The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.
June 2, 1997
Subject: Maintenance of Properly Constituted IACUCs
This letter provides guidance to Institutional Officials and Institutional Animal Care and Use Committees (IACUCs) on the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) regarding IACUC membership and functions.
The PHS Policy specifies that an IACUC shall consist of not less than five members, and shall include at least: one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the institution; one practicing scientist experienced in research involving animals; one member whose primary concerns are in a nonscientific area; and one individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution (PHS Policy IV.A.3.b.). In addition, institutions are reminded that in order to be consistent with the provisions of the 1996 Guide for the Care and Use of Laboratory Animals, nonaffiliated members should not be laboratory animal users.
For a variety of reasons, IACUCs may find their membership lacking one or more of the requisite members specified by the PHS Policy. Although there is no requirement that all members be present at all IACUC meetings, the requirement that the IACUC be properly constituted in order to conduct official business is explicit in not only the PHS Policy and USDA Animal Welfare Regulations, but also in the corresponding authorizing statutes. Accordingly, the validity of IACUC actions is always predicated on the existence of a properly constituted IACUC.
When it becomes apparent that an improperly constituted IACUC has approved a research proposal or taken other official action, that action is, by definition, invalid. It follows that animal-related activities without valid approval must be suspended until appropriate review and approval have occurred. In addition, prompt reporting of such findings and corrective actions to OPRR, in accordance with the PHS Policy (IV.F.3.), is expected.
Careful attention to PHS Policy language regarding IACUC membership, quorum, and procedures should prevent this problem from arising. Many institutions have found that appointing more than the minimum number of members who meet the respective PHS Policy criteria (paragraph IV.A.3.b.) obviates problems when an unexpected vacancy occurs.
|Nelson L. Garnett, D.V.M.
Director, Division of Animal Welfare
Office for Protection from Research Risks
Gary B. Ellis, Ph.D.
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