Instructions: Project Title: Project Length (3 year maximum): Start Date*: End Date: Coversheet. *Start date will be the date of committee approval

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1 Coversheet IACUC use only: Protocol number: Date Received: Approval Date: Start Date: Category(s) of animal use: Agricultural Biomedical Field Instructions: End Date: Training Verified? Yes No This is a fillable pdf form. Please provide as much information as possible. Use additional pages if needed. Submit your completed protocol to iacuc@uark.edu and be sure to sign the appropriate form(s). You may sign the form digitally or print out and sign manually. Please note that submitting an incomplete AUP form may result in a delay in processing. Your submission may be returned to you with a request for additional details. This form must be submitted to iacuc@uark.edu by 12:00 Noon on the last Friday of the month in order to be reviewed at the next meeting of the IACUC. The PI is responsible for ensuring that any additional information and/or approvals from EHS, the Institutional Biosafety Committee (IBC), or others are included, as appropriate, with this submission. Project Title: Project Length (3 year maximum): Start Date*: *Start date will be the date of committee approval Principal Investigator End Date: Co-Investigator(s) (if applicable) Name: Department/Division: Campus Mail Address: Telephone: Fax: Page 1 of 19

2 Coversheet Individual(s) Responsible for Animal Care Name: Office Address: Office City, State, Zip: Office Phone: Home/Cell Phone**: Individual(s) Responsible for Euthanasia Name: Office Address: Office City, State, Zip: Office Phone: Home/Cell Phone**: **This information is necessary to provide the IACUC with emergency contact information. Animals Used Species: Calculated number to be used, per species:** Common Name(s): Sex(es):* *Note: Biomedical studies that exclude females must include a justification for doing so. For more information, see NIH Notice Number: NOT-OD ** Note: this number (or numbers) must agree exactly with those listed in Section 2B (Experimental Design) of the Narrative. Be clear and concise. Include replacement and breeder animals specific to this project. The IACUC cannot approve a protocol with inconsistent animal numbers. Submissions with inconsistent numbers will be returned. Page 2 of 19

3 Coversheet Supplier:(all purchases must be from a licensed vendor) Name: Locations: (building and room number where animals will be housed and/or used. Animal Housing: Address: Surgical Facility: Data Collection: Page 3 of 19

4 Checklist Title of Project: Principal Investigator: Type of Project (select one): Research Teaching Course Number: Category of research and/or teaching (select one): Biomedical Agricultural Field Funding Source (check all that apply:) NIH NSF USDA University of Arkansas State of Arkansas Private Industry (provide name) Other Sponsor Name: Has this project been reviewed by the IBC? Yes (provide IBC number, if known) No Not applicable IBC number Has this project been reviewed by the EHS? Note: EHS may need to review projects involving chemical agents or other factors that may not be reviewed by the IBC or Biosafety Officer. Yes No Not applicable Page 4 of 19

5 Level of Pain or Stress: Check only one level. This should be the most severe level to which the animals will be subjected during the course of the study. Please read these carefully. (Level 1 corresponds to Category C or D on the APHIS Annual Report Form; Level 2 corresponds to Category D; Levels 3 and 4 both correspond to Category E) Level Description Examples & Comments Level 1 Experiments on vertebrate animals that are expected to product little or no discomfort. - Simple procedures such as injections and blood sampling; - Observations of field behaviors; physical examinations; - Experiments on anesthetized animals that do not regain consciousness; food/water deprivation for short periods of time; - Methods of euthanasia that induce rapid unconsciousness Level 2 Experiments on vertebrate animals that involve some minor stress or shortduration pain. - With anesthesia, "cut downs" or implantation of catheters; - Behavioral experiments on conscious animals that involve restraint; - immunization using Freund's adjuvant; - Noxious stimuli from which escape is possible; - Surgical procedures under anesthesia that may result in post-surgical discomfort (may require analgesics); - Experimental infection producing no significant pain or distress Level 3 Experiments on vertebrate animals that involve significant, unavoidable stress or pain. Level 3 mandates responsibility on the part of the investigator to explore alternative procedures. - Deliberate induction of behavioral stress; - Major surgical procedures under anesthesia that result in significant postoperative discomfort or an anatomic or physiological deficit that will result in pain or distress: - Noxious stimuli from which escape is impossible; - Prolonged periods of physical restraint; - Procedures that produce pain or distress in which anesthetics are not used (e.g. toxicity testing, radiation sickness, certain injections, stress or shock research, or experimental infection producing systemic disease that will result in pain, distress or death) Level 4 Procedures that involve inflicting severe pain on unanesthetized, conscious animals. - Use of muscle relaxants or paralytic drugs without the use of anesthetics; - Surgery, severe burn or trauma infliction on unanesthetized animals; Attempts to induce psychotic-like behavior or severe or terminal stress. Many of these procedures are specifically prohibited and may result in the withdrawal of federal funds and/or institutional USDA registration. Page 5 of 19

6 Surgical Procedures: If any of the methods/techniques listed below will be used, check the appropriate box and provide the requested details in Section 2D of the Narrative (Surgical Procedures): None Non-survival surgery (euthanasia will be administered before recovery from anesthesia Survival surgery (animal will be allowed to recover from anesthesia) Multiple survival surgeries (this requires detailed justification in Narrative) Non-Surgical Procedures: If any of the methods/techniques listed below will be used, check the appropriate box and provide the requested details in Section 2C of the Narrative (Non-Surgical Procedures): Non-surgical invasive procedures (e.g. blood collection, catheterization, intubation, etc. Provide appropriate details (volume, site, frequency, etc.) Abnormal environment. Provide information on departure from normal conditions (temperature, humidity, light, duration, etc.) Exposure of a living animal to a hazardous, toxic, and/ or radioactive substance. Provide name of substance, route of administration, dose, volume, frequency. Aversive stimuli. Provide type and intensity of the stimulus, duration of exposure, justification for use. Exposure of a living animal to an infectious agent. Note that if this box is checked, you must check either Pain Level 2 or 3 in the previous section. Provide name of agent, route of exposure, dose, and frequency. In "Method of Euthanasia" section, identify the criteria to be used to relieve suffering. Immunization Protocol. Provide name of adjuvant(s) used; injection site(s); volume per site; frequency of injections; method, frequency, and volume of blood draws (including anesthetics, if used). Note: this does NOT apply to standard prophylactic vaccinations. Hybridoma protocol. Provide name of priming agent, cells injected, schedule for collection of ascites, number of abdominal taps, gauge of needle used. Important: Provide justification for the use of in vivo mouse ascites methods versus various in vitro methods currently available. Provide adequate documentation. Prolonged restraint. Provide method, duration, frequency, procedure by which animal is adapted to restraint device. Use of neuromuscular blocking agents (muscle paralytics) during surgery. Provide a rationale for their use and explain how you will determine that adequate anesthesia is maintained. Food/Water Deprivation. Provide duration, frequency, extent (total/partial), methods used to assess and monitor distress. Note: removal of food and/or water for 24 hours prior to surgery or other procedure is NOT considered deprivation. Use of death (without anesthesia) as an endpoint of the study. Provide justification why an earlier endpoint is not acceptable. Page 6 of 19

7 Methods of Euthanasia: Identify the method(s) of euthanasia to be used. Method(s) must comply with the most recent version of the AVMA Guidelines on Euthanasia. Not used as part of this project. See Page 14 to describe euthanasia needed to address animal welfare issues. Overdose of anesthetic (specify agent, dose, and route of administration): Inhalation of carbon dioxide Physical means under general anesthesia (identify the specific means that will be used; e.g. cervical dislocation): Physical means without anesthesia - the use of captive bolt pistol on large farm animals, cervical dislocation on chickens, and some other physical methods (e.g. gunshot) are permitted, if done by properly trained personnel - OTHERWISE, physical means without anesthesia (e.g. cervical dislocation of mice) may be used only when scientifically justified. Specific, written justification is required. Provide justification below. You must include the method used. (AVMA 2013) Other (identify and describe): Disposal of Remains: Incineration at University Farm (this is the disposal site for non-conataminated animal carcasses that are placed in the CLAF freezer) Other (describe): Page 7 of 19

8 Narrative 1. ABSTRACT (approximately words) Please provide, in lay language: - a concise but specific statement of the scientific objective for the proposed research; - the rationale behind this objective; - the species of animals to be used; and - an overview of the procedures to be followed. This statement should be able to stand on its own and be comprehensible to a non-scientist. 2. METHODS Using the headings listed below, describe the methods to be used in your project. The level of detail for procedures involving animals should be comparable to that in the Methods section of a peer-reviewed journal article (i.e. sufficiently detailed to enable another researcher competent in your field to replicate your study). Do not copy and paste from your grant proposal; the detail in your grant proposal will usually exceed that required by the IACUC. Avoid repeating information in different sections unless absolutely necessary to communicate your research plans. A. Housing (Note: Cage size, amount of room per animal, etc. must conform to the requirements in one of the following (click to view): - ILAR Guide for the Care and Use of Laboratory Animals - Animal Welfare Act and Regulations (USDA) - PHS Policy on Humane Care and Use of Laboratory Animals - FASS Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching The only exceptions are those protocols that are to be done under "commercial conditions." These must be appropriately documented and approved. Page 8 of 19

9 Describe how the animals will be housed, including: - cage or pen size (include dimensions) - number of animals per cage where applicable (indicate area of floor space allotted per animals - a concise description of routine husbandry practices. B. Experimental Design Provide an overview of the experimental design, including: -numbers of groups (include table, list, chart, or other describing treatment groups, etc.) -numbers of animals per group (totals must agree with number listed on Page 2 of this form) -a schedule or timetable of the treatments to which the animals will be exposed -duration of treatments -terminal fate of animals (e.g. sent to processing; subjected to terminal procedure under anesthesia, euthanized for tissue collection, etc.) Page 9 of 19

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11 C. Non-surgical procedures involving animals - Written records of procedures and anesthesia must be kept for each animal. - Animals must be observed daily following procedures and observations must be recorded from the time the procedure is performed until the endpoint of the study. These records must be made available to the IACUC during its semiannual inspections. Blood draws; tumor injections; etc. should be listed and include method, volume, and frequency. Be particularly detailed regarding any procedures that are: -invasive; -involve stress; or -cause tissue damage. Be sure this section explains and agrees with what is indicated on the Checklist. Page 11 of 19

12 D. Surgical Procedures - Written records of surgery and anesthesia must be kept for each animal. - Animals must be observed daily following surgery and observations must be recorded from the time surgery is completed until incisions are healed. - These records must be made available for semi-annual inspections conducted by the IACUC. This section must explain what is indicated on the Checklist. 1. Surgeon(s) List his/her qualifications for doing the procedure(s) to be carried out. 2. Procedure(s) Must use aseptic techniques. Include your method for determining that the animal has reached plane of anesthesia; how often it will be checked to ensure animal remains in plane of anesthesia; and how it will be determined that the animal has fully recovered from the effects of anesthesia. Page 12 of 19

13 3. Medication For all medications, specify: - agent - route of administration (e.g. oral, sub-q, IP, etc.) - dose (indicate mg drug/kg body mass; include concentration of the drug, usually expressed as mg drug/ml solution and ml solution/kg body mass) - frequency of administration, when appropriate. a. Pre-operative medication and preparation b. Anesthesia and other medication during surgery c. Post-operative medication and observation Page 13 of 19

14 d. Explain Observations, Procedures, and frequency that they are performed to determine animal is in the plane of anesthesia, remains in the plane of anesthesia, and has fully recovered from anesthesia. E. Euthanasia and Final Fate of Animals (mandatory) Specify the criteria you will use to determine if and when euthanasia will be used to relieve suffering if animals become seriously ill or injured, even if this is not an expected occurrence. If euthanasia is not included as part of your protocol, indicate what will happen to the animals at the end of the study (e.g. return to colony; herd; sent to processing plant, etc.) This information should conform to what is indicated on the Checklist. Page 14 of 19

15 3. TRAINING/QUALIFICATIONS OF INDIVIDUALS PERFORMING WORK WITH ANIMALS Any questions regarding this training should be directed to the IACUC coordinator at or the Director of Research Compliance at A. Mandatory Online Training All individuals working with animals should complete the "Working with the IACUC" module from the CITI website (login under the University of Arkansas - Fayetteville) B. Personnel Performing Work at CLAF or ENRC only 1. Individuals working at CLAF or ENRC must also complete the module titled "Post- Procedure Care of Mice and Rats in Research: Minimizing Pain and Distress." 2. Individuals working with animals at CLAF or ENRC must complete a health survey form and submit it to the Pat Walker Health Center. C. Study Roster Please complete the table on the next page, indicating the designation, a brief summary of qualifications, and role for each person involved with this study. 1. Principal Investigator (PI) - a current vita must be on file with the IACUC 2. Student (S) - attach a resume or provide a brief description of qualifications 3. Technician (T) - attach a resume or provide a brief description of qualifications 4. Other (O) - Please define this person's role 5. Training - If you have students who do not have any background in animal research, please provide the name of the student's trainer. All training will be verified. If training records cannot be found for any individual listed, review of the protocol may be delayed until training is complete. Page 15 of 19

16 STUDY ROSTER CITI Training Completed NAME DESIGNATION WITHIN THIS STUDY Working with the IACUC (date) Minimizing Pain and Distress (date) Health Survey Completed (date) Qualifications & Role in Animal Contact/Handling on this Study Page 16 of 19

17 4. STATEMENT OF COMPLIANCE (check box): As the individual responsible for this research or teaching project, I confirm that the information contained herein is accurate and, to the best of my knowledge, conforms to all applicable University, PHS, and USDA policies pertaining to the care and use of animals in research and teaching. I confirm that I have completed the required training modules. I confirm that all individuals involved with the care and use of animals used in this project will complete the required training modules and will be instructed in the humane care, handling, and use of animals, prior to participation in the project, and I will have reviewed their qualifications. I agree not to proceed with any portion of this project or purchase animals until I receive written approval from the University of Arkansas Institutional Animal Care and Use Committee (IACUC). I agree that no substantive change will be made in the procedures contained in this proposal without prior written notification to and approval by the IACUC. I agree to allow inspection of my research facilities by members of the IACUC and the Attending Veterinarian, and to immediately address any incidents of noncompliance with the University of Arkansas, Fayetteville Policy on Animal Care and Use. I understand that failure to comply with the Policy on Animal Care and Use may jeopardize the University's Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (and with it all federal funding for the University), and may ultimately lead to revocation of my privileges to conduct animal research at the University of Arkansas. Name of Principal Investigator Date Page 17 of 19

18 Assurance Statement for Biomedical Research and Teaching DO NOT COMPLETE THIS SECTION IF PROTOCOL IS DESIGNATED AS AGRICULTURAL OR FIELD RESEARCH. The Animal Welfare Act (USDA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals require that protocols for biomedical research and teaching involving animals must address, in writing, the following concerns. Items in brackets [ ] identify the source of the requirement (AWA = Animal Welfare Act and Regulations; Guide = Guide for the Care and Use of Laboratory Animals, 8th edition) A. Animals should not be used if other methods exist that would provide substantially the same information. Indicate why the use of live animals is required in this research. [AWA 2.31(e)(2); Guide p. 12]: B. Provide justification for your choice of species. List the important characteristics of the species that make it suitable for use in the proposed research. Cost alone is not a sufficient justification. [AWA 2.31(e)(2); Guide p. 12]: C. The number of animals used should be the minimum number that can be reasonably expected to provide statistically valid results. Describe how the number of animals to be used was determined. A statistical explanation is required. [AWA 2.31(e)(2); Guide p. 12]: D. The principal investigator submitting protocols for biomedical research should not unnecessarily duplicate previous experiments, and must consider less invasive alternatives to procedures that may cause more than momentary or slight pain or distress to animals (i.e. Level 3 or higher). Provide a statement indicating that a literature review has been conducted, demonstrating that this research does not unnecessarily duplicate previous experiments, and that appropriate alternative research methods are not available for any proposed procedures that involve pain categories of Level 3 or higher. The database(s) used must be identified below. [AWA 2.31(d)(1)(i, ii, and iii) and Guide p.12] Note: this requirement does not apply to protocols for teaching projects. Page 18 of 19

19 Datatabase Date(s) of Search(es) Key Words Used Medline Agricola Index Medicus Biol. Abstracts Animal Welfare Infomation Center (National Agricultural Library) Other (specify below) Name of Principal Investigator Date By checking this box, I am attesting that the information in this submission is complete and accurate. Page 19 of 19