# MEMORANDUM OF UNDERSTANDING

# BETWEEN

**THE OFFICE OF RESEARCH COMPLIANCE AND ASSURANCE\***

**U.S. DEPARTMENT OF VETERANS AFFAIRS**

**AND**

#  THE OFFICE OF LABORATORY ANIMAL WELFARE

**NATIONAL INSTITUTES OF HEALTH**

**U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**CONCERNING**

**LABORATORY ANIMAL WELFARE**

## I. PURPOSE

The National Institutes Of Health (NIH) Office of Laboratory Animal
Welfare (OLAW) and the Veterans Affairs (VA) Office of Research
Compliance and Assurance (ORCA) share a common interest in the care and
welfare of laboratory animals used in research and testing. This
agreement sets forth procedures for cooperation to assist each agency in
meeting its responsibilities to ensure appropriate laboratory animal
care and welfare. The intent of this agreement is to:

-   maintain and enhance agency effectiveness by coordinating efforts
    and sharing resources and information, particularly in the areas of
    education and compliance;

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-   avoid duplication of effort in achieving standards for the care and
    use of laboratory animals, thereby reducing regulatory burden on VA
    and VA-affiliated institutions; and

-   promote harmonization among VA sponsored activities and between VA
    institutions and other PHS assured institutions.

Interagency cooperation provides an excellent opportunity to bolster
individual agency efforts, achieve program benefits and facilitate
program operations. A shared perspective on acceptable standards of
laboratory animal care presents a uniform Federal approach and fosters
compliance with the PHS Policy on Humane Care and Use of Laboratory
Animals within VA and VA-affiliated institutions.

## II. AGENCY RESPONSIBILITIES

Office of Research Compliance and Assurance (ORCA)

ORCA serves as the primary component of the Veterans Health
Administration to advise the Under Secretary for Health on all matters
affecting the integrity of research by ensuring the welfare of research
animals through promoting conformance with relevant regulations and
policies. Through VA Handbook 1200.7, the VA has adopted the standards
of the PHS Policy on

Humane Care and Use of Laboratory Animals for all animal research
conducted under VA auspices, and further requires that VA medical
centers conducting animal studies and accepting any PHS funds should
have a PHS Animal Welfare Assurance (1200.7.7e).

**\*On May 12, 2003, the Office of Research Compliance and Assurance
(ORCA) was**

**renamed as the Office of Research Oversight (ORO) per the Under
Secretary for Health,**

**Veterans Health Administration, Department of Veterans Affairs. All
responsibilities**

**indicated in this Memorandum of Understanding remain in place.**

Office of Laboratory Animal Welfare (OLAW)

The Office of Laboratory Animal Welfare (OLAW), Office of Extramural
Research, National Institutes of Health (NIH), is responsible for the
implementation, general administration, and interpretation of the Public
Health Service Policy on Humane Care and Use of Laboratory Animals (PHS
Policy). The PHS Policy implements the Health Research Extension Act of
1985 (Public Law 99-158), and incorporates the U.S. Government
Principles for the Utilization and Care of Vertebrate Animals Used in
Testing, Research, and Training and the standards for institutional
programs and facilities described in the National Academy of Sciences\'
Guide for the Care and Use of Laboratory Animals (Guide).

The PHS Policy requires each institution receiving PHS support for an
activity involving live, vertebrate animals to establish an appropriate
institutional animal care and use program, including an Institutional
Animal Care and Use Committee (IACUC) with specific responsibilities as
described in the PHS Policy. Adherence to the Policy and Guide are
achieved primarily through voluntary compliance with an institutional
animal care and use program described in an Animal Welfare Assurance
(Assurance). Assurances are submitted to and must be approved by OLAW,
on behalf of the Director, NIH, before PHS funds may be released for
activities involving laboratory animals.

In addition to the Assurance mechanism, OLAW fosters compliance with the
PHS Policy through a nationwide educational program for research
administrators, IACUC members, investigators, laboratory animal
veterinarians, and others with responsibility for animal care and use.
OLAW also conducts site visits to institutions, and evaluates alleged
noncompliance with the PHS Policy. Institutions are required to correct
confirmed noncompliance and to institute appropriate measures to prevent
repeated noncompliance. Possible sanctions for continued noncompliance
range from exclusion of individual projects from an approved Assurance
to withdrawal of approval of the institution\'s entire Assurance.
Without coverage by an approved Assurance, PHS support may not be
applied to animal-related activities of a project.

### III. SHARED INTERESTS 

The VA and HHS share common interests for the care and use of laboratory
animals, and for the quality of the research conducted under their
auspices. OLAW has statutory responsibility for implementing the PHS
Policy as described above. The VA recognizes the value of the standards
contained within PHS Policy in promoting high quality animal care and
use programs and requires compliance with them even if PHS funds are not
received by the local VA medical center. At the present time there are
about 75-80 PHS Assurances with VA and VA-affiliated institutions,
comprising approximately 7.5% of all PHS Assurances. A VA-affiliated
institution is one of more than 100 medical or academic institutions
that formally collaborate with the VA in conducting both human and
animal research.

Program features common to VA and NIH include promotion of PHS Policy
standards, monitoring of standards, correction of programmatic
deficiencies, and promotion of voluntary compliance with standards
through education and dissemination of information.

## IV. SUBSTANCE OF AGREEMENT

A. Interpretation of and determination of noncompliance with PHS Policy
remain the exclusive purview of NIH/OLAW as authorized by Public Law
99-158.

B. The cooperating agencies agree to share information, to the extent
permitted by law, of mutual concern and interest regarding animal
welfare at VA and VA-affiliated PHS assured institutions, including, but
not limited to, evidence of serious noncompliance with standards for the
care and use of laboratory animals, significant adverse findings
regarding animal care and use investigated, inspected, or site-visited,
and actions taken by the agencies in response to the findings.

C. The cooperating agencies agree, to the extent possible, to avoid
redundant evaluations of VA and VA-affiliated animal care and use
programs and duplication of respective efforts in order to minimize the
burden on Assured institutions and on the cooperating agencies.

D. ORCA and OLAW will consult with one another with regard to
investigations of noncompliance at VA institutions holding a PHS
Assurance. ORCA and OLAW will notify each other of information
concerning potential noncompliance at VA-affiliated institutions with
PHS Assurances.

E. ORCA may request that OLAW negotiate Animal Welfare Assurances for VA
or VA-affiliated institutions that do not receive direct PHS support for
activities involving live vertebrate animals.

F. At the request of ORCA, OLAW will provide substantive review and
consultation of internal VA policies and educational materials for
compliance with PHS Policy and harmonization of standards.

G. The cooperating agencies agree to work collaboratively to co-sponsor
educational meetings and workshops, and will provide each other with
resource persons, to the extent possible, for seminars, presentations
and workshops related to laboratory animal welfare and their respective
agency responsibilities.

H. Nothing in this agreement shall limit or otherwise affect each
party's ability to exercise its own authorities or gives the other party
approval power over the exercise of the other party's authorities.
Nothing in this agreement is intended or should be construed to
authorize the transfer of funds between the cooperating agencies.

## V. LIAISON OFFICERS 

The cooperating agencies each agree to designate a liaison officer who
will represent the agency in the implementation of this agreement. The
liaison officers will coordinate exchanges of information as necessary
and the provision of other items under the Substance of Agreement
described above.

For the VA Office of Research Compliance and Assurance:

Dale H. Conaway, DVM, MS

Deputy Director, Southern Region

Chief Veterinary Medical Officer

Office of Research Compliance and Assurance (1OR)

1670 Clairmont Road

Decatur, GA 30033

Phone: 404-417-2934

Fax: 404-417-2935

For the NIH Office of Laboratory Animal Welfare:

Patricia A. Brown, V.M.D., M.S.

Acting Director, Office of Laboratory Animal Welfare\
Office of Extramural Research\
National Institutes of Health\
RKLI, Suite 1050, MSC 7982\
6705 Rockledge Drive\
Bethesda, MD 20892-7982\
Phone: 301-451-4209

Fax: 301-402-2803

## VI. PERIOD OF AGREEMENT

This agreement becomes effective on the date of the last signature and
continues for 5 years. It may be modified by mutual written consent.
Either party upon 90-day advance written notice to the other party may
terminate this agreement. At the conclusion of 5 years the parties will
consider the development of a new agreement.

## VII. ACCEPTANCE AND APPROVAL OF AUTHORIZING OFFICIALS

For the Office of Research Compliance and Assurance, VHA, VA:

Signature: /s/

Name: John Mather, M.D.

Title: Chief Officer, Office of Research Compliance and Assurance

U.S. Department of Veterans Affairs

Date: 12/26/2002

For the Office of Laboratory Animal Welfare, OER, NIH:

Signature: /s/

Name: Wendy Baldwin, Ph.D.

Title: Deputy Director for Extramural Research, NIH

U.S. Department of Health and Human Services

Date: 12/18/2002