MICHAEL E. DEBAKEY VETERANS AFFAIRS MEDICAL CENTER

RESEARCH SERVICE LINE

Houston, TX

ANIMAL CARE AND USE PROGRAM

1\. **[PURPOSE.]{.underline}** Animal research contributes immeasurably
to advancements in medical science. As recognized by principle No. 3 of
the Nuremberg Code of 1947, it is often a moral imperative to perform
research or testing on animals before subjecting humans to new
procedures, pharmacologics, or devices. Most research and testing
involving human patients will continue to be based on the results of
animal experimentation. Pursuant to 38 U.S.C. Section 7303, VA is
authorized to carry out a program of medical research in connection with
the provision of medical care and treatment to veterans. To provide hope
for veterans suffering from diseases that currently lack cures or
effective treatments, VA actively supports the use of animals in
research, teaching, and testing. However, the use of animals in VA
research is a privilege granted with the understanding and expectation
that such research will be conducted according to the highest ethical
and legal standards. The purpose of this policy sets forth the
principles and procedures by which individual investigators receive and
maintain approval for animal studies.

2\. **[POLICY]{.underline}**

a\. This policy applies to all research involving animals that is
conducted completely or partially in VA facilities or conducted in
approved off-site locations and facilities by Michael E. DeBakey VA
Medical Center (MEDVAMC) researchers while on VA official duty time. The
research may be VA-funded, funded from extra-VA sources, or conducted
without external funding.

b\. The following principles apply to all research involving animals:

\(1\) Animal experiments should be undertaken only after due
consideration of their relevance for human or animal health and the
advancement of biological knowledge.

\(2\) The fewest number of animals needed to achieve scientific
objectives should be used.

\(3\) The least sentient species that will permit the attainment of
research objectives should be used.

\(4\) The least painful or distressful procedures needed to meet
research objectives should be used, and all reasonable measures to
minimize pain and distress should be utilized.

\(5\) The principles of replacement, reduction, and refinement should
always be considered when planning and conducting studies.

\(6\) Procedures that would be considered painful in a human should be
considered to be painful in an animal.

\(7\) The best possible living conditions should be maintained for
animals kept for research, training, or testing purposes. Animal care
should be supervised by a veterinarian experienced in laboratory animal
medicine. Housing should ensure that the general health of animals is
safeguarded and that undue stress is avoided, with appropriate attention
paid to environmental factors such as temperature, ventilation, and
humidity.

\(8\) Personnel should have appropriate qualifications, training, and
experience when conducting procedures on animals. Opportunities for
hands-on training should be provided as needed.

3\. **[DEFINITIONS.]{.underline}** For purposes of this policy, the
following definitions apply:

a\. [Animal]{.underline}. The term "animal" is defined in this Handbook
as any live vertebrate animal used or intended for use in research,
research training, experimentation, or biological testing, or for a
related purpose. An animal for purposes of compliance with the Animal
Welfare Act Regulations is any live or dead cat or dog, non-human
primate, guinea pig, hamster, rabbit, or any other warm-blooded animal
which is being used, or is intended for use in research, teaching,
testing, or experimentation. The term excludes birds, rats of the genus
*Rattus* and mice of the genus *Mus* bred for use in research, and
horses not used for research purposes and other farm animals, such as,
but not limited to livestock or poultry, used or intended for use as
food or fiber, or livestock or poultry used or intended for use in
improving animal nutrition, breeding, management, or production
efficiency, or for improving the quality of food or fiber.

b\. [Animal Component of Research Protocol (ACORP)]{.underline}. The
ACORP is the official VA animal protocol form. It must be used by
Principal Investigators when a project involving animal research is
submitted for consideration of VA funding.

c\. [Association for Assessment and Accreditation of Laboratory Animal
Care, International (AAALAC).]{.underline} The accrediting body for
animal research programs recognized by VA.

d\. [Attending Veterinarian]{.underline}. Veterinary medical services
are obtained through contract with the Baylor College of Medicine Center
for Comparative Medicine.

e\. [Chief Veterinary Medical officer (CVMO).]{.underline} The VA
Central Office veterinarian given the primary responsibility for
formulating VA animal research policy, advising senior VA administrators
on animal research issues, and providing support and guidance as needed
to field research personnel conducting animal research.

f\. [Institutional Animal Care and Use Committee (IACUC)]{.underline}.
The local committee charged with reviewing and approving research using
vertebrate animals, and assuring compliance with animal research
regulations and guidelines. The MEDVAMC has a Memorandum of
Understanding (MOU) with Baylor College of Medicine (BCM) for use of the
Baylor IACUC. The MEDVAMC does not have an IACUC. The BCM IACUC serves
as the IACUC of Record for the MEDVAMC.

g\. [Institutional Biosafety Committee (IBC).]{.underline} The affiliate
(Baylor College of Medicine) committee that provides specialized review
of research protocols involving the use of recombinant DNA (rDNA) and
biohazardous agents (carcinogen, infectious, etc.) in animals. The
MEDVAMC has a Memorandum of Understanding (MOU) with Baylor College of
Medicine (BCM) for use of the Baylor IBC.

h\. [Institutional Official (IO)]{.underline}. The IO for this medical
center is the Medical Center Director. The MEDVAMC is covered by the
Baylor College of Medicine Public Health Service (PHS) Assurance. The
Vice President and Dean of Research at Baylor serves as the
Institutional Official for PHS correspondence concerning the animal care
and use program, both at the MEDVAMC and Baylor College of Medicine, in
compliance with PHS Policy, and the role of IO for communication with
AAALAC regarding accreditation matters.

i\. [Office of Research and Development (ORD).]{.underline} The office
within VA Central Office responsible for the overall policy, planning,
coordination, and direction of research activities within the Veterans
Health Administration (VHA).

j\. [Subcommittee on Research Safety (SRS).]{.underline} The
subcommittee of the Research and Development Committee that reviews and
approves research activities involving biological, chemical, physical,
and radiation hazards.

k\. [Veterinary Medical Unit (VMU)]{.underline}. The animal research
facility (vivarium) plus the husbandry and veterinary technical
personnel assigned to care for animals.

l\. [Veterinary Medical Unit (VMU) Supervisor]{.underline}. The
individual responsible for day to day operations of the VMU. Through
training and/or experience, the VMU supervisor must possess adequate
knowledge and skills in laboratory animal science and technology,
record-keeping and personnel management. The services of a VMU
Supervisor are obtained through contract with Baylor College of Medicine
Center for Comparative Medicine.

m\. [Vivarium.]{.underline} A place or enclosure for keeping and raising
living animals for observation or research.

4\. **[RESPONSIBILITIES]{.underline}**

a\. The [Medical Center Director]{.underline}, as the Institutional
Official (IO), is responsible for ensuring that the animal research
program has the resources and support necessary to comply with all
federal regulations and guidelines that govern animal research and
protection of personnel involved in animal research. The IO is the point
of contact for correspondence addressing animal research with the United
States Department of Agriculture (USDA), the Public Health Service
(PHS), and the Association for Assessment and Accreditation of
Laboratory Animal Care (AAALAC). However, because the MEDVAMC is covered
by the affiliate's (Baylor College of Medicine) Public Health Service
(PHS) Assurance, the Vice President and Dean of Research assumes the
role of the IO for PHS correspondence to comply with PHS Policy, and the
role of IO for communication with AAALAC regarding accreditation
matters.

b\. [Research and Development (R&D) Committee]{.underline}. The R&D
Committee is responsible to the Medical Center Director, through the
Chief of Staff, for maintaining high standards throughout the Medical
Center's research and development program, including the program for
animal care and use in research.

c\. The BCM [Institutional Animal Care and Use Committee
(IACUC)]{.underline}, as the IACUC of Record for the MEDVAMC, is
responsible for performing the review and oversight functions required
by PHS Policy, the *Guide for the Care and Use of Laboratory Animals*,
the Animal Welfare Act, the USDA Animal Welfare Act Regulations and
Standards, the requirements in VHA Handbook 1200.7, and any other
federal regulations that impact IACUC function. The IACUC is also
responsible for performing a self-assessment review of the program of
animal care and use and an inspection of the animal facilities and
husbandry practices at least every six months. As part of this
semi-annual inspection, the IACUC observes safety issues within all
laboratories that use animals. Any concerns are brought to the attention
of (a) the investigators and research staff, (b) the Baylor College of
Medicine (BCM) Center for Comparative Medicine (CCM), or (c) IACUC
members, as appropriate.

\(1\) The IACUC must review and approve, require modifications in (to
secure approval), or withhold approval of all research proposals
involving species and activities included within the definition of an
"animal" (see paragraph 3.c(1) of this document). All research projects
involving animals must be approved by the IACUC of Record, the SRS, and
then by the R&D Committee prior to commencement. The IACUC shall review
proposed research at convened meetings at which a quorum (a majority of
voting members) is present. In order for the research to be approved, it
must receive the approval of a majority of those voting members present
at the meeting. A quorum must be maintained for each vote to occur. If a
quorum is not maintained, the proposal must be tabled although
suggestions for review may be recorded and communicated to benefit the
investigator. The date of continuing review is based on the date of
IACUC approval.

\(2\) Prior to the third anniversary of the animal research protocol,
the IACUC conducts a complete re-review of the protocol and the most
recent ACORP is used by the IACUC to evaluate the VA-funded project.

\(3\) The MEDVAMC will nominate as a voting member individual(s) with
animal research expertise to serve on the BCM IACUC. An ex-officio,
non-voting member may be designated by the MEDVAMC to also serve on the
IACUC. The Medical Center Director shall officially appoint all members
in writing.

\(4\) All members are expected to meet training and certification
requirements for IACUC members regardless of affiliation.

\(5\) The BCM IACUC will review the VA vivarium and program as part of
its own facility and program review.

\(6\) The BCM IACUC will review the VA ACORP during committee meetings
for those VA investigators submitting VA proposals to ORD.

\(7\) All internal and external allegations of improper animal care and
use at the MEDVAMC must be reviewed promptly by the IACUC, and
investigated if warranted. A written report of the review or
investigation shall be approved by a majority of a convened IACUC quorum
and sent to the Medical Center Director through the ACOS/R&D.

\(8\) Human diagnostic, treatment/monitoring areas and/or equipment can
be used for animal studies only with IACUC approval and/or appropriate
administrative approval.

d\. The BCM [Institutional Biosafety Committee (IBC)]{.underline}

\(1\) The BCM IBC includes veterinary members and coordinates with the
BCM IACUC to provide specialized review of biohazardous agents in
animals. Protocols involving the use of hazardous agents in animals
housed at the MEDVAMC will be reviewed by the IBC and the results of
that review will be conveyed to the SRS.

\(2\) The BCM IBC provides specialized review of protocols involving the
use of recombinant DNA in animals or humans. MEDVAMC protocols involving
the use of recombinant DNA will be reviewed by the IBC and the results
of that review will be conveyed to the SRS.

\(3\) The BCM IBC will include a member of the SRS who will convey the
IBC reviews of MEDVAMC protocols to the SRS.

e\. The [BCM Center for Comparative Medicine (CCM)]{.underline}, through
contract with the MEDVAMC, operates the MEDVAMC vivarium and procures
all research animals. CCM is responsible for maintaining a safe working
environment for personnel within the vivarium. CCM is also responsible
for providing education and training to personnel on the care and use of
animals in research and teaching, including safe animal handling
techniques.

f\. [Investigators]{.underline} are responsible for identifying
occupational hazards, minimizing risk in their work environment,
ensuring compliance with program requirements, and ensuring that all of
their employees using animals have been properly trained and equipped to
perform their job duties safely. The investigator is expected to conduct
the research in accordance with the approved protocol and to oversee all
aspects of the research, including:

\(1\) Training and supervision of the research support staff, and other
staff involved in the project.

\(2\) Compliance with institutional policies and administrative
requirements for the privilege of conducting research using animals.

g\. [Attending Veterinarian]{.underline}. The primary responsibilities
include:

\(1\) Review of protocols for proper IACUC approvals.

\(2\) Monitoring of protocols so that deviations and problems are
detected, reported, and resolved.

\(3\) Diagnostic monitoring and treatment of sick animals housed in the
vivarium, including emergency calls as needed.

\(4\) Consulting with Principal Investigators and their employees on
treatment plans.

\(5\) Examination of newly delivered animals to ensure that all animals
are healthy.

\(6\) Explanation and advisement of VA, American Association for
Accreditation of Laboratory Animal Care (AAALAC), U.S. Department of
Agriculture (USDA), and Public Health Service (PHS) regulations.

\(7\) Training, as needed, to investigators and employees in techniques
of animal care.

\(8\) Professional and technical support to Principal Investigators in
planning, executing, and reporting research projects using animal
subjects.

\(9\) Recommendations made to the MEDVAMC Research Service Line
management team to ensure that the MEDVAMC animal research facility
complies with all relevant animal welfare laws, regulations, and
policies.

h\. The [VMU Supervisor]{.underline} is responsible for overseeing daily
husbandry and other animal care duties. The primary responsibilities
include:

\(1\) Scheduling work assignments of the VMU staff and monitoring the
quality and quantity of work performed.

\(2\) Providing orientation and training for employees.

\(3\) Instructing and assisting research technicians and investigators
in performance of routine techniques for animal experimentation.

\(4\) Maintaining essential records (e.g., animal and equipment
inventories, procurement records, etc.).

\(5\) Ensuring the maintenance of a sound program of animal husbandry.

\(6\) Ensuring the maintenance of a stable animal environment
(temperature, lighting, and ventilation) and promptly reporting
malfunctions to proper authorities.

\(7\) Noting and reporting abnormal behavior or illness in animal
subjects to the Attending Veterinarian.

\(8\) Recording and reporting misuse of animals during experimentation
or deviation from approved protocols to the Attending Veterinarian or
other member(s) of the IACUC.

i\. [Animal Contact Personnel]{.underline} are responsible for
identifying and reporting unsafe working conditions to their supervisor
or principal investigator, complying with occupational health
requirements (e.g., health and risk assessments), and complying with all
other institutional health and safety policies and procedures.

5\. **[OCCUPATIONAL HEALTH AND SAFETY.]{.underline}**

a\. [Preventive Medicine.]{.underline} This medical center maintains an
active Employee Health Services Program (EHSP) for matters involving
injury or occupational disease incurred by employees in the performance
of duty, as well pre-employment physical examinations. All personnel (VA
employees and without compensation (WOC) staff) engaged in the care and
use of experimental animals must either participate, as applicable, in
the MEDVAMC EHSP, or in a similar EHSP provided by the affiliate, Baylor
College of Medicine. Personnel exposed to airborne or other animal
allergens on more than an occasional basis shall also participate.
Personnel must receive protective immunizations at appropriate intervals
(e.g., tetanus, rabies).

b\. [Occupational Safety Training.]{.underline} Personnel who have
contact with experimental animals will receive training in the proper
handling of the animals with which they will work, will be instructed to
avoid unnecessary risk when working with animals, and to seek expert
assistance when in doubt. Training will include the use of appropriate
protective clothing, equipment, and hygiene practices.

c\. [Reporting Injuries and Illness.]{.underline} Injuries, animal
bites, animal scratches, and cuts sustained in the vivarium or research
laboratory will be reported promptly to the employee\'s supervisor. The
employee will then be referred to the Employee Health Physician, and
complete appropriate paperwork. Illness should routinely be reported to
the employee\'s supervisor.

d\. [Personal Hygiene.]{.underline} An important factor in protecting
the health of personnel engaged in animal care or research is personal
hygiene. All employees need to understand the importance of personal
hygiene and specific measures that are to be taken routinely to protect
themselves against zoonotic agents found naturally in experimental
animals as well as hazardous agents used experimentally in approved
biomedical studies using animals.

e\. [Hand Washing.]{.underline} Hand washing is a crucial safety measure
for safeguarding personnel in the vivarium. Although the proper use of
disposable gloves provides an effective means of preventing hand
contamination, hands can easily become contaminated during the removal
of contaminated gloves.

f\. [Protective Clothing and Disposable Items.]{.underline} Protective
clothing is provided to employees, as appropriate, and the employees are
to wear it. Disposable protective items such as gloves, masks, and head
and foot covers, and gowns or other body cover will be provided when use
of these items is required. Soiled protective clothing must not be taken
away from the work site. Soiled outer garments must not be worn outside
the vivarium.

g\. [Hearing Protection]{.underline}. The noise level in vivarium areas
may reach potentially damaging levels, particularly in cage washing
areas and dog housing rooms. Ear protection will be provided whenever
noise levels exceed those permissible levels established by the
Occupation Safety and Health Administration (OSHA) regulations or
whenever requested by an employee. The VMU Supervisor will assume
responsibility for ensuring the appropriate use of ear protection.

h\. [Eye Protection]{.underline}. Protective eye ware should be used by
employees who handle corrosive or otherwise dangerous liquids or vapors.
Goggles or other devices that completely shield the eyes will be
provided when appropriate.

i\. [Other Precautions]{.underline}. Personnel shall be trained to avoid
hand contact with their eyes, face, mouth, or other body surfaces with
contaminated gloves or hands.

j\. [Special Circumstances]{.underline}. Special equipment and clothing
may be required when personnel are engaged in studies that involve
hazardous agents. The specific measures needed are to be appropriate for
the agents used, as determined by the MEDVAMC Safety Officer in
consultation with the investigator and the Attending Veterinarian.

k\. [Smoking, Eating, Drinking, and Cosmetic Application.]{.underline}
Smoking, eating, applying cosmetics, installing contact lenses and
similar procedures are prohibited within the animal facility or in
animal study areas except in designated areas that are free of
potentially contaminated materials. Signs will be posted instructing
personnel of the prohibitions.

l\. [Food and Beverage Storage]{.underline}. Employee food and beverages
shall be stored [only]{.underline} in refrigerators and/or freezers
designated exclusively for such use.

6\. **[HAZARDOUS AGENTS.]{.underline}** Safety in VA research
laboratories is the primary responsibility of the MEDVAMC Subcommittee
on Research Safety (SRS). These responsibilities include inspections,
training, investigation, documentation, and safety program review.
Additional safety measures may be needed to protect personnel who use or
work in the vivarium when biological, chemical, or radiological agents
are in use. The specific measures needed are dependent on the risk to
human and animal health represented by the agent, and the difficulty
involved in containing the agent. Procedures shall be in place for the
proper use, storage, and disposal of hazardous materials.

a\. [Procedures.]{.underline}

\(1\) Before experimental animals are treated with any hazardous agent,
the research must be approved by the Research and Development Committee
and the procedures must have been approved by the IACUC to include
approval of the Animal Component of Research Protocol (ACORP) for
proposals being submitted for consideration of VA funding, and the SRS.

\(2\) An appropriate standard operating procedure written for the
husbandry staff and other personnel who are working with animals must be
prepared by the Attending Veterinarian with assistance from the
principal investigator and the MEDVAMC Safety Officer for each hazardous
agent planned for use in animals.

\(3\) Prior to the initiation of any study, personnel who work with
animals exposed to hazardous agents (or who clean their cages) shall be
trained in proper procedures to work with the animals and in the proper
procedures relating to waste and equipment. Documentation of such
training needs to be made before employees manipulate experimental
animals treated with hazardous agents.

b\. [Special Xenozoonosis Considerations.]{.underline} Immunologically
compromised rodents, such as the nude mouse and the severe combined
immuno-deficient (SCID) mouse, that receive human xenografts, body
fluids, blood, or human infectious agents and related materials, present
a potentially unique and poorly understood (xenozoonosis) risk. These
rodents may develop persistent infections while remaining otherwise
healthy. For this reason, such animals injected with these materials
need to be handled with caution, following Biosafety Level 2 or 3
practices, in accordance with the recommendations of the MEDVAMC Safety
Officer.

c\. [Universal (Standard) Precautions]{.underline}. Universal or
"Standard" Precautions are a set of safe practices in which all human
blood and certain human body fluids are treated as if known to be
infectious for Human Immunodeficiency Virus (HIV), Herpes B Virus (HBV),
and other bloodborne pathogens. Intended primarily for personnel working
directly with human blood components, other body fluids and excreta, and
unfixed tissues, such practices are relevant to all personnel working
with potentially infectious materials in animal studies. Personnel
working with animals treated with such materials shall receive annual
training in Universal Precautions to comply with the Bloodborne Pathogen
Standards.

d\. [Chemical Agents and the Material Safety Data Sheet]{.underline}

\(1\) Although all chemicals and drugs are potentially dangerous,
special concern is necessary when working with known carcinogens,
mutagens, immunosuppressive agents, toxic drugs, potent steroids, agents
of unknown pharmacological activity, and other chemicals listed as
hazardous waste by the Environmental Protection Agency (EPA).

\(2\) A Material Safety Data Sheet (MSDS) shall be maintained for each
chemical agent by the using investigator and the vivarium. The VMU
Supervisor shall maintain a MSDS logbook for chemicals, such as
detergents, cleaners, and alcohols used.

e\. [Radioactive Agents]{.underline}. The safety principles for work
with radionuclides are similar to those for work with other hazardous
agents with some important additions:

\(1\) The MEDVAMC Radiation Safety Officer is to review and approve, or
require specific procedures that are to be followed when using
radionuclides in animals.

\(2\) Personnel working with radionuclides are to be trained
specifically for work with these materials.

\(3\) All acquisition and disposition of radionuclides are to be in
accordance with the Nuclear Regulatory Commission (NRC) regulations
covering these materials.

7\. [**TRAINING**.]{.underline}

a\. All personnel involved with animal research must be trained to
competently and humanely perform their duties related to animal
research, and participate in continuing education courses related
thereto. This mandate extends to husbandry staff, research technicians,
investigators and all others that perform procedures or manipulations on
laboratory animals. Training includes:

\(1\) Humane practices of animal care (housing, husbandry, and
handling).

\(2\) Humane practices of animal use (research procedures, anesthesia,
analgesia, euthanasia, surgery, pre- and post-operative care).

\(3\) Testing methods that minimize the number of animals used to obtain
valid results.

\(4\) Testing methods that minimize animal pain and distress.

\(5\) The safe use of hazardous agents and access to Occupational Safety
and Health Administration (OSHA) hazard notices.

b\. Prior to approval of any protocol, the IACUC will ensure that all
staff listed on the protocol have been adequately trained (ref: USDA
AWAR, 9 CFR Section 2.32(a); Principle 8, U.S. Government Principles for
the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training).

8\. **[VMU OPERATIONS]{.underline}**

a\. [Animal Care, Husbandry, and Animal Research Practices]{.underline}.

\(1\) Any laboratory animal used in the MEDVAMC vivarium must be
acquired in accordance with Federal laws, regulations, and policy.

\(2\) No request for animal procurement will be approved or initiated
until the attending veterinarian or VMU supervisor determines that the
source of animals is appropriate, that adequate and appropriate housing
is available upon arrival, and that the animals are going to be used in
a protocol approved by the IACUC.

\(3\) Delivery of live animals shall be made directly to the vivarium,
unless special arrangements have been made between the VMU staff and the
institutional receiving staff.

b\. [Explosive Agents.]{.underline} Newer anesthetic agents have
essentially eliminated the necessity of using explosive agents, such as
ether for anesthesia on any species. Therefore, explosive agents are not
to be used unless justified scientifically and approved by the IACUC and
the MEDVAMC Subcommittee on Research Safety.

c\. [Security Access]{.underline} to the vivarium, including storage
areas, is controlled and limited to approved/authorized individuals. The
animal facility is secured by a state-of-the-art keycard and video
surveillance system in which entry is controlled on a 24 hour/7 day per
week basis. An intrusion alarm system is also present and monitored by
the Research Office during duty hours and the MEDVAMC Police 24 hours a
day, 7 days a week.

9\. **[PROTOCOL REVIEW]{.underline}**

a\. Investigators shall submit proposals electronically to the MEDVAMC
Research Office. Submission must be accompanied by a VACS form.
Information and forms can be obtained at
<http://www1.va.gov/houston_va_rd/> or at
<http://intranet.bcm.edu/index.cfm?tmp=research/va_rd/index>.

b\. Submission of proposals to the BCM IACUC can be done electronically
through the Biomedical Research Assurance and Information Network
(BRAIN). The link to BRAIN is through the BCM Intranet at
<https://brain.bcm.edu/brainlogin.asp>. Investigators will need a Baylor
enterprise account and password to submit a protocol. Investigators may
contact their Baylor department administrator to help with this. Based
on the selections made when completing the on-line protocol, where
applicable, the protocol will automatically route to the IBC for review,
as well as append the ACORP template.

10\. **[RETENTION OF RECORDS]{.underline}**.

a\. Portions of IACUC minutes pertaining to VA Research will be provided
by BCM which shall be kept for three years.

b\. The BCM Institutional Official will make available semi-annual IACUC
reports which shall be kept for three years.

c\. Electronic IACUC files for closed protocols will be maintained by
BCM Office of Research for three years after the date of closure. The
MEDVAMC will duplicate any IACUC files from BRAIN in order to comply
with all applicable VA record retention policies. Documents in
connection with VA Research protocols that are not accessible through
BRAIN will be made available to the MEDVAMC Research Office upon
request.

11\. **[REPORTING REQUIREMENTS]{.underline}**

a\. [USDA Annual Report of Research Facility]{.underline}. This report
(required by Section 2.36 of the USDA Animal Welfare Act Regulations and
Standards) must be completed/submitted by December 1 of each year using
the USDA website. Species not covered by the definition of an \"animal\"
by USDA Animal Welfare Act Regulations are not included in the USDA
report. Instead, such animals will be included in the VMU Annual Report
to CVMO.

b\. [IACUC Semi-Annual Self-Assessment Reviews]{.underline}. Such
reviews must be performed and reports prepared by the IACUC of Record.
After approval by the IACUC, the report must be discussed with the
Medical Center Director by the IACUC Chairperson, Attending
Veterinarian, and one or more MEDVAMC research administrators. The
Medical Center Director then must sign the report indicating that the
report has been reviewed. Once the Medical Center Director has signed
the report, it shall be sent to the CVMO within 60 days of the
self-review date.

c\. [Annual VA VMU Report]{.underline}. This VMU Report covering the
previous fiscal year must be completed/submitted on-line to the CVMO by
January 15^th^ of each year. All animal species used will be included in
the Annual VMU Report.

d\. [Correspondence.]{.underline} The BCM Institutional Official will
make available to the MEDVAMC all PHS, USDA, AAALAC, and other reports
and correspondence related to the VA animal care and use program as
required by regulation or VA institutional policy.

12\. **[REFERENCES]{.underline}**

a\. VHA Handbook 1200.7, Use of Animals in Research

b\. VHA Handbook 1200.8, Safety of Personnel Engaged in Research

c\. CDC-NIH Biosafety in Microbiological and Biomedical Laboratories,
4^th^ Edition (or most recent revision)

d\. National Research Council, Guide for the Care and Use of Laboratory
Animals, 1996 (or most recent edition)

e\. PHS Policy on Humane Care and Use of Laboratory Animals, NIH Office
of the Director, Revised September 1986 and reprinted October 2000

f\. U.S. Department of Agriculture (USDA) Animal Welfare Act Regulations
and Standards, 9 CFR Part 2.

g\. U.S. Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training. Prepared by
the U.S. Interagency Research animal Committee, and originally published
in the Federal Register, May 20, 1985, Vol. 50, No. 97, by the Office of
Science and Technology Policy.

13\. **[RESCISSION]{.underline}**.

None

14\. **[RECERTIFICATION]{.underline}**

Research Service Line on or before the last working day of June 2012.

//hhb\\\\

HOLLY H. BIRDSALL, MD, PHD

Associate Chief of Staff/Research