Rev. September 2009
UNCW Institutional Animal Care and Use
Application to Use Live Vertebrate Animals in
Research or Educational Programs
For IACUC Use Only
Protocol #: A 1112 - ________
Approval Date: _____________
Expiration Date: ____________
PART A: General Project Information
1. Project Title (use same title as grant proposal, if applicable):
New Protocol
2. Project Support:
OR
Replacement for Protocol #
Awarded
Pending
Grant*: Agency
UNCW Grant #
Proposal #
*A copy of the grant proposal must be submitted
Intramural Research Support:
Submitted
Approved: Date
Departmental Support:
Teaching Course
Other: Specify
3. Estimated start date of project:
4.
Estimated completion date of project:
5. Scientific and Technical Merit Review – Check only one.
This study has undergone an extramural peer review for scientific and technical merit by
the funding agency referenced above.
This study has undergone a peer review for scientific and technical merit within
UNCW. I selected appropriate peer reviewers who are knowledgeable in this area of
research and qualified to conduct such a review.
NOTE TO UNCW PEER REVIEWERS: By signing below you are certifying that 1)
EXPIRATION
DATE:
you are appropriately qualified to conduct a peer review for
scientific and
technical
merit for the type of research described in this protocol, and; 2) you are confident
that the activities described in this protocol have scientific and technical merit.
Peer Reviewer Printed Name
Peer Reviewer Signature
Date Reviewed
1.
2.
FOR IACUC USE ONLY
Full Board Decision:
Approved
Changes Required - Referred to DR
Disapproved
Date of Full Board Decision:
Designated Review Decision:
Approved
Unable to Approve - Referred to Full Board
Date of Designated Review:
If applicable, revisions/clarifications received:
IACUC Reviewer Signature: ___________________ Print Name: _______________________
IACUC Chair signs on behalf of Full Board unless IACUC Chair is PI.
PART B: Confidential Project Information
The information in this part is not subject to release under NC public records law and will be kept
in a separate folder marked “confidential”.
1. Research Team Members
Provide contact and training information for all research team members. If a team member is
to be an emergency contact for the IACUC, please check the Emergency Contact box next to
the person’s name.
a. Principal Investigator (must be faculty member)
Emergency Contact
Name
Title
Department
Phone #
Email
Online IACUC Training Date:
Other experience/applicable training for this project (years of experience with species, etc.):
b. Role
Examples: Co-PI, Student Researcher (if student is primary researcher and PI
is providing oversight only), Research Assistant
Emergency Contact
Name
Title
Department
Phone #
Email
Online IACUC Training Date:
Project responsibilities: List responsibilities and experience/applicable training for them,
including hands-on training by PI or other qualified study personnel listed on this protocol:
c. Role
Emergency Contact
Name
Phone #
Email
Online IACUC Training Date:
Project responsibilities: List responsibilities and experience/applicable training for them,
including hands-on training by PI or other qualified study personnel listed on this protocol:
d. Role
Emergency Contact
Name
Phone #
Email
Online IACUC Training Date:
Project responsibilities: List responsibilities and experience/applicable training for them,
including hands-on training by PI or other qualified study personnel listed on this protocol:
e. Role
Emergency Contact
Name
Phone #
Email
Online IACUC Training Date:
Project responsibilities: List responsibilities and experience/applicable training for them,
including hands-on training by PI or other qualified study personnel listed on this protocol:
Note - If additional space is needed, complete an Additional Personnel Appendix. This form can
be found on the IACUC website: http://www.uncw.edu/orssp/conduct-animal-forms.html
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2. Primary housing locations: Provide building and room number of facility. Animal facilities are
subject to inspection twice per year. If animals will be housed anywhere else outside approved
animal housing facility for more than 12 hours, provide location and justification.
3. Locations where experiments and any other activities will be conducted: Provide building
and room number of facility. If animals in the wild will be used, state the location of the field
study and describe if the study will involve observation or interaction. As appropriate, describe
the observation method, type of interaction, whether the animals will be disturbed or affected,
and any special procedures anticipated. If federal or regional permits are required, respond to
PART D. #3b below and attach copies of permits.
4. Public Disclosure: Does this protocol describe any unpublished techniques, procedures or
data for which copyright or patent may be sought, or the disclosure of which would place your
research effort at a competitive disadvantage?
Yes
No If yes,indicate below the
protocol section number(s) you wish to be considered for exemption from disclosure.
5. Signatures and Certifications:
a. I hereby apply for a three-year protocol approval (with annual review required at the end
of the first and second years) for the project described below, and assume responsibility for
the animal care and use associated with this research.
b. I understand the requirements of the PHS Policy on Humane Care and Use of Laboratory
Animals, applicable USDA regulations if any, and UNCW policies governing the use of
vertebrate animals for research, testing, teaching or demonstration purposes. My
signature certifies that I will conduct the project in full compliance with the
aforementioned requirements.
c. I certify that the activities listed in this protocol do not unnecessarily duplicate previous
experiments.
d. I certify that all personnel involved in the animal care, treatment and use aspects of this
protocol are, or will be, adequately trained prior to participation in this study.
e. I certify that I will obtain approval from the IACUC before initiating any changes to the
study.
f. I certify that I have contacted the UNCW Environmental Health and Safety Office for any
applicable laboratory or other safety training for myself and/or my research team
members, and have obtained the required EH&S approval for any activities that involve
hazards materials, such as radio nuclides, biological agents, hazardous chemicals or
drugs, or recombinant DNA.
g. 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.
Principal Investigator: __________________________________
Signature
End of confidential section.
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________________
Date
UNCW Institutional Animal Care and Use
Application to Use Live Vertebrate Animals in Research or Educational Programs
For IACUC Use Only
Protocol #: A 1112- ______ Approval Date: __________ Expiration Date: __________
Project Title:
PART C: LAY SUMMARY
Under each question below, write a brief summary of the research (250-300 words) as if it were a
newspaper article. Use general terms so that a well-educated lay non-scientist can understand the
nature of the proposed work. Medical and technical terms and phrases should be defined in lay
terms to the extent possible.
1. What are you trying to find out? Why is it important to know this (what is benefit)?
2. What will you do with the animals? (Include common name for animal and describe all
interactions with animal.)
3. Why is this type of animal needed?
PART D: TECHINCAL METHODS AND PROCEDURES
1. State the scientific aims of the study and/or hypotheses to be tested:
2. Experimental Design and Methods: Describe the experimental groups and outline the procedures
involving live animals that will be used to accomplish the specific aims of the study. Surgical details
need not be described here. If performing surgery, attach a Surgery Appendix (see PART E of this
form). Procedures performed on tissues removed from animals need not be described in detail.
3. Technical Species Description and Information
Please note - IACUC protocols may be approved for up to 3 years, with annual reviews required
after years 1 and 2. Provide number of animals needed for each year. Updates will be requested
during annual reviews of the project. A Pain Category chart follows for your reference.
Species
Pain
Estimated Number of Animals
Identification
Source of Animal
Category*
Needed
Year 1 Year 2 Year 3 Total
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Totals
Notes or Clarifications Regarding the Above Chart (Optional):
a. Approximately how many animals do you expect to house on any given day?
b. Is any species listed above endangered or protected?
Yes No If yes, explain below:
c. Do you need any special permits or licenses to capture any species listed above?
Yes No If yes, explain below:
If permit is needed: By checking this box the principal investigator
certifies that neither s/he nor any member of the research team will conduct
any of the activities described in this protocol without first obtaining the
necessary permits.
* For Reference - - - Pain Categories and Examples
Classification B: Animals being bred, conditioned, or held for use in teaching,
testing, experiments, research, or surgery, but not yet used for
such purposes.
Examples include: breeding colonies; newly acquired animals;
animals held under proper captive conditions; wild animals that are
being observed.
Classification C: Animals upon which teaching, research, experiments, or tests
will be conducted involving no pain, distress, or use of painrelieving drugs.
Examples include: routine examinations; blood sampling; injection
of non-toxic materials; approved methods of euthanasia that induce
rapid unconsciousness; short periods (up to 24 hours) of
withholding food and water.
Attach Pain and Distress Appendix to this application for D & E Classifications (See
PART E of this form)
Classification D: Animals upon which experiments, teaching, research,
surgery, or tests will be conducted involving accompanying
pain or distress to the animals and for which appropriate
anesthetic, analgesic, or tranquilizing drugs will be used.
Examples include: terminal surgery, as well as recovery surgery
and procedures performed under anesthesia. Also included are
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behavioral studies on restrained animals; studies using noxious
stimuli from which escape is possible; use of Freund's complete
adjuvant; experiments involving predator-prey interactions. Also
included are studies in which diseases or toxicities are induced
and the animals are expected to become sick or abnormal.
Animals in Type D studies may experience
pain/stress/discomfort, but the necessary treatments to alleviate
the symptoms are available and provided, or the animals are
euthanized.
Classification E: Animals upon which teaching, experiments, research, surgery,
or tests will be conducted involving accompanying pain or
distress to the animals and for which the use of appropriate
anesthetic, analgesic, or tranquilizing drugs will adversely affect
the procedures, results, or interpretation of the teaching,
research, experiments, surgery, or tests.
Examples include: studies of acute and chronic pain; application of
noxious stimuli from which escape is impossible; the use of muscle
relaxants in surgery without concurrent use of anesthetics; studies
where death is the end-point, i.e. diseases are induced and infected
animals are permitted to succumb rather than treated or euthanized.
4. Justifications:
a. Number of Animals
Explain why the number requested above is the minimum number of animals you can use to
achieve valid results either by providing journal citations in which a similar number of
animals have been used for the specific type of research proposed, or by including a suitable
power calculation below. If you are unable to provide one or the other, explain why.
b. Alternatives
Explain how you have investigated alternatives to animal use and why alternatives are not
appropriate. List websites checked (such as Alt.web- http://altweb.jhsph.edu/ or the
Animal Welfare Information Center - http://www.nal.usda.gov/awic/).
c. Refinement of Procedures
Explain how procedures have been refined so as to eliminate or reduce unnecessary pain
and distress in animals.
5. Transport of animals: If you will transport animals between locations, describe containment
method and what safety precautions are in place for the animals and staff during transport.
6. Staff Safety: Please check any safety issues that personnel may encounter in performing the
research activities or husbandry responsibilities. NOTE: By checking a box the PI certifies that
staff has been appropriately trained on minimizing the risk of injury.
Safety Issue:
Back injury (from lifting cages/ feedbags)
- Train on proper lifting procedures
Slip/fall injuries (wet floors/boats)
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- Train on proper shoes to wear in lab/on boats
- Train on proper lab maintenance procedures to avoid wet floors
Bites (from handling animals)
- Train on proper handling procedures
- Provide protective gloves or other gear
Needle stick
- Train on proper sharps disposal
- Provide protective gloves or other gear
Burns (washing cages, chemical burns)
- Train on proper use of hot water/steam cleaner
- Protective gear
Eye injuries (from bedding particles, UV lights, chemicals)
- Provide goggles
- Train on proper use of eyewash station
- Periodic inspection of eyewash station (operational?)
Allergens (from animal hair, serum, animal proteins)
- Protective garments
- Fit-test for respirator
Other exposures (biohazard, chemical, radiation)
- UNCW Environmental Health and Safety training
No safety issues identified
7. Special Concerns: List any special concerns or requirements pertaining to special housing
needs, equipment, or animal care, etc.
8. Disposition of Animals:
a. Euthanasia
i. Method - must be consistent with the recommendations of the June 2007 AVMA
Guidelines on Euthanasia http://www.avma.org/issues/animal_welfare/euthanasia.pdf.
Provide a detailed justification if the method is not recommended by the AVMA.
ii. Confirmation of Death - describe how death will be confirmed. Note: any instances of
unsuccessful euthanasia must be reported to the IACUC immediately.
iii. Disposal – describe method of disposal.
b. Other
i. Describe if animals will be released, returned to pet store or other method of disposition.
ii. In the event a distressed animal cannot be released as stated above and requires euthanasia, please
state the method that will be used. This must be consistent with the recommendations of the June
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2007 AVMA Guidelines on Euthanasia http://www.avma.org/issues/animal_welfare/euthanasia.pdf
Provide a detailed justification if the method is not recommended by the AVMA.
PART E: DRUG ADMINISTRATION Complete if drugs will be administered.
1. What is the estimated time period the animal will be anesthetized per exposure to the
anesthetic drugs?
2. If neuromuscular blocking agents are used, how will the plan of anesthesia be monitored?
3. Describe the tracking and security of controlled drugs (Drug Enforcement Administration
requirements).
Table A. Anesthetic drugs (including neuromuscular blocking agents) administered to live
animals.
Drug (generic name) Initial Dose (mg/kg) Additional Maintenance
Route
Dose (mg/kg)
Table B. Post Surgical/post Procedural Analgesic or Tranquilizing Drugs
Drug (generic name)
Dose (mg/kg)
Route
Table C. All other Drugs or Agents (Experimental or therapeutic.)
Drug/Agent
Dose (mg/kg)
Route
Frequency
(generic name)
Frequency of
Administration
Estimated
Duration of
Treatment
PART F: SURGERY Complete if surgical procedures are a planned aspect of this study.
1. State whether the procedure is terminal or survival.
Terminal
Survival
2. Indicate the building and room number where the surgery will be conducted.
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Building
Room
3. Details of procedure: Provide a brief (less than 1 page) description of the surgical procedure.
4. Qualifications of personnel performing procedure:
5. Complete the table below:
Experimental Group
Number of Major
Survival Surgeries
per Animal *
Number of Minor
Survival Surgeries
per Animal
Previous Major
Surgeries per animal
from other studies
*Definition: Major survival surgery is any surgical intervention into a body cavity or having the potential
for producing a permanent handicap in an animal that is expected to recover. The body cavity involved
may be cranial, vertebral, thoracic, abdominal, peritoneal or joint.
6. If more than one major survival surgery is planned, provide scientific justification and
list interval between procedures. You must also consider major surgery that has been
performed prior to an animal’s inclusion in this protocol.
7. Describe post-surgical care, including:
a. Name(s) of individual(s) responsible for providing post-surgical care.
b. Frequency of animal monitoring
c. Signs of distress monitored
d. Criteria for analgesics
e. Criteria for removal from protocol
PART G: DIETARY MANIPULATIONS: Complete only if animal diets will be manipulated or
restricted for more than 24 hours.
1. Will the animals be fed experimental diets?
Yes
No
If yes, describe the features of the experimental diets and any potential adverse
consequences related to the diets.
2. Does the protocol involve food or water restriction?
Yes
No
If yes, provide a description of the procedures involving food or water restriction, and the
methods use to monitor the health of the animals.
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PART H: PAIN AND/OR DISTRESS Complete only if animals will experience more than momentary
or slight pain or distress, or if unanesthetized animals will be restrained for prolonged periods. Please
check the N/A box if one of the activities does not apply.
FEDERAL REGULATIONS REQUIRE RESEARCHERS TO CONSULT WITH THE
ATTENDING VETERINARIAN FOR ANY PROCEDURE INVOLVING PAIN OR
DISTRESS. PLEASE CONTACT DR. TIM FORD PRIOR TO COMPLETING THIS
SECTION (trford_dvm@yahoo.com, 910-431-1549).
1. Pain or Distress (
N/A)
a. Please describe the nature of pain or distress that will be experienced by the animals.
b. Will appropriate analgesia be used?
c. Will appropriate anesthesia be used?
If No to either, provide justification:
Yes
Yes
No
No
2. Prolonged Restraint
(
N/A)
Provide justification for the use of prolonged restraint on unanesthetized animals.
I certify that I have reviewed the pertinent scientific literature and the sources and/or
databases as noted 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.
Principal Investigator Signature
Date
Attending Veterinarian certification of review and consultation on proper use of anesthetics
and pain relieving medications for any painful procedures:
Veterinarian Signature
Date
Please submit one original, signed hard copy and one electronic copy of this form to Angela
Pennell Kelly in the Office of Research Services and Sponsored Programs (hard copy to
Hoggard Hall, Room 174 or Campus Mail Box 5973, electronic copy to kellya@uncw.edu).
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