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Common
Problems and Omissions in Preparing Animal Use Protocol Forms
All new protocols submitted for IACUC review, or those that are
three years old and will continue, must be documented on the
latest IACUC protocol forms found on our web site. Submissions
received on outdated
forms
will be returned to the PI without review
It
is the aim of the IACUC to review protocols and proposals in a
timely manner. Many of the protocols must be returned because of
housekeeping errors or over-sights, which have to do with the
procedural aspects of the protocol and not necessarily the
scientific content of the research. Listed below are common
reasons for preliminary approval instead of full approval by the
Committee. Attention to details and the elimination of simple
housekeeping errors would expedite the process and reduce the
investigators' and the Committee's time required for approval.
1. Omission Of Emergency Telephone Numbers. These are
important if the animal caretakers and veterinary staff find
animals that are ill and the principal investigator or designee
in managing these animals must make a decision. Office and lab
room numbers are not considered emergency numbers.
Please provide either a home phone number, pager or cell
2. Lay Summary. Goals of the research must be clearly
written to explain the purpose, scope, and significance of the
research being proposed. It should be written in language that
can be understood by a college graduate with no medical
background. Abstracts that are submitted to scientific meetings
and abstracts, which are parts of a grant proposal generally,
have too much scientific jargon and assume considerable
knowledge of the subject being discussed. Not all scientific
disciplines are represented on the Committee and the non-faculty
members of the Committee should be able to clearly understand
the intent and significance of the study.
3. Justification of Animal Numbers. A common error is
that the number of animals requested does not match up with the
number of experiments that have been outlined. Simply asking for
a specific number of animals without justifying the numbers and
indicating how they are going to be used is not sufficient for
the Committee. If there are a large number of animals with
multiple experiments, a brief table outlining the experiments
and the number of animals is extremely helpful.
4. The Administration of Drugs. When drugs are
administered to awake animals, the principal investigator should
indicate overt actions of the drug, whether side effects are
anticipated, and the consequences of the drug actions on the
animal. If the effects of the drug will alter the behavior or
well being of the animal to a considerable degree, describe what
changes are expected and for how long. The principal
investigator should describe possible adverse reactions and
outline corrective actions.
5. Clarification of Terminal Surgery as A Painful/Non-Painful
Procedure. It is the USDA position that terminal surgery has
the potential for pain. Thus, the USDA requires that the
investigator consider alternatives to the procedure and that the
IACUC review and approve the procedure. Accordingly, protocols
involving terminal surgery procedures will be classified as Category
B under USDA classification system (Class 2) and require
full IACUC review.
6. Anesthesia and Analgesia
- If a research, testing or
teaching procedure is likely to cause pain and discomfort
that would be reduced by the administration of anesthesia,
the animal shall first be rendered incapable of perceiving
pain and be maintained in that condition until the procedure
is completed. The only exception to this policy should be
those cases where the general anesthesia would defeat the
purpose of the experiment and data cannot be obtained. A
scientific justification must be recorded in the protocol in
these instances and approved by the IACUC.
- The person responsible for
direct supervision or implementation of anesthesia shall be
qualified by training and experience to assess the animal as
an anesthetic risk, and shall monitor the phases and depth
(plane) of anesthesia and determine the recovery status for
discharge.
- All personnel who are
performing anesthesia must be technically qualified in
procedures for induction, maintenance and postoperative care
of the species that is being used. The agent used must be
appropriate for both the species being utilized and the
requirements of the experimental procedure.
- Adequate grounding in the above
areas will enhance the well being of the subject and promote
the success of the procedure. Such procedures must be
specifically approved by the IACUC and shall be closely
supervised by the investigator in charge of the research
project or teaching activity, or a qualified designee.
- Post-procedural care of animals
shall include the use of anesthesia or analgesics as
required to minimize discomfort and the consequences of any
disability resulting from the experiment or teaching
procedure, in accordance with acceptable practices in
veterinary medicine. The investigator must outline
post-operative or post-procedure care and the duration of
such care. For procedures deviating from normal practice,
appropriate consultation and IACUC approval must be
obtained.
7. Surgery
- The surgical procedure should
be carefully explained, all sections of the protocol related
to surgical procedures and post-operative care should be
completed. Investigators or instructors performing any
surgical procedure on an animal shall conform to the
requirements stated in the Guide for the Care and Use of
Laboratory Animals and the Law. A facility intended for
aseptic surgery shall be directed and staffed by trained
personnel and used only for that purpose. All animals must
have survival surgery accomplished in an aseptic surgery as
defined in this paragraph. Aseptic techniques shall be used
on all animals undergoing survival surgery. Survival surgery
on rodents does not require a special facility but should be
performed using sterile instruments, surgical gloves, and
aseptic procedures. Surgery shall only be performed and/or
directly supervised by persons qualified by training and
experience
- Post-surgical care shall be
provided as necessary by qualified personnel
- Minor surgical procedures, such
as wound suturing and peripheral vessel cannulation, can be
performed under less stringent conditions if they are
performed in accordance with standard veterinary practice.
8. Euthanizing Animals. If it is necessary to
euthanize an experimental animal, the investigator in charge of
the research, testing or teaching procedure, or a qualified
designee, shall use only methods that are approved by the
American Veterinary Medical Association Panel on Euthanasia or
approved by the IACUC. The PI must describe in the protocol the
method and indicate the signs that indicate that the animal has
been successfully euthanized.
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