Canisius College Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals
Canisius College, hereinafter referred to as Institution, by means of this document, provides assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
I. APPLICABILITY OF ASSURANCE
This Assurance is applicable to all research, research training, experimentation, biological testing and related activities, hereinafter referred to as activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and conducted at Canisius College, or at another institution as a consequence of the subgranting or subcontracting of a PHS-conducted or supported activity by Canisius College. In this document, the term "Institution" includes all branches and components of Canisius College.
II. INSTITUTIONAL COMMITMENT
A. This Institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
B. This Institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
C. This Institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.
D. This Institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide).
III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE
A. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are:
College President
Vice President for Academic Affairs
IACUC Chair
Veterinarian
Biology Chair
Laboratoy Manager
Work study student employees
Our veterinarian has an independent and direct line of communication to our Institutional Official (our Academic VP), concerning any aspect of our animal care and use program that might concern her. In the event that our veterinarian were to perceive a problem, she has the ability to contact the Academic VP directly if that would be appropriate/necessary for resolving the problem.
B. Authority:
Our veterinarian’s responsibilities include, but are not limited to:
administering all needed veterinary treatments.
periodic inspection of all animals and animal facilities.
membership and participation in all IACUC activities.
C. The Institutional Animal Care and Use Committee (IACUC) at this Institution is properly appointed in accordance with the PHS Policy IV.A.3.a and is qualified through the experience and expertise of its members to oversee the institution's animal program and facilities. The IACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b. Attached is a list of the chairperson and members of the IACUC and their names, degrees, profession, titles or specialties, and institutional affiliations.
D. The IACUC will:
1. Review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semi-annual program evaluations are:
The Canisius College IACUC will meet at least semi-annually to review the College’s program for humane care and use of animals (and to conduct an inspection of the college's animal facilities). The frequency of other meetings will be determined by the demands placed by the frequency of applications for review.
At these meetings, the IACUC will review and evaluate the College’s program for humane care and use of animals. This review will follow the PHS Guide as its principal basis, but will also depend upon (1) the AAALAC Outline for Description of Institutional Animal Care and Use Program (although we are too small to make AAALAC Accreditation warranted in terms of cost, we periodically use their application forms to conduct our own internal evaluations), (2) the AVMA Panel on Euthanasia, and (3) the New York State Department of Health 19 point Lab Animal Facilities check list.
At each meeting, the IACUC Chair will present an overview of the College’s program using this Assurance as an outline, and he will invite discussion by the committee. At each meeting, the committee will also then focus particular scrutiny on a previously selected aspect of our college’s animal-related activity (e.g., personnel training, disposition of surplus animals, HVAC/Humidity, etc.), reviewing it in depth and seeking ways to make improvements. If room for improvement is identified, specific steps will be outlined and responsibility for carrying them out will be assigned to particular individuals along with a targeted time frame. Progress on the desired steps will then be reviewed at the next IACUC meeting.
2. Inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using the Guide as a basis for evaluation. The OLAW Checklist is used to assist IACUC members during their inspection. The IACUC procedures for conducting semi-annual facility inspections are:
The IACUC will meet at least semi-annually to conduct inspections of the college's animal facility. Our IACUC as a whole will visit each room in the entire animal facility. During this inspection, each member will have the specific charge to satisfy themselves that the facility as a whole as well as each room and procedure specifically are in full compliance with the Guide. Each member will be encouraged to ask questions and to look for real or potential problems. The IACUC Chair will make note of any questions or concerns raised and will specifically ask the Committee to decide (by majority vote) whether the concern should be classified as a minor or major deficiency. The IACUC Chair will then specifically solicit minority points of view. All concerns raised, deficiencies identified (both minor and major), as well as minority views will be recorded in our IACUC minutes and in our report to our Institutional Official. The Committee will also determine (by majority vote) the appropriate steps and timetable for correcting any deficiencies and the IACUC Chair will have the responsibility for including that information the committee's report to the Academic Vice President and also for communicating the need for corrective steps to other appropriate college personnel (e.g., animal care staff, maintenance department).
3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional Official. The IACUC process for developing reports and submitting them to the Institutional Official are as follows:
The IACUC Chairperson will have the responsibility for preparing a summary report for the Academic Vice President following each IACUC meeting. This report is to include a summary of the Committee's review of the College's Program for Animal Welfare and a summary of our findings during our facility inspection.
All protocols and husbandry/treatment practices are reviewed by the IACUC for departures from the “Guide”. Whenever any departures from the “Guide” are identified, this is included in the report to the IO. In such an event, either one of two alternative paths are followed: (a) An action plan for correcting the departure is included in the report, with a subsequent follow-up communication to the IO that the departure was corrected promptly, or (b) if the Investigator submits a proposed justification from the “Guide”, the full IACUC reviews the circumstances on a case by case basis and includes the outcome of that deliberation in its report to the IO. In any case, no departure from the “Guide” is permitted without IACUC approval.
This report will also contain specific mention of any minor or major deficiencies that were identified during our program and facility reviews, as well as the specific steps and timetables for correcting such deficiencies that were determined by the IACUC. This summary report is reviewed and signed by all IACUC members before it is forwarded to the Academic Vice President. In any instance in which deficiencies are noted (minor or major) in these reports, a subsequent communication from the IACUC Chair to the Institutional Official is required which will report the status of the proscribed corrective measure(s). Ideally, these follow-up communications will report that any deficiencies have been corrected. But in the case that any deficiency remains uncorrected, the attention of the Institutional Official will be directed to the problem and a new action plan will be described for the Institutional Official’s satisfaction.
4. Review concerns involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are:
Signs are posted in animal areas (and in laboratories where animals are used) that describe who to contact in the event of a concern (the IACUC Chair, the Consulting Veterinarian, and/or the Chair Biology) and how to reach those persons (email and phone numbers provided). In the event that any concern regarding animal care or use is raised by any college personnel, the IACUC Chair (or Acting Chair) will privately and confidentially interview that person. The IACUC Chair will immediately investigate the concern/complaint and make an interim report in writing to our Institutional Official within 24 hours of its being reported. The IACUC Chair will also call a meeting of the IACUC to review the concern within one week of its being reported. Within two weeks, the IACUC Chair will present a final written report to our Institutional Official detailing the nature of the concern and its resolution. Any minority points of view will be included. The report will be signed by all IACUC members and a copy of any such written report will be forwarded to OLAW at the same time.
Individuals reporting concerns to the IACUC will be provided protection against reprisal as required by the Animal Welfare Act.
5. Make written recommendations to the Institutional Official regarding any aspect of the institution's animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are:
The IACUC Chairperson will have the responsibility for preparing a summary report for the Academic Vice President following each IACUC meeting. This report is to include full explanation of any recommendations that the Committee has developed regarding any aspect of the institution's animal program, facilities, or personnel training. This summary report is to be reviewed and signed by all IACUC members before it is forwarded to the Academic Vice President.
6. In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require modifications in (to secure approval), or withhold approval of PHS-supported activities related to the care and use of animals. The IACUC procedures for protocol review are:
By College policy, no teaching or research use of non-human vertebrate animals can take place without prior review and approval by the College Institutional Animal Care and Use Committee. The Biology Department Laboratory Manager in conjunction with the College Purchasing Office have been directed to not allow the ordering of animal subjects for any given protocol until IACUC approval is obtained. The Biology Laboratory Manager sits as a member of the IACUC and thus has access to all records concerning the approval status of all protocols.
The IACUC Chair will disseminate relevant information and regulations to concerned individuals, will receive all applications for review, and will coordinate the review process on the part of the committee.
The IACUC in its entirety will convene in a meeting to review all applications. (A Designated-Member-Review process is not used at our institution.) In the event that any member(s) are unable to attend, a meeting of the IACUC will be considered valid if and only if a quorum of members is in attendance. These meetings will be held at least three times per year (or more frequently as the number of new applications warrants). The costs and benefits of each proposal will be reviewed with respect to animal welfare concerns, with respect to personnel safety and with respect to scientific merit. When reviewing each protocol, the IACUC members will consider the following criteria:
a. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
b. 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.
c. 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.
d. The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.
e. Medical care for animals will be available and provided as necessary by a qualified veterinarian.
f. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
g. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (PDF), unless a deviation is justified for scientific reasons in writing by the investigator.
If any IACUC member expresses a reservation, the concern will be fully aired. Where possible, an attempt will be made at the meeting to generate modification of the proposal to be suggested to the applicant so that the project would be both allowable while simultaneously having the IACUC concerns addressed. When this occurs, the application is referred back to the applicant to allow for its re-submission and re-consideration by the full committee. This effort notwithstanding, the IACUC, by majority vote, is empowered to approve, or withhold approval from, or request modifications in, any proposed animal-related activity.
The IACUC Chair will report the judgment of the committee both to the applicant and to the Institutional Official (Academic VP). The applicant will be informed by written memorandum from the IACUC Chair. The Institutional Official will be informed via a written meeting summary from the IACUC Chair.
7. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are:
When a significant change is contemplated in any ongoing animal-related activity, the Canisius College IACUC will require that a new application/protocol be prepared by the user and the Committee will review it de novo. The determination whether a proposed change is to be deemed "significant" will be made by the IACUC Chair. In this regard, any changes in the following will be considered significant:
• changes in the objectives of a study
• changes from non survival to survival surgery;
• changes resulting in greater discomfort or in a greater degree of invasiveness;
• changes in the species or in approximate number of animals used;
• changes in Principal Investigator;
• changes in anesthetic agent(s) or the use or withholding of analgesics;
• changes in the method of euthanasia; and
• changes in the duration, frequency, or number of procedures performed on an animal.
Any significant changes resulting in new applications will undergo IACUC review de novo at a meeting of the full IACUC as described in section III.D.6 above.
8. Notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy at IV.C.4. The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are:
The IACUC Chairperson has the responsibility for disseminating the Committee's decision to approve or withhold approval of those activities related to the care and use of animals, or of any modifications that have been deemed necessary by the Committee to secure its approval. The IACUC Chair will report the committee's judgment both to the applicant and to the Institutional Official (Academic VP). The applicant will be informed by written memorandum from the IACUC Chair. The Institutional Official will be informed via a written meeting summary from the IACUC Chair. In both communications, the reasons for the IACUC decision will be articulated. The applicant will then have the option to respond to the committee in writing and he/she will be allowed to clarify or amend the application whereupon it will be eligible for re-consideration by the IACUC.
In the event that any proposed animal-related activity is disapproved by the IACUC, the IACUC Chair will have the additional responsibility of notifying in writing all of the following institutional administrative officials: Academic Vice President (our "Institutional Official"), Departmental Chair, Consulting Veterinarian, Laboratory Manager, Purchasing Office. In such an event, the IACUC Chair is to seek follow-up confirmation that the disapproval has been specifically noted by each of the administrative officials listed here.
9. Conduct continuing review of each previously approved, ongoing activity covered by PHS policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS policy at IV.C.1-4. at least once every three years. The IACUC procedures for conducting continuing review are:
All previously approved, animal protocols at Canisius College are reviewed de novo annually. That is, each applicant/instructor is obliged to re-apply to use animals each year and the IACUC re-evaluates each teaching- or research-related use on an annual basis.
10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. The IACUC procedures for suspending an ongoing activity are:
The IACUC is also empowered to suspend, or withdraw approval from, any previously approved animal activity. 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. In such an event, the IACUC Chairperson will have the responsibility for notifying investigators in writing of the Committee's decision to suspend approval of any given activity related to the care and use of animals. The IACUC Chair will have the additional responsibility of notifying in writing all of the following institutional administrative officials: Academic Vice President (our "Institutional Official"), Departmental Chair, Consulting Veterinarian, Laboratory Manager, Purchasing Office. In such an event, the IACUC Chair is to seek follow-up confirmation that the suspension has been specifically noted by each of the administrative officials listed here. In the event of a suspension, the Institutional Official will review the reasons for the suspension in consultation with the IACUC. The Institutional Official will then take appropriate corrective action and report that action with full explanation to OLAW.
The College's Consulting Veterinarian sits as a voting member of the IACUC. The Consulting Veterinarian is additionally charged to make her own unannounced inspections of our facilities, husbandry procedures and other animal-related activities. The Consulting Veterinarian is separately authorized to temporarily suspend any animal activity that she deems unacceptable based on animal welfare considerations. In the event that the Veterinarian exercises this separate authority to suspend any given activity, she will immediately notify all of the following individuals (in person or by telephone): the animal user (the "PI"), the IACUC Chair, the IACUC full membership, the Laboratory Manager, the Department Chair and the Academic Vice President (our "Institutional Official"). The Consulting Veterinarian will follow any such temporary suspension with a written report within 24 hours. In such an event, the Consulting Veterinarian is to seek follow-up confirmation that the suspension has been specifically noted by each of the College personnel listed here. The IACUC Chair will convene a meeting of the full IACUC membership within one week of any such temporary suspension. At this meeting, the IACUC membership will review the matter, hearing from all concerned parties, and then determine whether the animal-use protocol in question will remain suspended, be disallowed, or be permitted to resume. In any event, a written report will then be presented to our Institutional Official within one week of such a meeting, and a copy of this report will be forwarded to OLAW.
E. The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is as follows:
1. The Director of the College Health Center is involved in the planning and monitoring of our animal care program. He/she has the responsibility to monitor our Occupational Health program.
2. The Biology Laboratory Manager serves as the Animal Unit Safety Officer. He/she is a member of the IACUC and is also involved in the planning and monitoring of our animal program.
3. All employees of the college, including work-study students, are covered by workman's compensation in the event of injury on the job. In the event of injury, this would provide for medical expenses and salary continuation.
4. All full-time employees and students are provided with the opportunity to choose among a number of private medical insurance plans and are required to carry personal medical insurance.
5. A year-round OSHA-Committee exists on campus, which has oversight responsibilities for employee safety and working conditions. A brochure on safety and health concerns is provided to all college employees, including employees of the animal facility. We presently do not utilize a “health evaluation” system.
6. All animal facility employees attend a mandatory training session on occupational health and safety. This training session is conducted jointly by the IACUC Chair and the Consulting Veterinarian.
7. The training session mentioned above specifically includes an overview of hazard identification and risk assessment. It includes training relative to the risks of zoonoses, chemical safety, physical hazards, allergies, handling of waste materials, and precautions appropriated during pregnancy, illness or immune suppression.
8. All relevant personnel are obliged to maintain a log of every training stage pertinent to animal work, and they are also required to pass written exam(s) associated with such training.
9. The college maintains an infirmary on campus staffed by a full-time nurse and a part-time physician. There is also a standing arrangement for ready-treatment at the Sister's Hospital Emergency Room which is four blocks from the campus.
10. Immunizations (including tetanus) and health testing are offered to all animal facility employees at the college infirmary, free of charge.
11. The following personal protective equipment is supplied free of charge for all animal workers: vinyl gloves, dust respiration masks, safety glasses, vinyl aprons. These items are to be used in all animal care work and in all applicable research procedures. Additionally, cloth laboratory coats, disposable laboratory coats, shoe protectors, and sleeve protectors are freely available and their use is expected whenever applicable.
12. In the event of any injury, it is mandatory that our campus Public Safety office be immediately notified. In addition, the details of any injury must be reported to supervisor, the Biology Dept Chair, the IACUC Chair. In the event of any bites, scratches, or any other injury, the responding Public Safety officer handles appropriate first aid and provides transportation to the emergency room at Sister’s Hospital (four blocks from campus).
F. The total gross number of square feet in our animal facility is approximately 3200. (There are no satellite facilities.)
G. The training or instruction of scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:
The College conducts a mandatory training session once each year for all personnel associated with animal work (scientists, instructors, lab assistants, caretakers, and facility manager). These animal-related sessions are conducted in conjunction with the semi-annual Biology Department Laboratory Safety training sessions, and they are jointly conducted by the IACUC Chair and the College’s Consulting Veterinarian. These sessions specifically include, among other topics, instruction and discussion on research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress. Written records of these sessions is maintained by the IACUC Chair including documentation of the particular topics covered and the specific individuals in attendance.
Additional instruction to our work-study animal caretakers on animal husbandry techniques, standards, and practices, is provided on-the-job by the IACUC Chair and the Biology Department Laboratory Manager. The caretakers are supervised by those two individuals on a day to day basis. Our Consulting Veterinarian supplements this training in person during his/her scheduled and unannounced visits to the campus.
Beyond this, according to College policy, Canisius faculty members involved in, or supervising, the care, handling, or treatment, of animals will be expected to satisfy the IACUC of satisfactory knowledge and/or training regarding the procedures to be employed. This occurs as part of the protocol-review process by the provision of relevant biographical information in the application.
Additionally, faculty members are expected to provide in-person training, or personally verify the ability of, any one else involved in animal activities before he or she is allowed to conduct such tasks in the absence of direct supervision. A written record must be kept specifying each training session, including the name of all persons involved and the nature and extent of their training, this record being kept available for inspection by the college IACUC.
IACUC members receive training in the following ways:
• at the first IACUC meeting of each year the Chair presents a 30-min overview of IACUC functions, responsibilities and procedures.
• each member of the IACUC receives copies of (a) the Animal Welfare Act, (b) the “Guide”, and (c) the college OLAW Assurance.
• prior to the deliberation of each protocol, the IACUC Chair draws attention to any applicable regulatory considerations
• the college’s Institute for Human-Animal Relations (ISHAR) maintains a library of reference material related to IACUC functions and laboratory animal welfare/care, including the IACUC Handbook.
IV. INSTITUTIONAL PROGRAM EVALUTION AND ACCREDITATION
All of this institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months in accord with PHS Policy IV.B.1-2. Reports have been and will continue to be prepared in accord with the PHS Policy IV.B.3. All IACUC semi-annual reports will include a description of the nature and extent of this institution's adherence to the Guide. Any departures from the Guide will be identified specifically and reasons for each departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, the report will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC evaluation will be submitted to the Institutional Official. Semiannual reports of IACUC evaluations will be maintained by this institution and made available to Office of Laboratory Animal Welfare (OLAW) upon request.
This Institution is Category Two—not accredited by the Association for Assessment and accreditation of Laboratory Animal Care, International (AAALAC). As noted above, reports of the IACUC’s semiannual evaluations (program reviews and facility inspections) will be made available upon request. The report of the most recent evaluations (program review and facility inspection) is attached.
V. RECORDKEEPING REQUIREMENTS
A. This institution will maintain for at least three years:
1. A copy of this Assurance and any modifications thereto, as approved by PHS.
2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.
3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.
4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official.
5. Records of accrediting body determinations.
B. This institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.
C. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.
VI. REPORTING REQUIREMENTS
A. This Institution’s reporting period is January 1 to December 31. The IACUC, through the Institutional Official, will submit an annual report to OLAW on January 31 of each year. The report will include:
1. Any change in the accreditation status of the Institution (e.g., if the Institution becomes accredited by AAALAC or AAALAC accreditation is revoked), any change in the description of the institution's program for animal care and use as described in this Assurance, or any changes in IACUC membership. If there are no changes to report, this institution will provide OLAW with written notification that that there are no changes.
2. Notification of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to the Institutional Official.
B. The IACUC, through the Institutional Official, will provide the OLAW promptly with a full explanation of the circumstances and actions taken with respect to:
1. Any serious or continuing noncompliance with the PHS Policy.
2. Any serious deviations from the provisions of the Guide.
3. Any suspension of an activity by the IACUC.
C. Reports filed under VI.A.2. and VI.B. above shall include any minority views filed by members of the IACUC.