Animal Research
Protocol #: AR-
New Protocol
Modification*
3-Year Renewal
ORSP Ref #:
Institutional Animal Care and Use Committee
Protocol Review Form
Directions: Submit this completed Protocol Review Form with original signature(s) along with any additional
information, including appendices, attachments, etc. to the Office or Research Compliance. If electronic signature is used,
submissions can be sent to IACUC@marquette.edu. The project cannot begin until the Principal Investigator (PI) has
received documentation of IACUC approval.
*If this is a Modification to a previously approved protocol, you must insert all changes in bold, italics or highlights
in order to distinguish between previously approved information and current requested changes.
Submit to: Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-6271
Fax: 414-288-6281
E-mail: IACUC@marquette.edu
Principal Investigator:
Department:
Telephone
E-mail:
Project Title:
(If funded, provide the title of the corresponding grant)
PI Certification
This signature certifies that the Principal Investigator has read and understands the requirements of the PHS Policy on Humane Care
and Use of Laboratory Animals, applicable USDA regulations, the Guide for the Care and Use of Laboratory Animals, and the
Marquette University policies governing the use of vertebrate animals for research, testing, teaching or demonstration purposes. This
signature certifies that the PI will maintain the project in full compliance with the aforementioned requirements and that the PI
assumes responsibility for all aspects of this project, including assurance that all research staff involved in handling animals are
qualified and appropriately trained. If grant funded, the PI further certifies that the information stated in this protocol is consistent
with the animal care and use information provided on the grant application. In signing this description of the research project, I agree
to accept primary responsibility for its scientific and ethical conduct as approved by the IACUC.
___________________________________________________________________________________________________________
Signature of Principal Investigator
Printed Name
Date
For Office Use Only
Institutional Animal Care and Use Committee
Date of Approval ____/____/____
Animals Approved (type & number/year): _______________
Disposition:
Full Review
Designated Review
Approved through ____/____/____
__________________________________________________________________
Signature of IACUC Representative
Printed Name
__________________________________________________________________
Signature of IACUC Representative
Printed Name
IACUC Comments:
1
____/____/____
Date
____/____/____
Date
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
***Please note that in order to choose any of the check boxes on this form, you must double click
the box and select "Checked" as the Default Value. To activate hyperlinks within this document
hold down the Ctrl button at click on link. ***
Section A: RESEARCH PROJECT CHARACTERISTICS
Collaborative Research Statement:
There may be a need for the IACUC to review studies that require transportation of animals to other
institutions. These collaborations raise several complexities, including compliance agreements between
the institutions, management of risk to animal health at both institutions, and regulatory compliance in
the transport of the animals.
For more information on Marquette University’s IACUC Guidelines on Collaboration with other
institutions, please click on the link.
NOTE: Collaborations with multiple institutions will require that protocol documentation be shared
with all institutions involved, including but not limited to all protocol reviews and approvals.
1. This protocol is for:
Research Proposal
Breeding Colony (you must complete Appendix A)
Teaching (you must complete Appendix B)
Other (specify):
Note: In the remaining sections of the protocol the term “procedures” corresponds to any and all
of the above.
2. Grant or Contract Funded (may select “Yes” and “Pending”):
Yes
Funding is Pending
Have you registered your project with Research and Sponsored Programs (ORSP)?
If Yes, Please list your ORSP Reference #: ______________
Yes
No
No
If your project is grant funded or funding is pending, submit a copy of the funding/grant
proposal and list the grant number and funding source here:
GRANT NUMBER:__________________________
FUNDING SOURCE:__________________________
If the funding agency requires an official IACUC approval letter, list the program area, contact person,
title and complete mailing address:
3. Inclusive dates of Project (Project may not start prior to approval)
Anticipated start date: ____/____/____
Anticipated end date: ____/____/____
4. Animal Housing Location:
Schroeder Facility
Wehr Life Science Facility
Other (specify): __________________________________________________________________
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
5. Identify the person(s) or unit responsible for daily animal husbandry care:
PI and/or PI research staff
Animal Care Staff
6. Classification of Animal Research Use (check highest category applicable):
USDA Category
Procedure
B
Breeding or Holding Colony Protocols
C
No more than momentary or slight pain or distress and no use of pain-relieving drugs, or
no pain or distress. For example: euthanized for tissues; just observed under normal
conditions; positive reward projects; routine procedures; injections; and blood sampling;
manual restraint that is no longer than would be required for a simple exam.
Pain or distress appropriately relieved with anesthetics, analgesics and/or tranquilizer
drugs or other methods for relieving pain or distress.
D
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.
*Note: If Category E is checked, the IACUC is required to perform a harm/benefit analysis
E
7. List the names, role in the lab, and contact phone and e-mail addresses of all individuals who will
come into contact with the animals used for this protocol. For each individual, please indicate whether
they have completed animal care and use training or if it is pending. Training must be completed prior
to personnel working with animals. Note that all individuals who handle animals must participate
in the Marquette University Occupational Health and Safety Program. Information on this
program will be discussed during the animal care and use training provided by the Animal
Resource Center. Also, any collaborative work with another institution will require the
submission of that institution's IACUC approval letter.
Name
Role in Lab
(student,
employee,
grad
student,
post doc,
etc.
Contact Contact e-mail Address
Phone
#
Animal Care
and Use
Training
(completed or
pending)
Enrolled in
Occupational
Health and
Safety
Program
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
Completed
Pending
(Add more tables if needed)
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
Personnel unknown at this time.
The Animal Resource Center will be notified prior to animal use and personnel will complete
Animal Care and Use Training.
If added personnel will be conducting surgery (survival and/or terminal), anesthesia, and/or
euthanasia using a physical method, I will complete and submit Appendix G (found on the ORC
website).
By checking the following box I certify that personnel will not perform any animal procedures until
they have been trained by the Animal Resource Center and will ensure that all personnel are
enrolled in the Occupational Health and Safety Program prior to their contact with animals.
PI certification with the above statement
Please Print Name (PI):
Section B: ANIMAL INFORMATION
8. Animal Species and where obtained:
Species (please check)
Strain and gender
(please write in)
Vendor (please check)
RAT
Other (specify if from a
vendor not listed and
answer Question 18)
Harlan Labs
Charles River Labs
MU PI with an
approved IACUC
protocol AR-______
Other
Harlan Labs
Charles River Labs
Jackson Labs
MU PI with an
approved IACUC
protocol AR-______
Other
Harlan Labs
Kuiper Rabbit
Ranch
Other
Niles Biological
Other
Acme Lamprey
DLM Aquatics
Hammond Bay
Biological Station
Other
Niles Biological
Other
MOUSE
RABBIT
FROG
FISH
TURTLE
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
OTHER
9. Total Number of Animals Per Year for each species selected from the above table (Note: The total
number per year includes all animals purchased, and obtained from other protocols or investigators. If
you will be using breeders please indicate the total number of offspring (the number born and number
off offspring that will be used in experiments):
10. Will any animals listed in Question 9 be used for training purposes? Note: This also includes animals
used for surgical training
Yes
No If Yes, please specify how many animals will be used. Note: animals used for
training should be accounted for in the Animal Project Summary:
11. In an effort to accommodate space requests from all investigators, please provide the anticipated
average number of cages in the facility at any given time and the expected maximum(add more tables
if needed):
Species 1
Average # of cages per day
Maximum # of cages anticipated
Species 2
Average # of cages per day
Maximum # of cages anticipated
12. Is the species endangered or protected? If the species is endangered or protected, indicate appropriate
federal/state license number:
Yes (License number_____________)
No
13. Any special care necessary for your animals beyond routine animal husbandry?
Examples of special care include: special diets, frequency of cage changes (beyond the once a week
mandatory for single housed or twice a week for group housed animals), PI or PI staff responsible for
administering food and/or water, and PI or PI staff responsible for cage changes.
Yes
No If Yes, please specify the special care required, and who will be responsible for this
care:
If the animals require a special diet (commercial or non-commercial prepared diet that has ingredient(s) altered
compared to maintenance diets) answer the following questions. If not, check N/A
For commercially prepared diets:
Provide the name/source of the diet:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
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Describe how the diet is altered:
How long will the animals be on the
proposed diet?:
Provide a scientific justification for the
use of the diet:
N/A
14. Will this study utilize food or fluid restriction?
If Yes, please complete Appendix C.
Yes
No
15. Animal Housing:
IACUC Guidelines and Policy for Housing and the Use of Enrichment for Laboratory Animals:
Group housing of social animals is the standard set by the “Guide for the Care and Use of Laboratory
Animals” and used by Marquette University. Any deviation from this standard must be scientifically
justified.
How will your animals be housed in the Animal Resource Center? (Please check all that apply)
NOTE: If your animals will be grouped housed upon arrival but, later singly housed check both group
and single and state your justification in the box provided.
Species
Single/Group Cage Type
Scientific justification is needed if “single” is
checked and if “other” cage type is selected (please
describe cage type). If using wire-bottom caging please
answer the following; Justify the need for wire-bottom caging,
how long will rodents be housed on wire-bottom caging, what
is the anticipated weight range of the rodents during the
housing period, what measures will be taken to monitor
animals for foot lesions and what will be the action taken if
foot lesions develop.
Rat
Single
Group
Mouse
Single
Group
Rabbit
Single
Group
Frog
Single
Group
Shoebox (standard)
XL shoebox
(for running
wheels)
Wire bottom
cages
Other
Shoebox (standard)
Super-mouse –
quarantine cages
Large Shoebox
(for trio breeding)
Other
Standard rabbit
caging
Other
Shoebox
Aquarium
Other
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
Turtle
Group
Fish
Single
Group
Single
Group
Other
Aquarium
Other
Aquarium
Other
16. Will animals be housed outside of the ARC facilities (e.g. labs) for more than 24 hours?
Yes
No
If Yes, describe where animals will be housed, duration of housing outside the ARC, the
environmental conditions of the housing (e.g. temperature, lighting), and who will be responsible for
animal care and monitoring:
17. Please list what enrichment items may be provided to your animals by checking the appropriate boxes
below. If “none” is selected, provide a scientific justification. Also, if only one type of enrichment is
preferred please select only one enrichment type. (Please coordinate special requests/needs with the
Animal Resource Center). For reference please see the IACUC Guidelines and Policy for Housing
and the Use of Environmental Enrichment for Laboratory Animals on the ORC website.
Enrichment type
Scientific justification needed when “none” is selected
Nestlets (nesting)
Paper tubes
PVC tubing
Shepard Shacks
Refuge Huts
Enviro-Dri (nesting)
Alpha-dri (nesting)
Wood Blocks
Wood Clothespins
Plastic balls
Plastic dumbbells
None (Justify at right)
All/Any
18. Quarantine Procedures: If you have selected “other” from the list of vendors in Question 8, this
indicates that you will be using vertebrate animals that were acquired from an outside source (other
University, vendor, or research laboratory) and must be placed into quarantine for a minimum of six
weeks.
18A: Will you be working with the animals while they are in quarantine?
Yes (see question 18B)
No (continue to question 19)
18B: Please describe how your quarantine procedures are designed to reduce the possibility of disease
transmission to vertebrate animals within the ARC facility (see ARC facility management staff on
training for quarantine procedures and read the quarantine policy and standard operating procedures).
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
19. Animal Transportation:
Will animals be transported to/from Marquette facilities or between Marquette and other institutions or
facilities? Please note that this does not apply to animals received or transported by commercial
vendors.
Yes
Check appropriate box (19A) below and complete the following questions
No
Proceed to question 20
1. Where will the animals be
transported to and from:
2. Describe the care of the
animals during transport:
19A.
I am familiar with the Marquette University Animal Transportation and Shipping
Guidelines and will file the Marquette University Transportation Check-Off sheet for Rats, Mice, Fish,
and Rabbits with the Animal Resource Center at the time of transport if I am personally transporting
the animals.
Section C: ANIMAL PROJECT SUMMARY
20. Below, please provide an outline addressing the following areas (use attachments as appropriate):
A. The specific goal(s) and significance of this project in language understandable to a lay person;
B. Discussion of why you have chosen the species; and
C. The basis for your estimate of the number of animals required.
21. Will this protocol incorporate a pilot study?
Yes (see question 30 on unexpected outcomes)
No
22. Does your protocol include the use of any surgical procedures?
Yes
No If Yes, you must complete Appendix D and attach to this protocol submittal.
23. Will animals be restrained for greater than 1 hour?
Yes
No If Yes, you must complete Appendix E and attach to this protocol submittal.
24. Will antibody production methods be used or body fluids collected?
Yes
No If Yes, you must complete Appendix F and attach to this protocol submittal.
25. Describe your experimental procedures (outside of routine husbandry) to be performed on the animals
and reference Appendices C-F where appropriate. For example, identify all drugs given, including
dosage range, routes and frequency of administration; social or environmental manipulation; biological
samples taken. Describe methods of physical restraint and length of time animal(s) are restrained and
describe acclimation procedures. Be sure to account for all animals and their inclusion in any and all
procedures from the beginning to the end of their involvement in this protocol. Specify the expected
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
sequence, frequency, and duration of these procedures. For IACUC recommended best practices, go to
http://www.marquette.edu/orc/animal-care-use/forms-reports.shtml
Marquette University IACUC policy requires consideration of the use of alternatives (such as in vitro
studies, computer models or less sentient animals) to procedures that may cause more than momentary or
slight pain or distress to animals. The IACUC is required to document that you have made such a
consideration.
26. May procedures cause more than momentary or slight pain or distress? Note that this includes survival
and terminal surgery (the IACUC considers cardiac perfusion as a terminal/non-survival surgery), in
which case you must address appropriate anesthesia in Appendix H.
Yes (complete Appendix H)
No (answer question #27)
27. Describe the method and frequency used to monitor your animals to ensure they are not experiencing
pain or discomfort from your procedure(s) or from unanticipated illness or injury (Signs of Pain and
Distress in Rodents). Also define who is responsible for training those tasked with monitoring animals:
28. Do you anticipate any adverse outcomes as a result of the listed procedure(s)? Examples include
infection, mortalities or morbidities due to injections, equipment used, experimental drugs, new
procedures, etc. Note: a separate question for reporting adverse outcomes as a result of surgical
procedures is asked in Appendix D.
29. Does this project utilize non-pharmaceutical grade compounds for administration to animals?
(Please refer to the Office of Research Compliance website for FAQ’s on non-pharmaceutical grade
compounds). http://www.marquette.edu/orc/animal-careuse/documents/UseofNonPharmaceuticalGradeCompounds.2012.pdf
Yes (complete Appendix I)
No
IMPORTANT: It’s expected that all chemical compounds administered to any animal species be
pharmaceutical grade, if that agent is available in pharmaceutical grade, even in acute procedures.
It’s expected that all PI’s that propose to use chemical compounds to be administered to animals
conduct a search in any recognized pharmacopeia to find a pharmaceutical grade equivalent to be
used. Please see Appendix I to propose justification for the use of non-pharmaceutical grade agents.
30. Reporting unexpected outcomes not listed in Question 28 or Appendix D:
“By checking the following box I certify that I, as the PI, will report any adverse events
(unanticipated outcomes) involving animals promptly to the IACUC. Please read a copy of the
“Guidance on Prompt Reporting of Adverse Events and Unexpected Outcomes” that can be
found on the Office Of Research Compliance website.” http://www.marquette.edu/orc/animalcare-use/forms-reports.shtml
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
PI certification of the above statement
Please Print Name:
Section D: ALTERNATIVES TO ANIMALS
Alternatives are commonly addressed within the context of the “3 Rs” – Replacement, Reduction, and
Refinement. Replacement alternatives, or non-animal models, may include in vitro methods, mechanical
systems, or computer simulations. Reduction of numbers of animals used may be accomplished by
conducting pilot studies, maximizing the data obtained per animal, using appropriate statistical methods in
the experimental design, etc. Refinement, or elimination or reduction of unnecessary pain and distress in
animals, may be accomplished by using pain-relieving drugs, establishing more humane endpoints, using
therapeutic techniques to reduce stress to the animal, etc.
31. Please provide a written narrative below addressing the use of alternatives, including the 3 Rs
(reduction, replacement and refinement):
32. Provide written assurance that the activity does not unnecessarily duplicate previous experiments. If
multiple searches are conducted, list them sequentially. A normal search should be broad enough to
bring up some results, but narrow enough that all results can be reviewed:
Literature search conducted (Required)
Database(s) used:
Key words used:
Date of search(es):
Years searched:
Number of results (per search):
Brief assessment of the results:
Consultation with colleagues (Encouraged, other than individuals listed on the protocol)
Name of colleague(s)
Qualification of colleague(s)
Date of consultation:
Content of consultation:
Section E: ANIMAL PROCEDURES
33. Will this protocol utilize genetically modified animals?
Yes (see question 30 on unexpected outcomes, and complete APPENDIX J)
No
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
10
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
34. Describe the methods of euthanasia used (including drugs, doses and routes of injection); if methods
deviate from the 2013 AVMA Guidelines on Euthanasia, provide a scientific justification. Describe
who is responsible for providing euthanasia training and how euthanasia training is conducted and
recorded.
If a physical method is used, list the names of those performing the euthanasia (include a description of
qualifications and/or training of person performing a physical method).
Please note: if there will be future additional staff that will be performing euthanasia using a
physical method, and are not listed on page 4 (of this protocol) at the time of IACUC approval,
Appendix G (found on the ORC website) must be completed and submitted to the ORC for
IACUC review before the staff performs any procedures. Note: If a training method is utilized that
is not listed in the IACUC Best Practices, a modification must be submitted to the ORC describing the
new/alternate training method. (Cardiac perfusion is considered a non-survival surgery and should be
addressed in Appendix D): [IACUC best practices on Euthanasia per species]
35. The IACUC encourages the reuse of animals when euthanasia is not necessary. Please select all
applicable boxes indicating what may be done with animals not euthanized at the end of the study.
Donation to the ARC for the serology program
Donation to a PI with an approved protocol for research or training purposes
Adoption
Other, please explain:
36. Does this project utilize any of the following? If any of the following boxes are checked,
APPENDIX J must be completed
Chemical agents hazardous to humans for administration in live animals (e.g. isoflurane, formaldehyde,
MS-222, BrdU, ether, DMSO etc.) Please note that this list is not exhaustive. Contact Environmental
Health and Safety for questions on proposed substances and their hazards.
Recombinant DNA or genetically modified organisms.
Radioisotopes - for use in live animals.
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX A – Part I
Breeding of Animals
YOU ARE REQUIRED TO KEEP ACCURATE RECORDS OF THE NUMBER OF ANIMALS
PRODUCED AND THEIR ULTIMATE DISPOSITION. THIS INFORMATION WILL BE
REQUESTED ANNUALLY.
1. Please provide a justification for the need for breeding (e.g. animals are not commercially available, in
utero studies, reproduction studies, etc.). Note that cost of commercially available animals is not a
justification:
2. List the species and strains of animals to be produced in your breeding program (If
transgenic/knockout, complete Part II below):
3. Estimate the initial number of animals necessary to establish the colony (number of breeder animals
should be stated for the duration of the project – a maximum of 3 years).
4. Describe your breeding scheme (Monogamous, Polygamous-trio, or other schemes).
5. Identify who will be responsible for colony management, including weaning and recording births and
deaths.
6. Anticipated total number of offspring for each species that will be produced per year (number born)
Note that this total should equal the sum of Question 7 and Question 10:
7. Anticipated number of offspring that will be used for experiments (pups and/or breeders):
8. If breeders will not be used experimentally, indicate their fate:
9. What cage size will be utilized?
Rat
Shoebox (standard)
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
12
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
Mouse
XL shoebox
Small Shoebox (see 9A if checked)
Super-mouse – quarantine cages
Large Shoebox (for trio breeding)
9A: If you will be using the standard mouse cages for breeding, indicate how you will comply with
animal welfare regulation on cage space, litter sizes, and the potential for overcrowding. For
reference please see the IACUC Guidelines and Policy for Housing and the Use of Environmental
Enrichment for Laboratory Animals on the ORC website.
10. What will be done with surplus animals (i.e. unused offspring)?
APPENDIX A – Part II
Transgenic/Knockout Breeding Programs
1. DNA/transgene or gene to be disrupted:
2. Anticipated consequences to the animal of genetic manipulation:
3. Method of monitoring presence of transgene in the animals. Please note that if tail snipping is used, it
must be performed according to IACUC guidelines:
4. Describe any special care or monitoring that may be required:
5. Who will perform this monitoring and care?
6. What is the disposition of the founders and how long will they be maintained?
7. If biological containment is required, state reasons and the level required. Describe your containment
and security procedures. How will you deal with breach of containment? Will there be any risks to
human health, wild populations of the environment generally if containment fails? Note: list date of
approved biosafety disaster plan.
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
13
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX B
Teaching/Classroom Protocols
All live animal work conducted under teaching/classroom protocols must be supervised at all times by
Marquette University faculty or staff listed in the protocol. If students will be handling live animals, the
PI must 1) arrange training of the students by a member of the ARC staff in proper animal handling
and 2) instruct the students in the ethical care and use of animals in research, teaching or testing.
Please describe how you will accomplish the second requirement:
(Suggested materials: Chapter 13 of the Marquette University Animal Care Manual and the animal
information on the ORC website at http://www.marquette.edu/researchcompliance/research/index.shtml).
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX C
Food or Fluid Restriction
(Note: 24 hour fasting prior to surgical procedures, maintenance diets to prevent obesity and rabbit diets
are excluded. 24hr fasting needs to be described in Appendix D, Surgery For reference please see the
IACUC Guidelines and Policy on Food or Fluid Restriction located on the ORC website.
1. Describe any food or fluid restrictions:
2. a) Describe the potential impact on the animal’s health and the potential for discomfort or distress.
Explain what will be done to alleviate or minimize these potential adverse effects (please be familiar
on how to report unexpected outcomes).
b) What endpoints will be used to determine termination of food/fluid restriction or euthanasia of the
animal?
c) Describe monitoring methods for the duration of the manipulation. Include who will be responsible
for animal health assessment and monitoring during periods of food/water restrictions.
3. Describe the length of time animals will be on experimental diet:
4. Will neonates be fasted beyond 3 hours OR other animals beyond 24 hours?
Yes
No If Yes, provide a scientific justification:
5. Will fluids be withheld for more than 12 hours (more than 5 hours for rodents)?
Yes
No
If Yes, provide a description of this aspect of the study, including the rationale and monitoring
methods:
6. Will animals be provided less than ad lib fluids or drinking water for experimental reasons?
Yes
No
If Yes, provide details, including amount/day, monitoring, criteria used to determine well being of
animals, and a scientific justification:
7. a) Describe record-keeping methods, including what information will be documented:
Note: The 2011 Guide for the Care and Use of Laboratory Animals states that “Body weights
should be recorded at least weekly and more often for animals requiring greater restrictions.
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
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Written records should be maintained for each animal to document daily food and fluid
consumption, hydration status, and any behavioral and clinical changes used as criteria for
temporary or permanent removal of an animal from a protocol.” Guide page 31.
b) Do you need an exception to these guidelines?
Yes (provide a scientific justification)
No
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
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APPENDIX D
Surgery
Please complete a separate page for each surgical procedure and/or species. Use attachments where
necessary. Cardiac perfusion is considered a non-survival surgery and should be addressed here.
For reference please see the IACUC Guidelines on Rodent Survival Surgery and Record Keeping and the
IACUC Wound Clip/Suture Policy.
1. Surgery procedure
Non-survival
Survival
2. Species:
3. Location of surgical procedure:
Building
Building
(Add more rows if needed)
Room #
Room #
Note: Survival surgery for all species must be performed in a pre-approved area properly designed
and maintained to enable adherence to the principles of aseptic surgery. Surgery on non-rodent
mammals must be done in a dedicated surgery area approved by the IACUC.
4. Please complete the following:
Name of Surgeon(s)
Relevant experience with the animal model
(training and past performance)
5. Describe who will provide training to new surgeons, and the training method used.
Please note: if there will be future additional staff that will be performing surgeries, and are not
listed as surgeons (on this protocol) at the time of IACUC approval, Appendix G (found on the
ORC website) must be completed and submitted to the ORC for IACUC review before the staff
performs any procedures Note: If a training method is utilized that is not listed, a modification must
be submitted to the ORC describing the new/alternate training method.
6.
Will any animals be used for surgical training? Note: these animals should be included in total animal
numbers listed in Question 9 of the main protocol form
Yes
No
If Yes, how many?
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
7. Check the box(s) below to describe how the surgical site(s) will be prepared prior to surgery.
Non-survival surgery:
Site clipped
Survival surgery:
Site clipped
Surgical scrub performed
Other: (please describe surgical site preparation)
8. Check the box(s) below that describe the preparation of the instruments, supplies and implant
materials. For multiple surgeries per session check box(s) to indicate how these materials are prepared
following the initial surgery preparation.
Non-survival surgery:
Clean instruments
Survival surgery (initial preparations):
Autoclave
Hot bead sterilizer
Chemical sterilant
Chemical disinfectant
Other: (please describe initial preparations)
Preparations of equipment after the initial preparation for multiple survival surgeries per session:
Autoclave
Hot bead sterilizer
Chemical sterilant
Chemical disinfectant
Other: (please describe initial preparations)
9. Check the box(s) below that describe the preparation of the surgeon:
Non-survival surgery:
Non-sterile gloves
Survival surgery:
Clean surgical attire
Surgical scrub
Sterile gloves
Mask
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
Other: (please describe surgeon prep)
10. Describe the surgical procedure, including detail on incision site(s) and tissue isolation methods. Note
that aseptic procedures must be used for all survival surgery:
11. Describe anesthetic method used, including all drugs, dosages, and routes of administration and
supplementation schedules:
8a. Please indicate methodology and physiological parameters used to assess depth of anesthesia. Note
that while monitoring of the animal should be performed continuously, documentation of the
assessment in the anesthetic record should be done at a minimum of 15 minute intervals. Guide page
119.
12. Describe analgesia method used, including all drugs, dosages, routes of administration and monitoring
methods:
13. If using neuromuscular blocking agents, describe the dose, route, frequency and criteria for judging the
depth of anesthesia:
14. Will animals be allowed to recover from surgery?
Yes
No
If Yes, describe the post-operative care and monitoring procedures, including all drugs and dosages,
monitoring of fluids, and measures designed to alleviate post-operative discomfort:
15. Will any animals undergo more than one major survival surgery procedure? (Defined as penetrating a
body cavity or having the potential for producing a permanent handicap for an animal expected to
recover)
Yes
No
If Yes, provide an appropriate scientific justification. Note that multiple survival procedures on the
same animal are not permitted unless the procedures are essential components of the same project.
Include any pain, distress, or functional deficit that may result and describe how it will be minimized:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
16. Do you anticipate any adverse outcomes as a result of the above surgical procedure(s)? Examples
include infection, mortalities or morbidities.
Yes
No
If yes, please describe.
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX E
Conscious Physical Restraint
If conscious animals will be restrained for more than one hour, this appendix must be completed and
submitted with the full protocol. To minimize distress or pain associated with restraint, the period of
restraint should be no longer than required to achieve the aims of the project.
1. Describe how the animal will be restrained:
2. Location where procedures will be conducted (building & room):
3. How long will the animal be restrained?
4. Describe how they will be acclimated to the restraint method:
5. Describe the care given during this time, including how often they will be observed:
6. Should the animal show signs of distress or clinical abnormalities, what course of action will be taken?
7. Will the animals be restrained for more than 12 hours?
Yes
No
If Yes, provide criteria you would use to determine that the animals should be released from the
restraint device:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
21
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX F – Part I
Immunization and Antibody Production
1. Species:
2. Antigen(s):
3. Adjuvant(s):
Initial immunization:
Subsequent immunization:
4. Injection. Describe anatomic site, volume administered per injection site (maximum 0.05 ml per site
for mice and 0.1 ml per site for rabbits), total volume administered at one time, frequency, and total
number of administrations:
5. If the mouse ascites method of production of monoclonal antibodies is being used, describe the
frequency of monitoring for pain or distress and criteria for euthanasia. (This method of production
should not result in spontaneous death of the animal. Euthanasia criteria described in the protocol
must be followed.):
APPENDIX F – Part II
Collection of Blood or Other Body Fluids (other than ascites)
1. Body fluid to be collected:
2. Frequency of collection:
3. Volume of fluid to be collected at each collection:
4. List the method and site of collection:
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560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
5. Will the animals be anesthetized, restrained or sedated during this procedure?
Yes
No
If Yes, provide the method of restraint or list the anesthetic agent or sedative, including dosage and
route of administration:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX H
Procedures that Cause More than Momentary or Slight Pain or Distress
1. Check all procedures listed below that apply to this study.
These procedures may cause more than slight or momentary pain and/or distress. Note: non-invasive
procedures such as needle aspiration, parenteral injections of non-irritating substances, blood
collection from a common peripheral vein per standard veterinary practice and manual restraint that
is no longer than would be required for a simple exam are not considered to cause more than
momentary pain or distress.
Surgical procedures (including terminal surgeries which are considered painful procedures alleviated
by anesthesia—USDA Policy 11
Administration of Freunds complete adjuvant
Ocular and skin irritancy testing
Complete food or water deprivation beyond that necessary for pre-surgical preparation (Note:
APPENDIX C should be completed if this box is checked)
Noxious electrical shock that is not immediately escapable
Paralysis or immobility in a conscious animal
Administration of chemical or biological agents at doses that may cause more than momentary pain or
distress
Any activity intended to induce a stress response
Prolonged forced confinement in a small enclosure
Other (please explain):
2. On what scientific basis (state methods and sources) is this procedure justified? Explain:
3. Indicate monitoring methods and other criteria that will be used to determine a humane endpoint for
animals involved in such procedures (Note: answers should include; What are the main endpoints?
Who will be responsible for animal monitoring? What training will be provided for those responsible
for monitoring/determining endpoints? What will be the response when the endpoint is reached?) For
reference please see the IACUC Humane Endpoints for Animals Used in Research or Teaching
Purposes located on the ORC website.
4. Describe any discomfort or pain as a result of the above procedure(s), what you will do to relieve this
discomfort, and assure that no animal experiences undue pain or distress during the course of your
research. Include anesthetics/analgesics, dosages, nursing care, mechanical devices, humane
euthanasia, etc.: [IACUC best practices for Rodent/Rabbit Analgesia-Anesthesia]
5. Describe the method and frequency used to monitor your animals to ensure they are not experiencing
pain or discomfort from your procedure(s) or from unanticipated illness or injury (Signs of Pain and
Distress in Rodents). Also define who is responsible for training those tasked with monitoring animals:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
6. If experiments will induce chronic disease, tumors or radiation sickness, describe the criteria for
termination of the affected animals:
7. Indicate the methods used to search for alternatives to procedures that may cause more than
momentary or slight pain or distress. If multiple searches are conducted, list them sequentially. A
normal search should be broad enough to bring up some results, but narrow enough that all results can
be reviewed.
Literature search conducted (Required)
Database(s) used:
Key words used:
Date of search(es):
Years searched:
Number of results (per search):
Brief assessment of the results:
Consultation with colleagues (Encouraged)
Name of colleague(s):
Qualification of colleague(s):
Date of consultation:
Content of consultation:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
25
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX I
Use of Non-Pharmaceutical Grade Compounds
This form must be completed for all non-pharmaceutical grade compounds being used, including
experimental drugs and chemicals, compounds that are mixed at an off-site pharmacy, compounds
for which there is no pharmaceutical grade option available, or compounds for which there is a
pharmaceutical grade option available but for which you wish to justify an alternative.
Please complete a separate page for each non-pharmaceutical grade compound that will be used.
For reference please see the IACUC Guidelines for the Use of Non-Pharmaceutical Grade
Compounds in Laboratory Animals located on the ORC website.
Please acknowledge by checking the box below:
The FDA publishes the Green Book (veterinary) and the Orange Book (human) databases
of approved drugs. Substances listed in these databases are recognized as pharmaceuticalgrade. Please use the links to aid in your search. Also, you may determine whether a
particular drug is available by consulting the FDA database.
As the PI on the protocol I assure, that I have conducted a search on a FDA recognized
pharmacopeia to see if there is a pharmaceutical grade equivalent to the compound that I
am proposing to use in this protocol.
1. Provide scientific justification for using the non-pharmaceutical grade compound:
2. Describe the steps that will be taken during the preparation of the compound to ensure sterility (if
injectable), that the appropriate pH will be established (when feasible) and that an appropriate vehicle
will be used. Include: drug safety, efficacy, shelf life, labeling methods, storage methods, and
pharmacokinetics.
3. Describe who will be responsible for monitoring the compound’s preparation and use, and any relevant
experience handling the compound:
4. Describe site and route of compound administration. Include potential side effects and adverse
reactions. Also include who will be responsible for monitoring the animals, and how they have been
trained to look for adverse reactions:
I assure that the compound will be labeled with the date of preparation and preparation
method.
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
26
Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
APPENDIX J
Use of Hazardous Chemical Agents, Recombinant DNA, Genetically Modified Organisms or
Radioisotopes
1. Check all that apply to this study:
Hazardous Chemical Agent for administration to live animals (See Question 2 & 5)
Recombinant DNA or genetically modified organisms (See Question 3 & 5)
Radioisotopes (See Question 4 & 5)
Directions for completing the below section for the use of Hazardous Chemical Agents
Marquette University Office of Environmental Health and Safety (EHS) has generated (4) standard SOP’s
for the most used hazardous chemical agents in the Animal Resource Center and the PI’s labs/research
areas. If you plan on using any of the listed chemicals and will be using the standard SOP set by EHS
please indicate this by checking the appropriate box below.
or
If you will be modifying the standard SOP for your experiments, indicate this by checking the appropriate
box. The SOP will need to be adjusted and then sent to EHS for approval. The IACUC cannot approve the
protocol until the adjusted SOP has been approved by the Director of EHS.
or
If a hazardous chemical(s) will be utilized that is not listed below, check the “other/not listed” and provide
the names of the chemicals in the blank table below and complete the appropriate SOP from the list on the
ORC website. The form will need to be sent to EHS for approval. The IACUC cannot approve the
protocol until the Hazardous Material form has been approved by the Director of EHS.
Material Safety Data Sheets for hazardous agents must be accessible to lab workers. General SOP’s
should be posted in the labs and/or where hazardous agents are being used. All workers who use
hazardous agents must be trained in their use. All workers who use hazardous agents must use
appropriate Personal Protective Equipment.
2. Note: It will be the PI’s responsibility to complete all relevant information in the SOP before it posts
in the lab (example; question #7 on animal information in SOP). The IACUC will review the SOP’s
at the time of the semi-annual inspection.
MS-222 – I have read the SOP and am using MS-222 as prescribed by the SOP. I have trained my
staff accordingly and will post the SOP in the lab.
I have modified the SOP to accurately reflect the handling and control measures for use of MS-222
and will submit the form to Environmental Health and Safety as well as post the SOP in the lab.
DMSO – I have read the SOP and am using DMSO as prescribed by the SOP. I have trained my
staff accordingly and will post the SOP in the lab.
I have modified the SOP to accurately reflect the handling and control measures for use of DMSO
and will submit the form to Environmental Health and Safety as well as post the SOP in the lab.
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
Formaldehyde/formaldehyde solutions/paraformaldehyde – I have read the SOP and am using
Formaldehyde/formaldehyde solutions/paraformaldehyde as prescribed by the SOP. I have trained my
staff accordingly and will post the SOP in the lab.
I have modified the SOP to accurately reflect the handling and control measure for the use of
Formaldehyde/formaldehyde solutions/paraformaldehyde and will submit the form to Environmental
Health and Safety as well as post the SOP in the lab.
Isoflurane - – I have read the SOP and am using Isoflurane as prescribed by the SOP. I have
trained my staff accordingly and will post the SOP in the lab. I am familiar with the safety procedures
for the use of Isoflurane and have trained my staff accordingly.
Other/Not listed – please complete in boxes below. Note:
Add additional rows, if necessary.
3. Describe intended use of recombinant DNA or genetically modified organisms:
3A.What is the biosafety level of this project?
BL1
BL2
BL3
BL4
For information about the use of transgenic animals please go to:
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Transgenic_Animals_and_the_Use_of_Recombinant
_DNA_in_Animals.pdf
For information on Biosafety Levels please go to:
http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf
and
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines_prn.pdf
3B. If your selected biosafety level is higher than BL1, has the project received approval from the
Institutional Biosafety Committee?
Yes
No
4. Describe your intended use of radioisotopes:
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Marquette University, IACUC Protocol Review Form
Revised: 03/27/2013
4A. Has the project received approval from the Radiation Safety Committee?
Yes
No
5. Do you anticipate any adverse outcomes as a result of the listed procedure(s)? Examples include
infection, mortalities or morbidities due to injections, equipment used, experimental drugs, new
procedures, etc.
Yes
No
If yes, please describe:
Please submit completed original to Marquette University’s Office of Research Compliance,
560 N. 16th Street, Room 102, Phone: 414-288-6271, Fax: 414-288-6281 IACUC@marquette.edu
29