MIAMI CHILDREN’S HOSPITAL
IACUC
NEW PROTOCOL TRANSMITTAL
FORM A
Instructions: This form is located on the internet at
http://www.mch.com/doctors_caregivers/research/Forms/forms.htm
All sections must be typed or printed. Please attach your research protocol
to this form.
For IACUC use only
Date Received:
Protocol No:
If you have any questions concerning the completion of this form, please contact Research Administration at (305) 663-8523, Dr. Jack
Wolfsdorf at 663-6836 or Dr. Dan Torbati at 663-8526.
Principal Investigator(s):
Department/Division:
Telephone:
Project Title:
Class of Support for this Project [Check As Applicable]:
[ ] Grant [ ] State [ ] Federal [ ]Private
[ ] Research [
[ ] Competing Continuation Application
[ ] Training
[ ] Contract ([ ] Industrial/Pharmaceutical) Provide Details
[ ] Research Fund (Specify)
[ ] None
Start Date:
Project Period:
Funding Source (if any):
If grant application - Submission Date:
Potential Patent? [ ] Yes
[ ] No
Space and Facilities Available? [ ] Yes [ ] No
If yes, Building
If no, attach alternative.
Will relocation or renovation be required? [ ] Yes [ ] No
If yes, indicate the source of funding.
]Type of Grant
MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
(Principal Investigator and Medical Director must print name and sign)
I, ________________________________________________(principal investigator) and
__________________________________________________(medical director) will take full
responsibility for the storage, dispensing and disposal of any narcotics used in this research
project.
Summary of Project (Stay within boundaries; use at least no. 10 font) Attachments are permitted for clarity
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
ASSURANCE: I certify the information herein and attached (referenced in summary) is correct I agree to adhere
to all policy requirements of the Department of Health and Human Services, NIH, and the Office for Protection
from Research Risks, and any other stipulations of Miami Children’s Hospital’s Animal Research Committee
concerning this protocol, or pertaining to the use of experimental animals generally.
Required signatures prior to IACUC submission:
Principal Investigator
Date
Director, Research Program
Date
Department Chairman/Chief of Staff
Date
For Hospital Use: The Miami Children’s Hospital IACUC approved the above project at its meeting on _________________ with the
following changes:  None
 Other (attached)
Signature [for the committee]
Date
Letter of approval sent to PI on (date)
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
ANIMAL RESEARCH COMMITTEE
QUESTIONNAIRE
Protocol No:
Project Title:
If you have any questions concerning the proper completion of this questionnaire, please contact Dr. Jack Wolfsdorf at
663-6836 or Dr. Dan Torbati at 663-8526 for information.
The following information is required for compliance with P.L. 89-544, P.L. 91-579, and PHS guidelines governing the
care and use of laboratory animals.
Live Vertebrate Animals Used? [ ] No [ ] Yes
Animal species to be used:
COMMON
NAME
ANNUAL USE
DAILY INVENTORY
(APPROXIMATE) (APPROXIMATE)
Mice
Rats
Guinea Pigs
Dogs
Cats
Pigs
Rabbits
Sheep
Hamsters
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BUDGET
BUDGET
ALLOCATED FOR ALLOCATED FOR
ANIMAL PURCHASE DAILY CARE
MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
Justify the necessity to use this (these) species. Indicate why non-animal alternatives cannot be used by
describing methods and sources which helped you to determine that alternatives are not available.
Has a literature search been done to verify that non-animal alternatives cannot be used? [ ] No [ ]Yes
If yes, indicate the source and key words utilized to conduct the search.
Have you considered alternative procedures that are non-painful or non-stressful to the animals?
[ ] No [ ] Yes
If such procedures cannot be used, please justify. For example, if a procedure will
cause more than momentary or slight pain or distress, please explain why appropriate sedatives,
analgesics, or anesthetics are withheld.
On what do you base your assurance that this study is not unnecessarily duplicative?
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
Has a literature search been done to verify that this study is not unnecessarily duplicative? [ ]No [ ]Yes
If yes, indicate the source and key words utilized to conduct the search.
Justify the number of animals to be used. Please note any statistical methods used in arriving at these
numbers.
Immunization and Bleeding [ ] No [ ] Yes
Frequency of bleeding:
Volume of blood drawn:
Method of collection:
Hybridoma or ascites:
Agents used:
Volume injected:
Site of injection:
Frequency of injection:
Frequency of fluid withdrawn:
Volume of fluid withdrawn:
Maximum number of collections:
Complete Freund’s adjuvant used? [ ] No [ ] Yes; Number of times:
Incomplete Freunds’ adjuvant used? [ ] No [ ] Yes; Number of times:
Name(s) and frequency of other adjuvant(s) used:
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
Surgical Procedures [ ] No [ ] Yes
Terminal? [ ] No [ ] Yes
Survival? [ ] No [ ] Yes
Multiple Survival? [ ] No [ ] Yes If yes, justify
Describe what happens to the animal during the surgical procedure(s):
Have the anesthetics and surgical procedures been discussed with the IACUC Veterinarian?
[ ] No [ ] Yes
Where will the surgery be performed? Bldg./Room:
Note: Aseptic techniques are required for all warm blooded animals undergoing survival
surgery. Surgery on goats, pigs, dogs, cats, rabbits and non-human primates must be performed
in an approval surgical suite. Upon Animal Research Committee (ARC) approval, rodent
surgery, using aseptic techniques, may be performed in your laboratory.
Identify the anesthetic agent(s), dosage(s) and route(s) of administration. Describe the methods
used to monitor the level of anesthesia. (Be very specific)
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
If a gas anesthetic is used, is a scavenging system in place? [ ] No [ ] Yes
Will paralytic drugs be employed? [ ] No [ ] Yes
If yes, indicate the agent, dosage,
frequency of administration and the method of monitoring anesthesia.
Will animal be euthanized at the conclusion of the surgical procedure(s)? [ ] No [ ] Yes
If yes, indicate the method of euthanasia.
Will post-operative antibiotics be used? [ ] No [ ]Yes If yes, name the antibiotic and how it
will be administered. If no, explain/justify.
What post-operative measures will be taken to minimize discomfort? If none, explain/justify.
If analgesia is used post-operatively, indicate:
Type (name):
Dose:
Frequency and route of administration:
Name the individual(s) responsible for post-operative care and indicate where post-op records will
be maintained.
Special Circumstances? [ ] No [ ] Yes
How will animal activity be restricted (as a result of surgical procedures or by chairs, tethers,
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
stanchions, metabolism cage, etc.)?
Indicate method of restriction:
Duration:
Frequency:
How frequently will the animal be observed during restraint?
Will the project require special diets? [ ] No [ ] Yes
If yes, specify:
List any special housing conditions required for the project (lighting, feed, caging, etc.):
Pain or distress experienced by animal(s)? [ ] No [ ] Yes
If yes, describe the measures which
will be taken to alleviate pain or distress. If no measures are taken, justify the reasoning:
Production of blindness or paralysis? [ ] No [ ] Yes
Will the animal be euthanized at the conclusion of the experiment? [ ]No [ ]Yes
If yes, please indicate the method of euthanasia.
If the method of euthanasia is not American Veterinary Medical Association (AVMA) approved,
please justify.
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
If cervical dislocation is your method of euthanasia, the animal must be sedated prior to the
Procedure. If not, please explain:
Will the animal be fasted? [ ] No [ ] Yes
If yes, how long?
Tissue Only? [ ] No [ ] Yes
Type of Tissue?
Species Utilized to Obtain Tissue?
Number of Animals Utilized?
Method(s) Utilized to Obtain Tissue?
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MCH Institutional Animal Care and Use Committee (IACUC)
New Project Proposal - Form A
Training of Research Investigators and Technical Staff
List the names of the person(s) participating in this protocol who will have contact with the animals and specify
the qualifications/training pertinent to the species being used. Be very specific and attach a copy of curriculum
vitae. If you or any of your staff need specialized training, please indicate. [ ] No [ ] Yes
Name
Surgeon (yes or no)
Training needed (yes or no)
Special Qualifications:
Assurance:
The policies and procedures of the MCH IACUC and the United States Department of Agriculture
(USDA) apply to all activities involving live vertebrate animals performed at or by the personnel at this
institution. No activities involving the use of these animals are to be initiated without the prior written
approval of MCH IACUC Animal Research Committee.
The Investigator must be familiar with and agree to adhere to the Public Health Service policy on
Humane Care and Use of Laboratory Animals, the regulations and policies of the USDA, the NIH Guide
for the Care and Use of Laboratory Animals and the MCH IACUC policies and Animal Assurance. Any
change in the care and use of animals involved in this protocol will promptly be forwarded to the Animal
Research Committee for review and approval prior to the implementation of the change. Only those
individuals who have received training pertinent to the species being used in this protocol will
participate in this study.
Principal Investigator
Date
Chairman/Chief of Department/
Chief of Staff
FORM A 06/15/2004.ac
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Date