Biomedical Engineering Reference
In-Depth Information
1965
), well-defined anatomy and physiology, high intelli-
gence, ease of adaptation, relative “robustness,” as well as
disadvantages, such as aggression, zoonoses (e.g. Ebola
and Herpes B virus infections), cost, susceptibility to
human diseases (e.g. tuberculosis, measles), and opposition
from animal rights groups. All experimental studies using
nonhuman primates should be designed and conducted in
the spirit of “The Three Rs
The immediate and long-term impact on normal phys-
iological functions, e.g. vision.
l
The duration of the procedure.
l
The argument that nonhuman primates are a precious and
limited resource, thus justifying their use on unrelated
projects, or in projects defined as multiple major survival
surgeries, must be conclusively resolved by the IACUC. If
nonhuman primates are involved in collaborative efforts on
more than one proposal, major survival surgeries may only
be included within one proposal and must be scientifically
justified and approved by the IACUC. When applicable,
a request must be made to the United States Department of
Agriculture/Animal and Plant Health Inspection Service
(USDA/APHIS) by the Institutional Official (IO) to seek
exemption from limiting regulated animals to being used in
only one protocol with a major survival surgical procedure
(
United States Department of Agriculture, 1985, 1997
).
There is no universally accepted number of allowable
major survival surgeries. Such number should be arrived at
after careful assessment of the desired data yield, realistic
experimental endpoints, available investigative experience,
and consideration of adverse consequences.
Replacement, Reduction,
Refinement” (
Russell and Burch, 1959
) by exploring the
following questions:
e
l
Can a “less sentient,” phylogenetically lower species be
used to get data of comparable quality?
l
What is the lowest number of animals needed to
generate statistically significant results?
Is the surgery a necessary component (e.g. oral v.
osmotic pump delivery of the studied agent)?
l
How can a sensible experimental endpoint be reached
with minimal distress to the animal?
l
The following paragraphs attempt to match the routine
chronology of surgical events startingwith protocol concerns,
then animal acquisition, preparation for surgery, select
research procedures, and post-procedural complications.
Safe Work Environment
Although the issues of occupational health concerns
related to nonhuman primates are covered extensively
elsewhere in this text, some issues specifically arise with
regard to anesthesia, surgery, and postoperative care. The
following recommendations will help to address these
issues:
NONCLINICAL CONCERNS
Ethics and Animal Welfare
Repetitive surgery, particularly multiple major survival
surgery, in nonhuman primate investigations is a chal-
lenging issue. A general guideline in use states: “Major
surgery penetrates and exposes a body cavity or produces
substantial impairment of physical or physiologic func-
tions, or involves extensive tissue dissection or transection”
(
Brown et al., 1993; National Research Council, 1996,
2011a
). Multiple major survival procedures on a single
animal are discouraged and should be reviewed critically
by the Institutional Animal Care and Use Committee
(IACUC). Such procedures performed on a single animal
are acceptable only if they are included in and essential
components of a single animal research project or protocol
and are scientifically justified or necessary for clinical
reasons. Laparoscopic surgeries and some procedures
utilized in neuroscience research (e.g. craniotomy, neu-
rectomy) may be categorized as major or minor surgery
depending on the procedural impact on the animal. Each
procedure should be evaluated on a case-by-case basis by
the veterinarian and IACUC (
National Research Council,
2011b
). While classifying a surgical procedure as major or
minor, the following factors should be considered:
Mandatory training with emphasis on the procedures
designed to minimize injuries and exposures to zoonotic
diseases (e.g. Macacine herpesvirus 1, Entamoeba his-
tolytica) as a central focus of the veterinary oversight of
investigative procedures.
l
Use of the Personal Protective Equipment (PPE)
e
clean scrub uniforms under the lab coats and disposable
gowns or sterile surgical gowns during surgery, poly-
propylene bouffant caps or surgical hats, face masks
and face shields or goggles (when dealing with anes-
thetized animals), shoe covers, and gloves. Other
procedures with emphasis on personal safety include
using devices such as electroscalpels (rather than stan-
dard scalpel blades), safety needles, syringes and cath-
eters (e.g. Vanishpoint
technology), fluid-impervious
surgery gowns, double-gloving techniques, and work
practices such as requirement of working in pairs with
nonhuman primates.
l
Standard Operating Procedures (SOPs) in exposures
(e.g. cuts during surgery)
l
The nature and the complexity of the procedure.
wound scrub, rinsing of
mucosal membranes, reporting to veterinary staff, and
examination by an occupational health practitioner.
e
l
The potential
for pain and other postoperative
l
complications.
