Lake Superior State University Institutional Animal Care and Use

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Lake Superior State University
Institutional Animal Care and Use Committee
APPLICATION TO USE VERTEBRATE ANIMALS
(Invasive Procedures)
University policy and federal law require a
review of projects for humane treatment
and judicious use of vertebrate animals. At
Lake Superior State University, adherence
to this policy and federal law is assured by
the Institutional Animal Care and Use
Committee (IACUC) through review of this
Application to Use Vertebrate Animals
(AUVA) for research, testing, or instruction.
While fulfilling its responsibility to ensure
the judicious use of animals, the IACUC also
reviews applications for scientific or
instructional merit.
Projects Requiring Review
The Principal Investigator (PI) or Course
Instructor (CI) must obtain approval from
the IACUC before initiating research,
testing, or, instructional use of vertebrates.
Failure to do so is a violation of federal law.
The following types of animal use do not
require IACUC review:
1.
2.
3.
Invertebrate animals
Whole dead animals not regulated by
USDA e.g. ectothermic vertebrates,
birds, Rattus sp., and Mus sp.
Animal tissues, fluids, internal organs,
eggs, embryos, fetuses, etc. obtained
as a commercial product or as a
byproduct of another IACUC-approved
research project
If you are uncertain whether an IACUC
review is required for your project, please
contact the IACUC for a determination.
The Application Review Process
Applications are reviewed each academic
semester. Completed applications should
be submitted electronically to the IACUC.
After an administrative review, applications
are forwarded to members of the IACUC for
a formal review. Following this review the
project will be either:
1) Denied – The IACUC has determined
that the project does not meet the
standards of humane use, or has serious
scientific flaws. No vertebrate use is
approved.
2) Conditionally Approved – The IACUC has
determined that the project does meet
the standards of humane use, but
exhibits minor scientific flaws or lacks
clarity. The PI/CI must address these
issues and re-submit a complete
application. No vertebrate use is
approved.
3) Approved – The IACUC has determined
that the project meets the standards of
humane use and is free of scientific
flaws. Vertebrate use is approved.
The PI/CI will be contacted by the IACUC to
resolve any issues of concern to the IACUC
members. Following approval, an Approval
Number will be assigned. This Approval
Number must be referenced on animal care
and use documents and may be requested
by outside inspectors.
Page 1 of 9
Application for the Use of Vertebrate Animals
Approval Period and Annual Review
IACUC approval is valid for a maximum of
three years for faculty research projects or
instructional activities. For multi-year
projects, the PI/CI will be sent a brief
Annual Review Form. Completion of this
form is required for compliance with the
regulations of the Federal Animal Welfare
Act. Failure to return the Annual Review
Form is a violation of federal law and will
lead to inactivation of IACUC approval to
use animals. The approval period for
undergraduate research projects is limited
to one year (undergraduate projects are
eligible for renewal).
Modifying Approved Applications
Prior to making significant changes in
animal research activities, investigators
must receive approval of the proposed
changes from the IACUC. These changes
should be described in a written narrative.
The name of the PI/CI, current Approval
Number, and title of the project must be
referenced in the narrative. The PI/CI
should be sure to describe all aspects in
which the change may alter their approved
protocol. This is best accomplished by
reviewing the currently approved
application, and addressing each question
affected. A modification to an approved
application undergoes the same review
process as do new or renewal applications.
Investigators should allow 2-3 weeks for
review of modifications by the IACUC.
General Instructions
The application should be completed and
submitted electronically. Complete the
application in its entirety. Abbreviations
Invasive Procedures
must be clearly spelled out and/or defined
upon first use. Applicants may find that
they will be asked to provide brief answers
regarding issues which they have discussed
in detail in another part of the form. Please
answer each question as stated and do not
simply refer to another answer elsewhere in
the application.
Michigan Freedom of Information Act
Applicants should be aware that approved
applications may be obtained through the
Michigan FOIA. Applications should be
written in a manner which will allow them
to sustain public scrutiny. Avoid
unnecessary use of inflammatory
descriptive language. For example, when
discussing euthanasia, use the word
"euthanize" and avoid the use of the words
"sacrifice" and "kill". Where practical,
include sufficient detail and explanations to
address anticipated questions and concerns
from the general public.
Unacceptable Applications
Reasons why applications may not be for
review include, but are not limited to:







Incomplete applications
Use of an obsolete form
The PI/CI is not affiliated with LSSU
Use of technical language that a nonscientist might not understand in
Questions 3 and 4
Inadequate description of animal use
procedures in Question 11
A single composite answer to questions
with multiple subparts
Missing signatures
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Application for the Use of Vertebrate Animals
Invasive Procedures
For IACUC Use Only
Date Received ____________
Approved
Approval Date ____________
Approval Period _________ Approval # ________
New Application
Revised Application
Renewal Application
Conditional
Denied
Conditional Approval Date Click here to enter a date.
Approval # Click here to enter #.
Save the completed application as a Word file (<name>_AUVA.docx) and email to the IACUC chair.
Principal Investigator (PI) or Course Instructor (CI): Click here to enter text.
Telephone: Click here to enter #.
Faculty
Student
E-mail: Click here to enter address.
Faculty Mentor: Click here to enter name.
Project Title/Course: Click here to enter text.
List all personnel who will perform procedures involving animals.
Name
Phone
Click to enter
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Duties
Page 3 of 9
Application for the Use of Vertebrate Animals
1.
Invasive Procedures
What species of animal are you requesting to use? (Please provide scientific names)
Click here to enter list.
2.
What type of animal use is proposed in this application?
Basic Research
Field Research
Testing (e.g. toxicology)
3.
Applied Research
Instruction or Training
Other Specify
How would you explain to a non-scientist, the objective(s) of the proposed work?
Click here to enter text.
4.
How would you explain to a non-scientist, how the proposed animal use will advance
our knowledge?
Click here to enter text.
5.
Check all planned experimental or instructional procedures* that will be performed on
the animals requested in this application. All procedures checked below must be
explained in Question 11.
Addiction or addiction withdrawal
Anesthesia
Antibody production
Behavior modification
Blood collection
Breeding
Catheterization
Capture of wildlife
Environmental manipulation
Euthanasia
Food/water manipulation
Injection
Noxious stimulus
Obesity, experimental
Restraint
Sensory dysfunction
Stress
Surgical procedure, non-recovery
Surgical procedure, recovery
Toxicity test
Other Specify
* If no invasive procedures are planned you should complete the Non-Invasive Procedures Application.
6.
Indicate how you have monitored scientific advances that would enable you to use less
painful or distressful procedures.
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Application for the Use of Vertebrate Animals
Invasive Procedures
Review of scientific journals
Attendance at scientific meetings
Discussion with colleagues
Click here to enter text.
7.
What anesthetic agent(s) will be used? (
None. Go to question 8)
a.
Dosage (mg/kg) Click here to enter text.
b.
Route of administration Click here to enter text.
c.
Frequency of administration Click here to enter text.
d.
What will be the maximum duration of anesthesia? Click here to enter text.
e.
How will depth of anesthesia be monitored? Click here to enter text.
f.
What indications will be used to determine that supplemental doses are
required?
Click here to enter text.
g.
Are animals expected to recover from anesthesia?
h.
Describe the post-anesthetic monitoring plan.
Yes
No (go to 8)
Click here to enter text.
8.
What analgesic(s) will be used? (
None. Go to question 9)
a.
Dosage (mg/kg) Click here to enter text.
b.
Route of administration Click here to enter text.
c.
Frequency of administration Click here to enter text.
d.
How will you determine if supplemental doses of analgesics are necessary?
Click here to enter text.
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Application for the Use of Vertebrate Animals
9.
Invasive Procedures
In the event that it becomes necessary to euthanize animals during or following this
project, what method will be used?
Click here to enter text.
a.
AVMA classification of euthanasia methods
Acceptable (Go to 9c)
Conditional
Unacceptable
b.
Justification for selecting a method of euthanasia classified as conditionally
acceptable or unacceptable.
Click here to enter text.
c.
How will you ensure that animals will not revive (e.g. removal of heart, induction
of bilateral pneumothorax, observation of rigor mortis)?
Click here to enter text.
d.
What will happen to animals that die or are euthanized during or at the
conclusion of the project?
Click here to enter text.
e.
What will happen to the animals that do not die or are not euthanized during
this project?
Click here to enter text.
10.
11.
What drugs will be used for euthanasia? (
None  go to 11).
a.
Drug(s) to be used Click here to enter text.
b.
Dose (mg/kg) Click here to enter text.
c.
Route of administration Click here to enter text.
Describe all planned procedures to be performed on the animals (e.g., blood collection,
surgery, behavioral training, administration of test compounds, breeding, etc.). Include
time frames and intervals and describe procedures in the order in which they will be
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Application for the Use of Vertebrate Animals
Invasive Procedures
performed. All procedures checked in Question 5 should be described below.
Click here to enter text.
12.
Describe expected adverse consequences that the animals may experience as a result of
the procedures or test compounds described in Question 11. Examples of expected
adverse consequences include loss of appetite, post-operative discomfort, pain at an
injection site, or loss of animal life including euthanasia.
Click here to enter text.
13.
Estimate the number of animals of each species that will be used over the duration of
the project for each Humane Use Category below. Explain how you calculated the
required number of animals. If applicable, indicate the number of animals in
experimental and control groups.
Humane Use Category
Number of Animals
1
Animals will not experience pain, discomfort, or distress for which
pain relieving drugs would customarily be given in human
medicine or standard veterinary practice. (Examples)
Click to enter #.
2
Animals might experience pain, discomfort or distress but
appropriate anesthetics, analgesics, or tranquilizers will be used to
prevent these effects. (Examples)
Click to enter #.
3
Animals might experience pain, discomfort or distress for which
anesthetics, analgesics, or tranquilizers would customarily be given
but these drugs cannot be used because their use would adversely
affect the experimental results or interpretation. (Provide below a
description of the procedures producing pain, discomfort or
distress in animals and the reasons anesthetics, analgesics or
tranquilizers cannot be used). (Examples)
Click to enter #.
14.
Why must animals be used to accomplish the proposed work?
Click here to enter text.
15.
Why was the requested species of animals chosen for the proposed work? Describe the
biological characteristics of the animal essential to the proposed study.
Click here to enter text.
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Application for the Use of Vertebrate Animals
16.
Invasive Procedures
Identify the source of the animals to be used in this project.
Click here to enter text.
17.
Will recovery surgery be performed on the animals?
Yes
No (Go to 18)
a.
Who will perform the surgical procedures? Click here to enter name(s).
b.
Identify and describe the facility where surgery will be performed.
Click here to enter text.
18.
Will animals be restrained for more than 30 minutes?
a.
Yes
No (Go to 19)
Describe the restraint devices to be used.
Click here to enter text.
b.
Specify the maximum duration and frequency of restraint.
Click here to enter text.
c.
Briefly describe the purpose of the physical restraint.
Click here to enter text.
19.
List any non-target species that are likely to be captured during this project.
Click here to enter list.
20.
Describe the procedures for handling non-target animals.
Click here to enter text.
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Application for the Use of Vertebrate Animals
Invasive Procedures
PRINCIPAL INVESTIGATOR'S ASSURANCE

I acknowledge responsibility for this project.

I am familiar with LSSUs policies for the care and use of laboratory animals and certify that
this project will be conducted in compliance with those principles.

I have obtained any and all required state or federal permits. (Attach copies of permits)

I assure that I will obtain IACUC approval prior to significant changes in the protocol.

I assure that all personnel on the project are qualified or will be trained to conduct the
project in a humane and scientific manner.
_____________________________________________
Signature of Principal Investigator/Course Instructor
_________________
Date
Page 9 of 9
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