| WASHINGTON
STATE UNIVERSITY
Assurance
of Compliance with the Public Health Service
Policy
on Humane Care and Use of Laboratory Animals
Washington
State University , hereinafter referred to as institution, hereby
gives assurance that it will comply with the Public Health Service
Policy on Humane Care and Use of Laboratory Animals, hereinafter
referred to as PHS Policy.
I.
APPLICABILITY
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 this institution,
or at another institution as a consequence of the subgranting or
subcontracting of a PHS-conducted or supported activity by this
institution.
"Institution"
includes the following branches and major components of Washington
State University :
A.
College of Sciences
and Arts
Eastlick
Vivarium and BL-3 Facility
Johnson
Tower , College Hall Animal Facility
B.
College of Pharmacy
Wegner
Hall Vivarium
C.
College of Agriculture
and Home Economics
Department
of Animal Sciences
Experimental
Animal Laboratory Building
Dairy
Center , Swine Center , Beef Center
Cattle
Feeding and Reproduction Barns
Department
of Natural Resource Sciences
Bear
Facility, Deer and Elk Pens, Small Mammal Research Facility
D.
College of Veterinary
Medicine
Department
of Veterinary Clinical Medicine and Surgery
McCoy
Hall, Veterinary Teaching Hospital
Animal
Resources Unit
Bustad
Vivarium, Large Animal Facilities
Washington
State University (WSU) maintains a Memorandum of Agreement between
the Institution and the U.S. Department of Agriculture (USDA) Agricultural
Research Service (ARS) located adjacent to the (WSU) Pullman Campus.
This agreement outlines the cooperative arrangements between the
two units. Specifically, the Washington State University IACUC reviews
USDA-ARS animal care and protocols, inspects the USDA-ARS animal
facilities every six months, and investigates any concerns regarding
the use of animals at the USDA-ARS facilities. The animals and facilities
are the property of the U.S.D.A.
II.
INSTITUTIONAL POLICY
A.
This institution will comply with all applicable provisions
of the Animal Welfare Act and other Federal statutes and regulations
relating to animals. This institution is registered as a research
facility with the USDA, registration number 91-R-002.
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)
and the Guide for the Care and Use of Agricultural Animals in
Agricultural Research and Teaching (Ag 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:
BOARD
OF REGENTS
PRESIDENT
(CHIEF EXECUTIVE OFFICER)
PROVOST
VICE
PROVOST FOR RESEARCH (INSTITUTIONAL
OFFICIAL)
INSTITUTIONAL
ANIMAL CARE AND USE
COMMITTEE (IACUC)
(PRESIDENT'S
STANDING COMMITTEE)
DIRECTOR,
OFFICE OF THE CAMPUS VETERINARIAN (ATTENDING DVM)
COLLEGE
DEANS
ANIMAL FACILITY MANAGEMENT
B.
The qualifications, authority, and percent of time contributed
by veterinarians who will participate in the program are:
Farol
N. Tomson, DVM, MBA
Diplomate,
American College of Laboratory Animal Medicine. 30 years training
and experience in laboratory animal medicine.
Interim
Director, Office of the Campus Veterinarian, 100% university appointment
by the Vice Provost for Research
Steven
Russell, DVM
Graduate
of WSU College of Vet Med in 1996. Completed 3-year lab animal residency
at the U of Missouri. 7 years experience in laboratory animal medicine.
Assistant
Director, Office of the Campus Veterinarian. 100% university appointment
by the Vice Provost for Research.
Steven
M. Parish, D.V.M.
Graduate
of Washington State University College of Veterinary Medicine.
Diplomate
of the American College of Veterinary Internal Medicine.
Professor,
Veterinary Clinical Medicine and Surgery.
Large
animal (food animal/ruminant) medical care.
100%
university appointment; provision of medical care to large animal
species.
Melissa
Hines, D.V.M., Ph.D.
Graduate
of The Ohio State University College of Veterinary Medicine.
Residency
in Equine Medicine, University of Florida .
Associate
Professor, Veterinary Clinical Medicine and Surgery.
Large
animal (equine) medical care.
100%
university appointment; provision of medical care to large animal
species.
The
Campus Veterinarian, as the Attending Veterinarian of record for
the WSU campus and as per the Federal Animal Welfare Act, has final
authority and responsibility to insure that campus programs of veterinary
care are adequate.
Washington
State University provides the Campus Veterinarian the authority
to oversee the adequacy of all aspects of animal care and use of
animals on the WSU campus and the authority to ensure that adequate
veterinary care and adequate pre & post procedural or surgical
care, in accordance with current established veterinary medical
and nursing practices, is provided at all times.
This
authority is exercised in the following manner:
•
While the responsibility for clinical care may be delegated to another
veterinarian, the Campus Veterinarian remains responsible for the
care provided to all research and teaching animals at WSU. The Campus
Veterinarian retains, at all times, the authority to immediately
access the medical records of non-client, research and teaching
animals to assess the care given.
•
Adequate veterinary care consists of
appropriate methods to: prevent disease; survey, diagnosis, treat,
and control disease; manage protocol-associated disease, disability,
or other sequel; provide anesthesia and analgesia; perform surgery
and provide post-surgical care; assess animal well-being; and perform
euthanasia.
•
Methods of disease prevention, diagnosis,
and therapy will be those currently accepted in veterinary practice.
•
All animals must be observed on a daily basis in order to assess
their health and well-being (e.g., monitor
for signs of illness, injury, or abnormal behavior). More frequent
observations might be warranted, such as during postoperative recovery
or when animals are ill or have a physical deficit.
•
This daily observation of animals is regularly performed by someone
other than the Campus Veterinarian
(e.g., animal care staff, research staff or by
a person trained to recognize such signs) but these individuals
must provide direct and frequent communication to the Campus Veterinarian
such that timely and accurate information on problems of animal
health, behavior, and well-being is conveyed to the Campus Veterinarian.
The Campus Veterinary staff is assigned the responsibility of assuring
corrective measures are provided once identified.
•
In addition to adequate veterinary care, the Campus Veterinarian
has the authority to ensure the provision of and to oversee the
adequacy of all other aspects of animal care and use on the WSU
campus. These other aspects can include
animal husbandry and nutrition, sanitation practices, zoonosis control,
and hazard containment. This oversight includes the authority to
access all animals at all times for evaluation of their health and
well-being. Visits to animal housing, study and surgery areas are
routinely scheduled by the Campus Veterinary staff in order to assess
the adequacy of veterinary care and other aspects of animal care
associated with the use of research and teaching animals.
•
The Campus Veterinarian also has the responsibility of providing
guidance to principal investigators and other research personnel
involved in the care and use of animals regarding handling, immobilization,
anesthesia, analgesia, tranquilization, and euthanasia in order
to ensure that humane needs are met and
are compatible with scientific requirements.
•
The College of Veterinary Medicine Veterinary Teaching Hospital
is available to provide care to research animals should one of the
individuals named above not be available.
•
It should also be noted that in the College of Veterinary Medicine
, there will be many researchers/instructors with D.V.M. degrees
who will provide clinical/medical care to their research subjects.
Other large animal veterinarians under the supervision of Drs. Parish
and Hines will also be involved in the provision of clinical care.
Oversight of the care, i.e., assuring care is provided, will rest
with the campus and assistant campus veterinarian.
C.
This institution has established an Institutional Animal
Care and Use Committee (IACUC), which is qualified through the experience
and expertise of its members to oversee the institution's animal
program, facilities and procedures. 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. The IACUC is a President's
Standing Committee with appointments to the Committee being made
by the Chief Executive Officer through the Vice Provost for Research.
Appendix A provides a list of the names, degrees,
position titles, specialties and institutional affiliations of the
IACUC chairperson and members.
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.
A
draft report of the institutionŪs program for humane care and use
of animals that will incorporate recommendations, concerns, or comments
noted by the IACUC during its deliberations and inspections will
be prepared by the campus veterinarian on a semi-annual basis and
provided to the IACUC for their review. The draft will be prepared
using the Guide as a basis for evaluation of the program
and will contain a description of the nature and extent of the institution's
adherence to the Guide and the Policy. Subsequent to review
by individual members and an opportunity provided for discussion
at a convened meeting of the IACUC, any comments or changes are
incorporated and a final document prepared for signature by the
IACUC.
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
IACUC will conduct a semi-annual review/inspection of all institutional
animal facilities using the Guide as a basis for evaluation.
Normally, a minimum of two members of the IACUC will perform an
inspection of each facility. Each committee member is assigned the
responsibility to visit one to two facilities on a rotating basis
every six months.
Site
visits will be performed by at least two IACUC members. Each member
will be given the opportunity to request a visit to and review of
any facility. A report will be prepared for each of the facilities
evaluated and will distinguish between significant and minor deficiencies.
Comments for improvement, where the condition is not considered
a deficiency, will also be listed. Each report will be provided
to the facility management, IACUC members and Vice Provost for Research
for Research as prepared. Facility supervisors and/or their superiors
will respond to listed deficiencies in writing to the IACUC with
a reasonable and specific plan and schedule for each deficiency
for correction. The responses will subsequently be reviewed by the
IACUC.
3.
Prepare reports of the IACUC evaluations as set forth
in the PHS Policy at IV. B. 3. and submit the reports to the Vice
Provost for Research.
The
report that incorporates the IACUC program and facility evaluation
will be prepared as described in III. D. 1. and submitted to the
Vice Provost for Research at least once every six months. The report
will be maintained by the institution and will be made available
to the Office of Laboratory Animal Welfare (OLAW) upon request.
4.
Review concerns involving the care and use of animals
at the institution.
The
IACUC will accept and review any and all concerns brought forth
concerning the care and use of animals at the institution. Concerns
may be brought forward to the IACUC by any individual by contacting
any of its members, the Campus Veterinarian or the Vice Provost
for Research. The individual may bring the concern to the IACUC
in an open or anonymous fashion. The Vice Provost for Research will
be notified of the concern and be briefed on the IACUCŪs findings.
Results of the review will be made known to the individual(s) bringing
forward the concern upon their request.
5.
Make written recommendations to the Vice Provost for
Research, regarding any aspect of the institution's animal program,
facilities, or personnel training.
Recommendations
to the Vice Provost for Research, regarding the institution's animal
care program, to include management practices concerning the humane
care and use of animals, physical condition of animal facilities,
and personnel training, will normally be accomplished in writing
as part of the semi-annual program review. Meetings with the Vice
Provost for Research or memoranda regarding specific topics will
also be utilized in providing the Vice Provost for Research specific
information on the program.
6.
Review and approve, require modifications in (to secure
approval) or withhold approval of those activities related to the
care and use of animals as set forth in the PHS Policy at IV. C.
The
IACUC will normally meet on a monthly basis to review and approve,
require modifications in (to secure approval) ,
or withhold approval of those activities related to the
care and use of animals. Each investigator or individual who proposes
to utilize animals must submit an Animal Subject Approval Form for
review by the IACUC. No project may be initiated until such review
has been conducted and use approved. Animal Subject Approval Forms
will be submitted to the IACUC office, where the form will be processed
and placed on the agenda for the next meeting of the IACUC.
Processing
of the submitted form includes: preparation of a memorandum to the
individual informing him/her that the form has been received and
will be reviewed at the next meting of the IACUC and reminding the
individual that activities should not begin prior to approval. The
form is screened and reviewed by the campus or assistant campus
veterinarian for completeness, appropriate use of anesthetics, analgesics,
and tranquilizing drugs, method of euthanasia, and the location
of facilities to be used to house the animals. Each member of the
IACUC will be provided a list and description of proposed activities
to be reviewed and any member of the IACUC may request a full review
of any activity. Each activity will be reviewed to assure that the
project conforms to the requirements as set forth in the PHS Policy
at IV. C. 1. a-g and the U.S. Government Principles For
the Utilization and Care of Vertebrate Animals Used in Testing ,
Research, and Training . For review purposes, each activity
that involves any vertebrate species is classified on the review
form using the USDA classification scheme for research (i.e., Type
C, research that involves no pain; Type D, research where pain will
be alleviated via the administration of drugs; or Type E, research
where pain or distress is not alleviated). Each new or renewal (3-yr)
protocol is sent to all members of IACUC for review. If no single
member requests a Full-Committee Review at the next regular meeting
of IACUC, then the protocol is assigned to a subcommittee of members,
the Designate-Member Review. Each member of the Designated-Member
Review now acts on behalf of the IACUC to approve the protocol,
request additional information from the PI to approve it, or refers
the protocol to a Full-Committee Review at the next regular meeting
of the full IACUC. The report of the Designated-Member Review is
reported at the next regular meeting of IACUC.
7.
Review and approve, require modification in (to secure
approval) or withhold approval of proposed significant changes regarding
the use of animals in ongoing activities as set forth in the policy
at IV. C.
Upon
receipt of information regarding a change to a project from the
responsible investigator, proposed significant changes regarding
the use of animals in ongoing activities will be performed and processed
by the IACUC as described in 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 as set forth in the PHS Policy at IV. C.
4.
Subsequent
to a review by the IACUC, the individual submitting the project
for review will be informed in writing of the decision of the IACUC
and provided the opportunity to respond should modifications be
requested or approval withheld.
The
written statement provided to the individual will list the reasons
for the committee's decision and will provide details as to how
the individual can respond to the concerns of the IACUC. Information
on approved activities will also be provided to the Washington State
University Office of Grant and Research Development (OGRD) such
that the institution is informed of animal use approval.
9.
Conduct continuing review of each previously approved,
ongoing activity covered by this Policy at appropriate intervals
as determined by the IACUC, including complete review in accordance
with the PHS Policy at IV. C. 1.-4. at least once every three years.
Previously
approved, ongoing activities will be reviewed by the IACUC at yearly
intervals. A one page renewal form will be provided to the investigator
by the IACUC, via the IACUC Office , requesting information regarding
the status of the project (active or inactive) and whether there
are changes to the project. If no significant changes are noted
by the individual submitting the renewal, the form will be reviewed
by the IACUC office, campus veterinarian and BioSafety Officer to
assure there are no modifications or concerns and will then be presented
to the IACUC as a consent agenda item at a convened meeting. Activities
with modifications will be noted for the IACUC. Ongoing USDA Type
E activities will be reviewed on a yearly basis using the procedures
as described in III.D.6. All projects
will be subject to a de novo review at least once every three years,
using the procedure as described in III. D. 6.
10.
Be authorized to suspend an activity involving animals
as set forth in the PHS Policy at IV. C. 6.
The
IACUC will 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
, this institutions assurance or section IV. C. 1. a.-g. of
the Policy. The suspension will take place only after review of
the matter by a convened quorum of the IACUC and only with the suspension
vote of a majority of the quorum present. If the IACUC suspends
an activity involving animals, the Institutional Official in consultation
with the IACUC will review the reasons for the suspension, will
take appropriate corrective action, and will report such action
with a full explanation to OLAW.
F.
The individuals authorized by this institution to verify
IACUC approval of those sections of application and proposals related
to the care and use of animals include:
Jim
Petersen, Ph.D. Vice Provost for Research
Dan
Nordquist Director, Grant &
Research Development
Ken
Kardong, Ph.D. Chair, IACUC
Farol
Tomson, DVM Campus Veterinarian
Steven
Russell, DVM Assistant Campus Veterinarian
•
The occupational health and safety
program for Washington State University (WSU) personnel who work
in laboratory animal facilities or have frequent contact with animals
is a comprehensive program that is an integral part of the overall
animal care and use program. It relies on strong administrative
support and interactions among the research program (as represented
by the investigator), the animal care and use program (as represented
by the attending veterinarian and IACUC), environmental health and
safety (EH&S), occupational health services, and administration
(e.g. human resources, facility operations, etc.). The general approach
of the program is based upon the guidelines set forth in the 1997
NRC publication Occupational Health and Safety in the Care and
Use of Research Animals .
WSU
has developed manuals and implemented occupational safety and health
programs to create and maintain a safe and healthful environment
for students, faculty, staff, and visitors. Animal care and use
personnel have access to these manuals and are required to follow
the policies and procedures. The WSU Safety Policies and Procedures
Manual (SPPM) is the primary publication used by the institution
to distribute safety and health information, directives, policies,
and regulations to the University community. The manual includes
subject areas that address the University safety and health functions
including, but not limited to, accident prevention, accident reporting,
accident follow-up, protective equipment, training, standard operating
procedures for handling hazardous agents, motor vehicle safety,
fire safety, lab safety, and radiation safety.
In
addition to the aforementioned programs, the WSU Animal Contact
Program is also in place as an occupational health program for personnel
who contact animals. All individuals at WSU who have contact with
research and teaching animals (this includes handling, cleaning,
feeding, exposure to unfixed tissues, exposure to animal waste or
bodily fluids) must register in the WSU Animal Contact Program.
It provides information and training to individuals regarding the
occupational health risks associated with animal contact (i.e. zoonotic
diseases, allergens, animal bites, scratches, biological hazards,
physical hazards, etc.) and invites all individuals with animal
contact to participate in the Medical Health and Risk Assessment
element of the program. The Medical Health and Risk Assessment element
of the program is risk-based with recommendations to individuals
based upon hazards posed by animals; materials used; exposure intensity,
duration, and frequency; personnel susceptibility; and history of
occupational illness and injury.
A
formal risk assessment process that entails site visits with walk-through
hazard recognition inspections, program reviews, and interviews
has been implemented to identify and record potential hazards associated
with animal care and use facilities. Findings generated from the
assessments that are not addressed immediately are evaluated and
prioritized in accordance with the Zurich Hazard Analysis Assessment
criteria which rates each hazard based upon potential severity of
the consequence and probability of occurrence. Once evaluated and
prioritized, un-addressed or open findings are categorized, quantified,
and incorporated into action plans that are monitored and tracked
until completion.
H.
The total gross number of square feet in each animal
facility (including each satellite facility), the species of animal
housed therein and the average daily inventory, by species, of animals
in each facility is provided in Appendix B .
I.
The training or instruction available to scientists,
animal technicians, and other personnel involved in animal care,
treatment, or use consists of a IACUC mandated seminar on the policies
relating to the care and use of animals at WSU presented by the
Campus Veterinarian in an ongoing fashion. On-line training is also
available and is required on a case-by-case basis when needed.
The
seminar describes the basic responsibilities of the institution
and investigator as per the PHS Policy on the Humane Care and Use
of Laboratory Animals and the Animal Welfare Act. Written material
is provided and is meant to supplement the seminar and to familiarize
those using animals with the concept of alternatives, minimizing
animal distress, and resources for information on the use of animals
and searching the animal welfare literature.
Training
is also often provided in an informal, one-on-one basis to individuals
by the Office of the Campus Veterinarian and through the availability
of videotapes, auto tutorial slide sets, and reference materials
on animal care and use that are available at the College of Veterinary
Medicine Library .
The
Office of the Campus Veterinarian also serves as a resource of material
and educational services for researchers and students with questions
or concerns regarding laboratory and teaching animals.
IV.
INSTITUTIONAL STATUS
As
specified in the PHS Policy at IV.A.2, as Category 2, 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 IV.B.1. and 2. of the PHS Policy, and reports prepared
in accord with IV.B.3. of the PHS Policy.
All
IACUC semiannual 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, reports will contain a reasonable and specific plan and
schedule for correcting each deficiency. Semiannual reports of the
IACUC evaluations will be submitted to the Vice Provost for Research.
Semiannual reports of IACUC evaluations will be maintained by this
institution and made available to the Office of Laboratory Animal
Welfare (OLAW) upon request. The most recent semiannual report of
the IACUC 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 reviews, as forwarded to the Vice Provost for
Research.
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.
At least once every 12 months, the IACUC, through the
Institutional Official, will report in writing to OLAW:
1.
Any change in the 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
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 Vice Provost for Research.
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.
VII.
INSTITUTIONAL ENDORSEMENT AND PHS APPROVAL
A.
Authorized Institutional Official
Name:
Jim Petersen, Ph.D.
Title:
Vice Provost for Research
Address:
PO Box 641030
Washington
State University
Pullman
, Washington 99164-1030
Phone:
(509) 335-9141 Fax: (509)
335-1949
Signature:
Date:
B.
PHS Approving Official
Name:
Title:
Address:
Phone:
Signature:
Date:
C.
Effective Date of Assurance:
D.
Expiration Date of Assurance:
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