November 22, 2013
Western University of Health Sciences
Animal Welfare Assurance for Domestic Institutions
I, Steven J. Henriksen, Ph.D., Vice President for Research, as named Institutional Official for animal care and use at Western University of Health Sciences, provide assurance that this Institution will comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy).
I. Applicability of Assurance
This Assurance applies whenever this Institution conducts the following activities: all research, research training, experimentation, biological testing and related activities, involving live vertebrate animals supported by the PHS. This Assurance covers only those facilities and components listed below.
A. The following are branches and components over which this Institution has legal
authority. Included are those that operate under a different name:
Western University of Health Sciences, Pomona, CA
College of Osteopathic Medicine of the Pacific
College of Allied Health Professions
College of Pharmacy
College of Graduate Nursing
College of Veterinary Medicine
College of Dental Medicine
College of Optometry
College of Podiatric Medicine
College of Biomedical Sciences
Center for Advancement of Drug Research and Evaluation
Western University of Health Sciences, Lebanon, OR
B. The following are other institution(s) or branches and components of another institution: None
The Institution understands that only those entities listed in this section will be entitled to use the Assurance number for grant and contract submissions to PHS agencies.
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 the Assurance. As partial fulfillment of this responsibility, this institution will ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities
for compliance with this Assurance and other applicable laws and regulations
pertaining to animals care and use.
D. This institution has established and shall maintain a program for activities involving
animals according to the Guide for the Care and Use of Laboratory Animals (Guide).
E. This Institution agrees to ensure that all performance sites engaged in activities
involving live vertebrate animals under consortium (sub-award) or subcontract
agreements have an Animal Welfare Assurance and that the activities have
Institutional Animal Care and Use Committee (IACUC) approval.
III. Institutional Program for Animal Care and Use
A. The lines of authority and responsibility for administering the program and ensuring
compliance with the PHS policy, both at the Pomona, CA, and Lebanon, OR,
campuses, are as follows: The IACUC, the veterinarians and the animal facilities
manager report directly to the Vice President for Research who shall serve as the
Institutional Official for the purpose of this Assurance. The Vice President for
Research reports directly to the Provost/Chief Operations Officer of the Institution
who in turn reports directly to the President/Chief Executive Officer of the
B. The qualifications, authority and percent of time contributed by the veterinarian(s)
who will participate in the program are as follows:
1) Dr. Marcelo Couto
Degrees: Ph.D., University of California, Davis (1990)
DVM, University of Buenos Aires Argentina (1978)
Training or experience in laboratory animal medicine or in the use of the species at the institution:
Board Certification by the American College of Laboratory Animal Medicine (1998)
Executive Director, Division of Laboratory Animal Medicine (2006- present), and Campus Veterinarian; Associate Professor of Pathology, UCLA School of Medicine
The Scripps Institute, La Jolla, CA, Associate Director for Comparative
Medicine, Chief of Medicine and Surgery (1998-2001)
UCLA Dept. of Medicine, Assistant Research Pathobiologist (1993-1994)
University of California, Davis, CA, Clinical Training-Internship & Residency Programs, Department of Reproduction (1981-1986) Private practice, Buenos Aires, Argentina (1979-1981)
Dr. Marcelo Couto is the Institutional Veterinarian and has delegated program authority and responsibility for the Institution’s animals care and use program including access to all animals at the Pomona, CA, and Lebanon, OR, campuses.
Dr. Couto will also serve as the Attending Veterinarian for the Pomona, CA, campus.
Time contributed to program:
Estimated and contracted time for Dr. Couto in performance of his duties as
Attending Veterinarian represents 50 hours of service per year with provisions in the contract for additional time as needed. Tom Phillips, DVM, serves as the back-up veterinarian for Dr. Couto. Dr. Phillips is a full-time faculty member in our College of Veterinary Medicine and is available in Dr. Couto’s absence.
2) Dr. Richard Nelson
Degrees: DVM, University of Illinois College of Veterinary Medicine (1974)
Training or experience in laboratory animal medicine or in the use of the species at the institution:
Postdoctoral Training in Laboratory Animal Medicine, Department of Comparative Medicine, University of Washington School of Medicine, Seattle WA, 1992
Bachelor of Veterinary Science, University of Illinois at Urbana- Champaign, Illinois, 1972
Interim Director, Laboratory Animal Resources Center/ Attending Veterinarian, Oregon State University, Corvallis, OR (1/2011-7/2011)
Director, Laboratory Animal Resources/Attending Veterinarian, Shin Nippon Biomedical Laboratories, Everett, WA (1/2005-4/2008)
Director, Transgenic Services San Diego, Charles River laboratories, Wilmington, MA (9/2000-1/2004)
Manager, Toxicology Unit/Animal Resource Unit, Neurocrine Biosciences, San Diego, CA (4/1996-8/1999)
Director, Laboratory Animal Resources, Cell Therapeutics, Seattle, WA (9/1992-7/1995)
Director, Laboratory Animal Resources Center/Campus Veterinarian, Washington State University, Pullman, WA (6/1987-1/1989)
Private Practice Veterinarian, Animal Clinic and Hospital, Moscow, Idaho (6/1974-1/1987)
Dr. Richard Nelson has delegated program authority and responsibility for the Institution’s animal care and use program at the Lebanon, OR, campus where he will serve as the Attending Veterinarian and have access to all animals there. Dr. Nelson will report directly to Dr. Marcelo Couto, the Institutional Veterinarian.
Time contributed to program:
Estimated and contracted time for Dr. Nelson in performance of his duties as
Attending Veterinarian at the Lebanon, OR facility represents 20 hours of service per year with provisions in the contract for additional time as needed. Connie Schmidt, DVM, will serve as the back-up veterinarian for Dr. Nelson. Dr. Schmidt operates Lebanon Animal Hospital that is staffed by four veterinarians. Dr. Nelson will train Dr. Schmidt in the necessary aspects of laboratory animal medicine. Dr. Schmidt is available in Dr. Nelson’s absence.
C. The IACUC at this Institution is properly appointed according to PHS Policy IV.A.3.a. and is qualified through experience and expertise of its members to oversee the Institution’s animal care and use program and facilities. The IACUC consists of
at least 5 members and its membership meets the composition requirements of PHS
Policy 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 (see
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 semiannual program reviews are as follows: The IACUC Chair, in consultation with the committee, shall schedule all program reviews every six months. The review team shall consist of at least two committee members. All members wishing to participate shall be included in the team. The team shall conduct a routine program review using a standardized format based on the Office of Laboratory Animal Welfare (OLAW) Program Review Checklist template.
2. Inspect at least once every six months all of the Institution’s animal facilities, including satellite facilities and animal surgical sites, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual facility inspections are as follows: The IACUC Chair, in consultation with the committee, shall schedule all facilities inspections every six months. Prior notification shall be given to the Vice President for Research to ensure access to all facilities.
The inspection team shall consist of at least two committee members; all members wishing to attend shall be included in the team. Outside consultants on animal care, housing, medical care, etc., shall be invited as deemed necessary. The team shall conduct a routine inspection using a standardized format derived from the OLAW Review Checklist template.
The IACUC shall maintain a list, map and architectural drawings of and contact persons for all animal facilities on campus. This list shall contain itemized information specifically regarding central animal housing facilities, temporary (less than 12 hours) containment facilities, and surgical facilities. Details shall include room numbers, room use, species contained, last noted deficiencies and corrective actions.
During inspections, facility personnel shall be advised of apparent deficiencies. Their input shall be included in the IACUC’s assessment of the issue in question.
3. Prepare reports of the IACUC evaluations according to PHS Policy at IV.B.3 and submit the reports to the Institutional Official. The IACUC procedures for developing reports and submitting them to the Institutional Official is as follows: Notes from the inspection, along with completed checklists, shall be used to prepare a final report to the Vice President for Research. The report shall include categorization of any deficiencies (acceptable vs. minor vs. significant) according to United States Department of Agriculture (USDA) and PHS policy and regulations, a plan and timetable for their correction and contingencies if deficiencies cannot be corrected. If a deficiency is noted during the facilities inspection, the IACUC will identify on the report the person responsible for correcting the deficiency. This person will then be contacted by the Animal Facilities Manager and informed, in writing, of the deficiency and the timetable within which it is to be remedied. The Animal Facilities Manager will then notify the IACUC Chair when the deficiency is corrected and the Chair will note this date on the report. If the deficiency is not corrected by the stated deadline, the IACUC Chair will so notify the Vice President for Research for further action. If a deficiency is noted during the program evaluation, the ICUC Chair will bring the issue before the IACUC for discussion and recommendations. These recommendations will then be presented, in writing, to the Vice President for Research for corrective action. The report shall also identify any IACUC-approved departures from the provisions of the Guide, the PHS Policy or the Animal Welfare Act regulations along with a statement of the reasons for each departure. The Vice President for Research shall contact relevant agencies when federally or independently funded projects are involved or impacted.
A quorum of the IACUC shall review, approve and sign the final report. An addendum shall be added for minority views. If there are no minority views, it shall be so stated in the report. The report shall be presented to the Vice President for Research by the IACUC Chair. Annually, the Vice President for Research shall notify OLAW of inspection and final report dates in a format acceptable to OLAW.
4. Review concerns involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are as follows:
The President, Executive Vice President of Academic Affairs, and the Vic President for Research at the Institution advocate the finest animal care and assure 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 shall reporting such instances be detrimental to an individual’s standing within the Institution; indeed, this action is provided protection under the law (9 CFR, Part 2, Subpart C 2.32 (c)(4)). The complaint reporting procedure and contact names shall be posted in each facility conducting research on or housing research animals.
Placards shall be posted in and surrounding research laboratories and the laboratory animal facility. If an individual wishes to report any concern regarding animals mistreatment, noncompliance or concern for human safety in research or teaching facilities, (s)he may contact the Vice President of Policy and Research, the IACUC Chair, the Campus Veterinarian or the Campus Safety Officer for immediate action. Complainants are encouraged to fully document and sign their complaints. Every effort shall be made to protect the identity of complainants, but absolute anonymity cannot be guaranteed. Every complaint shall be taken seriously and reviewed by the IACUC.
IACUC response to complaints:
The IACUC will request that all complaints be documented in writing and signed by the complainant. If the complainant refuses to do so, the IACUC will make a written record of the complaint and note the refusal of the complainant to provide a written, signed statement. In either case, the IACUC shall use its judgment on whether or not the complaint is of sufficient substance to proceed further. All documented and signed complaints shall be acknowledged as received and, when appropriate, the complainant shall be informed of the outcome. The IACUC reserves the privilege to keep committee discussions and conclusions confidential.
IACUC procedures for the investigation of a complaint:
The IACUC Chair shall designate an individual or subcommittee to handle allegations of mistreatment or noncompliance. All persons involved shall be informed of the purpose of the investigation and those against whom the complaint is addressed shall be given the opportunity to explain their side of the issue. Results of the investigation shall be documented and corrective actions recommended to the IACUC. When allegations result in an official IACUC investigation, the results shall be made available to all parties involved, including eh Vice President of Policy and Research who is ultimately responsible for taking corrective action.
The institutional response shall depend on the nature of the investigative findings. The Vice President of Policy and Research, in consultation with the IACUC, has the power to impose sanctions on the investigator found responsible for any mistreatment or noncompliance. In serious cases, the IACUC is empowered by the USDA regulations and PHS policy to suspend a previously approved project. If the activity is supported by PHS funds, the IACUC, through the Vice President of Policy and Research, shall file a full report to the Office of Laboratory Animal Welfare.
5. Make written recommendations to the Vice President for Research regarding any aspect of the Institution’s animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are as follows: Written recommendations as described in D.3. above shall be forwarded to the Institutional Official by email (copied to IACUC secretary) and interdepartmental mail (copied to IACUC secretary).
6. Review and approve, require modifications in to secure approval, or withhold approval of PHS-supported activities related to the care and use of animals according to PHS Policy at IV.C.1-3. The IACUC procedures for protocol review are as follows:
The Institution’s IACUC has a standardized animal protocol application that shall be submitted by all investigators who propose to conduct activities involving the use of animals. The IACUC shall meet on the second Friday of each month to review submitted protocol applications. Applications may be requested by faculty in computer template format or paper format from the Office of Vice President for Research. All applications shall be submitted to the Office of Vice President for Research no later than two weeks prior to the meeting at which it is to be reviewed.
In order to approve a proposed animal protocol application or proposed modifications in an ongoing approved protocol, the IACUC shall conduct a review and determine that the proposed protocol is in accordance with the Animal Welfare Act and PHS Policy, insofar as it applies to the research project, and that the protocol is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the protocol conforms to the Institution’s PHS Statement of Assurance and meets the following requirements:
1. Procedures with animals avoid or minimize discomfort, distress and pain to the animals and are consistent with sound research design.
2. Procedures that may cause more than momentary or slight pain or distress to the animals shall be performed with appropriate sedation, analgesia or anesthesia unless the procedures are justified for scientific reasons in writing by the investigator.
3. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved shall be painlessly killed at the end of the procedure prior to recovery.
4. The living conditions of animals shall be appropriate for their species and contribute to their health and comfort. The housing, feeding and non-medical care of the animals shall 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.
5. Medical care for animals shall be available and provided as necessary by a qualified veterinarian.
6. Personnel conducting procedures on the species being maintained or studied shall be appropriately qualified and trained in those procedures.
7. Methods of euthanasia used shall be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia unless a deviation is justified for scientific reasons in writing by the investigator.
Clear presentation of a proposal will assist the IACUC in its review. Preliminary discussions between the investigator and any IACUC member are encouraged and can help the investigator develop a proposal containing all the requisite information.
Prior to each monthly review cycle, IACUC members are provided with a list of animal protocol applications to be reviewed. Any member of the IACUC may obtain, upon request, full committee review (FCR) of the applications.
If FCR is requested, approval of the application shall be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. Final review and discussion of an application shall take place at a regularly scheduled monthly meeting of the IACUC. The investigator may be invited to the meeting to answer any questions that may arise from this discussion which will aid in the final decision-making process.
FCR may result in one of the 3 outcomes listed below:
1. Approval: The IACUC considers that all significant points have been addressed by the investigator. As a result of this approval, the investigator has permission to conduct the experiments on the number of animals described in the proposal.
2. Modifications required to secure approval: A proposal may require modifications to secure approval for one of the following reasons:
a) The IACUC considers that substantive changes must be made to secure approval or that there are significant points needing clarification before approval can be granted. This outcome correlates to the PHS Policy outcome referred to as “modifications required in (to secure approval)”. The IACUC is establishing a written policy that all IACUC members have agreed to that authorizes the quorum of members present at a convened meeting to decide by unanimous vote to use designated member review (DMR) subsequent to FCR when modification is needed to secure approval. The written policy also stipulates that any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol. The modified protocol will be reviewed using either FCR or DMR as determined by a unanimous vote of the members present at the convened meeting and following the processes as described in this document.
b) There is insufficient information available to make a determination.
c) There is an absence of a quorum of Committee members.
d) There is some other reason requiring deferral of consideration.
3. Disapproval: The IACUC does not permit the investigator to conduct experiments on animals under this protocol.
The IACUC has ultimate responsibility for the use of animals in research conducted at the Institution. Disapproved proposals cannot be administratively approved by a higher authority. However, the opposite is not true; an IACUC approved proposal can be administratively disapproved by the Vice President for Research or the Provost/Chief Operations Officer for financial, facility-related or other reasons.
If the quorum present at the convened meeting requires minor, administrative changes or corrections to a protocol, such as a typographical error, then a committee member is selected whose responsibilities are to convey the required changes to the investigator. This committee member then reviews the investigators changes to ensure that they have been made. If yes, the designated committee member informs the IACUC secretary and asks him/her to send the investigator a letter of approval. The notice of this approval is then read into the minutes of the next meeting of the IACUC. If no, the IACUC secretary informs the investigator of the issues yet to be resolved before an approval letter will be issued after which animal work may commence.
If FCR is not requested, at least one member of the IACUC, designated by the Chair and qualified to conduct the review, shall be appointed to conduct a DMR of the applications. The reviewer will convey his/her comments and concerns to the investigator, in writing, who then responds, in writing, to each concern. The DMR then decides if the investigator has adequately addressed the issues. If yes, the DMR so informs the IACUC secretary and asks him/her to send the investigator a letter of approval. The notice of this approval is then read into the minutes of the next meeting of the IACUC. If no, the DMR informs the investigator of the issues that need to be resolved.
DMR may result in one of the following outcomes:
1. Approval: The designated reviewer(s) considers that all significant points have been addressed by the investigator. As a result of this approval, the investigator has permission to conduct the experiments on the number of animals described in the proposal.
2. Modifications required to secure approval: A proposal may require modifications to secure approval for one of the following reasons:
a) The DMR considers that substantive changes must be made to secure approval or that there are significant points needing clarification before approval may be granted. This outcome correlates to the PHS Policy outcome referred to as “modifications required in (to secure approval)”.The modified proposal will be re-reviewed by the DMR who will then decide if the investigator has adequately addressed the issues. If yes, the DMR so informs the IACUC secretary and asks him/her to send the investigator a letter of approval. The notice of this approval is then read into the minutes of the next meeting of the IACUC. If no, the DMR informs the investigator of the issues yet to be resolved.
b) There is insufficient information available to make a determination.
c) There is some other reason requiring deferral of consideration.
3. Refer back to the IACUC for FCR: DMR may not result in disapproval. If the reviewer or reviewers, by unanimous decision feel that the protocol is not approvable then it must go back for FCR.
The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC. No member may participate in the IACUC review or approval of an application in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
7. Review and approve, require modifications to (to secure approval) or withhold approval of proposed significant changes regarding the use of animals in ongoing activities according to PHS Policy at IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are described above in Part III. D. 6.
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 according to PHS Policy IV.C.4. The IACUC procedures to notify investigators and the Institution of its decision regarding protocol review are as follows: Following review, the IACUC shall notify the investigator and the Office of Vice President of Policy and Research of its decision in writing. If the decision of the IACUC is other than unqualified approval, 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 as per the general guidelines stated above. An investigator may revise and resubmit a proposal which has previously been disapproved.
9. Conduct annual reviews by DMR, as described in Part III.D.6, of each previously approved, ongoing activity covered by PHS Policy. For the yearly review process, the IACUC may request that the investigator provide a written narrative or submit an Annual Progress Report form that can be obtained from the Office of the IACUC. Any member of the IACUC may obtain, upon request, FCR of the annual report.
All approved protocols expire 3 years from their dates of approval per PHS Policy IV.C.1-5. Investigators shall be notified of the impending expiration of their protocol 60 days prior to the actual expiration date. To continue work on a protocol beyond the expiration date, the investigator must resubmit the protocol as a new protocol for review and approval, prior to expiration of the original protocol, which will then be reviewed as if for the first time by FCR or DMR as described in Part III.D.6.
10. Be authorized to suspend an activity involving animals according to PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are as follows: The IACUC may suspend an activity that it 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 Institution’s PHS Statement of Assurance. 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 Vice President of Policy and Research, in consultation with the IACUC, shall review the reasons for suspension and take appropriate corrective action. The Institution shall also notify the sponsor.
IACUC oversight at the Lebanon, Oregon, campus will be provided by appointing their Attending Veterinarian and one or more of their research scientists engaged in animal research to the University’s IACUC. For real time audio and visual communication, IACUC meetings will be streamed between campuses using Haivision Mako HD which has been in use at both campuses for two years. The Attending Veterinarian and IACUC member(s) at the Lebanon site will be responsible for day-to-day oversight of animal activities at that campus and for conducting semiannual program and facilities reviews. The results of these reviews will be combined with the reviews from the Pomona campus into a single semiannual review document and submitted to the IO as required. Any issues at the Lebanon site will be brought to the IACUC Chair who will bring them before the full committee for open discussion and resolution.
E. The risk-based occupational health and safety program for personnel working in laboratory animal facilities and personnel who have frequent contact with animals is posted on the University’s intranet as part its Injury and Illness Prevention Program. All employees and students involved in research or educational projects involving animals at the Lebanon, OR, and Pomona, CA, campuses are required to be up-to-date on their tetanus/diphtheria boosters. Veterinary medical students will also be required to show proof of immunity to rabies.
The University consults with U.S. Healthworks Medical Group in developing its occupational health and safety program for both campuses. The clinical staff of U.S. Healthworks Medical Group consists of highly qualified doctors, physician assistants and nurses who also provide occupational health services to University faculty and staff in Pomona under a subcontract. They provide a pre-placement medical evaluation that includes determining existing risks relative to allergy, physical limitations, immuno- competence, etc. and monitor employee health regarding zoonoses, hazards, etc. Employees at the Pomona campus injured in the conduct of their duties with the University may be initially treated at the University-owned medical center on campus. Follow-up treatment, if required, is provided either by U.S. Healthworks Medical Group or the employee’s primary care physician. Students may receive initial treatment at the University’s medical center and follow-up treatment by their primary care physician. At the Lebanon campus, employees and students may be initially treated at the Samaritan Lebanon Community Hospital a block from campus with follow-up treatment provided by their primary care physician. Incident reports on all injuries or occupationally related diagnoses at either campus must be submitted by the employee to the University’s Office of Environmental Health and Safety. The University’s Director of Environmental Health and Safety is responsible for monitoring the occupational health and safety program. The IACUC Office maintains the names and contact information on specialists in zoonotic diseases that the subcontractor can call upon should the need arise. Students volunteering to work in laboratories with animal care responsibilities must access occupational health services through their regular medical provider.
Prior to job placement, individuals will receive general training in safe laboratory and animal use practices, including occupational health information. This training is repeated annually and includes hygiene, sharps management, protective gear, decontamination practices, fume hood use, etc. Additional training to individuals in contact with animals will be provided by the Attending Veterinarian in the areas of allergies, zoonoses and special precautions for pregnancy and immune suppression by means of a handout. The Attending Veterinarian will be available to answer questions about the information contained in the handout. Several on-line programs that provide this kind of training are under review. In addition, advanced training in specific areas or animal species is required based upon the particulars of the position description. Based on the current and anticipated levels of research and teaching at Western University, the following hazards/risks have been identified: rat/mouse/guinea pig exposure (i.e. allergens, bites, scratches), infectious agents, chemical hazards (i.e. cleaning solutions), wet surfaces, bedding materials (i.e. cedar), anesthetic gases, flammable gases (O2), sharps, controlled substances, biohazards (i.e. tumor cells, etc.), nuclear radioisotopes, and machinery. The procedures for identifying and reporting risks are included in the Injury and Illness prevention Program document. IACUC policies require that all individuals involved in the research project be identified in the IACUC protocol application and that documentation of appropriate training and experience of these personnel commensurate with their assigned duties be included in the submission.
The occupational health and safety program, as it relates to animals use and care, is reviewed semi-annually by the IACUC and the University’s Environmental Health and Safety officer. Based upon this review, improvements are recommended and implemented.
F. The total gross number of square feet in each animal facility (including each satellite facility), the species of animals housed there and the average daily inventory of animals, by species, in each facility is provided in the attached Facility and Species Inventory table.
G. The training or instruction available to scientists, animal technicians and other personnel involved in animal care, treatment or use at the Lebanon, OR, and Pomona, CA, campuses is available via the University’s on-line IACUC 101 Training Program, the IACUC itself and the World Wide Web. The qualifications of personnel are reviewed when animal protocols are submitted and the level of training required is assessed. Training documentation for Level I and II shall be completed prior to activation of an Animal Care Protocol. Training is reviewed annually in conjunction with the Annual Review of the Animal Care Protocol.
All individuals working with vertebrate animals in research or education as part of their assigned responsibilities at the Institution shall participate in Level I and II training administered by the IACUC.
Animal Care and Use Level I training includes Institutional policies, federal regulations and animal welfare, legal and ethical issues, the concept of the 3Rs, research issues, basic animal care/biology/techniques, occupational health and safety and facility-specific issues. This requirement can be satisfied by several self-directed learning experiences and assessments. Satisfactory completion shall be certified and maintained on file.
Level II training includes species-specific training covering the care, handling and research uses of the elected species. This requirement also can be satisfied by several self-directed learning experiences and assessments. Satisfactory completion shall be certified and maintained on file.
Level III training (advanced techniques, etc.) shall be required annually (one course) or as otherwise required by the IACUC. In addition to any advanced training required by the IACUC, an investigator may request procedure-specific training from the Attending Veterinarians at each campus upon request.
We include training in the area of minimization of animal numbers but we do not teach them how to perform a power calculation. We inform them that a power calculation is one way they can justify to the Committee that they have indeed minimized the number of animals needed. There have been cases, however, when we have recommended to investigators experimental designs that would reduce the numbers of animals needed or asked the investigator to explain why such a design would not be appropriate for their study. We also cover the importance of using, whenever possible, methods that minimize pain and we inform investigators that this is an area that the IACUC gives close scrutiny to when considering whether or not to approve a protocol.
As a requirement to serve on the IACUC, each member must attend an IACUC 101 training session sponsored by the Office of Laboratory Animal Welfare. A copy of each member’s Certificate of Attendance is kept on file in the Office of the IACUC. In addition, each member is provided with a copy of the Guide and the American Veterinary Medical Association’s Guidelines on Euthanasia. They are also directed to the Animal Welfare Act at http://www.gpo.gov/fdsys/pkg/CFR-2009-title9-vol1/xml/CFR-2009- title9-vol1-chapI-subchapA.xml and to the PHS Policy on Humane Care and Use of Laboratory Animals and the OLAW/ARENA IACUC Guidebook at http://grants.nih.gov/grants/olaw/request_publications.htm. A copy of the approved Animal Welfare Assurance is also provided to each committee member. The Attending Veterinarian provides additional guidance and training as needed. By way of continuing education, members are provided with copies of articles from professional journals and websites of professional organizations that deal with issues surrounding the care and use of animals in research and teaching, including social and political issues. These issues are often discussed in open forum at regularly scheduled meetings of the IACUC.
IV. Institutional Program Evaluation and Accreditation
All of this Institution’s programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC within the past six months and will be re-evaluated by the IACUC at least once every six months according to PHS Policy IV.B.1.-2. Reports have been and will continue to be prepared according to PHS Policy IV.B.3. All IACUC semiannual reports will include a description of the nature and extent of this Institution’s adherence to the PHS Policy and 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, reports will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC’s evaluations will be submitted to the Institutional Official. Semiannual reports of IACUC evaluations will be maintained by this Institution and made available to the OLAW upon request.
This Institution is Category Two (2) _ 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 shall maintain for at least three years:
1. A copy of this Assurance and any modifications made to it, as approved by the PHS.
2. Minutes of IACUC meetings, including records of attendance, activities of the committee and committee deliberations.
3. Records of applications, proposals, proposed significant changes in the care and
use of animals and whether IACUC approval was granted or withheld.
4. Records of semiannual IACUC reports and recommendations (including minority
view) as forwarded to the Vice President for Research.
5. Records of accrediting body determinations.
B. This Institution will maintain records that related directly to applications, proposals and proposed changes in ongoing activities reviewed and approved by the IACUC for
the duration of the activity and for an additional 3 years after completion of the
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 the calendar year (January 1 – December 31). The IACUC, through the Institutional Official, will submit an annual report to OLAW by January 31st of each year. The report will include:
Any change in the accreditation status of the Institution (e.g., if the Institution obtains accreditation 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
Any change in the IACUC membership
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 Vice President for Research who is the Institutional Official.
Any minority views filed by members of the IACUC
If there were no changes in the program then the report will indicate that there were no changes.
B. The IACUC, through the Institutional Official, will promptly provide OLAW with a
full explanation of the circumstances and actions taken with respect to:
Any serious or continuing noncompliance with the PHS Policy
Any serious deviations from the provisions of the Guide
Any suspension of an activity by the IACUC.
C. Reports filed under VI.A. and VI.B. above should include any minority views filed by
members of the IACUC.
VII. Institutional Endorsement and PHS Approval
A. Authorized Institutional Official
Name: Steven J. Henriksen, Ph.D.
Title: Vice President for Research
Address: Western University of Health Sciences
309 E. Second Street
Pomona, California 91766-1854
Phone: (909) 469-5299
Fax: (909) 469-5577
B. PHS Approving Official (to be completed by OLAW)
C. Effective Date of Assurance: ________________________________
D. Expiration Date of Assurance: ______________________________