Veterans Health
Administration
Washington DC
20420
VHA DIRECTIVE 10-95-031
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
- 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.
- 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.
- 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
- a. 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.
- b. 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.
- c. 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.
d. 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.
e. 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.
f. 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
- a.Manual M-3, Part I, Chapter 12.
- b.Title 7 CFR 2.17, 2.51, and 371.2 (g).
- c.Title 9 CFR Chapter 1 (1-1-92), subchapter A, Animal Welfare.
- d.Title 7 United States Code Sections 2131 through 2157.
- e.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
