FOR BEST VIEWING - USE VIEW-PRINT LAYOUT FLORIDA ATLANTIC UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE 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 OCCUPATIONAL 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 THE OFFICE OF RESEARCH INTEGRITY, ROOM 328, BS-12, BOCA RATON CAMPUS. INCLUDE PERMITS &ATTACHMENTS (INCLUDING GRANT, IF APPLICABLE, SURGERY FORM, WILDLIFE FORM, ETC.) b. ONE ELECTRONIC COPY OF PROTOCOL AND ALL ATTACHMENTS TO KRISTEN WARE (KCWARE@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. SYLVIA GOGRAFE, AT 7-4233 (SGOGRAFE@FAU.EDU) OR DR. KRISTEN WARE, AT 7-0961 (KCWARE@FAU.EDU). 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: Original: MODIFICATION DATE: 1st Renewal: 2nd 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) Name Work Phone Email Address For additional names copy section and add at the end of a section.) Animal Contact: 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 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 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. Name Work Phone Email Address Animal Contact: 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 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 Species FAU Protocol Page 2 of 17 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: NONE (Not required to answer species and jobs below; General Training req’d) Name Work Phone Email Address YES (Have to answer all below) TRAINING: Enter dates forFAU hands on or online training (If doing Anest. and Surg., it 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 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: NONE (Not required to answer species and jobs below; General Training req’d) Name Work Phone Email Address YES (Have to answer all below) TRAINING:Enter dates forFAU hands on or online training (If doing Anest. and Surg., it 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 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 info.) Personnel listed in this section must also be listed as project personnel in the above section PI Alternate Person B.1. TYPE OF SUBMISSION (CHECK ONE) New Protocol 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 FAU Protocol Page 3 of 17 Emergency Phone Emergency Phone PROVIDE RELATED IACUC NUMBERS (Not applicable for new protocols) B.3. PROJECT END DATE USDA Pain Level Other (Specify :) Anesthesia without surgery (i.e. blood collection, gavage, etc.) Paralytic Agents Diagnostic X-rays (B,C,D,E) Antibody Production Drugs (Drugs as research components other than anesthetics, etc.) . Immunization Procedures Burns or Trauma Biohazard Food / Water Deprivation Aversive Conditioning Prolonged Restraint Multiple Survival Surgery Collection of Cells, Tissues, Organs Est. Proj. Tot. Non-survival Surgery Survival Surgery (SPECIES Common Name and Strain) Special Diet PROCEDURES Check ALL that apply C.1. Pain level: BBreeding only(No tail nip); C-Only momentary or slight(needle stick);D-More than momentary or slight but relieved with medication; EMore than momentary or slight and not relieved 1 2 3 4 5 Other (Specify:) D.1. Facility and Room # Where Procedures Will Take Place (If multiple, so indicate) Non-Surgical Procedures Surgery and/or Anesthesia Euthanasia D.2. ANIMALS BROUGHT INTO AND TAKEN OUTSIDE OF THE ANIMAL FACILITY ANIMALS BROUGHT INTO THE FACILITY Approved Vendors Quarantine Animals ordered from approved, conventional vendors will enter quarantine as described in Comparative Medicine’s SOP’s. During the quarantine period, animals are not generally available to use for research without specific approval from Comparative Medicine. Proposed Vendor Unknown Comparative Medicine Choice From: (Fill in) Non-Conventional Animals ordered from other Universities or non-approved vendors can only be ordered after Vendor Quarantine completion of special animal request forms and receipt of animal health information from the vendor or source. These animals will undergo an extended quarantine period and may be health tested at the cost of the investigator. Contact Comparative Medicine 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 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 NO 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. D.3.b. D.3.c. Building Approximate duration in laboratory How many times will the animals be transported to the laboratory? Room 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. D.4.b. D.4.c. D.4.d. D.4.e. Justification Building Approximate duration in laboratory How many times will the animals be transported to the laboratory? Who will provide the husbandry? Room 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. D.4.f. If moved between buildings, animals must be transported in an insulated, (Coleman) Transport container. Please describe transport. FAU Protocol Page 5 of 17 PHARMACEUTICALS USED WITH ANIMALS E.1. ANALGESIC/ANESTHETIC (Generic name) SPECIES DOSE MG/KG ROUTE FREQUENCY SPECIES DOSE MG/KG ROUTE SPECIES DOSE MG/KG ROUTE FREQUENCY 1 2 3 4 E.2. EUTHANASIA METHOD/DRUG (Generic name) 1 2 3 4 E.3. OTHER DRUGS(List all injected/given i.e., antibiotics, fluids, Freund’s Complete Adj. etc.) 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 cannot 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 Chairperson FAU Protocol Page 8 of 17 Date 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 graphicallyclarifies how the groups, time frames, and totals of animal use are broken down. Example Group A Group B Group C Total Test 1 10 10 10 30 Test 2 10 10 10 30 Control 5 5 5 15 __________________________________________________ Total 25 25 25 75 J. JUDICIOUS USE OF ANIMALS FAU Protocol Page 9 of 17 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 K.2. Urine, feces or other body fluids sampling (If YES, complete the following) K.2.a. Material This information is required for the IACUC if the samples are obtained from the animal. If they are collected from the waste left in the cage, this is important information for the facility manager. FAU Protocol Page 10 of 17 NO K.2.b. Method What method will be used (e.g. from the waste in the cage, postmortem, expressed, drawn with a (?) size needle by (?) K.2.c. Frequency How often? Obviously, if postmortem, only once. Otherwise, how often (e.g. hourly, weekly, etc.)? K.2.d. Duration This is especially important if a restraint device has to be used (such as a metabolic cage) or if an indwelling catheter is required YES NO YES NO YES NO YES NO YES NO K.3. Collection of tissues (except blood) BEFORE euthanasia(If YES, complete the following) This would be filled out if animal tissues are collected prior to euthanasia. In some cases, the animal might be under anesthesia and might not be allowed to recover. Antibody collection might be another example. All unused tissues should be double-bagged and returned to the animal facility for disposal K.3.a. Tissues used only on this protocol If all the tissues will be used with this protocol, state “This Protocol.” If, however, tissue will be shared, then state who else will use tissue from animals on this protocol K.3.b. K.3.c. If Tissues are used on another protocol, List protocol numbers Tissues Collected What tissues will you collect (e.g. liver, spleen, kidney, blood, etc.)? K.4. Collection of tissues (except blood) AFTER euthanasia(If YES, complete the following) This is the same as above except it is after death, thus lowering the chance of pain or distress to the animal. In some cases, tissues will be collected both before and after euthanasia. If so, fill out both sections. The headings are the same as above All unused tissues should be double-bagged and returned to the animal facility for disposal K.4.a. K.4.b. K.4.c. Tissues used on this protocol If Tissues are used on another protocol, List protocol numbers Tissues Collected PROCEDURES and IMPLANTS K.5. In Vivo Administration of agents, other than anesthetics or analgesics, such as: drugs/reagents/etc. (If YES, complete the following) 1 K.5.a. Agent State what you are exposing the animal to. All chemicals, drugs used in the animals with the exception of anesthetics or analgesics should be individually listed here K.5.b. Route What is the route of administration (I.V., I.M., S.C.)? FAU Protocol Page 11 of 17 2 3 K.5.c. Frequency How often will you administer the agent K.5.d. Side Effects What do you expect to happen after the agent is placed into or on the animal? State "None" if no side effects are expected K.5.e. Treatment If side effects are expected, state how you plan to treat them or explain why they will not be treated. K.5.f. K.5.g. Needle Size Max Volume Administered YES NO YES NO YES NO K.6. Indwelling catheters or implants(If YES, complete the following) Any catheters or implants that will be put into an animal at a non-terminal procedure should be listed here. K.6.a. K.6.b. Size Type What is it (e.g. cerebral cannula, intravenous catheter, urinary catheter, infusion pump, drug release capsule, rumen cannula, etc.)? K.6.c. Maintenance What care is required for the item (e.g. does it have to be flushed, do antibiotics have to be applied where it exits through the skin, will inflammation occur, etc.)? If heparin or heparinized saline is used as a flushing agent, include this in section G.14 and the Drug Use Page, as well. K.6.d. Duration How long will the catheter or implant be in the animal? How long will it need care? K.7. Tumor Transplantation or Cell Inoculation (If YES, complete the following)) Tumors/cells derived from Humans may potentially carry disease that could infect caretakers/technicians. If so, this becomes a biohazard issue and Section (O) should be completed. Tumors/cells derived from rodents are potential sources of rodent viruses that could spread throughout animal facilities. Have you had the tumor/cell line tested for infectious viruses? (Contact Comparative Medicine for additional information.) K.7.a. Tumor or Cell Type State the size of a catheter or implant. K.7.b. Route of Administration What is it (e.g. cerebral cannula, intravenous catheter, urinary catheter, infusion pump, drug release capsule, rumen cannula, etc.)? K.7.c. Frequency of Administration What care is required for the item (e.g. does it have to be flushed, do antibiotics have to be applied where it exits through the skin, will inflammation occur, etc.)? If heparin or heparinized saline is used as a flushing agent, include this in section K.7.d. Anticipated functional deficit How long will the catheter or implant be in the animal? How long will it need care? FAU Protocol Page 12 of 17 K.7.e. Treatment How do you plan to care for the animal with this deficit? K.7.f. Monitoring Animals with deficits have to be monitored. Describe how you plan to monitor the animals. Weighing the animal on a weekly basis can be helpful to monitor how rapidly a tumor may be growing or how well an animal may be eating. K.7.g. End Point At what point will you stop using the animal? In some cases, this is at the earliest signs of an adverse effect. State the signs. Sometimes it is required that the animal be allowed to continue to a certain point despite the onset of some adverse event. Please state what that point is. Generally, if tumors surpass 15 to 20% of body weight (compared to untreated controls) the animal should be terminated. Remember, animals must be observed for painful sequelae and appropriate action must be taken as soon as possible. POST-PROCEDURE CARE YES NO K.8. Will post-procedure care for non-surgical procedures listed above be required?(If YES, complete the following) K.8.a. Who will provide care? K.8.b. What post-procedure care is required? K.8.c. When will post-procedure care be given? K.8.d. What analgesics will be given? (If none, explain) K.8.e. What will be the endpoint? L. ESTIMATION OF PAIN, DISTRESS AND SUFFERING The IACUC is required to review carefully any pain or distress involving animals. This section provides the required assurance that you will be as humane as possible. Federal law requires that the Principal Investigator consider alternatives to procedures that may cause more than momentary or slight pain or distress to animals (Level D or E).A written narrative description of the methods and sources (e.g. The Animal Welfare Information Center) used to determine that alternatives were not availableis required (Federal Regulations, 9 CFR Ch. 1, Sec. 2.31(d)(1)(ii)). YES L.1. Does this project involve procedures that may cause more than momentary or slight pain or distress to animals? (If YES, complete the following) Database(s) searched -State the database(s) L.1.a. searched (e.g. MEDLINE, AGRICOLA). L.1.b. L.1.c. L.1.d. Date range of the Database Search Date the Database Search was done Key words -State the key words used to determine that no alternative to procedures that may cause more than momentary or slight pain or distress to animals is available. FAU Protocol Page 13 of 17 NO L.1.e. Please provide a brief narrative description of search results that led you to believe that there are no alternatives to procedures that may cause more than momentary or slight pain or distress to animals (this section does not refer to “alternatives” to animal use) A simple statement of what you found from your literature search (e.g., "From my literature search, I found no alternative for the use of procedures that may cause more than momentary or slight pain or distress to animals."). L.2. What pain or distress is anticipated? (Be explicit and include potential for pain or distress (in the presence or absence of anesthesia) Fully describe the pain or distress you expect to occur or has the potential to occur during all procedures. In most cases, a simple statement that “The animal will only perceive the momentary pain associated with a needle stick” or Pain associated with the surgery will be alleviated by anesthetics and analgesics.” The PI, the project personnel and Comparative Medicine observe for the following signs of pain or distress: Loss of appetite Loss of weight Loss of mobility Guarding (protecting the painful area) Vocalizing Licking, biting, scratching or shaking a particular area Restlessness Failure to groom, causing an unkempt appearance Teeth grinding Abnormal resting postures in which the animal appears to be sleeping or is hunched up Failure to show normal patterns of inquisitiveness YES NO YES NO L.3. Are there other signs that will be used to assess pain and distress? (If YES, explain below) L.4. For protocols that have procedures that are potentially more than momentarily painful or distressful, special observation is generally necessary. Does this protocol include such procedures? In many cases, the correct answer will be NO. If an animal is just euthanized for tissue collection, this should be marked NO. Any time more than momentary pain or distress will be expected for the animals, the answer has to be YES L.4.a. Frequency of observation How often will the animal be observed? The frequency will depend on the amount of pain or distress. If in doubt, check with the University Veterinarian. Whatever you put in this box needs to be documented and submitted on request by the IACUC, Veterinarian or External Reviewers; if you will observe the animal “daily” you need to have records that include documented weekend checks. L.4.b. Beginning (date or condition) The period when the animal will be checked has to be defined. It generally starts just before the time you expect to see signs of pain or distress. L.4.c. Ending (date or condition)This is to ensure the animal will be properly observed until the pain or distress is ended YES NO L.5. Will there be unalleviated pain or distress in this protocol? (If YES, this protocol falls into the USDA pain level E. Please supply the scientific justification why animals on this protocol will be subjected to unalleviated pain or distress and enter USDA code E in Section A-9.The law states that any procedure that could cause more than momentary pain or distress requires relief, generally through analgesics. The University Veterinarian is not allowed to diverge from the law. It is assumed that an animal that has undergone surgery has pain post-surgically. Other procedures may also cause pain. Such a procedure is usually evaluated as to how painful or distressful it would be to a human, and appropriate analgesia has to be provided. If USDA level "E" is specified, therefore, no drugs are to be used and a full justification is required. FAU Protocol Page 14 of 17 M. STUDY TERMINATION/ANIMAL DISPOSITION There are three possible outcomes for an animal assigned to a protocol: 1. Absolutely no harm to the animal will occur, and the animal will be available for redistribution 2. The animal will be euthanized at the end of the research 3. The animal will be in the experiment until it dies (commonly referred to as “death is the endpoint”) YES NO M.1. Will any animal(s) survive the research with no harm? (Often yes for Agricultural Teaching and Wildlife protocols) Examples of "no harm" include only small amounts of blood drawn or animals which only ran a maze Complete M.1.a. and M.1.b. if “Yes” only M.1.a. Will any animal(s) be used in another protocol? (If YES, indicate protocol # and PI) Protocol # PI YES NO YES NO YES NO YES NO YES NO M.1.b. Will any animal(s) be adopted? (Rarely done but if the answer is YES, contact the University Veterinarian to make arrangements.) M.2. Will any animal(s) be euthanized? M.3. Will death be the endpoint for any animal(s) in this protocol? (i.e. The animal’s death is a required experimental data-point.) (For example, heart failure is induced in a rabbit and it is allowed to survive until it dies of congestive heart failure without being euthanized). (If YES, complete the following) M.3.a. Will euthanasia ever be considered or is there any other measurable endpoint at which euthanasia will be performed? If YES, this may not be death as an endpoint; ONLY COMPLETE THIS SECTION IF M.3. is “YES” Please explain M.3.b. If euthanasia will never be considered, please justify why death is the end point rather than euthanasia M.3.c. What signs are the animals expected to exhibit as they go through the terminal stages? M.3.d. What measures can be taken to alleviate pain (e.g. analgesics)? (If NONE, please justify) M.3.e. Who will observe the animal during the terminal stages? FAU Protocol Page 15 of 17 M.4. Instructions for disposition of sick or injured animals. This section is used to indicate what is to be done with animals in case they become sick or injured and what is to be done with dead animals and tissue. (Weekend, holidays and nights are times that animals need care too, e.g., without being able to contact the investigator, the animal caretaker may not know whether or how to keep the carcass until it can be examined or utilized by the investigator). An alternate person should always be designated. The alternate person cannot include routine CM animal caretakers and that person should also be listed under the project personnel. YES M.4.a. NO Call investigator Immediately? (A “no” answer means the investigator will be called the next working day.)Normally, the investigator should be called. The investigator may wish to be notified the next working day; complete I.5.b. M.4.b. In case of emergency, should the Veterinarian treat the animals? In case of an emergency, the veterinarian needs to know whether the animal should be treated. If the animal should not be treated, why not? Should the animal just be euthanized? If the animal is to be treated, what restrictions, if any, should the veterinarian be aware of (i.e. no steroids; no drugs; etc.) If NO, include justification on why the animal will not be treated. If YES, explain any restrictions on treatment below. M.4.c. Comments M.5. Instructions for disposition of dead animals. M.5.a. Call investigator Immediately? (A “no” answer means the investigator will be called the next working day.) M.5.b. Do you specifically request the Veterinarian to do a necropsy? The veterinarian is required to be notified of any unexpected death and will either perform or be present at the necropsy. When deaths occur that are expected, the veterinarian does not need to be notified, but if the death occurs after normal hours, or if the investigator or his/her backup cannot be reached, the veterinarian may be asked to try to save certain tissues. In such circumstances, what instructions would you have for him/her? Discuss any special instructions for the Veterinarian.(i.e. look at lungs, save heart, save implant) FAU Protocol Page 16 of 17 YES NO YES NO Special Procedures Note: If any of the following are a “yes” answer, you will have to complete additional information specific to what was checked “yes.” ANITIBODIES N. Antibody production (If YES, complete SECTION N) YES NO HAZARDS O. Infectious/potentially infectious agents (If YES, complete SECTION O) O. Toxicity testing and toxic materials (If YES, complete SECTION O) O. Radioisotopes/radiation (If YES, complete SECTION O) O. Recombinant or non-Recombinant DNA/RNA (If YES, complete SECTION O) YES NO BEHAVIORAL TESTING P. Behavioral testing WITHOUT significant restraint or noxious stimuli. Explain YES NO YES NO YES NO DIETARY MODIFICATION R. Special Diets or Food/Water Restriction(If YES, complete SECTION R) YES NO ANESTHESIA S. Anesthesia (If YES, complete SECTION S) YES NO SURGERY, POST OPERATIVE CARE T. Non-survival surgery (If YES, complete SECTION S and SECTION T) T. Single survival surgery (If YES, complete SECTION S and SECTION T) T. Multiple major survival surgeries (If YES, complete SECTION S and SECTION T) T. Other Non-Surgical Procedures (If YES, explain below) This space is provided to describe any procedures not YES NO YES NO YES NO YES NO If animals’ behavior will be observed or animals will be used in trials not involving restraint or noxious stimuli, complete this section. RESTRAINT Q. Behavioral testing WITH significant restraint or noxious stimuli (If YES, complete SECTION Q) Q. Prolonged restraint (If YES, complete SECTION Q) covered above. BREEDING COLONY A breeding colony is one that is used to produce offspring which will be used in research. It can be a protocol by itself or combined with the research phase to be a part of the research protocol. Either way, if animals are used for breeding, then this form should be completed. U. Breeding Colony(If YES, complete SECTION U) TEACHING Use of animals in a classroom, in a building or outside, where faculty and/or students of FAU are involved requires a protocol. V. Teaching(If YES, complete SECTION V) WILDLIFE STUDY A wildlife study involves using animals outside the animal facility that are free ranging animals not raised for research. W. Wildlife Study(If YES, complete SECTION W) Once completed A minimum of 3 signatures are required: PI, University Veterinarian, and Dept. Chair. 1 Original Copy with all attachments and licenses plus an electronic copy must be submitted to Research Integrity. FAU Protocol Page 17 of 17