Institutional Animal Care and Use Committee

Keith J. O’Neill Center for Healthy Families, Room 208

2300 Adams Ave., Scranton, PA 18509 (570) 961-4778 email:

APPLICATION FOR ANIMAL USE IN RESEARCH AND TEACHING

The purpose of this application is to determine if proposed animal use is in accordance with both Marywood University and Federal Regulations. Marywood University’s IACUC will make this determination. Incomplete application packages will not be reviewed.

TITLE OF STUDY:
Principal Investigator (PI) / Name:
University Status:
__Faculty
__Staff
__Doctoral Student
__Graduate Student
__Undergraduate Student
__Researcher from outside Marywood University
__Other – Specify:______/ Academic Department:
Mailing/Campus Address (room, building, street address):
Phone: Email:
CITI Use of Animals Basic Course Completion Date:
Responsible Conduct of Research (RCR) Course Completion Date:
Co-Investigator / Name:
University Status:
__Faculty
__Staff
__Doctoral Student
__Graduate Student
__Undergraduate Student
__Researcher from outside Marywood University
__Other – Specify:______/ Academic Department:
Mailing/Campus Address (room, building, street address):
Phone: Email:
CITI Use of Animals Basic Course Completion Date:
Responsible Conduct of Research (RCR) Course Completion Date:
Sponsor/Advisor / Name:
University Status:
__Faculty
__Staff
__Doctoral Student
__Graduate Student
__Undergraduate Student
__Researcher from outside Marywood University
__Other – Specify:______/ Academic Department:
Mailing/Campus Address (room, building, street address):
Phone: Email:
CITI Use of Animals Basic Course Completion Date:
Responsible Conduct of Research (RCR) Course Completion Date:
KEY PERSONNEL
Please list all other individuals involved with this study. Individuals involved in handling the animals and/or data must be listed.
Name / Research Role
(Thesis committee member, research assistant, etc) / University Status
(Faculty, staff, doctoral student, graduate student, undergraduate student) / CITI Human Subjects Training Completion Date / RCR Training Completion Date

EMERGENCY CONTACT

Primary contact person in case of emergency:

Name:______Phone:______Email:______

COLLABORATING INSTITUTION(S)

Is another agency/institution granting access to data or animals or their facilities for your research (e.g. school, university, hospital, laboratory, or other facility)?
___ No ___Yes - Name of Organization(s): ______
Has this study been submitted to the collaborating institution’s IACUC for review: ___Yes ___ No
__ I am submitting the Approval letter from the collaborating institution(s) to Marywood’s IACUC.

FUNDING

___ None
___ Funded research (select (X) all that apply):
___ Internal Funds (Student or Faculty Research Award) ___ External Funds (State/Fed./other)

DESCRIPTION OF PROPOSED RESEARCH

Please provide an overview of the proposed research project, using the space provided in each section below to clearly and thoroughly describe your proposed research. Be as specific as possible. Use as much space as needed. Do not modify or delete the instructions for each section. Narratives that do not follow the outline or are not written clearly may delay the approval process.
SECTION 1: PROJECT OVERVIEW
Provide a description the purpose and objectives of your research or instructional project. Please include Benefits to man, animal or advancement of knowledge that will be or has been obtained from this study. Please describe the experimental design in “layperson’s” terms so that it is easily understood by IACUC members who are not in your academic discipline.
SECTION 2: PAIN CATEGORY
Categorize the potential for pain and distress based upon the USDA definitions. Assign animal numbers for each category. Total must equal the total number of animals requested.
___ / Category B – No pain or distress (e.g. holding protocols, colony animals not on study).
___ / Category C – Minimal pain or distress (e.g. momentary - gavage, injections, fasting up to 24 hrs, euthanasia only, etc.).
___ / Category D – Relieved pain or distress (e.g. orbital sinus bleeds under anesthesia, surgery or any study in which anesthetics or analgesics are administered).
Not an option / Category E – Unrelieved pain or distress (e.g. toxicology studies, adjuvant studies, footpad injections) Marywood University does not support Category E studies.
___ /
Total number of animals requested
SECTION 3: ANIMAL MODEL INFORMATION
A. Animal Description: Please describe the species, strain/breed, weight and gender of the animals in the
“Description” column below:
Description
Species
Strain/Breed
Weight
Gender
B. Are these transgenic animals? ____ Yes ____ No
If Yes, describe genetic background: List adverse phenotypes and appropriate monitoring for health and well-
being.
C. Please provide experimental information about the group designators (e.g. affected vs. controls), group sizes
(number of animals per group), and any animals to be utilized for model development or pilot study purposes:
Total listing of experimental groups by name / Number of animals/group / Additional animals needed
Example: Treated
Example: Control

D. What is the total number of animals to be used in this study each year? Provide a 3-year total in the bottom row:

Total number requested
Year 1
Year 2
Year 3
Total requested for the entire 3 year approval period
E. Will any animal/s be re-enrolled in future experiments? ___ Yes ____ No
If yes, how many re-enrollments and for how many animals? (No more than 3 times without a justification for
continued re-enrollment).
F. How did you determine the group size and animal number to best achieve scientific validity for the project?
Provide the rationale for the choice of this animal species and the number to be used. Cite statistical tests,
power calculations, regulatory requirements, etc.
SECTION 4: Alternatives to Painful Procedures
Please submit a separate document entitled “Alternatives to Painful Procedures” that contains a written narrative of the methods and literature databases used to determine that alternatives to EACH potentially painful procedure are not available. (A minimum of 2 separate database searches should be included. State database searched [e.g. Medline, Agricola, Current Research -information, System (CRIS), Biosis/Life Science, CAB Abstracts, Embase, Altweb, Animal Welfare Information Center, Others, etc.] date of search and years covered. The following key words are provided as suggestions to use when looking for alternatives: “animal model, animal testing alternative, animal alternative and in vitro techniques”. The search must reflect a sincere effort to consider alternatives; please include EACH PROCEDURE that has the potential to cause pain/distress to the animal).
Do the activities of this protocol duplicate experiments done by you or others based on your knowledge and a review of the literature? ____No ____Yes If yes, justify why duplication is of scientific necessity.
SECTION 5: PROCEDURES
A. Provide a clear, step-by-step description of all procedures including details of methods of anesthesia.
IACUC reviewers should be able to track the animals through the protocol. A flow chart is recommended,
which may be submitted separately. Please be sure to provide information about experimental endpoints
related to the study length.

B. If the animals are to be sacrificed at the end of the protocol, give details of the method by which they will be euthanized. Euthanasia methods must be acceptable based upon the June 2007 “AVMA Guidelines on Euthanasia” (http://www.avma.org/issues/animal_welfare/euthanasia.pdf). If the animals will not be sacrificed, describe what will be done instead (adoption, donation, etc.).

C. If the protocol includes invasive survival surgery procedures (major survival surgery that penetrates a body
cavity), you must include a detailed description of the following:
(1) pre-operative care, (2) surgical preparation, (3) anesthesia, (4) surgical techniques and procedures, and (5)
post-operative care and handling, including analgesics, antibiotics, special diets, and subsequent monitoring.
Please provide evidence of your training and experience in the procedures used.
D. If additional researchers (including students) will be involved, describe their responsibilities and how they
will be trained to perform specific procedures. Include:

Name of each employee/assistant

Indicate “Not hired” if applicable / Description of all procedures to be performed by the employee/assistant (non-surgery, surgery, monitoring, supervisory duties, euthanasia, hazardous procedures, etc.) /

List all training needed in order to adequately perform each procedure

/ /
/ /
/ /
/ /
SECTION 6: PROCEDURES TO MINIMIZE PAIN/DISTRESS
Describe procedures to minimize pain and/or distress. How will anesthesia or euthanasia be administered? Please list the route (intravenous, intramuscular, subcutaneous) for any injections.
Describe the process for intervention or removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated.
USDA animals – if procedures are used which cause more than momentary pain/distress, whether relieved by anesthesia or not, you must provide justification to determine that alternatives to the procedure are not available. Ref: USDA Policy Manual, Policies #11 & #12.
All other species (laboratory mice/rats/birds/crustaceans)- if there is reasonable likelihood that the procedures will cause more than momentary pain/distress, not relieved by anesthesia, you must provide justification as specified above for USDA animals.
In addition, please identify if the protocol includes the following procedures. Steps to minimize pain and distress specific to these procedures must be clearly addressed:
·  Physical restraint
·  Multiple major survival surgery
·  Restriction of food/fluid
·  Use of adjuvants
·  Death as an end point
·  Use of noxious stimuli
·  Skin or corneal irritancy testing,
·  Excessive tumor burden
·  Intra-cardiac or orbital-sinus blood sampling
·  Use of abnormal environmental conditions

Use the space below to complete Section 6. Use as much space as necessary.

SECTION 7: ENVIRONMENTAL/HUSBANDRY ISSUES
A. Are there any exceptions requested from the approved exercise, socialization or environmental enrichment
procedures in the laboratory animal facilities?
____No ____Yes If yes, describe the deviation and provide a justification.
B. Will either food and/or water be restricted for this study?
____No _____Yes, list length of restriction (hours, days):______
If food and/or water restriction is longer than 24 hours, justify why this restriction is necessary and how
animals will be monitored.
C. What type of caging will you require?
_____ Solid Bottom
_____ Wire bottom - justify the need ______
_____ Isolator
_____ Metabolism
_____ Individually Ventilated Cage System
_____ Other – explain: ______
D. What type of feed will you require?
_____ Standard
_____ Other – describe:
SECTION 8: OCCUPATIONAL SAFETY AGAINST HAZARDOUS AGENTS POTENTIALLY HARMFUL TO HUMANS
Note: All protocols using any of the following materials must be reviewed and approved by the Biological and Chemical Safety Committee of Marywood University prior to final approval by the IACUC.
Please describe the working environment and identify any safety risks for personnel. What strategies will be implemented to minimize risks?
A. Check any of the following that may be handled in this project:
______No hazardous agents will be used in the protocol (Proceed to Section 9)
______Pathogenic micro-organisms (bacteria, viruses, parasites, infectious material)
______Radioisotopes
______Recombinant DNA (source and type; DNA IBC registration number)
______Ionizing radiation
______OSHA regulated carcinogens
______Human tissue
______Tumor cell lines
______Hazardous chemicals (including toxins, anesthetics or drugs used in protocol)
______Other
B. Has the listed hazardous agent use been approved by the Biological and Chemical Safety Committee?
______Yes, I am submitting an approval letter from the Committee
______No - Pending approval date: _____
C. Describe how the hazards will be controlled for all substances checked above whose use poses a hazard
to humans.
SECTION 9: STATEMENTS AND ASSURANCES
By submitting this IACUC application and electronically signing your packet on IRB Net, you and your sponsor/advisor state that you have read and agree to the following:
I, as the Principal Investigator, am responsible for conducting these studies in compliance with all applicable regulatory and Marywood University IACUC requirements. Every effort will be made to ensure that animal care and use procedures are performed by trained and competent personnel and that aseptic techniques are employed for all procedures as indicated. Assurance is made by me that all painful procedures which cannot be alleviated by drugs will continue for only the minimal time period in which to obtain the necessary information. If any unexpected pain or adverse clinical signs are observed, appropriate veterinary services will be initiated immediately. Any future animal care and use change will be submitted in writing for review by the Marywood University IACUC before the procedure is performed.
The IRB Net application package must contain the electronic signatures from the following individuals before it is submitted for review:
·  PI and Co-investigators
·  Veterinarian
·  Department Chairperson
·  Department Head (New protocols only)
In addition to this Application Form, please submit all other required documents to the IACUC on IRB Net.

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Rev. 05/09/2011