Institutional Animal Care and Use Committee

1. It is the policy of Butler University to comply with all applicable federal, state, and local laws and regulations governing the use of animals in research and teaching.
2. Animal studies will be conducted under the direction of a principal investigator who will be a member of the faculty and qualified to perform such studies.
3. It is the responsibility of the principal investigator and co-investigators to know and comply with all applicable federal, state, local, and Butler laws, regulations, and policies governing the use of live animals.
4. Principal investigators must obtain approval from the Butler University Institutional Animal Care and Use Committee (IACUC) prior to using any vertebrate animal for research or teaching. Any deviations from the approved protocol must receive prior approval from the Butler University IACUC.
5. Adherence to the procedures identified in the animal use protocol is the responsibility of the principal investigator. The Butler University IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the approved protocol. In addition, a non-compliance report indicating any principal investigator not in compliance with the policy outlined herein will be forwarded to the Provost for appropriate action.
6. All persons using animals will be appropriately trained. Training will include but will not be limited to reading the training manual provided by the Butler University IACUC and signing a statement of participation.
7. Studies using vertebrate animals will be performed only if suitable alternatives to the use of these animals is unavailable. The phylogenetically lowest species consistent with scientific validity will be employed in all studies and the principal investigator must provide written assurance that the studies do not unnecessarily duplicate previous experiments.
8. Numbers of animals used will be the minimum consistent with validity and reliability of the study. Methods such as videotaped procedures or computer-assisted simulations will be employed whenever possible to reduce the number of animals needed for student teaching laboratories.
9. Studies employing biologically hazardous materials must be approved by Butler's Institutional Biosafety Committee. Studies using radioisotopes must be approved by Butler's Radiological Control Committee.
10. No animal will be employed more than once in a major operative experiment from which it is allowed to recover unless:
    1. it is scientifically necessary as a part of a protocol approved by the Butler University IACUC, or
    2. it is required as a veterinary procedure to protect the health and well being of animals as determined by the attending veterinarian.
       Any exception to this policy must be approved by the administrator of the Animal and Plant Health Inspection Service, United States Department of Agriculture.
11. Living conditions of animals will be appropriate for their species in accordance with applicable federal, state, and local laws and regulations. Adequate food, water, airflow, temperature, space, and cleanliness are to be insured.
12. Medical care for the animals will be available and provided as necessary by a qualified veterinarian.
13. Euthanasia will be performed by a qualified individual in an approved manner to produce rapid unconsciousness and subsequent death without evidence of pain or distress. The procedure will follow current American Veterinary Medical Association recommendations for acceptable methods of euthanasia.
14. Animal carcasses and tissues are considered to be biohazards by Butler's Department of Public Safety, Office of Environmental Programs. Disposal of these materials will be through the Environmental Programs Laboratory.
15. An occupational health program, including both a medical and an educational component, will be provided for all animal care personnel, and for faculty and students having substantial (an average of 8 or more hours per week) animal contact. The level and extent of the occupational health program needed for each individual will be determined by the species of animal and the nature and extent of the contact.

The Institutional Animal Care and Use Committee (IACUC) exists to oversee the use of animals in research and teaching at Butler University and to ensure that all applicable federal, state, and local regulations governing the use of animals are met.

Administrator shall mean the Administrator of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture, or any other official of the Animal and Plant Health Inspection Service to whom authority has been delegated to act in his stead.

APHIS shall mean the ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE.

Chief Executive Officer (CEO) shall mean the President of the University.

Institutional Official shall mean the Vice President of Finance of the University. The Institutional Official is the individual who is authorized to legally commit on behalf of the University that the requirements of 9 CFR parts 1, 2, and 3 will be met.

USDA shall mean the U.S. Department of Agriculture.

The IACUC is made up of six members, qualified through experience and expertise to assess the University's animal program, facilities, and procedures, appointed by the Chief Executive Officer or his/her appointed designee and will include the Director of the Institute for Research and Scholarship, a doctor of veterinary medicine who is experienced in the care of laboratory animals, and a member who is not affiliated with the University in any way other than membership on the committee. If the CEO delegates authority to appoint the IACUC then the delegation must be specific and in writing.

1. review all Protocol for Animal Use forms for compliance with federal, state, and local regulations as well as Butler University regulations,
2. review the University's policies for the humane care and use of animals at least once every six months using USDA regulations and the Guide for the Care and Use of Laboratory Animals as a basis,
3. inspect the animal care facilities for compliance with regulations at least once every six months,
4. prepare reports of its evaluations conducted and submit the reports to the Institutional Official of the University,
5. review and investigate legitimate complaints about the care and use of animals at the University as well as reports of non-compliance,
6. make recommendations to the Institutional Official regarding any aspect of the Butler University animal program,
7. review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals,
8. review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities, and
9. be authorized to suspend an activity involving animals which is in non-compliance with applicable regulations.

All teaching and research activities involving the use of any vertebrate animals at Butler University must receive prior written approval of the IACUC. This includes, but is not limited to, animals owned by Butler University, wildlife animals whose behavior is altered by the proposed activities, and animals owned by other institutions or individuals.

Projects using wildlife species are subject to review by the IACUC if they will alter species-specific behavior in any way. This includes, but is not limited to, any procedure in which the animal will be trapped, penned, or handled. Studies that involve only non-intrusive observation of wildlife species and will not interfere with their normal behavior do not require a protocol. The Principal Investigator must also consider the impact of the project on other wildlife populations that occupy the same area as the species under study.

Studies involving animals not owned by Butler University may also fall under the jurisdiction of the IACUC. If the animals are owned by another institution with an IACUC, the Principal Investigator must submit a protocol to that institution's committee for approval. The approved protocol should then be forwarded to the Butler IACUC for approval.

Studies using animals owned by individuals will require protocol submission as well. Upon approval of the protocol, the Principal Investigator must obtain written consent to use the animal from the animal's owner. In addition, the IACUC has the right to visit the home of the animal or other location of the project to ensure that all animal care and use regulations are being met.

Professional scientists must consider the effects of their activities on the organisms under study, on the validity of study results, and on the use of these organisms by other segments of society. The IACUC recognizes these relationships and supports the sound application of responsible methods for the conduct of animal research in all field and laboratory investigations. This position reflects our ethical and moral concerns regarding human interactions with each other and with other species, and recognizes the scientific benefits of investigations that are not compromised by the manner in which animals are handled or maintained. These concerns are the foundation for our philosophy that responsible methods of animal investigations must include all animal species including cold-blooded vertebrates. (Adapted from The Wildlife Society, Guidelines for the Proper Care and Use of Wildlife in Field Research).

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals is intentionally broad in scope and does not prescribe specifics about the care and use of any species, assigning that task to the IACUC and allowing for professional judgment. Many of the principles embodied in the Guide for the Care and Use of Laboratory Animals, although not specifically addressing cold-blooded vertebrates, generally can be adapted to animal care and use programs for various kinds of amphibians, reptiles, and fishes. It is clear from the literature, however, that individual requirements for these 3 classes of vertebrates, which contain more than 28,000 species that have a diversity of requirements, cannot be addressed in a single set of guidelines. Consequently, the IACUC, while extending its regulatory purview to cold-blooded vertebrates, will seek input from faculty researchers and request a review of their research proposals involving cold-blooded vertebrates to ensure suitable housing and care procedures are being used for these species.

The IACUC will consider for approval animal activities described in a properly completed Protocol for Animal Use form signed by the Principal Investigator. This form may be obtained from the Institute for Research and Scholarship (JH 109) or on the BIRS website. A completed Protocol for Animal Use must be submitted for each study or procedure to be performed. Completed, signed animal use protocols should be submitted to the Institute for Research and Scholarship for distribution to the IACUC.

The Principal Investigator must meet each of the following criteria:

1. Be a member of the faculty of Butler University.
2. Have an academic or professional degree in a discipline based upon animal experimentation, or have similar credentials by virtue of experience.
3. Successfully complete Butler's training program, sign the statement of participation, and agree to comply with the principles of humane animal treatment contained therein.

The Principal Investigator must complete and submit with the protocol an Animal Use Qualifications Form obtained from the Institute for Research and Scholarship (JH 109) or on the BIRS website.

A student may conduct a project using vertebrate animals providing they have a faculty member who meets the above requirements and agrees to act as their mentor and oversee the project as the Principal Investigator. Students must complete and submit an Animal Use Qualifications Form for Student Investigators obtained from the Institute for Research and Scholarship (JH 109) or on the BIRS website.

1. The Principal Investigator must sign the Protocol for Animal Use, thereby certifying the accuracy of the information upon which the IACUC bases its decision to approve or withhold approval of the protocol.
2. The Principal Investigator must complete and sign the Animal Use Qualifications Form, listing the Principal Investigator's experience and credentials to perform animal research, if one is not already on file.
3. The Principal Investigator is responsible for the proper and ethical conduct of the study as well as the humane treatment of the animals used.
4. In addition, it is the responsibility of the Principal Investigator to ensure that all personnel handling animals (including technicians and students) are properly trained.

Effective October  1, 2011

Any employee and/or student, including Principal Investigators, of Butler University who will have responsibility for the care and use of animals as an activity of his/her duties must undergo training prior to initiating that activity and annually thereafter. The training includes an on-line training course as well as training with the animal care staff. Certification from another institution may be considered but must be submitted and approved prior to animal use.  The University offers an on-line training program through the University of Miami's CITI Course for Research Involving the Use of Animals and is available at www.citiprogram.org.

To complete the required education go to CITI's website.  

• Select Butler University as your "participating institution" and create an account.
• When you have created an account you will be directed to a page titled "Select Curriculum" which displays a list of courses on Animal Care.  Complete the module titled Working with the IACUC as well as any research module most appropriate to the type of research you conduct.
• The course may take a few hours to complete but can be done over a period of time. When you complete the course, CITI will e-mail your completion record to the BIRS office.

If you have done CITI education for another organization, add Butler to your profile.  You will be given credit for your previous courses to the extent they overlap with Butler's requirements.

Principal investigators must provide sufficient proof of qualifications for animal use to the Consulting Veterinarian (for invasive procedures) prior to beginning animal use.  Any investigator lacking sufficient qualifications will be provided with appropriate training from the Consulting Veterinarian as needed.

1. In the case of a supervised employee and/or student, the Animal Care Facility Supervisor, the Principal Investigator, or the appropriately trained designee trains the employee and/or student in specific requirements of the particular animal activity protocol.

Required Training for Change of Species or Manipulation

Before any new species, new animal manipulation, or major change to a manipulation is introduced into a facility or animal activity, all employees and/or students caring for or handling the new species or carrying out the manipulation must be trained in the appropriate care and handling of the species and in the manipulation. The Institute for Research and Scholarship procures and provides appropriate training materials, if available, otherwise, it will be the responsibility of the Principal Investigator or Animal Care Facility Supervisor to obtain appropriate training and to ensure that his/her support staff is adequately trained.

Continuing Education

It is the professional responsibility of each Principal Investigator or Animal Care Facility Supervisor working with laboratory animals to acquire up-to-date information in the care and handling of his/her animals and to update his/her support staff accordingly. The Institute for Research and Scholarship is utilized as a resource for up-to-date information and for revisions of federal regulations.

Assurance of Training

Upon approval of a Protocol for Animal Use, the Principal Investigator and any other personnel handling the animals will be required to sign the Qualifications for Animal Use Form. Completion of the form assures the IACUC that the signatory has received required training prior to the initiation of the protocol and that the signatory will continually acquire up-to-date information relevant to the protocol as it becomes available.

Each IACUC member evaluates the proposed animal use activity and either:

1. unconditionally approves the activity;
2. approves the activity conditional upon some suggested modification(s);
3. withholds approval of the activity; or
4. asks for a meeting of the IACUC to discuss the protocol.

When all IACUC members unconditionally approve the protocol, the Principal Investigator is provided with a written approval signed by the chair. Copies of the approval are sent to the Institute for Research and Scholarship where they are archived and available to USDA inspectors and to the Animal Care Technician.

When one or more members of the IACUC gives conditional approval, the Principal Investigator is notified and asked to sign a statement agreeing to the modification(s). Upon receipt of this signed statement, the chair sends an approval notice to the Principal Investigator, the Institute for Research and Scholarship, and the Animal Care Technician. Alternatively, the Principal Investigator may request a meeting with the IACUC to discuss the protocol and the suggested modification(s).

When a majority of IACUC members withholds approval of a protocol, the Principal Investigator is to be notified of the action and the reasons for the action. The Principal Investigator is extended the opportunity to meet with the IACUC to clarify and explain the protocol in greater detail. When a minority of IACUC members withholds approval of a protocol, the IACUC will meet to further discuss the protocol before a final decision is made.

When a Principal Investigator who is also a member of the IACUC submits a Protocol for Animal Use, he or she must abstain from the review process for that protocol.

The duration of approved protocols will be for three years from the date of initial approval by the IACUC unless a different ending date was justified by the Principal Investigator and approved by the IACUC.

The Principal Investigator is required to report the status of his/her research on an annual basis. The Institute for Research and Scholarship will notify the Principal Investigator of the need to submit an annual renewal request prior to the anniversary date of the three-year initial approval. If the Principal Investigator would like to renew the protocol without any modifications or retire the protocol, the Principal Investigator must submit a Protocol Annual Renewal form to the Institute for Research and Scholarship indicating his/her intentions. If the Principal Investigator would like to renew the protocol with modifications, he/she must submit a Request to Modify an Approved Protocol form to the Institute for Research and Scholarship. In addition, the Principal Investigator will be required to submit a new Protocol for Animal Use form every three years. These documents are available from the Institute for Research and Scholarship (JH 109) or on the BIRS website.

If the Principal Investigator requests continuation of the protocol, the Protocol Annual Update form and the Project Narrative will be sent to the Chair of the IACUC. The Chair may renew the protocol on behalf of the IACUC. If the Chair raises an objection to the update, it will be sent in its entirety to all IACUC members for approval and/or a meeting will be called to discuss the update.

Any changes to an approved protocol must be reviewed and approved by the IACUC before they can be implemented by the Principal Investigator. Such changes will include, but are not limited to, changes in procedures, increases in the number of animals to be used, and changes in the species to be used. The Principal Investigator must submit a Request to Modify an Approved Protocol form obtained from the Institute for Research and Scholarship (JH 109) or on the BIRS website.

No vertebrate animals may be acquired without an approved protocol on file. In addition, all animal procurements must be pre-approved by the Chair of the IACUC to ensure there is space available to house the animals.

It is the responsibility of the Principal Investigator to ensure that all persons using animals be made aware of the Bite Reporting and Quarantine Program. This policy is available from the Institute for Research and Scholarship (JH 109) or on the BIRS website below.

The Animal Bite Reporting and Quarantine Program is required by federal law. All animal care personnel should have appropriate immunizations before working with the animals.

Procedures to follow after being bitten by a laboratory animal:

1. Immediately scrub the wound with an antiseptic soap and large volume of water for at least five minutes.
2. Notify immediate supervisor of the incident and report to the Institute for Research and Scholarship to fill out a Bite Report Form and to file an Accident/Incident Report.
3. At the discretion of the supervisor, the injured person may be sent to a designated health care facility for treatment.
4. Identify the biting animal and all associated animals and record the incident and the animal identifier, if appropriate, in the log book.
5. Always preserve the life of the biting animal for diagnostic purposes.
6. Notify the Animal Care Facility Supervisor or Chair, IACUC, so the animal can be placed under quarantine. The veterinarian or his/her representative will examine the animal and institute the proper quarantine measures.
7. During the period of quarantine, the quarantine card shall remain on the cage. The animal shall not be removed from the cage or room and shall not be used for experimental purposes.
8. Notify the Animal Care Facility Supervisor or Chair, IACUC, if there is any sign of sickness or altered behavior in the biting animal during the quarantine period.
9. In the case of death of the biting animal before or during the quarantine period, notify the Animal Care Facility Supervisor or the Chair, IACUC, immediately. The whole carcass shall be refrigerated. DO NOT FREEZE the carcass since this interferes with diagnostic procedures.
10. Animals surviving the quarantine period will be released to the investigator for further use.

Revised 7/03

The Director of the Institute for Research and Scholarship shall be responsible for the overall implementation and maintenance of this program. The Animal Care Facility Supervisor, Principal Investigators, and department heads are responsible for implementation and maintenance of the program at the departmental level. A copy of this OSHP is available from the Institute for Research and Scholarship (JH 109) or on the BIRS website below.

The Occupational Safety and Health Program (OSHP) for personnel who have frequent contact with animals is as follows:

Administrative Responsibilities and Policies

The Director of the Institute for Research and Scholarship shall be responsible for the overall implementation and maintenance of this program. The Animal Care Facility Supervisor, Principal Investigators, and department heads are responsible for implementation and maintenance of the program at the departmental level.

Principal Investigators responsible for the use of animals in research, teaching, or testing shall inform their staff and students of the potential risks involved with working with animals, particularly if hazardous agents are involved. It shall be the responsibility of each department, section, unit, or laboratory to provide proper safety devices and to see that proper safety measures are established and followed by the participants in a project.

Principal Investigators and The Animal Care Facility Supervisor shall adequately inform new personnel regarding this program and of safety or health hazards and procedures. They shall ensure that individuals who are injured or exposed to hazardous materials receive prompt medical attention. Principal Investigators and the Animal Care Facility Supervisor should report potential health and safety hazards within the animal facility or laboratory to the Institute for Research and Scholarship.

Research requiring containment above Biosafety Level I must be approved by the Institutional Biosafety Committee of Butler University.

The Institutional Animal Care and Use Committee (IACUC), in the course of conducting its inspections of the animal facilities, shall review issues related to this OSHP, and, if necessary, shall make recommendations for its revision.

This OSHP shall supplement, not replace, existing departmental programs. Where this OSHP is in conflict with a departmental program, the more stringent of the two shall apply.

Applicability

At the time of employment or shortly thereafter, new animal care employees, those individuals who will have substantial contact with research animals (i.e. an average of 8 hours/week or more) and other personnel, including students, electing to participate in the program will be subject to the following: (a) they are informed of this OSHP and (b) require tetanus immunization. All personnel will be advised about the need for other immunizations. If any employee/student will be working at Biosafety Level 2 or above, he/she will also need to contact Butler's Institutional Biosafety Committee for any further requirements.

Bite Wounds and Other Injuries

When an employee or student has been bitten, is otherwise injured, or is exposed to potentially hazardous animal fluids while working with animals in the University's research facilities, he/she will immediately notify their immediate supervisor and follow the policy and procedures of the Bite Reporting and Quarantine Program and Butler University's Accident/Incident Reporting Policy.

Health Surveillance

The Institute for Research and Scholarship will keep records of bite wounds, other injuries, and unusual illnesses encountered by users of its animal facilities. A summary report will be given to the IACUC and Institutional Official on a semi-annual basis.

Training of Personnel

The immediate supervisors of personnel subject to this OSHP are responsible for training the employee and/or student in each of the following:

Potential hazards and risks

Handling hazardous agents

Animal/animal-related waste disposal procedures

Personal hygiene and personal protection practices

Special precautions in the event of allergy, pregnancy, or illness

Emergency procedures

Questions

Technical questions concerning this OSHP should be addressed to the Institute for Research and Scholarship at birs@butler.edu.

Procedural or Policy questions should be submitted in writing to the IACUC.

Adherence to the procedures identified in the Protocol for Animal Use is the responsibility of the Principal Investigator. The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the approved protocol. In addition, a non-compliance report indicating any Principal Investigator not in compliance with federal, state, local, or Butler University regulations will be forwarded to the Institutional Official for appropriate action.

The University shall maintain the following IACUC records in the Institute for Research and Scholarship:

1. Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations;
2. Records of proposed activities involving animals and proposed significant changes in activities involving animals, and whether IACUC approval was given or withheld; and
3. Records of semiannual IACUC reports and recommendations (including minority views) forwarded to the Institutional Official.

All records and reports shall be maintained for at least three years. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be available for inspection and copying by authorized APHIS or funding Federal agency representatives at reasonable times. APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the University's premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes. Release of any such materials, including reports, summaries, and photographs that contain trade secrets or commercial or financial information that is privileged or confidential will be governed by applicable sections of the Freedom of Information Act. Whenever the Administrator notifies the University in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the University shall hold those records until their disposition is authorized in writing by the Administrator.