Download animal use

1
Hello and thank you for accessing this form from the
University of Maryland, Baltimore County Office for
Research Protections and Compliance
web site.
Prior to submitting, please ensure that spelling and
grammar are correct; this will assist in the timely review of
this form during the IACUC evaluation process. Complete
all sections of the protocol application (indicate N/A in the
section not applicable to your protocol). "See attached
proposal" or “See the previous section” are not an
acceptable responses.
Further instruction on the use of this form and guidance
about submission may be found on the Animal Care and
Use link
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
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Institutional Animal Care and Use Committee
Animal Research Protocol Form (Part 1)
Please complete areas below (attach additional pages, if necessary).
Investigator/Instructor:
Phone/E-mail:
Title of Protocol:
Sponsored Project Title and Number:
Anticipated Project Period:
(1)
ANIMALS (to be housed and used for
Research or
Teaching).
(Transgenic animal users – please complete section 3.B.5 below)
Species
Common
(Latin Name)
Strain
Room number
Age/Wt/Sex where housed
Projected # of animals
Year 1
Year 2
Year 3
Laboratory Rat
(Rattus norvegicus)
Laboratory Mouse
(Mus musculus)
Zebrafish
(Danio rerio)
Other (specify)
(
)
Other (specify)
(
)
Other (specify)
(
)
Maximum Daily Census
Will animals be obtained from a commercial supplier?
Yes
No If Yes, see the list of
approved commercial suppliers at http://www.umbc.edu/research/ORPC/IACUCprotdevelop.html#purchase.
If No, describe the source and supplier:
Note that animals from non-commercial suppliers must be quarantined and tested by UMB
Veterinary Resources before they are placed in the UMBC colonies.
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
3
(2)
PERSONNEL
A. Provide the name, title, the duties will this person perform relating to the animal
studies, dates of training completion for animal care (CITI) and occupational safety and
health (OSHP) and qualifications of each person involved in the animal use. NOTE:
Training must be completed before personnel may work on an approved animal
protocol.
CITI training is available at
http://www.umbc.edu/research/ORPC/Animal_care_use_training.html.
OSHP training is available at http://www.umbc.edu/safety/training.html.
Name
Title
Role
Current Training Dates
CITI
OSHP
Qualifications
B. Attach a CV for the PI to this application
C. What occupational health hazards exist for personnel? How will these risks be
minimized?
(3)
MANDATORY NARRATIVES
A. RATIONALE IN LAY TERMS. Federal regulations require that all investigators
provide a narrative describing the rationale for using animals, the appropriateness of the
species and the methods and specific sources used to determine that alternatives (e.g.
replacement, reduction, refinement) to the use of animals and to the procedures have been
considered. Provide a brief (100 word) description of what is being proposed and why.
B. ANIMAL USE. Justify the use of animals, the choice of species, the numbers to be
used, and the length of stay in the animal facility.
1.
Justify why animals are required, the choice of species, the numbers to be
used, and the length of stay in the animal facility.
Note: The animals selected for a procedure should be of an appropriate species and quality and the minimum
number required to obtain valid results. Methods such as mathematical and statistical models, computer
simulation, and in vitro biological systems should be considered.
(http://grants.nih.gov/grants/olaw/references/phspol.htm#USGovPrinciples)
2. Describe proposed animal living conditions and if species appropriate. When using
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
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mice, pay attention to the IACUC’s guidance on maximum cage population densities.
Also, will conditions be altered for the research in question?
3. Procedure and sources used for consideration of animal alternatives. Investigators are
required to conduct a search of at least two databases to search for suitable alternatives to
the use of animals, to substitute procedures that may cause more than momentary, slight
pain or distress to the animals and to prevent unintended and unnecessary duplication of
research. This is an AWA requirement and is specified in the government principles for
use and care of animals in the PHS policy. Alternatives can include non-animal models,
procedures that cause less pain or distress, or non-mammalian models. At least two (2)
databases must be consulted that address the “3 R’s” (replacement, reduction and
refinement). A variety of resources to complete the database search are found at the
Animal Welfare Information Center (click http://www.nal.usda.gov/awic/databases/database.htm for
samples). Please note that Medline, PubMed & Current Contents extract from the same
database and should NOT be considered as two separate searches.
Suitable Alternatives (submit one copy of this search with the application)
Date of search:
Databases used:
Dates included in search:
Key word search strategy, relevant to the protocol, used:
Use the Animal Use Alternatives Thesaurus Terminology
(http://www.nal.usda.gov/awic/alternatives/alternativeanimalusethesaurus.htm) for examples of key words
Momentary, slight pain or distress justification (submit one copy of this search with the application)
Date of search:
Databases used:
Dates included in search:
Key word search strategy, relevant to the protocol, used:
Use the Animal Use Alternatives Thesaurus Terminology
(http://www.nal.usda.gov/awic/alternatives/alternativeanimalusethesaurus.htm) for examples of key words
Unintended and Unnecessary duplication (submit one copy of this search with the application)
Date of search:
Databases used:
Dates included in search:
Key word search strategy, relevant to the protocol, used:
Use the Animal Use Alternatives Thesaurus Terminology
(http://www.nal.usda.gov/awic/alternatives/alternativeanimalusethesaurus.htm) for examples of key words
Additional information regarding these searches:
4. Describe potential biohazards (e.g., carcinogens, radioactive material, infectious
agents, recombinant DNA, etc) that may be used in the protocol and explain how its use
will be consistent with regulatory and university guidelines. Explain methods in detail.
Consult the Biosafety information found at, http://www.umbc.edu/research/ORPC
regarding the use of hazardous materials in animal protocols. Indicate N/A if biohazards
will not used.
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
5
5. Provide the date of approval from the recombinant DNA Safety Officer (see below
notes):
Research with animals involving certain types of recombinant DNA, the purchase of commercially-available
transgenic animals, as well as breeding of rodents with defined genetic ‘knock-outs’ (e.g. crossing two single
knock-out lines to produce a double knock-out rodent in the F1 generation) may be exempt from review
under the NIH Guidelines under Section III-F (1-8) Exempt Experiments , Appendix C-VI, The Purchase
or Transfer of Transgenic Rodents and/or Appendix C-VIII, The generation of BSL-1 Transgenic
Rodents via Breeding. Knock-out (gene silencing, gene ablation, etc.) rodents are exempt from the
NIH Guidelines as long as the method to generate the knock-out animal does not leave any “new”
genetic material behind in the genome after the procedure.
At the minimum, research with NIH Guidelines exempt transgenic animals will require a Biosafety Level 1
environment (pose minimal potential hazard to laboratory personnel, the laboratory is not separated from the
general traffic patterns in the building, work is generally conducted on open bench tops).
Experiments involving whole animals in which the animal's genome has been altered by stable introduction
of recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic animals) or experiments
involving viable recombinant DNA-modified microorganisms that do not fall under the NIH Guideline
exemption rule and will require review and approval from the IACUC and/or a properly constituted
Institutional Biosafety Committee.
6. Provide information that animal housing, husbandry and care requirements can be met.
Complete the Protocol Summary Sheet for Animal Care Staff form. Check here
complete Part 3 of the application)
C. METHODS.
(Note: if animal surgery is planned, please check here
complete Part 2 of the application)
and
and
1. Describe the experimental protocol in detail. Include information on behavioral,
dietary, environmental, pharmacologic, physiologic, surgical, and non-surgical
manipulations, etc, manipulations. Please describe the relevance and value of research
addressed, including research design. In particular, describe procedures designed to
minimize discomfort, distress, pain and injury to the animals. If anesthetics, analgesics
or tranquilizers are to be used, detail the dosage, route of administration with explanation,
the estimated duration, magnitude and relief of discomfort. If rodents are used, please
describe the animal enrichment devices for animals are to be singly housed. Provide a
diagram flow chart showing the number of animals used in each experimental
procedure. Please review the procedures for Common Drugs Used for Laboratory Animals and
Antimicrobial Drug Dosages for Laboratory Animals, found at
http://www.umbc.edu/research/ORPC/IACUCspecialtopics.html
2. Describe plan for monitoring post procedure or post-intervention care if utilizing
procedures that may cause pain, discomfort, or distress.
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
6
3. Restraints. Please justify the use of restraint devices. What restraint devices will be
used? What is the duration of the restraint? How often will animals be observed? Will
animals be conditioned to the device? Please review the procedures for Handling Common
Laboratory Species, found in the Appendices of the UMBC Animal Protocol Policy.
4. If surgery (survival or non-survival) is required, explain procedures in detail, including
methods, anesthetics, pre and post-operative care, aseptic techniques, room location, etc.
Complete the Animal Surgery Information form (Part 2). Indicate N/A on this form if
surgery is not required.
D. EUTHANASIA AND DISPOSITION
1. Explain the methods to be used for euthanasia and the reasons for their selection.
Specifically describe study end points and indicate the time point, if any, when animals
will be euthanized and how the death of the animal will be confirmed. Endpoints other
than death must always be considered and should be used whenever the research
objective can be attained with non-lethal endpoints. If death is an endpoint, explain why
it is not possible to euthanize the animals at
an earlier point in the study.
Using the guide at the left, list agents,
dosages and routes of administration. Refer
to the UMB Attending Veterinarian’s
Resource for Recommended Methods of
Euthanasia for species used in research at
UMBC. Please contact the veterinarian with
questions for other species.
2. Provide information
disposition of the animal.
on
the
final
Courtesy of Annabelle Crusan, DVM
3. If animals will not be euthanized, check below what will be done with any (describe
the disposition of) animals at the completion of a protocol (i.e. that are bred in excess of
your needs, or those that don't meet your needs of the approved protocol). Note: it is the
responsibility of the investigator to ensure that the final disposition of the animal is both
humane and acceptable.
euthanize and dispose
transfer to other IACUC approved protocols (must have IACUC approval)
transfer to another OLAW assured institution (must have IACUC approval)
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
7
(4)
COLLABORATIONS.
If you are collaborating with an investigator at another institution or organization,
or if you are housing your animals at another institution, include a copy of that
institution’s official IACUC protocol approval and protocol with this application.
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
8
Principal Investigator Assurances
I certify that I, the principal investigator/instructor, am responsible for all aspects of my animal
protocol. The information contained on this form provides an accurate description of the animal
care and use protocol and all personnel working on projects covered by this protocol have
received adequate and proper training in research procedures. I agree to abide by governmental
regulations and university policies concerning the use of animals and that compliance with the
standards for the humane treatment of animals that are described in the Guide for the Care and
Use of Laboratory Animals and the “Animal Welfare Act” is a prerequisite for purchasing,
housing and using animals at UMBC.
I understand that any changes to proposal design involving animal use or changes to personnel
involved in the project will be reported to the IACUC. I understand that unauthorized animal use
is reportable to the Office of Laboratory Animal Welfare (OLAW). I understand that any
unanticipated adverse events, morbidity, or mortality must be reported to the IACUC
immediately.
I will allow veterinary care to be provided to animals showing evidence of pain or illness. If the
information provided for this project concerning animal use should be revised, or procedures
changed, I will so notify the committee of those changes. All proposed changes will not be
implemented until full IACUC approval has been granted. I understand that failure to report
significant changes may place the university and me in violation of federal regulations.
I have conducted a search of at least two databases to assure that my research does not
unnecessarily duplicate the research of others and I have submitted one written copy of that
search. I have conducted a search of data bases for alternatives to use of live animals and have
submitted one written copy of that search. I have considered alternatives to procedures that may
cause more than momentary or slight pain or distress to the animals and by my signature I
stipulate that I have submitted one written copy of evidence of searches for alternatives.
PHS policy on the humane care and use of animals requires that all institutions receiving federal
research grants verify that the use of animals and the numbers of animals specified in a grant or
grant application are correspond with the use of animals and the numbers of animals specified in
all IACUC-approved animal use protocols associated with that grant or grant application. I verify
that the use of animals and the numbers of animals specified in my grant or grant application
correspond with the use of animals and the numbers of animals specified in the animal use
protocol.
Finally, I understand that if I or any of the project personnel have a financial interest related to the
research or sponsor (e.g. payment for services, equity interests, etc.) that it must be disclosed
according to UMBC Conflict of Interest policy.
________________________________________________________________
Signature of Principal Investigator
Date
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
9
Animal Surgery Information (Part 2)
NOTE: Leave blank if not applicable
Name of All Participating Surgeons,
Technicians and Students
1.
Species Used
Indicate Certification by Either
Training or Experience--Explain
Number Used
S = Survival
N = Nonsurvival*
Building/Room Where
Surgery Performed
*Non-survival surgery animal not allowed to awaken, once anesthetized
2.
Check following procedures that apply. If procedure is not listed, please use an additional page and describe
completely or attach literature reference article.
Biopsy:
target organ/tissue
Laparotomy
Intracranial
Thoracotomy
Orthopedic
Other
3.
PREOPERATIVE PROCEDURES
Have unhealthy animals been exempt for surgery?
Yes
No
Person responsible for evaluating health status of animals:
4.
ANESTHETIC PROCEDURES
Drug
Dose
Route
Duration
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
10
5.
POSTOPERATIVE PROCEDURE
Analgesics/
Anti-infective
Dose
Route
Duration
If postoperative analgesics will not be used, provide justification
Sterile technique must be used on all surgical procedures, including non-recovery procedures.
This includes a minimum of sterile instruments and gloves, a surgical mask, and surgical scrub of
the surgery area. All animals must be attended until they are able to right and stabilize
themselves.
CHECK THE FOLLOWING PROCEDURES THAT APPLY TO THIS PROJECT
Body temperature recorded
Surgical record kept
Veterinarian available
Kept on warm blanket until conscious
Veterinary technician available during procedure
Food and water withheld until fully conscious
Sutures removed at (when)
Notation made when animal eats/drinks
Dressing changes (frequency)
Other: describe:
6.
Will animals be subjected to more than (1) survival surgery?
Yes
7.
No If yes, provide justification for multiple survival surgeries. (Cost is not a
valid justification)
Describe arrangements for after-hours, weekend and holiday provision of the post-op care of your
animals
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
11
Protocol Summary Sheet for Animal Care Staff (Part 3)
NOTE: Leave blank if not applicable
IACUC USE
ONLY
Protocol Number
1. Investigator:
Expiration Date
Dept:
Phones:
Co-investigator
Dept:
Phones:
Technician:
Dept:
Phones:
Student:
Dept:
Phones:
2. Species (common names/Estimated numbers per year)
3. Location of animal housing (bldg & room)
4. Title of Protocol:
5. Sponsored Project Title and Number:
6. Anticipated Project Period:
7. Abstract of Research/Teaching Plan for the Information of Animal Care Staff
In the space provided, give a brief layman's description of the procedures involving animals.
8. Special Requirements for maintaining animals: Yes
No. If yes, indicate your
requirements below. If you have no special requirements, animals will be maintained according to
the standard operating procedure of the vivarium.
a. Temperature range: (oF)
; humidity (%):
b. Caging: type
size:
;
; light cycle:
; filter tops?
; cage changes/wk:
Animal facility personnel: please review the IACUCs guidance on maximum cage population densities for mice
c. Bedding/litter & type
; autoclaved?
; bedding changes/wk:
d. Type of water (ie sterile, deionized, acidified, tap):
e. Diet and feeding requirements: Special diet?
If other than ad lib feed & water, state amounts:
f. Type of enrichment provided for singly housed animals:
g. Other Special Instructions for Animal Care Staff:
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013
12
9. Check all that apply:
Biohazard
Yes
No
Agent
Radioisotope
Yes
No
Agent
Chemical Carcinogen
recombinant DNA
Yes
Yes
No Agent
No
Agent
Consult the Biosafety information found at, http://www.umbc.edu/research/ORPC/ regarding the
use of hazardous materials in animal protocols.
IACUC Animal Research Protocol Form
Electronically submit the entire protocol to [email protected]
Updated 11/13/2013