**[Memorandum of Understanding]{.underline}\
regarding the\
Care and Use of Animal Subjects**

**Between the**

**University of Florida\
and the\
Malcom Randall VA Medical Center**

The University of Florida (UF) and the Malcom Randall VA Medical Center,
Gainesville, Florida (VA) make this agreement pertaining to UF personnel
who plan to house and/or use animals at the VA facility and to VA
personnel who plan to house and/or use animals at UF.

This agreement also covers animals that will be housed and/or used
temporarily at the VA or UF as well as VA funded studies approved for
off-site waiver and conducted at UF. The agreement is effective February
15, 2005. The terms of this agreement shall be valid for three years
from the date of this agreement. This agreement will continue from
year-to-year unless the agreement is terminated by either institution in
writing at least 60 days in advance of the ending date of this
agreement. Either institution may terminate this agreement at any time
and regardless of cause on 60 days written notice to the other delivered
by hand or by registered mail to the address and person shown below
(Section X.4) or such other address for notices as specified in writing.
This agreement may be modified or altered in writing and signed by both
parties. This agreement is inclusive of all vertebrate animal species.

For the purpose of the agreement, the "UF form" is defined as the UF
Animal Use Approval Form. The "VA form" is defined as the VA Animal
Component of Research Protocol (ACORP).

By virtue of this agreement, each institution (UF and VA), along with
their respective Institutional Animal Care and Use Committees (IACUCs),
is obligated to ensure continued compliance with all applicable laws and
regulations governing the use of research animas (e.g., USDA Animal
Welfare Act (AWA) and PHS Policy for the Humane Care and Use of
Laboratory Animals). In this agreement, IACUC is used as a generic term
to include the equivalent UF IACUC and the VA IACUC. Each institution
will work to maintain the standards required for Association for
Assessment and Accreditation of Laboratory Animal Care International
(AAALAC) accreditation and will maintain a current Animal Welfare
Assurance with the Office of Laboratory Animal Welfare (OLAW) at the
National Institutes of Health (NIH).

When personnel elect to house or use animals at either the UF or VA
facilities, all interested parties agree to the following arrangements
in order to ensure that both parties provide appropriate oversight:

## I. Veterinary Care

Both institutions shall provide adequate veterinary care at their
respective institutions in accordance with the Animal Welfare Act (Title
9 CFR, Part 2, Subpart C, Section 2.33), the most recent edition of the
*Guide for the Care and Use of Laboratory Animals* (*Guide*), currently
the 1996 edition, and the VA\'s professional services contract for
veterinary oversight and support in effect. The Veterinary Medical
Officer has the authority and responsibility for making determinations
concerning adequate veterinary care. Any deviation from the
veterinarian's recommendation without prior consultation with the
veterinarian constitutes non-compliance as outlined in PHS policy and
Animal Welfare Regulations (AWRs). Investigators may not provide
clinical treatments of the animals unless it is described in the IACUC
approved Animal Care and Use Protocol or directed by the VMO or his/her
designee. The IACUC is required to investigate and report such
non-compliance to regulatory agencies and the Chief Veterinary Medical
Officer.

## II. Protocol Review

The necessary forms that all investigators must complete, as well as the
necessary IACUC approval process, will be governed by the policies
stated in Table 1. If a protocol must be reviewed by both IACUCs,
personnel may not initiate the research until both IACUCs approve the
protocol. If there are differences not easily resolved between the two
IACUCs, the chairpersons of the two IACUCs will meet with the
investigator to attempt to resolve the issues. However, both IACUCs must
approve the final outcome of the resolution. By this agreement, the UF
IACUC agrees to accept as valid the VA form as the policy dictates, and
the VA IACUC agrees to accept as valid the UF form as the policy
dictates.

# TABLE 1: PROTOCOL REVIEW PROCESS

This table describes which IACUC form will be used based on which
institution employs the individual.

+-----------------------+-----------------------+-----------------------+
|                       | ### UF Employees      | **VA Employees**      |
+-----------------------+-----------------------+-----------------------+
| **Animals Housed and  | UF form only.         | VA form only.         |
| Used at UF**          | Reviewed by UF IACUC  | Reviewed by VA and UF |
|                       | only.                 | IACUCs.               |
+-----------------------+-----------------------+-----------------------+
| **Animals Housed and  | VA form only.         | VA form only.         |
| Used at VA**          | Reviewed by VA IACUC  | Reviewed by VA IACUC  |
|                       | only.                 | only.                 |
|                       |                       |                       |
|                       | Approved form sent to |                       |
|                       | UF for release of     |                       |
|                       | funds.                |                       |
+-----------------------+-----------------------+-----------------------+
| **Animals Housed or   | UF form only.         | VA form only.         |
| Used at both UF and   | Reviewed by UF and VA | Reviewed by UF and VA |
| VA**                  | IACUCs.               | IACUCs.               |
+-----------------------+-----------------------+-----------------------+

Dual appointment employees will be treated as if they were 100% employed
by the majority employer. In the case of equal employment, the employee
will be deemed a VA employee.

Any changes in the ACORP require notification and approval by the IACUC
prior to implementation. In cases where both IACUCs reviewed the
protocol, written approvals must be obtained from each of the two IACUCs
prior to initiating such changes.

## III. Personnel Qualifications

The UF and VA IACUCs shall have access to each other's records to the
extent permitted by law for the purpose of evaluating the
qualifications, experience and training of those who are specifically
responsible for the care and use of animals. This may include
scientists, research personnel, and animal care technicians. The records
to be requested may include Occupational Health and Safety Program
documentation.

The VA animal care staff and research personnel will be able to
utilize/access any of the animal-related training opportunities
available through UF. This will include, but is not limited to, the
Humane Awareness Seminar, various hands-on workshops, the online
training available on the UF website, vendor training for new equipment,
or any other in-house training available. The UF animal care staff and
researchers will also be able to utilize animal-related training
opportunities available through the VA, including on line training site
on the VA website: [www.researchtraining.org.]{.underline}

## IV. Reports

Upon reasonable request and notice, each institution shall provide the
other with copies of their PHS Assurance Statements as well as their
semi-annual reports as required by OLAW. This includes, but is not
limited to, any official correspondence regarding the semi-annual (OLAW)
and annual (USDA, AAALAC) reports of animal care and use, as well as any
correspondence from AAALAC, OLAW, or the USDA concerning the UF or VA
facilities. Each institution will provide the other with the report that
is relevant to this agreement.

## V. Transport of Animals

The transport of animals from one facility to another must be conducted
in accordance with the USDA regulations as specified in the Animal
Welfare Act (Title 9 CFR, Part 3, Transportation standards). The VA at
this time has no vehicles to transport animals and relies on UF to
supply these services.

1.  The transport of animals to or from the UF or VA facilities shall be
    conducted during normal business hours (Monday-Friday, 7 am -- 4
    pm), unless prior arrangements have been made with the appropriate
    veterinary staff. Animals shall be transported in an appropriate
    climate-controlled vehicle to the approved designated entry points
    for each facility. Transport of animals from UF to the VA shall
    comply with Veterinary Medical Unit policy.

2.  The responsible person shall notify the veterinary staff, along with
    any other appropriate departments, at least 24 hours prior to
    transporting an animal between facilities. The responsible person
    shall also notify the veterinary staff of any cancellations or
    changes in transport plans.

3.  In the event of unforeseen emergencies strictly related to the
    clinical care and well-being of a research animal, personnel may
    elect to transport an animal from one institution to the other. In
    such a case, the responsible person must contact the veterinary
    staff of each facility prior to transport in order to request
    approval for the transfer and proposed procedure(s). Personnel
    should document any special arrangements that are made for the
    clinical care of research animals and forward the documentation to
    the appropriate IACUC(s) as soon as possible after such transport.
    In all cases involving a significant change (i.e., increasing the
    risk to animals), approval must be obtained from the appropriate
    IACUC(s) as described in Section II -- Protocol Review.

## VI. Housing

If animals are scheduled to be transported to either facility and will
not be returned to the original facility, the responsible person will
make housing arrangements with the veterinary staff of the receiving
facility according to that facility's policies and procedures. The
transported animals must be alert and should not be under the influence
of any anesthetics or sedatives, unless permission has been obtained
from the veterinary staff of the receiving facility and a qualified
person is accompanying the animals en route.

If animals are to be housed temporarily in one facility and will be
returned back to the other, the responsible person shall make
arrangements with the veterinary staff for special space assignments in
advance of the animals' arrival. Returning animals must be housed in the
receiving facility in compliance with institution policies governing
transport and/or transfer of animals. The veterinary staff is
responsible for information and policies regarding vendors, health
certificates, and other considerations to prevent cross contamination of
the resident animals.

## V. Facility Inspections

At a minimum, the UF and VA IACUCs should conduct facility inspections
and program reviews every six months of their respective facilities as
required by the AWA and the *Guide*. Documented deficiencies of the AWA
or of the *Guide* will be submitted by the IACUC members conducting the
inspection to their respective IACUCs for correction/action along with
deadline dates for these actions.

Semi-annual program reviews and facility inspections are the
responsibility of the respective institutions\' IACUCs, with formal
reports being submitted to the Institutional Official as required by
OLAW and the *Guide*. These reports will be maintained in both the
offices of the IACUCs and the respective Institutional Officials. These
reports are public documents and are available for review by either
IACUC.

## VIII. Use of Hazardous Agents

The use of infectious agents, toxic chemicals, or radioisotopes requires
the prior written approval of the respective Subcommittee for Research
Safety, the Radiation Safety Committee and/or the Environmental Health &
Safety office of the institution whose IACUC approved the protocol.
Notification of such use must be given to the veterinary staff attending
such animals.

This Memorandum of Understanding is not intended to restrict or
otherwise reduce the effectiveness or responsibility of the committees
mentioned above (or other committees) to carry out their respective
charges, especially as it relates to cooperative animal research
projects between the VA and UF. As a result, UF's EH&S (Biosafety)
office may still have input into UF projects conducted at the VA.
Similarly, VA\'s Subcommittee for Research Safety may have input into VA
projects conducted at UF.

## IX. Reports of Non-Compliance

Each institution shall be responsible for notifying the other of any
instance of non-

compliance with respect to the care or treatment of animals that are
involved in UF or

VA sponsored research in a timely manner. The UF IACUC shall be
responsible for resolving any reports of non-compliance involving
animals while en route to or while housed at UF. The VA IACUC shall be
responsible for resolving any reports of non-compliance involving
animals while en route to or while housed at the VA. If a case of
non-compliance has been verified (after a formal or informal
investigation), the responsible IACUC shall submit a written report
describing the circumstances and subsequent resolution to their
respective Institutional Official as required by the AWA and the
*Guide*. Information of all verified non-compliance issues should be
shared by both institutional IACUCs so that an effective review of
related policies and procedures can be done as proof of ongoing
institutional self-monitoring.

## X. Emergencies

There may be times when the lack of personnel, equipment, or space
becomes a major problem for one institution to resolve. This Memorandum
of Understanding is intended to help facilitate the resolution of such
emergencies rather than to be restrictive. Towards that end the
following practices have been used in the past and can continue in the
future with the mutual agreement of both parties. Responsible parties
here are the Supervisors, Managers, Directors and veterinary staffs of
the institutional animal facilities at the VA and UF.

1.  Equipment failures: Depending on the equipment, down time, and
    projected repair time, arrangements can be made to share such items
    as long as the resident animal populations are not put at risk of
    contamination.

2.  Personnel absences: Depending on the person, reason for absence, and
    projected time of return to duty, arrangements can be made to share
    personnel for the sole purpose of animal care. There is no provision
    here to supply data gathering support or personnel for any research
    effort. The emergency here is for the direct care of animals until
    the depleted staff can be returned to normal strength.

3.  Space shortages: Depending on the what space is short or what
    species is involved and for the projected time of the shortage,
    arrangements can be made to temporarily house animals for each other
    until the space shortage is relieved. Space or room shortages could
    exist under major power failures, floods, etc. where space becomes
    unsuitable to house animals or certain species.

4.  Notices: Written notices of termination shall be delivered by hand
    or by registered mail to the Institutional Official (00), thru the
    Associate Chief of Staff for Research (151) Malcom Randall VA
    Medical Center, 1601 S.W. Archer Road, Gainesville, FL 32608-1197 or
    to the Vice President for Research, c/o University of Florida, 2233
    Grinter Hall, P.O. Box 115500, Gainesville, FL 32611-5500 as the
    Institutional Official for the University of Florida.

This agreement is accepted and executed by the parties below as of the
day and year first written.

North Florida/South Georgia Veterans University of Florida

Health System

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Institutional Official Date Institutional Official Date

F. L. MALPHURS Winfred M. Phillips, Ph.D.

Medical Center Director Vice President for Research

Address: Address:

Research Service (151) P.O. Box 100006

1601 S.W. Archer Road Gainesville, FL 32610-0006

Gainesville, FL 32608