Kansas 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 the PHS Policy.
I. I. APPLICABILITY
This Assurance is applicable to all research, research training, experimentation, biologic 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 subcontracting or subgranting of a PHS-conducted or supported activity by this institution.
"Institution" includes the following branches and major components of Kansas State University: Colleges of Agriculture, Arts and Sciences, Engineering, Human Ecology, and Veterinary Medicine.
II. II. INSTITUTION POLICY
A.
A. This institution will comply with all
applicable provisions of the Animal Welfare Act and other Federal statutes and
regulations relating to animals.
B.
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.
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 other applicable laws and
regulations pertaining to animal care and use.
D.
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. III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE
A.
A. The lines of authority and responsibility
for administering the program and ensuring compliance with this Policy
are:
Provost,
Vice Provost for Research and
Dean of the
Institutional Official (IO): R.W. Trewyn, Ph.D.
Associate Vice Provost for Research Compliance
and University Veterinarian: Jerry Jaax, DVM, ACLAM
Institutional Animal Care and Use Committee (IACUC)
Attending Veterinarian and Director
of the Animal Resources Facility, CVM Bart
Carter, DVM
* Schematic attached - Attachment 1
The Institutional Official (IO) is R.W. Trewyn, the KSU Vice Provost for Research, and the Dean of
the
The Chair of the IACUC is Dr. Janice Swanson,
Associate Professor in the Department of Animal Science and Industry. The Chair is appointed by the IO. Each person in the described line of
authority maintains an open door policy for comments or concerns about
campus-wide animal care and use.
B.
B. The qualifications, authority, and
percent time contributed by the veterinarians** who participate in the program
are:
Institutional
Veterinarian: Jerry Jaax
Experience:
Dr. Jaax received his DVM from KSU in 1972.After a formal residency program in laboratory animal medicine at
USAMRIID, Ft. Detrick MD, he became a Diplomate of the
Program
Authority: Dr. Jaax has programmatic
responsibility for the animal care and use program, and provides administrative
support for the IACUC. Holding an
appointment in the central research administration, Dr. Jaax is able to
interface effectively with researchers, educators, and administrators across
college and department boundaries. He
receives strong support from IO and the central administration on animal care
and use issues. .
Time
Commitment: Dr. Jaax is a full time employee of the institution. On average, he spends approximately 55-60% of
his time on animal care and use issues at the institution.
Attending
Veterinarian: Bart Carter
Experience:
Dr. Carter is the Director of the Animal Resource Facility (ARF) in the College
of Veterinary Medicine (CVM). The ARF is
the central animal facility for the CVM located in Coles Hall. Dr. Carter received his DVM from
Program
Authority: Dr. Carter is the
Attending Veterinarian for the animal care and use program. As such, he exercises the full campus authority
of the attending veterinarian under animal welfare laws, guidelines, and
regulations.
Time
Commitment: Dr. Carter devotes 100% time to the animal care and use program.
** The institution is a land grant university with a
C.
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
care and use program, facilities, and procedures. The IACUC consists of at least five members,
and its membership meets the composition requirements set forth in the PHS Policy
at IV.A.3.b. Attached is a list of
names, degrees, position titles, specialties, and institutional affiliations of
the IACUC chairperson and members (Attachment 2). Neither of the non-affiliated IACUC members
are animal users. Their primary charge
from the committee is to represent the general community interests.
D.
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 evaluations are: Semi annual program evaluations are conducted on the 2nd
or 3rd week of April, and on the 2nd or 3rd
week of October each year. The dates of
the evaluation are scheduled six months apart in accordance with regulatory
guidance. The IACUC performs its formal
program review using "The Guide," and a review instrument adapted from the
online semiannual review checklist on the OLAW website http://grants.nih.gov/grants/olaw/sampledoc/cheklist.htm. Deficiencies noted during the review are
categorized as either significant (deemed to be a threat to the health or
welfare of the animal) or minor. A plan
and schedule for resolution of deficiencies is prepared and included in formal
correspondence from the IACUC to the responsible individual. Final findings,
recommendations and actions are reviewed, discussed, and voted upon in a
convened full committee meeting. All
members of the IACUC sign and date the final report to the IO. There is a provision for minority opinion on
the signature sheet accompanying the final report to the IO.
2.
2. Inspect at least once every six months
the institution's animal facilities, including satellite facilities, using the
Guide as a basis for evaluation. The
IACUC procedures for conducting semiannual facilities inspections are:
semiannual facilities inspections are conducted on the 2nd and 3rd
week of April and on the 2nd or 3rd week of October of
each year. The dates of the inspection
are scheduled six months apart IAW regulatory guidance. All institutional animal care and use
facilities are inspected, regardless of accreditation or PHS Assurance status.
The IACUC performs its formal facilities inspection using "The Guide," and a
review instrument adapted from the online semiannual inspection checklist on
the OLAW website http://grants.nih.gov/grants/olaw/sampledoc/cheklist.htm. Since the actual facilities inspection
typically takes approximately four days, the IACUC often uses subcommittees to
help accomplish this task. Final
findings, recommendations and actions are reviewed, discussed, and voted upon
in a convened full committee meeting.All members of the IACUC sign and date the final report to the IO. There is a provision for minority opinion on
the signature sheet accompanying the final report to the IO.
Attending Veterinary Care Surveillance Program: The
IACUC has implemented a formal program of surveillance of attending veterinary
care for facilities using animals in teaching, research, or testing. In addition to the attending veterinarian,
the IACUC has designated AALAS certified veterinary technicians as adjunct
agents of the IACUC. They perform
unannounced attending care assistance visits to animal care and use facilities
across campus.
During attending care visits, they monitor research
animal health and well being, husbandry, sanitation, and other pertinent aspects
of animal care and use, to include IACUC protocol compliance. Additionally, they assist personnel with
animal care and use issues, procedures, and training, etc. The frequency of visits to individual animal
care and use areas is based on animal use activity and need, but occur at least
once a month. The University Research
Compliance Office (URCO) maintains documentation of the attending care
visits. If significant issues or
problems are identified during visits, the attending veterinarian and/or university
veterinarian perform appropriate follow-up actions. If warranted, the university veterinarian
and/or attending veterinarian refer significant findings to the IACUC, or the
Institutional Official (IO) for additional consideration and/or formal action.
3.
3. Prepare reports of the IACUC evaluations
as set forth in the PHS Policy at IV.B.3., and submit the reports to R.W. Trewyn, the Institutional Official. The IACUC process for developing the report
and submitting to the IO is: The
semiannual evaluations are performed as scheduled for all aspects of the
program, and all animal facilities in the unit.Findings, deficiencies, recommendations and proposed actions are
reviewed, discussed, and voted upon in full committee. Deficiencies noted during the review are
categorized as either significant (deemed to be a threat to the health or
welfare of the animal) or minor. A plan
and schedule for resolution of deficiencies is prepared and included in formal
correspondence from the IACUC to each responsible individual. The results of the program evaluation, along
with specific findings and recommendations, and/or actions are forwarded to the
Institutional Official for information, and if appropriate, further action. The
IO reviews and signs the final semiannual report of program and facilities.
4.
4. Review concerns involving the care and
use of animals in the institution. The
IACUC procedures for reviewing concerns are: The animal care and use program
home page http://www.ksu.edu/research/animal/index.htm.
has a site with pertinent information and procedures for any person who desires
to register a concern or a complaint about animal care and use at the institution.
http://www.ksu.edu/research/animal/iacuc/index.htm. It explains the rights of any individual to
express concerns, and reaffirms that any concern will be treated
confidentially, or anonymously, if desired.The names, and contact information to include e-mail, for key
individuals is provided on the site. In
addition, the IACUC has prepared colorful signs that are prominently posted in
all areas used in the animal care and use program. This sign also contains all pertinent
information about how, and to whom to register a concern or complaint about
animal care and use in the institution.The sign also explains that concerns or complaints can be made
anonymously, and with no fear of reprisal.
Upon receipt of a concern or complaint, the IACUC
initiates a formal investigation. This
may be performed initially by a designated subcommittee of the IACUC, usually
including the university veterinarian, the attending veterinarian, and the Chair. The findings of the investigation are
presented and discussed in the full committee.When a concern or complaint is received by the IACUC, the IO is informed
immediately. Once the issue has been
properly investigated by the IACUC, the IO is informed in writing of the full
findings and results. The IO may then
take whatever action is deemed appropriate, to include notification of the
Office of Laboratory Animal Welfare (OLAW) with a full explanation of the issues
and actions.
The IACUC has its Administrative Operating Procedures
(AOP) posted on the animal care and use homepage http://www.ksu.edu/research/animal/iacuc/index.htm. IACUC procedures for investigating concerns
or complaints are outlined in the AOP.
5.
5. Make recommendations to Dr. R.W. Trewyn, the IO, regarding any aspect of the institution's
animal program, facilities, and personnel training. The procedures for making recommendations to
the IO are: As described in III.D.2., and III.D.3. above, the IACUC presents
the IO with a formal semiannual report of the program and facilities. Dr. Trewyn reviews
the report and takes any action deemed appropriate as a result of the IACUC
inspection and/or review. As other
unanticipated or non-routine issues appropriate for notification arise, they
are brought to the attention of the IO.
Since the IO is the direct line supervisor and is
daily contact with the university veterinarian (Dr. Jaax), he has immediate
access to information about all pertinent issues regarding the animal care and
use program.
6.
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 procedures for protocol review
are:
·
· IACUC Procedures for review and approval: The animal
care and use program home page has an online IACUC Application for Approval
document in standard word processing formats. http://www.ksu.edu/research/animal/iacuc/index.htm. The principal investigator (PI) downloads the
template, completes the application, and forwards the application proposal to
the University Research Compliance Office (URCO). The URCO logs in the application in a
comprehensive Access database, and forwards the proposal to all members of the
committee. All members review the
proposal with a primary eye to determining whether a convened "full" committee
review, or a formal "designated" review is appropriate. Only proposals that are
Category 1, defined as no, or slight or temporary pain and/or distress are
eligible for designated review. During
initial review, any member can request full committee review for any proposal,
even those in Category 1. Requesting a
full committee review requires no explanation or justification from the
requestor.
·
· Designated Review: (Category 1 proposals only). If members unanimously recommend designated
review, the URCO selects a member to review the proposal. Stipulations are
forwarded to the PI, who must respond to them in a satisfactory manner. Once the proposal has been adequately
reviewed and a recommendation made, the Chair approves, or disapproves the
proposal. The results of all designated
reviews are recorded in the minutes of a convened full committee. A flow chart graphically describing the designated
review process is provided at Attachment 3.
·
· Full Committee Review: {All Category 2 proposals
(alleviated pain and/or distress), all Category 3 proposals (unalleviated pain
and/or distress), or those Category 1 proposals that a member requested a full
committee review}. The IACUC meets twice
a month. The Chair directs the meeting
with a quorum being necessary for reviewing proposals. PI's with proposals are invited to the
meeting, provide a brief oral overview of the proposal, and answer questions in
turn from each of the members. Following
the questions and/or clarifications, the PI (and any committee member with a
potential conflict of interest) is excused and general committee discussion
ensues. A voice vote, and if necessary,
a hand vote determines the issue. A
majority vote of a convened quorum is necessary for approval of a proposed
activity. Committee deliberations and
voting usually results in approval with a varying number of stipulations,
although occasionally a proposal is disapproved outright. In-committee review typically lasts from
15-30 minutes per proposal, with exceptions on both ends of the scale.
Following full committee review, the PI is notified in
writing of the results of the deliberations of the committee. He/she must respond to stipulations to the
satisfaction of the committee. Once this
is done, the Chair approves the proposal, the PI is notified in writing and is
authorized to proceed with the protocol.The approval period lasts for a maximum of three years, or until the
approved activity is completed in the manner described in the protocol, which
ever comes first. All activities are
reviewed on at least an annual basis.Conversely, if the proposal is disapproved, the PI is notified in
writing of the decision and the basis and/or rationale for the decision of the
committee.
Even though IACUC approval of a proposed activity may
be subject to further review at the institution, the decision of the IACUC to
disapprove or withhold approval for a specific animal care and use activity
cannot be overruled by other administrative elements at the institution.
7.
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 are: The IACUC has Administrative Operating Procedures
(AOP) posted on the animal care and use homepage http://www.ksu.edu/research/animal/iacuc/index.htm. Procedures for approval of proposed
significant changes and in ongoing research as described in the AOP
follow.
III.G. Changes
to Protocols/Activities: The Chair will make the determination whether a
proposed change to an activity or protocol is minor or significant. Regardless of the determination and level of
review by the Chair, all approved changes or modifications will be recorded in
the minutes at a full committee meeting for documentation, and discussion if
appropriate. The PI is notified in
writing of the formal approval/disapproval of their proposed change or
modification. No proposed change or
modification in an approved ongoing animal care and use activity can commence
prior to formal approval of the proposed change.
·
· Significant Modifications/addenda: If determined by
the Chair that the proposed change(s) to ongoing activities is a major change,
the P.I. must complete a new protocol application, completing the sections of
the application for approval pertinent to the proposed changes. The Chair will make a determination whether
the proposed change will be reviewed in full committee, subcommittee, or can be
approved by the Chair.
·
· Minor Modifications/addenda: Upon determination by the
Chair that a proposed modification is indeed a minor change, the P.I. may
submit a memo to the IACUC describing in detail the proposed minor
modification/addenda. If adequately
presented and justified by the P.I., a minor modification/addenda may be
approved by the Chair.
8.
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: as
described in III.D.6. above - all formal activity, decisions and actions of the
committee are documented in writing.Investigators are notified in writing as soon as possible of the results
of the deliberations and decisions of the committee. If desired, the PI may respond to the committee
in writing, or appear at a meeting of the IACUC to discuss or receive
clarification of the actions of the committee.All committee correspondence is maintained by the University Research
Compliance Office for reference and examination by authorized regulatory
oversight and accrediting bodies.
9. Conduct
continuing review of each previously approved, ongoing activity covered by PHS
Policy at IV.C.1-4 at least once every three years. The IACUC procedures for conducting
continuing review are:
·
· Protocol Approval Period: Protocols are approved for
up to three years. If the ongoing
activity is going to exceed the three year IACUC approval window, the PI must
submit a new application for approval (http://www.ksu.edu/research/animal/iacuc/index.htm.)
with all pertinent data required by the committee for any new proposed animal
care and use activity. The application
for approval for an ongoing activity that will soon exceed the three year
window of approval is managed and reviewed by the committee in the same manner
as any new proposal.
·
· Continuing Review of Protocols: The access database
maintained by the University Research Compliance Office (URCO) is the primary
tool used to flag ongoing animal care and use activities for continuing
review. This ongoing review is
accomplished on at least an annual basis.The URCO contacts the PI three months prior to the yearly anniversary of
the approval date of the protocol. The PI
must complete a standardized form that questions key aspects of the
activity. The PI responds to the
questions on the review form, and sends it back to the URCO. If the protocol is proceeding in accordance
with the provisions of the original approval and any IACUC approved changes or
modifications, the activity may continue with no further action by the IACUC or
URCO. If the continuing review reveals
that additional oversight or review by the URCO or the committee is required,
the appropriate actions are initiated.
10. Be
authorized to suspend an activity involving animals as set forth in the PHS
Policy at IV.C.6. The IACUC procedures
for an ongoing activity are: The IACUC Administrating Operating Procedures
(AOP) section III.G. states that "The IACUC may suspend a previously approved
activity involving animals if it determines that the activity is not being
conducted in accordance with applicable provisions of animal welfare laws,
regulations and guidelines. The IACUC
may suspend an activity only after investigation and review of the matter at a
convened meeting of a quorum of the IACUC, and a suspension vote by a majority
of the quorum present. If the IACUC
suspends an activity, the Institutional Official in consultation with the IACUC
shall review the reasons for the suspension, take appropriate corrective
action, and report that action with a full explanation to appropriate
regulatory and oversight bodies."
E.
E. The individuals authorized by this
institution to verify IACUC approval of those sections of applications and
proposals related to the care and use of animals are
·
· Bart Carter- IACUC Chair
·
· Steve Upton - IACUC Vice Chair
·
· Jerry Jaax - University Veterinarian, University
Research Compliance Officer, IACUC member
F.
F. The Occupational Health and Safety
Program (OH&SP) for personnel who work in laboratory animal facilities or
have frequent contact with animals is: administered out of the University
Research Compliance Office (UCO). A
significant amount of information about the OH&SP and other related matters
is available for animal workers or researchers online at http://www.ksu.edu/research/animal/occhs/index.htm. The OH&S program pertains to all
occupational animal workers and/or personnel working with animals in research
or teaching at the institution. A
concise overview of the program that is sent to eligible personnel is provided
at Attachment 4. Key elements of the
OH&SP program are described below:
·
· This program consists of a required assessment of
health history, follow-on diagnostic tests and immunizations (if required), and
a possible physical examination (if required).All personnel with occupational contact with animals in research,
testing, or teaching must complete an Animal Worker Questionnaire (provided as
Attachment 5). The questionnaire is
reviewed by a physician who assesses risk and makes appropriate
recommendations. Recommendations usually
consist of requesting additional information, diagnostic testing, vaccinations,
or clearance to work with animals. The
animal worker is notified in writing of the results and recommendations of the
physicians review of the questionnaire.
·
· Any person at the institution working with animals in
an occupational way, such as animal care takers, herdsmen, student workers,
etc.; or researchers, graduate students, or students having contact with
animals in research or teaching activities are required to enroll in the
OH&S program. The IACUC application
form has a section where PI's list all protocol-associated personnel. This is used to identify personnel for both
animal care and use training and enrollment in the OH&SP.
·
· Based on species contact information in the
questionnaire, the URCO sends each animal worker a tailored packet of "fact
sheets" targeting potential risks for that individual. These fact sheets provide specific information
including but not limited to hygiene, allergies, immunosuppression,
sharps, pre-exposure rabies prophylaxis, respiratory hazards, and common
zoonotic diseases, etc., and are available online at http://www.ksu.edu/research/animal/occhs/index.htm
.
·
· There is no automatic pre-employment physical required
for animal care personnel.
·
· The animal worker questionnaires are reviewed by a
physician (Dr. Reppert) at the university health
clinic, who evaluates potential risks associated with the activity using
animals. He makes professional
recommendations based on the information in the questionnaire provided by the
animal worker. Dr. Reppert is also a voting member of the Institutional Biosafety Committee (IBC) and the
institution's Environmental Health and Safety Committee.
·
· Institutional employees have a standard procedure to
follow if they are injured while working.They are required to report to a local hospital, if appropriate, and to
complete a standard institutional form describing and documenting the injury. The OH&SP fact sheets also address the
issue of animal-related injury.
·
· The Institutional Biosafety Committee (IBC) has
responsibility for oversight and review of any proposed activity using
recombinant DNA molecules or infectious agents. The IBC must approve these activities prior
to initiation of those new activities.The IBC homepage is available online at
http://www.ksu.edu/research/ibc/index.htm.Personnel using infectious agents or recombinant DNA molecules are
required to complete online training for those activities prior to initiation
of that activity. Animal use with rDNA
and infectious agents is addressed in the IBC training modules. There are no current institutional
activities using infectious agents classified above the CDC's Biosafety Level
Two (BL-2) category.
·
· The institution has an Environmental Health and Safety
Department, and an Environmental Health and Safety Committee that addresses
many of the other common laboratory hazards and safety issues such as radiation
protection, chemical hygiene, respiratory protection, laboratory safety, fire
prevention, etc. Their online homepage
is available at http://www.ksu.edu/research/animal/occhs/index.htm.
·
· The institution currently has no nonhuman primates in
its animal care and use program, and has no plans to use them.
·
· All personnel working with animals must have a current
tetanus vaccination (within 10 years).
G.
G. The total gross number of square feet in
each animal facility (including each satellite facility), the species of
animals housed therein and the average daily inventory of animals by species,
in each facility is provided in the attached table (Attachment 6).
H.
H. The training or instruction available to
scientists, animal technicians, and other personnel involved in animal care,
treatment, or use is: The IACUC application for approval form has a section
that addresses training for personnel involved in animal care and use. The IACUC considers documentation of
adequate training as part of its review of animal care and use proposals. Specific aspects of the training program are
as follows:
·
· Online Training: An online training program has been
implemented for the animal care and use program. The training is targeted for all
institutional personnel who are involved in the use of animals in research,
teaching or training. An IACUC proposal
to use animals in research, testing, or teaching will not be approved prior to
documentation of completion of each required training module by all personnel
associated with the proposed activity.Based on species and procedure, the URCO will verify that personnel
complete the required training modules.Documentation of training is maintained in the URCO access
database. Re-training will be required
every three years at a minimum.
·
· Overview of Animal Care and Use: This basic
introductory module is required for all institutional personnel involved in
animal care and use. It addresses but is
not limited to topics such as: history of animal experimentation; animal use
laws, regulations and policies; overview of the animal welfare movement, animal
use alternatives, various reference services, reporting of deficiencies,
concerns, or complaints about animal use, ethical considerations, the PHS
Policy, "The Guide," occupational health information, compliance requirements,
humane endpoints, IACUC functions, general euthanasia issues, surgical considerations,
etc.
·
· Species Specific Training Modules: Each commonly used
species in the animal care and use program, such as rats, mice, guinea pigs,
dogs, cats, etc., has a required training module. These individual modules address species specific
issues, such as: animal use history, basic needs and husbandry, handling,
identification, procurement, specific requirements under the CFR or other
regulatory drivers, nutrition, behavior, anesthesia/analgesia, surgery
considerations, applicable diseases, euthanasia, biosampling
sites, etc.
·
· Procedure Specific Training: modules are being
developed for specific animal care and use procedures, such as: aseptic surgery
techniques for rodents, etc.
·
· The institutional training modules can be accessed
online at http://www.ksu.edu/research/animal/training/index.htm.
·
· Audio-visual Materials: The Animal Resource Facility
(ARF) at the College of Veterinary Medicine, and the Laboratory Animal Care
Service (LACS) in the Department of Biology, College of Arts and Sciences have
amassed a significant library of audio visual animal care and use training
materials. Investigators are encouraged
to utilize the materials as appropriate to supplement their training. A listing of the extensive training materials
library is at http://www.ksu.edu/research/animal/training/index.htm.
·
· Hands-on Training: As necessary, individual
investigators are trained on animal care and use procedures by the attending
veterinarian, or other appropriate subject matter expert. Examples could include aseptic surgical
procedures, handling and restraint, venipuncture
techniques, etc.
·
· AALAS Technician Certification: The institution has
emphasized certification training for personnel involved in the animal care and
use program. There are three animal care
and use personnel certified at the Assistant Laboratory Animal Technicians
(ALAT), and two technicians certified at the Laboratory Animal Technician (LAT)
level. This contrasts with no AALAS
certified technicians in the animal care and use program as recently as three
years ago.
·
· Institutional Biosafety Committee (IBC) Online
Training Program: The IBC has a mandatory training program for those using
infectious agents and/or recombinant DNA molecules. Personnel are required to complete online
training for those activities prior to initiation of that activity. Many issues pertinent to animal care and use
are addressed in the IBC training modules.
IV. IV. INSTITUTIONAL STATUS
E.
E. The individuals authorized by this
institution to verify IACUC approval of those sections of applications and
proposals related to the care and use of animals are
·
· Bart Carter- IACUC Chair
·
· Steve Upton - IACUC Vice Chair
·
· Jerry Jaax - University Veterinarian, University
Research Compliance Officer, IACUC member
F.
F. The Occupational Health and Safety
Program (OH&SP) for personnel who work in laboratory animal facilities or
have frequent contact with animals is: administered out of the University
Research Compliance Office (UCO). A
significant amount of information about the OH&SP and other related matters
is available for animal workers or researchers online at http://www.ksu.edu/research/animal/occhs/index.htm. The OH&S program pertains to all
occupational animal workers and/or personnel working with animals in research
or teaching at the institution. A
concise overview of the program that is sent to eligible personnel is provided
at Attachment 4. Key elements of the
OH&SP program are described below:
·
· This program consists of a required assessment of
health history, follow-on diagnostic tests and immunizations (if required), and
a possible physical examination (if required).All personnel with occupational contact with animals in research,
testing, or teaching must complete an Animal Worker Questionnaire (provided as
Attachment 5). The questionnaire is
reviewed by a physician who assesses risk and makes appropriate
recommendations. Recommendations usually
consist of requesting additional information, diagnostic testing, vaccinations,
or clearance to work with animals. The
animal worker is notified in writing of the results and recommendations of the
physicians review of the questionnaire.
·
· Any person at the institution working with animals in
an occupational way, such as animal care takers, herdsmen, student workers,
etc.; or researchers, graduate students, or students having contact with
animals in research or teaching activities are required to enroll in the
OH&S program. The IACUC application
form has a section where PI's list all protocol-associated personnel. This is used to identify personnel for both
animal care and use training and enrollment in the OH&SP.
·
· Based on species contact information in the
questionnaire, the URCO sends each animal worker a tailored packet of "fact
sheets" targeting potential risks for that individual. These fact sheets provide specific information
including but not limited to hygiene, allergies, immunosuppression,
sharps, pre-exposure rabies prophylaxis, respiratory hazards, and common
zoonotic diseases, etc., and are available online at http://www.ksu.edu/research/animal/occhs/index.htm
.
·
· There is no automatic pre-employment physical required
for animal care personnel.
·
· The animal worker questionnaires are reviewed by a
physician (Dr. Reppert) at the university health
clinic, who evaluates potential risks associated with the activity using
animals. He makes professional
recommendations based on the information in the questionnaire provided by the
animal worker. Dr. Reppert is also a voting member of the Institutional Biosafety Committee (IBC) and the
institution's Environmental Health and Safety Committee.
·
· Institutional employees have a standard procedure to
follow if they are injured while working.They are required to report to a local hospital, if appropriate, and to
complete a standard institutional form describing and documenting the injury. The OH&SP fact sheets also address the
issue of animal-related injury.
·
· The Institutional Biosafety Committee (IBC) has
responsibility for oversight and review of any proposed activity using
recombinant DNA molecules or infectious agents. The IBC must approve these activities prior
to initiation of those new activities.The IBC homepage is available online at
http://www.ksu.edu/research/ibc/index.htm.Personnel using infectious agents or recombinant DNA molecules are
required to complete online training for those activities prior to initiation
of that activity. Animal use with rDNA
and infectious agents is addressed in the IBC training modules. There are no current institutional
activities using infectious agents classified above the CDC's Biosafety Level
Two (BL-2) category.
·
· The institution has an Environmental Health and Safety
Department, and an Environmental Health and Safety Committee that addresses
many of the other common laboratory hazards and safety issues such as radiation
protection, chemical hygiene, respiratory protection, laboratory safety, fire
prevention, etc. Their online homepage
is available at http://www.ksu.edu/research/animal/occhs/index.htm.
·
· The institution currently has no nonhuman primates in
its animal care and use program, and has no plans to use them.
·
· All personnel working with animals must have a current
tetanus vaccination (within 10 years).
G.
G. The total gross number of square feet in
each animal facility (including each satellite facility), the species of
animals housed therein and the average daily inventory of animals by species,
in each facility is provided in the attached table (Attachment 6).
H.
H. The training or instruction available to
scientists, animal technicians, and other personnel involved in animal care,
treatment, or use is: The IACUC application for approval form has a section
that addresses training for personnel involved in animal care and use. The IACUC considers documentation of
adequate training as part of its review of animal care and use proposals. Specific aspects of the training program are
as follows:
·
· Online Training: An online training program has been
implemented for the animal care and use program. The training is targeted for all
institutional personnel who are involved in the use of animals in research,
teaching or training. An IACUC proposal
to use animals in research, testing, or teaching will not be approved prior to
documentation of completion of each required training module by all personnel
associated with the proposed activity.Based on species and procedure, the URCO will verify that personnel
complete the required training modules.Documentation of training is maintained in the URCO access
database. Re-training will be required
every three years at a minimum.
·
· Overview of Animal Care and Use: This basic
introductory module is required for all institutional personnel involved in
animal care and use. It addresses but is
not limited to topics such as: history of animal experimentation; animal use
laws, regulations and policies; overview of the animal welfare movement, animal
use alternatives, various reference services, reporting of deficiencies,
concerns, or complaints about animal use, ethical considerations, the PHS
Policy, "The Guide," occupational health information, compliance requirements,
humane endpoints, IACUC functions, general euthanasia issues, surgical considerations,
etc.
·
· Species Specific Training Modules: Each commonly used
species in the animal care and use program, such as rats, mice, guinea pigs,
dogs, cats, etc., has a required training module. These individual modules address species specific
issues, such as: animal use history, basic needs and husbandry, handling,
identification, procurement, specific requirements under the CFR or other
regulatory drivers, nutrition, behavior, anesthesia/analgesia, surgery
considerations, applicable diseases, euthanasia, biosampling
sites, etc.
·
· Procedure Specific Training: modules are being
developed for specific animal care and use procedures, such as: aseptic surgery
techniques for rodents, etc.
·
· The institutional training modules can be accessed
online at http://www.ksu.edu/research/animal/training/index.htm.
·
· Audio-visual Materials: The Animal Resource Facility
(ARF) at the College of Veterinary Medicine, and the Laboratory Animal Care
Service (LACS) in the Department of Biology, College of Arts and Sciences have
amassed a significant library of audio visual animal care and use training
materials. Investigators are encouraged
to utilize the materials as appropriate to supplement their training. A listing of the extensive training materials
library is at http://www.ksu.edu/research/animal/training/index.htm.
·
· Hands-on Training: As necessary, individual
investigators are trained on animal care and use procedures by the attending
veterinarian, or other appropriate subject matter expert. Examples could include aseptic surgical
procedures, handling and restraint, venipuncture
techniques, etc.
·
· AALAS Technician Certification: The institution has
emphasized certification training for personnel involved in the animal care and
use program. There are three animal care
and use personnel certified at the Assistant Laboratory Animal Technicians
(ALAT), and two technicians certified at the Laboratory Animal Technician (LAT)
level. This contrasts with no AALAS
certified technicians in the animal care and use program as recently as three
years ago.
·
· Institutional Biosafety Committee (IBC) Online
Training Program: The IBC has a mandatory training program for those using
infectious agents and/or recombinant DNA molecules. Personnel are required to complete online
training for those activities prior to initiation of that activity. Many issues pertinent to animal care and use
are addressed in the IBC training modules.
IV.
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 facilities deficiencies are noted, reports will contain
a reasonable and a specific plan and schedule for correcting each
deficiency. Semiannual reports of the
IACUC evaluations will be submitted to Dr. R.W. Trewyn,
the Institutional Official (IO). Semiannual reports of the IACUC evaluations
will be maintained by this institution and be made available to the Office
of Laboratory Animal Welfare (OLAW) upon
request. The most recent semiannual
report of the IACUC is provided at Attachment 7.
V.
V. RECORD KEEPING REQUIREMENTS
A.
A. This institution will maintain for at
least three years:
1.
1. A copy of this assurance and any
modifications thereto, as approved by the PHS.
2.
2. Minutes of IACUC meetings, including
records of attendance, activities of the committee, and committee
deliberations.
3.
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.
4. Records of semiannual IACUC reports and
recommendations (including minority views) as forwarded to Dr. R.W. Trewyn, the IO.
B.
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 the completion of the
activity.
C.
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.
VI. REPORTING REQUIREMENTS
A.
A. At least once every 12 months, the IACUC
through the institutional official will report in writing to OLAW:
1.
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 the IACUC membership. If
there are no changes to report, this institution will provide OLAW with written
notification that that there are no changes.
2.
2. Notification of the dates that the IACUC
conducted its semiannual evaluations ofthe institution's program and facilities (including satellite
facilities) and submitted the evaluations to Dr. R.W. Trewyn,
the IO.
B.
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.
1. Any serious or continuing noncompliance
with the PHS Policy
2.
2. Any serious deviations from the
provisions of the Guide.
3.
3. Any suspension of an activity by the
IACUC.
C. Reports
filed under VI.A. and VI.B. above shall include any minority views filed by
members of the IACUC.
VII.
VII. INSTITUTIONAL ENDORSEMENT AND PHS
APPROVAL
A.
A. Authorized Institutional Official
Name: R.W.
Trewyn
Title: Vice
Provost for Research and Dean of the
Address: 108
Phone: (785)
532-5110
Fax: (785)
532-6507
Signature:
Date:
B.
B. PHS Approving Official
Name:
Title:
Address:
Phone:
Fax:
Signature:
Date:
C.
C. Effective Date of Assurance:
D.
D. Expiration Date of Assurance: