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IACUC Animal Protocol Writing Workshop 101 How to Write an Effective and Successful Animal Activity Protocol: Hands On Training.

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Presentation on theme: "IACUC Animal Protocol Writing Workshop 101 How to Write an Effective and Successful Animal Activity Protocol: Hands On Training."— Presentation transcript:

1 IACUC Animal Protocol Writing Workshop 101 How to Write an Effective and Successful Animal Activity Protocol: Hands On Training

2 A Good Sources of Information Working with the IACUC: Writing an Animal Protocol Working with the IACUC: Writing an Animal Protocol AALAS Publication: American Association for Laboratory Animal Science “Bookstore” link How to Write an Application Involving Research Animals How to Write an Application Involving Research Animalswww.niaid.nih.gov/ncn/clinical/researchanimals/tutorial/index.htm Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research ILAR Publication: Institute for Laboratory Animal Research

3 Protocol Form 6 sections  General information  Number of animals  Surgical and non-surgical procedures  Alternative considerations and literature search  Statement of Assurances  IACUC actions

4 1.Principal InvestigatorName Susan Warren, Ph.D. Susan Warren, Ph.D.Title Associate Professor Associate Professor Dept Anatomy Ext/pager X X Must be full-time UMC faculty (Instructor – Professor)

5 Other PersonnelName Eddie Perkins Eddie Perkins Name Title grad student grad student Title Post Doc Post Doc Dept Anatomy/NeurosurgeryDept Ext/pager X Ext/pager Name Olga Golanov, MD Olga Golanov, MDName Title research tech research tech Title undergraduate student undergraduate student Dept Anatomy Dept Ext/pager X Ext/pager Identify all persons associated with the animal work. This information assists the LAF and IACUC in contacting knowledgeable persons to answer questions/concerns relative to the animal experimentation. For access to the animal facility, all personnel working on this protocol must be listed.

6 Have all the individuals listed above submitted their completed training requirements registration form? Yes No If no, you must complete the IACUC Mandated online training requirement (www.researchtraining.org) And complete the IACUC Training Registration Form Laboratory Personnel Training Certification

7 Project Title This title will be used in the IACUC database to identify the project. (may be the same as the grant title) The title should briefly state procedures to be carried out and the animal species to be used.

8 Project Title - Examples Tissue Harvest in Rats Health Monitoring of Guinea Pigs Production of Transgenic and Gene Knockout Mice Evaluation of Drugs for Osteoporosis in Squirrel Monkeys Breeding protocol for AXt-1a knockout mice

9 4. Proposal is New - designation of a de novo submission Revision of Existing Protocol - designation of amendments/revisions to the protocol. Any “revised” information should be easily identified [highlighted, bold, italics, colored font] 3 year Full Submission designation of a previously approved protocol that must be re-written after three years Needs to include Appendix K

10 5.Outside Contracts? Will any “outside” contracts be used in this study that involve live animals (antibody production, toxicology screening, subcontracts with other facilities, etc)? No Yes (provide information on the level of involvement) Mark YES if any non-UMC entity will be involved in any animal care and use activities. Examples include housing your animals at another institution for specialized procedures, use of a contract toxicology research lab, antibody production techniques by another lab, etc.

11 6. Funding Source This question aids the IACUC and LAF in allocation of resources. In times of lean animal housing space, the LAF will further give top priority to those extramurally- supported protocols. Generally, the IACUC does not attempt to provide scientific review of a protocol, yet is obligated to provide some level of scientific review for those departmentally-funded protocols lacking any peer review.

12 6. Funding Source  Title: Grant Application Title  GrantFunding Agency: NIH, NSF, American Heart, etc Covered Dates: thru  Departmental Funds  Has this proposal received any peer review? YesNo Pending

13 7. Procedure Category Acute (anesthesia without recovery or euthanasia) Acute procedures not only refer to an anesthesia without recovery, but also those studies where no advance forms of animal manipulations have occurred. Examples include  animal sacrifice  tissue collection  terminal surgical procedure

14 7. Procedure Category Survival Survival procedures not only include survival surgical procedures but any animal manipulations that may be conducted on the animal. Examples include  any type of dosing (oral, feeding, injections, topical, gavage, etc)  sample collection (blood, urine, CSF)  behavioral experimentation (swim test, radial arm maze, single unit recording)

15 8. Dates of Study A. Anticipated start date of study: thru B. Study Duration (maximum 3 years): 2 years Response assists the LAF in planning/coordinating space for the study.

16 9. Animal Requirements List all animals required to complete the study. Animal numbers must be calculated for a period of three years. Complete all columns of the chart. If using nonhuman primates, must complete Appendix A. If using time pregnant animals, must complete Appendix B. If using animals from an in-house breeding program, must complete Appendix B.SpeciesStrain/StockSexSource Total for Project Average daily census ratSDmale21313 mouseC57BL/6female11321

17 10. Breeding Program Will animals be involved in a breeding program at UMMC or will time-pregnant animals be used? No Yes (provide information in Appendix B) Mark YES for any study proposal involving animal mating or for proposals utilizing time-pregnant animals. Must also include Appendix B.

18 11. Potential HazardsYesNoPendingA Chemical toxins in bedding/cages/carcasses? Reviewed by Risk Mgmt? B Radioisotopes in bedding/cages/carcasses? Radioisotopes in bedding/cages/carcasses? Reviewed by Radiation Safety? C Infectious agents or recombinant DNA usage? Infectious agents or recombinant DNA usage? Reviewed by Biohazards Committee? If YES, provide specific details of specialized animal husbandry, care, cleaning, or decontamination procedures, especially identifying responsible parties.

19 11. Potential Hazards Specific check boxes are included for chemical, radioisotopes, and/or infectious agent exposures in research animals. Boxes should be checked where appropriate and the proposal must be reviewed by the responsible oversight group. IMPORTANTLY, any YES answers must also include specific details of any specialized animal care procedures to be used, paying particular attention to occupational safety of animal caretakers. The explanation should state type of exposures, personal protective equipment to wear, decontamination procedures, and any other relevant information.

20 12. Animal HusbandryStandard Non Standard Feeding High/low sodium chow; beef fat Watering sweetener/ alcohol/water restriction Caging/Housing Metabolic cages/ single housing following surgical implants

21 12. Animal Husbandry Standard:Standard methods for UMC include ad lib access to water LAF feeding of commercial diets conventional housing

22 12. Animal Husbandry Nonstandard: Examples include providing limited access to water limited quantities of water feeding specialized diets (e.g., high fat, High/Low sodium) feeding specialized amounts “unconventional” housing (metabolic cage, single housing) behavioral manipulation of environment (e.g., changes in light-dark cycle)

23 13. Housing Will animals be housed outside of the LAF for greater than 12 hours? No No Yes Where? Yes Where? Note:If yes, provide complete explanation and justification for any de- centralized animal housing. Mark YES for any proposal that requires an animal to be maintained in a laboratory/testing location in excess of 12 hours. Any location maintaining animals for greater than 12 hours will be considered as a housing location and must be maintained in accordance with the USDA, OLAW, and AAALAC. The IACUC will need to provide approval for such sites.

24 14. Objectives in lay terminology In non-technical/lay terminology, what is the proposed in this Animal Activity Protocol? (i.e. Response should be written in non-scientific language, as though explaining the study to a high school student. In non-technical/lay terminology, what is the objective of the experiments proposed in this Animal Activity Protocol? (i.e. Response should be written in non-scientific language, as though explaining the study to a high school student.  Why are the experiments proposed?  What knowledge do you hope to achieve?  Generally, single sentence explanations for these types of questions will suffice

25 14. Objectives in lay terminology Important to write response in non-technical, lay language. Imagine this response presented to a local news media. Ideally, this response will highlight a particular human/animal problem that the study seeks to investigate. How will the use of animals help you investigate this particular problem? What answers do you anticipate from the proposal?

26 15. Rationale A. What is the rationale for using the particular animal species noted in #9? This question seeks to understand why a particular animal is noted in #9. Literature searches provide numerous examples of appropriate animal models for specific types of studies. This response should support the animal species noted in #9. Cost alone should not be a reason for choosing a particular animal species. This question seeks to understand why a particular animal is noted in #9. Literature searches provide numerous examples of appropriate animal models for specific types of studies. This response should support the animal species noted in #9. Cost alone should not be a reason for choosing a particular animal species. B. What is the rationale for using animals rather than using non-animal models? This question seeks to understand if all in vitro, inanimate models have been considered. In many cases, in vitro methodologies may exist that could support the study, yet will not provide the level of understanding required to meet the objectives. If in vitro methods are being used in conjunction with animal, state that also.

27 16. Brief Outline Provide a general description of the animal procedures included in the experimental design.  Briefly outline the proposed animal manipulations and provide a time-line of events.  Note that specific details about methods and procedures will be required in the appropriate appendix (see list below)  Verbatim descriptions from a grant submission are not acceptable and will not be reviewed.

28 16. Brief Outline Appropriate responses to this question will briefly outline all animal manipulations. This question also contains a check list of related appendices (A through K). Investigators will note that many specific details of surgical procedures, sample collection, administration of test compounds, antibody production, etc will necessitate completion of the appropriate appendices. An important consideration for inclusion is a time-line of events. This time-line helps the IACUC clarify the proposed work.

29 16. Brief Outline For example, a study seeks to feed an experimental diet to rabbits then surgically instrument each animal with telemetry devices. Following the surgery, the animals will be monitored for 4 weeks and intermittent urine/fecal samples will be collected. 6 week old rabbits Diet 1 Diet 2 Surgical manipulations Urine/fecal sample Sacrifice 2 weeks 4 weeks

30 Example Answer In this response, #16 would include information about the diet, especially if potential nutrient deficiencies were anticipated. General information about the surgical procedure would be included. Likewise, any information about urine/fecal collection methods would need to be a part of the response (metabolic cage, catheterization, litter pan retrieval, etc). In this response, #16 would include information about the diet, especially if potential nutrient deficiencies were anticipated. General information about the surgical procedure would be included. Likewise, any information about urine/fecal collection methods would need to be a part of the response (metabolic cage, catheterization, litter pan retrieval, etc). A probable time-line might be: A probable time-line might be: Experimental diet (4 weeks) →Telemetry implant (1 day) → Monitor (4 weeks) → behavioral test (forced swim) → euthanasia Experimental diet (4 weeks) →Telemetry implant (1 day) → Monitor (4 weeks) → behavioral test (forced swim) → euthanasia Additionally, the following appendices must be included: Additionally, the following appendices must be included: Appendix C [Surgery] Appendix C [Surgery] Appendix D [Biological samples] Appendix D [Biological samples] Appendix F [Administration Test Compound (diet)] Appendix F [Administration Test Compound (diet)]

31 Appendix A Appendix A Environmental Enhancement/Enrichment Appendix B Appendix B Breeding Programs Appendix C Appendix C Surgery & Management of Surgical Pain & Distress Appendix D Appendix D Collection of Biological Samples Appendix E Appendix E Antibody Production Appendix F Appendix F Administration of Drugs/Test Compounds Appendix G Appendix G Prolonged Physical Restraint Appendix H Appendix H Multiple Major Surgical Procedures Appendix I Appendix I Food and /or Fluid Restriction Appendix J Appendix J Animal Pain and/or Distress Appendix K Appendix K Progress Report Appendices Check and complete only those appendices that apply to the animal manipulations in your experimental design.

32 17. Justification of Animal Number The total number of animals needed to complete item #16 should be explained in this response. Likewise, this number should match the requested number provided in #9. It is often beneficial to include a flow diagram or chart/table that defines the animal use. Break numbers down into number of animals/group, number of groups, number of replicates, etc. Any animals needed for pilot work or training new technical personnel should be accounted for. Responses should have some statistical merit.

33 18. Location and Transportation A. Indicate room(s) where animal procedures will be conducted. This response is noted in the IACUC database as the experimental area. Semi-annual program reviews will include this location into subsequent inspections. Likewise, affirmative answers to #13 (Housing) should also be listed in this response.

34 18. Location and Transportation B. Studies involving animal transportation to locations other than the housing area must identify the animal transport device, the nature of shrouds used to cover the transport device, and describe the route of transport Numerous laboratories are required to remove their animals from the LAF environment to their respective labs. The method and route of transport should be courteous to Medical Center visitors/patients, conscious of occupational exposures, and respectful of those opposing the use of animals in research. All animal movement must occur in appropriate restraint boxes/cages and with a concealment shroud/drape. Consult LAF SOPs for descriptions of routes of appropriate animal transportation.

35 19A. Euthanasia A.At what point in the proposed experiments will animals normally be euthanized (experimental end-points)? Or at what point will any individual animal be euthanized? This response would correlate with the experimental end points described in #16. The question seeks to clarify the IACUC’s understanding of when any particular animal will conclude the study.

36 19B. Euthanasia B. What criteria will be used to determine if an animal is to be euthanized prior to, rather than at, the anticipated end- point of an experiment? Note: Contact LAF, ext , for recommendations on the assessment criteria. The appropriate response will articulate potential adverse consequences or effects of the experiment. Investigators should list potential surgical complications, adverse effects of drug/diet administration, or failure to manage pain and distress. Specific, objective criteria may also be incorporated (e.g., 20% loss in body weight, hematocrit falls below 25%, creatinine levels above 2.5 mg/dl, etc) to note when an animal is removed from the study.

37 19C. Euthanasia C. If proposing a natural death (or death due to manipulations), explain and justify. This type of scenario is described as “death as an endpoint”. These studies must firmly justify the scientific need to allow an animal to advance through a potentially painful/distressful terminal event. Unless information to the contrary is known, it is assumed that all “death as an endpoint” studies will result in some level of pain and/or distress to the animal while in the moribund state. Ideally, some definitive, objective criteria can be used to “measure” when an animal can be removed. For example, in a model of renal failure, perhaps BUN levels >100 coupled with Cr values >3.5 are indicative of end-stage kidney disease and will provide the necessary endpoints. Likewise, in an oncology study, perhaps tumor growth beyond a specific size could be used.

38 20. Euthanasia Procedures What procedures will be used to euthanize the animals? Note: Secondary methods are recommended to ensure death. (Consult Section VII of the LAF Training and Procedural Manual for appropriate methods of euthanasia.) Procedures must be consistent with the 2000 Report of the AVMA Panel on Euthanasia [copy located in the LAF Training & Procedural Manual]. Likewise, secondary methods should be proposed to ensure and/or guarantee death. Secondary methods are typically those involving exsanguination, pneumothorax, or tissue harvest.

39 Institutional requirement for all persons to be registered and known by the health services organization.  Have all personnel received a medical evaluation from UMC Student/Employee Health?  Have all personnel become familiar with the LAF Training & Procedural Manual? Assurances

40 The LAF Training and Procedural Manual is jointly produced by the LAF and the IACUC. The manual is designed to answer many commonly asked questions and address particular areas related to animal-based research programs at UMC. Each Principal Investigator is issued a copy of the manual. The manual should be available to all research personnel in the laboratory in an effort to foster a better understanding of animal care and use programs. Assurances

41 To comply with the USDA’s Animal Welfare Act [9 CFR, part 2, Section 2.31 (d)(1)(ii) and (iii)] you must complete a written NARRATIVE of the sources you consulted to determine whether or not alternatives exist to procedures that may cause pain and distress. Likewise, this search will ensure that the proposed studies are not unnecessarily duplicative. Assurances

42 Review of the available resources and previous experiments have determined that the proposed activity is not unnecessarily duplicative of previously reported activities? The question seeks to prompt the investigator to conduct a literature review and assure the IACUC that the proposal does not duplicate existing work. Assurances

43 Appendix A: Environmental Enhancement/ Enrichment  Enrichment Techniques Are there any enrichment forms/techniques that are included in this protocol? YES NO  Description Describe the above techniques  No Enrichment? Are there any forms of enrichment/enhancement that should not be used in this study? YES NO  Justification for exemption YES NO If YES, provide complete justification for this exemption

44 1. Description Provide a specific description of the type of breeding program to be utilized (harem, monogamous pair, etc). 2. Personnel Responsible Identify personnel responsible for the breeding program. 3. Records Identify personnel responsible for maintaining breeding program records. Appendix B:Breeding Programs Complete Appendix B for all proposals planning on establishing a breeding colony or for those studies utilizing time-pregnant animals. Studies incorporating breeding programs or offspring from time-pregnant animals will be required to report annual production (number of offspring used) at the time of IACUC protocol annual renewal.

45 Appendix B:Breeding Programs 4. Adults How many adults will be utilized in this breeding program? 5. Final Disposition of Adults What is the final disposition of these adults at the conclusion of their breeding program? 6. Offspring How many offspring are anticipated from each breeding or time-pregnancy? 7. Final Disposition of Offspring What is the final disposition of any offspring not utilized in the experimental program?

46 Surgical site preparation The surgical site will be shaved, cleansed with soap, swabbed with alcohol and bathed in providine solution The surgical site will be shaved, cleansed with soap, swabbed with alcohol and bathed in providine solution Surgical approach A midline incision will extend from brow ridge to the occipital protuberance. The skin and underlying muscle will be reflected. A bilateral craniotomy will be made 3 mm from the midline using a hand-held drill equipped with a ¼” burr. Any unique or special techniques An ICV cannula, having an internal diameter of 0.25 mm, will be implanted via a craniotomy into the underlying lateral ventricle and cemented to the skull using dental acrylic and stainless steel screws. An ICV cannula, having an internal diameter of 0.25 mm, will be implanted via a craniotomy into the underlying lateral ventricle and cemented to the skull using dental acrylic and stainless steel screws. Wound closure method, suture materials, and suture removal plan Wound will be closed in layers. Vicryl suture will be used for muscle. Silk sutures will be used for skin. Skin sutures will be removed 7-10 days post-operatively Wound will be closed in layers. Vicryl suture will be used for muscle. Silk sutures will be used for skin. Skin sutures will be removed 7-10 days post-operatively Appendix C Surgery & Management of Surgical Pain and Distress 1. A Complete description of surgical procedure

47 AgentDoseRouteFrequency/Duration Pre-anesthetic ketamine HCL ketamine HCL Atropine sulfate AcepromazineXylazine10mg/kg im once for cage removal once for cage removal Anesthetics sodium pentobarbital Isoflurane iv, inhalant iv, inhalant 1 time for induction; 2-5 hours 1 time for induction; 2-5 hours AnalgesicsSensorcaineCarprofen buprenorphine buprenorphine Ibuprophin im, sub q 1x for 2-3 days; 1x every 12 hours 1x every 12 hours Fluid/blood replacement 5% lactated ringers Antibiotics Appendix C Item 2A: Formulary

48 Appendix C: Anesthesia 2b. Anesthesia Who will conduct the anesthesia procedure(s)? List Individual(s) by name 2c. Anesthesia criteria What criteria will be used to assess anesthetic depth and how will this be monitored? toe pinch, reduced/absent corneal reflex, withdrawal reflex 3. Experience/training Describe the training/experience, including species of animals, of personnel conducting the anesthetic procedure? List individual named in #2B and indicate level of training, number of years actively involved in procedure, and what species he/she has worked

49 Appendix C: Surgical Procedures 4. Surgical procedure Who will conduct the Surgical procedure(s)? List individual(s) by name 5. Experience/training Describe the training/experience, including species of animals, of personnel conducting surgical procedures? List individual named in #4 and indicate level of training, number of years actively involved in procedure, and what species he/she has worked. 6. Location of procedures Where will the surgical procedures be conducted? Indicate Room in which dedicated space for surgical procedures is located, e.g., LAF procedure room, R-717, N-412.

50 Criteria for Assessing Level of Anesthesia Respiration rate Respiration rate Heart rate Heart rate ECG ECG Toe pinch Toe pinch Tail pinch Tail pinch Corneal reflexes Corneal reflexes Color of mucous membranes Color of mucous membranes Muscle relaxation Muscle relaxation Other Other  Pulse oximeter  respirometer

51 Appendix C: Post-operative Care and Emergencies 7. Experience/training Who will conduct and document post-procedural animal care? (post-op analgesia, nursing care, etc.) Include a plan of monitoring frequency, duration and intervals of post-op analgesia, nursing care, etc.? List Individual responsible Indicate a plan for monitoring - twice daily for the first three days; three times per week for the duration of the recovery period 8. Emergency Contacts Emergency contact (pager/phone number) for evenings or weekends concerning post-operative complications. Provide a named individual(s) and appropriate phone/pager numbers

52 AgentDoseRouteFrequency/Duration Biological samples include blood collection, urine collection, ascites, cerebrospinal fluid, biopsy, etc. Appendix D is completed for all sample collections from live animals (excludes sample collection at necropsy. Indicate the body fluid or material to be collected. Indicate the method and site of collection. Indicate the volume of fluid or material to be collected. Indicate the frequency of collection. Will the animal(s) be anesthetized or sedated during this procedure? YES NO Appendix D: Collection of Biological Samples from the Live Animal

53 Appendix E: Antibody Formation / Tumor Induction / Hybridoma & Ascites Indicate what antigen will be used. Indicate what vehicle/adjuvant will be used: initial immunization: subsequent immunizations: anticipated complications/side effects: Indicate sites for immunization: Indicate route of administration: What is the total and per site injection volume? What is the frequency/duration of immunization (e.g., 1 injection every 2 weeks for 3 injections)?

54 Appendix E: Antibody Formation / Tumor Induction / Hybridoma & Ascites ASCITES PRODUCTION Fluid accumulation associated with ascites/hybridomas should not become greater than 10% of body weight. Animals should be euthanized if they become moribund. Indicate the maximum volume of ascites fluid to be collected per sampling (ml/mouse) and the method of collection (skin prep, gauge needed, gravity vs suction, etc) Indicate the number of fluid collections and anticipated frequency of collection. Describe procedures used to care for and monitor the health of animals with ascites and the point of euthanasia.

55 Appendix F: Administration of Drugs/Test CompoundsAgentDoseVolumeVehicleRouteFrequency WGA-HRP 20% solution 20% solution ul ul sterile water sterile water one time one time BDA 4% solution 4% solution ul ul sterile water sterile water one time one time BDNF MK Describe any potential adverse side effects that may result from the administration of this material. If agents are unknown or their potential side effects are not documented, provide a reasonable estimate of the effects of the general class of chemicals (e.g., cmpd may have sedative properties, cmpd will likely produce diarrhea, etc). No adverse affect anticipated. We will consult with the veterinary staff should unanticipated problems arise. 3. What special procedures do animal care personnel and veterinary caregivers need to assume when working with these animals or their bedding/cages? These compounds pose no threat to the health and welfare of the animal care staff. 1. Provide the Following Information All agents listed in Animal Activity Protocol question #11 (Potential Hazards to personnel or other animals) must be listed in this section. Additionally, other experimental (Test) compounds used in the study should be noted. This section is not for the listing of veterinary pharmaceuticals (antibiotics, anesthetics, analgesics).

56 Justify the need for prolonged physical restraint. Why you need to employ restraint – safety of the animal during procedure; training Describe the restraint device: Tether, harness, primate chair Describe how the animal(s) will be adapted to the restraint device. Detail the time frame for adaptation to device; detail any rewards/encouragements used to achieve compliance What is the duration of a restraint period? Daily – indicate the total numbers of hours/day Long term - weeks/ months Appendix G: Prolonged Physical Restraint

57 Are animals monitored during the restraint period? Yes No If YES, describe who and document procedures How often? Are there any anticipated problems as a result of the restraint device (e.g., skin lesion from harness, moist dermatitis, etc) Indicate plan for monitoring and detail procedure for corrective measures Appendix G: Prolonged Physical Restraint

58 A major surgical procedure is defined as a surgical intervention that penetrates or exposes a body cavity (peritoneal, thoracic, cranium) or produces substantial impairment of physical or physiologic function. Multiple major procedures are those whereby an animal will regain consciousness after each procedure. Procedures must be described in Appendix C. A major surgery followed by a second procedure where the animal is sacrificed is not considered in multiple major surgical procedures. Justify the need for multiple major surgical events in a single animal. Need for sequential administration of tracer materials; need to instrument animal proir to manipulations What is the time interval between the surgical events? Day to weeks to months Appendix H: Multiple Major Survival Surgical Procedures

59 METHOD FREQENCY OF CHECKS Body weight Urine output Fecal output BUN Hct Food intake Appendix I: Food and/or Fluid Restriction 1.Will FOOD or FLUIDS be restricted? Justify the need to restrict food and/or fluid. 2. Check all methods that will be used to ensure adequate nutritional intake and hydration

60 Appendix I: Food and/or Fluid Restriction 3. Restriction protocols typically base the restriction amount relative to a baseline, (free-choice consumption) parameter (body weight, intake amount). What will this restriction amount use as the baseline? What is the maximum % restriction for any animal? 4.Growing animals must be frequently re-assessed to ensure normal growth patterns. What provisions will be made for these animals to assure that their nutritional needs are maintained? 5. The Animal Welfare Act states that if “water is not continually available, it must be offered to them as often as necessary to ensure their health and well-being, but no less than twice daily for at least 1 hour each time, unless otherwise required by the attending veterinarian”. Will animals be provided unrestricted access to water/fluids twice daily for at least 1 hour each time? YesNo If NO, explain and justify

61 1.Justify the scientific need to withhold appropriate drugs or induce the pain/distress. 2.What is the duration of time that an animal may experience this pain/distress. 3.Describe non-pharmaceutical means to alleviate pain/distress (soft bedding, social housing, supplemental heat, etc). 4.Describe situations where an animal may be removed prematurely from a study. Appendix J: Animal Pain and/or Distress

62 NON-SURGICAL PAIN/DISTRESS 5.Describe those proposals whereby animals are likely to experience more than momentary pain or distress as a result of manipulations or procedures (noxious injections, tumor growth, sequelae to compound administration, etc). 6.Will any anesthetics, analgesics, or tranquilizing drugs be used to reduce this pain or distress? 7.What non-pharmaceutical measures will be used to minimize discomfort, distress, pain, or suffering (e.g., fluids, supplemental heat, soft bedding, etc)? Appendix J: Animal Pain and/or Distress

63 Criteria used to Assess Pain/Distress/Discomfort Criteria used to Assess Pain/Distress/Discomfort Loss of appetite Loss of appetite Loss of weight Loss of weight Restlessness Restlessness Abnormal resting posture Abnormal resting posture Licking, biting, scratching, shaking Licking, biting, scratching, shaking Failure to show normal patterns of inquisitiveness Failure to show normal patterns of inquisitiveness Failure to groom Failure to groom Guarding Guarding

64 Criteria used to Assess Pain/Distress/Discomfort Loss of mobility Loss of mobility Red stain around eyes (rats) Red stain around eyes (rats) Unresponsiveness Unresponsiveness Self-mutilation Self-mutilation Labored breathing Labored breathing Other Other

65 Appendix K: Progress Report This appendix must accompany every 3 year Full Submission


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