Three-Year Renewal Application for Animal Use in Research or Teaching

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Three-Year Renewal Application for Animal Use in Research or Teaching
General Information
First Name *
Last Name *
Title *
Email *
Phone *
Department *
Title of Project *
Unit Head (Authorizing Official) Name *
Unit Head (Authorizing Official) Department *
Other Personnel* (persons who will be working with you on this project such as co-investigators and assistants)
First Name
Last Name
Title
Email
Phone
Department
First Name
Last Name
Title
Email
Phone
Department
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Three-Year Renewal Application for Animal Use in Research or Teaching
Emergency Contact Numbers
First Name *
Last Name *
Email *
Primary phone *
Secondary phone
First Name
Last Name
Email
Primary phone
Secondary phone
Type of Project *
Research
Teaching
Inclusive Dates of Project
Intended Start Date *
End Date *
Funding
Source
Date Available
Amount
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Other
Three-Year Renewal Application for Animal Use in Research or Teaching
Purpose of Project
1. How would you explain to a non-scientist the long-term or overall scientific goals of the
proposed research or teaching exercise? (Please define terms and avoid using jargon)
2. How would you explain to a non-scientist the specific objectives of the proposed research
or teaching exercise? (Please define terms and avoid using jargon)
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Three-Year Renewal Application for Animal Use in Research or Teaching
3. How would you explain to a non-scientist the ways this might benefit human or animal
health, the advancement of knowledge, or the good of society?
4. Provide a brief summary of your proposed project.
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Three-Year Renewal Application for Animal Use in Research or Teaching
5. From the list below, check all experimental or instructional procedures that will be performed
on the animals requested in this application.
Addiction or withdrawal
Euthanasia
Operant conditioning
Amputation
Food/water manipulation
Anesthesia
Gavage
Organ/system failure or
dysfunction, induced
Antibody production
Immunization, experimental
Ascites production
Immunosuppression
Biopsy
Implant
Blood collection
Injection
Breeding
Injury/trauma
Burn
Inoculation, experimental
Cannulation
Irradiation
Capture of wildlife
Irritation, experimental
Cardiac puncture
Lavage
Catheterization
Myocardial infarction
Collection
Noxious stimulus
Dental procedure
Obesity, experimental
Environmental manipulation
Observation (no manipulation)
Paralysis, experimental
Peritoneal lavage
Prey, animal
Radiography
Restraint
Sepsis induction
Stress
Stroke
Stun
Surgery, non-recovery
Surgery, recovery
Toxicity test
Transplantation
Tumor growth, induced
Other
Animal Subjects
Species *
Reporting Code *
Total Number of Animals for Project *
Total Number of Animals for First Year *
Maximum Daily Population *
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Three-Year Renewal Application for Animal Use in Research or Teaching
Species *
Reporting Code *
Total Number of Animals for Project *
Total Number of Animals for First Year *
Maximum Daily Population *
Please describe the procedures producing pain, discomfort or distress in animals and the
reasons such drugs cannot be used.
Animal Husbandry and Housing
Will animal husbandry be a part of this project?
Yes
No
Will GVSU personnel be responsible for all aspects of animal husbandry and housing?
Yes
No
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Three-Year Renewal Application for Animal Use in Research or Teaching
1. If the animal housing does not meet or exceed the specifications of the NIH Guide,
describe the proposed housing in detail; where housing is located; and justify why nonstandard housing is needed.
2. If the light cycle under which the animals are to be maintained is a controlled cycle, indicate
the cycle.
Per GVSU protocol
Other
3. If the temperature and humidity are to be controlled, indicate the expected temperature and
humidity ranges to which the animals will be exposed during the project.
Per GVSU protocol
Other
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Three-Year Renewal Application for Animal Use in Research or Teaching
4. If temperature and humidity are not controlled, what is the expected ranges of temperatures
and humidity to which the animals will be exposed?
5. If using other than standard commercially available bedding and diet, please provide the
rationale for their use. In addition, describe the diet and who will be preparing it (include any
additions to a routine diet).
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Three-Year Renewal Application for Animal Use in Research or Teaching
Veterinary Care
Will Veterinary care be part of this project?
Yes
No
1. If someone other than GVSU Veterinary personnel will be responsible for Veterinary care,
please complete table below.
Name
Institution
Phone
Type of Care:
Routine
Emergency
Animal Use Justification
Guidelines issued by the United States Government entitle Principles for the Utilization and care
of Vertebrate Animals Used in Testing, Research, and Training () and GVSU policy require that
animals selected for procedure should be of an appropriate specs and that the minimum number
required to obtain valid results should be used.
1. Why were the requested species of animals chosen for the proposed work? Describe the
biological characteristics of the animal that are essential to the proposed project.
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Three-Year Renewal Application for Animal Use in Research or Teaching
2. Please select how the number of animals needed for the project was determined. (How were
the experimental and control group size determined)
Statistical Methods
Summarize your power analysis:
Previous reports with similar procedures
Provide a list of 1-3 references:
Other
Please Explain
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Three-Year Renewal Application for Animal Use in Research or Teaching
3. Please select why non animal models such as mathematical models, computer simulations,
or vitro biological systems, cannot be used as acceptable alternatives to the use of animals
in this project.
No Alternatives are available (Please provide a justification and evidence to support
this statement below)
Alternatives are available but are not satisfactory. (Please explain below)
Pain and Distress
According to the regulations of the Federal Animal Welfare Act [9CFR 2.31 (d)(ii)], the
institutional animal care and use committee shall determine that "..The principal investigator has
considered alternatives to procedures that may cause more than momentary or slight pain or
distress to the animals, and has provided a written narrative description of the methods and
sources used to determine that alternatives are not available."
Alternatives to procedures that may cause more than momentary or slight pain or distress may
include:
1. The use of procedures that cause less pain or distress.
2. The use of anesthetics, analgesics or tranquilizers that would reduce pain or
distress.
3. The use of methods that do not utilize animals
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Three-Year Renewal Application for Animal Use in Research or Teaching
1. If you chose B or C in Question 1 of Section III, please describe methods and sources
used to determine that suitable alternatives were not available. Use the space below for
elaboration.
Animal Welfare Information Center
Literature Search(specify databases and keywords used below)
Review of scientific journals (specify journals below)
Attendance at scientific meetings (specify meetings below)
Consultation with colleagues(specify colleagues below)
Other(please elaborate below)
2. Has a Veterinarian been consulted regarding this project?
Yes
No
Name of Veterinarian Contacted
Institute they are affiliated with
3. If your procedures will result in pain and/or distress to the animals which are more than
momentary or slight and you experimental plan does not allow for euthanasia of sick or
moribund animals please provide scientific justification for withholding these procedures.
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Three-Year Renewal Application for Animal Use in Research or Teaching
Anesthesia
Will the animal be anesthetized?
Yes (Fill out information below)
No
1. Please List those people who will perform the anesthesia
Name
Title
Experience
Name
Title
Experience
2. What will be the maximum duration of anesthesia (minutes)
3. Describe how will depth of anesthesia be monitored?
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N/A
Three-Year Renewal Application for Animal Use in Research or Teaching
4. If paralytic agents will be used, explain how you will assess the degree of analgesia.
Controlled Substances
Will Controlled Substances be used in this project?
Yes (Fill out information below)
No
1. List all controlled substances that will be used in this project.
2. Indicate the name of the individual(s) who will be responsible for the use of all controlled
substances and all other anesthetics/analgesics used in this project. Only the persons
listed below will be permitted to purchase and store these drugs.
Name
Name
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Three-Year Renewal Application for Animal Use in Research or Teaching
Non-Surgical Procedures
Non-surgical procedures include blood sampling, conditions and training procedures,
medications, observations, etc.
Will non-Surgical procedures be performed?
Yes (Fill out information below)
No
1. Describe the non-surgical procedures to be performed, including the species and number
of animals involved in each procedure. Indicate whether any pain or distress might occur
and, if so, state what will be done to minimize or eliminate the pain or distress. Complete
the table in (3) below if anesthetics or analgesics are to be used, If these drugs are to be
withheld for some reason complete Section III, category C.
2. Indicate all anesthetics, analgesics, or other measures to be used in the alleviation of
pain or distress associated with any non-surgical procedure.
Species
Drug
Dosage
Frequency of Administration
Route of Administration
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Three-Year Renewal Application for Animal Use in Research or Teaching
Species
Drug
Dosage
Frequency of Administration
Route of Administration
3. When will the pain/distress alleviation measures be employed? (check all that apply)
Before procedure
Following procedure
At the discretion of the principal investigator
During procedure
Long Term
Other
4. Will un-anesthetized animals undergo physical restraint for more than 5 minutes?
Yes
No
5. Will procedures involve blood collection?
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Yes
No
Three-Year Renewal Application for Animal Use in Research or Teaching
6. Describe in detail any expected clinical conditions or abnormalities that the animals may
experience (i.e. weight loss, loss of appetite, pain at injection site, death, etc.) as a result
of the non-surgical procedures. Indicate any provisions for the animals' comfort and care
should such conditions develop.
7. Where will these procedures be performed?
GVSU
Other
If other, please specify:
8. Please list each personnel who will perform non-surgical experimental procedures, test
procedures or teaching demonstrations.
Name
Department
Procedure
Name
Department
Procedure
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Three-Year Renewal Application for Animal Use in Research or Teaching
Please List the experience of each person in the table above in the gives procedure(s) they will
perform.
Surgical Procedures
Will surgical procedures be performed?
Yes (Fill out information below)
No
1. Describe in detail the surgical procedure(s) to be performed, including the species and
number of animals involved in each procedure.
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Three-Year Renewal Application for Animal Use in Research or Teaching
2. Indicate all anesthetics, analgesics, or other measures to be used in the alleviation of
pain or distress associated with any surgical procedure.
Species
Drug
Dosage
Frequency of Administration
Route of Administration
Species
Drug
Dosage
Frequency of Administration
Route of Administration
3. List Each person who will perform surgical procedures
Name
Department
Procedure
Name
Department
Procedure
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Three-Year Renewal Application for Animal Use in Research or Teaching
List the experience of each person in the table above in the given procedure(s) they will
perform.
4. Will the animals be allowed to recover from surgical procedure?
Yes
No
Post-Anesthetic/Post-Operative Care
Will the animal receive post-anesthetic/post-operative care?
Yes (Fill out information below)
No
N/A
1. List all persons who will be responsible for post-anesthetic/post-operative care. (care
includes general maintenance, administration of medications, treatments, etc.)
Name
Department
Procedure
Name
Department
Procedure
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Three-Year Renewal Application for Animal Use in Research or Teaching
List the experience of each person for the procedure(s) they will perform.
2. Do you expect animals to experience any pain or distress during the postanesthetic/post-operative period?
Yes
No
Please describe the pain or distress and indicate when the distress might occur (e.g.
during restrain or handling, following treatment, etc.)
3. Complete the table below if analgesics/tranquilizing agents will be given to alleviate pain
or distress
Species
Drug
Per Protocol
Yes
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No
Three-Year Renewal Application for Animal Use in Research or Teaching
Species
Drug
Per Protocol
Yes
No
4. When will the pain/distress alleviation measures be employed? (check all that apply).
Before procedure
Following Procedure
At the discretion of the Principal investigator (Please explain)
During the procedure
Long term
At the discretion of veterinary personnel
Other (please explain)
How will you determine whether supplemental doses of post-operative/post-procedural
analgesics of tranquilizers are necessary?
5. If any therapeutic drugs/antibiotics will be administered, please list them below.
Species
Drug
Per Protocol
Yes
No
Yes
No
Species
Drug
Per Protocol
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Three-Year Renewal Application for Animal Use in Research or Teaching
6. If you expect animals to develop any clinical conditions or abnormalities (including loss of
appetite, weight loss, post-operative infections, wound dehiscence, hemorrhage,
paralysis, etc.) during the post-operative period, describe the situation in detail. Indicate
any provisions for the animals' comfort and care should such conditions develop.
7. By clicking here you are confirming that you have read and will comply with the
provisions of the GVSU Standard Operating Procedure Guidelines for postanesthetic/post-operative care and record keeping for research animals.
I agree
Euthanasia
Is Euthanasia applicable to this project?
Yes
No
1. Will All animals die or be euthanized during or at the conclusion of this project?
Yes
No
2. If animals will not be euthanized, state their final disposition.
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Three-Year Renewal Application for Animal Use in Research or Teaching
3. State the specific criteria for euthanizing abnormal or moribund animals. (Assume
someone may have to euthanize animals in your absence.)
4. Add all species that will be euthanized.
Species
Method of euthanasia
Dosage
Route of administration
AMVA
Acceptable
Conditionally acceptable
Acceptable
Conditionally acceptable
Species
Method of euthanasia
Dosage
Route of administration
AMVA
5. If you have chosen a method of euthanasia that is considered conditionally acceptable,
please provide scientific justification.
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Three-Year Renewal Application for Animal Use in Research or Teaching
6. How will you ensure that the animal will not revive? (the following are suggested:
absence of heart sounds, absence of respiratory sounds, dilation of pupils, observation of
cyanosis, and/or observation of rigor mortis)
Principal Investigator Assurance
I acknowledge responsibility for this project.
Everyone working under my direction on this project and I will comply with all
standards for animal care and investigation established in the Guide for the care and use
of Laboratory animals, 8th Ed. (NRC 2011), and the Federal Animal Welfare Act, and will
follow all policies established by GVSU to assure that these standards are met.
All individuals working with the animals are, or will be qualified by virtue of training or
experience to perform proper handling, experimental and errant techniques required for
the species to be used
I assure that I will obtain GVSU Institutional Animal Care and Use Committee approval
prior to any significant changes in the protocol.
This research does not represent unnecessary duplication of previous experiments..
I realize that failure to adhere to polices related to animal care and use may result in
suspension or revocation of permission to perform animal research in GVSU facilities or
to use live vertebrate animals in testing in teaching laboratories and demonstrations.
I realize that serious violations of federal regulations must be reported to the Office of
Laboratory of Animal Welfare.
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Three-Year Renewal Application for Animal Use in Research or Teaching
Personnel Training/Education
1. Please list those people who will be involved in providing training for the personnel
involved in this project. Describe the education, training, or experience that qualifies
these individuals to train others in the animal use procedures to be used in this project.
Assurance of Scientific or Educational Merit
1. This protocol's scientific or instructional merit has been established by
Instructional research Committee
Specify Institution
Other
Please Specify
Date
Hazardous Agents
Are hazardous agents applicable to this project?
Yes (Fill out information below)
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No
Three-Year Renewal Application for Animal Use in Research or Teaching
Chemical
Agent/Chemical
Route(s) of Administration
Dosage(s)
Route(s) of Excretion
Known/Suspected carcinogen
Yes
No
Yes
No
Agent/Chemical
Route(s) of Administration
Dosage(s)
Route(s) of Excretion
Known/Suspected carcinogen
Radioisotopes
Agent/Chemical
Route(s) of Administration
Dosage(s)
Route(s) of Excretion
Time period isotope presents hazard
Agent/Chemical
Route(s) of Administration
Dosage(s)
Route(s) of Excretion
Time period isotope presents hazard
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Three-Year Renewal Application for Animal Use in Research or Teaching
Biological
Agent/Chemical
Route(s) of Administration
Dosage(s)
Route(s) of Excretion
Indicate species at risk and virulence of agent
Agent/Chemical
Route(s) of Administration
Dosage(s)
Route(s) of Excretion
Indicate species at risk and virulence of agent
Additional Information
Describe the measures that will be taken to minimize the risks from all hazards indicated.
Specify the procedures that will be used to decontaminate equipment prior to routine washing.
Describe the process by which all agents or chemicals listed will be discarded.
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