Form-Application-for-Protocol-Approval-Involving-Laboratory

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UNIVERSIDAD CENTRAL DEL CARIBE
APPLICATION FOR PROTOCOL APPROVAL INVOLVING LABORATORY
ANIMAL USE
Institutional Animal Care and Use Committee
Instructions for Filling out this Form
1.
This application should be completed and submitted to the Institutional Animal Care and
Use Committee (IACUC) in order to obtain authorization:


for all use of vertebrate animals and/ or
to obtain tissues and cells from vertebrate animals, procured and sacrificed
solely and specifically for research and teaching purposes.
2.
The National Institutes of Health (NIH) require that funded grant applications including
the use of vertebrates animals must have an approved IACUC protocol before funds are
released to the Principal Investigator (PI) and affiliated institution.
3.
All animal use protocols will require an annual update and must be re-submitted for reevaluation every three years.
4.
The electronic form of this application is available at (under construction) and has to be
submitted via e-mail to at least one month before our scheduled meetings of IACUC.
IACUC approval needs to be obtained prior to beginning the research project. Hardcopy
applications will not be processed.
5.
Applications submitted by postdoctoral fellows, graduate and undergraduate students
should be accompanied by the name and contact information of his/her academic
advisor on the certification section of this application.
6.
All personnel included in the Application are required to have current animal handling
procedure training.
7.
Protocols involving an animal’s exposure to radioisotopes, biological and/or, chemical
hazardous agents and tumor lines/body, and use of the rodent breeding must be
accompanied with the appropriate attachments #1, 2, 3, 4 and 5.
1
Form: UCC/APAILAU-2014-06-02
UNIVERSIDAD CENTRAL DEL CARIBE
APPLICATION FOR PROTOCOL APPROVAL INVOLVING
LABORATORY ANIMAL USE
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
FOR OFFICIAL USE
Identification Number:
A. INVESTIGATOR/PERSONNEL INFORMATION
Principal Investigator
1
Principal Investigator/PI Name:
(Last name, first name)
2
Department
3
E-mail
4
Emergency Phone
extension
Research Staff (List all individuals handling live/dead animals or animal tissue, including PI).
NAME
ROLE IN
THE
PROJECT
ANIMAL TRAINING
Date
Month/year
General
Content
E-MAIL
Specie (s)
2
B. PROJECT INFORMATION
5
Title of
Project
6
Type of Application
Research
Training
Pilot
Primary
(
)
(
)
(
)
Additiona
l
(
)
(
)
(
)
7
From (mm/dd/yy): ___________
C.
Protocol
Period
Other (specify)
To (mm/dd/yy):_______________
FUNDING SOURCES
Source 1
8
Name of
source
9
Title grant
Source 2
Source 3
Institutional
Department Director
Signature
_________________
10 Grant #
11 Start date
3
E.
ANIMAL MODEL
12. Description of Animal to be used:
Animals must be obtained from Animal Resources Center approved sources/vendors only.
Quarantine before entering UCC Animal House is required for certain animals based on their origin.
Refer to the Handbook for the Use of Laboratory Animal or contact the Animal Resources Center
administrative office 787-798-3001, ext. 2096 or betzaida.torres@uccaribe.edu for further information.
Note that protocol approval does not guarantee that the desired space for housing animals will be
available.
Sources
Species
Strain
Age
Weight
Sex
♀
♂
Projected numbers
#
# Animals
Animal
/month
/week
If rodent breeding is included in the study, Investigators who plan to breed rodents refer to
Mice Breeding Protocol, as part of their study must complete the Rodent Breeding and
Weaning Supplemental (Attachment #5).
4
E.
CAGING AND HOUSING
13. Housing/ Identification of animals
Strain
Sex
Weight
(age)
* Housing
Location
(Animal
Facility)
Maximum # of
Animals Housed at
One Time
1
year
2
year
3
year
If an identification
method in addition
to a cage card is
used (tattoo, ear
clip, punch method,
etc.). Describe
Below*
*For Satellite Animal Housing (holding animal’s outside for more than 12 hours) Request Policy on Satellite
Animal Facilities.
General Specifications (mark with an X)
14
Is special caging required for holding animals more than 12 hours?
(
)YES (
) NO
15
Does caging deviate from the standards specified in either the
Guide for the Care and Use of Laboratory Animals (GUIDE) or the
Animal Welfare Act?
(
)YES (
) NO
16
Will special husbandry requirements be needed to accomplish this
protocol (e.g. individual housing, special diets, water or feed
restrictions, treatments in feed or water, etc.)?
(
)YES (
) NO
If yes, provide the following: please describe details and scientific justifications below:
5
Specifications for Rodents
17
The standard caging (microisolator caging is standard in this
facilities)
(
)YES
(
) NO
18
Special microisolators are needed since animals are
immunocompromised and/or would be exposed to biohazards
(
)YES
(
) NO
Wire bottoms cages are required for this protocol.
(Rat weight should not exceed 500 grams and cannot be
housed for more 9 months)
(
)YES
(
) NO
(
)YES
(
) NO
(
The research requires species specific environmental cage
enrichment devices and techniques?
If you answered “yes, please describe and scientifically justify below:
)YES
(
) NO
19
20
F.
Indicate any other special cages that are required in addition
to the ones mention above. (Provide justification below)
ANIMAL ENRICHMENT
21
Behavioral Testing Facilities support required.
Coordinator must sign.
G.
USE SITES AND TRANSPORTATION METHODS
22
Will animals be transported out from the Animal Resources
Center?
(If you marked YES, provide justification, below)
(
)YES
(
) NO
Justification
Description of animal
transportation
route(s) and
mechanism
23
Will live animals be returned after handling procedures
outside the Animal Resources Center?
(
)YES
(
) NO
6
Will vertebrate animals be housed in these alternate
locations for more than 12 hours? (If yes, fill and attach
special section, Satellite Animal Facilities to this application)
24
(
)YES
(
) NO
Indicate laboratory sites where hazardous tissue (e.g. animal tissues from studies
involving radioisotopes, hazardous chemicals, or BSL-2 or higher) will be collected and
stored.
Note that if the tissue (s) being transferred will be handled by investigators not
listed on this protocol, you are required to inform that person (s) of any inherent
danger associated with the tissues.
25
H.
PROCEDURE NARRATIVE
26
Concisely describe in non-technical language the procedures to which animals will be
exposed (in their sequential order) for duration of the project.
Procedure
#
Procedure Name
# of animals
required
Description of the Procedure
1
2
3
4
5
7
27
I.
Provide, whenever possible, flow charts/tables, illustrating experimental design
and numbers of animals required for each procedure.
OFFICE OF LABORATORY ANIMAL WELFARE (OLAW) REQUIRED
INFORMATION
If this protocol is duplicated, by LAW (PUBLIC LAW 99-158 ANIMAL RESEARCH SEC. 495
(http://grants.nih.gov/grants/olaw/olaw.htm) you must consider alternatives. In the following
section, check which of the following databases and other sources have been searched to
assure that the proposed experiments do not unnecessarily duplicate, that previous
experiments do not cause undue distress or pain, and that alternative species or alternative
methods have been considered and are not available. The search should include “refining”
by using less stressful procedures, “replacing” the species selected, with one lower on the
phylogenetic scale, and “reducing” the number of animals you are requesting. The search
should have been conducted within the last 3 months.
28
Does this research duplicate any previous work?
(If you marked YES, please explain below)
(
)YES
(
) NO
What is the scientific justification for the number of animals to be used (i.e. statistical validity,
previous experience, etc.)?
Please be aware of the following when planning your experiments:
 Limit animal involvement by using the minimum number required to obtain reliable results.
 Use non-animal methods, such as mathematical models, computer simulation, or in vitro
8


29
30
31
32
33
biological systems if possible.
Use appropriate sedation, analgesia, or anesthesia when your procedures will cause more
than momentary pain or distress. Do not perform surgical or other painful procedures on
non-anesthetized animals.
In addition, include information such as the number of control and experimental groups,
number of animals per group or other reasoning.
Justify the rationale for animal use, including why non-animal models cannot be used.
Justify the selected model and why phylogenetically lower species were not selected.
Justification for total numbers of animal model.
Approach
for
determination
Sample
No prior information is available to
determine the numbers of animals
required for completing the experiments.
(The IACUC accepts requests to perform
pilot studies to collect preliminary data to
fulfill this purpose, <10 animals total)
(
)
(
)
Previous experience by this PI
(
)
Previous literature
size
Describe power analysis to determine sample size
9
J.
DRUG ADMINISTRATION
For all drugs used please note:
 Animals must be treated exactly as indicated in this protocol with regards to drug dose and
duration of the treatment.
 Changes in type of drug, dose, etc. must be approved via protocol amendment. If a
veterinary recommendation results in a permanent change to the protocol, the investigator
should submit an amendment of protocol to obtain IACUC approval.
 Include clinical, laboratory or other parameters used to determine length of treatment.
 Investigators are required to maintain treatment records on all animals. (Refer to Post
Procedure Care of Mice and Rats in Research: Reducing and Distress)
 For anesthesia, analgesia, tranquilizing and paralytic drugs specify dosage in mg/kg
(provide justifications below and/or provide information and/or data that demonstrate the
proposed)
34
NON-SURGICAL
Species
Strain
Drug
Dose
Route
(I.V., I.P, I.D.)
Administration
Frequency
35
Duration and Monitoring
Supply duration and method of monitoring treatment efficacy for drug listed above.
Drug
Duration
Drug Efficacy Monitoring
10
36
Drugs administered for therapeutic purposes (excluding anesthetics, analgesics, and
tranquilizers).
ROUTE
SPECIES
AGENT
DOSE
EFFECT
(I.V., I.P,
Strain
I.D.)
Describe any adverse effects associated with the administration of these agents and a
detailed plan for monitoring and alleviating these effects if applicable:
If you are using aquatics (e.g., frogs or fish), rats, and mice.
37
Are *non-pharmaceutical agents to be introduced into Animal
Welfare Act (AWA) non- regulated species (rats, mice, birds,
or aquatics) for the purpose of veterinary medical care or to
relieve pain and distress (e.g. anesthetics, analgesics,
sedatives, antibiotics, or paralytics)?
(
) YES
(
) NO
Please note: As per Universidad Central del Caribe IACUC approved policy all compounds
used in aquatics, rats, or mice for veterinary medical care or to relieve pain and distress (e.g.
anesthetics, analgesics, sedatives, antibiotics or paralytics) must be pharmaceutical grade
(when available) unless scientifically justified. Cost savings alone are not considered by the
IACUC an adequate justification for using non-pharmaceutical grade drug for veterinary
medical care or to relieve pain and distress in these species.
*Non- pharmaceutical agent: An agent that was not specifically prepared for injection into
animal or human in its purchased form.
If Yes, provide the scientific rationale for their use, source, proposed sterilization
technique, sterile packaging, labeling and expiration information along with proposed
methods to determine efficacy.
11
K.
PROCEDURE DETAILS
Non-Surgical
Animal Handling Rationale
38 Will blood sampling be conducted?
If yes provide rationale, method, site, volume frequency.
Rationale
Method
Site
(
Volume
(ml)
39
Will food scheduling or restriction (other than standard preoperative fasting) be conducted?
If yes provide rationale, frequency and duration.
Rationale
(
) NO
Frequency
(
Frequency
) YES
(
) NO
Duration
Will water scheduling or restriction (other than standard preoperative fasting) be conducted?
If yes provide rationale, frequency and duration.
Rationale
Frequency
(
41 Will restraint methods be utilized?
If yes provide rationale, frequency and duration.
Rationale
Frequency
(
40
) YES
) YES
(
) NO
Duration
) YES
(
) NO
Duration
12
42
SURGICAL
Route
Species
Strain
Drug
Dose
(I.V., I.P,
I.D.)
Administration Frequency
43 Duration and Monitoring
Supply duration and method of monitoring treatment efficacy for drug listed above.
Drug
Duration
Drug Efficacy Monitoring
Postoperative Plan (Methods to assess/alleviate pain/distress, recovery criteria, monitoring
criteria.
44
Will two or more of these survival surgeries involve major
procedures (defined as a surgical intervention that penetrates
and exposes a body cavity or any procedures that produce
substantial or permanent impairment of physical or
physiological function?
(
) YES
(
) NO
Federal guidelines specify that no animals are to be used in more than one major survival
operative procedure except in cases of scientific necessity or to provide adequate veterinary
care.
13
J. ANIMAL EXPOSURE: These sections will be compared to applicable safety committee
(s) regulations and should be consistent between documents.
45
Radioisotopes (Prior to any study involving the administration of radioisotopes to animals,
the Radiation Safety Office must review and approve the use).
( ) YES
( ) NO
Will radioisotopes substance be administered in live animal?
If you marked YES, complete attachment # 1 and provide the next information.
Species
Isotope
Activity
Dose
Location of Use
Strain
46
Biological Agents (Introduction of any genetically modified tissues, cells, viruses, or
vectors into animals requires approval from the Institutional Biosafety Committee).
Will biological agents be used in living hold or animal tissue?
(
) YES
(
) NO
If you marked YES, complete attachment #2 and provide the next information.
Species
Biological
Dose
Route
Effect
Strain
agent
Describe any adverse effect associated with the administration of these agents and a detailed
plan for monitoring and alleviating these effects if applicable:
47
Chemical Hazardous Agents (Do not include drugs used for therapeutic purpose) (Prior
to any study involving the administration of chemical agents to animals, approval from the
Institutional Chemical Committee is required).
Will chemical agents be introduced to the living animals?
If you marked YES, complete attachment #3
Species
Chemical
agent
Dose
(
) YES
(
) NO
and provide the next information.
Route
Effect
14
Describe any adverse effect associated with the administration of these chemicals and a
detailed plan for monitoring and alleviating these effects if applicable:
48
Tumor Lines/Body (Introduction of any genetically modified tissues, cells, viruses, or
vectors into animals require approval from the Institutional Biosafety Committee).
Will tumor lines or body fluids be introduced to the live animals?
(
) YES
(
) NO
If you marked YES, complete attachment #4 and provide the next information.
Species
Agent
Dose
Route
Effect
K.
EUTHANASIA
49
Will animals be euthanized
50
If YES, provide details of euthanasia procedure.
(
) YES
(
) NO
See http://www.avma.org/issues/animal_welfare/euthanasia.pdf for approved euthanasia
methods AVMA Guidelines 2007
15
L. LITERATURE SEARCH
Instructions:
Provide at least 2 keywords and delimiters used to search the literature for reference on
the background and experimental procedures addressed in this protocol.
Check (X)
keywords and
Database
Date Search
Years Covered
delimiters
Performed
Medline
Highwire.org
Schoolar.google.com
Current Research
Information (CRIS)
EMBASE
Other
M. PRINCIPAL INVESTIGATOR CERTIFICATION.
Your electronic signature or e-mail response on this protocol form certifies your agreement
to the following terms.

I certify that the research proposed herein does not unnecessarily duplicate any previous
investigations.

I confirm that the IACUC will be notified before initiating any changes in this protocol.

I certify that IACUC will be informed of any unexpected results that impact animals in use.
Any unanticipated pain, distress, morbidity or mortality will be reported to the attending
veterinarian.

I understand that in the event that I cannot be contacted, any animal that shows evidence
of distress, illness or pain, emergency care, including euthanasia if necessary, will be taken
care by the veterinary medical staff.

I ensure that I will inform any recipient (not listed on section A) of any hazard associated
with the use animal body fluids or tissue, derived from the studies described in this
protocol.

I certify that I will hand copy of the approved protocol to personnel identified in the section
A and will assure that they become familiar with details contained in this protocol.
Today’s Date (mm/dd/yy)
Signature
16
N.
CHECKLIST (Please respond by placing an X in the appropriate box).
General Sections (required)
X
Attachments
Include
X
Investigator/Personnel Information
Radioisotopes Use
#1
Project Information
Biological Hazard
#2
Funding Sources
Chemical Agents
#3
Animal Model
Tumor Lines/Body
#4
Rodent Breeding
and Weaning
Supplement
#5
Caging and Housing
Animal Enrichment
Use Sites and Transportation Methods
Procedure Narrative
Animal Welfare Act Required Information
Drug Administration
Procedure Details
Animal Exposure
Euthanasia
Literature Search
Certification
17
FOR OFFICIAL USE ONLY
COMMITTEE MEMBER
NAME
COMMITTEE
MEMBER
SIGNATURE
COMMENTS
1. Dr. Pedro Ferchmin
2. Dr. Krishna Baksi
3. Dr. Priscilla Sanabria
4. Dr. Legier Rojas
5. Dr. Juan Amieiro
Veterinarian Consulting
6. Dr. Misty Eaton
7. Dr. Thomas Schikorski
8. Mrs. Vivian Valiente,
Community Member
9- Dr. Luis Cubano
10- Lic. Betzaida Torres,
Supervisor
Animal Resource Center
11. Gerardo Torres
Student Representative
(Class 2016)
ACTION
Approved
Prof. Zilka Ríos
President of
UCC/IACUC
(
)
Approved with
modifications
(
)
Disapproved
(
)
Date (mm/dd/yy)
18
IACUC Attachment 1
Form: UCC/IACUC/URAAS-2012
USE OF RADIOISOTOPES ACTIVITY IN ANIMAL STUDIES
Approval must be obtained from the IACUC before this study may be performed.
Prior to any study involving the administration of radioisotopes to animals, the
Radiation Safety Office must review and approve the use. This form will be forwarded
to the Radiation Safety office by the IACUC.
1
2
3
4
5
6
7
8
9
e-mail
Principal Investigator
Title of Project
Strain
Radionuclide/
compound
# of animals
/study
# of animals
experiment/study
Dose
Project start date
Period of time over which experiments
will be performed
Location
where Room#
Building
administration will occur:
Location where radio- Laboratory
Animal facility room
labeled animals will be
housed
Period of time before animal will be
sacrificed
( ) YES
Are pathogenic/infectious agents to be administered also?
Route
(
) NO
REQUIREMENTS:
UNLESS AN EXEMPTION IS GRANTED BY THE RADIATION SAFETY OFFICE, THE FOLLOWING
REQUIREMENTS ARE MANDATORY:
1. In the Animal Resource Center, all cages with animals must be labeled with a “Caution
Radioactive Material” label stating the isotope and amount per animal, the date of
administration, and the authorized user name.
2. Animal cages must be properly surveyed for contamination before being returned to the Animal
Resource Center washer.
3. Animal carcasses that are disposed of as radioactive waste must be packaged separately. Do
not include any other material such as pads, tubing, needle, instruments, etc. with the carcass.
Signature of
Investigator
Date(mm/dd/yy)
Reviewed by
Date(mm/dd/yy)
Special Conditions and
Requirements
19
IACUC Attachment #2
Form: UCC/IACUC/ UBAA -2012
USE OF BIOLOGICAL ACTIVITY IN ANIMAL STUDIES
Approval must be obtained from the IACUC before this study may be performed.
Prior to any study involving the administration of biological to animals, the Biohazard
Committee must review and approve the use. This form will be forwarded to the
Biohazard Safety representative by the IACUC.
1
Principal Investigator
2
Title of Project
Species
Strain
3
4
5
6
7
8
Pathogen
e-mail
# of animals
/study
# of animals
experiment/study
Project start date
Period of time over which experiments will be performed
Location where administration will Room#
occur:
Location where pathogen-labeled
Laboratory
animals will be housed
Dose
Route
Building
Animal
facility
room
Period of time before animal will be sacrificed
REQUIREMENTS:
UNLESS AN EXEMPTION IS GRANTED BY THE BIOSAFETY SAFETY COMMITTEE, THE
FOLLOWING REQUIREMENTS ARE MANDATORY:
1. In the Animal Resource Center, all cages with animals must be labeled with a “Caution
Biosafety Material” label stating the pathogen and amount per animal, the date of
administration, and the authorized user name.
2. Animal cages must be properly surveyed for contamination before being returned to the Animal
Resource Center washer.
3. Animal carcasses that are disposed of as radioactive waste must be packaged separately. Do
not include any other material such as pads, tubing, needle, instruments, etc. with the carcass.
Signature of
Investigator
Date(mm/dd/yy)
Reviewed by
Date(mm/dd/yy)
Special
Conditions and
Requirements
20
IACUC Attachment # 3
Form: UCC/IACUC/UCAAS-2013-12-12
USE OF HAZARDOUS CHEMICAL AGENTS IN ANIMAL STUDIES
Approval must be obtained from the IACUC before this study may be performed.
Prior to any study involving the administration of hazardous chemical hazardous to
animals, the Chemical Committee must review and approve the use. This form will be
forwarded to the Chemical Committee representative by the IACUC.
1 Authorized User Name
e-mail
2 Title of Project
3
4
5
6
7
8
9
Strain
Hazardous
Chemical
Agent/compound
# of
animals/study
# of animal
experiments/study
Dose
Project start date
Period of time over which experiments
will be performed
Location
where Room#
Building
administration will occur:
Location where chemical Lab.:
Animal facility room
agent animals will be
housed
Period of time before animal will be
sacrificed
( ) YES
Are pathogenic/infectious agents to be administered also?
Route
(
) NO
REQUIREMENTS:
UNLESS AN EXEMPTION IS GRANTED BY THE CHEMICAL COMMITTEE, THE FOLLOWING
REQUIREMENTS ARE MANDATORY:
1. In the Animal Resource Center, all cages with animals must be labeled with a “Caution
Chemical Agent” label stating the chemical and the date of administration, and the authorized
user name.
2. Animal cages must be properly surveyed for contamination before being returned to the Animal
Resource Center washer.
3. Animal carcasses that are disposed of as chemical agent should be packaged separately in
special containers. Do not include any other material such as pads, tubing, needles,
instruments, etc. with the carcass.
Submitted by
Date(mm/dd/yy)
Reviewed by
Date(mm/dd/yy)
Special Conditions and
Requirements
21
IACUC Attachment # 4
Form: UCC/IACUC/UCTAS-2012
REQUEST TO INTRODUCE CELL LINES, TRANSPLANTABLE TUMORS, BODY FLUIDS,
SERUM, TISSUES, AND ANTIBODIES INTO ANIMALS.

Due to the risk of human or animal cell lines, transplantable tumors, body fluids, serum,
tissues, and antibodies being contaminated with rodent viruses, which can cause
disease outbreaks within the rodent’s colony or adversely affect research, the IACUC
requires testing of all such material that is deemed to be at risk.

Required testing is for pathogens to which the colony of recipient species is Specific
Pathogen Free (SPF). See the “Cell Line Usage and Rodents Biological” policy on the
IACUC web site for more details. Failure to complete any required testing prior to use in
animal is considered a noncompliance issue and puts the whole program at risk.

An investigator wishing to introduce any of the above biological into animal, must have
an approved protocol that describes the use of these biological and receive written
permission from the university consulting veterinarian or their designee before any
animals may be ordered.

To ensure rodent biosecurity, previously tested materials may be required to be
retested depending on how the materials have been handled and stored since testing
and if the original testing still meets the current policy standards. The need to retest
previously tested biological materials will be reviewed as part of the standard three year
IACUC protocol renewal
process and upon submission of IACUC protocol
modification.

Introduction of any genetically modified tissues, cells, viruses, or vectors into animals
require approval from the Institutional Biosafety Committee.
1
Principal Investigator
2
Title of Project
List the category of the biological (cell line, transplantable tumor, body fluid, serum,
tissue or antibody):
3
4
5
Designation (i.e. ID#, name, description)
Species
cell lines,
# of animals
Strain
etc.
/study
e-mail
# animals
experiment/stu
dy
Dose
Route
22
Description of Biological
Indicate the category of the biological (cell line,
6
transplantable tumor, body fluid, serum, tissue or
antibody):
7
Designation (i.e. ID#, name, description)
8
Histological type of material introduced
9
Species of origin of material introduced
10
Provide the name and contact information of the
source (institution and/or individual) providing the
biological.
11
Has this material been PCR, MAP or RAP tested for
viral pathogens? Is yes, send test result to IACUC
12
Please describe how the biological is stored or propagated in you laboratory. In the
case of a cell line please include the following information in your description:
 Is culture medium containing rodent serum or
rodent-derived feeder cells used during in vitro
( ) YES
( ) NO
propagation?
 Is the cell line incubated in the same incubator
( ) YES
( ) NO
with other rodent or human cell lines?
 Is the cell line ever manipulated at the same
time in the same biosafety cabinet as other
( ) YES
( ) NO
rodent cell lines?
 Is the cell line frozen as a stock and used as
( ) YES
( ) NO
needed or is it propagated in vivo or in vitro?
REQUIREMENTS:
UNLESS AN EXEMPTION IS GRANTED BY THE BIOSAFETY SAFETY COMMITTEE, THE
FOLLOWING REQUIREMENTS ARE MANDATORY:
1. In the Animal Resource Center, all cages with animals must be labeled with a “Caution
Biosafety Material” label stating the pathogen and amount per animal, the date of
administration, and the authorized user name.
2. Animal cages must be properly surveyed for contamination before being returned to the Animal
Resource Center washer.
Animal carcasses that are disposed of as radioactive waste must be packaged separately. Do
not include any other material such as pads, tubing, needle, instruments, etc. with the carcass.
Signature of Investigator
Date(mm/dd/yy)
Reviewed by
Date(mm/dd/yy)
Special Conditions and
Requirements
23
IACUC Attachment # 5
Form: UCC/RBWS-2013-12-12
RODENT BREEDING AND WEANING SUPPLEMENT
A.
Individual(s) Responsible for Colony Maintenance
1
P.I Name
Department
Emergency
Phone
(after hours) #
2
Work Phone #
3
E-Mail
4
Other Individuals Involved in Colony Maintenance (Must Also be Listed in Application
for Protocol Approval Involving Laboratory Animal Use, section A)
5
Describe training and experience of these individuals as it relates to colony
maintenance & breeding of animals:
B. Breeding Colony Justification
6
What strains will be bred?
Provide a justification for establishing and maintaining a breeding colony of animals at the
Universidad Central del Caribe.
24
C. Housing and Husbandry Issues
7
Building
8
Are there any special husbandry requirements needed for
the maintenance of the colony?
( )Yes
( ) No
If you answered yes, please describe the needs (e.g., special diets, special housing,
immunocompromized strains, etc.).
D. Colony Management Information (Please provide the following information below.
Request the Mice Breeding Protocol for additional instruction)
9
Breeding Scheme
(
)
(
)
(
)
Timed (hand) Mating
(
)
Other- Describe and provide a justification:
10
Pair Breeding (monogamous)
If this method is selected, describe how you will ensure that multiple litters do not occur
within once cage?
Weaning Plan (no greater than one litter is to be kept in a cage.
The
Investigator is responsible for weaning unless otherwise contracted).
(
)
(
)
11
Harem Mating (polygamous)
Principal
Animal will be weaned at 21-28 days.
The breeding requires additional time for weaning (beyond 28 days).
Please describe and justify below. You must include in your response how you will
ensure that the density of animals does not exceed the Guidelines for Animal Care and
Use.
Phenotype Information
Are there any health concerns associated with the development
( ) Yes
( ) No
25
of the phenotypes for the strains described?
If YES, please describe the health concern (e.g., behavioral, anatomical and/or physiological)
and describe how the health of these animals will be managed.
E. Genotyping and Other Colony Management Procedures
The goal of this section is to identify techniques and procedures used to manage your
colony.
12
Genetic Identification
(
)
Tail Clip- If clipping is done on animals
over 28 days of age, local or general
anesthesia is required.
If this is the case what anesthetic method
(s) will be used? (Specify to the right)
(
)
Blood sample-describe
procedure:
(
)
Anesthesia method (if applicable):
(
)
Other, (e.g., ear notch, buccal swab).
Specify:
13
the
collection
Age of animals for genotyping
(
)
0-21 days (anesthesia is recommended)
(
)
21-23 days (anesthesia is highly recommended)
(
)
21-28 days (anesthesia is strongly recommended)
(
)
>28 days and older (adult post-weaning-anesthesia is mandatory)
14
What method of animal identification will be used?
(
)
Ear notch
(
)
Ear tag
26
(
)
Tattoo
(
)
Microchip implant
(
)
Cage card identification only
15
Euthanasia
Will animals that cannot be utilized be euthanized in the same ( )Yes
manner as described in the IACUC Protocol Application?
( ) No
IF no, please describe the alternate euthanasia method planned
F. Estimated Number of Animals to Establish and Maintain the Colony
A mechanism for tracking colony management should be employed to allow review during
semiannual IACUC inspections. If you need assistance in estimating numbers, please refer to
ILAR Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research
(2003): http://www.nap.edu/books/0309089034/html
17
Enter Estimates
Estimated number of weaned and adult animals to be subject to
experimental manipulations.
(Please specify number of animals by: week, month or per year).
Estimated number of suckling animals to be subject to
experimental manipulations.
(Please specify number of animals by: week, month or per year).
Estimated number of breeder held but not subject to
experimental manipulations.
(Please specify number of animals by: week, month or per year).
Estimated number of suckling animals to be euthanized at or
prior to weaning, and not subject to experimental manipulation.
(Please specify number of animals by: week, month or per year).
TOTAL ESTIMATED
(Please specify number of animals by: week, month or per year):
27
FOR OFFICIAL USE ONLY
COMMITTEE MEMBER
NAME
COMMITTEE MEMBER
SIGNATURE
COMMENTS
1. Dr. Pedro Ferchmin
2. Dr. Krishna Baksi
3. Dr. Priscilla Sanabria
4. Dr. Legier Rojas
5. Dr. Juan Amieiro
Veterinarian Consulting
6. Dr. Misty Eaton
7. Thomas Schikorski
8. Mrs. Vivian Valiente ,
Community Member
9- Dr. Luis Cubano
10- Lic. Betzaida Torres,
Supervisor
Animal Resource Center
11- Gerardo Torres
Student Representative
(Class 2016)
ACTION
Approved
Prof. Zilka Ríos
President of
UCC/IACUC
(
)
Approved with
modifications
(
)
Disapproved
(
)
Date
(mm/dd/yy)
28
29
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