Biomedical Engineering Reference
In-Depth Information
recuperation process can be judged by establishing some
objective measures of return to health
complications such as seizures, loss of function, paralysis
or self-mutilation. Anticipated interventions may range
from therapy (antibiotics, NSAIDs), temporary cessation of
the experiment (e.g.
body weight,
progress of wound healing, bone healing (monitored
radiologically), or gradual return of function (e.g. precision
grip after hand paralysis).
e
implant explantation followed by
recuperation),
re-instrumentation, or
in extreme cases
where the subject
is judged unsuitable for
therapies,
termination of the animal.
Endpoints
Experimental Endpoint
An experimental endpoint is chosen to mark the planned
end of an experimental manipulation and associated data
gathering (
National Research Council, 2003
). It should be
realistic, attainable, and consistent with the study's
objectives and clearly spelled out to be approved by the
IACUC. Ideal endpoints are those that can be used to end
a study before the onset of pain and/or distress without
jeopardizing the study's objectives (
National Research
Council, 2003
). Some nonhuman primate studies may not
have a defined experimental endpoint as the researchers
may need to collect the maximum amount of data possible.
Such studies should be carefully evaluated by the IACUC
and approved only when extensive literature search iden-
tifies no alternatives and the researchers have submitted
clearly defined humane endpoints (see below) to monitor
the well-being of the animal. Determination of humane
endpoints, in fact, should involve the principal investi-
gator, the veterinarian, and the IACUC (
National Research
Council, 2011b
). Sometimes, the needs of the study require
data collection for a period of time followed by tissue
harvest and histopathology, in which case a terminal
transcardial perfusion under anesthesia allows removal of
blood from tissues and organs of interest followed by their
harvest.
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e
Humane Endpoint
The recommended humane endpoint is the point at which
pain or distress is prevented, terminated, or relieved in an
experimental animal (
National Research Council, 2011b
).
The clinical parameters developed and used in clinical
assessment in studies in which the animal's health may be
deteriorating must be described in the protocol, approved
by the IACUC, and executed by the investigator in coop-
eration with the veterinarian. As many objective health
parameters as possible should be described, including
percentage of body weight loss and rectal temperature
shifts. Explantation may be part of the study design and
built into the protocol as a means of allowing the animal
time to recuperate between different phases of the study.
Explantation may be necessary when the implant is
not functioning properly or its presence is having a signif-
icant local or systemic impact on the animal's health,
including inflammation/infection, foreign body reaction,
protracted bleeding, chronic weight loss, and postsurgical
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