II:01:11 Animal Care and Use in Research and Teaching

I. INTRODUCTION

Middle Tennessee State University (“MTSU” or “University”) is committed to the humane care and use of all vertebrate animals used for research and training in laboratories and in field work. These activities will be conducted in accordance with applicable federal and state laws and regulations including the Guide for the Care and Use of Laboratory Animals (Guide), Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), and the Animal Welfare Act and Animal Welfare Regulations.

II. DEFINITIONS

A.  Animal.  Any live or dead vertebrate animal used or intended for use in biomedical or behavioral research, research training, teaching, or testing.
 

B.  Animal Facility.  Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments. 

C.  Animal Welfare Assurance.  The documentation from an institution assuring institutional compliance with PHS policy.

D.  Euthanasia.  The humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death. 

E.  Field Studies: Observations.  Any study conducted observing free-living, wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or significantly alter the behavior of the animals under study.

F.  Field Studies: Experimental Manipulation.  Any study conducted on free-living, wild animals in their habitat, which requires removing the animal from its habitat for experimental manipulation.

G.  Institutional Animal Care and Use Committee (IACUC or the Committee). A University committee that, according to U.S. federal law, must be established to oversee the use of animals for research and instructional purposes, and evaluate all aspects of the University’s animal care and use program. 

H.  Institutional Official.  An individual who signs and has the authority to sign the Institution’s Assurance, making a commitment on behalf of the institution that the requirements of this Policy will be met.

I.   OLAW.  Office of Laboratory Animal Welfare

J.   PHS.  Public Health Service

K.  Quorum.  A majority of the members of the Institutional Animal Care and Use Committee (IACUC) needed to vote.

L.   USDA.  United States Department of Agriculture

M.  USDA Pain Category B.  Animals involved in breeding or housing only.

N.  USDA Pain Category C.  Animals involved in experiments, teaching, research, surgery, or tests which are conducted involving no pain and no distress.  There should be no need for pain-relieving drugs.

O.  USDA Pain Category D.  Animals involved in experiments, teaching, research, surgery, or tests which are conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs are used.

P.  USDA Pain Category E.  Animals involved in experiments, teaching, research, surgery, or tests that involve accompanying pain or distress, and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs are not used because they would adversely affect the procedures, results, or interpretation of the data.

III. COMMITTEE MEMBERSHIP

Members of the IACUC are recommended by the Vice Provost for Research and Dean of Graduate Studies (VPR/Dean) and appointed by the President of the University for a three-year term and may be reappointed upon recommendation of the VPR/Dean. The Committee shall consist of a least five (5) members.  The membership shall include at least:

A.  One practicing scientist who is a MTSU faculty member and 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 MTSU faculty member whose primary concern is in a non-scientific area (e.g., attorney, ethicist, or liberal arts faculty).

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.

E.  One graduate student may also serve on the Committee, but it is not a requirement.  This member shall serve a one-year term.

F.  Other members of the Committee shall be faculty members involved in research. 

G.  The Research Compliance Officer shall serve as an ex-officio/non-voting member of the Committee.

H.  A representative from the Department of Environmental Health & Safety shall serve as an ex-officio/non-voting member of the committee.

IV. OFFICERS

A.  Chairperson.  The Chairperson shall be elected annually from and by the Committee membership at the last meeting of the academic year.  The Chairperson shall:

1.  Preside at all meetings.

2.  Call special meetings and appoint ad-hoc subcommittees when necessary.

3.  Assume responsibility for the preparation of the annual report to the VPR/Dean in collaboration with the Research Compliance Officer.

4.  Assume responsibility for execution of Committee policies.

B.  Vice-chairperson. The Vice-Chairperson shall also be elected from and by the IACUC membership at the last meeting of the academic year. The Vice-Chairperson shall:

1.  Take on all of the aforesaid responsibilities of the Chairperson should the Chairperson not be available. 

C.  Institutional Official. The Institutional Official shall be the VPR/Dean and shall be appointed by the President of the University. The Institutional Official shall: 

1.  Serve as the Institutional Official and as the liaison between the University, the IACUC, and the Office of Laboratory Animal Welfare.

2.  Be responsible for the University’s Animal Welfare Assurance.

3.  Provide an annual report to the Office of Laboratory Animal Welfare, describing the activities of the Committee including any changes in membership, dates of the semiannual program reviews and facility inspections.

4.  Serve as a consultant to the Committee and provide assistance to the Chairperson in the conduct and coordination of activities of the Committee. 

D.  Research Compliance Officer. The Research Compliance Officer will: 

1.  Attend Committee meetings but without voting privileges.

2.  Prepare the agenda for all Committee meetings.

3.  Record the minutes of all Committee meetings.

4.  Prepare the semi-annual reports for the Institutional Official.

5.  Assist in preparing the annual report to the Office of Laboratory Animal Welfare.  

6.  Serve as a consultant to the Committee.

7.  Provide administrative support and assistance to the Chairperson in the conduct and coordination of activities of the Committee.

V. MEETINGS AND ATTENDANCE

A.  Meetings 

1.  The Committee shall meet monthly during the academic year.  Special meetings may be called by the Chairperson as deemed necessary for the performance of Committee responsibilities.

2.  A majority of the membership shall constitute a quorum.

B.  Attendance 

1.  Attendance of members at Committee meetings is expected and required.  If a member must be absent, notice should be given to the Research Compliance Officer as soon as it is known.

2.  Absence for fifty percent (50%) of regular meetings without due cause will result in a request by the Committee to the VPR/Dean for replacement of that member. 

VI. TRAINING 

The University is required by federal regulations to make available training for all personnel including students, faculty and staff involved in the use and/or care of vertebrate animals in research, testing, or teaching.  PHS Policy and USDA regulations require that training be made available in the following areas:  

A.  Humane methods of animal maintenance and experimentations, including the basic needs of each species of animal, proper handling and care for the various species of each animal used by the facility, and proper pre-procedural and post-procedural care of animals.

B.  Research and testing methods that minimize the number of animals required to obtain valid results, and research and testing methods that minimize pain and distress. 

C.  Use of proper anesthetics, analgesics, and tranquilizers for any species of animal used by the facility. 

D.  Methods whereby deficiencies in animal care and treatment are reported and investigated.  

Training is offered through the Collaborative Institutional Training Initiative (CITI).  This online program offers a “working with IACUC” module that must be completed by all students, faculty, and staff prior to approval of an IACUC protocol.  This training provides instruction on proper and humane animal care and use. Modules are available for training on species-specific issues which are taken as needed. The IACUC, with assistance from the Research Compliance Office, ensures that individuals identified on a protocol have completed the appropriate training. 

All IACUC members shall receive initial training, to include an overview of the PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the Applied Research Ethics National Association/OLAW IACUC Guidebook.  New IACUC members are also required to take the “IACUC Chairs, Members, and Coordinators” module from CITI. 

VII. ANIMAL PROTOCOL REVIEW 

A.  Protocol Review Process 

1.  Submission: The process for reviewing and approving protocols using animals begins with the completion of an Animal Use Protocol Application by the investigator(s), which is available as a template on the MTSU Research Compliance Office Website. Information required for the protocol is consistent with requirements detailed in the PHS Policy and the Animal Welfare Regulations.  The completed application is submitted by email to the Research Compliance Office for processing. Designated Member Review protocols may be submitted any time.  Protocols requiring full review must be submitted 2 weeks prior to an IACUC meeting. The meeting schedule is available on the Research Compliance Office webpage.  

2.  Initial Review: Following the receipt of a protocol by the Research Compliance Office, completeness of the protocol is reviewed by the Research Compliance Officer. Additionally, each investigator’s training record and health screening certification is checked to make sure it is up-to-date. Copies of all protocols under review are provided to IACUC members by email and IACUC members have access to all protocols through a shared document service.  

3.  Designated Member Review: This category includes continuing reviews, previously approved protocols that have been resubmitted or identical protocols submitted to different funding agencies, protocols with no direct animal use (e.g. funds will be used for salary support only on a previously approved protocol), or use of shared animal products or slaughterhouse materials. Additionally, investigators conducting a new project that qualifies as USDA Pain Category C or below can request designated member review. 

One IACUC member as designated by the IACUC Chair is assigned to review the protocol. The reviewer’s comments and the protocol are then forwarded to the remainder of the Committee for their review. If no comments or request to review at the full committee are received from the Committee, the decision of the Designated Reviewer is forwarded to the investigators. The outcomes of a Designated Member Review could include approval, require modifications to secure approval, or referral to the full IACUC committee for review. Designated Member Review cannot result in disapproval. For approvals, a letter will be sent to the investigators.  For decisions requiring modifications to secure approval, investigators will be notified by email of what areas clarification is required. These responses will be reviewed by the Designated Member Reviewer. Approval will be granted when an acceptable response has been received.

4.  Full Review: At monthly meetings, the IACUC considers new protocols requiring full committee review.  The protocol is provided to the IACUC members for review prior to the IACUC meeting. The protocol is then open for discussion by the Committee at the IACUC meeting, which includes input from the Veterinarian. Possible outcomes of the Committee's review include approval, require modification to secure approval, table (defer), or disapproval. For approvals, a letter will be sent to the investigators.  For decisions requiring modifications to secure approval, investigators will be notified by email of what areas clarification is required. In such cases, the response by the investigator is reviewed by the IACUC Chair or an IACUC member designated by the Chair using the Designated Member Review process as described above. Approval will be granted when an acceptable response has been received. In cases of a tabled or disapproved protocol, the investigator is notified by the Chair by letter which shall include detailed reasons for disapproval and the investigator shall be advised of the available options, which could involve a response in writing or in person at an IACUC meeting. 

5.  Voting Procedures. A majority of the membership shall constitute a quorum. Should a quorum not be met, the protocol must be tabled until the next meeting to assure there is a quorum for voting.  A majority vote of the quorum present is needed to approve, require modifications to secure approval, or withhold approval of a protocol. Should a Committee member have a protocol before the Committee as an investigator, he/she must recuse him/herself from the voting process and allow the remaining Committee members to discuss issues and identify questions.  Then, the investigator is invited back into the Committee meeting to discuss the protocol and answer questions.  After questioning, the investigator is asked to leave while the remaining Committee members continue the discussion and votes.   A quorum must be maintained for the voting.

6.  Criteria for Review.  The following specific areas are reviewed for all protocols to ensure that federal requirements for granting IACUC approval are met:

7.  Animals. A rationale for involving animals, identification of the species, description of the appropriateness of the species, and numbers of animals to be used.

8.  Activities.A complete description of the proposed useof the animals with all activities involving animals must be in accord with USDA Regulations/PHS Policy

9.  Pain/Distress. A description of procedures designed to assure that discomfort and painto animals will be limitedto that which is not avoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals. If pain/distress is caused, appropriate sedation, analgesia or anesthesia will be used and the Attending Veterinarian must be involved in planning.  Use of paralytics is prohibited.  Animals with chronic/severe un-relievable pain will be painlessly euthanized.

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

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

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

13.  Euthanasia.A description of any euthanasia method to be used must be included in the protocol. The euthanasia method must be consistent with USDA Regulations/American Veterinary Medical Association recommendations, a copy of which can be obtained online by clicking here

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

15.  Qualifications.Personnel must be appropriately trained and qualified.  

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

17.  Post Approval: Upon receiving the official letter of approval from the Research Compliance Office, investigators may begin study activities. At this point, investigators can purchase their animals and/or begin study activities. Animals may not be purchased from vendors or collected from the wild until you have an approved IACUC protocol. No study activities may begin until the approval letter is issued. If animals will be housed in the vivarium, investigators must contact the Research Compliance Office for current per diem rates for housing of animals.

B.  Annual and Triennial Review 

The  IACUC will conduct continuing reviews of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review at least once every 3 years according to PHS Policy. The IACUC procedures for conducting continuing reviews are as follows:  

All PHS animal defined research protocols are approved for a three-year term, subject to review at least annually. 

An email from the Research Compliance Office is sent prior to the anniversary date of approval to the investigator indicating that the continuing review is due.  The investigator must complete and return a progress report to the Research Compliance Office indicating the status of the project and occurrence of any unexpected events. Responses are reviewed by the Research Compliance Officer. If any unexpected events or changes were reported on the progress report, this is forwarded to the IACUC for review. If these issues are adequately addressed in the progress report, the IACUC will grant approval for continuation. If these issues are not addressed adequately, the IACUC will meet to discuss the issue and take appropriate actions which could include an official suspension of the activity by the IACUC.  

At the end of the third year of a protocol, the investigator must complete a final report and resubmit the protocol for Committee review in order to continue research activities. A new Animal Use Protocol Form must be submitted; this form undergoes the same review process as any new protocol. Thus, the procedures for an initial review outlined in the Protocol Review section of this policy are conducted prior to the expiration date. The renewal should include all previous modifications or amendments made to the protocol since its original approval. 

C.     Amendments to Previously Approved Protocols

Approved protocols grant permission to conduct only those activities listed in the protocol, conducted in the manner described, by the individuals listed, with no more than the number of animals indicated in the protocol.  Any changes in procedures, personnel, endpoints, care or use of additional animals require IACUC approval before the changes are implemented. 

Review of requests for protocol modification may result in approval of the modification, a request for more information, or disapproval of the request.  Approval of a modification does not alter the expiration date of a protocol.  The IACUC recognizes two (2) general classes of modification to open protocols:  

1.  Significant Modifications. These include but are not limited to:  changes in the objectives of a study; proposals to switch from nonsurvival to survival surgery; changes in species or the number of animals used; changes in key personnel; and changes in anesthetic agent(s), the use or withholding of analgesics, and methods of euthanasia. Changes in the duration, frequency or numbers of procedures performed on an animal are considered a significant change.  Requests for significant modifications will be reviewed using the Designated Member Review procedures described above unless there is a request for full Committee review.   Requests for significant modifications should be submitted electronically to the Research Compliance Office, which will then be forwarded to the IACUC.  If a full Committee review is requested by a member of the IACUC, then the request will be reviewed at the next available IACUC meeting with the procedures listed above.

2.  Minor Modifications. These are all changes not classified as significant.  Requests for minor modifications will be reviewed by the Chair or the designated reviewer.  The investigator is encouraged to consult with the IACUC Chair for assistance in determining the category into which proposed modifications fall.  

VIII. IACUC PROGRAM REVIEW, INSPECTIONS, AND REPORTING   

A.  Review. The IACUC will review at least once every 6 months MTSU’s program for humane care and use of animals using the Guide as a basis for evaluation. All IACUC members are invited to participate in this review, which will occur at an IACUC meeting. The Semiannual Program Review and Facility Inspection Checklist shall serve as a guide for this process. Areas covered include: 

1.  IACUC membership and functions, including protocol review practices; 

2.  IACUC records and reporting requirements; 

3.  Veterinary care, to include: 

a.  Preventive medicine, animal procurement, and animal transportation;

b.  Surgery;

c.  Pain, distress, analgesia, and anesthesia;

d.  Euthanasia;

e.  Drug storage and control.

4.  Personnel qualifications and training; and,

5.  Occupational health and safety of personnel. 

Each topic will be discussed at the IACUC meeting, areas of deficiency will be identified, and a corrective action plan will be developed. 

B.  Inspection. The IACUC will inspect animal research facilities including satellite and animal surgical sites. The IACUC will use the Guide as a principal reference document and the Semiannual Program and Facility Review Checklist when conducting its review of the facilities. These inspections must occur every 6 months. No IACUC member wishing to participate in any review shall be excluded.  The IACUC may invite ad hoc consultants to assist in the reviews.  

C.  Reporting. Upon completion of the Semiannual Program Review and Facility Inspection by the IACUC, the IACUC Chairperson shall assume responsibility for the preparation of the Semiannual Report to the Institutional Official in collaboration with the Research Compliance Officer. 

The report shall describe the University’s adherence to the Guide and shall state the reasons for any deficiencies.  Deficiencies identified during the reviews are categorized as either minor or significant.  A significant deficiency is defined by USDA regulations and the PHS Policy as something that is or may be a significant threat to animal health or safety.  The report shall include a plan and a schedule with dates for correction of each program or facility deficiency.  The report must be reviewed and signed by a majority of the IACUC members and shall include minority views.  The IACUC shall submit the approved report to the Institutional Official.  The Research Compliance Officer shall monitor compliance with required corrective actions as identified in the semiannual report.  If any deficiencies are not remedied within the time period set forth in the report, the IACUC shall take appropriate corrective action. 

The IACUC, through the Institutional Official, will submit an annual report to OLAW by January 31st of each year.  The annual report will include: 

1.  Any change in the accreditation status of the Institution (e.g., if the Institution obtains accreditation by AAALAC or AAALAC accreditation is revoked);

2.  Any change in the description of the Institution's program for animal care and use as described in the Institutional Assurance;

3.  Any change in the IACUC membership;

4.  Notification of the dates that the IACUC conducted its semiannual evaluations of the Institution's program and facilities (including satellite facilities) and submitted the evaluations to the Institutional Official; and,

5.  Any minority views filed by members of the IACUC. 

Outside of the regular reporting, if the IACUC has any recommendations regarding the animal program at MTSU, these will be formally written by the IACUC Chairperson. These recommendations will then be forwarded to the Institutional Official.  

IX. RECORDKEEPING 

MTSU will maintain: 

A.  A copy of the Assurance with OLAW and any modifications made to it, as approved by the PHS.

B.  Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations.

C.  Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was granted or withheld.

D.  Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official.

E.  Records of accrediting body determinations. 

MTSU will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional 3 years after completion of the activity. 

All records shall be accessible for inspection and copying by authorized OLAW or PHS representatives at reasonable times and in a reasonable manner. 

X. RISK BASED OCCUPATIONAL HEALTH AND SAFETY PROGRAM   

A representative from the MTSU Environmental Health & Safety department shall provide guidance on health and safety issues during tours of animal facilities and shall be represented as a non-voting member on the IACUC. 

All students, faculty, and staff coming into contact with animals are required to successfully complete training that covers occupational health and safety. Training completion on these topics will be monitored by the Research Compliance Office and Environmental Health & Safety.  Modules are offered through the Collaborative Institutional Training Initiative (CITI) program and include: Personnel Training and Experience, Occupational Health and Safety, and Using Hazardous and Toxic Agents in Animals. Additionally, online training on laboratory standards is required annually by Environmental Health & Safety. No individual is allowed to undertake a job until he/she has received adequate safety instructions and is authorized to perform the task.  Supervisors are responsible for ensuring that individuals working in their labs are adequately trained on laboratory tasks. 

The IACUC requires that all students, faculty, and staff that work with animals undergo a yearly health screening that meets HIPAA regulations. The Health Screening form (click here to access) is submitted to the MTSU Health Services and is reviewed by a physician. Once the Health Screening has been reviewed and relevant referrals and recommendations have been carried out, a certification that the Health Screening has been completed is sent to the Research Compliance Office.   

XI. ACTION AND INVESTIGATION OF CONCERNS OF ANIMAL WELFARE/ VIOLATION OF POLICY   

The Attending Veterinarian has authority to immediately halt a protocol if he/she has reason to believe that animal welfare is being compromised.  The Attending Veterinarian shall immediately notify the affected investigator and the IACUC Chair in writing of any such incident.  The issue or issues shall be investigated as quickly as possible and the IACUC Chair shall call an emergency meeting of the IACUC to review the matter. 

The IACUC reviews and investigates concerns involving the care and use of animals at the research facility resulting from public complaints and from reports of non-compliance received from students, faculty, and staff. Individuals with concerns can contact the Research Compliance Office. The contact information including phone number and email address is located on the Research Compliance Office webpage. Contact information is also posted at the office for each animal research facility. The Attending Veterinarian and individual IACUC members must also report any suspected incidence of noncompliance for review by the IACUC. 

A subcommittee of the IACUC will be appointed by the Chair to conduct investigations of concerns regarding the care and use of animals.  All persons involved shall be informed of the purpose of the investigation and the manner in which it will be conducted.  The subcommittee shall evaluate the status of any animals involved and the interim status of the investigator’s protocols, and shall prepare a report to be presented at an IACUC meeting. The IACUC may, in its discretion, obtain external review of the matter; however, the IACUC shall be the final authority regarding the decision and any action taken in response to a report of noncompliance.  

The actions taken by the IACUC in response to a finding of noncompliance depend on the seriousness of the violations.  IACUC actions may include the following:  

A.  the IACUC determines that the allegation also violates the Policy on Misconduct in Scholarly Activities and Research, the allegations will be sent to the Vice Provost for Research for inquiry/investigation.

B.  Notify OLAW and USDA (if applicable) and any funding agencies involved.  This notification is mandatory for any suspended protocols. 

C.  Suspend or continue suspension of some or all of an individual’s use of animals until it is clear that the personnel and procedures have been brought into compliance with federal laws and policies.      

D.  Require oversight of protocol activities by an IACUC member, the Attending Veterinarian or other designee. 

E.  Require retraining or additional education for project personnel.

F.  Implement any other action necessary to protect the welfare of the animals or integrity of the IACUC oversight

The IACUC can officially suspend a protocol (or uphold the Attending Veterinarian’s decision to halt a protocol) by a majority vote at a meeting with a quorum of IACUC members. All members shall have the opportunity to present minority views. The IACUC will then notify the Institutional Official of the suspension. 

If a protocol is suspended by the IACUC, then the IACUC and the Institutional Official shall review the reasons for suspension, determine appropriate corrective action(s) to be implemented by project personnel, and report this information with a full explanation to OLAW.  Relevant federal regulatory and granting agencies will be notified by the Institutional Official of the plan for corrective actions and then the implementation of these actions. 

Revisions: May 19, 1993 (Original); September 3, 2014. 

Cross-references: Animal Welfare Act (AWA, United States Code, Title 7, Chapter 54, Sections 2131-2159); Animal Welfare Act Regulations (AWAR, CFR, Title 9, Chapter 1, Subchapter A, Parts 1-4); Guide for the Care and Use of Laboratory Animals - National Research Council - 2011 edition; Policy on Humane Care and Use of Laboratory Animals (2002), Public Health Service/ Office for Laboratory Animal Welfare.