May 21, 1990
This letter is to clarify a provision of the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) regarding protocol review by Institutional Animal Care and Use Committees (IACUCs). The Office for Protection from Research Risks (OPRR), as a result of increased site visit activity, has identified a number of situations in which the requirements for IACUC review of proposed activities have been misinterpreted.
The problem involves the misuse of so-called "expedited" review procedures by IACUCs using the designated reviewer provision set forth in Paragraph IV. C. 2. of the PHS Policy. Some institutions have inappropriately allowed designated reviewers to grant approval and for animal research activities to begin before all members of the IACUC have had an opportunity to request review by the entire Committee. This procedure is frequently referred to as "provisional approval."
The process of approving research prior to providing opportunity for each Committee member to request review by the full Committee is contrary to the PHS Policy. OPRR considers the opportunity for any member to call for full Committee review before approval is given and before animal work begins to be an important safeguard of the well-being of animals. This PHS Policy requirement is also explicitly stated by the U.S. Department of Agriculture in Part 2, Section 2.31(d)(2) of their Animal Welfare Regulations.
All institutions are advised to evaluate IACUC procedures for review of animal-related activities for compliance with the PHS Policy and USDA Regulations. Additionally, the institution's Animal Welfare Assurance should be reviewed and, if appropriate, clarified in order to bring institutional practices into full compliance with the PHS Policy and USDA Regulations. If needed, amendments to Institutional Animal Welfare Assurances should be forwarded to OPRR without delay.
Charles R. McCarthy, Ph.D.
Director, Office for Protection
from Research Risks
John G. Miller, D.V.M.
Director, Division of Animal
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
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