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:
The primary question posed in the scenario is whether federal regulations and policy permit an institution to have a single IACUC with an AV assigned to each of its different campuses or whether each institution is required to have a single IACUC and one AV to oversee all of its facilities and program areas.
Great Eastern could continue to have one IACUC and one AV, provided that communications with, and oversight of, the satellite campus veterinarians are clear and adequate. We also note, however, that federal regulations do not preclude institutions from having one IACUC and several AVs (one of whom must be a voting member of the IACUC).
A description of the duties and responsibilities of each veterinarian associated with the animal care and use program, and a statement regarding the direct or delegated authority of these individuals to implement the Public Health Service (PHS) Policy1 and the provisions of the Guide for the Care and Use of Laboratory Animals2, are required elements in Section III.B of the negotiated Animal Welfare Assurance3 for PHS-Assured institutions. An indication of the approximate percentage of time that those individuals will contribute to the program must also be included.
USDA and OLAW recognize that the size and complexity of institutions vary, and that no single organizational or administrative structure will be compatible with the needs of all institutions. While the Animal Welfare Act and regulations4 and the PHS Policy1 allow for such institutional flexibility, it is strongly recommended that organizational channels for implementation be as direct and straightforward as possible5. Unclear or inappropriate lines of authority and responsibility have been the underlying cause for serious cases of programmatic failure.
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals (National Academies Press, Washington, DC, 1996).
Office of Laboratory Animal Welfare. Sample Animal Welfare Assurance, Section III.B. http://grants.nih.gov/grants/olaw/sampledoc/assursmp.htm#sectionIII.
Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare: Part 1 Definitions and Part 2 Regulations. §1.1, §2.31(b)(3)(i) and §2.33(a)(1-3).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. 4. (US Department of Health and Human Services, Washington, DC, 2006; revised 2008). http://grants.nih.gov/grants/olaw/faqs.htm#instresp_4.
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 38, 113 (2009). https://doi.org/10.1038/laban0409-113b
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DOI: https://doi.org/10.1038/laban0409-113b
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