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ANIMAL USE PROTOCOL

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ANIMAL USE PROTOCOL ...

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    FLORIDA ATLANTIC UNIVERSITY

    INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

    Rev.5/08

    ANIMAL USE PROTOCOL FORM

WELCOME TO THE FAU PROTOCOL PROCESS FOR ANIMAL USE

    1. PLEASE NOTE THE REVISION DATE. YOU SHOULD USE THE LATEST VERSION FROM THE WEB.

2. PLEASE COMPLETE ALL SECTIONS

    A. SOME SECTIONS MAY NOT PERTAIN TO YOUR PARTICULAR PROTOCOL BUT IT IS STILL REQUIRED

    INFORMATION. JUST INDICATE “NO” IF NOT APPLICABLE.

    B. IF A MAJOR PARAGRAPH IS MARKED “NO, THEN DO NOT FILL OUT THE SUBPARAGRAPHS.

    C. IF A MAJOR PARAGRAPH IS MARKED “YES, ALL SUBPARAGRAPHS MUST BE FILLED IN. IF NOT

    APPLICABLE, THEN STATE, “N/A”

    3. AFTER A DRAFT IS COMPLETED, THE PI MUST MAKE AN APPOINTMENT TO MEET WITH THE UNIVERSITY

    VETERINARIAN. (FEDERAL REQUIREMENT)

    4. ALL PERSONNEL ON THE PROTOCOL HAVE TO BE TRAINED BY THE UNIVERSITY VETERINARIAN BEFORE THE

    PROTOCOL WILL RECEIVE FINAL APPROVAL.

    5. ENROLLMENT IN THE OCCUPATONAL HEALTH PROGRAM (OHP) FOR ANIMAL USERS IS ALSO REQUIRED

    BEFORE FINAL APPROVAL.

    6. THERE ARE AT LEAST 3 SIGNATURES THAT ARE REQUIRED BEFORE SUBMISSION PI, UNIVERSITY

    VETERINARIAN, AND DEPARTMENT CHAIRPERSON. (SECTIONS F & G)

7. SUBMIT THE PROTOCOL

    A. AFTER ALL SECTIONS ARE COMPLETED

    B. AFTER ALL SIGNATURES ARE OBTAINED

    C. AFTER ALL REQUIRED PERMITS OR LICENSES ARE OBTAINED

    D. SUBMIT

    a. ONE COMPLETE ORIGINAL COPY WITH ALL SIGNATURES TO RESEARCH SUBJECTS PROTECTIONS

    OFFICE, OFFICE OF SPONSORED RESEARCH, ROOM 239, ADMINISTRATION BUILDING, BOCA CAMPUS.

    INCLUDE PERMITS & ATTACHMENTS (INCLUDING GRANT, IF APPLICABLE, SURGERY FORM, WILDLIFE FORM,

    ETC.)

    b. ONE ELECTRONIC (EMAIL OR ON DISK) COPY OF PROTOCOL AND ALL ATTACHMENTS TO ANGELA CLEAR

    (ACLEAR@FAU.EDU) OR ELISA GAUCHER (EGAUCHER@FAU.EDU)

    8. FINALLY: PLEASE DELETE THIS PAGE BEFORE SUBMITTING. PUT YOUR CURSOR ON THE FRAME AND CLICK. IT

    SHOULD BECOME A HASH LINE. THEN HIT THE DELETE KEY UNTIL THE TOP LINE IS DELETED. CLICK ONCE

    MORE TO BRING THE PROTOCOL TO THE TOP OF THIS PAGE.

    QUESTIONS? CALL THE UNIVERSITY VETERINARIAN, DR. JIM NICHOLS, AT 7- 4233 (JNICHOLS@FAU.EDU) OR THE RESEARCH SUBJECTS PROTECTIONS OFFICE AT 7-0777.

FAU Protocol Page 1 of 17

    FLORIDA ATLANTIC UNIVERSITY

    INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE Rev. 5/08

    ANIMAL USE PROTOCOL FORM A. ANIMAL USE PROTOCOL SUMMARY

    IACUC DATE STAMP: Shaded areas for IACUC use only. PROTOCOL NUMBER:

    APPROVAL DATES: MODIFICATION DATE:

     Original:

     st1 Renewal: nd2 Renewal:

A.1. PROTOCOL TITLE

A.2. PRINCIPAL INVESTIGATOR (PI) NAME AND ADDRESS

     First Name Department

     Last Name Work Phone

     Email Address After Hours Phone

A.3. PROJECT PERSONNEL

    (Include names of all individuals involved with the animals and this project).

    ROLE IN PROJECT (please answer all that apply) For additional names copy section and add at the end of a section.)

    Animal Contact: Name ; NONE (Not required to answer species and jobs below; General Training req’d) ; YES (Have to answer all below)

     TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it Work Phone requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occup. Health Program for Animal Users.

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Email Address

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll

     Discuss previous training and background working with each species and each procedure marked including when trained and how trained.

    Animal Contact: Name ; NONE (Not required to answer species and jobs below; General Training req’d) ; YES (Have to answer all below)

     TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it Work Phone requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occup. Health Program for Animal Users.

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Email Address

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll

    FAU Protocol Page 2 of 17

     Discuss previous training and background working with each species and each procedure marked including when trained and how trained.

    Animal Contact: Name ; NONE (Not required to answer species and jobs below; General Training req’d) ; YES (Have to answer all below)

     TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it Work Phone requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occup. Health Program for Animal Users.

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Email Address

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll

     Discuss previous training and background working with each species and each procedure marked including when trained and how trained.

    Animal Contact: Name ; NONE (Not required to answer species and jobs below; General Training req’d) ; YES (Have to answer all below)

     TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it Work Phone requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occup. Health Program for Animal Users.

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Email Address

    Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll

     Discuss previous training and background working with each species and each procedure marked including when trained and how trained.

    To add more people, place your pointer at the top, left corner of the above group (just outside of the “N”), right click, copy and then paste just below this line. Add as many as required.

    EMERGENCY CONTACT AND ANIMAL DISPOSITION A.4. Daily and weekend contact numbers for emergencies. (Please provide PI and an alternate’s emergency

    Personnel listed in this section must also be listed as project personnel in the above section info.)

     PI Emergency Phone

     Alternate Person Emergency Phone

    B.1. TYPE OF SUBMISSION (CHECK ONE) PROVIDE RELATED IACUC NUMBERS

    New Protocol (Not applicable for new protocols)

    Amendment of IACUC Protocol #

    Year 3 Renewal of IACUC Protocol #

    Identical to IACUC Protocol #

    B.1.a. FUNDING SOURCE(S)

    B.2. PROJECT START DATE B.3. PROJECT END DATE FAU Protocol Page 3 of 17

     PROCEDURES

    C.1. Check ALL that apply USDA Pain

     Level

     (B,C,D,E) Pain level: B-Breeding only(No tail nip); C-Only momentary or slight(needle stick); D-More than momentary or slight but Survival Surgery relieved with medication; E- Non-survival Surgery More than Est. momentary or Multiple Survival Surgery slight and not Proj. (SPECIES Common Name relieved Tot. and Strain) Prolonged Restraint

    1 Collection of Cells, Tissues, Organs 2 Aversive Conditioning 3

    Special Diet 4

    5 Food / Water Deprivation

     Other (Specify:) Biohazard Burns or Trauma

    D.1. Facility and Room # Where Procedures Will Take Place (If multiple, so indicate) Drugs (Drugs as research components other Non-Surgical Procedures than anesthetics, etc.) . Immunization Procedures Surgery and/or Anesthesia

    Antibody Production Euthanasia

     Diagnostic X-rays D.2. ANIMALS BROUGHT INTO AND TAKEN OUTSIDE OF THE ANIMAL FACILITY

    Anesthesia without surgery (i.e. blood collection, gavage, etc.) Paralytic Agents ANIMALS BROUGHT INTO THE FACILITY

     Other (Specify :)

    Approved Vendors Animals ordered from approved, conventional vendors will enter quarantine as described in

    Veterinary Services SOP’s. During the quarantine period, animals are not generally available to Quarantine

    use for research without specific approval from Veterinary Services.

    Proposed Vendor Unknown Veterinary Services Choice From: (Fill in)

    Non-Conventional Animals ordered from other Universities or non-approved vendors can only be ordered after

    completion of special animal request forms and receipt of animal health information from the Vendor Quarantine

    vendor or source. These animals will undergo an extended quarantine period and may be

    health tested at the cost of the investigator. Contact Veterinary Services for more information

Animal Stabilization To reduce the impact of stress-induced elevation of hormones on your research, all animals

     require a period of stabilization after transport to Florida Atlantic University. Stabilization periods

    occur during the quarantine period. Literature suggests the following guidelines:

     Rodents and Rabbits 3 days

     Dogs, Pigs, Other Mammals 5-7 days

    ANIMALS TO BE TAKEN OUTSIDE OF THE FACILITY.

     YES NO D.3. Will animals be used in a laboratory outside the animal facility for less than 12 hours? (If YES, complete the following)

    FAU Protocol Page 4 of 17

    If the animal will be transported from one building to another for short-term housing (less than 12 hours), complete this section. PLEASE NOTE: If the animal goes anyplace outside the ANIMAL FACILITY (animal quarters, vivarium), the answer should be YES. Room: State the room OUTSIDE the facility where the animal will be used. Duration: How long will the animal be outside the animal facility? For animals taken to a lab for tests and then returned in an average of 2 hours, state "2 hours." For animals that are never to return, state "Will not return to the animal facility." Frequency: How often will each animal go out of the animal facility? In some cases, some will go more than others. You might say that the controls will go once a week and group A will go every day.

    D.3.a. Building Room

    D.3.b. Approximate duration in laboratory D.3.c. How many times will the animals be

     transported to the laboratory?

    To ensure legal and safe transportation of animals, the following guidelines MUST be followed.

    This is to ensure legal and safe transportation of the animals. It also will help to determine what arrangements are required to support your transportation requirements.

     If moved within the building, animals must be transported in a covered cage in designated elevators.

     If moved between buildings, animals must be transported in an insulated, (Coleman) Transport container.

     D.3.d. Please describe transport.

     “As described above” is suggested for a reply if applicable.

    STUDY AREAS

     YES NO D.4. Will animals be used or housed in an area outside the animal facility for more than 12 hours?

     If YES then you are requesting that the area be designated as a STUDY AREA. A study area requires special

    justification, requires special animal monitoring requirements, and is subject to additional inspection by the

    IACUC and federal authorities. Additionally, the study area must be inspected and approved by the IACUC

    prior to animal housing.

D.4.a. Justification

    D.4.b. Building Room

    D.4.c. Approximate duration in laboratory

    D.4.d. How many times will the animals be

     transported to the laboratory?

    D.4.e. Who will provide the husbandry?

    To ensure that the animals receive proper husbandry and veterinary care, state who will care for the animals while they are out of the animal facility. Federal law states how often the animals have to be fed, watered, cleaned, etc. We have to ensure that this is done and that the proper food is used, stored, etc. The statement normally would be "PI" or "Animal Facility."

    To ensure legal and safe transportation of animals, the following guidelines MUST be followed: This is to ensure legal and safe transportation of the animals. It also will help to determine what arrangements are required to support your transportation requirements

     If moved within the building, animals must be transported in a covered cage in designated elevators.

     If moved between buildings, animals must be transported in an insulated, (Coleman) Transport container.

     D.4.f. Please describe

    transport.

FAU Protocol Page 5 of 17

    PHARMACEUTICALS USED WITH ANIMALS E.1. ANALGESIC/ANESTHETIC (Generic name) ROUTE SPECIES DOSE MG/KG FREQUENCY 1 2 3 4

    E.2. EUTHANASIA METHOD/DRUG (Generic name) ROUTE SPECIES DOSE MG/KG 1 2

    3

    4

E.3. OTHER DRUGS(List all injected/given i.e., antibiotics,

    fluids, Freund’s Complete Adj. etc.) SPECIES DOSE MG/KG ROUTE FREQUENCY 1 2

    3

    4

    5

    6

    FAU Protocol Page 6 of 17

F. INVESTIGATOR ASSURANCE

    READ CAREFULLY AND SIGN AND DATE BELOW

    PRINCIPAL INVESTIGATOR'S ASSURANCE

     I have provided an accurate description of the proposed animal care and use protocol and agree to the following conditions: All personnel will be informed of the requirement to report all animal bites and animal related accidents. All personnel will be informed that any concerns for inhumane care and treatment of animals or unlawful acts

    involving animals should be reported to the IACUC or the Attending Veterinarian and that anyone reporting such

    concerns cannot be discriminated against or be subject to any reprisal for reporting their concerns. I agree to abide by governmental regulations and policies concerning the use of animals. I will ensure that veterinary care is provided to animals showing evidence of pain or illness. I agree to give consideration to tissue sharing and will do so whenever possible.

     If the procedures concerning animal use in this research activity are to be revised or changed, I will so notify the

    IACUC of these changes before the change is implemented. I understand that failure to request an amendment

    for changes in animal use may place the University and myself in violation of Federal regulations and the Animal

    Welfare Act.

     As required by Federal regulations, I assure that the activities described do not unnecessarily duplicate previous

    experiments and I assure the animal models proposed are the most appropriate for achieving the objectives of

    this project and have provided justification for each model used in the protocol (Animal Research Plan, Rationale).

    Principal Investigator Signature Date

     Requires a review of the protocol in a meeting with the veterinarian prior to submittal.

     Attending Veterinarian’s Initials

    Indicating that the meeting occurred.

FAU Protocol Page 7 of 17

G. CONFIRMATION OF SCIENTIFIC/INSTRUCTIONAL MERIT REVIEW

     Before any project that utilizes animals can be initiated, it must be reviewed and approved based on scientific or

    instructional merit. The IACUC is responsible for ensuring a scientific or instructional review is conducted, not

    necessarily to conduct the review. The IACUC is responsible for the proper, legal, and humane use of animals.

    To assure the IACUC that this review is in place, the following information is needed regarding the review

    process which is applicable for this protocol.

    (Check one of the boxes below).

     This project will only be initiated after it has been peer-reviewed outside Florida Atlantic University (e.g. NIH,

    NSF, AHA, etc.) or within the University by a formal interdepartmental review group. If so, identify which group,

    agency or board has reviewed or will review this project for scientific or instructional merit.

     Name of Review Agency, Committee, or Board Date of Review

OR

     This project is being reviewed within FAU by one of several methods.

     Departmental Committee for review of scientific or instructional merit

     Name of Committee Date of Review

     Name of Committee Chairperson or Official Designee of the committee indicating approval

     OR

     Other Review Process

     Describe the review process such as the IACUC, Department Chair person, etc.

    Note: While it does not necessarily require someone who is an “expert” in the field of study, it does

    require someone with sufficient scientific knowledge who can review a paper to ensure the project will

    have merit and not use animals unnecessarily. Until a review is completed and the protocol

    approved, the project can not be started.

    Additional note: If the IACUC is asked to complete the scientific review, the project may be delayed until

    someone with the required expertise can be recruited.

     Name of person or persons who conducted the Scientific or Instructional Merit review.

    If this is to be reviewed by the IACUC, then nothing will be required in this block since the IACUC will

    have records of who reviewed the project.

     Signature of Person Date

    In addition to any review within FAU, an “administrative review” by the chair person to indicate his/her

    knowledge of the project and approval is required.

     Signature of Department Date

    Chairperson

FAU Protocol Page 8 of 17

H. PROTOCOL SYNOPSIS

Describe the proposed use of animals in non-technical terms. Briefly outline all procedures involving the use of animals.

    Focus on describing how animals will be monitored for pain and distress, and reduce excessive detail on dosages and operative techniques. Include the following subheadings, as applicable: 1) Goals/Rationale; 2) Quarantine/Stabilization; 3) Procedures (with anticipated effects and what researcher and/or the veterinarian will do in response); 4) Euthanasia; 5)

    Breeding. Safety of personnel and other animals should also be discussed when applicable. If this is a teaching protocol, discuss how animals will be used in teaching.

NOTE: If this is a 3 year renewal, give a brief synopsis of study progress to date (research aims completed, numbers

    of animals used) BEFORE you discuss your current proposed work.

    ANIMAL RESEARCH and TEACHING PLAN

I. RATIONALE

The regulations of the Animal Welfare Act (9 CFR 2.31(3) (2)) and University policy requires that animals selected for a

    procedure should be of an appropriate species. The minimum number required to obtain valid results should be used.

I.1. Very briefly state the objective(s) and potential significance of the activities involving animal use

    Briefly discuss the role of animals in the proposed activity. Indicate why these experiments cannot be done without animals or, if applicable, why less invasive procedures that cause less potential or actual animal pain or discomfort cannot be used. If appropriate, include a brief discussion of the medical or other practical dimension of the problem you are studying. Keep in mind that we are only interested in live animal use. Any other parts of your total project should only be stated if it affects the use of animals.

     I.2. List each species selected and discuss its appropriateness as a research or teaching model.

    (If wildlife, state species selected by [Agency] to be studied.)

I.3. Discuss the appropriateness of the NUMBER of animals to be used as follows:

    State the number of animals needed for the total project. If the animals will be used for research, provide a justification, either statistical, quantitative, etc. Even pilot studies, when selecting a number of animals (i.e. 3 or 6) should have a basis for its selection. (A suggested approach is to use a statistical power calculation or a yield of tissue per organ).

    Note: Wildlife studies. In wildlife studies it is often hard to scientifically justify the number. What should be stated is the desired number to be “used” and how you came up with that number such as number requested by an agency or expected population available. Often a number is desirable but circumstances do not allow control of number “caught” (such as using a fish net and one may get no fish or 100 fish.) In such circumstances, the IACUC should expect a report of the actual number “used” (caught, touched, disturbed, etc.) as soon as practical for its reports.

    I.4. Summarize the experimental design in a simple table or other form that graphically clarifies how the

    Example Group A Group B Group C Total groups, time frames, and totals of animal use are broken down. Test 1 10 10 10 30 Test 2 10 10 10 30 Control 5 5 5 15 __________________________________________________ Total 25 25 25 75

FAU Protocol Page 9 of 17

J. JUDICIOUS USE OF ANIMALS

Respond to all items. For all YES responses, provide descriptions and additional information in the blanks provided.

    Attach additional sheets as necessary.

According to federal regulation (9CFR 2.31(e)(2), a proposal to conduct research or teaching utilizing animals "must

    contain... a rationale for involving animals."

     YES NO

     J.1. Are "whole live animals" required for this project rather than alternatives, such as

    cultured cells? The questions the public may ask are: "Why do you need animals? Why can't you use a computer, tissue culture, etc.?"

     If YES, include a brief explanation of efforts that you have made to reduce the number of animals used in

    research (as it pertains to the 3 R’s [Replacement, Reduction, Refinement])

K. ANIMAL USE PROCEDURES

Respond to all items. For all YES responses, provide descriptions and additional information in the blanks provided.

    Attach additional sheets as needed.

    COLLECTION OF CELLS, TISSUES AND ORGANS

     YES NO K.1. Blood sampling (If YES, complete the following)

    If blood collection is one of the procedures, please complete the following information. Cardiac puncture requires anesthesia. Tail snips in adult animals requires anesthesia (cuts through cartilage of the tail). Nicking the blood vessel with a needle or scalpel does not require anesthesia. Periorbital/periocular bleeding is discouraged and requires scientific justification of why an alternative method can’t be used. See this website for a popular blood collection technique for rodents (http://www.uib.no/vivariet/mou_blood/Blood_coll_mice_.html)

     K.1.a. Technique

    How do you plan to collect blood (e.g., after death, under anesthesia, etc.?

     K.1.b. Site

    From where do you plan to collect the blood (e.g. jugular vein, femoral vein, heart, carotid artery, tail vein, etc.)?

     K.1.c. Volume (Max)

    What is the maximum volume in ml. you plan to collect each time? Generally, the blood volume of an animal is about 6 8 % of body weight and only about 10% of the blood volume should be collected at one time and then 1 to 2

     K.1.d. Frequency

    How often will you draw blood (e.g. once, once every day, once a week, etc.)?

     YES NO K.2. Urine, feces or other body fluids sampling (If YES, complete the following)

FAU Protocol Page 10 of 17

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