members are provided relevant materials and have access to all other documentation related to the study.

 

7.A.2.  Designated Review

 

Protocols that meet the criteria for designated review are posted to allow all IACUC members an opportunity to review.  If no member calls for a Full Committee review, the IACUC Chair will assign one Committee member and the University Veterinarian to complete the review.  The reviewers’ comments and clarifications and/or stipulations are resolved with the investigator.  The Designated IACUC reviewer or the IACUC Chair may at any point call for a Full Committee Review. 

 

7.A.3.  Administrative Review

                                                

The chair alone (or his/her designee from the Committee) reviews and approves actions in this category. This category captures review of actions that do not require an actual Committee review, e.g., minor amendments, some continuing reviews, previously approved protocols that have been resubmitted or identical protocols submitted to different funding agencies, protocols with no direct animal use, or when funds will be used for salary support only  on a previously approved protocol.

 

7.A.4.  Projects in which Animal Use is Limited to Animal Products

 

Animal products is defined as material obtained from a USDA slaughterhouse, animal byproducts, or shared animal products from other investigators.  These projects do not require IACUC review.  For additional information see the Animal Tissue policy.

 

7.B.  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 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 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.

 

7.C.  Initial New Protocol Review and Submission Process

 

7.C.1.  Initial New Protocol Review

 

                      Any project with USDA pain level D or above requires a “full committee” review.  (see 7.A.1. above). 

 

                      Any project with USDA pain level C or below may qualify for a “designated” review. (see 7.A.2. above) 

 

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 the research project has scientific merit.

 

7.C.2.  Initial New Protocol Submission

 

Meetings are routinely held on the fourth Monday of each month. The deadlines for submission of materials for full committee review are: the first Monday of the month to the Veterinarian and the second Monday of the month to the IACUC office. 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.

 

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. Possible outcomes of the Committee's review include unqualified approval, approval pending stipulations, clarification(s), and/or modification(s), table, 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 in writing 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, corresponding grant applications (where applicable), IACUC amendments and any documents submitted to the IACUC (perhaps in a Research Regulatory Binder) as evidence of IACUC submissions and approval record. 

 

 

7.C.3.  Review of Grants

 

The IACUC is required to ensure that all research described in a grant application or proposal is entirely consistent with any corresponding protocol(s) reviewed and approved by the IACUC.  Any discrepancies must be resolved prior to the start of the project.  The IACUC works with Pre-Award Services to establish that an appropriate connection is made between the application and the protocol being reviewed.

7.C.3.i.  New Competing or Competing Renewal Grant Applications

 

To meet the requirement listed above, any time you will be submitting a new competing grant or a competing renewal application, a new protocol must be submitted to the IACUC for review and approval.  Pre-Award Services will not clear funds for release until there is an approved protocol.  Continued approvals will be checked on an annual basis for the life of the grant.  

 

Note:  It is very important that the proposal and protocol be matched correctly for the reason mentioned above. 

 

7.C.3.ii.   When the Project is a New Competing or a Competing Renewal Application and the New Protocol is Identical or Substantially Similar to an Approved Protocol

 

Obtaining grant funding is extremely competitive.  The same grant proposal may be submitted to multiple funding agencies at once or the same agency at different time points.  If you obtain new funding, it is your responsibility to submit the corresponding grant and protocol for IACUC review and approval. 

 

The IACUC treats identical protocols as new applications, however, a new committee review may not be required if the project is the same or substantially similar to the previously approved protocol.

 

If this is the case, you must submit the following:

 

1.  One copy of your new grant application and the corresponding protocol.

2.  A letter to the committee chair explaining that you are submitting a similar grant application to a different funding agency.  State that this new protocol application is identical to the old one (provide IACUC file #) with regard to hypotheses, specific aims, and vertebrate animal involvement (or describe minor differences).

 

If this application is essentially the same as the previously approved application with only minor differences clearly described in a letter, the protocol will receive administrative review.  If substantial changes are proposed, then a new committee review may be required.

7.C.3.iii.  Competing Resubmissions or Supplements

 

Grant resubmissions require an amendment to a previously approved protocol if it is identical or substantially similar to that protocol and grant.  The amendment form and a copy of the resubmitted grant application are to be submitted for review and approval.   Administrative and competitive supplements also require an amendment to a previously approved protocol.  The amendment form and a copy of the supplement are to be submitted for review and approval.

7.C.3.iv.  Just-in-Time Provision for IACUC Submissions

What is “Just-in-Time” Review

The NIH just-in-time policy allows grant applications to be submitted to NIH for peer review without prior IACUC approval.  This policy has been extended by the University to all UVM grant proposals where the granting agency does not require IACUC approval at the time the proposal is submitted.  Researchers should check with the Pre-Award Services Office to determine the funding agency’s IACUC approval requirements.

 

Process for “Just-in-Time” Review

If the sponsor accepts just-in-time vertebrate animal review, as soon as the researcher is notified that the proposal received a favorable priority ranking from the granting agency, the protocol should be submitted to the IACUC for review.   If the project is a new or competing renewal and is identical or substantially similar to a previously approved protocol, see section 7.C.3.ii., above, for further guidance.  If the project is not identical or substantially similar, researchers should check the IACUC submission deadlines for the next available IACUC meeting as special requests for insertion onto an agenda after the scheduled deadline may not be possible.  NOTE:  It is not necessary for the researcher to submit a protocol if the priority ranking is unfavorable. 

 

If the just-in-time request is for a resubmission, see section 7.C.3.iii. for submission guidance.

 

The delay in submission of a protocol for IACUC review approval may delay an award but should not affect the receipt of an award.

 

7.D.  Continuing Review

 

7.D.1.  Requirements

 

There are requirements for continuing review in both the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and the United States Department of Agriculture (USDA) Regulations on Animal WelfareAnimal welfare regulations require a continuing review at least annually for USDA-covered species and according to PHS Policy Section IV.C.5, “The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. at least once every three years.” The IACUC developed the following processes to meet the requirements of both of the above.  It is the policy of the IACUC to review all vertebrate animal research appropriate to the degree of pain involved, but not less than once per year.  Each protocol continuing beyond every three-year point will receive complete de novo review (triennially).

 

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;

 

 

7.D.2.  When to and How to Report on Continuing Protocols

 

For the first and second year of the protocol, the Investigator will be forwarded a notice and continuing review form for completion and submission.  The Investigator will complete only the relevant sections and submit the form for review and continued approval. 

 

Prior to the end of the third year (and every three years thereafter - triennially), the Investigator will be forwarded the same continuing review form indicating that it is a triennial review and that all sections need to be completed.  The additional triennial section of the form allows the Committee to do a “complete review” as required by PHS Policy.   The Investigator will also be provided a copy of his/her currently approved protocol.  They will be required to confirm in the continuing review form that that is the protocol they are using.  This will verify that the Committee and the Investigator’s records are in agreement.

 

Continuing reviews that are not on a triennial year will be reviewed administratively either by the IACUC Chair (non-USDA regulated species only) or through the Designated Review Process. 

 

Continuing reviews that are on a triennial year will be reviewed by the designated review process to conduct a “complete review.”

 

No new changes to the protocol are to be requested by the Investigator at the time of continuing review.  Often, as part of the completion of the continuing review forms, it becomes apparent that a change in animal numbers will need to be made.  If Investigators need to make a change in the currently approved protocol, they must submit a separate protocol amendment request for review.  The same reviewer will be assigned the Continuing Review and any associated amendments whenever possible.

 

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.

 

In addition, the IACUC may also require an Investigator to complete a new Animal Use Protocol form when protocols continue for extended periods of time or if the version of the form template has changed significantly (e.g., substantive changes to the questions or complete reorganization of information). 

 

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.

 

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 noncompliance with the regulations.

 

7.D.3.  Documentation 

 

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.

 

 

7.E.  Request for Modification/Amendment to Previously Approved Protocol

 

7.E.1. Requirements 

 

Review of any changes to previously approved research is required by regulation and is an essential element of the ongoing review of research involving vertebrate animals. 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 Veterinarian, as necessary.

 

7.E.2. 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 a new use of hazardous materials or radiation, additional review by other committees is required prior to implementation.

 

7.E.3. How to Request an Amendment to Approved Protocol and Review Process

 

The Animal Use Protocol Amendment form is intended to capture all of the required elements for a significant review of proposed amendments. Complete the form and attach a revised version of the protocol.   

 

Minor amendments will usually be reviewed administratively by the IACUC Chair and Significant Amendments will be reviewed through the Designated Review Process in accordance with the algorithm noted above.

 

Note: The Animal Use Protocol Amendment form is located in the forms section of the IACUC website and should be downloaded each time it is needed as forms are frequently updated.

 

Changes to protocol personnel require an amendment to the protocol.  The Committee has a specific form, Request for Change in Personnel, to make these changes.  Submit this completed form and your amended protocol.  Note:  Make sure any new personnel have completed the required training.

 

7.E.4. Documentation 

 

Once approved, the IACUC will return a signed Animal Use Protocol Amendment form. Proof of the amendment 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.

           

7.F.  Notice of Termination

 

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 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.

 

 

8. PRINCIPAL INVESTIGATOR RESPONSIBILITIES

 

8.A.  Expectations of a Principal Investigator

 

There are certain expectations of a principal investigator (PI).  When the principal investigator submits a research protocol to the IACUC, by signing the Protocol Form you agree to the expectations listed below:   

 

I have provided an accurate description of the proposed animal care and use protocol and agree to the following conditions:

 

All experiments involving live animals will be performed under my supervision or that of other qualified individuals as indicated in the attached forms.  The personnel involved have been or will be trained prior to any animal work in proper procedures of animal handling, administration of anesthetics and analgesics, and AVMA recommended methods of euthanasia to be used in this project. This includes: 1) each person working with animals in this protocol will take the UVM General Training course prior to working with animals; 2) each person working with animals in this protocol will be briefed by the PI on the hazards associated with the project prior to working with animals; 3) each person who will perform surgery in this protocol will take the required UVM Surgical Training Course prior to surgery: each person who will perform anesthesia will meet with the University Veterinarians, each person who will work with Agricultural Animals will receive Agricultural Training by the University Veterinarians

 

All research personnel who have substantial direct contact with animals over 8 hours/week will be referred to Office of Animal Care Management by me regarding the necessity for having an Occupational Health Physical.

 

All personnel will be informed of the requirement to report all animal bites and animal related accidents to Risk Management.

 

 All personnel will be informed that any concerns for inhumane care and treatment of animals or unlawful acts involving animals should be reported to the Office of Animal Care Management or, alternately, to the Office of Sponsored Programs and that anyone reporting such concerns cannot be discriminated against or be subject to any reprisal for reporting their concerns.

 

I agree to abide by governmental regulations and University policies concerning the use of animals.

 

I will ensure that veterinary care is provided to animals showing evidence of pain or illness.

 

I agree to give consideration to tissue sharing and will do so whenever possible.

 

I certify that any animal use proposed in a grant or contract proposal to support this research corresponds to the information provided herein.

 

If the procedures concerning animal use in this research activity are to be revised or changed, I will so notify the IACUC of these changes before the change is implemented.  I understand that failure to request an amendment for changes in animal use may place the University and myself in violation of Federal regulations and the Animal Welfare Act.

 

As required by Federal regulations, I assure that the activities described do not unnecessarily duplicate previous experiments and I assure the animal models proposed are the most appropriate for achieving the objectives of this project and have provided justification for each model used in the protocol (Animal Research Plan, (1) Rationale).

 

Other research personnel (technicians, graduate students and post-doctoral associates)  have an equally important role in that they often conduct the day-to-day activities of the study. 

 

8.B.  Requirements of the Principal Investigator

 

            As the principal investigator you must:

 

Ensure proper training and occupational health of the research team;

Ensure protocol adherence, and;

Provide reports on the progress of the study.

 

8.B.1.  Ensure Proper Training of the Research Team

 

The principal investigator is responsible for ensuring that the research team has appropriate training prior to and during the conduct of the study as listed in Section 5

 

8.B.2.  Ensure Protocol Adherence

 

It is the principal investigator’s responsibility to ensure that the IACUC-approved protocol is being followed at all times by the research team.  This includes making sure that amendments are submitted for IACUC review in a timely fashion and then once approved implemented by the research team.

 

8.B.3.  Provide Reports on the Progress of the Study 

 

During the course of a research study, new information might become available.   As new information becomes available, the principal investigator is obligated to report to the IACUC.  Common items that need to be reported in a timely fashion to the IACUC are described in detail below.

a. Continuing review of approved studies

It is the responsibility of the principal investigator to submit the current status of active protocols at least annually.  Some protocols require more frequent review based on pain level/risk.  The IACUC makes this determination and notifies the principal investigator.  Please refer to Section 7.D. for additional information on submission of continuing reviews.

 

Note:  As part of the progress report, investigators are requested to breakdown how the animals have been used by pain level.  Therefore accurate records of ongoing animal use must be kept. 

b.  Reporting incidents and animal deaths

Principal investigators and/or research staff are responsible for reporting animal welfare incidents to OACM and IACUC.  Please refer to Section 9 and the Reporting Animal Death Policy for additional information.

c.  Amendments to a previously approved protocol

Requests for changes (amendments) to approved studies may be submitted at any time but before the change is implemented, it must receive IACUC approval.  Refer to Section 7.E. for further instructions on how to submit an amendment.

e.  Change in personnel

It is required that the investigator notifies the IACUC office when there are any additions or deletions to research staff participating in a protocol.  Refer to Section 7.E.3. for further instructions on how to submit this type of amendment. 

 

Amendments to add personnel will not be approved until the new personnel have completed the required training.  Refer to Section 5 to learn more about required training. 

f.  Premature termination/suspension

The IACUC should be notified when a protocol has been terminated or suspended prematurely and the reasons for the premature termination or suspension.   To notify the IACUC, submit a memo or email.

g.  Study closures

Notify the IACUC when a protocol has been closed permanently.    

 

8.B.4.  Coverage for PI

 

In order to fulfill these PI responsibilities, the IACUC must be notified when a sabbatical or extended leave of absence of more than four weeks will be taken. IACUC notification needs to include a designated investigator who will comply with the requirements noted above.  This does not apply when the investigator does not have active protocols.

 

8.C.  Guidance for the Investigator

 

8.C.1.  Communication with the IACUC

 

Beginning 10/01/09 the IACUC will require investigators to submit all protocols and protocol-related submissions (e.g. amendments, key personnel changes) in portable document format (PDF).   Investigators in turn can expect to receive their IACUC correspondence via email.  This change is a giant step forward and should result in less paperwork for the investigators and the IACUC staff. 

 

We continue to require protocol submissions to be signed by the vet, the PI and others (e.g. departmental reviews) as necessary.  This will require that investigators scan final submission documents into a PDF document and then forward them to our office.   We have identified a potential pitfall with this new process to be confusion with document versions.  We must all be vigilant about making sure we are always working with the currently approved version of the protocol and protocol roster.  Please update your documents every time they are submitted by completing the footer with the date of the submission as shown below.

Picture of Form

This date footer is not automatic, therefore you must change it each time you revise your protocol.  You should not use the automatic date feature as this will add further confusion by changing your date every time you happen to open the document.  Failure to update this protocol version date may delay review of the submission.

 

All submissions need to be sent to the IACUC@uvm.edu email box where new submissions will be monitored and processed in the order they are received.

 

When you are in communication with the office, whether in writing, by telephone, fax or e-mail, you should have the following information available.

 

- IACUC number, if assigned at the time of contact

- Principal investigator’s name

- Protocol title

- Date and type of submission (if applicable)

 

We can more readily assist you with this information.

 

 

8.C.2.  Written Communication of IACUC Decisions

 

Decisions made by the IACUC will be communicated to the principal investigator (or designee if provided) through a memorandum outlining the approval status and/or concerns, questions and/or comments of the IACUC.  This correspondence will be forwarded via email to the principal investigator.

 

The IACUC Chair will convey one of the following four decisions in writing to the investigator promptly after the meeting:

Approval 

The principal investigator may begin the research study upon receipt of the Verification of Approval form. 

Approval Withheld Pending Stipulations/Clarifications

This decision is determined when the protocol is recommended for approval by the IACUC pending the investigator’s response to IACUC-directed stipulations/questions and/or revisions.  The principal investigator must provide, via email, a memorandum responding to the IACUC’s recommendations. We ask that you indicate the IACUC number on this correspondence.  If a revision to the protocol is necessary, attach a full revised protocol with changes indicated. Remember to update the protocol version date in the footer of the protocol.

Tabled

More substantive issues regarding the protocol must be addressed.  Clarifications or requested revisions may have a significant impact on the involved animals.  A memorandum is sent to the investigator requesting that these issues be addressed.  Full committee review of the investigator’s response is required prior to approval.

Disapproved

Questions regarding the scientific merit and use of animals are of such significance that the committee finds approval of the study to be unwarranted. The authority of the IACUC to disapprove a study may not be overridden.

 

NOTE:  The IACUC has a 30, 60, 90 day reminder system for all pending protocol items.  The investigator is reminded that the IACUC has requested something from them in regards to a protocol and is awaiting his/her response.  At the 120 day mark the protocol is withdrawn from the Committee’s consideration.  This helps to ensure that changes to protocols are handled in a timely fashion.

 

8.C.3.  Accessibility of Records

The investigator must make available all research records for direct access by the IACUC staff.   A copy of completed medical records for animals of USDA-covered species must be sent to OACM in a timely manner.  Depending upon the protocol sponsorship there may be others with access needs such as the FDA or other regulatory authorities. 

 

9.  Animal Welfare Incident Reporting

 

9.A.  Policies

 

9.A.1. 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 deficiencies in animal care and treatment are reported, including deficiencies 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.

 

9.A.2.  Local Policy:  Priority One-UVM SOP #1.1.3 Reporting Animal Welfare Concerns

 

All procedures performed at the Priority One Services, Inc. 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.

 

9.B.  Determining When and How to Report Incidents 

 

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 veterinarian first at tel: (802)656-0459 fax: (802)656-8315 or via email to DrRuth@uvm.edu.   An alternative would be to contact the IACUC office 656-5040 or penni.cross@uvm.edu.  A third alternative would be to complete the Animal Welfare Form for submission to the veterinarian.  This form is located on OACM’s website and hard copies are available in various places within the animal facilities.

 

You may provide the information anonymously and, to the extent possible, the university will preserve your anonymity.

       

10. OVERSIGHT AND MONITORING

 

10.A.  Internal

 

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 NRC Guide for the Care and Use of Laboratory Animals and Animal Welfare Act 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.  All survival and non-survival surgical sites are also visited.  Researchers can expect a notice of inspection 1 month in advance. 

 

Written reports of the program evaluation and inspection are prepared according to PHS policy criteria and are submitted to the full committee for discussion and modification, if necessary, prior to taking action.  Final reports are then forwarded to the institutional official.

 

In addition to looking at the research facilities during the semiannual inspection, IACUC members will conduct protocol monitoring visits.  For further information, see Monitoring Process/Protocol Followup policy. 

 

10.B.  External

 

Annually an Animal Welfare Officer from the USDA will inspect the animal facilities and may inspect individual labs.  The inspector will meet with the University Veterinarian or a designee who will escort the Animal Welfare Officer through the facilities. 

 


Attachment A:

E: Committee Policies

 

These are direct links to the individual policies that have been approved by the IACUC.  Updated 2/26/13

 

#

Policy

Date

Reviewed

Date Originally

Approved

1.

Agricultural Animal Use

01/24/11

01/12/01

2.

Animal Numbers:  Initial and Continuing Review

inactive

inactive

3.

Animal Tissue Use  

NA

12/17/07

4.

Antibody Production (retired 11/20/12)

inactive

04/28/03

5.

Autoclave Use and Sterilization (5/3/11 refer questions to EHS)

inactive

11/24/03

6.

Biohazardous Material

10/22/12

3/24/08

7.

Biological Agents (included in Hazardous Material Policy)

inactive

inactive

8.

Blood Collection

01/23/12

02/24/03

9.

Euthanasia Methods

11/26/12

10/23/06

10.

Death as An Endpoint

10/24/11

12/22/03

11.

Emergency Evacuations During Animal Surgery

10/24/11

02/28/05

12.

Emergency or Disaster

10/24/11

07/11/05

12.1

Enrichment and Social Housing for Laboratory Rodents

 

03/28/11

13.

Food or Fluid Restriction

02/27/12

05/28/03

14.

Frog Oocyte Harvest

02/25/13

11/24/03

15.

Housing Animals Outside and/or Removal from Central Animal Facility

10/22/12

12/22/03

16.

Post-Approval Monitoring

01/23/12

04/28/03

16.1

Neoplasia in Rodents

2/25/13

11/23/09

17.

Occupational Health and Safety Program (section 5.E)

11/20/12

10/23/06

18.

Ordering Animals

inactive

inactive

19.

Pain and Distress, Determination of Levels

04/30/12

05/28/03

20.

Pet Policy (refer to University policy on pets)

inactive

inactive

21.

Physical Restraint

6/18/12

05/28/03

22.

Reporting Animal Deaths 

11/26/12

01/23/06

23.

Rodent Cage Density

10/22/12

11/28/05

24.

Storage of Controlled Drugs

12/17/12

10/26/04

25.

Survival Surgery

2/25/13

02/24/03

25.1

Testing for Biological Materials

 

1/24/11

26.

Animal Identification

11/26/12

05/18/09

27.

Use of Expired Medical Materials 

11/26/12

01/23/06

27.1

Visitor Policy

05/23/11

10/22/07

28.

Votey Satellite Facility, Oversight Plan for

inactive

inactive

29.

Weaning

12/17/12

11/28/05

30.

Aged Animals

 

01/23/12

31.

Random-Source Animals

 

2/27/12

32.

Non-Pharmaceutical Grade Drugs

 

2/25/13

 

 

 

 


Attachment B:

G: Committee Forms

 

All forms and form instructions are located in the forms section of our website and should be downloaded each time you need one. (SEE: http://www.uvm.edu/iacuc)

 

 

 

Last modified February 26 2013 03:47 PM

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