Write Your Protocol
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Coordinate writing your application and protocol.
Be sure to write and submit your protocol
early enough for the IACUC review.
It is extremely important that the information in the protocol
you submit to the IACUC is consistent with the information
in your grant application.
Most IACUCs require investigators to submit information about proposed
animal use on an institutional protocol review form. Before writing
your protocol, consult with the attending veterinarian on the latest
technologies and procedures that could improve your approach. Also
send the veterinarian a draft of your protocol to resolve any issues
before it goes to the IACUC.
A standard animal protocol includes the following information.
- Description of project. Help IACUC members understand
your animal procedures by avoiding technical language only people
in your field will understand. Use visual aids, such as flow charts
and bullets, to illustrate your points or break up text.
- Justification for using animals. Describe why an animal
model is necessary. If you're studying a human health problem,
state its cause, existing therapies, and the potential contribution
of your experiments to further its understanding. Use lay language,
explaining all medical terms and defining acronyms the first time
you use them.
- Justification for species. Tell IACUC members why you
chose one species over others. You should generally use the most
appropriate and least sentient species capable of providing the
data you need. The following is a typical hierarchy of sentient
animal species.
- Non-human primates, such as monkeys, marmosets, and baboons.
- Large animals, such as cats, dogs, and pigs.
- Rabbits.
- Rodents, such as hamsters, rats, and mice.
- Non-mammalian vertebrates, such as poultry, reptiles, and
fish.
Your rationale for using a species may be size or availability;
the existence of previous work or laboratory data that validates
the use of a certain animal model; or the availability of reagents.
- Justification for number of animals. Request the amount
of animals you need and explain why. Use the minimum number needed
to yield statistically significant results.
- Consideration of alternatives. Convince IACUC members
that you have adequately explored alternative methods. Use techniques
to minimize pain and distress. These are known as "refinements"
to your protocol. List databases you searched and when, citations
derived, and the keywords or search strategy. List other sources,
such as journal articles, presentations, and colleagues.
- Description of animal procedures. Include non-surgical
methods, such as injections and sample collections; surgical methods,
such as suturing and anesthesia; and other measures, such as pre-anesthetic
fasting, drugs, and care during recovery.
- Assurance that qualified staff will perform work. Name
all personnel who will be working on your study, along with their
animal research experience and familiarity with your proposed
procedures. If you or someone on your staff does not have the
necessary experience, list experts at your institution who can
provide training. Your IACUC will have to verify that this training
took place before animal work can begin.
- Endpoint criteria. Choose endpoints that achieve the
aims of the study and avoid unnecessary pain and distress. Include
the criteria you will use to decide when to intervene or end animal
use in the study, e.g., pain that cannot be controlled with analgesics,
tumor size, and stage of disease. Interventions include euthanasia,
treatment, or discontinuance of procedure. Many institutions have
default criteria, so check with your IACUC for guidance.
Also see Working with the IACUC: Writing an Animal Protocol,
a booklet published by the American Association for Laboratory Animal Science,
for help preparing your animal protocol as well as interacting with
an IACUC.
Resources
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