REQUEST FOR AUTHORIZATION TO UTILIZE LIVE ANIMALS

FOR THE PURPOSE OF RESEARCH, EDUCATION, OR TRAINING

Please complete this application in its entirety.Providing insufficient information will delay the review process. The IACUC reserves the right to request additional information. When complete, return it along any other required documents via email (no paper copies) tothe Human & Animal Research Protection Program Office (HARPPO) four to eight weeksprior to your anticipated start date.Note: This does not guarantee a specific approval date. Be sure to keep a copy of your entire submission in your study file.

Use this form only if this is:

  1. A new project, never before reviewed by the IACUC;
  2. An existing project due for triennial/de novo review;
  3. An existing project for which a significant change is requested and the IACUC has determined that a new application is required.

IMPORTANT:

  1. Animals will be transported in cages placed on carts, not in hands. If only one animal is to be transported, it can be carried by hand and covered (see 2. below).
  2. Cages will be covered during transport with non-transparent, breathable material.
  3. All doors to labs where animals are used (waiting to be tested, experimented, etc.) will be closed.
  4. No animals are to be left in labs overnight.
  5. Carts with caged animals will not be left in hallways, attended or unattended.
  6. Blood-stained materials will not be discarded in garbage cans; instead, they will be discarded in red plastic bags specifically for medical waste.

Project ID #: / Date Submitted:
Most Recent Approval Date (existing studies only): / Expiration Date (existing studies only):
A. Administrative Data
1.Department:
2.Principal investigator:
3. Status of PI: / Faculty/Staff Doctoral/ Graduate Student
Undergraduate StudentOther (specify):
4.Mailing address:
5.Phone: / 6.Fax: / 7.E-mail:
8.Project title:
9. Submission Type (select one):
Initial submission: / Renewal: / Modification:
Initial submission means this is the first time the IACUC is receiving this proposal / Renewal means this study was reviewed by the IACUC already, but it has reached its 3 year max and a complete application is again required. / Modification means this study is either a) modified at the request of the IACUC, or b) undergoing a major modification for which a revised proposal is required.
10. Funding: / a. Are you seeking funding or sponsorship for this project?
Yes No (If No Skip to Question 11)
b.Funding Source:
c.Status of Grant Application:
ApprovedGrant #:
Pending - Submission date: Anticipated decision date:
Other (specify):
d. Grant Title:
You must attach a copy of your funding application or the latest progress report.

11.List the names and information of all individuals authorized to conduct procedures involving animals under this proposal (add additional rows as needed). If this is an existing project and you wish to add new personnel or remove previously approved personnel, you must also complete and submit an amendment request form. Denote new personnel in the table below by placing an asterisk preceding the person’s name (e.g. *Doe, Jane).NOTE: CITI IACUC training must be renewed every 3 years. CITI RCR training must be renewed every 5 years. Training must be current prior to submission. Copies of both CITI IACUC and CITI RCR training reports must be provided for all individuals listed below.

Name
(Last, First) / Role (e.g.
co-investigator) / Department / CITI IACUC Completion Date / CITI RCR Completion Date / Phone / Email
[Name] / [Role] / [Department] / [Date] / [Date] / [Phone] / [Email]
[Name] / [Role] / [Department] / [Date] / [Date] / [Phone] / [Email]
[Name] / [Role] / [Department] / [Date] / [Date] / [Phone] / [Email]
[Name] / [Role] / [Department] / [Date] / [Date] / [Phone] / [Email]
[Name] / [Role] / [Department] / [Date] / [Date] / [Phone] / [Email]
[Name] / [Role] / [Department] / [Date] / [Date] / [Phone] / [Email]

12.I certify that all of the individuals listed in Section A are authorized to conduct procedures involving animals under this proposal, have completed the institutionally required investigator training course, and received training in: the biology, handling, and care of this species; aseptic surgical methods and techniques (if necessary); the concept, availability, and use of research or testing methods that limit the use of animals or minimize distress; the proper use of syringes, sharps, medications, anesthetics, analgesics, and tranquilizers (if necessary); and procedures for reporting animal welfare concerns.[PI Initials]

PIs are responsible for ensuring that all of their research staff is trained, knowledgeable, and qualified to conduct procedures related to animal use and this protocol.

B. animal requirements
1.Genus: / [e.g., Mus] / 2. Species: / [e.g., musculus]
3.Strain, subspecies, or breed: / [e.g., C57BL/6] / 4. Common name: / [e.g., Black6]
5.Approximate age, weight or size:
6.Sex:
7.Bacteriological status: / [e.g., germfree (axenic), defined flora (gnotobiotic), specific pathogen free (SPF), conventional]
8.Viral status: / [e.g., simian immunodeficency virus, simian retrovirus]
9.Source(s): / [e.g., name of vendor or breeder, or bred in-house]
10.Primary housing location(s): / [Facility manager must certify in Section Q that facility has the resource capability to support the study. If animals will be housed in lab or anywhere else outside central facility for more than 12 hours, provide building and room number.]
11.Location(s) where manipulation/procedures will be conducted:
12.Number of animals to be used:
Year 1: / Year 2: / Year 3:
13.Total number of animals to be used:
c. transportation

1.Transportation of animals must conform to all institutional guidelines/policies and federal regulations (see Appendix 1).

  1. If animals will be transported on public roads or out of state, describe methods you will use to comply with USDA regulations.

explain here

or N/A, animals will NOT be transported on public roads or out of state

  1. If animals will be transported between facilities (buildings), describe the methods and containers that will be used.

explain here

or N/A, animals will NOT be transported between facilities

  1. If animals will be transported within a facility (floor to floor, room to room, within the same building), include the route and elevator(s) that will be used.

explain here

or N/A, animals will NOT be transported withina facility

d. Protocol objectives

1. Briefly explain,in language that a layperson can understand:

  1. the aim of the protocol: explain here
  1. why is the aim of the protocol important to human or animal health, the advancement of knowledge, or the good of society?explain here
  1. whether the protocol unnecessarily duplicates other studies:explain here

e. rationale for animal use
  1. Explain your rationale for animal use. [The rationale should include reasons why it is necessary to use animal models.]explain here
  1. Justify the appropriateness of the species selected. [The species selected should be the lowest possible on the phylogenetic scale.]justify here
  1. 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.]justify here

f. description of experimental design and animal procedures
  1. 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 (to provide flow chart, attach to submission).

explain here

  1. Provide the following specific information, where applicable:

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.

  1. Animal identification methods [e.g., ear tags, tattoos, collar, cage card, implant, etc.].

describe

  1. Methods of restraint [e.g., restraint chairs, collars, vests, harnesses, slings, etc.].
  1. Describe how animals are restrained for routine procedures like blood withdrawals.

describe

  1. Prolonged restraint must be justified with appropriate oversight to ensure it is minimally distressing.

justify

or N/A, there will not be prolonged restraint

  1. Describe any sedation, acclimation or training to be used.

describe

or N/A, there will not be any sedation, acclimation or training.

  1. Experimental injections or inoculations [substances, e.g., infectious agents, adjuvants, etc.; dose, sites, volume, route, and schedule].

describe

or N/A, experimental injections or inoculations will not be performed.

  1. Blood withdrawals [volume, frequency, withdrawal site, and methodology].

describe

or N/A, blood withdrawals will not be performed.

  1. Radiation [dosage and schedule].

describe

or N/A, radiation will not be used

  1. Food or fluid restriction
  2. 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.]

describe

or N/A, neither food nor fluid will be restricted (skip to g)

  1. If you are seeking a departure from the recommendations of the Guide, provide a scientific justification.

justify

or N/A, I am not seeking a departure from the recommendations of the Guide.

  1. Pharmaceutical-grade and Non-pharmaceutical-grade Compounds
  2. Identify any drugs, biologics, or reagents that will be administered to animals.

identify here

or N/A, Nodrugs, biologics, or reagents will be administered (skip to h).

  1. 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.

justify and describe here

or N/A, these agents are human or veterinary pharmaceutical-grade substances.

  1. Other procedures [e.g., survival studies, tail biopsies].

describe

or N/A, no other procedures.

  1. Consequential effects, if any, that the animals are expected to experience [e.g., pain or distress, ascites production, etc.].

describe

or N/A, there will be no consequential effectsthat the animals are expected to experience.

  1. 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.

describe

or N/A, no other potential stressors are anticipated.

  1. 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.

specify, list, and Justify here

or N/A, the administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals are NOT expected to cause significant symptomatology or are potentially lethal, or such procedures will not be performed.

  1. Veterinary care Indicate the plan of action in case of animal illness[e.g., initiate treatment, call investigator prior to initiating treatment, euthanize].

indicate here

  1. Surgical procedures[provide details of survival and non-survival surgical procedures in Section G.].

indicate here

or N/A, surgical procedures (survival or non-survival) will not be performed.

g. surgery

1. Does the PI intend to conduct surgical procedures? Yes No (If No Skip to Section H)

2.If ‘Yes’, surgery is proposed complete the following (a-h):

  1. 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.
  1. Identify the individual(s) that will perform surgery and their qualifications, training, and/or experience.
  1. Identify the location where surgery will be performed. [building(s) and room(s)]
  1. Will this study involve survival surgery? Yes No
  1. If survival surgery, describe postoperative care that will be provided and frequency of observation.
  1. If survival surgery, identify the responsible individual(s) and location(s) where care will be provided. [building(s) and room(s)]
  1. If survival surgery, include detection and management of postoperative complications during work hours, after hours, weekends and holidays.
  1. Will this study involve non-survival surgery? Yes No
  1. If non-survival surgery, describe how euthanasia will beprovided and how death will bedetermined.
  1. Are paralytic agents used during surgery? Yes No
  1. If yes, please describe how ventilation will be maintained and how pain will be assessed.
  1. Has major or minor survival surgery been performed on any animal prior to being placed on this protocol? [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)].

Yes No

  1. If yes, please explain.
  1. Will more than one survival surgery be performed on an animal while on this study? Yes No
  1. If yes, please justify.

h. pain or distress classification and consideration of alternatives
1.Pain or distress classification.See Appendix 2 for classification definitions and examples (attach additional charts if needed).
Species
(common name) / Classification*
B, C, D or E / Number of animals used each year / 3 years total number of animals
Year 1 / Year 2 / Year 3
Total number of animals
  1. Attachment 1, Explanation for Classification E, must be completed for animals listed in Classification E.

Attached

3. Consideration of Alternatives

If any procedures fall into 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 wholeanimal use with in vitro or other tests.

NOTE: If you useascites production to produce antibodies, you mustprovide the reason for not using an in vitro system. Note that you must certify in Section P.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

1.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. Describe tracking and security of controlled drugs (Drug Enforcement Agency requirements).

j. method of euthanasia or disposition of animals at end of study
  1. Indicate the proposed method of euthanasia. If a chemical agent is used, specify the dosage range and route(s) of administration.
  1. If the method(s) of euthanasia include those not recommended by the AVMA Guidelines onEuthanasia[e.g., decapitation or cervical dislocation without anesthesia], provide scientific justification as to why such methods must be used.
  1. Indicate the method of carcass disposal:

k. hazardous agents

1.Use of recombinant DNA requires the approval of the Institutional Biosafety Committee (IBC). Attach documentation of approval for the use of recombinant DNA.

Use of hazardous agents requires the approval of your departmental laboratory safety committee. Attach documentation of approval.

Hazardous Agent / Yes / No / Agent / Date of IBC Approval (for rDNA)or Departmental Lab Safety approval / Tracking #
Radionuclides
Biological Agents
Hazardous Chemicals or Drugs
Recombinant DNA
Study Conducted at Animal Biosafety Level: / 1 / 2 / 3 / 4

If all responses to 1. above are NO, go to Section L

2.Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated with this study. Also describe methods for removal of radioactive waste and, if applicable, the monitoring of radioactivity.

3.Additional safety considerations:

l. biological material / animal products for use in animals

[e.g., cell lines, antiserum, etc.]

  1. Specify Material: None or [specify]

(if response to 1. is None, go to section M)
  1. Source:
/
  1. Material Sterile or Attenuated:
/ Yes / No
  1. Has the material been tested for pathogens? (e.g., MAP - Mouse Antibody Production; RAP - Rat Antibody Production; HAP - Hamster Antibody Production, PCR test)

Yes / [Attach copy of results] / No
  1. I certify that the tested materials to be used have not been passed through rodent species outside of the animal facility in question and/or the material is derived from the original tested sample. To the best of my knowledge the material remains uncontaminated with rodent pathogens.

Initials of Principal Investigator
M. genetically engeneered animals
1.Describe any anticipated phenotypic consequences of the genetic manipulations to the animals. Describe any special care or monitoring that the animals will require.
None or [describe]
n. field studies

1. Will animals in the wild will be used or observed? Yes No (if No, skip to Section O)

2.If ‘Yes’, animals in the wild will be used or observed, answer the following:

a)Field Study Location. Specify the location(s) where the field study will take place. Include special precautions or equipment required:

b)Field Capture. Will any animals be captured in the field for observation, marking, measurements, testing, euthanasia, or other data collection activities?

No. Animals will not be captured for any purpose.

Yes. Animals will be captured.

i.If yes, describe all procedures to be used for the capture and immediate post-capture handling and care of the animals.

c)Field Observations. Will any animals be observed in the field or natural environment without capture or handling?

No. Animals will not be observed in the field without capture or handling.

Yes. The study includes observation of animals in the field without capture or handling.

i.If yes, describe all methods and procedures for observing the animals (tree stand, tracking, etc.):

d)Permits and Authorizations. Are local, regional, or national permits or other authorizations required for the observation, capture, transportation, data collection or other proposed activity using these animals?