IACUC Number:
Approval Date:
Expiration date:
Boston College
IACUC Proposal Form
(Initial and 3-year Reviews)
Instructions: Complete this animal use proposal to use any vertebrate animals in teaching, testing or research at Boston College.
The application form must have complete information on the background, purpose, previous experiments or findings that led to the
proposed use of animals and a description of the science that will be used for animal tissue experimentation. This application is also
reviewed for biosafety, and radiation safety, so complete information on potential deleterious effects of solutions used in the tissue
analysis or preparation must be included in this application. Incomplete applications will not be forwarded to the IACUC for review.
Initial Submission
Date of Application:
Title :
Three Year Renewal
If Renewal, Provide Previous Protocol Number:
A. ADMINISTRATIVE DATA
1. Principal Investigator:
2. School/Department:
3. Mailing Address:
4. Telephone:
5. Email:
7. Research Personnel/staff/students: List all personnel who will handle the animals or animal tissues:
Name:
E-mail:
Date of ACF Training:
Name:
E-mail:
Date of ACF Training:
Name:
E-mail:
Date of ACF Training:
Name:
E-mail::
Date of ACF Training:
Name:
E-mail::
Date of ACF Training:
8. Funding Sources
A.
None -- Do you plan to apply for funding in the future?
Yes
No
B.
University Funded: List source:
C.
External: List source and grant number:
D.
Federal*: List agency, department and grant number:
*submit a complete copy of the Federal funding proposal with your IACUC application
Provide Per Diem Expense Chartstring:
B.
ANIMAL REQUIREMENTS
1. Genus:
4. Strain, subspecies, or breed (s):
6. Approximate age, weight or size:
2. Species:
3. Common name:
5. Common name (s):
7. Number of Males:
8. Number of Females:
9. Bacteriological status:
[e.g., germfree (axenic), defined flora (gnotobiotic), specific pathogen free, conventional]
10. Viral status:
11. Name of vendor or breeder name &
institution, or bred in-house]:
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12. Will animals be housed in
Yes
No
BC Animal Care Facility?
If No indicate the institution, or BC building and room where animals will be housed:
13. Will all procedures or
Yes
No*
manipulations occur in the
*If No indicate the institution, or BC building and room where animals will be housed:
BC ACF?
14. Total Number of Animals to be
Used:
Year 1:
Year 2:
Year 3:
C.
TRANSPORTATION
Transportation of animals must conform to all institutional guidelines/policies and federal regulations. If animals will be
transported on public roads or out of state, describe efforts to comply with USDA regulations. If animals will be transported
between facilities, describe the methods and containment to be utilized. If animals will be transported within a facility, include
the route and elevator(s) to be utilized.
Full description of animal source vendor:
Description of animal transportation in and out of facility:
D. STUDY OBJECTIVES
A literature search concerning the study must be performed. Please discuss the search you performed including appropriate
citations:
This search covered the years:?
Have results fulfilling the experimental goals of this research been published by you or others? Yes:
If YES, provide details as to why the experiment requires repetition:
No:
Briefly explain in language understandable to a layperson the aim of the study and why the study is important to human or animal
health, the advancement of knowledge, or the good of society.
E.
RATIONALE FOR ANIMAL USE
1. Explain rationale for animal use (include reasons why non-animal models cannot be used):
2. Justify the appropriateness of the species selected. (The species selected should be the lowest possible on the phylogenetic
scale):
3. Justify the number of animals to be used. (The number of animals should be the minimum number required to obtain statistically
valid results ]:
4. What is the basis of your number calculation (e.g., power analysis, publication or other factors):
F.
DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES
1. Briefly explain the experimental (or assay) design and specify all experimental, assay and animal procedures. This
description should allow the IACUC to understand the experimental procedures that require the use of an animal from its entry
into the experiment to the endpoint of the study and then what basic procedures and assays will be performed with animal
tissues or fluids:
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G. SURGERY
1. Will surgery be performed on the animals while they are alive Yes*
No
* If yes proposed, complete the following: (Use additional sheets if necessary.)
A. Identify and describe the surgical procedure(s) to be performed. Include preoperative procedures (e.g., fasting,
analgesic loading), and monitoring and supportive care during surgery. Include the aseptic methods to be utilized.
B. Who will perform surgery and what are their qualifications and/or experience (please describe training for the specific
procedures listed)?
Names:
C. Where will surgery be performed and where will postoperative care provided (building and rooms, and attach sample
forms that will be used to document surgery and postoperative care)?
Location:
4. Paralytic Use During Surgery
Will you use Paralytic Agents? Yes
(if yes explain how ventilation and pain will be assessed below) No
Name of Paralytic
Agent:
How will Ventilation and pain
be assessed:
5.
Previous Major Survival Surgery
Has major survival surgery been performed on any animal prior to being placed in this study? [Major survival surgery penetrates and
exposes a body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy,
crainotomy, joint replacement, or limb amputation).
Yes
(if yes explain how below) No
Date of Surgery:
Explanation of Previous
Surgery:
6. Multiple Major Survival Surgeries
Will more than one major survival surgery be performed on an animal while on this study?
Yes
(if yes, please justify :) No
Please provide justification:
H. PAIN OR DISTRESS CLASSIFICATION AND CONSIDERATION OF ALTERNATIVES
1.
Complete the following table that best describes pain classification:
Species
(common name)
USDA
Classification Pain
*
B, C, D** or E**
Number of animals used each year
Year 1
Year 2
Year 3
3 yr Total
3 year Total number of animals (should equal total from Section B):
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(*See USDA Classifications and Examples BC IACUC Policies and Procedures
** For Pain level D & E answer question 2 below)
2. Consideration of Alternatives:
For procedures that fall into USDA's Classification D or E, causing more than momentary or slight pain or distress to the animals,
describe your consideration of alternatives and your determination that alternatives are not available. Delineate the methods and
sources used in the search. Database references must include databases searched, the date of the search, period covered, and the
keywords used.
Alternatives include methods that (1) refine existing tests by minimizing animal distress, (2) reduce the number of animals necessary
for an experiment, or (3) replace whole-animal use with in vitro or other tests. When ascites production is used to produce
antibodies, justification needs to be given as to why in vitro systems cannot be used. Note that you must certify in Section P.5. that
no valid alternative was identified to any described procedures which may cause more than momentary pain or distress, whether
relieved or not.
I. ANESTHESIA, ANALGESIA, TRANQUILIZATION, OTHER AGENTS
For animals indicated in Section H.1., Classification D, specify the anesthetics, analgesics, sedatives or tranquilizers that are to be
used. Include the name of the agent(s), the dosage, route and schedule of administration. If information is provided in Section G.
above, please cross-reference. Describe tracking, dosage, route and schedule.
Note: For controlled substances, also attach a copy of the blank tracking form you will use to track usage as an attachment to this
application
Name
Dosage
Route
DEA Schedule
J. METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY
Indicate the proposed method of euthanasia. If a chemical agent is used specify the dosage and route of administration. If the
method(s) of euthanasia include those not recommended by the AVMA Panel Report on Euthanasia (e.g., decapitation or cervical
dislocation without anesthesia), provide scientific justification why such methods must be used. Indicate the method of carcass
disposal if not described in Section K. below.
K. HAZARDOUS AGENTS
The use of hazardous agents requires the approval of the Institutional Biosafety Committee and/or the Radiation Safety Committee
Attach documentation of the required approval by one or both of those committees.
Hazardous Agent
Yes
No
Agent
Date of Biosafety or Radiation
Safety Approval
Tracking #
Radionuclides
Biological Agents
Hazardous Chemicals or Drugs
Recombinant DNA
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Study Conducted at Animal Biological Safety Level: 1
2
3
4
For information on Animal Biosafety Levels please contact the Office for Research Protections
Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated
with this study. Also describe methods for removal of radioactive waste and, if applicable, the monitoring of radioactivity:
Additional safety considerations:
1.
2.
L. BIOLOGICAL MATERIAL/ANIMAL PRODUCTS FOR USE IN ANIMALS (e.g., cell lines, antiserum, etc.)
Specify Material:
Source:
Material Sterile or Attenuated: Yes
If derived from rodents, has the material been PCR Assay tested?
Yes
3.
(Attach copy of results)
No
or No
I certify that the PCR Assay tested materials to be used have not been passed through rodent species outside of the animal
facility in question and/or the material is derived from the original PCR Assay tested sample. To the best of my knowledge the
material remains uncontaminated with rodent pathogens.
Initials of Principal Investigator
M. TRANSGENIC AND KNOCKOUT ANIMALS
Describe any phenotypic consequences of the genetic manipulations to the animals. Describe any special care or monitoring that
the animals will require.
N. FIELD STUDIES
If animals in the wild will be used, describe how they will be observed, any interactions with the animals, whether the animals will be
disturbed or affected, and any special procedures anticipated. Indicate if Federal permits are required and whether they have been
obtained.
O. SPECIAL CONCERNS OR REQUIREMENTS OF THE STUDY
List any special housing, equipment, animal care (e.g., special caging, water, feed, or waste disposal, environmental enhancement,
etc.) or other information you would like the IACUC to consider when reviewing this proposal.
P. RESEARCH PROCEDURES TRAINING (DO NOT INCLUDE CITI TRAINING PROGRAM)
Describe how the Research Personnel listed in Section A are trained in your lab with regard to the specific research
methods/procedure used in this protocol. Include the following as they may be applicable to the research: the biology, handling, and
care of the species; aseptic surgical methods; research or testing methods that limit the use of animals or minimize distress; proper
use of anesthetics, analgesics, and tranquilizers; and procedures for reporting animal welfare concerns. Also, describe how training
during the coming year will be documented.
Name(s) of Those Conducting Training
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Provide Qualifications of Those Conducting Training
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Q. PRINCIPAL INVESTIGATOR CERTIFICATIONS
Please note that certified electronic signature are allowed or scanned, faxed, or handwritten signature are also acceptable to
process the application
1. I certify that I have attended the institutionally required CITI training program, and that I will take the refresher course every
three years.
2. I certify that I have determined that the research proposed herein is not unnecessarily duplicative of previously reported
research.
3. I certify that all individuals working on this proposal who are at risk are participating in the Institution's Occupational Health
and Safety Program.
4. For all USDA Classification D and E proposals (see section H.1.): I certify that I have reviewed the pertinent scientific
literature and the sources and/or databases as noted in Section H.2. and have found no valid alternative to any procedures
described herein which may cause more than momentary pain or distress, whether it is relieved or not.
5. I certify that I will obtain approval from the IACUC before initiating any changes in this study.
6. I certify that I will notify the IACUC regarding any unexpected study results that impact the animals. Any unanticipated pain
or distress, morbidity or mortality will be reported to the attending veterinarian and the IACUC.
7. I certify that I am familiar with and will comply with all pertinent institutional, state, and federal rules and policies.
Principal Investigator:
Name :
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Signature:
Date:
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R. CONCURRENCES
Faculty Supervisor required for student submissions:
By signing this form, the faculty research supervisor attests that (s)he has read the attached protocol submitted for IRB review,
and agrees to provide appropriate education and supervision to the student investigator, and to take and maintain the
appropriate level of CITI training.
Name & Title:
Signature:
Date:
TO BE COMPLETED BY THE OFFICE FOR RESEARCH PROTECTIONS:
BC Biosafety Committee Certification of Review and Concurrence: (Required of all studies utilizing bio-hazardous agents.)
Date of Biosafety Committee Approval:
BC Radiation Safety Committee Certification of Review and Concurrence: (Required of all studies utilizing radiation agents.)
Date of Radiation Safety Committee Approval:
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Attachment 1
Explanation of USDA Classification E
Please note that any research requesting USDA Pain Classification E must be reported to the USDA along with USDA Form 7023 to
support any USDA Classification E listings.
This document must be typed.
Principal Investigator:
Animal Project Title:
Species and number of animals listed in Classification E for each year:
1. Genus
Number of Animals
Year 1
Year 2
Year 3
2. Genus
Number of Animals
Year 1
Year 2
Year 3
3. Genus
Number of Animals
Year 1
Year 2
Year 3
Species:
Species:
Species:
Do any of the above listed animals require special care, handling, diet or water? Yes
Please describe in detail, attach additional documents if necessary:
No
Provide a scientific justification to explain why the use of anesthetics, analgesics, sedatives or tranquilizers during and/or following
painful or distressing procedures is contraindicated:
Signature of investigator:
Name:
Signature:
Date:
Signature of IACUC Chairperson:
Name:
Signature:
Date:
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