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B.
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The qualifications, authority, and percent of time contributed
by veterinarian(s) who will participate in the program are:
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Dr. Carolyn McMasters received her training in veterinary medicine
at Cornell University in 1978, where she completed course work in
laboratory animal care. Dr. McMasters also has 27 years of experience
diagnosing and treating laboratory and exotic species in her veterinary
practice.
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Dr. McMasters provides expert direction for the overall supervision of the laboratory animals at Ithaca College. She has delegated the normal day-to-day maintenance of the animals to the animal caretaker, who is regularly supervised by the IACUC chair. Dr. McMasters conducts regularly scheduled visits (at least two per year) and unscheduled visits (at least two per year) to the animal facilities in addition to serving as a member of IACUC. Dr. McMasters notifies the chair of the IACUC in the event of any discrepancies from normal policy of animal husbandry and care. It is the Chairman's responsibility to assure expeditious remedy of the situation. Dr. McMasters retains the prerogative of ordering or personally undertaking the necessary actions to insure that no animal undergoes inhumane treatment or suffering. It is estimated that she devotes 2 percent of her time to these tasks.
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The animal facilities are inspected
at least once a year by a veterinarian employed by New York State.
These are unannounced visits. Copies of the results of these inspections
are provided for the IACUC chair and Dr. McMasters.
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In addition, the services of the diagnostic center at the Cornell
University Veterinary School are readily available. This service
can be utilized for necropsy interpretation and advice on special
problems.
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C.
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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. Attached is a list of the
names, position titles, earned degrees and other credentials of
the
IACUC chair and members.
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D.
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The IACUC will:
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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.
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|
The IACUC procedures for conducting semiannual program evaluations
are: Any changes in normal animal care procedures are submitted
in writing to the members of the committee at least two weeks prior
to the semiannual meeting. All changes to procedure are voted on
by the entire committee, with any absent members submitting their
vote and/or concerns in writing to the chair.
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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.
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|
The IACUC procedures for conducting semiannual facility inspections
are: All committee members attending the semiannual meetings
inspect all animal housing facilities with the animal care staff,
veterinarian, and chair of the IACUC. Any concerns are noted and
corrected under the guidance of the chair.
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3.
|
Prepare reports of the IACUC evaluations as set forth in the PHS
Policy at IV.B.3. and submit the reports to Provost Peter Bardaglio.
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The IACUC procedure for developing reports and submitting them
to the institutional official is: Minutes of the semiannual
IACUC meeting and inspections are submitted, including any minority
opinions. A list of all approved protocols is also included and
submitted by the IACUC chair to the institutional official.
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4.
|
Review concerns involving the care and use of animals at the institution.
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|
The IACUC procedures for reviewing concerns are: Individual
concerns about animal care can be submitted to any member of the
IACUC committee. All concerns are presented to the chair, who discusses
them with the veterinarian, if necessary, the animal caretakers,
and the principal investigator using the animals. If deemed necessary
by the chair, a meeting of the IACUC can be called to discuss the
concerns. Any necessary changes in animal care or use can be mandated
by the IACUC, with no reprisals to the reporting individual.
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5.
|
Make written recommendations to Provost Bardaglio regarding any
aspect of the institution's animal program, facilities, or personnel
training.
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|
The procedures for making recommendations to the institutional
official are: The IACUC chair will submit recommendations, as
approved by the IACUC, to the institutional official regarding changes
in the animal care procedures, facilities, or personnel training.
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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.
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|
The IACUC procedures for protocol review are:
Animal protocols involving live vertebrate animals are submitted
by the principal investigator to the chair of the IACUC at least
two weeks prior to the scheduled IACUC review. These protocols include
a project description (suitable for non-scientists), a statement
of the purpose of the project, a rationale for the use of animals
and the number of animals used, an explanation of why a non-living
model is not appropriate, certification that this project does not
duplicate previous studies, a description of how the animals will
be used and cared for and what means are taken to insure a minimum
of discomfort and suffering of the animals, and how the animals
will be disposed of at the end of the study. All members of the
IACUC review each protocol and vote for either (1) approval, (2)
approval with revisions, or (3) rejection. Protocols requiring revisions
are given two weeks to make the necessary changes. The revised protocols
are reviewed by the chair, and at least one other committee member,
prior to final approval. All IACUC meetings must have a quorum for
protocol reviews. Members unable to attend will submit their comments
and votes in writing to the chair prior to the meeting. In cases
where expedited review is necessary, such as initial laboratories
involving animals for new teaching labs, or amendments to current
active protocols, the chair will assign one committee member to
serve as the designated reviewer of the protocol. In addition, the
protocols are distributed to the entire committee and any committee
member may request a full committee review. If no concerns are raised
by the general membership and both the designated reviewer and the
veterinarian recommend approval, the protocol will be approved by
the chair. If any IACUC member raises concerns, a full review by
the IACUC will be convened.
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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.
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| |
|
The IACUC procedures for reviewing proposed
significant changes in ongoing research projects are: Proposed
changes and concerns are submitted to the IACUC by the principal
investigator (PI). The PI will submit a protocol to the committee
for review and the review will follow the procedures outlined previously.
If the changes require expedited review, the chair will assign one
committee member to serve as the designated reviewer. The protocol
is also submitted to the entire committee and any committee member
may request a full committee review. If no concerns are raised by
the general membership and both the designated reviewer and the
veterinarian recommend approval, the protocol will be approved by
the chair. If any IACUC member raises concerns, a full review by
the IACUC will be convened.
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| |
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.
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| |
|
The IACUC procedures to notify investigators
and the institution of its decisions regarding protocol review are:
The chair of the IACUC informs all investigators of the decisions
regarding submitted protocols in writing immediately after the IACUC
meeting. Any protocols requiring revision are notified as the concerns
of the IACUC and the revisions needed to obtain approval. Any protocols
not approved by the IACUC are notified in writing as to the reasons
for rejection. Rejected protocols must be revised and re-reviewed
by the entire IACUC to obtain approval for the animal use. A summary
of all protocol decisions are forwarded to the Institutional Official.
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| |
9.
|
Conduct continuing review of each previously approved,
ongoing activity covered by PHS Policy at appropriate intervals
as determined by the IACUC, including a complete review in accordance
with the PHS Policy at IV.C. 1-4. at least once every three years.
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| |
|
The IACUC procedures for conducting review are:
Protocols funded by federal agencies can be approved for a maximum
of a three year period. Any funded protocols that continue beyond
the three year period will need to submit a protocol for review
by the IACUC for animal use to continue, as described in the procedures
for protocol reviews. Unfunded protocols and protocols for teaching
laboratories will be reviewed annually.
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| |
10.
|
Be authorized to suspend an activity involving animals as set forth
in the PHS Policy at IV.C.6.
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| |
|
The IACUC procedure for suspending an ongoing
activity are: If necessary, the IACUC can suspend an ongoing
activity. The investigator, all members of the IACUC, the Institutional
Official, and the OLAW are notified of the suspension. The animal
use cannot be resumed without full review by the IACUC and evidence
that the corrective actions recommended by the IO and the IACUC
have been implemented. A full report of any suspensions and corrective
actions will be reported to the OLAW.
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|
E.
|
The individual authorized by this institution to verify IACUC
approval of those sections of the applications and proposals related
to the care and use of animals is Provost Peter Bardaglio.
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F. |
The occupational health and safety
program for personnel who work in laboratory animal facilities or
have frequent contact with animals is: A new-employee screening
is conducted to determine that employees are aware of the risk of
workplace-related allergies, to verify they possess the necessary
physical stamina to carry out the work, and to inform them of the
procedures for health monitoring, accident prevention and accident
reporting Currently, Ithaca College requires the animal care staff
receive a tuberculosis test at least once a year (or every six months
if a staff member has/will received training at non-Ithaca College
laboratories where TB may be an increased risk). They must demonstrate
a negative test for tuberculosis (Tine test or other) or provide
verification from their physician that the disease is in remission.
In the latter case, a yearly verification will be required. The
animal care staff also undergo a yearly physical examination at
the Ithaca College Hammond Health Center. The physical may also
be administered by the staff member's personal physician; verification
is required in writing. Animal care staff are also vaccinated against
tetanus. Ithaca College will provide two routine TB tests, tetanus
vaccinations, and one routine physical, yearly, for animal care
staff. Minor injuries resultant from on-the-job accidents are cared
for at the Hammond Health Center. Injuries or illness requiring
more than first-aid procedures may require immediate response by
Campus Safety officers and are cared for by the Cayuga Medical Center
Emergency Room or the employee’s primary-care physician. Any
injurious accident or any disease suspected of being employment
related is to be reported in writing, within 24 hours, to the Ithaca
College Office of Human Resources and the IACUC Chair.
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| |
Ithaca College Office of Environmental
Health and Safety also holds programs on fire safety and hazardous
materials safety, yearly. Protective equipment (lab coats, gloves,
masks, etc.) are provided as needed, with consultation with the
department of Environmental Health and Safety. Resources on occupational
health and safety are kept in CNS 131 and regular review is required
of animal care staff. Material Safety Data Sheets are kept in CNS
171.
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|
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, by species, of animals in each
facility, are:
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| |
Animal Facilities, Total Sq.Ft: 2876
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| |
See attached table
(Facility and Species Inventory)
for breakdown of square footage and animal census.
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|
H.
|
The training or instruction available
to scientists, animal technicians, and other personnel involved
in animal care, treatment, or use is: All personnel involved
in animal care and use must undergo training with the animal caretaker,
or provide certification of previous training, prior to animal use.
The animal caretaker provides a training session to all new animal
users, particularly undergraduate research students, a minimum of
three times a year. Principal investigators must provide sufficient
proof of qualifications for animal use to the chair of the IACUC
and the veterinarian (for invasive procedures) prior to beginning
animal use. Any investigator lacking sufficient qualifications will
be provided with appropriate training from the animal caretaker,
IACUC chair, and/or veterinarian as needed. This training will include
such topics as minimizing pain and distress and determination of
animal number. When necessary, faculty and the IACUC Chair can consult
with experts at nearby Cornell Veterinary Medical School. Documentation
of all individuals certified for animal use will be maintained with
the IACUC records.
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2.22.4 Semiannual Reports
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 Provost Peter Bardaglio. Semiannual reports of IACUC evaluations will
be maintained by this institution and made available to the Office of
Laboratory Animal Welfare (OLAW) upon request.
2.22.5 Record Keeping Requirements
|
A.
|
This institution will maintain for at least three years:
|
| |
1.
|
A copy of this Assurance and any modifications thereto, as approved
by PHS.
|
|
| |
2.
|
Minutes of IACUC meetings, including records of attendance, activities
of the committee, and committee deliberations.
|
| |
3.
|
Records of applications, proposals, and proposed significant changes
in the care and use of animals and whether IACUC approval was given
or withheld.
|
| |
4.
|
Records of semiannual IACUC reports and recommendations (including
minority views) as forwarded to Provost Peter Bardaglio.
|
| |
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.
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|
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.
|
2.22.6 Reporting Requirements
|
A.
|
At least once every 12 months, the IACUC, through the Institutional
Official, will report in writing to the Office of Laboratory Animal
Welfare (OLAW).
|
| |
1.
|
Any change in the status of the institution (e.g., if the institution
becomes accredited by AAALAC or AAALAC accreditation is revoked),
and 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 submit a letter to OLAW stating that there are no changes.
|
| |
2.
|
Notification of the date that the IACUC conducted its semiannual
evaluations of the institution's program and facilities (including
satellite facilities) and submitted the evaluations to Dean Erlich.
|
|
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 in the IACUC.
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