|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
January 11, 1994
This letter is being forwarded to Institutional Officials and
Institutional Animal Care and Use Committee (IACUC) Chairs throughout
the country. Its purpose is to convey a recommendation to all
institutions conducting animal-related activities supported by
the U.S. Public Health Service (PHS).
The Animal Welfare Assurance (Assurance) represents a legally binding institutional commitment to the PHS, necessary for eligibility to receive
PHS support. Because of its fundamental importance to that relationship,
and because it outlines the mechanisms for implementation of the
PHS Policy on Humane Care and Use of Laboratory Animals (Policy)
at the institution, the Office for Protection from Research Risks
(OPRR) believes that the core contents of the Assurance should
be generally known by all interested parties at the institution.
Although IACUC members usually have some knowledge of the document,
OPRR has encountered situations where individual members had not
actually seen it. More frequently, many investigators and their
staffs have expressed a complete lack of awareness of the document.
When assessing compliance with the PHS Policy by awardee institutions,
e.g., during site visits, one of the principal standards against
which institutional performance is measured is the extent to which
the Assurance is adequate and accurate. In other words, does the
Assurance conform with the basic requirements of the PHS Policy
and is it an accurate description of the actual practices at the
institution? These same questions should always be addressed by
the IACUC during the semiannual review of programs and facilities.
Major discrepancies between described and actual practices have
been the basis for a number of adverse findings and actions by
Therefore, OPRR recommends that institutions make the core contents
of their Assurance widely available within the institution for
information purposes and as an educational tool, not only for
IACUC members, but also for animal care staff, investigators,
administrators, and other interested parties.
Thank you for your attention to this important matter. Please
contact the professional staff of the Division of Animal Welfare,
OPRR (301/496-7163), if you have any questions concerning this
or any other PHS Policy matter.
Gary B. Ellis, Ph.D.
Director, Office for Protection from Research Risks
Nelson L. Garnett, D.V.M.
Director, Division of Animal Welfare, OPRR
Director, Office of Laboratory Animal Welfare
Office of Extramural Research,
Office of the Director, National Institutes of Health
RKL 1, Suite 360
6705 Rockledge Dr.
Bethesda, MD 20892-7982
(For express or hand-delivered mail use zip code 20817)
Telephone (301) 496-7163