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Section I – Institutional Animal Care and Use Committee

[1 - 01] Roles and Responsibilities

The Institutional Animal Care and Use Committee (IACUC) at С��Ƭ��Ƶ has been established to implement the University’s commitment to assuring humane care and use of animals in research and education. The IACUC operates in accordance with  the United States Public Health Service (PHS) policy on humane care and use of laboratory animals, the PHS “Guide for the Care and Use of Laboratory Animals,” the provisions of the United States Animal Welfare Act, and other applicable laws and regulations. 

               The IACUC has the following responsibilities:

1. Review at least once every six months, the university’s program for humane care and use of animals and ensure compliance with state and federal regulations.
2. Inspect the University animal facilities at least once every six months, using “The Guide” as a basis for evaluation, to ensure facilities meet established guidelines and regulations.
3. Prepare and submit reports of the semi-annual facility inspection and program evaluations to the Institutional Official.
4. Provide assistance and guidance on research involving animals. Make recommendations to the Institutional Official regarding any aspect of the university’s animal program.
5. Implement University guidelines and state and federal regulations in all aspects of the humane care and use of animals.
6. Review and approve, require modifications, or withhold approval of all research protocols and changes to on-going protocols involving the use and care of animals.
7. The IACUC shall review and investigate any concerns regarding the care and use of animals.
8. The IACUC is authorized to suspend an activity involving animals, if that activity is not being conducted in accordance with the applicable provisions of the Animal Welfare Act, the PHS Guide, the institution’s Assurance, or the PHS Policy.
9. Ensure that all personnel involved with animal care, treatment or use are adequately trained and/or experienced in the humane care and use of animals and the occupational health and safety programs associated with the use of animals in research.

The Office of Research Compliance is responsible for the maintaining of the following records:

• Office of Laboratory Animal Welfare (OLAW) Assurance documentation.
• Minutes of IACUC meetings.
• Records of IACUC activities and deliberations.
• Minority IACUC views.
• Documentation of protocols reviewed by IACUC, and proposed significant changes to protocols.
• IACUC semiannual program evaluations and facility inspections, including deficiencies and identified plans for correction.
• Accrediting body reports, and determinations.
• USDA reports, and determinations.

[1-02] Appointment and Role of the Institutional Official

The С��Ƭ��Ƶ President appoints and approves the Institutional Official (IO).

The IO is the individual who is authorized to legally commit on behalf of the research facility that it will meet the requirements of the Animal Welfare Act Regulations (AWAR).  Similarly, PHS Policy defines the IO as the individual who signs and has the authority to sign the institution’s Assurance, which commits the institution to meet the requirements of the PHS Policy.  The IO is the individual who is responsible for ensuring that an institution complies with all applicable animal welfare laws, regulations, and policies.  The IO signs forms, reports, and letters on behalf of the institution, and interacts with the IACUC in overseeing the institution’s animal care and use program. The IO appoints the Chair of the IACUC.

[1-03] IACUC Member Appointments and Training

According to the PHS Policy on the Humane Care and Use of Laboratory Animals, the IACUC must consist of not less than five (5) members, and shall include at least one (1) Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine, one (1) practicing scientist experienced in research involving animals, one (1) member whose primary concerns are in a nonscientific area, and one (1) individual who is not affiliated with the institution in any way other than as an IACUC member.

IACUC members are appointed by the Institutional Official/Vice President for Research and are charged with assessing the institution’s animal care program, facilities and procedures based upon their education, experience, and expertise. The IACUC at С��Ƭ��Ƶ includes a chair, an attending veterinarian, a non-affiliated member, experienced scientists and researchers, faculty, and staff.

[1-04] IACUC Member Training

IACUC members complete a training course developed by, and under the direction of the attending veterinarian. The training provides an overview of PHS and USDA polices/regulations, Standard Operating Procedures for laboratory safety practices, and IACUC functions and requirements.  In addition to the training, IACUC members receive training from the IACUC administrator regarding KSU University policies and procedures for reviewing protocols. Each committee member is provided:

• A copy of The Guide for the Care and Use of Laboratory Animals
• AAALAC Program Description
• A committee roster
• Information regarding meeting dates – also available on Research website
• Sample protocol form

[1-04.1] Additional Support

IACUC members can meet with either the Chair or the attending veterinarian with any additional questions that they may have.

Ad hoc and continuing education are provided during meetings.

[1-05] IACUC Meetings

The IACUC meets monthly unless cancelled by the IACUC chair, or a member of the Research Compliance office staff under direction from the IACUC chair.  A meeting quorum consists of one more than half of the regular IACUC voting members.

[1-06] IACUC Meeting Minutes

IACUC meeting minutes are recorded and maintained by the Office of Research Compliance and are made available for review to the pertinent regulatory agencies, as required.

• Minutes are taken at the meeting and are as inclusive as possible to record the true breadth of discussion by the IACUC.
• Minutes shall include the time of the meeting and those members present.
• All votes are recorded in the minutes listing number for, against and abstaining, along with major discussions and any conditions for approval.
• Minutes from the previous meeting are included with the Agenda for IACUC members to review.
• Any corrections/comments needed to the minutes are noted in the minutes of the next meeting.
• The minutes are corrected accordingly and are then considered final.
• Copies of the finalized minutes are posted to the Research Compliance server and/or website shared only with IACUC members.
• Distribution of the minutes is limited to the IACUC, the Institutional Official, accrediting bodies and regulatory agencies charged with federal oversight responsibilities for animals used in laboratories.

[1-07] Reporting Mistreatment of Animals or Noncompliance Issues

The Administration of С��Ƭ��Ƶ advocates the finest animal care and assures the public, researchers, employees and students that there is a true desire to investigate allegations of mistreatment or noncompliance. The IACUC and veterinary staff fully support this philosophy. Under no circumstances will reporting such instances be detrimental to an individual’s standing within the University as this action is protected under the law (9CFR, Part 2, Subpart C 2.32 (c)(4).  

Staff and researchers working in the animal facilities are instructed to report all incidents of non-compliance with regulatory standards of animal care and use to the facility supervisors or managers, IACUC Chair, IO, and Attending Veterinarian. Non-compliance may take on many forms, including but not limited to, mishandling of animals, inappropriate housing, deviation from an approved protocol, etc.

Please refer to Appendix W, “Reports of Concerns and Investigations Involving Animal Care and Use” for more information.

[1-13] General Information

If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the IACUC-approved protocol. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.

If the IACUC suspends an activity involving animals, the IO in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW.

[1-14] Use of Electronic Mail (Email) for Official Correspondence

Electronic mail (email), like postal mail, is a mechanism for official University communication. The IACUC will exercise the right to send email communications to all laboratory animal users and the IACUC will expect that email communications will be received and read in a timely manner.

This policy applies to all faculty, staff, students, or any other person listed on a Request to Use Animals submitted to the IACUC for review and approval. Official communications using email can include email to a group, or an email message to only one person.

Section II – Protocol Review Process

The IACUC is responsible for assuring that the research, husbandry, teaching and testing programs involving animals at С��Ƭ��Ƶ provide for animal welfare and comply with all applicable regulations and policies. To fulfill this responsibility, the IACUC reviews all animal research and testing procedures. No animal experimentation, or use is permitted at С��Ƭ��Ƶ without written approval by the IACUC. As such, all animal users at С��Ƭ��Ƶ must complete the Request to Use Animals protocol application, which can be obtained from the IACUC website (http://www.kent.edu/research/researchsafetyandcompliance/iacuc/forms).

Only full-time faculty or staff may serve as principal investigator on С��Ƭ��Ƶ IACUC protocols.

[2-01] New Protocol applications

According to the Public Health Service (PHS) guidelines, protocols can only be approved for a three (3) year period, after which the investigator is required to submit a new protocol for de novo review in order to continue the project. To comply with these guidelines and the requirements of the Animal Welfare Regulations (AWR), investigators will be notified when a protocol is approaching the expiration of its 3-year approval limit.

The protocol approval date for all submissions is the date on which the final designated reviewer votes to approve, or the full committee grants approval. However, a PI may request that de novo approval take effect upon the expiration of the previous protocol. By making this request, the PI acknowledges that only procedures outlined in the protocol being replaced will be conducted until the de novo approval is active.

Investigators are advised that because С��Ƭ��Ƶ is a state institution, all activity is assumed to be public record, including protocols.

1. The Principal Investigator (PI) submits the application via the defined process.
   
    
2. The Office of Research Compliance administers the review per the OLAW assurance and the Office of Research Compliance SOPs. 
   
    
3. Protocol information is maintained in a database. 
   
    
4. Projects involving Category E procedures are reviewed at a fully convened IACUC meeting.

Protocols are assessed for:

• Federal Criteria for Granting IACUC approval
• Activities – Must be in accordance with USDA regulations/PHS policy.
• Pain/Distress - Must avoid/minimize discomfort/distress/pain. If pain/distress is caused, appropriate sedation, analgesia or anesthesia will be used unless scientifically justified. Attending Veterinarian must be involved in planning. Use of paralytics without anesthesia is prohibited. Animals with chronic/severe unrelieved pain will be  humanely euthanized.
• Surgery – Must meet requirements for sterile surgery and pre/post operative care. Cannot use one animal for multiple major operative procedures from which it will recover without meeting specified conditions.
• Euthanasia – Method must be consistent with USDA and Public Health Service regulations.
• Housing/Health - Animal living conditions must be consistent with standards of housing, feeding and care.
• Alternatives - Alternatives to painful procedures must be considered; also must document in the protocol consideration of alternatives if animals experience pain or suffering.
• Rationale and Methods - Must provide written narrative of methods/procedures performed on all animals and a rationale for any painful/distressful procedures.
• Duplication - Must provide assurance that activities do not unnecessarily duplicate previous efforts.
• Number of Animals – Must provide justification for the number of animals included in the proposal.
• Qualifications - Personnel must be appropriately qualified and trained.
  
   

[2-02] Annual Reviews

Annual Review are not conducted as a matter of regular business, but the IACUC reserves the right to request an annual review be submitted. Researchers are responsible for de novo reviews when applicable.      

[2-03] Modification Requests and Personnel Changes

Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities according to PHS Policy IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are as follows:

A modification request must be submitted and reviewed via DMR or FCR procedures when a change or addition to an IACUC-approved protocol is proposed. Investigators are informed that significant changes to the research cannot be implemented without prior IACUC approval. Significant changes include the following changes:

• nonsurvival to survival surgery;
• any activities resulting in greater pain, distress, or degree of invasiveness;
• in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
• in species;
• in study objectives;
• in Principal Investigator (PI);
• that impact personnel safety;
• increases in animal numbers greater than 10%, or any increase in USDA species;
• anesthesia, analgesia, sedation, or experimental substances;
• euthanasia technique ; and
• duration, frequency, type, or number of procedures performed on an animal.

Investigators may use fewer animals than approved. This does not require IACUC approval, notification, consultation, or administrative handling.

Changes that may be handled administratively without IACUC-approved policies, consultations, or notifications include:

• Correction of typographical and grammar errors,
• Changes to house or use animals in a location that is currently used for the same purpose and is part of the animal program overseen by the IACUC;
• Contact information updates; and
• Changes in personnel, other than PI (there must be an administrative review to ensure that all such personnel are appropriately identified, adequately trained and qualified, enrolled in the OHP, and meet other criteria as required by the IACUC).

All personnel working with animals must complete (see also training):

• Online training through the Collaborative Institutional Training Initiative (CITI) online training, which covers the basic principles of proper animal care and use in a research, teaching and testing environment
• CITI Online Biosafety Module (if applicable) training
• Occupational Health and Safety Training
• Basic Laboratory Safety Course
• General animal facility training/orientation
• Laboratory/Protocol specific procedures training

All changes, including amendments and personnel, are documented as part of the protocol. 

Section III – Institutional Administrative Policies Regarding Animal Care and Use

С��Ƭ��Ƶ Policy (10-02.2) of the official Register lists the administrative policies regarding animal care and use.  This policy can be found at the following website: /policyreg/chapter-10-research-sponsored-programs

Section IV – IACUC Policies

The following is a list of IACUC guidelines/policy statements.  Please contact the IACUC Chairperson, attending veterinarian, or the Office of Research Compliance staff should you have any questions regarding procedures or policy related to laboratory animal use or care.

[4-01] Training for lab personnel in decapitation or cervical dislocation 

If animal decapitation or cervical dislocation procedures are being utilized it is the responsibility of the principal investigator to ensure that lab personnel are adequately trained in the proper techniques for this process. Upon training, lab personnel must demonstrate the procedure to a qualified IACUC member and training/approval should be notated on the “Addition of Personnel” form.

[4-02] Changes in personnel on an approved protocol  

The С��Ƭ��Ƶ IACUC requires that changes in personnel be reported with the submission of an “Addition of Personnel” form.

[4-03] Changes in protocol design, procedures, or animals 

A change in protocol design, procedures, or animals requires the submission and IACUC approval of a “Modification Request to Use Animals” form.

[4-04] Decapitation and Cervical dislocation 

Manual cervical dislocation is a humane technique for euthanasia of poultry, other small birds, mice, rats weighing < 200 g. can be classified as pain category C.

[4-05] Animal Care and Use Online Training

Must be completed before final IACUC approval is received for an animal protocol.

[4-06] Online Occupational Health and Safety training 

See Occupational Health Program for Personnel Involved in Animal Care and Use.

[4-07] Literature Searches 

Must be documented to occur within the last 30 days before submission of a Request to Use Animals application.

[4-08] 

See When an Animal Use Protocol May or May Not be Required and Supporting Tissue Transfer/Usage Form

[4-09] 

The applications (IACUC Forms) are used by the IACUC to evaluate the research with respect to the care and treatment of animals. It is also used by various regulatory agencies (e.g., the USDA) to evaluate the compliance of the institution with the various policies and regulations. Therefore, investigators are required to complete all sections of the IACUC forms according to the instructions on them, and in so doing, provide all the information necessary to all these purposes. Failure to include required information can result in delays for gaining IACUC approval (October 10. 2011).

[4-10] 

New procedure for conducting congruency reviews between IACUC protocols and grant applications (minutes, February 13, 2012).

[4-11] 

A new form for the transfer of animals from one protocol to another was developed (minutes, August 13, 2012).

[4-12] 

A procedure and form were developed for exporting animals from KSU animal facilities (minutes, August 13, 2012 and January 14, 2013).

[4-13] 

A policy for the restraint of animals was developed (minutes, edited for clarity, October 14, 2024).

Prolonged restraint (>15 minutes) OR restraint of any amount of time that is utilized to induce stress as part of the experimental paradigm must be documented in the IACUC Protocol.

Prolonged restraint may be stressful to the animal and should be avoided unless it is essential to the research objectives. When restraint is required, consideration should be given to using the least restrictive method possible independent of financial or technical constraints. If prolonged restraint is required, the following procedures should be used unless they are counter to the study objectives.

• Animals to be placed in restraint equipment should be conditioned to the equipment by gradually increasing times of restraint until the maximum is reached.
• The period of restraint must be limited to the minimum required to accomplish research objectives.
• For comfort and safety of the animal, certain types of restraint equipment, such as slings for dogs, require that the animals be monitored throughout the period of restraint. For each situation, the IACUC will make a determination as to the degree of the attention required.
• Restraint utilized as a method of inducing animal stress is a well-established model. Protocols requesting restraint stress must scientifically justify the need for such and minimize the stress period to that which is scientifically justified. Restraint devices for rodents should be designed so that they cannot injure themselves.

[4-14] 

A policy regarding pilot studies was developed (minutes, July 22, 2013).

When novel studies are proposed or information for an alternative endpoint is lacking the use of a pilot studies is an effective method for identifying and defining humane endpoints and reaching consensus among the PI, IACUC, and AV. All pilot studies must be approved by the IACUC. When necessary, the IACUC /AV/Chair may request the study’s PI to communicate in writing any significant findings that relate to the health and welfare of animals.

[4-15] 

A policy on toe-clipping of rodents was developed (minutes, July 22, 2013).

This method of identification should only be used when no other individual identification method is feasible. Scientific Justification is required if this procedure is performed. Under all circumstances aseptic practices should be followed. When possible, this method of identification and genotyping should be combined. Toe-clipping without anesthesia is limited to rodents within the first week of life (7 days) and must be limited to one digit per animal. General anesthesia must be used for toe-clipping of mice older than one week. The recommended age range to toe clip pups is 4-7 days.

[4-16] 

A policy on seeking veterinary consultation when the anticipated pain or distress level is exceeded was developed (minutes, July 22, 2013).

Veterinary consultation must occur as soon as possible when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible.

[4-17] 

A Procedure for Reporting IACUC-Approved Exceptions to the Regulations and Standards to the USDA was developed (minutes, July 22, 2013).

Multiple major survival surgical procedures on a single animal must be clearly described in the animal protocol and approved by the IACUC. Scientific justification must be provided.  USDA Regulated Species: The Institutional Official must submit a request to the USDA/APHIS and receive approval in order to allow a regulated animal to undergo multiple major survival surgical procedures in separate unrelated research protocols. See USDA Guidance for procedures.

Definitions:

Pharmaceutical grade compound: A drug, biologic, reagent etc. which is approved by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written/established by United States Pharmacopeia (USP), National Formulary (NF), or British Pharmacopeia (BP).

Appendix B: Congruency Reviews

PHS Policy and the NIH Grants Policy Statement (Part II, Terms and Conditions) require the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals.

Appendix C: Animal Transit (guidance)

The IACUC recognizes that there may be limited instances when an animal must be transported to a satellite location that is not immediately in the animal’s home building. This guidance document provides the IACUC’s recommendations for developing transport plans. Animal transport and transport procedures must be approved by the IACUC and included as part of an approved Request to Use Animals or amendment. No animal work may occur in a satellite lab until the IACUC has inspected and approved the space, and, if necessary, on a continuing 
semi-annual basis. 

Animals and animal caging must be transported in a contained manner to minimize animal distress, minimize risk of escape, and to protect personnel along the transport route from potential exposure to animal allergens. Additionally, it is essential to transport animals in a manner that does not expose the colony to pathogens or other contaminants.
General guidelines for transporting live animals between buildings/labs:
 

• It is essential to meet with your Facility Manager to discuss transport schedules and methods for limiting the introduction of pathogens or other contaminants to the vivarium. 
• Water bottles must be removed prior to transport to guard against flooding.
  Cages must be tightly sealed by putting tape from bottom to the lid and enclosed in a transport container, to limit the possibility of escape. 
• The transport container should be opaque and sanitizable.
• A lab cart should be used. 
• Consideration must be given to the route and time of day the animals will be moved. Busy times and routes should be avoided.
• Transport must be done in a timely manner and animals should not remain in transport containers for more than 20 minutes.
• Transport should be avoided on days that are excessively hot or cold. Hand warmers can be placed in the transport container (not the cage) to keep animals warm. 
• When possible, use disposable caging and accessories. 
   

Return transport to the building and vivarium:
Live animals:

• Caging and accessories should be sanitized by chemical disinfectant if possible. Care should be given to not expose animals to chemical cleaners. 
• Animals typically need to be held in quarantine upon return. 
• Please be advised that limited space is available in quarantine. The ability to perform experimental procedures in quarantine is limited and must be approved by the IACUC.

Tissue and/or accessories only:

• Tissue and accessories should be separately bagged prior to leaving the satellite location. 
• Tissue should be returned to the vivarium only if it is absolutely necessary.
• Accessories and caging must be sanitized with chemical disinfectant prior to re-entry and immediately placed in the “dirty” cage wash using the dirty corridor.

Appendix D: Animal Concern Report

Appendix E - Exporting Animals

See Facility Manager/Attending Veterinarian. 

Appendix F - When an Animal Protocol May be Required (guidance)

YOU MUST SUBMIT AN ANIMAL CARE AND USE PROTOCOL FORM:

1. You plan to use live vertebrate animals for teaching, testing, or research at С��Ƭ��Ƶ (including regional campuses and centers).
2. You submit a grant application that includes the use of live vertebrate animals at С��Ƭ��Ƶ for which the funding will be administered by the University.
3. You receive or plan to receive funding administered by the University for studies of live vertebrates at another institution (whether or not the animals are owed by С��Ƭ��Ƶ, a University based investigator, or by the host institution).

No animal work can proceed until a protocol has received full Institutional Animal Care and Use Committee (IACUC) approval. 

YOU MAY NOT NEED TO SUBMIT AN ANIMAL CARE AND USE PROTOCOL FORM:

1. You use invertebrates.
2. You are involved in a project at a PHS assured institution which involves vertebrates for which С��Ƭ��Ƶ provides no funding, no aspect of the animal research takes place at С��Ƭ��Ƶ, and the animals are not owned by the University or a University-based investigator. The IACUC may require documentation of the host approval. 

YOU PLAN TO USE TISSUE ACQUIRED FROM A VERTEBRATE ANIMAL:

1. You must notify the IACUC if you are using tissue from vertebrates that have already been euthanized under approval by С��Ƭ��Ƶ or other IACUC or regulatory body. The IACUC may require the submission of supporting documentation (i.e. an IACUC approval letter) for tissue received from other institutions.  

Appendix G: Semiannual Program Review and Inspection

Appendix H: Post Approval Monitoring

Appendix L: Needle Recapping Policy

To reduce the risk of needle sticks, cuts, and punctures and to support a safe work environment, the IACUC requires that all used needles must be disposed of in an appropriate sharps container immediately after use WITHOUT RECAPPING.

Needles must never be recapped with one exception; needles which have NOT been in contact with an animal and have been charged (prefilled) for future use may be recapped by using a one-handed technique – see procedure below. Charged needles should be labeled and used the same day.   Do not draw more of the preparation than is needed.

Needles must never be intentionally broken or bent prior to disposal.

Responsibilities:

• Office of Research Compliance
  • Facilitate ongoing review of this policy
• IACUC
  • Ensure investigators are educated about this policy
  • Review the policy at appropriate intervals
  • Examine sharps containers during inspections or other lab visits
• Principal Investigators
  • Review this policy with all personnel working in their lab
  • Ensure that sharps containers are easily accessible

One handed recapping procedure per the Food and Drug Administration:

1. Place the cap on a flat surface like a table or counter with something firm to “push” the needle cap against.
2. Holding the syringe with the needle attached in one hand, slip the needle into the cap without using the other hand.
3. Push the cap needle against a firm object to “seat” the cap onto the needle firmly using only one hand. 

Appendix N: Social Housing and Enrichment Policy

To support an environment that promotes positive animal welfare and that meets regulatory requirements (Guide 8^th Ed.), the IACUC considers social housing (two or more animals in a cage) the default. Any animals housed individually must be provided an enriched housing environment.  Any exception to this must be approved by the IACUC with scientific justification or as deemed appropriate by the Attending Veterinarian for the provision of veterinary care or other welfare related concerns, including post-operative recovery.

Exceptions to social housing and enrichment standards should be limited to the minimum necessary time period. Enrichment must be provided to singly housed animals.

Responsibilities:

• Principal Investigators
  • Seek an exception through the protocol review process with scientific justification
  • In collaboration with facility personnel, ensure all animals are socially housed by default and provided with sanitary enrichment
  • Maintain records in a manner that allows the veterinary, animal care staff, and the IACUC to be aware that an exception has been approved and is active (for example, door signs may indicate the exception)
• IACUC
  • Ensure investigators are educated about this policy
  • Review the policy at appropriate intervals
  • Review, approve, disapprove or require modifications to secure approval of any exceptions of this policy on a protocol-by-protocol basis
  • Report exceptions to these standards to the IO as part of the semi-annual program review and inspection process
  • Investigate concerns related to these standards
• Office of Research Compliance
  • Facilitate the review of IACUC exemptions
  • Maintain a spreadsheet listing all exceptions
  • Facilitate ongoing review of this policy
  • Report deviations from the policy to regulatory agencies and accrediting bodies

Examples of species commonly housed at С��Ƭ��Ƶ:

• Mice
  • Should be housed with socially compatible groups. Consult appropriate literature for additional information.
  • Individually housed animals must be provided with appropriate enrichment, or scientifically justify why this is not allowed.
    • This may include Nestlets, Nylabones, paper towels, wood blocks, plastic/paper huts (when permissible) or other suitable products as approved by the IACUC for mice.   Mice may also be given sunflower seeds or seed mix.
• Rats
  • Should be housed with socially compatible groups. Consult appropriate literature for additional information.
  • Individually housed animals must be provided with appropriate enrichment, or scientifically justify why this is not allowed.
    • This may include wood blocks, Nylabones, Nestlets, paper towels, cardboard/plastic tubes, tubing, or food enrichments such as nuts or cereal or other suitable products approved by the IACUC. Rats may also be given sunflower seeds or seed mix.
• Avian Species, Environment enhancement to promote psychological well-being  ()
  • Must be housed in socially compatible groups if the species is known to exist in social groups in nature. Exceptions include birds that exhibit vicious or overly aggressive behavior, is/are debilitated, or suspected of having a contagious disease.
    • Social housing conditions must not prevent access to food, water, shelter, and are not known to be hazardous to the health and well-being of each other.
    • Compatibility of birds must be determined in accordance with generally accepted professional practices and actual observations as directed by the attending veterinarian, to ensure that the birds are in fact compatible. Individually housed social species of birds must be able to see and hear birds of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being. If individually housed social species of birds are unable to see and hear birds of their own or compatible species then special attention regarding enhancement to their environment must be provided.
    • Other social species will be housed with socially compatible groups.  Consult appropriate literature for additional information.
  • Provide enrichment by materials or activities that would provide the birds with the means to express noninjurious species-typical activities.
    • Environmental enrichments may include providing perches, swings, mirrors, and other increased cage complexities; providing objects to manipulate; varied food items; using foraging or task-oriented feeding methods; and providing interaction with the care giver or other familiar and knowledgeable person consistent with personnel safety precautions.
  • Special considerations; Certain birds must be provided special attention regarding enhancement of their environment, based on the needs of the individual species and/or individual bird and in accordance with the instructions of the attending veterinarian. Birds requiring special attention are the following:
    • Nestlings, chicks, or fledglings;
    • Those that show signs of being in psychological distress through behavior or appearance;
    • Those used in research for which the Institutional Animal Care and Use Committee (IACUC)-approved protocol requires restricted activity; and
    • Individually housed social species of birds that are unable to see and hear birds of their own or compatible species.
  • Restraint devices; birds must not be permitted to be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the IACUC at research facilities. Any restraining actions must be for the shortest period possible. If the bird is to be restrained for more than 12 hours, it must be provided the opportunity daily for unrestrained activity for at least 1 continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the IACUC at research facilities.
  • Exemptions from housing and enrichment requirements:
    • The AV may exempt an individual bird from participation in the environmental enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted bird. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian.
    • The IACUC may exempt an individual bird from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the IACUC, but not less than annually.
    • Records of any exemptions must be maintained by research facility for at least 1 year.

Sanitation and disposal

• Discard disposable items at suitable intervals (for example, nestlets for mice typically last two weeks)
• Sanitizable items should be sanitized at appropriate intervals (for example, items can be washed with detergents and/or hot water and, where appropriate chemical agents – see Guide p. 71)

Appendix O: Surgery

STANDARD OPERATING PROCEDURE

In order to provide small animals with the highest care during survival surgical procedures, an aseptic technique is required.

Preparation of the Procedural Site

• The procedural site must be dedicated to that purpose while surgery is conducted.  This area should be separated from high-traffic areas and free of unrelated equipment and supplies. If possible, the procedural site should be subdivided into separate areas for animal preparation, surgery, and recovery.
• The surgery table and associated equipment (e.g., stereotaxic apparatus) must be sanitized prior to use.  Suitable products for disinfecting the surgery area include a disinfecting soap and water rinse, 70% alcohol, and quaternary ammonium based disinfectants.
• Covering of the surgical surface with clean paper (e.g., plastic-backed lab bench paper) or cloth will help prevent hypothermia and absorb fluids.

Preparation of the Surgical Instruments and Supplies

• Surgical instruments and implantable materials must be sterilized by an approved method.  Sterilization may be achieved via autoclave or by other means as approved by the IACUC. Autoclaving generally is the preferred method for sterilization because of its convenience, and efficacy. Depending upon the nature of the surgical procedure, the degree of instrument contamination during the surgery, and the type of animal, a sterile set of instruments may be used for up to 2-5 small animals during the same surgery session.  Instruments must be decontaminated during the procedure and between animals using a point heat source, such as a glass bead sterilizer. Exercise care to allow the instrument to cool down before use.
• Instruments and other autoclavable supplies such as gauze pads and drape material can be easily placed within disposable sterilization pouches designed for that purpose or double-wrapped in reusable cloth towels/drapes. Autoclave confirmation tape or color-change indicators should be used in/on each pack that is autoclaved and the date on which the items are autoclaved should be written on the pack. Autoclaved instruments are considered sterile for variable lengths of time depending on the manner in which they are wrapped.  Double cloth wrapped instruments stored in an enclosed cabinet or container and protected from moisture are recognized as sterile for up to 6 months unless the integrity of the wrapping is compromised. Scalpel blades should be purchased sterile and not autoclaved as they are dulled by autoclaving.
• The same methods used to sterilize instruments may be applicable to implantable materials.  Some materials may be commercially available as a sterile product (e.g. polyethylene tubing).
• Surgical instruments should be cleaned with an instrument cleaner or soap and water, rinsed, and dried after each surgery session.  A soft toothbrush or test tube brush is often useful for thorough cleaning of delicate instruments.  Instruments should be stored such that the cutting edges, tips, and points are protected from damage.  Instruments should be sharpened periodically as needed.

Preparation of the Animal

• Food and water are not usually withheld from rodents unless there is concern about ingesta within the gastrointestinal tract as may occur for abdominal surgery.  If this is the case, it needs to be justified in the approved protocol.  Food and water withholding is not recommended in rodents for more than 12 hours.
• Preparation of the animal is usually best done in an area close to, but separate from, the surgery area.
• Plucking or shaving with electric clippers are preferred techniques for removal of fur/hair.  Depilatories and razor shaving should be used carefully due to the potential for dermal irritation.  Loose hair can be removed with a vacuum, tape, or wet gauze.
• The depilated area should extend well beyond the surgical margins so as to facilitate the maintenance of aseptic technique during surgery, but not so far as to contribute to hypothermia.
• Gauze sponges and cotton-tipped applicators are convenient means to wash, rinse, and disinfect the surgical site. The use of cotton tipped applicators are preferred because they help to minimize loss of body heat that may be associated with excessively moistening the skin surface.
• The surgery site must be aseptically prepped including removal of hair and disinfection by an approved method.  For mice, rats and guinea pigs washing with iodine or a chlorhexidine-based surgical soap (e.g. Betadine scrub or Nolvasan scrub) followed by disinfecting with 70 percent alcohol; alternating with an iodine solution is acceptable.  Three applications of 70 percent alcohol alternating with 3 applications of iodine solution should be used to assure aseptic preparation.
  • A new gauze sponge or cotton-tipped applicator should be used for each application.

Surgical Technique

• Sterile gloves, a surgical mask, cap, and a clean outer garment (e.g., lab coat or scrub top – not street clothes) are required.  Exam gloves may be used provided that they are disinfected with a product such as Spor-Klenz (or other IACUC approved disinfectant) and allowed to dry for a minimum of one minute before use.
• The surgery should be conducted so as to minimize trauma to the tissues and preserve the sterility of the instruments and the surgical field. It should be completed as quickly as possible without compromising technique; tissues should be handled delicately and depending on the nature of the surgery, kept moist with warm, sterile saline.  Sutures and staples should not be placed too tightly.  A subcuticular skin suture pattern will often preclude the chewing and removal of sutures by the animal.
• Whenever possible, the surgery site should be draped with sterile cloth, paper, surgical gauze, or clear adhesive vinyl to minimize the risk of contamination to the surgery site.  Care should be taken to avoid placing a drape such that the animal cannot be monitored.  Drapes can have the added benefit of keeping the animal warm.
• Animals should be kept warm using an external heat source, particularly for procedures of any significant length (i.e., longer than 30 minutes).  An electric or water circulating (preferred) heating pad, an overhead heat source such as a lamp or hand warmers can be used.  Great care must be taken to prevent overheating or burning the animal. In all cases the external heat source should be separated from the animal by a towel or other protective barrier.
• Anesthetic agents must be suitably scavenged to prevent inadvertent exposure to humans or animals. A F/Air canister or fume hood can be used. If F/Air canisters are used, they are weighed before and after each use.  After an increase of 50 grams over the initial weight the canisters are disposed of properly. For prolonged procedures, particularly those accompanied by blood loss, warmed fluid therapy should be administered.  The recommended amount is equal to 1-2 cc per 100 g body weight per hour of anesthesia plus any blood loss.  Because of the small size of the patients covered by this policy, the intraperitoneal or subcutaneous routes are usually used.
• During the surgery the animal’s respiration, tissue color and response to aversive stimuli should be monitored so that corrective action can be taken promptly if necessary.

Recovery from Surgery

• Depending upon the nature and duration of the surgery, it may be necessary to provide the post-operative patient with an external heat source during the recovery period.  As described above, steps should be taken to protect the animal from the heat source.  At the very least, animals should be placed on absorbent material or substrate or provided with other external insulating material (e.g. a towel).  Animals recovering from anesthesia or surgery should not be recovered in a wire bottom cage.
• During the recovery period, the animal’s clinical condition should be monitored.  Specific observations should include the body temperature, respiratory pattern, condition of the surgical wound, and the strength and rate of heartbeat.
• Rodents can often be stimulated to breathe in the case of apnea using gentle chest compression or inflating the lungs with a rubber bulb (from a pipette) applied to their nostrils. Supplemental oxygen may be beneficial.
• Animals must be monitored until they have recovered satisfactorily from anesthesia, i.e., normal respiration, sternal posture and moving about.
• The date and a brief description of the surgical procedure, including any drugs administered and the anesthetic agent(s) used, and analgesics used, must be noted on the animal’s cage card.
• Mice and rats cannot remain in investigator laboratories or other unapproved housing areas for longer than twenty-four hours without IACUC approval.  USDA-covered species cannot remain in unapproved housing areas for > 12 hours.

Post-Procedural Monitoring

• Animal must be monitored post-surgically as often as necessary to assure their well-being, depending upon the nature of the procedure and the condition of the animal.  Post-surgical monitoring may range from once daily for one or two days to multiple times per day for extended periods.
• Any abnormal findings must be recorded on the cage card and the veterinarian should be contacted directly or through the facility manager.
• Conditions of observation are reviewed by the IACUC at the time of protocol review.  In some cases, such as when the same procedure is conducted on many animals, alternative methods of record keeping (other than on a cage card) can be used but should be kept near the animals for review.  Please contact your facility manager to discuss alternative means of record keeping.

Responsibilities:

• Office of Research Compliance
  • Facilitate ongoing review of this procedure
  • Report deviations from the procedure to regulatory agencies and accrediting bodies
• IACUC
  • Ensure  investigators are educated about this procedure
  • Review this procedure at appropriate intervals
  • Investigate concerns related to these standards
• Principal Investigators
  • Ensure all personnel involved in surgical procedures are trained on this procedure
  • Maintain surgical records and permit the IACUC access to surgical records

Appendix Q: Obtaining Project Renewals

STANDARD OPERATING PROCEDURE

According to the Public Health Service (PHS) guidelines, protocols can only be approved for a three (3) year period, after which the investigator is required to submit a new protocol in order to continue the project. In order to comply with these guidelines and the requirements of the Animal Welfare Regulations (AWR), the IACUC will review all protocols annually through the use of an annual review form and require a new protocol submission every three years (IACUC Policy and Procedure Manual 2-01).

WHEN AN ANNUAL REVIEW OR THREE YEAR RENEWAL OF AN ONGOING PROJECT IS NOT APPROVED IN A TIMELY MANNER:

The Office of Research Compliance makes every effort to provide investigators timely reminders of project renewal dates. However, it is the responsibility of Principal Investigator (PI) to be aware of project expiration dates and to submit the required materials accordingly. In instances where the appropriate approvals are not obtained in a timely manner the Office of Research Compliance will initiate the following steps:

1. An email memo will be sent to Facility Management, the Attending Veterinarian, the IACUC Chair, and the PI regarding the project’s expired approval status.
2. Animals will be placed on the Holding Protocol according to the procedures outlined in the Holding Protocol Policy.
3. Animals are held on the Holding Protocol until the IACUC is able to convene and review project. The PI may be invited to attend the meeting.
4. The Office of Research Compliance or the IACUC Chair communicates the IACUC’s decision to Facility Management, the Attending Veterinarian, the IACUC Chair, the PI, and the Department Chair.   

Appendix R: Manual Cage Sanitizing

STANDARD OPERATING PROCEDURE

In some instances it may be necessary to sanitize cages and accessories by hand. For example, in emergency situations, or when an IACUC approved protocol involves alternative or specialized housing. Please refer to the emergency preparedness manual for situations where power failures or other emergencies may be in effect. Housing, water bottles, bottle stoppers/sipper tubes, feeders, enrichment items and other small pieces of equipment should be washed with detergents, hot water (note: some detergents may require water to achieve a certain temperature), and where appropriate, chemical agents to destroy microorganisms.

Equipment Needed:

• Quatricide PV (Pharmacal #68020) or equivalent or better
• Cloths, sponges, brushes
• Bucket
• Deep sink
• House water supply
• Personnel Protective Equipment (plastic aprons, rubber boots, cap, mask, rubber gloves, goggles)

Method:

1. Dilute Quatricide (2 ounces per gallon) or equivalent or better solution in bucket with house hot water
2. Thoroughly wash all interior/exterior surfaces of soiled caging, accessories, bottles, etc. with solution
3. Thoroughly rinse caging until all evidence of residual solution is gone
4. Allow caging to drain and air dry before filling/stacking for reuse
5. If the manufacturer provides written guidance, their methods should be followed

Additional Disinfection for Water Bottle Stoppers and Sipper Tubes:

Disinfecting water bottle stoppers/sipper tubes presents a unique challenge since it is difficult to determine if all interior surfaces have been properly decontaminated.  Therefore, in addition to washing and rinsing as described above, these items require additional attention to assure disinfection.

1. Place bottle stoppers/sipper tubes in accessory basket
2. Immerse basket of bottle stoppers into a 10% bleach solution; soak for 15 minutes
3. Manually agitate the basket of stoppers back and forth and up and down carefully through the bleach solution several times
4. Thoroughly rinse all items and allow to drain before re-circulating for use
5. If the manufacturer provides written guidance their methods should be followed

Assessing the effectiveness of disinfection and sanitization:

The effectiveness of manual cage washing should be monitored more frequently than when using conventional methods of cage cleaning (i.e., cage and rack washers). Weekly testing of clean cages and accessories should, therefore, be taken during those times when manual cage washing is being performed.

Method for assessing the effectiveness of disinfection and sanitization:

1. Conduct adenosine triphosphate (ATP) testing and record results (see facility management for details).
2. Microbiological cultures may be conducted as needed.

Appendix T: Occupational Health Program for Persons Involved in Animal Care and Use

Appendix V: Drugs and Chemicals Used in Animals (guidance)

Appendix W: Training (guidance)