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Laboratory Animal Care
Service
Forms and Instructions
The following represents a list of forms sometimes needed for KSU
faculty and staff to utilize animals in teaching and research. Some
forms are in pdf format, thus requiring Adobe acrobat reader or Adobe
acrobat exchange for viewing and download. All
researchers are required by the University to complete the IACUC protocol
application; other forms may or may not apply. Step by step instructions
for filling out the IACUC protocol application, and comments concerning
the review process, follow below. NOTE: when printing out forms, it is
helpful to turn off your option to print backgrounds (see "page setup") so
that black letters
will show up on a white (rather than shaded) background.
PART I. Forms
-
ARF 90 Animal Requistion form, Animal Resource Facility (ARF).
This form is
required when ordering any animals through ARF.
- DEA
225. This is the Drug Enforcement Agency (DEA) individual
researcher or teacher
application for registration under the controlled substances act of 1970
(DEA 224 is the
institutional application form). All individuals using or
purchasing controlled substances (i.e. nembutal, ritalin,
M 99, demerol, etc.) in the US are required to possess the permit. The
cost is $130 for one year. Applications are also available by either
writing or
calling (option 5) the following: United States
Department of Justice, Drug Enforcement Administration, Central Station, PO Box 28083,
Washington, DC 20038-8083 (202) 307-7255.
-
IACUC Application form This link takes you to the IACUC
webpage where you can view and download the IACUC protocol application
form. The form can be downloaded in Word or
Wordperfect. Because the form is changed several times a year, please
be sure to download a new form each time you submit a new protocol.
-
IACUC Teaching document form This link also takes you to the
IACUC
webpage where you can view and download forms that involve teaching
protocols. First, simply look over the IACUC Type Protocol
for Animal Use in Non-Invasive,
Non-Painful Teaching, Observations, or Demonstrations (this is protocol
1698). It is a demonstration only; you need not download or print out
this protocol. If you utilize animals in teaching and find that all
procedures are painless, non-invasive and fit within protocol 1698, then
simply download the addendum, fill it out, and send it in. The protocol
will be reviewed by a special subcommittee to
speed up the process. This addendum is a Word 6.0 document.
-
IACUC Training document form This link takes you to the
IACUC webpage where you can download a pdf document. It
represents the suggested format for submitting training qualifications of
individuals performing animal research to Research and Sponsored
Programs. You are free to develop your own training documentation forms.
-
IACUC Pain and Distress Observational Worksheet Examples This
link again takes you to the IACUC webpage. You may view examples of
animal pain and distress recording worksheets which are now
required to accompany all category 2 and 3
protocols. You may use any one of the generic worksheets if one fits into
your project, or you may opt to develop your own.
-
IBC Application forms All animal work involving infectious
agents or other biohazards may not begin until the Institutional
BioSafety Committee approves the protocol. This link takes you to the IBC
webpage so that the appropriate forms may be downloaded.
- Kansas State Board of
Pharmacy application
This link is to the Kansas State Board of Pharmacy webpage where
research and training applications in pdf format may be downloaded for
registration
under the Kansas uniform controlled substances act of 1972. An
application is needed by any
researcher or teacher using or purchasing controlled substances within the
state. The application fee is $140.
Forms may also be ordered by either calling or writing the
following: Kansas
State Board of Pharmacy, Landon
State Office Building, 900 Jackson, Room 513, Topeka, KS 66612
(785) 296-4056; toll free (888) RXBOARD; fax (785)
296-8420.
PART II. Instructions for filling out the
IACUC protocol application
In 1999, the Institutional Animal Care and Use Committee (IACUC) protocol
application
underwent major revisions in order to comply with federal guidelines. It
continually undergoes revision and refinement as new rules and
regulations become emphasized by the federal government. It is
critical to download
the updated forms whenever you are submitting a new application since
outdated forms are viewed by the IACUC as containing insufficient
information.
It is important to word the IACUC application concisely and in a format
easily understood by
non-scientists. By law, not all members of the IACUC are scientists and
it is likely that few of the biologically oriented
scientific members themselves are very familiar with your specific area of
expertise. Thus, many members
may not be able to understand the scientific jargon you commonly use in
your grant applications,
and the simple outcome of your select writing style almost certainly will
be delays in approving your
application. Each IACUC member reviews 15-20 applications each month, and
the easier an
application is to read the better chance it has of sailing through. A
concise (yet specific), well organized protocol application that
addresses the pertinent questions in a straightforward manner should be
your goal. Cutting and
pasting entire sections of NIH or NSF grants and all of the non-essential
details and technical jargon annoys the committee and often delays the
progress of your application.
Because of public disclosure laws, it is highly likely that your
final, completed application will be publically accessed. Thus, it is
very important that all applications be complete and correct and the
committee often nit-picks seemingly minor details to assure federal
compliance. Because
nearly all applications need some degree of revision prior to final
acceptance, you should retain the
entire application on computer disk. Then, the requested changes can
be made easily and in a timely
manner and without addenda or other supplementation. Requested
changes most frequently involve the need for clarification of specific
procedures, or requests to avoid the use of particular
terminology. Occasionally there may be directives by the IACUC that
require an investigator to change his or her procedures but these are an
exception rather than the rule. Try not to be offended if you are asked
to revise your protocol. The requirements are often complicated,
sometimes confusing, and the rules and regulations
extensive. Few people with a normal psychological profile
know them all. Virtually
every question within the protocol application
is there to satisfy a specific federal guideline or directive. Most
researchers, including IACUC members engaged in animal research, are
normally required to make some changes to their protocols. Perhaps the
best way to look at the IACUC, and the protocol application procedure, is
as a buffer. It helps to insure that the investigator is not
inadvertently violating
any federal laws for which legal complications might arise.
Title page
- Title of Project/Course: This should be relatively concise and
reflect the type of proposed
study. For grant funded studies, it may be important to word the title of
the grant and IACUC
application precisely the same. If you plan to submit the grant to
multiple funding agencies under
different titles, be sure to relay this to Research and Sponsored programs
when submitting an
application. Multiple letters with the different grant titles can be
issued under the same IACUC
protocol umbrella. Alternatively, additional letters reflecting the
different grant titles can be
issued at a later date upon request. NOTE: If multiple grants are
submitted using the same IACUC protocol number, and if the
investigator happens to accept more than one grant (generally not ethical
anyway), the committee HAS
NOT authorized the investigator to use double the number of animals. A
revised or new protocol will need to be submitted.
- Species/Strain to be Used: Simply put rats, mice, pigs,
calves,
goats, rabbits, etc. here. If the
animal is exotic, you may wish to include the nomen triviale (i.e.
cotton rats, Sigmodon
hispidus).
- Type of Application: Applications fall under 3 catagories;
both new
and renewal applications (boxes 1 and 3, respectively)
undergo examination by each member of the committee. However, addendums
and modifications (box 2)
may or may not be seen by each committee member, depending upon the extent
of the change.
These are handled on a case by case basis. If you believe that your
application may fit into the
addendum/modification catagory, you should probably contact the chair of
the IACUC anyway to see
what types of paperwork need to be submitted. Also, be sure to check the
appropriate box whether the application represents a
teaching or research protocol.
- Funding source: The letter of approval will usually specify
the funding source/agency
designated if applicable. If you wish the cover letter to offer more
specifics, notify Research and Sponsored Programs.
- Principal Investigator: Simply include the name, department
affiliation, degrees, and campus
phone number of the PI. The PI must be a faculty member at Kansas State
University. Students and most other staff members are NOT allowed to be a
PI on an IACUC application.
- Campus Address: Building and room of the PI.
- E-mail and Fax number: Sometimes information will be
communicated to the PI by e-mail or FAX concerning IACUC queries or
meeting times.
- Co-Principal Investigators: If you plan to include any other
faculty members as Co-PIs, then
you may wish to include these names. All Co-PIs should read the
application prior to its submission and be familiar with the experimental
design. We suggest that the names of students not be included as Co-PIs.
- For IACUC members only: Don't write in this box or you will
look foolish. Note, however, that any pain Category 2 or 3 proposal is
mandated to undergo full committee review. The IACUC formally meets the
first and third Thursdays of each month somewhere on the main campus at
3:00 pm. If you have a Category 2 or 3 protocol, you will be specifically
invited to attend the meeting so that you can address
questions that might arise. Additional meeting times are also
scheduled
at various times depending upon special needs of an investigator.
The Animal Use Proposal
Name and Project Title: Again, include your name and
title.
- NON-TECHNICAL SYNOPSIS: Provide a concise, brief narrative of
the proposed study. This should
be written in non-scientific language, perhaps 200 words or less in
length, similar to the abstract required
by NIH or NSF. Remember, most committee members will not be able to
follow your own type of scientific jargon so trying to impress them with
your knowledge will not work in your favor. Indeed, it will result in
members taking up additional time trying to wade through
the morass and they will be annoyed. Suggested length: 1 paragraph with
5-10 sentences.
- BACKGROUND: This is a simple, perhaps a one paragraph
introduction/review of the literature.
You simply want to make sure the committee members realize that there is a
basis for your studies. Here again, use non-scientific language whenever
possible and don't use references. Suggested length: 1/2 page or
less.
- LITERATURE SEARCH FOR UNNECESSARY DUPLICATION: This must be
filled out. Cite the sources searched (i.e. Medline, CAB, Agricola,
etc.), provide the years each database covers, the keywords you used in
your search, and 1-2 sentences concerning
your findings for each database. Do not provide the references. If you
are
making reagents, i.e. monoclonal antibodies to newly purified proteins,
polyclonal antiserum to new
antigens (i.e. not commercially available), testing newly generated
pharmaceuticals in animals, or if the application involves
teaching protocols, then state so. However, in many cases, a literature
search will still be required to demonstrate that you are not duplicating
the creation of a reagent that already exists at a reasonable cost. You
should also search sources pertinent to your research. For instance, if
you are working on cattle diseases and you simply list Medline as a search
source, then you have obviously missed
most of the pertinent literature since Medline misses many
agricultural-related journals. If you
have questions concerning the type of search engine you should use,
contact Gayle Willard, 2-6006, who has been specifically trained to
help researchers in this area. Do not include
copies of the search results to the committee, but retain them for record
keeping. Suggested length: 1/5 of a page or less. NOTE: For applications
requiring necessary duplication (i.e. protocols
involving teaching, monoclonal or polyclonal antibody production, etc.), a
statement explaining why duplication is necessary needs to be added. Such
a statement can be found at the IACUC
website (second paragraph), and can be modified as appropriate.
- OBJECTIVE\HYPOTHESIS: Very briefly, state the objective(s) of
the study and the null hypothesis to be tested (i.e., do you expect or not
expect a significant difference?). Some
studies, i.e. monoclonal antibody and polyclonal antiserum generation,
teaching protocols, etc.,
will have no hypothesis to test so simply state so. Suggested
length: 1/5 of a page or less; perhaps only 1 sentence.
- MATERIALS AND METHODS:
- Experimental design and general procedures: Describe the
procedures to be used on the
research animals. Try to be as concise as possible, and be sure to avoid
too much scientific
jargon. At least one-half of the people reading the application will be
non-biology oriented, so
confusion on their part (or anyones part) will breed inquiries,
explanations, and overall delays. However, be complete enough so that
the various parameters are adequately described. DO
NOT cut and paste your entire NIH or NSF grant in here or you will
certainly annoy virtually everyone on the committee. Here are some
helpful hints:
- Be sure that
the number of animals listed in the
experimental design correspond exactly to the number of animals listed
elsewhere within the proposal;
- If you are working with an infectious agent, be sure that you are well
aware of the appropriate Biosafety level (BSL) for that pathogen and any
federal permits needed to transport/work with that pathogen. Kansas
State University has animal facilities for BSL-1 and BSL-2 pathogens. It
does not have animal facilities for BSL-3 or BSL-4 pathogens;
- Know
the exact details of all procedures
in case you are contacted and asked to clarify specific points;
- Use a spell-checker program to correct errors. Pay particular
attention to doses, amounts, etc. where type-Os can raise significant
questions;
- Double-check to make sure the concentrations of
reagents (i.e. ml) are truly correct;
- Explain how data is to be quantified/qualified; don't just say that
you will be checking for clinical signs since that could include a
wide variety of parameters. If you are counting or scoring something,
then state what it is you plan to look for;
- If you are using experimental groups of animals, be sure that you
clearly relay what is happening to each group. Sometimes it helps
to simply itemize (i.e. group 1, group 2, etc.) and give the treatment
regime for each.
- If a proposal is particularly involved, you may wish to break it
down into 2 proposals, or at least provide some sort of flow chart to
better explain it to members of the committee.
- Suggested length: 1/2 page (up to 2 pages for a detailed
protocol). DO NOT
cut and paste your entire grant here; describe only work pertaining to
animal use.
- Non-animal alternatives considered: If other alternatives are
available, i.e. in vitro
alternatives, then state why they will not suffice to answer the questions
in hand. It may be
something as straightforward as stating that monoclonal antibodies cannot
yet be generated in
vitro, and that mice are the standard model for virtually all associated
reagents.
- Animal model and species/strain justification: Briefly explain
why you require your choice of
animals (i.e., you are testing a drug to reduce hypertension in dogs so
obviously dogs would be the only
target animal; and, in vitro systems do not develop hypertension).
- Animals requested: This is a place to be specific about the
species of animal(s) to be used,
strain of animal, and if there are any problems you expect using a
particular species (i.e. laboratory mice, Mus
musculus, BALB/c, 20 per year, Vendor Annonymous Inc.). Do not leave
this blank or you will be asked to revise the application.
- Justification for number of animals/Data analysis: State why
you need the number of requested
animals. If you plan to perform
20 fusions to generate monoclonal antibodies from mice, then obviously
that corresponds to 20
mice. If you only need 20 ml polyclonal antiserum, then committee
members are intelligent enough to know that this
translates into 1 bunny or 2-3 large, retired breeder rats rather than
100 animals. However, if you are performing experiments with groups of
animals, do not simply state
that you are using the appropriate number of animals that will be
statistically significant. The members hear this all the time and the
standard reply that the IACUC will throw back at you is how did you
really determine that exact number? The following lists some common
problems that you should avoid:
- If you request 50 animals per group when 10 animals can show the
same results, you will be denied 50 animals per group.
- If you propose 3-4 per group when 10-12 per
group are required to get statistically meaningful results, then the
committee will suggest you use additional animals per group.
- If you are not exactly sure of how many animals per group you will be
using (i.e. you may be working with groups based on litter sizes or you
have no idea how much variability will be found), then
don't use jargon such as "...from previous experiments we have found
this number to be required for statistical significance..." Since you
don't know how many animals per group you will be using, the wording is
nonsense. Sometimes you have absolutely no literature base to go on, so
take your best guess (but state so) based on some form of related
research.
- If you are involved in studies where multiple animals are housed
within the same cage or pen, and the parameter you are measuring is
something like fecal consistency, then you technically have an N=1 per
group (i.e., you cannot tell the feces of one animal from another). This
will not be acceptable and the committee will probably suggest that you
house the animals individually.
- Be sure that the statistical tests cited are suitable for the type of
proposed study.
- Be sure that adequate control groups are proposed. Additional animals
may be suggested by the committee to assure that the results
generated from the experimental animals
are not wasted.
The IACUC is very sensitive to all of the above issues (including
NOT using enough animals to validate a study). You may wish to
provide references that reveal appropriate number of animals per
group in your field of research. This tends to go hand in hand with the
literature review. NOTE: The IACUC has a statistician available for free
consultation with investigators. On several occasions the
statistician has shown investigators how to collect more data with fewer
animals, thus saving the investigator time and money plus making a
study more complete.
- HUMANE CONSIDERATIONS: It is important to pay attention to
details in this section of your
proposal. The incorrect placement of animals within a particular
category, and failure to provide
detailed information if needed, will result in a rewrite of the
application and a delay. Animals
placed solely in Category 1 (no or momentary pain) do not require full
committee review unless
other problems arise. However, KSU is mandated to hold full
committee reviews for all Category 2 and Category 3 proposals.
- Pain category: This is very critical and is carefully
scrutinized by
the members of the IACUC.
If your animals are experiencing levels of pain or distress that are not
particularly significant, then
include all of the experimental animals under Category 1. If you are
unsure whether animals in your experiments belong in Category 1 or not,
one simple rule of thumb is to ask yourself whether a physician would
prescribe an analgesic if you underwent the same
procedure/infection/stress. Some specific examples are as follows:
- If you were hyperimmunizing 20 mice and performing terminal procedures
to get splenic lymphocytes, then you
would probably place all 20 in Category 1. This if you were talking about
needle sticks and euthanizing animals in standard ways without
causing significant pain
or prolonged distress. Thus, under Species 1, you would
write Mus musculus
(mice), and under Category 1 you would write 20 (NOTE: under Categories 2
and 3 be sure to write 0
rather than leave them blank).
- If you were giving an animal an enteric virus that caused mild to
moderate diarrhea, then you would place all animals in Category 1.
However, if animals were experiencing severe diarrhea with prolonged pain,
the potential for electrolyte imbalance/shock, or bloody stools because
the organism was invasive, then you would be talking about non-Category 1
procedures.
- If you were performing some survival surgeries under anesthesia on 5
mice and another 15 did not undergo surgery or significant pain or stress,
then the 5 alone would be placed in a category separate from the 15.
There would probably be some pain involved until the wounds healed, and
you may use some analgestic the first
day or simply cover the wounds sufficiently. Thus, the 5 might best fit
under Category 2 and the other 15
under Category 1 (note that there are many ways to relieve pain or
distress without the use of
controlled substances).
If an investigator suspects that some of
the animals in their proposal belong in Category 3,
unalleviated pain or distress, then it is best to consult the chair of the
IACUC to insure that the
animals fit under this category. Animals in this category
will generate considerable discussion among IACUC members who will attempt
to explore alternative procedures with you. NOTE: Any study planning to
utilize death as an endpoint, or look at 50% lethal doses of compounds,
MUST place the animals in Category 3 (see
further comments on this topic below).
- Pain and/or Distress Observation Form: All Category 2 and 3
protocols must attach a sample of their pain and/or distress observation
form(s). If you are required to have the form, then check the yes
box. Once checked, briefly describe how often you plan to observe the
animals and record your observations on the form, and who will be
performing the observations.
- Pain Alleviation: This normally pertains only to Category 2
and Category 3 proposals. Tell what means you will use to help alleviate
pain and distress (i.e. analgesia, anesthetic, electrolyte therapy, types
of behavior modifications, etc.). If you will be using drugs, list them
and provide information on dosages and routes of administration.
- Alternatives to Painful Procedures: This pertains ONLY to
Category 2 and Category 3 proposals. You must perform an extensive
literature source search on alternatives to
the painful procedures, provide the key words used and, if relevant,
provide details on alternatives you've found. DO NOT include a copy of
your search; simply keep it on file somewhere. List the searchable
data bases used. This is different from the literature search you
performed in section III as this one only pertains to painful alternatives
and not to the overall experiment itself.
- Date of literature search. Simply provide the date when you
conducted your literature search. Much be within one month of submitting
your application.
- Databases Searched. List which databases you searched. Minimum
of two required. Also provide the years the databases covered.
- Keywords/Search Strategy. Simply list the key words you used
in your searches, the
date(s) you performed the searches, and 1-2 sentences concerning the
results. Do not list references.
- Concise narrative. 1-2 sentences each to describe what was
found when searching each database.
- Painful Procedure Justification. Provide
strong justification for the use of painful procedures. Members of the
IACUC often consult
experts in the field concerning alternatives and types of techniques, so
they are often aware if an
investigator really has a handle on alternatives. Analgesics should be
mentioned here whether used or not.
- Attending Veterinarian Consultation. All procedures
involving pain or distress of
animals (Categories 2 and 3) requires an attending veterinarian to agree
to act as a
consultant. Dr. Bart Carter (2-5648), the attending University
veterinarian, is available for such consultation and in most cases
should be the person listed here. It is a conflict of
interest to utilize a PI or Co-PI as an attending veterinarian. DO NOT
list yourself here.
- Prolonged restraint: If the protocol involves keeping the
animals restrained for periods
greater than (perhaps) 15 min, then a written justification should go
here. Examples might include
restraint to prevent catheter removal, or suspension restraints to help
offset the effects of gravity during bone resporption
experiments. Restraints may be necessary to prevent animals from removing
sutures or a cannula.
- Surgery: If no surgery is required, or if the procedure is
immediately terminal, all one does is
check NO and move on. However, if true surgery is involved, then items
1-6 should be filled out.
Procedures such as spleen harvesting for monoclonal antibody production
are not generally included under this category since it is terminal. You
are instructed to describe the surgical
procedure, room where the surgery is to be performed, document the
qualifications/training of persons involved, detail
how the animals will be treated post-operatively, if the surgery is
multiple on a given animal
(Note: special IACUC guidelines apply to multiple surgeries on the same
animal), and whether the surgery is a survival surgery. Do not duplicate
procedures found in the materials and methods section. Simply state in
the materials and methods that the procedures will be described in greater
detail later in this section. NOTE: If you opt to perform surgeries within
your individual laboratory, then your laboratory will be inspected by
the IACUC at 6 month intervals.
- Animal manipulations:
- Injections: If injections are involved, list the gauge of the
needle, the type of compound to be
injected, and route of administration.
- Drugs: This section applies predominately to a list of the
drugs to be used for administration,
although some substances might fit into both this and the above
category. List pharmacological
agent, exact dose, route of administration, etc. Of particular importance
are controlled substances. Remember, both federal and state permits are
required for any individual in Kansas to use a controlled substance.
- Biosamples: This involves tissue biopsies, blood and serum
collection, feces, ascites collection, etc.
The exact types of tissue, plus amounts, should be briefly listed.
- Tissue sharing: If you plan to give tissue samples to other
investigators, list types of tissue, amount, and the investigators name.
- Other procedures: Simply list any procedures that you haven't
placed
elsewhere and you cannot find a place for them
in any other catagory.
- Adjuvants: This category is the place to list all adjuvants
and
antigens used for hyperimmunization procedures. IACUC guidelines apply if
Freund's complete adjuvant is to be used. It is to be used only when
other alternatives are found to be unsuitable.
- Study endpoint: Describe how you will determine when the study
will end. It may be after a
defined number of days, when the animal is sufficiently hyperimmunized so
that splenic
lymphocytes are secreting antibodies in the appropriate amounts, or you
may have some other
parameter in mind. If there is a chance that animals could become
moribund or die, then you must explain the parameters you will use to
determine when to euthanize and show that you are checking the animals at
regular intervals. Anytime animals might become ill enough to
experience prolonged pain or die during the experiment cannot be placed in
pain Category 1
(above). Please note that death as an endpoint must be explicitly
justified, and all other alternatives considered, before the procedure
will be approved.
- Euthanasia: If applicable, explain how animals are to be
euthanized (i.e. which type of reagent/solution will be used and route of
administration), and which individual or
service (i.e. ARF or LACS) will be performing the procedure. If
animals may experience pain or distress to a level where
euthanasia may be needed, you must provide the parameters to be
used in determining when to euthanize. Particular
attention must be paid to the 1993 American Veterinary Medical Association
Panel on Euthanasia
report for types of approved euthanasia procedures.
- Animal disposition: State whether the animals are to be
euthanized,
placed up for adoption,
released, sold, etc. Be sure to tell exactly how carcasses will be
disposed of or at least which service (ARF, LACS) will be taking care of
the disposal.
- Veterinary Care
- Husbandry Considerations. List the location where
the animals are to be housed. If special housing conditions need to be
met, then they need to be explained
here as well.
- Animal Surveillance. List the
individual(s) who check the animals daily during the experiment(s).
Generally, this will be someone
either on the research team, or perhaps a specially designated animal
caretaker in ARF or
LACS. Although ARF and LACS does check each laboratory animal on a daily
basis, this in itself may not be sufficient here for some experiments.
- Medical Attention. List the person, and phone number, of the
person who you will contact in the event of an immediate health problem
with the animal(s). In most cases, this will be the attending
veterinarian, Dr. Bart Carter, 2-5648.
- Wire bottom rodent caging. If you check the "yes" box, you must
explain the rationale for using them. Long term maintenance of rodents on
wire is strongly discouraged by the IACUC and requires justification.
- INVESTIGATOR AND TECHNICIAN QUALIFICATIONS/TRAINING: All
individuals working on animals at
KSU must have on file documentation that they have received the
appropriate training. It may
help to simply list the individual and state that the training document is
on file with the
Compliance Officer (Research and Sponsored Programs, Fairchild 01). Then,
simply go through the checklist.
- HAZARDOUS MATERIAL USE: If you answer
yes to recombinant DNA
or biological (infectious) agents here, you must
provide an Institutional BioSafety Committee (IBC) registration document
number. If a current IBC protocol is
required but not yet approved, the IACUC sometimes allows the protocol to
move through review but will not allow an investigator to utilize or
order any animals until the IBC gives the final word. NOTE: the type of
work approved by the IBC is cross-checked against the proposed animal
work.
- EXTRAMURAL FUNDING: If you are applying for an extramural
award, it is important that all procedures listed on the IACUC application
are consistent with those submitted to the funding agency. If the
procedures submitted to the granting agency are not consitent with those
approved by the IACUC and on file with the University, your applications
may be considered fraudulent.
- ClINICAL TRIAL. Simply mark the box appropriately. If the "yes"
box is checked, you must provide the name of the product and the funding
agency.
Whew! Once you run the prose through a spell-checker, simply sign the
document, date it, and send it to the University
Research Compliance Office in
Fairchild 01. An application is not considered valid until signed by the
investigator. By federal
law, an IACUC protocol can only be approved for a maximum of 3 years
before it must be re-reviewed. Thus, if you are writing a 4 or 5 year
grant, any animal work performed in those latter years would come under
re-review.
Review process
Once an application has been received, the document is photocopied and
sent to all members of the IACUC. The committee members have one week to
review the application and generate comments. After that, multiple
possibilities exist. In the simplest scenario, there would be no problem
and the animals would fall into Category 1 (no or momentary pain and
distress). The protocol would then be sent to a designated reviewer for
scrutiny and final approval (within 2 weeks). If there is a minor problem
with the
document, for instance some information is missing or unclear, the
IACUC members may request clarification on specific points. All Category
2 (alleviated pain or drug relieved), Category 3 (unalleviated
pain or distress), and questionable Category 1 (no or momentary pain or
distress) proposals require a full committee review (the first and third
Thursday afternoons of each month). The PI or his/her representative will
be invited
to attend the meeting (optional)
to provide a very brief (i.e. 5 minutes or less) overview and then
to clarify specific points. Individuals who are verbose, talkative,
loquacious, prolix, garrulous, rambling, longwinded, confused,
placating, and redundant will
fall into disfavor.
Investigators may check on the status of their application at any time by
either calling the Compliance Office at 532-3224 or by clicking on their
individual proposal tracking number.
Because of the shear number of regulations now governing animal research,
and because the IACUC forms have become more complex to comply with
those regulations, few applications are approved without some form
of modification or inquiry. Thus, the investigator should not feel
singled out if the committee requests clarification. Indeed, to
anticipate virtually everything the committee might require is nearly
impossible. Following the review process, Research and Sponsored
Programs will send each PI simple Occupational Health and Safety
questionaires to be filled out by each individual involved in the project.
This sheet is designed to insure that all
individuals exposed to animals are properly vaccinated, and have no health
problems that may affect themselves or the animals. Once the
questionaires are reviewed and the type of
animal use determined, individual fact sheets pertaining to specific
animal-related diseases will be supplied to the investigator for review
and distribution to all individuals involved.
Kansas State University
| Laboratory Animal Care Service
Last updated 05 November 2004
|