Animal Subjects in Research

  • Policy

    Policy for the Care and Use of Laboratory Animals in Experimentation | TTU Policy 740
    (Updated 1/1/2018)

    I.     Purpose
    The purpose of the policy is to ensure the humane care and use of vertebrate animals in research, testing, and training, and to adhere to applicable laws, principles, standards, guidelines, best practices, and policies affecting such care and use. The Institutional Animal Care and Use Committee (IACUC) provides for and protects the welfare of laboratory animals used for research and pedagogy. IACUC reviews research protocols and conducts evaluations of the University’s animal care and use, which includes the results of inspections of facilities that are required by law and set forth by the University in accordance with the Public Health Service Act (PHS Act) mandated by the Health Research Extension Act of 1985, Public Law 99-158, and its amendments from the U.S. Department of Agriculture, 9 CFR 9, Parts 1-3.

    II.     Review
    This policy will be reviewed every three years or whenever circumstances require review, whichever is earlier, by the Tennessee Tech Institutional Animal Care and Use Committee, with recommendations for revision presented to the Vice President for Research and Economic Development, Administrative Council, and University Assembly.

    III.     Definition
    Institutional Animal Care and Use Committee (IACUC) – committee charged with the review of research protocols and with conducting evaluations of Tennessee Tech’s animal care and use, which includes the results of inspections of facilities that are required by law. The IACUC consists of at least five members who are qualified to regulate animal care at Tennessee Tech, and must include a veterinarian with expertise in the animal species used at Tennessee Tech, a practicing scientist experienced in animal research, a member with primary concerns that are in nonscientific areas, and one member with no affiliation with Tennessee Tech, except for serving on the IACUC. One member can fulfill more than one role, but the committee must still consist of at least five members.

    IV.      Policy

    A.    Tennessee Tech hereby adopts policies on the use of
           vertebrate animals in research, testing, and training
           (sponsored or non-sponsored) that are in compliance
           with federal laws and regulations in accordance with
           the Public Health Service Act (PHS Act) mandated by
           the Health Research Extension Act of 1985, Public Law
           99-158, and its amendments from the U.S. Department
           of Agriculture, 9 CFR 9, Parts 1-3; and the Guide for
           the Care and Use of Laboratory Animals (2011 or the
           most current version published by the National
           Research Council of the National Academies, and/or
           the Animal Welfare Act (Title 9 CFR Chapter 1
           Subchapter A)).
    B.    Researchers are responsible for the humane care and
           use of vertebrate animals in research, testing, and
           training, and for complying with all federal laws and
           regulations, Tennessee Tech policies and guidelines,
           and any other requirements related to the humane
           care and use of animals in research, testing, and
           training.
    C.    The procedures/application for approval to use
           laboratory animals in research, testing, and training
           are in accordance with Tennessee Tech’s procedures as
           established by the Institutional Animal Care and Use
           Committee (IACUC) and found on its page within the
           Office of Research and Economic Development
           website.
    D.    The IACUC may approve, require modification of, or
           withhold approval of a project. Animal use in the
           absence of IACUC approval is a serious violation of
           Tennessee Tech’s policy and a violation of federal law.

    E.    Researchers are also responsible for adhering to
           federal guidelines for the handling of animals and
           contingencies for their evacuation as provided in 7
           U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371,
           descriptions of which can be found on the Government
           Publishing Office website and the Cornell Law School
           website.
    F.     Tennessee Tech will comply with TTU Policy 770
           (Whistleblower Protection in Research).

    G.    Tennessee Tech is committed to the ethical and
           compliant care and use of animals in research,
           teaching, and testing. The policy and procedures for
           preventing and reporting fraud, waste, or abuse with
           regard to animal care and use in laboratory research
           can be found in TTU Policy 131 (Preventing and
           Reporting Fraud, Waste, or Abuse).

    H.    Researchers must familiarize themselves and comply
           with applicable guidelines and policies including, but
           not limited to:

    1.    TTU Policy 132 (Conflict of Interest) 
    2.    TTU Policy 735 (Conflict of Interest in Research)
    3.    42 CFR 50.601 et seq.
    4.    45 CFR 94.1 et seq. 

    I.     Non-compliance that occurs in the context of IACUC-
           approved research requires corrective action. The
           IACUC will determine the actions required and will
           take into consideration the nature, severity, and
           frequency of the non-compliance and the risk that
           non-compliance poses to animal welfare. 
           Consequences for non-compliance may include, but are
           not limited to: (1) implementing measures to prevent
           recurrence; (2) notifying the Executive Officer of IACUC
           and Human Resources of the actions; (3) notifying
           funding or regulatory agencies, as required; and/or (4)
           notifying the complainant, any persons against whom
           allegations were directed, and pertinent program
           officials (appropriate supervisory and management
           staff, the public affairs office, institutional attorneys,
           etc.).

    J.     Before applying for grants that involve the use of
           vertebrate animals in research, testing, and training,
           and before filing an application with the IACUC to
           undertake animal care research, investigators must
           complete and pass CITI training as defined by the
           Office of Research and Economic Development and
           found on the CITI Training page of its website under
           the Research Compliance section. Submission of a
           current passing certificate from CITI indicates
           successful completion of all appropriate general and
           taxon-specific modules.

    K.    The President will appoint members of IACUC as
           subject to requirements described in the Public Health
           Service Act (PHS Act) mandated by the Health Research
           Extension Act of 1985, Public Law 99-158, and its
           amendments from the U.S. Department of Agriculture,
           9 CFR 9, Parts 1-3, the Animal Welfare Act (Title 9 CFR
           Chapter 1 Subchapter A).

    IV.     Interpretation

    The Vice President for Research and Economic Development or his/her designee has the final authority to interpret the terms of this policy.

    V.     Citation of Authority for Policy

    T.C.A. § 49-8-203 (a)(1)(E); 9 CFR 9, Parts 1-3; Public Law 99-158; 7 U.S.C. 2131; 42 CFR 50.601 et seq.; 45 CFR 94.1 et seq.

    Approved by:

    Administrative Council:       11/15/17; 2/25/15
    University Assembly:           11/29/17; 4/22/15

  • Committee Procedures

    Institutional Animal Care and Use Committee | Procedures

    1. Name
      The name of this Committee shall be the Institutional Animal Care and Use Committee (IACUC).

    2. Membership
      The Committee shall consist of at least five members.
      1.  The membership shall include at least:
           a.  One practicing scientist experienced in research involving animals.
           b.  One veterinarian (DVM) with training or experience in laboratory animal
               science and medicine and with direct or delegated program responsibility for   
               activities involving animals at the University.
           c.  One member whose primary concern is in a non-scientific area (e.g., attorney,
               ethicist, or member of the clergy).
           d.  One member who is not affiliated with the University in any way other than as
               a member of the Committee, and who is not a member of the immediate
               family of a person affiliated with the University.
      2.  Other members of the Committee shall be faculty and administrators.
      3.  Members will serve on three-year staggered terms and may be reappointed at the
          discretion of the President of the University.

    3. Functions/Responsibilities
      The Committee shall:
      1.  Inspect all laboratory animal facilities and the University's animal care and use program every six months and submit a written report to the Executive Officer.
      2.  Make recommendations to the Executive Officer regarding any aspect of the University's laboratory animal programs, facilities, or personnel training.
      3.  Determine whether proposed research will be conducted in accordance with the Animal Welfare Act and conforms with the University's Animal Welfare Assurance.
      4.  Determine whether procedures used in research avoid or minimize distress, discomfort, and pain to laboratory animals.
      5.  Approve procedures that may cause no pain or only momentary or slight pain/distress to the animals. If warranted by the procedure, appropriate sedation, analgesia, or anesthesia may be approved for use.
      6.  Determine if the living conditions of animals are appropriate for the species and contribute to animal health and comfort.
      7.  Require the availability of medical care for animals as necessary by a qualified veterinarian.
      8.  Notify (in writing via the Executive Officer) the investigators and the University of its decision to approve or withhold approval of those activities related to the care and use of animals in experimentation. If approval is withheld, the Committee's written notification will include the reasons for its decision and will give the investigators an opportunity to respond in writing or in person or both.
      9.  Suspend an activity that it previously approved if it is determined that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Public Health Service Guide, and the University's Animal Welfare Assurance.

    4. Officers
      1.  Chairperson:  The Chairperson shall be elected annually from and by the Committee membership at the first meeting of the academic year. The Chairperson shall:

      a.  Preside at all meetings or designate a member to serve in his/her absence.
      b.  Prepare and distribute a tentative agenda to Committee members at least three working days prior to the meeting.
      c.  Provide for the recording of minutes.
      d.  Call special meetings and appoint ad hoc committees when necessary.
      e.  Assume responsibility for the preparation of the annual report to the Administrative Council in collaboration with the Executive Officer.
      f.  Assume responsibility of execution of Committee policies via the Executive Officer.

      2.  Executive Officer The Executive Officer shall be an administrator in the Office of Research and shall be appointed by the President of the University according to the approved procedure for making such appointments. The Executive Officer shall:

      a.  Serve as the Institutional/University Officer for the Committee and as the liaison between the University, Committee, and Office for Protection from Research Risks, Division of Animal Welfare, Department of Health and Human Services.
      b.  Be responsible for the University's Animal Welfare Assurance.
      c.  Provide an annual report to the Office for Protection from Research Risks, Division of Animal Welfare, describing the activities of the Committee including any changes in membership, dates of inspection, and dates evaluations were submitted to his/her office.
      d.  Serve as a consultant to the Committee and provide assistance in the conduct of Committee business.
      e.  Provide administrative support and assistance to the Chairperson in the conduct and coordination of activities of the Committee.
      f.  Attend Committee meetings, but without voting privileges, unless he/she is a member of the Committee.
      g.  Receive and prepare research proposals for review by the Committee.

    5. Meetings and Attendance
      1.  Meetings
      a.  There shall be a minimum of one meeting of the Committee each semester. Meetings shall be held in September and in March. Special meetings may be called by the Chairperson as deemed necessary for the performance of Committee responsibilities.
      b.  Research proposals shall be made available to members for review prior to scheduled meetings.
      c.  The meeting agenda shall be approved at the beginning of each meeting.
      d.  A simple majority of the membership shall constitute a quorum.

      2.  Attendance
      a. Attendance of members at Committee meetings is expected and required. If a member must be absent, notice should be given to the Chairperson or Executive Officer as soon as it is known, along with the name of the person who will attend for the absent member.
      b. The representative for the absent member should have comparable training/background to that of the member. The representative shall not have voting privileges and will not count as part of the quorum.
      c.  Absence from fifty percent (50%) of regular meetings without due cause will result in a request by the Committee to the President of the University via the Executive Officer for replacement of that member.

    6. Amendment of Procedures/Committee Actions
      These procedures shall be amended at any regular meeting of the Committee by a majority vote of the membership present, provided that the amendment has been submitted in writing to the members at least one week prior to the meeting where the voting will take place.

    7. Parliamentary Authority
      The rules contained in the current edition of Robert's Rules of Order, Newly Revised shall govern the Committee's actions.

    8. Effective Date of Implementation
      These procedures shall become effective upon review by the Administrative Council and approval by the President of the University.

      *These procedures cannot be in conflict with the Public Health Service Act (PHS Act) mandated by the Health Research Extension Act of 1985, Public Law 99-158, and its amendments from the U.S. Department of Agriculture, 9 CFR 9, Parts 1-3.

      Approved by the Administrative Council - April 10, 1991

      Amendment to Section V.A.1. Approved by the Committee - January 12, 1999

      Amendment Approved by the Administrative Council - January 20, 1999

      Approved name change to Institutional Animal Care and Use Committee (IACUC) Sept. 16, 2010

  • Membership

    Historic Membership (Note:  This link takes you to the President's Office's web page housing historic IACUC membership information.)

    Name Classification Campus Box No.  Email Term Expires
    Dr. James Baier Faculty 5034 jbaier@tntech.edu 2021
    Dr. Chris Brown Faculty 5063 cabrown@tntech.edu 2021
    Ms. Tammy Howard Faculty 5001 thoward@tntech.edu 2021
    Dr. Tyler Verble Veterinarian   tverble@frontiernet.net 2021
    Dr. Christopher Murray Faculty  5063 cmmurray@tntech.edu 2020
    Dr. Steve Hayslette Faculty 5063 shayslette@tntech.edu 2020
    Dr. Jessica 
    Oswalt
    Faculty 5015 joswalt@tntech.edu 2020
    Mr. Joe Weatherly Clergy 885 Spring Valley Rd., Cookeville, TN 38501 jweatherly@stmichaelcookeville.com 2020
    Ms. Sarah Difurio Admin 5041 sdifurio@tntech.edu 2020
    Executive Officer to Provide Staff Support Services Dr. Francis Otuonye, Associate Vice President for Research      
    Nonvoting Resource Person Mr. Greg Holt      

  • Minutes

    Contact the Office of Research (research@tntech.edu or (931) 372-3897) for requests to view minutes of the IACUC.

  • Process of Application Review

     

    Process of Application Review for Use of Laboratory Animals in Experimentation
    If laboratory animals are to be used in any type of research performance/ training (sponsored or non-sponsored), activities must be in compliance with federal and University policies. The stepwise procedure is as follows:

    1. Obtain an application from your departmental office or the Office of Research. Read it carefully and fill it out. (Please type or print.) Applications are also available here.
    2. The completed application for approval to use laboratory animals in experimentation is to be submitted by the Principal Investigator (PI) or Activity Director (AD) to the Office of Research, Derryberry Hall, Room 306. The original and seven (7) copies are to be submitted.
    3. A quorum of committee members will be notified and allowed seven (7) working days after notification to inspect the application and act upon it, either in the Office of Research or via mail.
    4. The action of the committee will be sent in writing to the PI or AD.
    5. If the application is given unconditional approval, in addition to the committee notifying the PI or AD in writing, a memorandum will be sent to the funding agency, if appropriate, letting them know of the approval.
    6. If an application is given conditional approval, the committee will notify the PI or AD in writing stating clearly what the conditions are. The PI or AD will be given a time limit for meeting or removing the conditions and returning written verification that the conditions have been met or removed.
    7. If conditions required for approval necessitate full committee review, the chair will call a special meeting to resolve the issue unless it coincides with a regular meeting of the committee. This process will extend the time required for approval by at least five (5) working days. The committee will then send notification as described in Items 4, 5, and 6.
    8. Full approval of the committee must be obtained before the proposed use of animals is permitted to begin.
    9. Applicants should allow ten (10) working days for the process of application review to take place and be notified.
    10. It is the prerogative of the committee to (a) approve the application as presented or unconditionally, (b) approve the application with stipulations or conditionally, or (c) disapprove the application completely.

    General Statement

    • If an applicant wishes to discuss any part of the process or is unhappy about the committee's decision, the committee stands ready and willing for dialogue and understanding. Call the Office of Research (372-3374) for an appointment with the committee or committee representative or member.

    For further information about the requirements and procedures for animal care and use in experimentation, call the Office of Research.

  • Forms

     

    Forms for Animal Care and Use issues must be returned to the Office of Research in Derryberry Hall, Room 305.

    Guide for Lab Animals in Research 

    IACUC SharePoint Site


    Please note: form accessibility may vary from browser to browser and among different operating systems. Follow the steps below to save the forms and submit them to the Office of Research. For form accessibility issues or troubleshooting, please contact Amy Hill at extension 3464 or amyhill@tntech.edu.

    1. Click the link for the form. If the form opens in your browser, choose the "Save" icon in the top right portion of your screen and save it as a file on your computer (Note: if you begin typing in the form from your browser, the information will not be saved. You must save the file to your computer). If the form downloads instead of opening in the browser, double-click the name and open it. Save the file from there to a location on your computer.
    2. Open the form in Adobe Acrobat Reader or Adobe Acrobat (Note: varying versions of Reader may yield different results. If you have issues, please contact your ITS support person to ensure that you have the most up-to-date Reader).
    3. Fill in the form.
    4. After completing the form, choose File>Save As from the Adobe Acrobat Reader menu and save the file using a new name in a location you will be able to access later (Desktop, My Documents, etc.).
    5. Close the form.
    6. Create a new mail message and attach the recently saved file to the message. Submit the form to research@tntech.edu

    Note: if none of these steps work on your computer, please contact your ITS support person or print the file, hand-write your responses, and return it to the appropriate office or building as designated above.


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  • Training

     

    Collaborative Institutional Training Initiative (CITI)
    Direct links to CITI
    CITI Home Page: https://www.citiprogram.org/ 
    Directions: https://www.citiprogram.org/citidocuments/citiinstructions

    Step-By-Step Guide to the CITI registration process 

    TTU subscribes to the Collaborative Institutional Training Initiative (CITI) as means of providing training in animal care and use.  The courses you take depend on your role in research.  The following are the available modules related to animal research:

    Laboratory Animal Research
    PIs and Faculty Researchers
    Graduate and Undergraduate Student Researchers
    Animal Technicians and Lab Workers
    Institutional Officials
    Research Administrators and Staff
    IACUC Members and Staff
    IACUC Community Members

    Electives (species specific)
    Frogs, Toads or other Amphibians
    Mice Family:  Muridae Cricetidae
    Rats Genus:  Rattus
    Fish
    Zebrafish
    Reptiles

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