7. Is it necessary for our IACUC to track the numbers of
animals used in the various protocols it has approved to ensure
that the numbers do not exceed those that were approved in the
proposal review process? If so, could you provide guidance on
the best means for accomplishing this?
Although neither the PHS Policy nor the USDA regulations explicitly
require an institutional mechanism to track animal usage by
investigators under IACUC-approved activities, both require that
proposals to the IACUC specify and include a rationale for the
approximate number of animals proposed to be used. These
provisions implicitly require that institutions establish
mechanisms to monitor and document the number of animals acquired
and used in approved activities. The OPRR is aware of many
institutions at which such mechanisms preclude an investigator
from using a single animal in excess of the number approved by
the IACUC. Other institutions have reported mechanisms that
allow the number of rodents acquired to exceed the number
approved by a small percentage (e.g., 5%), although they still
may require investigators to obtain and use only the precise
number of nonrodent mammalian species approved by the IACUC.
Administrative linkage of animal acquisitions to IACUC approval
numbers is the method of choice used by many institutions to
track the numbers of animals being acquired under approved
activities. Many also have described relatively simple automated
data processing systems that will alert the systems' operator and
generate a report when an investigator has reached a preset
percentage (e.g., 80-90% of the animals approved for that
activity). This report then is submitted to the investigator
with a request to provide a specific justification if they
anticipate that the number of animals ultimately required will
exceed the number approved. Small institutions that use limited
numbers of animals may choose to maintain a hard-copy log of each
IACUC-approved activity, merely subtracting the number of animals
acquired for each order from the number approved, with verbal or
written notification to the investigator as the number of animals
approved is approached. Whatever mechanism an institution
chooses, however, it must satisfy the PHS Policy requirement that
the number of animals used be limited to the appropriate number
necessary to obtain valid results.
8. In conducting its semiannual facility reviews, is it
necessary for our IACUC to consider laboratories or other sites
where animal procedures or holding activities are conducted only
sporadically or for periods of less than 24 h? How does our
IACUC determine whether to follow the requirements of the PHS or
the USDA regarding the definition of "study area?"
Each assured institution, acting through its IACUC or facility
veterinarian, is responsible for all animal-related activities at
the institution regardless of where the animals are maintained or
the duration of their stay. The degree, frequency, and method of
IACUC oversight often depends on the nature of the activity. For
example, satellite holding facilities and areas in which surgical
manipulations are performed must always be included in semiannual
reviews, whereas laboratories in which only routine immunization,
dosing, and weighing take place may be monitored by other means
such as random site visits and evaluations. Regardless of
whether such laboratories are included in the semiannual review
process or are monitored by other means, the IACUC must have
reasonable access to them for the purpose of verifying that
activities involving animals are being conducted in accordance
with the proposal approved by the IACUC. The PHS Policy requires
compliance with the USDA regulations regarding areas where USDA-covered species are
maintained for any purpose for more than 12 h. The term "satellite facility", as defined in the PHS
Policy,
remains unchanged and is applicable to the housing or holding
facilities provided for all vertebrate animals. It is important
to keep in mind that the institution is accountable for all
activities involving animals, regardless of technical differences
in definitions and time limits, and that institutional policies
should be designed to obtain the desired outcome of both the PHS
Policy and the Animal Welfare Act (namely, the appropriate,
humane care of all animals at each institution).
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