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Coordinate
writing your application and protocol. Be sure to write your protocol
early enough for the IACUC.
It is extremely important that the information in the protocol submitted
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, availability, or cost;
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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