In response to the questions posed 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:
The intent of the NIH Notice issued 12 February 2001 (ref. 1) is to provide guidance concerning the use of alternate IACUC members. It outlines a number of provisions that must be met in order to properly use such a system. One of these provisions is that 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, in accordance with PHS Policy and Animal Welfare regulations.
This does not preclude one alternate being designated for more than one regular member, provided the alternate for a member who fulfills a particular membership requirement2,3 also fulfills that requirement.
The scenario states that “Hendricks, also a scientist, had been appointed by the CEO as the alternate for any of the scientific members of the Committee.” This is not a one-to-one designation. If the CEO had appointed Hendricks as the alternate for Smith, and Hendricks as the alternate for Jones, and Hendricks as the alternate for Brown, each appointment would be a specific one-to-one designation. However, if multiple scientific members (Smith and Brown) were absent for a Committee meeting, Hendricks would serve as an alternate for only one of them. This could result in the IACUC not achieving a quorum for the meeting.
Conversely, the CEO might appoint more than one alternate to represent a particular member (assuming the provision in the second paragraph is met) as long as each designate is specific one-to-one (e.g., Hendrick is appointed as the alternate for Smith, and Taylor is appointed as the alternate for Smith). The use of a generic “pool of alternates” for IACUC members is prohibited in order to ensure proper IACUC constitution.
Regardless of the system used by the research institution, the alternate designations should be listed on the IACUC rosters for review by both OLAW and USDA.
References
National Institutes of Health. Office of Extramural Research guidance regarding administrative IACUC issues and efforts to reduce regulatory burden. NOTICE: NOT-OD-01-017 (12 February 2001).
Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals IV. A.3.b.(1)-(4) (US Department of Health and Human Services, Washington, DC. revised 2002).
9 CFR 1, Chapter 1, Part 2, 2.31. (b)
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Wigglesworth, C., Gipson, C. A Word from OLAW and USDA. Lab Anim 34, 12 (2005). https://doi.org/10.1038/laban0105-12
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DOI: https://doi.org/10.1038/laban0105-12
