VHA DIRECTIVE 10-95-031

Department of Veterans Affairs
Veterans Health Administration
Washington DC 20420

April 14, 1994

DEPARTMENT OF VETERANS AFFAIRS (VA) RESPONSIBILITY FOR VA-OWNED RESEARCH ANIMALS HOUSED IN NON-VA FACILITIES AND NON-VA-OWNED RESEARCH ANIMALS HOUSED IN VA FACILITIES

1. PURPOSE: The purpose of this Veterans Health Administration (VHA) directive is to make explicit the application of provisions of M-3, Part I, Chapter 12, Animal Subjects in Research, to: (a) animals owned by the Department of Veterans Affairs (VA), but housed in non-VA research facilities, and (b) animals housed in VA facilities, but owned by non-VA entities. This directive will be incorporated into M-3, Part I, Chapter 1 by February, 1995.

2. BACKGROUND: In 1992, The United States Department of Agriculture (USDA) informed VA that research animals owned by VA but held in non-VA facilities, were subject to VA oversight by the SAS (Subcommittee on Animal Studies (SAS) of the VA medical center Research and Development (R&D) Committee. In response to these expectations, and similar expectations where converse arrangements for housing non-VA animals in VA housing existed, further clarification to avoid duplication of effort was sought with USDA and Office for Protection from Research Risks (OPRR)/National Institutes of Health (NIH). The policies and procedures announced in this directive are designed to meet VA, USDA, and OPRR requirements with respect to oversight of research animal care and use practices in the situations described.

3. POLICY

  1. VA medical centers, acting through the SAS, are responsible for ensuring the humane care and treatment of vertebrate animals used or intended for use in laboratory research. This responsibility extends not only to animals owned by VA and housed in VA facilities, but also to those: (1) owned by VA, but housed in non-VA research facilities, and those (2) housed in VA research facilities, but owned by non-VA entities.

  2. The SAS must fulfill the programmatic responsibilities described in M-3, Part I, Chapter 12; Federal Regulations (9 Code of Federal Regulations (CFR) Ch. 1, Subch. A, "Animal Welfare"); and the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals. Compliance with the PHS Policy is required of all VA medical centers that receive PHS research funds or have a letter of assurance of compliance with PHS Policy on file with OPRR. This directive calls special attention to:

    (1) Review of research proposals using animals,

    (2) Oversight of the animal care and use program, and

    (3) Record keeping for animal use.

  3. Efforts should be made to avoid duplication of oversight by VA and affiliated organizations without nullifying the responsibilities and obligations contained in M-3, Part I, Chapter 12, the Federal Regulations, and the PHS Policy.

4. ACTION

  1. In situations where animal subjects are moved between the VA medical center and its affiliated institutions for research or care and housing, the VA medical center remains accountable for compliance of the research and the care and housing of all animals that are housed at the VA medical center, or held there temporarily for research.
  2. The semi-annual program review of the Institutional Animal Care and Use Committee (IACUC) of an institution that houses, holds temporarily, or conducts research on VA-owned animals may be accepted by the VA medical center provided that the report is submitted to and accepted by the SAS of the VA medical center for the responsible Institutional Official (medical center Director) of the VA medical center. Such reports must be held by the VA medical center and acted upon in accordance with the IACUC findings.
  3. When desirable or feasible, a VA medical center and its affiliated institution may have a joint SAS (or IACUC), provided that the appointment of the committee members is concurred in by the VA medical center responsible Institutional Official, has representation from the VA medical center, and is accountable to the VA medical center Institutional Official. In such cases it is recommended that joint committees have responsibility to the VA medical center and the affiliated institution.
  4. Responsibility for animal subject studies initiated by VA investigators, regardless of funding source, cannot be delegated. It remains the responsibility of the VA medical center to ensure that these studies comply with regulations and policies governing the use of animal subjects in experimentation, irrespective of administrative arrangements with affiliated institutions.
  5. A VA medical center that houses animals belonging to an affiliated institution may accept the animal subject protocol review of the affiliated institution provided that the protocol is submitted to, and accepted by the R&D Committee and the SAS of the VA medical center. Such protocols must be maintained on file, subject to review as described in the Federal Regulations, VA Policy, and PHS Policy when applicable. NOTE: All animal subject protocols submitted to VA Central Office for VA funding must use the VA Animal Component of Research Protocol (ACORP), see M-3, Part I, Chapter 12, Appendix 12C.
  6. When preparing the USDA Annual Report of Research Facility, it is acceptable to report animals owned by the VA medical center, but housed in an affiliated institution, on the VA medical center report form or the report of the affiliated institution. This practice must be consistent across species. It is recommended that when VA medical center animals are reported by affiliated institutions, a copy of the report of the affiliated institution be retained by the VA medical center. Records of ownership and research use of such animals must be retrievable at the VA medical center.

5. REFERENCES

  1. Manual M-3, Part I, Chapter 12.
  2. Title 7 CFR 2.17, 2.51, and 371.2 (g).
  3. Title 9 CFR Chapter 1 (1-1-92), subchapter A, Animal Welfare.
  4. Title 7 United States Code Sections 2131 through 2157.
  5. OPRR/PHS Policy on Humane Care and Use of Laboratory Animals. Revised September 1986.

6. RESCISSION: None. This VHA Directive will expire (Date).

7. FOLLOW-UP RESPONSIBILITY: Associate Chief Medical Director for Research and Development (12/4).

S/ by Dennis Smith for
John T. Farrar, M.D.
Acting Under Secretary for Health

DISTRIBUTION:
CO: E-mailed 4/15/94
FLD: RD, MA, DO, OC, OCRO and 200 - FAX 4/15/94
EX: Boxes 104, 88, 63, 60, 54, 52, 47 and 44 - FAX 4/15/94

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