In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA/APHIS/AC) offer the following clarification and guidance:

First, it is important to note that the IACUC chair's proposal does not meet the requirement of the PHS Policy at IV.3.C.2 and the AWA regulations because it fails to provide a list of research projects; make written descriptions of the research available; and provide an opportunity for members to call for full committee review1,2. It is not acceptable to allow designated reviewers to grant approval without first giving all IACUC members an opportunity to request full committee review. This is described in OLAW's Report of May 21, 1990, and in Part 2, Section 2.31(d)(2) of the Animal Welfare Regulations2,3.

If the workload is too heavy for an IACUC, the institution should evaluate other options for meeting its obligations (such as appointing additional regular members). In this scenario, however, the chair may use alternates for designated-member protocol review if he is very careful to use an alternate for a regular member that is truly unavailable.

NIH Notice OD-01-017 states, “There must be a specific one-to-one designation of IACUC members and alternates. This is necessary to ensure that a Committee is properly constituted, even when alternates are serving ....Use of a pool of alternates would not be consistent with this requirement”4. This section of the notice makes it clear that alternate members are specific substitutes for unavailable members and may not be used as a pool of general IACUC helpers.

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