A. ADMINISTRATIVE DATA
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List the names of all individuals authorized to conduct procedures involving animals under this proposal and
identify key personnel [e.g., co-investigator(s)], providing their department, telephone, and e-mail.
B. ANIMAL REQUIREMENTS
[e.g., musculus]
[e.g., C57BL/6]
[e.g., Black6]
[e.g., simian immunodeficency virus, simian retrovirus]
[e.g., name of vendor or breeder, or bred in-house]
If animals will be housed in lab or anywhere else outside central facility for more than 12 hours, provide building and room number.
Location(s) where manipulation or procedures will be conducted
C. TRANSPORTATION
Transportation of animals must conform to all institutional guidelines/policies and federal regulations. If animals will be transported on public roads or out of state, describe methods you will use to comply with USDA regulations. If animals will be transported between facilities, describe the methods and containers that will be used. If animals will be transported within a facility, include the route and elevator(s) that will be used.
D. STUDY OBJECTIVES
Briefly explain the aim of the study and why the study is important to human or animal health, the advancement of knowledge, or the good of society in language that a layperson can understand. Please comment on whether the study unnecessarily duplicates other studies.
E. RATIONALE FOR ANIMAL USE
[The rationale should include reasons why it is necessary to use animal models.]
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. Include justification for group size through a power analysis when possible.]
F. DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES
Briefly explain the experimental design and specify all animal procedures. All procedures to be employed in the study must be described. This description should allow the IACUC to understand the experimental course of an animal from its entry into the experiment to the endpoint of the study. A flowchart may be an effective presentation of the planned procedure.
A best practice is to provide an acceptable range of the specific items described below to allow flexibility in the use of professional judgment and avoid non-compliance due to work conducted off protocol as a result of overly restricted parameters.
Include the following specific information, if applicable:
• Animal identification methods [e.g., ear tags, tattoos, collar, cage card, implant, etc.].
• Methods of restraint [e.g., restraint chairs, collars, vests, harnesses, slings, etc.]. Describe how
animals are restrained for routine procedures like blood withdrawals. Prolonged restraint must be justified with appropriate oversight to ensure it is minimally distressing. Describe any sedation, acclimation or training to be used.
• Experimental injections or inoculations [substances, e.g., infectious agents, adjuvants, etc.; dose, sites, volume, route, and schedule].
• Blood withdrawals [volume, frequency, withdrawal site, and methodology].
• Radiation [dosage and schedule].
• Food or fluid restriction If food, or fluid, or both food and fluid, will be restricted, describe method for
assessing the health and wellbeing of the animals. [Amount earned during testing and amount freely given must be recorded and assessed to assure proper nutrition.] If you are seeking a departure from the recommendations of the Guide, provide a scientific justification.
• Pharmaceutical-grade and Non-pharmaceutical-grade Compounds Identify any drugs, biologics, or reagents that will be administered to animals. If these agents are not human or veterinary pharmaceutical-grade substances, provide a scientific justification for their use and describe methods that will be used to ensure appropriate preparation and administration.
• Other procedures [e.g., survival studies, tail biopsies].
• Resultant effects, if any, that the animals are expected to experience [e.g., pain or distress, ascites
production, etc.].
Animal Study Proposal v12/8/2015 2
• Other potential stressors [e.g., noxious stimuli, environmental stress] and procedures to monitor and minimize distress. If a study is USDA Classification E, describe any non-pharmaceutical methods that will be used to minimize pain and distress.
• Experimental endpoint criteria [e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavioral abnormalities, clinical symptomatology, or signs of toxicity] must be specified when the administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals are expected to cause significant symptomatology or are potentially lethal. List the criteria that will be used to determine when euthanasia is to be performed. Death as an endpoint must be scientifically justified.
• Veterinary care Indicate the plan of action in case of animal illness [e.g., initiate treatment, call investigator prior to initiating treatment, euthanize].
• Surgical procedures [provide details of survival and non-survival surgical procedures in Section G.].
G. SURGERY
If surgery is proposed, complete the following:
Identify and describe the surgical procedure(s) to be performed. Include preoperative procedures [e.g., fasting, analgesic loading], and monitoring and supportive care during surgery. Include the aseptic methods to be used.
Identify the individual(s) that will perform surgery and their qualifications, training, and/or experience.
Identify the location where surgery will be performed. [building(s) and room(s)]
Describe postoperative care that will be provided and frequency of observation. Identify the responsible individual(s) and location(s) where care will be provided. [building(s) and room(s)] Include detection and management of postoperative complications during work hours, after hours, weekends and holidays.
For non-survival surgery, describe how euthanasia will be provided and how death will be determined.
Please describe how ventilation will be maintained and how pain will be assessed.
[Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions or involves extensive tissue dissection or transection (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb amputation)]
[Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions or involves extensive tissue dissection or transection (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb amputation)]. If yes, please explain.
H. PAIN OR DISTRESS CLASSIFICATION AND CONSIDERATION OF ALTERNATIVES
Fill out the USDA Classification Table
If any procedures fall into USDA's Classification D or E, causing more than momentary or slight pain or distress to the animals, describe your consideration of alternatives and your determination that alternatives are not available. Delineate 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. Alternatives include methods that:
• refine existing tests by minimizing animal distress,
• reduce the number of animals necessary for an experiment, or
• replace whole-animal use with in vitro or other tests.
If you use ascites production to produce antibodies, you must provide the reason for not using an in vitro system. Note that you must certify in Section Q.5. that no valid alternative was identified to any described procedures which may cause more than momentary pain or distress, whether relieved or not.
I. ANESTHESIA, ANALGESIA, TRANQUILIZATION, OTHER AGENTS
For animals indicated in Section H.1. Classification D, specify the anesthetics, analgesics, sedatives or tranquilizers that will be used. [A best practice is to provide an acceptable range of the specific items to allow flexibility in the use of professional judgment and avoid non-compliance due to work conducted off protocol as a result of overly restricted parameters.] Include the name of the agent(s), the dosage range, route(s) and schedule of administration. Description of tracking and security of controlled drugs (Drug Enforcement Agency requirements) will be found in Section K..
J. METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY
If a chemical agent is used, specify the dosage range and route of administration. If the method of euthanasia is not consistent with the AVMA Guidelines for the Euthanasia of Animals, provide scientific justification as to why such method must be used. Indicate the method of carcass disposal if not described in Section K. below.
K. HAZARDOUS AGENTS
Use of hazardous agents requires the approval of the institutional Biosafety Office/Committee. Attach documentation of approval for the use of recombinant DNA or potential human pathogens.
Detail the radionuclides used in your animal proposal
Describe the practices and procedures required for the safe handling and disposal of removal of radioactive waste and, if applicable, the monitoring of radioactivity.
Detail the biological agents used in your animal proposal
Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated with this study.
Are any chemicals or drugs state regulated and require a letter of exemption from the Division of Business & Professional Regulation (DBPR)?
Please provide the ID number for your DBPR Exemption letter
Describe any additional safety considerations
L. BIOLOGICAL MATERIAL / ANIMAL PRODUCTS FOR USE IN ANIMALS
[e.g., cell lines, antiserum, etc.]
Specify Material, Source, Sterile or Attenuated, whether tested for pathogens
Please provide pathogen testing data: eg MAP - Mouse Antibody Production; RAP - Rat Antibody Production; HAP - Hamster Antibody Production, PCR test
M. GENETICALLY ENGINEERED ANIMALS
Describe any anticipated phenotypic consequences of the genetic manipulations to the animals. Describe any special care or monitoring that the animals will require.
N. EXEMPTIONS FROM ENVIRONMENTAL ENRICHMENT FOR NONHUMAN PRIMATES OR EXERCISE FOR DOGS
If you are seeking an exemption for scientific reasons from the institution’s plan for environment enrichment, please provide the basis of the request.
O. FIELD STUDIES
Indicate if federal, state, and/or local permits are required
Indicate the particular federal, state, and/or local permits needed
P. SPECIAL CONCERNS OR REQUIREMENTS OF THE STUDY
Special housing, equipment, animal care, special caging, water, feed, waste disposal, environmental enrichment, etc.
Q. PRINCIPAL INVESTIGATOR CERTIFICATIONS
Please provide the year of course attendance and location.
Principal Investigator Authentication