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 guidance:
May an institution have more than one institutional official (IO) and be compliant with the requirements of the Public Health Service Policy on Human Care and Use of Laboratory Animals (PHS Policy) and the Animal Welfare Act and Regulations? The PHS Policy defines the IO as “an individual”, not several individuals1. OLAW interprets the PHS Policy to limit the authority and responsibility of the IO to a single individual, even at very large programs with multiple IACUCs. Institutions may have individuals who are knowledgeable about the animal care and use program and perform some of the daily operations for the IO, but there must be one individual who signs, and has the authority to sign, the institution's Assurance, and commits on behalf of the institution that the requirements of the PHS Policy are met1. OLAW has opined that “direct, clear and straight forward lines of responsibility and corresponding authority function well and allow organizations to respond quickly and effectively when necessary”2. Such guidance is applicable in this scenario to maintain a smoothly functioning animal care and use program. In the scenario, the four campuses have the option of having four individual Assurances, which would permit separate IOs for each campus.
The definition of an IO in the Animal Welfare Act and Regulations is “an individual at a research facility who is authorized to legally commit on behalf of the research facility that the requirements of 9 CFR Parts 1, 2 and 3 will be met”3. As a result, USDA APHIS AC limits the authority and responsibility to a single individual and consequently accepts one IO per registrant.
We note that the head of an institution such as the Chief Executive Officer, President, Provost or Director has the latitude to appoint an individual to serve on his or her behalf as the IO for the animal care and use program.
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).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.4. (US Department of Health and Human Services, Washington, DC, 2006, revised 2013).
Animal Welfare Act and Regulations. 9 CFR §1.1 Definitions.
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 43, 267 (2014). https://doi.org/10.1038/laban.594
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DOI: https://doi.org/10.1038/laban.594
