THE UNIVERSITY OF KANSAS, LAWRENCE
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
ANIMAL USE STATEMENT MODIFICATION
This form should be used to request modifications to approved Animal Use Statements. If the
proposed modification significantly alters the aims or methods of the originally approved work,
the IACUC may request submission of a new protocol. Personnel changes should be made using
the Animal Use Statement Personnel Modification Form.
For assistance in completing this form, contact KU IACUC personnel (iacuc@ku.edu or
864-8841), any KU IACUC member, or Animal Care Unit veterinarians (864-5587).
Principal Investigator:
Project Title:
Animal Use Statement Number:
1. Describe the requested modification(s) to the Animal Use Statement. If additional animals are
requested, please complete questions 5 and 6. Appendices are included at the end of this
document. Complete all that apply to the modification being requested at this time.
2. Provide the rationale for requested modifications. Please provide a thorough response and
indicate how the proposed modification impacts the overall goal of the work.
3. Animal Welfare Regulations require principal investigators to consider alternatives to
painful/distressful procedures. A painful procedure is defined as any procedure that would be
reasonably expected to cause more than slight or momentary pain and/or distress in a human to
whom the same procedure is applied. Does the proposed modification have the potential to
cause pain and distress? ☐ Yes
☐ No
IF YES, AN ALTERNATIVE SEARCH IS REQUIRED
Alternatives are generally regarded as those that incorporate some aspect of replacement,
reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress
consistent with the goals of the research. The KU IACUC believes that the performance of a
database search remains the most effective and efficient method for demonstrating compliance
with the requirement to consider alternatives. A minimum of 2 databases must be searched.
REVISED JUNE 2015
However, in some circumstances (as in highly specialized fields of study), conferences,
colloquia, subject expert consultants, or other sources may provide relevant and up-to-date
information regarding alternatives in addition to, a database search. In these cases, sufficient
documentation, such as the consultant’s name and qualifications and date and content of the
consult should be provided to demonstrate the expert’s knowledge of the availability of
alternatives in the specific field of study.
Database 1
Database 2
Name of Database searched *
Date of search (must be within 6
months of protocol submission)
Years covered by search
Search strategy (must show how
keywords were combined)
Other sources consulted
* For suggestions on performing appropriate database searches and for a list of acceptable databases
visit: http://awic.nal.usda.gov/literature-searching-and-databases
For each painful procedure, were alternatives identified? ☐ Yes
If yes, please describe:
☐ No
If alternatives were identified, will they be incorporated into your proposed work?
☐ Yes ☐ No
If not, please explain?
4. Does the proposed modification involve use of hazardous materials? ☐ Yes ☐ No
If yes, an Animal Hazard Control Form must be completed. Contact the IACUC at
iacuc@ku.edu to obtain the appropriate form.
5. Complete the table below for requests for additional animals.
Species
Number Originally
Number of
Approved
Additional Animal
Requested
Source of Additional
Animals
6. Provide an explanation for the request for additional animals. The number of animals should be
justified scientifically and where applicable, statistically.
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REVISED JUNE 2015
Signature Statement
When submitting this document via email attachment, I certify that,
a) I am the Principal Investigator and I am the one submitting the document.
b) I would like for my email to serve as an electronic signature.
c) The date of submission corresponds with the date identified in the email that includes the
protocol as an attachment.
Alternatively, a signed original document is being submitted to the IACUC for review.
Signature and date follow.
My electronic signature, or the one below, verifies: 1) the information contained herein is
accurate, 2) a willingness to accept responsibility for compliance with all legal standards for
animal use established under Federal and state laws and university policies, 3) protocol
personnel have been appropriately trained prior to performing animal procedures.
Signature of Principal Investigator or Instructor
Date
FOR IACUC USE ONLY
KU AUS Number:
Review Process:
☐ Full Committee ☐ Designated Member Review ☐ Review by IACUC Chair
Pain/Distress Category:
Approval Date:
Biohazard:
Chemical hazard:
Radiation hazard:
Inter-institutional Collaboration:
☐
☐
☐
☐
Guide or AWA Exception:
Restraint:
Food/Water Restriction:
Survival Surgery:
Multiple Major Survival Surgery:
☐
☐
☐
☐
☐
Post-Approval Monitoring Review:
APPENDICES
Animal Procedures: Please check all that apply and complete the corresponding appendix. Nonapplicable appendices may be deleted.
☐ A. Antibody production
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REVISED JUNE 2015
☐ B. Substances collected from live animals including body fluids (blood, urine, etc.) and
tissue (biopsy, tail snips, etc.)
☐ C. Substances administered to live animals (gavage, injections)
☐ D. Restraint of conscious animals with mechanical devices (for procedures other than
routine care)
☐ E. Food or water deprivation
☐ F. Temperature, light, or other environmental manipulations
☐ G. Tumor models, disease models, or toxicity testing
☐ H. Behavioral studies
☐ I. Tissues, sera, or tumor lines of rodent origin or that have been previously passaged
through rodents
☐ J. Creation or use of genetically modified animals
☐ K. Wildlife field studies
☐ L. Anesthesia, Sedation, or Analgesia
☐ M. Surgical Procedures
☐ N. Dietary manipulation
☐ O. Aquatic species
☐ P. Animal breeding
☐ Q. Hazardous agent use (biological, radioactive, or chemical)
☐ R. Other study procedures not described above
☐ S. Intramural and Extramural Funding Sources
Appendix A: Antibody Production
1. Polyclonal antibody production
a. Antigen/Adjuvants to be used: [ text box here ]
If Freund’s Complete Adjuvant is to be used, concentration of mycobacterium
[ text box here ]
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REVISED JUNE 2015
b.
c.
d.
e.
f.
g.
h.
i.
j.
Route of injection: [ text box here ]
Location of injection(s): [ text box here ]
Volume of injection per site: [ text box here ]
Total number of injection sites: [ text box here ]
Frequency and maximum number of boosts: [ text box here ]
Interval between injection and booster: [ text box here ]
Frequency of monitoring injection sites/who will monitor:[ text box here
What will be done to minimize pain / distress: [ text box here ]
Adverse effects/endpoints: [ text box here ]
]
2. Monoclonal antibody production
Please provide scientific justification in the Animal Welfare Section of this proposal
explaining why in vitro monoclonal antibody production methods cannot be used.
a. Describe methodology: [ text box here ]
b. Adjuvant used: ☐ Yes ☐ No
If yes, name of adjuvant: [ text box here ]
Volume of adjuvant: [ text box here ]
c. Number of cells to be injected into peritoneal cavity: [ text box here ]
Volume of cells: [ text box here ]
d. Will ascites be generated: ☐ Yes
☐ No
e. Criteria/signs that will dictate ascites harvest: [ text box here ]
f. Will animal be anesthetized before harvest: ☐ Yes
☐ No
g. Total number of taps: [ text box here ]
h. How will animals be monitored/cared for following taps: [ text box here
i. What will be done to minimize pain / distress: [ text box here ]
j. Person responsible for monitoring/harvesting ascites: [ text box here ]
]
Appendix B: Substances collected from live animals including body fluids and
tissue
Substance
Collected*
Site of
collection
Method of
collection
Amount
Collected
Frequency of
Collection(s)
Use tab key to
insert more lines
as needed
Appendix C: Substances administered (for anesthesia and immobilization,
complete Appendix L)
Substance
Administered
Route
Dose
Concentration Maximum Frequency
volume/site
Use tab key to
insert more lines
as needed
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REVISED JUNE 2015
Investigators are expected to use pharmaceutical-grade drugs and compounds whenever
available, even in terminal procedures. If non-pharmaceutical grade drugs/compounds
must be used in live animals, list the drugs and/or compounds and how the drugs will be
prepared and used. [ text box here ]
From the following list, identify why pharmaceutical grade drugs are not acceptable.
☐ Not applicable, only pharmaceutical grade compounds will be used.
☐ No equivalent veterinary or human drug is available for experimental use.
☐ Although an equivalent veterinary or human drug is available for experimental use,
the chemical-grade reagent is required to replicate methods from previous studies
because results are directly compared to those of replicated studies.
☐ Although an equivalent veterinary or human drug is available, dilution or change in
formulation is required.
☐ The available human or veterinary drug is not concentrated enough to meet
experimental needs.
☐ The available human or veterinary drug does not meet the non-toxic vehicle
requirements for the specified route of administration.
☐ The pharmaceutical grade drug is effectively unavailable.
Appendix D: Restraint of conscious animals with mechanical devices (for
procedures other than routine care.)
a. Restraint device: [ text box here ]
b. For what procedures: [ text box here ]
c. Duration of restraint: (If greater than 30 minutes in a natural body position or greater than
10 minutes in an unnatural body position, justification must be provided) [ text box
here]
d. Frequency of observations during restraint/person responsible:[ text box here ]
e. Frequency and total number of restraints: [ text box here ]
f. Conditioning procedures: [ text box here ]
g. Steps to assure comfort and well-being: [ text box here ]
Appendix E: Food or water deprivation (excluding routine pre-surgical fasting)
1. Food Restriction
a. Amount restricted: [
text box here
]
b. Duration (hours for short term/weeks or months for long term):[ text box here
c. Frequency of observations: [
d. Person responsible: [
text box here
text box here
e. Potential adverse events: [
]
text box here
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REVISED JUNE 2015
]
]
]
2. Water Restriction
a. Amount restricted: [
text box here
]
b. Duration (hours for short term/weeks or months for long term): [ text box here
c. Frequency of observations: [
d. Person responsible: [
text box here
text box here
e. Potential adverse events: [
]
]
]
text box here
]
Appendix F: Temperature, light, or other environmental manipulations
a. Describe manipulation(s): [
text box here
b. Duration: [
text box here
]
c. Intensity: [
text box here
]
d. Frequency: [
text box here
e. Potential adverse events: [
]
]
text box here
]
Appendix G: Tumor models, disease models, or toxicity testing
a.
b.
c.
d.
e.
Describe methodology: [ text box here ]
Expected model and/or clinical/pathological manifestations: [
Frequency of observations: [ text box here ]
Person responsible for oversight of animals: [ text box here
Potential adverse events: [ text box here ]
text box here
]
]
Appendix H: Behavioral studies
a.
b.
c.
d.
e.
Describe animal methodology/test(s) to be used: [ text box here
Intensity and duration of stimulus: [ text box here ]
Frequency of tests: [ text box here ]
Length of time in test apparatus: [ text box here ]
Potential adverse events: [ text box here ]
]
Appendix I: Tissues, sera, or tumor lines of rodent origin or that have been
previously passaged through rodents
a.
b.
c.
d.
Tissues must be free of rodent infectious agents. Evidence of testing is required.
Source: [ text box here ]
Species: [ text box here ]
Tissue type: [ text box here ]
Provide evidence of appropriate testing or certification (MAP, PCR, etc):
[ text box here ]
Appendix J: Creation or use of genetically modified animals
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REVISED JUNE 2015
a.
b.
c.
d.
Describe approach or procedure to produce modification: [ text box here ]
What gene(s) were intentionally modified: [ text box here ]
If known, expected product over expressed / under expressed: [ text box here ]
Describe any potentially debilitating phenotypes associated with this animal:
[ text box here ]
Appendix K: Wildlife Field Studies
1. List required permits
Name and number: [
2. Study Site(s)
General Location: [
text box here
text box here
]
]
3. Capture with mechanical devices
a. Type/description of capture device/method: [ text box here ]
b. Frequency of checking capture device: [ text box here ]
c. Maximum time animal will be in capture device: [ text box here ]
d. Methods to ensure well-being of animals in capture device: [ text box here
e. Methods to avoid non-target species capture: [ text box here ]
f. Expected injury and/or mortality rates: [ text box here ]
g. Precautions used to minimize injury and/or mortality? [
text box here
]
]
4. Capture with chemical immobilization (Anesthetizing drugs are covered under Appendix
L, this section covers the mechanics).
a. Type of dart or device to administer drugs: [ text box here ]
b. Method of dart propulsion: [ text box here ]
c. Precautions used to minimize injury and/or mortality: [ text box here ]
5. Marking/Telemetry Procedures
a. Describe marking procedures to be used: [ text box here ]
b. If a telemetry package is to be attached, describe:
1. Weight of the total package [ text box here ]
2. Type of antenna (including length) [ text box here ]
3. Method of attachment (for surgical attachment, complete appendix N)
[ text box here ]
4. Will marking/telemetry device be removed ☐ Yes ☐ No
If yes, explain how: [ text box here ]
6. Release of animals other than at capture site (for non-survival collection please see #7)
a. Where will captured animals be released [ text box here ]
b. If the animals are transported indicate the method of transportation.
[ text box here ]
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REVISED JUNE 2015
c. If the animals are to be housed, please check your preferred housing location. Animal
housing space is assigned by the Attending Veterinarian. Every reasonable attempt will
be made to accommodate investigator requests for preferred housing locations.
☐ Malott Hall Animal Facility
☐ Haworth Hall Animal Facility
☐ Higuchi Animal Facility
☐ Life Science Research Laboratory Animal Facility
☐ KU IACUC Approved Satellite Facility
List bldg/room # [ text box here
]
*
☐ Other [ text box here
]
*
Locations where animals are housed for greater than 12 hours must be approved by the KU IACUC.
Information on establishing a satellite facility may be obtained from the KU-IACUC Office.
Are there any special requirements for housing/husbandry?
If yes, please indicate:
☐ Sterile Cages
☐ Wire Bottom Cages
☐ No Enrichment
☐ Social Isolation
☐ Other [ text box here
]
☐ Yes
☐ No
Provide scientific justification below for maintaining animals on wire bottom cages,
without environmental enrichment, or in social isolation.
[text box here]
d. If release is not the general location of capture, justify. [
text box here
]
7. Non-Survival Collection
a. Describe procedure(s) to be used. [ text box here ]
b. Describe precautions that will be taken to prevent non-target mortalities.
[ text box here ]
Appendix L: Anesthesia, Sedation, or Analgesia
Adequate records describing anesthetic monitoring and recovery must be maintained and
available. Animals must be monitored until awake and can maintain sternal recumbancy.
Agent
Concentration
Pre-emptive analgesic
Pre-anesthetic
Anesthetic
Post-procedural
analgesics
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REVISED JUNE 2015
Dose
Volume Route Frequency
(mg/kg)
Agent
Concentration
Dose
Volume Route Frequency
(mg/kg)
Paralytics (need to
justify below in
question h.)
Other
a. Reason for administering agent(s): [ text box here ]
b. For which procedures: [ text box here ]
c. Method of monitoring anesthetic depth, including paralyzing drugs:
[ text box here ]
d. Methods of physiologic support during anesthesia and recovery:
[ text box here ]
e. Frequency of recovery monitoring: [ text box here ]
f. Specifically what will be monitored: [ text box here ]
g. Describe any behavioral or husbandry manipulations that will be used to alleviate
pain, distress, and/or discomfort. [ text box here ]
h. If using paralytic drugs, scientific justification needed: [ text box here ]
i. Potential adverse events: [ text box here ]
Appendix M: Surgical Procedures
All survival surgical procedures must be performed aseptically, regardless of species or
location of surgery. Adequate records describing surgical procedures, anesthetic monitoring
and postoperative care must be maintained and available.
1. Location (Room, Building) of surgery: [
text box here
]
2. Type of Surgery
☐ Nonsurvival surgery: (animals euthanized without regaining consciousness).
☐ Major survival surgery: (major surgery penetrates and exposes a body cavity or
produces substantial impairment of physical or physiologic function).
☐ Minor survival surgery.
☐ Multiple major survival surgery?
If yes, provide justification for multiple major survival surgical procedures: [text
box here ]
3. Pre-op preparation of the animals: [ text box here
a. Food restricted for [ text box here ] hours
b. Water restricted for [ text box here ]hours
4. Sterile techniques will include (check all that apply):
☐ Sterile instruments
☐ Sterile gloves
☐ Cap and mask
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REVISED JUNE 2015
]
☐ Sterile gown
☐ Sterile operating area
☐ Removal of hair or feathers
☐ Skin preparation with a sterilant such as betadine
☐ Practices to maintain sterility of instruments during surgery
5. Describe the following surgical procedures:
a. Skin incision size and location on the animal: [ text box here ]
b. Describe surgery in detail (include size of implant if applicable):
[ text box here ]
c. Method of skin closure (include number of layers, type of wound closure, proposed
suture type, size ranges, etc.): [ text box here ]
i. Type: [ text box here ]
ii. Suture size / wound clips: [ text box here ]
iii. Pattern: [ text box here ]
6. Recovery from Surgical Manipulations
a. Following recovery, what parameters will be monitored? [ text box here ]
b. Person who will monitor the animals? [ text box here ]
c. How frequently will animals be monitored? [ text box here ]
d. How long post-operatively will animals be monitored: [ text box here ]
Appendix N: Dietary manipulation
a. Compound supplemented and amount: [
b. Compound deleted and amount: [
text box here
text box here
]
]
c. Duration (hours for short term/weeks or months for long term): [ text box here
d. Frequency of observations: [
e. Person responsible: [
text box here
text box here
f. Potential adverse events: [
]
]
]
text box here
]
Appendix O: Aquatics
1. Water quality monitoring
a. How is the water quality established/determined prior to introduction of animals?
[ text box here
]
b. How is the water filtered to remove nitrogenous/animal waste compounds? [ text box
here]
c. How frequently and what parameters for the water quality are monitored? [ text box here]
2. Housing
a. Briefly describe the system design and housing used (include type of water circulation,
tank size etc). [ text box here ]
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REVISED JUNE 2015
b. Provide the approximate housing density. [ text box here
]
c. Provide how often and how the housing will be sanitized. [ text box here
]
d. What type of environmental enrichment is being provided in the tank/housing? (PVC
pipe, plants etc). If none is used, please justify. [ text box here ]
Appendix P: Animal Breeding
a.
b.
c.
d.
e.
How many offspring do you anticipate generating over the 3 year life of this AUS?
These numbers [ text box here ]
Describe any known or potentially debilitating phenotypes associated with offspring.
[text box here ]
Describe any special husbandry requirements for offspring. [ text box here ]
Will offspring be typed for the gene of interest? ☐ Yes
☐ No
a. If yes, specify tissue collected and age of animal at collection.
[ text box here ]
Will offspring be transferred to another approved AUS? ☐ Yes ☐ No
a. If yes, specify AUS# and investigator. [ text box here ]
Appendix Q: Animal Hazard Control Form
Principal investigators using hazardous materials in animals are responsible for informing all
individuals handling animals, including ACU personnel, of the hazards involved and appropriate
risk mitigation strategies. Please contact Environmental Health and Safety for assistance in
completing this appendix.
Principal Investigator:
Campus Phone:
Emergency Phone:
Email:
Secondary Contact:
Campus Phone:
Emergency Phone:
Email:
Hazardous Material:
EHS Approval/Permit Number:
Required Personal Protective Equipment (PPE)
☐ Gown/lab coat ☐ Hair bonnet ☐ Eye protection ☐ Surgical mask ☐ Respirator
☐ Gloves ☐ Shoe covers ☐ Other, specify [ text box here]
Excretion:
Material/metabolites will be excreted in: ☐ No Excretion ☐ Urine ☐ Feces
☐ Other, specify [ text box here]
How long will material be shed? [
text box here]
Bedding/Waste Disposal
☐ Discard as regular waste ☐ Incineration by ACU
☐ Other, specify [ text box here]
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☐ Disposal through EHS
Cage Decontamination:
☐ No decontamination required ☐ Autoclave prior to washing
☐ Decay required, specify number of days:
☐ Other, specify [ text box here]
Animal Disposal
☐ Incineration by ACU ☐ Disposal through EHS ☐ Other, specify [
text box here]
Precautions for Handling Live or Dead Animals:
Additional Precautions to Protect Personnel, Adjacent Research, and Environment:
Study Location:
Animal Biosafety Level:
Appendix R: Other Study Procedures
Describe in detail all other study procedures performed on live animals not described in prior
appendices.
1. Other Study Procedures
a. Describe animal methodology/manipulation/test(s) to be performed:[
b. Duration: [ text box here ]
c. Frequency of tests: [ text box here ]
d. Potential adverse events: [ text box here ]
text box here]
Appendix S: Intramural and Extramural Funding Sources
Complete the following table for each intramural and extramural funding source of the work
described in this AUS.
Principal
Award or
Investigator Proposal #
Sponsored Project Title
Funding Agency
Funding
Period
A copy of the vertebrate animal section for each extramural grant listed should be pasted below.
For multiple grants, please delineate each vertebrate animal section by grant number and title.
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