Georgia Institute of Technology
Institutional Animal Care & Use Committee
Protocol Amendment
Instructions: This form was created in Word. Fields will expand to accommodate text entry. When complete, please return
the form by email to iacuc@gatech.edu. See GA Tech IACUC Policies and Procedures.
All amendments are reviewed by the full committee, either at a convened meeting or by designated review.
Type of Proposed Amendment
Check all that Apply:
Personnel
Species/Animal Number
1
Procedures
Funding Source
Protocol & Principal Investigator
Protocol Number requiring Amendment:
Protocol Title:
Principal Investigator:
Emergency Contact number:
2
Title & Funding
If there are no changes from the approved protocol check here
and skip to the next section
List all Sponsored funding sources you would like to add to this protocol (copy & paste as needed).
Note: Department of Defense (DoD) awards (including subs under a DoD Prime) require a separate protocol for each DoD award. Please
provide a copy of the final grant pages for each sponsored award.
Discretionary accounts need not be noted in the funding section below as any discretionary account may be used on any IACUC protocol.
Sponsor name:
Award Title:
PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending):
* Please note: If the title or funding source amendment reflects the addition of a grant to an approved project, a copy of the final grant
proposal pages must be submitted with this amendment.
3
Other Personnel
If there are no changes from the approved protocol check here
and skip to the next section
List all personnel (other than PI) to be directly involved with the animals. Describe each person’s relevant
training and experience, and indicate whether he or she (1) will serve as emergency contact for animal care issues
and (2) be responsible for weekend/holiday/afterhours observation of animals.
Note: No photographs or videos may be taken without prior approval from the PI and/or PRL Manager or Director. Photos may only be
used for scientific purposes. (copy & paste for additional personnel)
Name:
Role on Protocol:
Email:
(Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.)
(Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #:
)
(Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals
(Yes or No) (3) is individual authorized to order animals
(Yes or No) Enrolled in the Occupational Health Program
(Yes or No) Completed Required CITI Training
Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…]
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 1
Name:
Role on Protocol:
Email:
(Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.)
(Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #:
)
(Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals
(Yes or No) (3) is individual authorized to order animals
(Yes or No) Enrolled in the Occupational Health Program
(Yes or No) Completed Required CITI Training
Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…]
Name:
Role on Protocol:
Email:
(Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.)
(Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #:
)
(Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals
(Yes or No) (3) is individual authorized to order animals
(Yes or No) Enrolled in the Occupational Health Program
(Yes or No) Completed Required CITI Training
Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…]
Name:
Role on Protocol:
Email:
(Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.)
(Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #:
)
(Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals
(Yes or No) (3) is individual authorized to order animals
(Yes or No) Enrolled in the Occupational Health Program
(Yes or No) Completed Required CITI Training
Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…]
4
Veterinary Consultation
Consistent with the Animal Welfare Act (AWA), Principal investigators must involve in their planning
consultation with the Attending Veterinarian. You may contact Attending Veterinarian / Director of Animal
Resources, Dr. Laura O’Farrell, at 404.385.6233 or via email to: vet@gatech.edu.
Date of Consultation:
5
Study Objectives and Benefits to Society
Briefly state the objective(s) of the study in lay terms. Describe the purpose of the study as it relates to the
proposed amendment, and the proposed amendment. Clarify how this differs from the currently approved
protocol. ** Note: If proposed changes are substantive, a new IACUC application may be required**
The answer should be written like a newspaper story about science or medicine using easily understood lay terms. Make
minimal use of technical terms, and provide a brief explanation of any technical terms you must use. Routine use of
acronyms is not appropriate. A scientific abstract from the funding application using highly technical terms is not
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 2
acceptable. Note that scientific merit is not part of the evaluation of this proposal and that representatives of the general
community who have no scientific background may be among the readers.
6
Animal Species and Classification by Pain Level
USDA Pain Classifications (see IACUC Policy 004 USDA Pain Categories for additional clarification).
Class A: There is no direct contact with live animals. This includes observational field studies or use of cadavers
not euthanized specifically for this study.
Class B: This includes animals used for breeding or being held, but not directly used in research or teaching.
Example: breeders and culls from breeding colonies. Breeding colony includes parents and offspring.
Class C: Non-Painful/Non-Stressful: Animals upon which teaching, research, experiments, or tests will be
conducted involving no pain, distress, or use of pain-relieving drugs. Example: routine procedures causing only
slight or momentary discomfort such as venipuncture, injections, and the use of non-inflammatory adjuvants.
Class D: Painful/Stressful WITH Analgesia, Anesthesia or Tranquilizers: Animals upon which experiments,
teaching, research, surgery, or tests will be conducted that involve accompanying pain or distress to the animals
and for which appropriate anesthetic, analgesia, or tranquilizing drugs will be used.
Class E: Painful/Stressful WITHOUT Pain or Stress Relieving Measures: Animals upon which teaching,
experiments, research, surgery, or tests will be conducted that involve accompanying pain or distress to the
animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely
affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests.
Species
A current Scientific Collection Permit from the
appropriate Fish & Game Department must
accompany the IACUC application for all wild
caught animals*
USDA Pain Classification
(A, B, C, D, or E)
Total Number of
Animals
for 3-Year Project Period
(including pups)
Why is it necessary to use this species for this purpose? [TIP: Explain in language that can be easily
understood by a non-scientist.]
If animals are listed in Class E, Painful/Stressful WITHOUT Pain or Stress Relieving Measures, provide
references and scientific justification showing that all available or any particularly prescribed anesthetics,
analgesics or tranquilizers will interfere with the specific measurements that are proposed in this protocol.
7
Justification of Animal Numbers
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 3
[TIP: If you have previously measured the parameters you propose to measure, then the number of animals per group needs to be justified
using statistical power analysis. If you have no previous measurements, so state and indicate that the number of animals per group will
be the minimum needed to obtain statistically significant differences between groups. The second part involves listing all your
experimental groups with the number in each and the total at the bottom, which should add up to the total number of animals requested. ]
[TIP: A power calculator for determining the number of animals per group, if applicable, may be found at
http://www.stat.uiowa.edu/~rlenth/Power/index.html. Include a brief description of the statistical analyses, including tests, power and
probability levels utilized, if applicable.]
[TIP: Note: Scientific need should be used when possible to justify animal numbers rather than limitations of time, personnel, space,
money, etc.]
Justify the number of animals
List and briefly justify the groups, if applicable, or otherwise justify the total animal numbers requested.
Animals used for breeding must be included. The total number of animals must equal the number requested
in the chart above. Make a list or flowchart or insert a table, if appropriate. The total number of animals must
equal the total number of animals requested.
8
Alternatives and Non-Duplication
Perform sufficient database searches to verify that unnecessary duplication will be avoided and that there are no
alternatives to proposed painful and/or distressful procedures. Alternatives concern both replacement of
animals and refinement of procedures so that they cause less pain and/or distress. Describe the searches in the
following table:
Keywords Used
Date limitations placed on the
(must include names of
Databases Searched
Date of the Search
search, if any
painful or distressful
procedures)
Provide a written narrative of the sources consulted to determine whether or not alternatives exist to
procedures that may cause pain or distress. For example: “Medline was searched on November 1, 2011 for
alternatives to tailing a mouse, using keywords: genotyping, tailing, alternative, mouse, animal. No limits were
placed on the search.” [TIP: Alternatives are anything that contributes to replacement, reduction, or refinement (the 3 R’s) of
animal use with the goal of minimizing pain and distress. The Animal Welfare Information Center, a service of the National Agricultural
Library established to provide information about alternatives, can be searched at http://www.nal.usda.gov/awic/. Examples of searches are
available via Altweb http://altweb.jhsph.edu/.]
Results of the database search:
(YES, alternatives were found or NO, alternatives were Not found)
If yes, explain why those alternatives cannot be used in lieu of the proposed procedures that may cause more
pain or distress. (For example: “Alternatives to tailing were found, which include use of hair follicle, oral/anal epithelial
swabs as sources of DNA. These methods, though possibly less painful/distressful, do not typically yield enough DNA for
Southern Blot”).
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 4
9
Minor Changes in Procedures (Surgical and Non-surgical)
If there are no changes from the approved protocol check here
and skip to the next section
** Note: If proposed changes are substantive, a new IACUC application may be required.**
See Protocol Modification and Approval_IACUC Policy 003
Procedure location(s) (Include building and room for each):
Completely describe the planned procedures, including breeding and surgery.
Describe the aseptic methods to be utilized.
Will more than one major survival surgery be performed on any animal?
[TIP: Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic
functions or involves extensive tissue dissection or transection (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb
amputation). Insertion of needles or placing subcutaneous implants is not considered major surgery.]
(Yes or No)
If “Yes,” provide scientific justification for multiple major survival surgeries on the same animal. You must state
why the research goal cannot be accomplished by performing the surgeries in separate animals.
What is the training or experience of the people who will perform the procedures above?
Procedure Summary: List or tabulate all the procedures that will be done to animals in each group in order
making the time interval between clear, if applicable, so total life experience is summarized.
[Tip: Recovery from prolonged, general anesthesia is normally limited to three times per week, per animal.]
Example:
Surgical Implantation Study
Animals received and acclimatized for a minimum of 5 days
Day 0
Surgery
Day 12 +/- 5 days Anesthesia for blood collection, recovery
Days 20-24
Restraint for once daily gavage
Day 30
Anesthesia (3hrs) for imaging, recovery
Day 42
Restraint for subcutaneous injection
Day 62 +/- 2 days Terminal anesthesia for imaging, blood collection, euthanasia, tissue collection
Describe post-procedural observation and care. Include:
o Names of personnel responsible for monitoring / observing animals, including
afterhours/weekends/holidays
o Frequency of observation
o Clinical signs you will observe to determine whether treatment is necessary
[TIP: Animals must be monitored continuously until fully recovered from anesthesia and ambulatory]
10
Administration of Materials
If there are no changes from the approved protocol check here
and skip to the next section
List materials animals will be exposed to as a part of experiments, teaching or testing including but not limited to drugs,
anesthetics, analgesics, fluids, vehicles, diluents, polymers, substances, structures, cells, tissues, organs, plants,
microorganisms, prions, genetic material or subparts thereof.
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 5
Species
Material
Route
Dose (mg/kg) /
Frequency
Where
manufactured
or obtained
from*
Possible
Complications
* List the general type of manufacturing, not the particular company name i.e., drug company, compounding
pharmacy, chemical company, manufactured in house, etc.
Note: All animal cells, tissues, etc. must be tested for pathogens by the animal facility prior to introduction into the facility.
Federal regulations require that pharmaceutical grade materials be used for all animal-related procedures
when available, unless justified. Pharmaceutical grade is defined as materials approved by the Food and Drug
Administration or for which a chemical purity standard has been established by the United States PharmacopeiaNational Formulary or British Pharmacopeia.
Please list and provide justification for each non-pharmaceutical grade material that will be administered to
animals. Please see IACUC Policy #002 for further clarification.
If non-pharmaceutical grade materials will be used, please address how adverse events related to grade,
purity, cleanliness, sterility, pH, pyrogenicity, osmolality, stability, formulation, compatibility, etc. as
applicable will be minimized.
Who will perform the anesthesia? Describe each person’s training to perform the anesthesia procedures.
If the materials will result in a tumor, will the size of the tumor exceed 1.5 in any dimension or 10% of the
body weight of the animal?
If Yes, provide written scientific justification:
11
Summary: Collection of Fluids, Tissue, Substances or Tail Collection
If there are no changes from the approved protocol check here
and skip to the next section
Species
Agent Collected
Volume
Route
Frequency
Collected
12
Infectious Agents, Biologics, X-rays/Radiation or Chemical Hazards, or rDNA Use
If there are no changes from the approved protocol check here
and skip to the next section
Check if any of the following will be used, and specify each by name. Attach copies of approval emails or
letters.
[TIP: IACUC review will not be delayed by these parallel reviews. However, documentation of the appropriate approval(s) must be
received by the ORIA prior to issuance of IACUC approval.]
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 6
Does Protocol involve any of the following? (answer Yes or No for each)
These require approval of the Institutional Biological Materials Safeguards Committee (BSMC):
Does protocol involve Infectious Agents or Biologics?
(yes or no) If yes, list type:
Does protocol involve Biological Hazards? List Type:
(yes or no) If yes, list type:
Does protocol involve Hazardous Chemicals, including Chemical Carcinogens?
(yes or no) If yes, list
type:
These require approval of the Radiation Safety Committee (RSC):
Does protocol involve Radioactive Materials?
(yes or no) If yes, list type:
Does protocol involve X-rays/Radiation?
(yes or no) If yes, list type:
These require approval of the Institutional Biosafety Committee (IBC):
Does protocol involve recombinant DNA (rDNA) and Synthetic Nucleic Acid Molecules?
(yes or no)
If applicable, do you have IBC, BSMC or RSC approval for the materials indicated above?
Not applicable
Approval Pending
Approval Attached - Protocol number:
Describe how personnel safety will be ensured. Specify the containment methods to be followed in protecting
other research animals and personnel from any of the agents/hazards listed above.
[TIP: If applicable, state how radioactive carcasses, cages and bedding will be handled]
13
Housing and Husbandry
If there are no changes from the approved protocol check here
and skip to the next section
Please indicate your preferred housing location. Note: Housing location is subject to availability and will be
approved at the time of order by the PRL Manager (see Animal Housing Space Request Form)
GT PRL Location (IBB, TEP, or EBB):
If Not in a GT PRL, state campus, building and room number:
Provide justification for housing other than the PRL:
If animals will be moved between laboratories and housing, provide justification and state that animals will
be transported in accordance with GIT Guidance on Transfer and Receipt of Animals. If there will be any
exception from Policy 001, please describe and provide justification.
14
Diet Manipulation / Environmental Modifications
If there are no changes from the approved protocol check here
and skip to the next section
Unless indicated differently, all animals will be housed, fed and cared for according to legally mandated standards. Unusual
diet or housing include:
o need for autoclaving cages or deviation from the standard housing (wire-mesh floors must be justified)
o special food or water, dietary / water manipulations (withholding of food or water, addition of drugs to
food/water)
o wearing of additional protective gear by the animal care staff (gloves and lab coat / scrubs are standard)
o withholding of PRL standard enrichment devices
o use of cages that are larger or smaller than the required minimums
o use of running wheels, metabolism cages
o individual housing of social species. If social animals are to be housed singly, provide scientific justification for
single-housing. This does not apply to animals briefly housed singly post-operatively.
o need for special light/dark cycles.
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 7
Describe any non-standard diet, housing or environmental modifications, and how they will be accomplished.
[TIP: Procedures that are specifically pre-operative should be described in Procedures below]
15
Clinically Adverse Rodent Phenotype
If there are no changes from the approved protocol check here
and skip to the next section
Will the study involve transgenic/knock-out/knock-in animals?
(Yes or No) (If no, skip to next section).
If yes, is the strain being made in your lab or commercially available?
If the phenotype is known, please describe any clinically adverse effects and what percentage of the
offspring is affected. (i.e. seizures, skin ulcer, kidney failure, inflammatory bowel disease. If age effected,
indicate whether it is present in homozygotes versus heterozygotes and what the morbidity/mortality is, etc.).
If you expect any abnormalities to cause pain or distress, how will you minimize or alleviate it? Describe
your monitoring and recording procedures for detecting physical or behavioral abnormalities which are
indicative of pain or distress.
16
Euthanasia / Disposition of Animals
List early endpoints to the study otherwise known as euthanasia criteria. State the clinical signs that will
indicate that an animal should be withdrawn from the study and euthanized. Unless otherwise noted it is
assumed that meeting ANY ONE CRITERION listed below is an indication for euthanasia. For criteria such as
weight loss or loss of appetite, include frequency of observation and measurement.
A reference to the original protocol number alone is not acceptable. Include frequency of observation and clinical signs indicating
treatment is necessary. Animals should be monitored continuously until fully recovered from anesthesia and ambulatory.
Describe the method of euthanasia. Include agent and dose if applicable. Euthanasia shall be in accord with
methods approved by the AVMA guidelines.
[Tip: The AVMA Guidelines on Euthanasia can be found at www.avma.org/issues/animal_welfare/euthanasia.pdf . Physical methods of
euthanasia (decapitation, thoracotomy, exsanguination, cervical dislocation) may be used when scientifically justified and generally only
under general anesthesia. Carbon dioxide must be delivered from a compressed gas cylinder (no dry ice) and must be delivered very
slowly to a chamber that has not been pre-filled.]
If euthanasia is not the endpoint, specify the planned disposition of the animals. If animals are to be
considered for adoption, so indicate here.
[TIP: Wild caught animals may not be adopted without express written authorization from the Issuer of the Scientific Collection Permit.
This documentation must accompany the IACUC application for review.]
Required Protocol Submission Checklist:
The following are required for all protocol applications submitted for consideration:
Amendment Application signed below by PI (or submitted via GIT email by the PI)
Application signed below by Chair/Dept. Head/ Lab Director (or authorizing email sent to
iacuc@gatech.edu)
Copy of final grant pages & OSP routing sheet (if Sponsored funding was added)
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 8
All personnel completed CITI modules (if personnel added)
All personnel enrolled in Occupational Health (if personnel added)
The following are required if applicable:
Scientific Collection Permit from the Fish & Game Department (Required for use of wild caught animals)
Approval emails or letters from Institutional Biological Materials Safeguards Committee or Radiation Safety
Committee (Required for proposed use of infectious agents, biological hazards, hazardous chemicals, carcinogens,
radioactive materials, or X-rays/radiation)
Approval letters from Institutional Biosafety Committee (Required if use of rDNA is proposed)
Submit this application and all attachments via email to:
iacuc@gatech.edu
Use of GA Tech email accounts (.gatech.edu) is required when submitting protocols and amendments.
Office of Research Integrity Assurance http://www.researchintegrity.gatech.edu
Certifications and Signatures
Certification: I will comply with the procedures and methods described in the NIH Guide for the Care and Use
of Laboratory Animals (Pub. 85-23), with PHS policy, the Animal Welfare Act, the Georgia Institute of
Technology Animal Welfare Assurance A-3822-01, and other applicable Institute policies.
Certification: I assure that the activities involving vertebrate animals as described in this application do not
unnecessarily duplicate previous experiments.
Certification: I assure that the animal use proposed in a grant or contract proposal to support this research
corresponds with the information provided herein (if applicable).
Certification: As Principal Investigator, I acknowledge responsibility for this project and assure that the
personnel who participate in it are qualified and adequately trained to conduct it in a humane manner.
In lieu of a written signature, PI may submit protocol amendment via e-mail to iacuc@gatech.edu from your
GT email account.
Date:
Principal Investigator Signature ________________________(or submit via GIT email for electronic signature)
Departmental sign off:
I have reviewed this IACUC Application and related research plans and concur with their submission to the
Institutional Animal Care and Use Committee for review.
Date:
Department Chair Signature ________________________(or submit via GIT email for electronic signature)
In lieu of Department Chair signature, the Office of Research Integrity Assurance will accept an email from
the Department Chair, sent to IACUC@gatech.edu, indicating:
“I have reviewed this IACUC Protocol and related research plans and concur with their submission
to the Institutional Animal Care and Use Committee for review.”
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Amendment Application
December 2015
Page 9