PROTOCOL NUMBER:
PROTOCOL
REVIEW FORM
INSTITUTIONAL
ANIMAL CARE AND USE COMMITTEE
GENERAL INSTRUCTIONS: The
Institutional Animal Care and Use Committee (IACUC) consists of scientists from
several disciplines as well as non-scientists, members of the University community,
and persons who have no other affiliation with the University than as members
of the Committee. The protocol should
therefore be described in terms understandable by an audience of educated
nonspecialists. Please return the
completed protocol to the Institutional Animal Care and Use Committee, c/o
Office of Research and Sponsored Programs, 443 Corbett Hall. The form is due TWO weeks prior to a scheduled IACUC
meeting. The meeting dates are posted
at: http://orspdocs.umesp.maine.edu/Ethical/duedates.htm. Protocols received late will be held until
the next month’s meeting. Please
call Gayle Anderson at 1-1498 if you have questions.
The
Principal Investigator or Instructor must justify the ethical costs of using
live animals by demonstrating a reasonable expectation that such usage will
contribute to the advancement of knowledge which may eventually benefit
humankind and/or animals. The Principal
Investigator or Instructor must further demonstrate that he or she has applied
the concepts of "alternatives" in designing the protocol. The term “alternatives” includes three
components: replacement (using
organisms that are phylogenetically lower, cell cultures, tissues from
slaughter or autopsy, or nonanimal systems); reduction (in the number of
animals used); and refinement (of design and methods to reduce pain and
stress to animals used).
1. Principal Investigator,
Co-Investigator(s), or Instructor(s), with campus address, office phone, and
lab phone of PI (NOTE: The Principal
Investigator or Instructor must be a faculty member or professional staff):
Title and number of course/Title of project:
Project/Course
Start Date:
Number
of years project is planned to continue:
(IACUC
approval is granted for three years)
If
this is a renewal application, please enter the exact project or course title
and previous protocol code, if any. Be
sure to identify any changes from the previously approved protocol.
Funding agency for project, if
applicable. Include title of proposal if
different from this protocol.
2. Describe
the research or teaching objectives (not procedures) that involve use of
animals. Explain these objectives in
non-technical language.
3. How
will this use of animals contribute to the advancement of knowledge which may
eventually benefit humankind and/or animals.
4. Identify
the species of animals to be used and number (for the entire project) of each
species to be used. Check
http://orspdocs.umesp.maine.edu/Ethical/animalweb.htm for current guidelines
for use of animals in research/teaching.
5. State the rationale for use of this/these
species. Address the issue of replacement
by explaining why educational or research objectives cannot be met by the use
of phylogenetically lower organisms, cell or tissue cultures, or nonanimal
systems. (Please note: the IACUC does not consider "hands-on
experience" to be in and of itself an adequate
educational objective, unless the course serves students whose anticipated
educational and professional futures will require the skills imparted through
such hands-on experience. If that is
true in this instance, please describe the student population that typically
enrolls in the course.)
6. Justify
the number of animals:
a. Explain
how the number of animals required for this proposal fits your study design.
b. Give the
rationale for the number in terms of the statistical methods to be used. Address the issue of reduction by
explaining why the proposed number is sufficient, but not excessive. (A simple statement that the number proposed
is required for statistical significance is not an adequate response.)
7. PROCEDURES
The
Committee does not wish to receive copies of research proposals or laboratory
manuals. The Principal Investigator or
Instructor is asked to address succinctly the following questions, as applicable. Special care should be taken to justify any
procedures generally discouraged by the University's code of ethics and policy.
a. Major
categories of procedures. Please check
the appropriate box for each category.
Any
“yes” responses must be described in sections b. (nonsurgical procedures)
and/or c. (surgical procedures) that follow.
Please use the category heading (from 1-17 below) with the description
of procedures.
Yes No
2. kill and harvest tissue
3. immunization for antibody production: describe antigen, adjuvant used, route of
immunization, method of obtaining blood.
6. pharmacology/toxicology: material used, route of administration, etc.
8. environmental stress, e.g.,
temperature, restraint, forced exercise
9. irradiation: type, facility to be used
10. biohazardous materials, e.g.,
carcinogens, radioactive materials
11. hazardous materials
12. infectious agents (use of Class 2 or
higher agents requires the approval of the University's Biosafety Committee)
14. nonsurvival surgical procedure
15. survival surgical procedure (animal is
allowed to recover for any length of time)
16. multiple major operative procedures from
which animal is allowed to recover.
b. Nonsurgical
Procedures:
Describe all nonsurgical manipulations or procedures,
if any, involving the animal, e.g., drug administration, blood collection, diet
change, collection, capture. Specify the
drug(s), dose, route of administration, or other methods used. Specify duration of procedures. If an adjuvant will be used, state the number
of injection sites per dosage and the number of doses.
Will the animals be killed? If so, what method of euthanasia will be
used? (Include dosages if
applicable.) See the 2000 Report of the
AVMA Panel on Euthanasia for assistance
(http://www.avma.org/resources/euthanasia.pdf). If not, what final disposition of the animals
is planned?
If euthanasia becomes necessary, due to unplanned
injury or illness to the animal(s), how will it be accomplished (include
dosages if applicable)? See the 2000
Report of the AVMA Panel on Euthanasia for assistance (http://www.avma.org/resources/euthanasia.pdf).
c. Surgical
Procedures:
Describe briefly any surgical procedures. Describe the anaesthetic method, including
all drugs, dosages, routes of administration, and supplementation
schedules. Describe the postsurgical
monitoring and care procedures, and the method of euthanasia (if it becomes
necessary due to unplanned injury or illness).
Is animal allowed to recover for any length of
time? If so, how long will animal
survive surgery?
If there is potential for discomfort or pain as a
result of the procedures, describe their nature and duration. Explain what will be done to relieve them,
including drugs and dosages, nursing care, mechanical devices, etc.
d. Search
for Alternatives: If the proposed
procedures cause more than momentary or slight pain or distress to the
animal(s), federal regulations require that you search for alternatives. The PI must provide a written narrative
description (see NOTE below) of the sources used to determine that less
painful alternatives are not available.
To fulfill this requirement, bibliographical searches may be performed
through the
Will
the proposed procedures cause more than momentary or slight pain or distress to
the animal(s)?
No. (Examples of procedures for which this
response is appropriate include observation of behavior under conditions of
little or no distress, dietary manipulations, and injections or blood sampling
by qualified personnel.)
Yes. (Examples of procedures for which this
response is appropriate include survival surgery, nonsurvival surgery,
electrofishing.) The required narrative
is attached. NOTE: When preparing the narrative, the
instructions in the USDA policy MUST be followed. For a description of this policy, see: http://www.aphis.usda.gov/animal_welfare/downloads/policy/policy12.pdf.
8. Animal
Sources and Housing
a. Please indicate source of animals. Note: The IACUC will approve animal purchases from a licensed pet store provided the researcher/instructor informs the pet store (in writing) that the purchased animals will be used for research/teaching.
b. If the animals are caught in the wild, where
and how will the animals be trapped? How
often will the traps be checked? What
other steps will be taken to protect the animals from exposure or other danger? Indicate if Federal/State permits are
required and whether they have been obtained.
If the animals will be brought to the campus, what precautions will be
taken to prevent zoonotic diseases?
c. Where will the animals be housed?
d. Identify the room or facility in which
the procedures will be conducted.
9. Person(s) who will handle animals (e.g.,
carry out the procedure(s), animal care, etc.).
If someone other than the PI is responsible for supervision of those
handling animals, please list that person as well.
Name/Title
10. If
animals will be housed, please list the name, phone number, and email of the
person who should be contacted to accompany the IACUC during facility
inspections:
11. Have
all personnel named above been certified by the IACUC for Responsible Care and
Use of Animals?
Yes No A web-based tutorial for this certification is
available at: http://www.umaine.edu/iacuc. (Note: protocols will not be processed until all
personnel have been certified.)
ASSURANCES FOR THE HUMANE
CARE AND USE OF ANIMALS
As
the Principal Investigator on this protocol, I assure that…
1) I have provided an accurate description of the animal care
and use protocol to be followed in the proposed project/course.
2) the activities proposed do not
unnecessarily duplicate previous experiments.
3) all individuals named in this application who are at risk
will be registered in the Occupational Health and Safety Program.
4) all individuals performing animal procedures described in
this application are technically competent and have been (or will be) properly
trained in the procedures to ensure that no unnecessary pain or distress will
be caused as a result of the procedures.
5) I will obtain approval from the IACUC before initiating any
changes to this protocol.
6) I am familiar with and will comply with the University of
Maine’s Policies and Procedures for the Humane Care and Use of Animals, and
I assume responsibility for compliance by all personnel involved with this
protocol.
7) I have read and will follow the appropriate guidelines for
the proposed species.
8) if using laboratory animals, all personnel handling the
animals have had a tetanus shot within the past ten years.
9) all applicable rules and regulations regarding radiation
protection, biosafety, recombinant issues, hazardous chemicals, etc., have been
addressed in the preparation of this application and the appropriate reviews
have been initiated.
10) animals will be purchased only from licensed, reputable
vendors. If animals are purchased from a
pet store, the pet store has been informed (in writing) that the animals will
be used for research or teaching purposes.
11) I will maintain appropriate animal records (e.g., census,
health, veterinary care, euthanasia, surgery, diagnostic, anesthesia, etc.)
12) I will report at once to the IACUC any
unanticipated harm to animals.
___________________________________________ _____________________
Signature
of Principal Investigator/Instructor Date
I
hereby confirm that I have read this protocol and my signature denotes
departmental approval of this project.
___________________________________________ ______________________
Signature
of Department Head/School Director Date
PROTOCOL NUMBER:
Course/Project Title:
PI:
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For Committee Use Only: Date of
IACUC Receipt: __________ Date of IACUC Review: _____
Committee Action:
_____ 1. Approved
until ___________________
Species
and # of animals approved:
_________________________________
_____ 2. Modifications
required. See attached statement.
_____ 3. Disapproved. See attached statement.
_____ 4. Reviewed
and determined not to fall under the Policies and Procedures for the Humane
Care and Use of Animals (explanation)
__________________________________________
______________________________________________________________________
Full IACUC Review:
_________ Subcommittee
Review: ________
IACUC Signatures:
_______________________ _______________________ ______________________
_______________________ _______________________ ______________________
_______________________ _______________________ ______________________
June
2006