REGISTRATION - Office of Research Integrity Assurance

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GEORGIA INSTITUTE OF TECHNOLOGY (GIT)
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE APPLICATION
Under the Georgia Open Records Act, protocol applications, including information incorporated by reference,
may become accessible by the general public.
This PROTOCOL APPLICATION must be approved before any animal work begins. Note the institute
policy regarding eligibility for the role of Principal Investigator on an animal protocol (See IACUC Policies &
Procedures). Occasionally, a large Program or Center grant to a single Principal Investigator will fund multiple
faculty members’ activities, and the Program or Center grant PI may not be a member of the research team on
animal protocols that the grant funds. For these “umbrella” programs, the IACUC accepts protocols from
Principal Investigators who are not PI on the supporting Program/Center grant.
Attachments: Statement of Work or Proposal Detailing Vertebrate Animal Research
A copy of the funding proposal or final grant pages sent to the funding agency and OSP routing sheet is
required. Federal regulations require the IACUC to compare the protocol to the funding proposal Statement of
Work or Project Description. Substantive differences must be satisfactorily addressed prior to IACUC approval.
Required Training: Everyone named on the protocol—including students, lab techs, Visiting Scholars, and
affiliates—is required to complete the online CITI training course, “Working with the IACUC” and the other
CITI training modules appropriate for the planned work. For example, if the protocol proposes the use of mice
or rats, all named personnel must complete “Working with Mice (or Rats) in Research Settings.” Refresher
training is required every 3 years. The online training is linked from the Office of Research Integrity Assurance
(ORIA) website at www.researchintegrity.gatech.edu.
Enroll in Occupational Health Program: Everyone named on the protocol must enroll in the Georgia Tech
Occupational Health Program, managed by Environmental Health & Safety and provided by contract with
Concentra Health Services. An opt-out provision is available, but enrollment is still mandatory. See the link to
the Occupational Health Program at www.researchintegrity.gatech.edu.
Departmental Sign Off: This prepared IACUC application is to be signed by the applicant’s department head
or, in lieu of a written signature, department heads may send an email to iacuc@gatech.edu stating that they are
aware of the proposed work and concur with its submittal to the IACUC. When the department chair is the
Principal Investigator named in the protocol, no other sign-off is required.
Preliminary Protocol Submission: Submit the protocol application and attachments to the ORIA via email to
iacuc@gatech.edu.
Initial Review Process: The protocol application will be given a preliminary review by the ORIA and then will
be forwarded to the Georgia Tech Attending Veterinarian/Director of Animal Resources for veterinary
consultation. The Principal Investigator may be contacted for clarification or additional information. Following
veterinary consultation, the protocol will be returned to the Principal Investigator for modifications, if
necessary.
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 1
Final Protocol Submission: If modifications are required, the Principal Investigator should revise the protocol
in accordance with the combined veterinary and preliminary consultation and submit the revised protocol to
the Office of Research Integrity Assurance via email to iacuc@gatech.edu for distribution to the committee.
If none are needed, the protocol will be forwarded by the Veterinarian to the Office of Research Integrity
Assurance for distribution to the committee.
Committee Review: All protocols are distributed to the committee in the order received. If a committee
member calls for Full Committee Review (FCR), the protocol will be placed on the agenda for that month’s
meeting, unless it was received without sufficient lead time. The majority of protocols do not require FCR.
However, protocols requiring full committee review are due the first of the month for review at that month’s
meeting.
For assistance, contact the Office of Research Integrity Assurance at 404.385.7316 or 404.385.2083. Please note
that Institutional Animal Care and Use Committee approval is required prior to procurement or use of animals.
If the project involves the use of any infectious agent or hazardous chemical (including chemical carcinogen),
review by the Institutional Biological Materials Safeguards Committee (BSMC) is required. Protocols involving
rDNA or synthetic nucleic acids require review by the Institutional Biosafety Committee. See guidance at
www.researchintegrity.gatech.edu.
In cases where other reviews or approvals are required (i.e., Institutional Biosafety Committee, Material
Transfer Agreement, Office of Technology Licensing, Radiation Committee), those should be sought in parallel.
If there are any transgenic animals, organisms/agents or proprietary issues necessitating a Material Transfer
Agreement (MTA), consult the Office of Technology Licensing for guidance.
IACUC Guidelines are located on the Office of Research Integrity Assurance website at
http://www.researchintegrity.gatech.edu/forms/IACUC/GIT_IACUC_Policies_and_Procedures.pdf.
Applications should be saved as a Word file and submitted to the Office of Research Integrity Assurance by
email to iacuc@gatech.edu
Please feel free to delete the above tips and
guidance before submitting IACUC application.
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 2
Application for the Use of Laboratory Animals in Research, Training, and/or Teaching
Institutional Animal Care and Use Committee (IACUC)
Office of Research Integrity Assurance (ORIA)
Georgia Institute of Technology (GIT)
PHS Assurance # A3822-01
Office of Research Integrity Assurance Use Only
Protocol Number
Submit via email to iacuc@gatech.edu
IACUC Policices at: www.iacuc.gatech.edu
Protocol Type
Check category of this project:
New Research Protocol
New Teaching/Training Protocol
If this is a Renewal (new application after end of 3rd year) please list old protocol number:
1
Principal Investigator
Principal Investigator:
Emergency number:
PI Title:
Telephone:
Department:
Email:
Enrolled in the Occupational Health Program:
(Yes or No)
Completed Required CITI Training:
(Yes or No)
Briefly describe training plan or qualifications: [Tip: has been working with animals since 20xx…, Surgical skills
include…]
2
Title & Funding
List all Sponsored funding sources that will be used on 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 & copy of the OSP routing sheet 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.
Protocol Title:
Sponsor name:
Award Title:
PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending):
Sponsor name:
Award Title:
PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending):
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 3
Sponsor name:
Award Title:
PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending):
3
Other Personnel
List all personnel (other than PI) to be directly involved with the animals. Describe each person’s relevant
training and experience, and indicate whether s/he will (1) 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.
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…]
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 2
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…]
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:
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 3
5
Study Objectives and Benefits to Society
Briefly state the objectives of the study in lay terms and their relevance to advancing scientific knowledge and
benefits to society (human/animal health).
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
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)
Lay Summary of 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 Application
December 2015
Page 4
[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.
9
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
Procedures
IACUC Protocol Application
December 2015
Page 5
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
Summary: Administration of Materials
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.
Where
Dose (mg/kg) /
manufactured
Possible
Species
Material
Route
Frequency
or obtained
Complications
from*
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 6
* 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
Species
Summary: Collection of Fluids, Tissue, Substances or Tail Collection
Agent Collected
Volume
Route
Frequency
Collected
12
Infectious Agents, Biologics, X-rays/Radiation or Chemical Hazards, or rDNA Use
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.]
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 or Chemical Carcinogens?
(yes or no)
If yes, list type:
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 7
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)
For Each YES answer above, do you have IBC, BSMC or RSC approval for the materials indicated above?
Not applicable
Approval Pending
Approval Attached – Approval 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
Where will animals be housed?
GT Physiology Research Laboratory (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
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.
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
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?
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 8
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.
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:
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
All personnel completed CITI modules
All personnel enrolled in Occupational Health
The following are required if applicable:
Copy of 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 or sNA is proposed)
Georgia Institute of Technology
Office of Research Integrity Assurance
IACUC IACUC@gatech.edu
IACUC Protocol Application
December 2015
Page 9
Submit this Word doc Application and all attachments via email to: iacuc@gatech.edu
Use of GA Tech email accounts (.gatech.edu) is required when submitting protocols.
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 application 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 Dept. head signatures, the Office of Research Integrity Assurance will accept an email from the
Dept. head, sent to IACUC@gatech.edu, in which the department head states something like:
“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 Application
December 2015
Page 10
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