ࡱ> +.()* Rbjbj 4J)++{{{8{760'!(III x5555555g7 :5{J!"J!J!5++IIs5"""J!v+8I{I5"J!5""2 c5 If:!^4<560764:":x5:{5 J!J!"J!J!J!J!J!55"J!J!J!76J!J!J!J!:J!J!J!J!J!J!J!J!J! :  PROTOCOL NUMBER ___________ INITIAL PROTOCOL ___________ FIRST UPDATE ___________ SECOND UPDATE ___________ NEW PROTOCOL ___________ Institutional Animal Care And Use Committee ANIMAL USE PROTOCOL FOR INSTRUCTION AND RESEARCH Please type all responses to questions; no hand-written responses Principal Investigator/Instructor: ____________________________________________________ If PI is a student, name of faculty supervisor: ___________________________________________________ Department: _______________________________ Campus phone: ________________________ EMAIL: ____________________________________________________________________________________ Project Title: ___________________________________________________________________________ _______________________________________________________________________________ THIS PROTOCOL IS: NEW  FORMCHECKBOX  TRIENNIAL RENEWAL  FORMCHECKBOX  If New, date you wish to begin working with animals: __________________. If Renewal, provide previous PROTOCOL NUMBER: _________________. PURPOSE OF ANIMAL USE: Instruction  FORMCHECKBOX  Research  FORMCHECKBOX  Both  FORMCHECKBOX  For Instruction Protocols: Course(s) ______________________________________________________________ Quarter/Year(s) _______________________ No. of Students _______________ If animals will be housed on campus, list room(s): _____________________________________ For research projects, list source(s) of funds: _________________________________________ _______________________________________________________________________________ DEPARTMENT CHAIR SIGNATURE ________________________________ DATE: ____________ *** I. ALTERNATIVE TO THE USE OF ANIMALS USDA Policy #12 states The Animal Welfare Act (AWA) regulations require principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions and replacements. The best way to satisfy this requirement is to perform and describe a literature search. A source of information on techniques for conducting this search, and a list of possible databases to be searched, are found at the website for the Animal Welfare Information Center (AWIC)  HYPERLINK "http://www.nal.usda.gov/awic/" http://www.nal.usda.gov/awic/. The 3 Rs are defined as follows: REFINE existing tests by minimizing animal distress, (2) REDUCE the number of animals necessary for an experiment, or (3) REPLACE whole animal use with in vitro or other tests. A. Search methods: [Provide a description of the methods and sources used in the search. Database references must include databases searched, the date of the search, period covered, and the keywords used.] II. ANIMAL INFORMATION A. Species: ________________________________________________________________ B. Number of animals: ____________ C. Ages: __________ D. Sex: __________ E. Weight: __________ F. Where and how are the animals to be acquired? G. Where and how are the animals to be housed? H. Who is responsible for daily care of the animals? I. Are permits required for handling, importation, collection or maintenance of animals? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, list agency that require permits, and permit status below: Agency:_______________________________________________________ Permit Application: Approved____ Pending____ To be submitted____ III. DESCRIBE THE PROJECT/EXPERIMENT [Use language that is understandable to a layperson.] IV. RATIONALE FOR ANIMAL USE Explain your rationale for animal use. [The rationale should include reasons why non-animal models cannot be used.] Justify the appropriateness of the species selected. [The species selected should be the lowest possible on the phylogenetic scale.] Justify the number of animals to be used. [The number of animals should be the minimum number required to obtain statistically valid results in research and the minimum number necessary to accomplish the objectives of the proposed educational activity for instruction. Explain how this number was derived.] Potential Scientific Benefits: State potential value of study with respect to human or animal health, advancement of knowledge, or good of society. Please limit explanation to one or two paragraphs and avoid technical jargon. V. PAIN/DISCOMFORT Check the applicable boxes in the table below: PAIN/DISTRESS CATEGORIES:  FORMCHECKBOX  Experiments which involve no pain, distress or use of pain relieving drugs.  FORMCHECKBOX  Experiments which involve momentary or slight pain or distress.  FORMCHECKBOX  Experiments involving accompanying pain or distress to animals and which appropriate anesthetic, analgesic, or tranquilizing drugs are used.  FORMCHECKBOX  Experiments involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would adversely affect the procedures, results, or interpretation of the experiments CATEGORIES OF USE:  FORMCHECKBOX  Tissue procurement after euthanasia  FORMCHECKBOX  Non-surgical procedure  FORMCHECKBOX  Surgery  FORMCHECKBOX  Non-rodent  FORMCHECKBOX  Rodent  FORMCHECKBOX  Survival  FORMCHECKBOX  Multiple survival surgery in one animal  FORMCHECKBOX  Non-survival  FORMCHECKBOX  Physical restraint  FORMCHECKBOX  Using chairs or slings  FORMCHECKBOX  Others  FORMCHECKBOX  Exemption from Environmental Enrichment  FORMCHECKBOX  Hazardous agents (Approval required)  FORMCHECKBOX  Biological (human/animal pathogens/human tissue, tumor cells, non-replicating human/animal viruses) or recombinant DNA. . FORMCHECKBOX  Toxicological  FORMCHECKBOX  Carcingens  FORMCHECKBOX  Radioactive isotopes or ionizing radiation A. Answer the following questions with the number of animals for each category: 1. No pain/distress Number: _______________ 2. Momentary/slight pain/distress Number: _______________ 3. Alleviated pain/distress Number: _______________ 4. Non-alleviated pain/distress Number: _______________ B. If any animals will experience pain/distress, provide a description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research and instructional purposes including provisions for the use of analgesic, anesthetic, and tranquilizing drugs where appropriate to minimize pain. Unrelieved pain must be justified for scientific and instructional reasons. C. For all protocols: Complete the following table of Humane Endpoints, as applicable to the species and/or procedures you are using: HUMANE ENDPOINTS TO PREVENT CHRONIC PAIN AND DISTRESS  FORMCHECKBOX  Not eating > 48 hours FORMCHECKBOX  Weight loss > 15% of normal weight FORMCHECKBOX  Mutilation of operative site FORMCHECKBOX  Depression > 72 hours FORMCHECKBOX  Non-weight bearing > 72 hours FORMCHECKBOX  Infection not resolved with antimicrobial therapy FORMCHECKBOX  Moderate to severe clinical signs of pain and distress unalleviated by appropriate analgesics FORMCHECKBOX  Other, specify VI. DESCRIPTION OF SURGICAL EXPERIMENT/ PROJECT/PROCEDURE Is surgery included in the protocol? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, answer the questions in this section. Major survival surgery: Penetration and exposure of a body cavity or resulting in a permanent impairment of physical or physiologic functions. All survival surgery must be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. (AWAR Ch. 2.31, d, 1, ix) Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, answer the following: Preoperative care and pre-anesthetics (Type, dose, route of administration of medication and/or anesthesia, or special care such as fluids, fasting,. etc.) Anesthesia/analgesia/paralytic (Type, dose, and route of administration) Monitoring and supportive care during surgery (If applicable, fluids, oxygen, antibiotics, analgesics, temperature) Postoperative care (How animal care will be observed and monitored, treatments such as fluids, antibiotics or analgesics; procedures for unexpected outcomes; clinical indications for use of analgesics) Will more than one major survival surgery be performed? Yes ___ No ___ If yes, provide justification for multiple survival surgeries. Minor survival surgery: Does not expose a body cavity and causes little or no physical impairment. Minor survival surgery and all surgery on rodents does not require separate dedicated facilities, however, aseptic technique must be used (AWAR Ch. 2.31, d, 1, ix) Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, answer the following: Preoperative care and pre-anesthetics (Type, dose, route of administration of medication and/or anesthesia, or special care such as fluids, fasting,. etc.) Anesthesia/analgesia/paralytic (Type, dose, and route of administration) Monitoring and supportive care during surgery (If applicable, fluids, oxygen, antibiotics, analgesics, temperature) Postoperative care (How animal care will be observed and monitored, treatments such as fluids, antibiotics or analgesics; procedures for unexpected outcomes; clinical indications for use of analgesics) Will more than one minor survival surgery be performed? Yes ___ No ___ If yes, provide justification for multiple survival surgeries. Non Survival Surgery: Animals are euthanized under anesthesia without regaining consciousness. APHIS/AC Policy #3 does not require aseptic technique or dedicated surgical facilities when performing non-survival surgery. However, the area to be used should be clean and free of clutter. Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, answer the following: Preoperative care and pre-anesthetics (Type, dose, route of administration of medication and/or anesthesia, or special care such as fluids, fasting, etc.) Anesthesia/analgesia/paralytic (Type, dose, and route of administration) Monitoring and supportive care during surgery (If applicable, fluids, oxygen, antibiotics, analgesics, temperature) How will death be determined? VII. DESCRIPTION OF NON-SURGICAL EXPERIMENT/ PROJECT/PROCEDURE Provide a detailed methodology of your experiment: Will procedures in the protocol produce pain or discomfort? Yes  FORMCHECKBOX  No  FORMCHECKBOX . If yes, answer the questions in this section. Anesthesia and pain: Are the animals anesthetized or otherwise rendered incapable of perceiving pain throughout the procedure? Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, complete this section. Name of anesthetic ____________________________________________ Concentration ________________________________________________ Dose to be administered (Amount/kilogram body weight) _____________ How will the level of anesthesia be assessed, how often, and by whom? B. Will the procedure result in what may be presumed to be more than minor pain for which drug intervention would defeat its purpose? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, describe and explain why drug intervention would defeat the purpose of the research/instruction. VIII. METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY 1. Will the animals survive? Yes  FORMCHECKBOX : Go to A; No  FORMCHECKBOX : Go to B. A. If the animals are to survive, what will be the disposition of them? If the animals are not to survive, indicate the method of euthanasia. Is a chemical method employed? Yes  FORMCHECKBOX  No  FORMCHECKBOX . If yes, specify the product, dose and route of administration: 2. Does the method of euthanasia meet the recommendations of the AVMA Guidelines on Euthanasia? ( www.avma.org/resources/euthanasia.pdf ) Yes  FORMCHECKBOX  No  FORMCHECKBOX  If no, describe the reason for the alternative method: IX. FIELD STUDIES The PHS Office of Laboratory Animal Welfare states: IACUCs must know where field studies will be located, what procedures will be involved, and be sufficiently familiar with the nature of the habitat to assess the potential impact on the animal subjects. Studies with the potential to impact the health or safety of personnel or the animals environment may need IACUC oversight, even if described as purely observational or behavioral. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, the IACUC must ensure that proposed studies are in accord with the Guide. The IACUC must also ensure compliance with the requirements of pertinent state, national and international wildlife regulations. A study on free-living wild USDA covered species that involves invasive procedures, harms or materially alters the behavior of an animal under study is covered by USDA animal welfare regulations and requires IACUC review and approval. Will animals in the wild be used or observed? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, answer the following. If a question is not applicable, indicate by checking N/A. Animal Capture Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Animal Restraint/Handling Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Animal Marking and Radiotelemetry Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Release, Euthanasia or Other Disposition of Animals Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Recapture of Animals Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Health Precautions for Personnel Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Housing of Captive Wild Animals Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Transportation of Animals Yes  FORMCHECKBOX  N/A  FORMCHECKBOX  Description of Proposed Procedures (provide under Section III above) X. QUALIFICATION OF PERSONNEL List all the participants (including students) who will be involved in the protocol and describe their qualifications that are relevant to this protocol, or specify the projected training they will be given for this protocol. Note: All personnel using animals must complete the required CITI training course and submit proof of successful completion to ORSP before they may begin work on this protocol. Answer the following questions for each person working on the protocol. Name (First/Last): ____________________________________________ Highest earned degree (circle one): High school, AA, BA/BS, MA/MS, MD/DVM/DDS, PhD/DPhil, Other:____________ Status (circle one): Faculty, Permanent Staff, Temporary Employee, Visiting Scientist, Resident/Post-doctoral fellow, Graduate student, Undergrad student, Other (Specify):____________________________ E-Mail Address: _______________________________________________ Role on project (circle as applicable): PI, animal care and handling, anaesthesia, surgery, euthanasia, other (specify): _________________________ Have you completed the CITI training? Yes  FORMCHECKBOX  No  FORMCHECKBOX  How many years of experience have you had working with animals? Additional training description: XI. TRIENNIAL REVIEW Is this a Protocol Renewal? Yes  FORMCHECKBOX  No  FORMCHECKBOX . If yes, provide the following information: What progress has been made toward reducing animal numbers, stress, discomfort, and/or pain in your studies? Were any adverse effects or problems observed in your previous studies and how have they been managed or will be managed? Provide a brief summary of results to date. XII. APPLICANT'S CERTIFICATION I agree to abide by all AV, East Bay Institutional Animal Care and Use Committee requirements regulating the use of all animals in instruction and research; by the provisions of the NIH Guide for the Care and Use of Laboratory Animals; and by all other applicable laws, policies, and regulations governing the use of animals in research. I certify that all personnel involved on this protocol, including myself, will complete the federally-required animal care training and provide certification of such training to the Office of Research and Sponsored Programs PRIOR to beginning work on this protocol. If project personnel change during the course of the study, I will inform the IACUC and have the new personnel complete the training prior to their involvement with animals. The training certification is valid for 3 years; each person involved in animal research must complete update training every three years. I certify that the activities in this protocol do not unnecessarily duplicate previous experiments. I certify that this application accurately reflects all procedures involving animal subjects described in the proposal submitted for the support of this project. Any proposed revision to or variation from his application as approved will be promptly forwarded to the IACUC for review and approval. I understand that "The IACUC may suspend an activity that is previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the Committee." (Code of Federal Regulations 9 Ch. 1 Part 2.31 d 6 Animal Welfare Act Regulations). Signature of Principal Investigator_________________________________ *** The Institutional Animal Care and Use Committee reviewed this protocol on _______________________________ Committee Action: Approved  FORMCHECKBOX  Modification Required  FORMCHECKBOX  (details attached) Disapproved  FORMCHECKBOX  Deferred  FORMCHECKBOX  ATTENDING VETERINARIAN: _______________________________________ DATE: ____________ IACUC CHAIR ______________________________________________________DATE: ____________ ***protocol revised 2/5/2009     PAGE 6 PAGE 1   <=}   F H j k ¸۰|xoaX۰J>hdhUD6OJQJhdhUD6CJOJQJhUD5OJQJhdhUD;CJOJQJhUD>*OJQJhUD hdhUD>*B*OJQJph# *hdhUD>*B*OJQJph hdhUDhdhUD:CJ hUDOJQJhdhUD5CJhdhUDCJhdhUD5CJOJQJ\hdhUDCJOJQJ hUD5\ jhUD5U\mHnHu =]}  F G H   Y Z $a$gdUDgdUD$a$gdUD$H^Ha$^ ^` ^`     1 2 > @ X Z _ a   J K ` 뺬냬m]]hdhUD5CJOJQJ\*jthdhUD5CJOJQJU$jhdhUD5CJOJQJU*jhdhUD5CJOJQJUhdhUD5CJOJQJjhdhUD5CJUhUD5OJQJ\hUD5OJQJhdhUD;CJOJQJhdhUDCJOJQJhUDOJQJ$   g h  I J K 9 : CDgdUD` hx^hgdUDh^h` y z DRSTVWxttpkbbhUD5OJQJ hUD5hUDhdhUD;CJOJQJhdhUDCJOJQJhdhUDOJQJhUDOJQJ]hUD6OJQJhdhUD6OJQJjhUD5CJUj\hUD5CJUjhUD5CJU hUD5CJjhUD5CJUhUDOJQJ&RSTz{_67     %&uvh^h 8^8`^ ^` 0^`0 @d8xy{=>?#47<JL$%4tuv׷zzzzhUDCJ OJQJhUD5OJQJ\hUD56OJQJhUD5OJQJhUD>*OJQJhUD5>*OJQJhUD0JOJQJaJ'jDhdhUDOJQJUaJjhUDOJQJUaJhUDOJQJaJhUD6OJQJhUDOJQJ0MNOUV^gdUD^8^8gdUD hh^h`hh`h !h^hLMDILMefhe۽{nhUD5CJOJQJ^JhdhUDOJQJhdhUD5OJQJh-(;hUD6OJQJh-(;hUDOJQJhUD6OJQJhUD5OJQJ\jehUD5CJUjhUD5CJU hUD5CJjhUD5CJUhUDOJQJhUD5OJQJ(EFGHIghefg^gdUD & F^ 0^`0^$O'bw&`  @^d$If^`^  @^d8$If^`^ @^d$If^`^OP^_`wx   jU(j)hUD5CJOJQJU^J(jhUD5CJOJQJU^J(j=hUD5CJOJQJU^J(jhUD5CJOJQJU^J(jQhUD5CJOJQJU^J(jhUD5CJOJQJU^J"jhUD5CJOJQJU^JhUD5CJOJQJ^JhUD5CJOJQJ^J!(7> } E!F!G! !Lkd $$IflF0R&VD%4 laz @^d$If^`^ ()789EFTUVeftuvwb(jhUD5CJOJQJU^J(jhUD5CJOJQJU^J(j hUD5CJOJQJU^J(jhUD5CJOJQJU^J(jhUD5CJOJQJU^J(jhUD5CJOJQJU^J"jhUD5CJOJQJU^JhUD5CJOJQJ^J! =>LMNjkyz{  ̷̢̍xc(j hUD5CJOJQJU^J(jQ hUD5CJOJQJU^J(j hUD5CJOJQJU^J(ja hUD5CJOJQJU^J(j hUD5CJOJQJU^JhUD5CJOJQJ^J"jhUD5CJOJQJU^J(jq hUD5CJOJQJU^J !!!!!F!!!!!!" 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