NATIONAL PRIMATE RESEARCH CENTER Institutional Animal Care & Use Committee Protocol for the Use of Nonhuman Primates for Research, Teaching or Demonstration
Protocol #: Approval Date: TNPRC 18703 Three Rivers Rd, Covington, LA. 70433 (985-871-6636) Vet Assigned: Census Code: IACUC Office 1430 Tulane Ave TB 23 N.O., LA. 70112 (504-988-6868) Project #:
Email a copy of this protocol to [email protected]
Date Filed: Principal Investigator: Position/Title:
Division: E-mail: Phone: Lab Phone: Other: Address/Mailbox:
Co-investigator and/or TNPRC contact: (required if PI is an outside collaborator)
Position/Title: Division: E-mail:
Additional Contact Person(s): Phone: Email:
Emergency Contact: Phone:
TITLE OF PROTOCOL: List the title of the grant only if it differs from the protocol title:
FUNDING AGENCY OR SOURCE:
DURATION OF PROJECT: Project Start Date: Please include animal use for the duration of the entire study. While protocols are approved for three years the IACUC needs to review the complete project.
IS THIS PROTOCOL A SUBCONTRACT OR FEE-FOR-SERVICE? YES (If the PI of the grant is affiliated with an institution other than TNPRC, “yes” should be indicated.) IF YES, INDICATE PI OF THE GRANT: NO
INITIAL PROTOCOL –Proceed to Section II. Species
RENEWAL PROTOCOLS – List current protocol number: and complete Section I.A. and B.
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SECTION I. RENEWAL PROTOCOLS ONLY
A. Please enter a brief summary of what has been accomplished thus far so that the continuation efforts described in this protocol can be better understood. Please include any relevant publications from your study.
B. Please list the animals assigned to the previous protocol that will continue on this protocol. Do not list any animals released from the project (transferred or dead). If this protocol involves multiple projects you must list the animals per project. SPECIES PROJECT # NUMBER USDA CATEGORY
Other: Comment:
SECTION II. SPECIES, NUMBER & CATEGORY OF ANIMAL USE for animals to be assigned to this project - Do not include animals listed in Section I .B. If this protocol involves multiple projects you must list the animals per project.
SPECIES PROJECT # NUMBER USDA CATEGORY
Comment: *USDA Category: for a complete description please go to http://tulane.edu/asvpr/iacuc/hsc/
SECTION III. USE OF ANIMALS ASSIGNED TO OTHER PROTOCOLS Approval of a protocol that utilizes animals assigned to other protocols binds the principal investigator into an agreement to coordinate all animal sampling and procedures with the corresponding principal investigator so that all procedures follow the guidelines by the governing agencies and the IACUC
PROTOCOL SPECIES # OF USDA PI SIGNATURE- If you are piggybacking # ANIMALS CATEGORY your own protocol, then you must have the signature of assigned veterinarian for the parent protocol.
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Comment: If you have chose one of the Breeding colony protocols please review the Policy for Piggybacked Use of Breeding Colony Nonhuman Primates and complete the checkbox below. I have read the Policy for Piggybacked Use of Breeding Colony Nonhuman Primates
IMPORTANT Questions must be answered completely for the protocol to undergo IACUC review. Do not refer to or attach passages from grants.
SECTION IV. REGULATORY INFORMATION
Please check YES or NO as it applies to the animals requested. If you answer YES to a question, you must provide an explanation and justification.
1. Is this an endangered or threatened species? No Yes - Provide explanation and justification:
2. Is shortterm (> 30 minutes; < 12 hours) physical restraint of a conscious animal employed? No Yes - Provide explanation and justification:
3. Is longterm (12 hours or more) physical restraint of a conscious animal employed? No Yes - Provide explanation and justification:
4. Will specialized management procedures be required, e.g. specialized caging equipment, restricted or altered feeding/watering/sanitization schedules, periods of isolation from other nonhuman primates, or environmental parameters such as cage size, temperature, lighting or other fall outside the “Guide for the Care and Use of Laboratory Animals”? No Yes - Provide explanation and justification:
5. Will you perform more than one major survival surgery on any animal? PLEASE NOTE: Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiological functions (such as laparotomy, thoracotomy, craniotomy, joint replacement or limb amputation). No Yes - Provide explanation and justification:
6. Will animals be housed outside of AAALAC-accredited Tulane facilities for over 12 consecutive hours? If YES, the proposed site must be inspected and approved by the IACUC prior to use. Please list the location with justification below. No Yes - Provide explanation and justification:
7. Will pain or distress be experienced where the use of analgesic or anesthetic agents is not allowed because of experimental protocol? This is Category E and must be scientifically justified with references.
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No Yes - Provide explanation and justification:
8. Will these procedures be filmed, videotaped or photographed for use outside the institution? If so, you must obtain approval from the Executive Director of Comparative Medicine. (985-871-6285) No Yes - Provide explanation and justification:
SECTION V. PERSONNEL HAZARDS
A. Is there potential exposure of humans to chemical hazards, physical hazards, radioactive agents, or biohazardous agents during the course of animal experimentation?
No Yes - please respond to the choices below.
Physical Describe: Chemical Describe: Radioactive Describe:
Biohazards Describe: Does this biohazard require IBC approval? NO YES- IBC approval #
Describe: Does this biohazard require IBC approval? NO YES- IBC approval #
Describe: Does this biohazard require IBC approval? NO YES- IBC approval #
Questions regarding IBC approval should be directed to http://tulane.edu/asvpr/biosafety/committee/ SECTION VI. NON-TECHNICAL SUMMARY
Using non technical language that a layperson without scientific knowledge would understand, provide a brief summary that describes the nature and purpose of this study and its potential value to human or animal health, the advancement of knowledge or the betterment of society. Do not use scientific terminology, acronyms, or abbreviations and do not cut and paste passages from your grant application.
SECTION VII. COMPLETE DESCRIPTION OF ANIMAL USE
A. CONCISE DESCRIPTION 1. Please state your hypotheses in this section and limit the text to a few lines. Do not cut and paste passages from your grant application 2. Provide a concise description including all steps, in chronological order, the experimental course of an animal from its entry into the experiment to the endpoint of the study. Do not include specific
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information about timepoints, doses, routes, sampling, SOPs etc. in the description, as this information must be included in your table.
B. TABLE OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES - You must provide a table or tables that includes the following: Animal Group Composition - It is recommended that you describe each group and assign a number that you can reference in your table (Example 1.1, 1.2, 2.1). Sampling, Procedures, Drugs, Compounds– You must include all procedures and sampling. Sampling information must include the frequency, number of samples, volume, and type of sampling. All drugs or compounds given must be listed on the table and include the dose, route and frequency. Time points – You must list the time points on the table and be sure to include whether you are using day, week, month, or year. Please provide a table title reference if using more than one table.
Insert table
C. STANDARD OPERATING PROCEDURES (SOPs) Procedures may reference an approved TNPRC SOP/Policy in lieu of a complete description. The dropdown menus below list the most common procedures conducted. Please choose all of the SOPs that will be used on your study. The SOP/policy table of contents is available upon request to [email protected].
If there is no approved SOP, then a complete description must be included in the Concise Description (B.).
List any SOPs (# and title) that will be used but are not on the menu above:
Is the following applicable to your study? No Yes- I understand that the no more than 12.0 ml of blood per kilogram of body weight in a four-week period can be collected.
D. PROPOSED TREATMENTS Pain and Distress: Describe the use of analgesics, anesthetics, and tranquilizing drugs to minimize discomfort, distress, pain and injury. The list below contains some common drugs and doses for nonhuman primate use and must be checked if they will be administered in this protocol.
DRUG DOSE ROUTE FREQUENCY FREQUENCY Preanesthetic Drugs Glycopyrrolate 0.01mg/kg im/iv Prior to anesthesia Acepromazine 0.2mg/kg im Prior to anesthesia
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Other: Anesthetic Drugs Isoflurane gas 1.5-2.5% to effect inhalation Continuous Ketamine hydrochloride 10mg/kg im prn Tiletimine/zolazepam (Telazol) 8mg/kg im prn Other: Analgesic Drugs Butorphanol (Torbutrol) 0.013mg/kg im tid Buprenorphine 0.01mg/kg im bid Meloxicam (Metacam) Oral Once a day Other
List all drugs, agents, compounds, and substances that are introduced to the animals throughout the study period as described in the complete description.
SELECT TYPE NAME DOSE ROUTE
IN VIVO RADIONUCLIDE(s) VOLUME INSECT VECTORS NUMBER MODE
E. VETERINARY CARE Routine care as specified in the standard operating procedures of the Division of Veterinary Medicine (985-871- 6266) Special care. Provide a plan of action including phone numbers of essential personnel.
F. ADVERSE EFFECTS RESULTING FROM ADMINISTRATION OF A TEST ARTICLE Please list any adverse effects or reactions that have been documented or could be expected from the use of the test article (drug, inoculum. antibody, other material or devices) animal phenotype or procedure during the study. If none are expected, please state that and provide information that supports the statement.
Please list what treatment plan(s) will be employed in response to such adverse effects, should they be noted during the course of this study.
G. ENDPOINTS The TNPRC endpoint policy is acceptable for this study.
There is NO ANIMAL ENDPOINT to this study other than the approved study period. At the end of the study the animals may be returned to the general colony and euthanasia is not required. However, if an animal’s physical condition deteriorates the TNPRC endpoint policy is acceptable for this study.
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The endpoints for this study are time based and noted on the Experimental Design table in Section VII.B. However, if an animal’s physical condition deteriorates the TNPRC endpoint policy is acceptable for this study.
I choose not to use the TNPRC endpoints - Please list the criteria to use to determine when euthanasia will be performed. You must provide justification supported by references if you choose not to use the TNPRC endpoints.
H. EUTHANASIA METHOD The standard method of euthanasia for nonhuman primates at the TNPRC follows the IACUC approved TNPRC SOP 3.23 Euthanasia Procedures in Nonhuman Primates. This method is consistent with the recommendation of the American Veterinary Medical Association Guidelines on Euthanasia. http://www.avma.org/issues/ The TNPRC method of euthanasia is acceptable for this study.
If you propose to use a different method of euthanasia, please provide a description and if a chemical agent is used, specify the dosage and route of administration in your description.
YES, the method described above is consistent with the recommendation of the AVMA Guidelines on Euthanasia. NO, it is not consistent. Please provide justification (supported with references) for not following the recommendation:
SECTION VIII. ANIMAL USE JUSTIFICATION
A. RATIONALE FOR ANIMAL USE. It must include the reasons why non-animal models cannot be used.
B. APPROPRIATENESS OF THE SPECIES SELECTED (Please address if preliminary studies have been conducted using other species or lower life forms.)
C. ANIMAL NUMBER JUSTIFICATION Please identify the approaches listed below used to justify the number of proposed animals for this study and provide an explanation. More than one justification may be necessary for renewal protocols.
Please provide sufficient information, accompanied by your citation to indicate that the previous research is similar enough in concept and methodology to make it reasonable to use similar sample sizes in the proposed research project. Explanation Statistical analysis- if numbers are chosen with the intent of obtaining statistically significant differences, the most objective tool is usually a power analysis to determine sample size. When groups are compared, the goal of conducting a power analysis is to determine the appropriate number of animals per group to ensure detection of a significant difference. Please use the attached link for an example of the information needed to review a power analysis Explanation Pilot study- the following information must be included:
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Main outcome measure being evaluated (e.g. reduction in tumor size) The definition of success (e.g., a 50% reduction in tumor size in 3 animals) that would indicate that the study should be followed up by a full study. Explanation Teaching or Training
Explanation Is your study a USDA Category D or E? (Noted in Section III) No – Skip the next section and proceed to Section X. Yes - Please complete Section IX
4/25/188:41 A4/P4 Page 8 of 11 SECTION IX. ALTERNATIVES TO PAINFUL AND DISTRESSFUL PROCEDURES
As required by Policy 12 of the Animal Welfare Act, “the IACUC is required to assure that the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress” and “that the PI has provided a written narrative description of the methods and sources, such as the Animal Welfare Information Center, Biological Abstracts, Index Medicus, PubMed, and the Current Research Information Service.” Alternatives are defined as new methods that refine existing usage by minimizing animals’ distress such as the use of analgesics, reduce animal usage such as the use of certain experimental designs, or replace whole animal tests with other procedures such as the use of in vitro analyses.
Database Date of Period Keywords used Number Were Used search covered by Alternatives must be one of the of alternatives search key words relevant found references
If alternatives were found, justify why they are not being used.
Additional relevant sources may include scientific meetings, scientific discussion, consultation with veterinary faculty and federal law or other legal guidelines. Please list below. SECTION X. ENVIRONMENTAL ENHANCEMENT OF NONHUMAN PRIMATES
The United States Animal Welfare Act requires research facilities to provide environmental enhancement to promote the psychological well-being of nonhuman primates. To assist in meeting these requirements, please consider the needs of all nonhuman primates involved in the project, and indicate housing categories and enrichment categories that will be appropriate for the duration of the study. If different components of the study have different housing and/or enrichment needs, please indicate all that apply. Contact the Environmental Enrichment Coordinator in the Division of Veterinary Medicine (985-871-6578) if you need additional information concerning the categories or enrichment options. Categories selected by the investigator may be changed, with investigator approval, to accommodate health, behavior, or management needs of the animals.
A. HOUSING CATEGORIES: (Select all that apply) For protocols involving more than one housing category or species, indicate the phase of the study, treatment groups, or species to which the categories apply. Please specify if there are constraints within a socialization category, i.e. if only those individuals in the same arm of the study can be housed together. Explanations must be explicit. Statements such as "the research or the science requires separate housing", without substantive justification will not be accepted.
GROUP HOUSING - Three or more monkeys housed together in the same enclosure. This housing category is considered optimal for all age classes but especially encouraged for infants and young juveniles. No justification of this category is required. Comments:
PAIR HOUSING - Two monkeys housed together in a specific enclosure or cage. This category is particularly encouraged for infants and young juveniles when group housing is not feasible. No justification of this category is required. If there are restrictions to the composition of social groups (e.g. treatment groups and/or age/sex), please specify:
PROTECTED CONTACT HOUSING - Two monkeys housed in adjacent cages separated by a partition that permits social contact. This setting is encouraged for subjects who would otherwise by singly housed due to differences in diets between individuals, or due to frequent removal from primary housing for procedures. This setting also reduces the risks of injury to surgical sites and experimental appliances. The specific type of pairing may be selected. This housing option MUST be scientifically justified. If there are restrictions to the composition of social groups (e.g. treatment groups and/or age/sex), please specify:
Scientific justification for protected contact housing is as follows:
SINGLE HOUSING - A monkey housed alone, with visual, auditory, and olfactory contact with others of the same or compatible species. Investigators requesting this type of housing MUST provide justification. This housing option is particularly discouraged for infants and young juveniles due to its persistent negative effects on development. Scientific justification for single housing is as follows:
ISOLATION HOUSING - A monkey housed alone without visual, auditory, and olfactory contact with others of the same or compatible species. Monkeys housed in this manner must receive supplementary human attention and inanimate environmental enrichment. Investigators requesting this type of housing MUST provide justification. This housing option is particularly discouraged for infants and young juveniles due to its persistent negative effects on development. Scientific justification for isolation housing is as follows:
B. ENRICHMENT CATEGORIES (Select all that apply). For protocols involving more than one enrichment category, indicate the phase of the study, treatment group, or species to which the category applies.
STANDARD ENRICHMENT - This type of enrichment is appropriate for the vast majority of research projects. This type includes: Manipulable items in cage Perches or swings Various food supplements (fruit, vegetables, primate treats) Foraging or task-oriented feeding methods Human interaction with caretakers and research staff The implementation is tailored to the species as dictated by the Animal Welfare Act and outlined in the Tulane National Primate Research Center Policy on Environmental Enrichment. Animals showing signs of being in psychological distress through behavior or appearance must receive special attention, which may include additional enrichment devices, alterations to room configurations, and/or clinical intervention.
RESTRICTED ENRICHMENT - If any of the types of enrichment listed above are not compatible with the proposed research, describe each exception and provide justification. Note that study subjects CANNOT be exempted from all enrichment categories at any one time.
Scientific justification for restricted enrichment is as follows:
SECTION XI. PERSONNEL
Provide a listing of all personnel who will have direct contact with animals involved with the proposed experimentation. Do not list veterinary medicine staff involved with the daily husbandry. You must list each person’s role on the project. All individuals must be appropriately qualified and trained in the proposed animal care and use.
NAME/ TITLE Only list people who will have direct contact with animals SPECIFIC ROLE ON PROJECT -i.e. surgery, tissue collection, euthanasia, consult TRAINING - List training for role or indicate that additional training is needed.
Outside Persons who will conduct procedures Persons who will conduct any procedure on-site must have completed the training and occupational health programs. All persons involved must complete the required training prior to the start of the project.