Institutional Animal Care and Use Committee (IACUC)

Overview:

Animal experimentation is a crucial component of scientific research and education. Most advances in modern biomedical science can be traced back to original, critical studies in animals. It is recognized that useful tools such as computer modeling techniques, cell tissue, or organ culture methodology have been developed which have contributed in part to a reduction in the number of animals used in biomedical research and in teaching in recent years. However, because of the inherent complexity of biological systems functioning in either health or disease, such tools currently serve primarily as adjunctive aids to the investigational process, and are not yet substitutes for the study of the living animal. In addition, because of ethical considerations, in many instances living systems cannot be studied in the required depth in living human subjects. Therefore, animal based experiments will continue to be essential for a considerable period in order to solve existing health problems and to provide for high quality biomedical educational experiences.

The use of animal subjects in scientific and educational activities is governed by professional standards of ethical conduct as well as by federal and state regulations which reflect the general concerns of society.

Federal and state statutes as well as the Public Health Service Animal Welfare Policy requires that all research institutions establish an Institutional Animal Care and Use Committee (IACUC). Under these regulatory mandates the IACUC is charged with the responsibility and authority for oversight of the proper care and use of all laboratory animals.

The IACUC employs the use of Animal Welfare Regulations CFR, Title 9, Chapter 1, Subchapter A, Parts 1, 2 and 3 along with The Guide for the Care and Use of Laboratory Animals to assure the University is in compliance with all federal, state, and local regulations as well as University policy and Assurance to the Office for Laboratory Animal Welfare (OLAW).

The University's Animal Care Program and Laboratory Animal Facilities are fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, a voluntary peer review process. AAALAC accreditation, as the gold standard in animal care, is confirmation to all external organizations, including funding bodies and governmental authorities, that the animal care program is conforming to internationally accepted standards.

FEDERALLY MANDATED FUNCTIONS OF THE IACUC:

  • Review at least once every six months the institution's program for humane care and use of animals using THE GUIDE and AWA 9 CFR, Chapter I, Subchapter A as a basis for evaluation.
  • Inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using THE GUIDE and AWA 9 CFR, Chapter I, Subchapter A as a basis for evaluation.
  • Prepare reports of the IACUC evaluations as required by the Animal Welfare Act and PHS Policy and submit these reports to the Institutional Official. The reports must contain a description of the nature and extent of the Institution's adherence to THE GUIDE, AWA 9 CFR Subchapter A, and PHS Policy and identify specifically any departures and the reasons for such departures, the reports must distinguish significant deficiencies from minor deficiencies and contain a reasonable and specific plan for correcting each deficiency.
  • Review concerns involving the care and use of animals at the institution.
  • Make recommendations to the Institutional Official.
  • Review and approve, require modification in or withhold approval of the use of animals.
  • Be authorized to suspend an activity involving animals in accordance with specifications in PHS Policy or USDA regulations.

IACUC MEMBERSHIP:

The Vice President for Research, as the designated Institutional Official, appoints the IACUC qualified through experience and expertise to oversee the Institution's Animal Care Program and Laboratory Animal Facilities. The IACUC must have at least 5 members and include at least one DVM (Doctor of Veterinary Medicine) with experience in Laboratory Animal Science and Medicine, one practicing scientist experienced in research involving animals, one non- scientist, and one non-affiliated member.

The University's IACUC currently consists of ten members of which one is a veterinarian experienced and trained in Laboratory Animal Medicine, one practicing scientist, experienced in research involving animals, one member whose primary concerns are in a non-scientific area (ethicist, lawyer, clergy), and one member not affiliated in any way with the institution and is not a member of the immediate family of a person affiliated with the institution.

The IACUC has an advisory group that consists of personnel from the University Biosafety Committee, Environment Health and Safety, Radiation Safety, Sponsored Programs Administration and the Laboratory Animal Facilities.

IACUC PROTOCOL REVIEW CRITERIA:

  1. Procedures with animals will avoid or minimize discomfort.
  2. Alternatives to procedures that may cause more than momentary or slight pain or distress to the animals have been considered, and the investigator has provided a written narrative/description of the methods and sources used to determine that alternatives were not available or acceptable.
  3. Investigators have provided written assurance that the proposed activities do not unnecessarily duplicate previous experiments.
  4. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia unless the procedure is justified for scientific reasons in writing by the investigator.
  5. The attending veterinarian or his/her designee have been consulted for procedures that may cause more than momentary or slight pain or distress to the animals.
  6. Procedures do not include the use of paralytics without anesthesia.
  7. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate during the procedure.
  8. The living conditions of the animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non medical care of the animals will be directed by a qualified veterinarian.
  9. Personnel conducting procedures will be appropriately qualified and trained in those procedures.
  10. Activities that involve surgery include appropriate provision for pre-operative and post-operative care. All survival surgery will be performed using aseptic procedures. Surgery performed on non rodents will be conducted in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures.
  11. No animal will be used in more than one major operative procedure from which it is allowed to recover unless justified for scientific reasons in writing by the investigator.
  12. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.

GUIDELINES FOR OBTAINING APPROVAL FOR THE USE OF ANIMALS:

State, Federal, and PHS regulations require that ALL uses of animals within the institution are reviewed and approved for humane care by the University's Institutional Animal Care and Use Committee (IACUC) regardless of funding sources.

The IACUC requires a full application be submitted for review every three years, whether or not changes have been made to a protocol. For annual reviews, a short questionnaire must be completed for submission to the IACUC. Notification will be sent to the PI one month before the anniversary date of the approved protocol. If at any time, a change is needed to a protocol, an Animal Use Minor Amendment Form must be submitted and approved by the IACUC before applying this change to the protocol.

No project may begin or animals purchased until approval has been granted by the IACUC. For continuing projects (annual review, 3 year renewal), no additional animals can be entered into the study or additional animals purchased without continuing IACUC approval. Research cannot continue past the expiration date of the project without IACUC re-approval. Approved protocols are held on file for a period of three years beyond completion of the protocol. Approved protocols are read by authorized personnel of the federal, state, and accreditation agencies.

SUBMISSION OF APPLICATION:

Applications are due by the last business of the month. Submit the original signed copy of the application form and one copy of the application form electronically. Parts 1-12 must be completed and submitted along with the other applicable Parts, 13-22, of the application form. Do not reference previously approved protocols or parts of previously approved protocols or procedures. Do not refer to other pages in the form. The parts of the application that do not apply do not need to be completed and should be discarded and/or deleted from your application. The signed original (hard copy) must be typed. The IACUC will not accept for review any forms that deviate from the format.

Care should be taken when filling out the application form to ensure completeness and accuracy. Attachments will be discarded and not considered for review. Incomplete forms will be returned without review.

Applications must be submitted by faculty as the PI, non faculty, e.g. post-doc fellows, students, may be named as secondary investigators. The PI is responsible to the University for the conduct of the research under his/her supervision.

Investigators are encouraged to contact the veterinary staff at 829-2919 for assistance in protocol development and pre-review before submission to the IACUC to avoid any delays in obtaining approval or contact the IACUC for assistance at 829-2752.

Protocols that involve the use of biohazardous materials such as radioactive substances, infectious agents, recombinant DNA, and toxic chemicals, documentation of approval from the appropriate oversight committee (e.g. University Biosafety Committee, Radiation Safety) must be submitted with the animal use application .

AMENDMENTS AND CHANGES TO PROTOCOLS

If, at any time, a change in protocol is needed, an “Animal Use Minor Amendment” form must be submitted (hard copy or electronically) and approved by the IACUC before applying this change to the protocol. The IACUC recognizes that research is dynamic and creative, however, during the course of the project, variances must be justified and described in writing to the IACUC and prospectively approved by the IACUC.

A change in species is not considered “minor” and therefore, an application form would need to be submitted for IACUC review and approval.

Changes to protocols involving the use of a biohazardous agent, e.g. radioisotope, toxic chemical, would also require the approval of other University oversight committees, such as Radiation Safety Committee or the Biosafety Committee before the IACUC would approve the changes to the animal protocol.

Amendments can be submitted at any time and are reviewed as received.

Submit all amendment forms to the Institutional Animal Care and Use Committee, 150 Parker Hall, South Campus or to Campanella@research.buffalo.edu
.

Protocol Submission Deadlines:

Proposals must be submitted by the close of business by the last day of the month for the next months review. Proposals received after the due date will be held for the following month’s review session. No exceptions will be allowed.

Deadlines:

(Due by the last day of each month for the following months review)

  • Monday, January 31, 2005, for February review
  • Monday, February 28, 2005, for March review
  • Thursday, March 31, 2005, for April review
  • Friday, April 29, 2005, for May review
  • Tuesday, May 31, 2005, for June review
  • Thursday, June 30, 2005, for July review
  • Friday, July 29, 2005, for August review
  • Wednesday, August 31, 2005, for September review
  • Friday, September 30, 2005, for October review
  • Monday, October 31, 2005, for November review
  • Wednesday, November 30, 2005, for December review
  • Thursday, December 29, 2005, for January 2006 review

IACUC FORMS:

ALL PERSONNEL working on currently approved projects MUST fill out the ALL of the following:

Please returned these forms to the IACUC, 150 Parker Hall, South Campus.

APPLICATION FORM in Word (in Word)
Please fill out all sections of the Application that apply. Return the completed original signed Application with 15 copies to the IACUC

MINOR AMENDMENT FORM in Word (in Word)
Please fill out the minor amendment form completely. Return the completed original signed form to the IACUC.

QUALIFICATION FORM in Word(in Word)
All personnel working on approved projects should read, fill in entire form, and return it to the IACUC.

OCCUPATIONAL HEALTH PACKET (pdf)*

All personnel working on approved projects should read this entire packet, fill in the check list, and return the completed check list to the IACUC.
(The Occupational Health Packet can be obtained by using the Adobe Acrobat Reader Software*.)

OCCUPATIONAL HEALTH MONITORING PROGRAM
All personnel working on approved projects should read and complete either the waiver form or enrollment form for the enclosed information.


Enrollment of Program
(last updated: 7/9/2004)

Waiver of Program
last updated: 7/9/2004)

ADDITIONAL FORMS

Anesthesia Monitoring/Surgery Post Operative Report
(last updated: 8/19/2004)

Rodent Surgery Post Operative Report
Rats and Mice only
(last updated: 8/19/2004)

*INSTRUCTIONS for using Adobe Reader:

  • Click here to download Adobe Acrobat Reader FREE!
  • Click on the desired form and then the Adobe Acrobat Software will load and open the form. Click on the hand tool on the Acrobat Reader toolbar. This will allow you to fill out the forms electronically.
  • You can tab between the text fields and point to the check boxes to activate them.
  • Once you have completed filling out the form click on the print icon from the Acrobat Reader toolbar, sign (original signature is required) and send it in.

IACUC POLICIES FOR SPECIAL PROCEDURES:

Policy on the use of multiple surgical procedures:

  1. The nature of the protocol requires it to achieve the desired physical or physiological effect.
  2. There is no other alternative available.
  3. The surgical procedure is needed to create the animal model.
  4. Sufficient time between surgeries is allowed for proper recovery.
  5. Written scientific justification is provided to the Institutional Animal Care and Use Committee (IACUC) and approved.

Policy on the use of physical restraint:
Prolonged restraint should be avoided unless it is essential for achieving the research objectives

  1. The period of restraint should be the minimum required to accomplish the research objective.
  2. Animals should be given training to adapt to equipment and personnel.
  3. Provision should be made for observation of the animal at appropriate intervals.
  4. Veterinary care must be sought and provided if lesions or illness are observed.
  5. Restraint devices are not to be considered normal methods of housing.
  6. Restraint should not be used simply as a convenience in handling or managing animals.

Policies on the use of food/water restriction: Protocols involving the use of Food/Water Restriction are required to include the following provisions:

  1. Food/water restriction for research purposes must be scientifically justified and a program to monitor the physiologic and behavior indexes must be established.
  2. At a minimum, daily logs of food or water intake should be maintained and body weight recorded at least once a week.
  3. Specific criteria indicating an animal’s early removal from the study must be clearly defined.
  4. For food restriction, special attention should be given to ensure animals are consuming a balanced diet.
  5. For conditioned-response protocols, use of a highly preferred food or fluid as positive-reinforcement is recommended in place of restriction.

MECHANISM FOR REPORTING ISSUES OF NON-COMPLIANCE OR MISUSE OF ANIMALS:

Concerns or complaints regarding animals used within the University at Buffalo should be brought directly to the attention of the people involved whenever possible. If the concern or complaint cannot be handled directly, it may be handled in one of two ways:

  1. If an emergency exists, the Director of the Laboratory Animal Facility should be contacted immediately by calling 829-2919. The Director will then take any necessary action and report the incident to the IACUC Chair.
  2. If the situation is not an emergency, the concern or complaint should be submitted to the IACUC Chair through the Office of the Institutional Animal Care and Use Committee, 150 Parker Hall, South Campus, Phone number: (716) 829-2752. The Chair will assign an Ad Hoc committee to investigate the concern or complaint and prepare a report for the IACUC. The IACUC will review the report at their next scheduled meeting.


A written reply will be made to those primarily involved and a report will be sent to the Institutional Official. All actions and recommendations must be approved by a majority of the IACUC.

The IACUC may suspend an activity that is previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, The Guide, or the University's letter of Assurance with OLAW.

No facility employee, committee member or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Animal Welfare Act.

TRAINING REQUIREMENTS:

Federal regulations require that anyone working with laboratory animals have appropriate training and/or experience with the species and specific procedures to be performed, and include the basic needs of each species; proper handling and care; proper pre and post procedural care; aseptic surgical methods and procedures; proper use of analgesics, anesthetics, and tranquilizers; and the concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress. This includes PI's, technicians, research fellows, students, visiting scientists. PI's who may not work directly with animals but supervise an animal use protocol are required to have animal care use training.

The IACUC along with the LAF conduct the Responsible Care and Use of Laboratory Animals Certification Program. It is offered at the beginning of each semester and before the summer session. To be notified of the next training session please contact the IACUC office at 829-2752 or email your request to be notified to IACUC

The current program consist of 4 modules. Modules 1 and 2 are required before attending modules 3 and 4. All personnel using animals are required to attend modules 1 and 2, and any additional relevant modules and demonstrate competence in basic animal procedures in order to receive IACUC certification.

CURRENT TRAINING PROGRAM CONTENT

Module 1 - Lecture Series

  • Regulations impacting on research
  • IACUC guidelines
  • LAF services
  • Research variable (3 R's)
  • Occupational Health and Safety
  • Animal handling and blood collection
  • Disease and diagnosis

Module 2 - Lecture Series

  • Principles of anesthesia
  • Introduction to surgery
  • Pain management

Module 3 - Wet Lab

  • Basic skills and procedures - small animals (mice, rat, etc.)

Module 4 - Wet Lab

  • Basic skills and procedures - large animals (guinea pig, rabbit, etc.)


All personnel are required to complete the Responsible Care and Use of Laboratory Animals Certification Program or provide documentation of having attended and completed a comparable program at another institution.

Acceptable documents of animal use training from another institution. All three criteria must be documented.

  1. Institution is AAALAC accredited.
  2. Certificate/document of animal use training, including course content.
  3. Attendance within the last 5 years.

OTHER TRAINING REQUIREMENTS:

For protocols that involve the use of a biohazard, it is the responsibility of the PI to provide training and information to all personnel who may be exposed to the biohazard including the PI's research staff and appropriate LAF staff.

Documentation of this training must be provided to the IACUC prior to the purchase and use of animals. The documentation should include the date the training was given, who attended (signatures), what information was provided, and who presented the information (instructor).

Training and documentation on the use/exposure to the biohazard must be provided to the IACUC on a yearly basis.

microPET: POSITRON EMISSION TOMOGRAPHY IMAGING FOR SMALL ANIMALS

Department of Nuclear Medicine has recently installed a high resolution dedicated positron emission tomography scanner for studying small animal models of human diseases (microPET). We welcome the researchers at UB and its affiliated institutes to use this state-of-the-art research tool in their research. Department would ensure delivery of radiotracers and provide necessary expertise and support for any collaborative research involving microPET. Department operates a cyclotron, a radiochemistry laboratory, a radiopharmacy and a medical physics division. In addition to the routinely used short-lived tracers, like F-18, C-11, N-13, 0-15, department has recently installed systems to synthesize long-lived positron emitter, I-124. This will enable to develop and characterize novel molecular imaging probes with longer biological half-lives. Please contact us or consult the procedures if you are interested in using microPET in research.

microPET APPLICATIONS

microPET offers the unique opportunity to image small animal models of diseases, including genetically engineered animals. It is a functional imaging modality at molecular level and provides valuable insights into biochemical, physiological, pathological or pharmacological process in vivo. Data can be obtained noninvasively, repeatedly, and quantitatively in the same animal. Current applications include a diverse field including perfusion, metabolism and substrate utilization in various vital organs including heart and brain, gene expression and stem cell tracking, neurotransmitter and receptors, neural activation and plasticity, targeting tumor antigens and elucidating tumor biology such as angiogenesis, hypoxia and apoptosis. Recent research efforts find its application in a wide area ranging from basic insights into the normal physiology and disease processes to drug development and early response to anticancer and gene therapy. Research can also be conducted in the field of imaging physics and scanner development, image and data analysis, attenuation correction and reconstruction techniques, and tracer kinetics and modeling. Several links to current microPET research are available (see the document microPET: Positron Emission Tomography Imaging for Small Animals)

IACUC RELATED DOCUMENTS:

IACUC forms can be obtained as an attachment via email or send a disk to the IACUC offices at the address below. At request, copies of the following documents are available from our offices or at the web sites indicated:

The Office of the Institutional Animal Care and Use Committee
150 Parker Hall,
South Campus
Buffalo, NY 14214-8004

or

Main Office of the Laboratory Animal Facility
116 Biomedical Education Bldg.
South Campus.

For Members Only

UB IACUC, 1999-2004
Comments and Questions can be emailed to the IACUC