Office of Laboratory Animal Welfare - MOU Between NIH and VA

MEMORANDUM OF UNDERSTANDING
BETWEEN
THE OFFICE OF LABORATORY ANIMAL WELFARE
NATIONAL INSTITUTES OF HEALTH
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
THE OFFICE OF RESEARCH OVERSIGHT AND
THE OFFICE OF RESEARCH AND DEVELOPMENT
VETERANS HEALTH ADMINISTRATION
U.S. DEPARTMENT OF VETERANS AFFAIRS
CONCERNING
LABORATORY ANIMAL WELFARE

I. PURPOSE

The National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) and the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Office of Research and Development (ORD)and Office of Research Oversight (ORO), hereinafter referred to as the Cooperating Agencies, collectively share a common interest in the appropriate care and welfare of laboratory animals used in research and testing. This Memorandum of Understanding (“MOU”) 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 MOU is to: 

• Maintain and enhance agency effectiveness by coordinating efforts and sharing resources and information, particularly in the areas of education and compliance; 
• Avoid duplication of effort in achieving standards for the care and use of laboratory animals, thereby reducing regulatory burden on the VA and VA-affiliated institutions; and 
• Promote harmonization among VA-sponsored activities and between VA institutions and other Public Health Service (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 at VA-affiliated institutions that conduct VA research.
 

II. AGENCY RESPONSIBILITIES RELEVANT TO THIS MOU

NIH Office of Laboratory Animal Welfare (OLAW)

OLAW, Office of Extramural Research, NIH, is responsible for the implementation, general administration, and interpretation of the PHS 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 current edition of 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 PHS Policy and the Guide are achieved primarily through voluntary compliance with an institutional animal care and use program described in a PHS 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 recurrence. Possible sanctions for continued noncompliance without appropriate corrective actions 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.

VA Veterans Health Administration (VHA)

Within VHA, VA, the Office of Research and Development (ORD) and the Office of Research Oversight (ORO) have distinct, complementary responsibilities in the effort to ensure that VA research with animals is conducted appropriately.

VHA ORD serves as the primary internal research funding and research policy formulation component within VA. It bears primary responsibility for supporting field research programs through education, training, and consultation. Support for VA field programs of research with animals is managed primarily through the office of the Chief Veterinary Medical Officer (CVMO), which is responsible for establishing VA policy about VA research with animals (VHA Handbook 1200.07), and assumes responsibility for interactions with other federal agencies (such as NIH OLAW) regarding policy and training relevant to research with animals. VA policy requires all VA animal research to be conducted in compliance with the United States Department of Agriculture (USDA) Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR) (VHA Handbook 1200.07, par. 4.b(5)) and the PHS Policy (VHA Handbook 1200.07, par. 4.b(4)), regardless of whether it is supported by PHS funds. This includes accepting that OLAW's interpretation of PHS policy is definitive (PHS Policy, Section V.A.3).

VHA ORO serves as the primary VHA office to advise the VA Under Secretary for Health on matters of research compliance. With regard to VA animal research and in accordance with the requirements of VHA Directive 1058.01, ORO performs periodic prospective reviews of VA animal research programs to identify noncompliance and vulnerabilities. Further, ORO investigates reports of alleged noncompliance with the laws, regulations, and policies applicable to VA animal research when it is determined that such investigations are best conducted by an entity independent of the VA medical facility where the noncompliance is alleged to have occurred.
 

III. SHARED INTERESTS

The VA and NIH share common interests in the appropriate care and use of laboratory animals and in the quality of the research conducted under their auspices. OLAW has statutory responsibility for implementing the PHS Policy as described above. VA recognizes the value of the standards contained within the PHS Policy in promoting high quality animal care and use programs and therefore requires compliance with them even when the animal research at a local VA medical facility is not supported with PHS funds. Compliance with PHS requirements also promotes VA adherence to the standards common to the other medical or  academic institutions that affiliate with VA and/or collaborate with VA in conducting animal research.

Program features common to VA and NIH include promotion of PHS Policy standards, monitoring of standards, correction of programmatic deficiencies, promotion of voluntary compliance, and creation and implementation of educational programs that foster compliance, dissemination of information, and quality animal care.

IV. SUBSTANCE OF MOU

1. Interpretation of PHS Policy remains the exclusive purview of NIH/OLAW as authorized by Public Law 99-158.
2. Subject to each agency’s internal guidelines and upon receiving a request, the Cooperating Agencies agree to share information of mutual concern and interest regarding animal welfare at VA medical facilities and VA-affiliated PHS-assured institutions, including, but not limited to, evidence of serious noncompliance with established standards for the care and use of laboratory animals, significant adverse findings of investigations, inspections, or site visits regarding animal care and use, and documentation of actions taken by the agencies in response to the findings.
3. The Cooperating Agencies agree to limit to internal agency officials who have a need to know, the dissemination of shared information received. If a Cooperating Agency receives a Freedom of Information Act request for records provided by the other agency, the recipient agency will refer the request to the agency that provided the records. The recipient agency will promptly notify the agency that provided the information of any judicial order that compels the release of information.
4. 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, to minimize the burden on Assured institutions and on the Cooperating Agencies.
5. Subject to item IV.2 above, ORO and OLAW will consult with one another, as necessary, with regard to investigations of serious noncompliance in VA research with animals.
6. Subject to item IV.2 above, the ORD CVMO will share information relevant to VA compliance with PHS Policy with OLAW and ORO.
7. OLAW agrees to negotiate Animal Welfare Assurances from VA or VAaffiliated institutions that do not receive direct PHS support for activities involving live vertebrate animals.
8. At the request of ORO or ORD, OLAW will provide substantive review and consultation of internal VA policies and educational materials related to animal research for compliance with PHS Policy and harmonization of standards.
9. The Cooperating Agencies agree to work collaboratively to co-sponsor educational meetings and workshops, to collaborate on online training, and to 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.
10. Nothing in this MOU shall limit or otherwise affect each party’s ability to exercise its own authorities or gives either party approval power over the exercise of the other party’s authorities. Nothing in this MOU 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 at least one liaison officer who will represent the agency in the implementation of this MOU. The liaison officers will coordinate exchanges of information as necessary and the provision of other items under the Substance of MOU section (IV) described above.

For the NIH Office of Laboratory Animal Welfare:

Patricia A. Brown, VMD, MS, DACLAM
Director, Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
RKL 1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982
Phone: 301-496-7163

For the VHA Office of Research and Development:

George W. Lathrop, Jr., DVM, MS, DACLAM
Chief Veterinary Medical Officer
Office of Research and Development (151V)
Veterans Health Administration
Department of Veterans Affairs
1670 Clairmont Road
Decatur, GA 30033
Phone: 404-731-8237

For the VHA Office of Research Oversight:
James M. Trout, PhD
Director, Research Safety & Animal Welfare (RSAW)
Office of Research Oversight (10R)
Veterans Health Administration
Department of Veterans Affairs
810 Vermont Ave. NW
Washington, DC 20420
Phone: 202-632-7677

VI. PERIOD OF AGREEMENT

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

VII. ACCEPTANCE AND APPROVAL OF AUTHORIZING
OFFICIALS

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

Date: 01/04/2023
Name: Michael Lauer, M.D.
Title: Deputy Director for Extramural Research
National Institutes of Health
U.S. Department of Health and Human Services
1 Center Drive (MSC 0152)
Room 144
Bethesda, MD 20892-0152
Phone: 301-496-1096

For the Office of Research and Development, VHA, VA:

Date:  01/03/2023
Name: Rachel B. Ramoni, DMD, ScD
Title: Chief Research and Development Officer (10P9)
Office of Research and Development
Veterans Health Administration
1100 1st Street, NE, Rm 622
Washington, DC 20000
U.S. Department of Veterans Affairs

For the Office of Research Oversight, VHA, VA:

Date: 01/03/2023
Name: Doug Bannerman, PhD
Title: Executive Director
Office of Research Oversight (10RO)
Veterans Health Administration
810 Vermont Ave. NW
Washington, DC 20420
U.S. Department of Veterans Affairs