STEVENS INSTITUTE OF TECHNOLOGY
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES
APPLICATION TO USE ANIMALS FOR RESEARCH OR TEACHING
Use this form to:
(1) Submit a new application to use animals in a research or teaching protocol.
(2) Submit a renewal application for a protocol that has been active for three years.
PROTOCOL APPLICATION INSTRUCTIONS:
Submit an electronic copy to IACUC Coordinator: justin.samolewicz@STEVENS.edu and fax ((201) 216-8909) or
deliver completed application and signed signature page to IACUC Coordinator.
Applications will not be sent out for review until signature page is received in IACUC office.


Hazardous materials. If your protocol involves the use of hazardous materials (radioactivity, chemical hazards,
infectious agents or recombinant DNA) then it is your responsibility to secure approval from the appropriate safety
committee or safety office. Failure to do this will result in a delay in considering your protocol.
Training or instruction available to scientists, animal technicians, and other personnel involved in animal care,
treatment, and/or use is: All individuals must complete the online training course covering the use of animals in
biomedical research and should reference the links/websites below for online regulatory material on the handling,
manipulation and transportation of animals.
IACUC Online Training Website Instructions can be found in STEVENS’ Handbook of Research Processes (SHARP)
“IACUC Policy Regarding Training Requirements”
References
1.
2.
3.
4.
5.
The Guide (http://www.nap.edu/openbook.php?record_id=12910&page=1)
Animal Welfare Act (http://awic.nal.usda.gov/animal-welfare-act)
Office of Laboratory Animal Welfare (http://OLAW.org)
AVMA Guidelines for the Euthanasia of Animals (https://www.avma.org/Euthanasia-Guidelines.aspx.pdf)
AALAC (http://www.aaalac.org/)

In-house standard operating procedures will be provided and are available for all personnel handling animals. All
training guidelines will follow procedures in accordance to the Stevens Institute’s SOPs, The Animal Welfare Act,
AALAC International, and PHS Policy.
Phone numbers for contact persons:
Director of Research: Dr. Philip L. Leopold
201-216-8957
Clinical Veterinarian: Dr. Antoine D. Carlisle 973-204-1968
IACUC Coordinator: Justin Samolewicz
201-216-5280
Acronyms commonly used in this application:
1. IACUC – Institutional Animal and Care Use Committee
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5.
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11.
CCBBME Dept – Chemistry, Chemical Biology, and Biomedical Engineering Department
CCBBME AF – Chemistry, Chemical Biology, and Biomedical Engineering Animal Facility
SIT – Stevens Institute of Technology
P. I. – Principal Investigator
AWA - Animal Welfare Act
OLAW - Office of Laboratory Animal Welfare
PHS - Public Health Service
AVMA – American Veterinary Medical Association
AALAC - American Association for Laboratory Animal Care
N/A – Not Applicable
If you require assistance completing this form please contact your IACUC Coordinator
justin.samolewicz@STEVENS.edu.
No research may begin until written final approval is received
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Principal Investigator Checklist
SUBMISSION CHECKLIST (MANDATORY)
DID YOU:
Yes N/A
Sign and date your application form? Submit an electronic copy and Fax signature sheet; or deliver one signed
copy to the IACUC office?
Submit completed IACUC training and occupational health requirements for all personnel
listed within this protocol?
Attach applicable appendices?
Consult with the attending Veterinarian for Category C, D and E protocols prior to submission?
Obtain Radiation Safety approval [if applicable]?
Attach approval letters from IACUC’s of all collaborating institutions? (if applicable)
Have you reviewed and signed your inter-institutional agreement(s) (if applicable)
(i.e., collaborations with outside institutions and/or vendors)
Obtain The Institutional Biosafety Committee (IBC) approval prior to submission [for projects
using Hazardous materials]?
Attach Standard Operating Procedures for uncommon/novel techniques or compounds. (if
applicable)
Highlight any proprietary information?
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STEVENS INSTITUTE OF TECHNOLOGY
Institutional Animal Care and Use Committee
(IACUC)
Application to Use Animals for Research or Teaching
To be completed by IACUC
Protocol Number:
Date: Click here to enter a date.
To be complete by Investigator
USDA Pain Classification:
USDA Classification B
Breeding or Holding Colony
Protocols
B
C
D
E
USDA Pain Levels:
USDA Category C
No more than momentary
or slight pain or distress
and no use of painrelieving drugs, or no pain
or distress. For example:
euthanatized for tissues;
just observed under normal
conditions; positive reward
projects; routine
procedures; injections; and
blood sampling.
USDA Category D
Pain or distress
appropriately relieved with
anesthetics, analgesics
and/or tranquilizer drugs or
other methods for relieving
pain or distress.
*USDA Category E
Pain or distress or potential
pain or distress that is not
relieved with anesthetics,
analgesics and/or
tranquilizer drugs or other
methods for relieving pain
or distress.
*Unalleviated pain or distress. You must provide a detailed scientific justification and indicate the
number of animals (per year) that will experience unrelieved pain or stress.
1. Title of Protocol
2. Principal Investigator(s)
Name, Degree
Title
Department
Phone
Pager
Email
Animal Protocol Director
[person(s) coordinating/conducting animal study if other than PI]
Name, Degree
Title
Department
Phone
Pager
Email
Emergency Contact Person
Name
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Phone
Evenings:
Weekends:
Personnel Working with Animals on this Project
Specify Role Involving
Animal Use
Name
Department
Phone
Email
This includes but not limited to:
- Monitor animals
[Feeding, breeding, etc.]
- Conduct Experimental
Procedure
[Surgery, blood draws, etc.]
Describe
specific
training &
expertise
[Identify trainer
and include
brief outline of
expertise/
qualifications to
train others.]
LIST ALL ACTIONS
Personnel Responsible for Animal Care:
CCBBME AF: Members of the full-time veterinary staff of the Institution are available 24 hours/day, 7 days/week. The
Chemistry, Chemical Biology, and Biomedical Engineering Animal Facility (CCBBME AF) will strictly follow the guidelines
laid out by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC
International), the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory and the Animal Welfare
Act.
Have all the individuals listed above submitted their completed IACUC training and occupational health
requirements?
Yes
No
If Yes, Documents must be submitted before application will be accepted.
If no, this application will not be reviewed until completed.
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3. Protocol
Category:
New
Type:
Research
Resubmission
Breeding
Other
Teaching
Device Development
Specify:
4. Outside Contracts?
Will any “outside” contracts be used in this study that involves live animals (antibody production, toxicology screening,
subcontracts with other facilities, etc)?
No
Yes (if yes, provide information on the level of involvement)
Mark YES if any non-Stevens entity will be involved in any animal care and use activities. Examples include housing your
animals at another institution for specialized procedures, use of a contract toxicology research lab, antibody production
techniques by another lab, etc. The Stevens Institute Of Technology IACUC may require submission of the approved
protocol from the outside contracted organization.
* Review and sign your inter-institutional agreement(s)
5. Funding Source
Are funds available?
Source:
Grant
Yes
No
Department
Other
____________
Funding Agency:
Covered Dates:
Has this proposal received any peer review?
Scientific Review Group
(check appropriate boxes)
Pending
Has a previous IACUC reviewed this study?
Yes
Peer Review Journal
Other
No
The Stevens Institute Of Technology may require a copy of
the previous IACUC review.
6. Procedure Category
(Complete Appendix C {Surgical} and/or Appendix D {Non-Surgical})
Non-Survival (anesthesia without recovery or euthanasia)
Survival
7. Dates of Study
A. Anticipated start date of study:
B. Study Duration (maximum 3 years):
1 year
2 years
3 years
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8. Objectives in lay terminology
Using non-technical/lay terminology, answer all the following questions (i.e. Response should be
written in non-scientific language, as though explaining the study to a high school student).
Generally, single sentence explanations for these types of questions will suffice.

In non-technical / lay terminology, what is the objective of the experiments proposed in
this Animal Activity Protocol?
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How could humans or animals benefit from your experiments?

Why are the experiments proposed?

What knowledge do you hope to achieve?
9. Rationale
A. What is the rationale for using the particular animal species?
B. What is the rationale for using animals rather than using non-animal models?
10. Brief Outline
Provide a general description of the animal procedures to be conducted. Including a flowchart and/or timeline of events
is strongly recommended. Indicate duration of time animals will be on study.
Note: Specific details about methods, animal manipulations and procedures in your experiment(s) will be
required in the appropriate appendix.*Verbatim descriptions from a grant submission are not acceptable and will not
be reviewed.
11. Animal Requirements
Animal numbers MUST be calculated for a period not to exceed three (3) years from the start of the study.
Species
Strain/stock
Sex
Source
Total for Project
Grand Total
Are any of the animals Genetically Altered/Manipulated?
No
Yes – Complete Appendix N
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12. Justification of animal number
Number of control group(s):
Number of experimental group(s):
Number of animals per group
control:
experimental:
*(Number of Control Group(s) X Number of Animals per group) + (Number of Experimental Group(s) X Number of Animals
per group) should equal the total number of animals delineated in the responses to Question 11.
How was sample size determined? (Answer by placing an X in the appropriate box)
Pilot study. No report of a similar study exists. The proposed study will utilize a small number of animals (typically less
than 10) to obtain preliminary data to justify the performance of a larger study.
Previous experience by this PI (if checked, answer question 12a)
Studies cited in the literature (If checked, answer question 12a)
Note: The number of animals requested should be the minimum required for statistically valid results. See links
below to help with choosing appropriate numbers, species and address fundamental issues.
1.Protocol Review Animal Use (The Guide)
(http://www.nap.edu/openbook.php?record_id=12910&page=25)
2. Experimental Design and Statistics (The Guide)
(http://www.nap.edu/openbook.php?record_id=12910&page=5)
3. Protocol Review Criteria (IACUC Handbook)
(http://grants.nih.gov/grants/olaw/GuideBook.pdf)
12a) Explain and justify below how the number of animals requested was determined. A
power analysis should be described if possible, citing type of statistical analysis
used. If the experimental approach is not amenable to a power analysis, a thorough
justification of the number of animals required must still be provided.
(Flow diagrams/tables to define animal use are encouraged. This number should support the
request made in # 11)
13. Animal Husbandry
Standard
*Nonstandard
Feeding
Watering
Caging/housing
*Note: Provide complete explanation and justification for any nonstandard animal husbandry. Protocols listing nonstandard husbandry (e.g. metabolic caging, restraint chairs, transport devices) must provide complete details of the
cleaning and sanitation.
CCBBME AF standard caging/housing:
Small Animal
1. Rodent (Mice, Rats) – Static / Passive ventilated micro-isolator caging individual or group
housed.
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CCBBME AF standard food/water:
Small Animal
1. Rodents - Ad libitum Pico Rodent Chow with water bottles.
14. Housing
Will animals be housed outside of the CCBBME AF for greater than 12 hours?
No
Yes Where?
Note: If yes, provide complete explanation and justification for any decentralized animal housing. Animals
that are removed from the Animal Facility CANNOT be returned UNLESS approved by the Facility Manager.
15. Location & Transportation
Note: Animals that are removed from the Animal Facility CANNOT be returned UNLESS
approved by the Facility Manager.
A. Indicate room(s) where animal procedures will be conducted.
B. Studies involving animal transportation to locations other than the housing area must identify the animal transport
device, the nature of shrouds used to cover the transport device, and describe the route of transport.
16. Breeding program
Will animals be involved in a breeding program at STEVENS or will time-pregnant animals be used?
No
Yes (Provide information in Appendix B)
17. Exogenous Substances (Complete Appendix G)
Substance
Dose
Route
Yes
No
If yes for any, has it been reviewed by BioSafety Committee?
Volume
Frequency
Are any of the substances hazardous?
Yes
No
18. Potential Hazards (If Yes for any, complete Appendix G)
Yes
No
Pending
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A
B
C
D
Chemical biohazard in bedding/cages/carcasses?
Radioactive Materials (radioisotopes, radiation producing device such as xray, CT scan, or fluoroscopy) in bedding / cages / carcasses?
Infectious agents or recombinant DNA usage?
Test or Novel Compound(s) in bedding/cages/carcasses?
If yes for any, has it been reviewed by BioSafety Committee?
19. Euthanasia (Refer to AVMA Guidelines for the Euthanasia of Animals 2013)
A. At what point in the proposed experiments will animals normally be euthanized, (experimental end-points)? Or at what
point will any individual animal be euthanized?
B. What criteria will be used to determine if an animal is to be euthanized prior to, rather than at, the anticipated end-point
of an experiment?
C. If proposing a natural death (or death due to manipulations), explain and justify.
D. What procedures/methods will be used to euthanize the animals?
Note: Secondary methods are recommended to ensure death.
E. Who will conduct the euthanasia (P. I., P. I. Staff, Technician, CCBBME AF personnel etc)?
20. Assurances
1.
Have all personnel received a medical evaluation from Employee Health or personal medical doctor and updated
Occupational Health Information annually?
No
2.
Have all personnel become familiar with the Training & Procedural Manual for Animal Use at STEVENS?
No
3.
Yes
Yes
Review of the available resources and previous experiments have determined that the proposed activity is not
unnecessarily duplicative of previously reported activities.
No
Yes
21. Literature Search for Alternatives to Animal Use
NOTE: USDA Policy #12, “Consideration of Alternatives to Painful/Distressful Procedures” states the
following: The Animal Welfare Act (AWA) regulations require principal investigators to consider alternatives to
procedures that may cause more than momentary or slight pain or distress to the animals and provide a
written narrative of the methods used and sources consulted to determine the availability of alternatives,
including refinements, reductions, and replacements.
Conduct two searches of the literature to determine if alternatives exist to procedures that
may cause more than momentary pain and distress:
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The same key words or subject headings can be used for both searches, however be sure you are using appropriate
syntax for the resource being used. (Note; please use the help section for each database to make sure you are
using the correct syntax)
Sources utilized: Examples are listed below (please note: PubMed and Medline are the same and cannot both be used).
This step requires the use at least two different databases (check below).
Medline/PubMed (http://www.ncbi.nlm.nih.gov/pubmed)
Toxnet/Toxline (http://toxnet.nlm.nih.gov)
AWIC (http://awic.nal.usda.gov)
Agricola (http://agricola.nal.usda.gov)
ISI Web of Science (http://apps.isiknowledge.com )
Biosis
CAB Abstracts
Agris
Other (
)
Key words: The IACUC recommends the inclusion of “in vitro” and “animal model” with search terms specific to
your research.
Search 1
Database Used:
Search date: Click here to enter a date.
Covered years of search:
Words Searched:
Summarized Search Results:
Citations:
Search 2
Database Used:
Search date:
Click here to enter a date.
Covered years of search:
Words Searched:
Summarized Search Results:
Citations
22. Certifications by Principal Investigator:
Certify in this section that no valid alternative was identified to any described procedures that may cause more than
momentary pain or distress, whether relieved or not. Reduction, replacement and refinement (the “3 R’s) must be
addressed, not just animal replacement.
1. Are methods that refine existing tests by minimizing animal pain and/or distress available?
No
Yes
If yes, explain why the method is not suitable.
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2. Are methods that reduce the number of animals necessary for an experiment available?
No
Yes
If yes, explain why the method is not suitable.
3. Are methods/techniques to replace whole-animal use with in vitro or other tests available?
No
Yes
If yes, explain why the method is not suitable.
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Appendix Checklist
Principal Investigator must complete and include all appropriate appendices
with protocol submission.
Appendix A
Appendix B
Environmental Enhancement/Enrichment
Breeding Programs
Appendix C
Management of Surgical Pain & Distress
Appendix D
Management of Procedural (non-surgical)Pain & Distress
Appendix E
Collection of Biological Samples
Appendix F
Appendix G
Antibody Formation / Tumor Induction / Hybridoma &
Ascites
Exogenous Substances
Appendix H
Experimental Disease Induction
Appendix I
Prolonged Physical Restraint
Appendix J
Multiple Major Survival Surgical Procedures
Appendix K
Food and/or Fluid Restriction
Appendix L
Animal Pain and/or Distress
Appendix M
Behavioral Testing and Training
Appendix N
Genetically Altered or Manipulated Mouse Welfare
Profile
Three Year Summary Report for application
resubmissions
Appendix O
PLEASE CHECK ALL THAT APPLY, IF UNSURE CONTACT IACUC OFFICE.
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Certification of the Principal Investigator:
Signature certifies that the Principal Investigator will conduct the project in full accordance with the PHS Policy on
Humane Care and Use of Laboratory Animals, USDA regulations, and CCBBME AF policies governing the use of live
vertebrate animals for research and teaching purposes. The procedures involving animals will be conducted by trained or
experienced personnel or under the direct supervision of trained or experienced persons. It is understood that IACUC
approval is valid for a period of 12 months following the date of original approval and must be renewed annually. I
understand there is a 3-year requirement for full protocol rewrite. It is further understood that should this project be
submitted for external funding, the information presented on the STEVENS IACUC Animal Protocol Application accurately
reflects the animal use in the full grant application.
Signature of Principal Investigator
Click here to enter a date.
Date
INTAKE BY THE IACUC:
Signature of IACUC Coordinator
Click here to enter a date.
Date
*Note : Signature and date above indicates that the protocol is accepted for processing and placement into the queue for
review. Investigators should be aware that the IACUC normally operates on a monthly meeting schedule and protocols
are reviewed according to that schedule with protocol intake needed two weeks prior to a scheduled meeting, in order to
be reviewed in a timely fashion. Additionally, investigators should note that the approximate timeline to obtain full
approval on a protocol can take up to 2 or 3 months depending on the revisions requested and the ability to meet stated
requirements for approval to be granted.
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