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Thiel College Review Board
Animal Subjects Protocol Application Form

Principal Investigator Information
     
Date:
 
Principal Investigator name:  
 
Principal Investigator email:
 
Other Investigator(s):
Please list all individuals authorized to conduct procedures involving animals
Project Title:
     

If this is a continuation of a previously approved project, please provide the Thiel College IACUC Approval Number and previous title of the project. 

If this project is externally funded, please provide the name of the funding agency:
     

By indicating my signature below, I certify that I am familiar with and will comply with all Federal regulations, Thiel policies, and ethical principles of my discipline.

  • I certify that I will obtain approval from the Thiel College IACUC before initiating any significant changes in this study.
  • I will personally conduct or supervise the described protocol activities.
  • I certify that I will notify the Thiel College IACUC regarding any unexpected study results that impact the animals. Any unanticipated pain or distress, morbidity, or mortality will be reported to the attending veterinarian and the Thiel College IACUC.
  • I certify that I have determined that the research proposed herein is not unnecessarily duplicative of previously reported research.
  • I have completed the institutionally-required investigator training course.
   
Signature of Principal Investigator
 
By checking this box, I acknowledge that I am signing the Thiel College Institutional Animal Care and Utilization Committee's Animal Subjects Protocol Application Form as the Principal Investigator.

Date

 
 
     
Signature of Other Investigator  
 
By checking this box, I acknowledge that I am signing the Thiel College Institutional Animal Care and Utilization Committee's Animal Subjects Protocol Application Form as an Other Investigator.
Date    
 

Animal Requirements    
     
Genus:
   
Species:
   

Strain, subspecies, or breed:

   
Common name:
   
Approximate age, weight or size:
   
Sex:
Male
Female
   
Bacteriological status (if other than conventional):
   
Viral status:
   
Source(s) (e.g.-name of vendor, bred in-house):
   
Primary housing location(s):
   
Location(s) where manipulations will be conducted:
   

Number of animals to be used:
Year one:
Year two:
Year three:
Total:

   

Transportation    
     

Transportation of animals must conform to all local and federal regulations.

   

Will animals be transported on public roads or between facilities?
Do not include transport from point of purchase to arrival at Thiel College
Yes
No
If yes, describe the methods of transport, including locations:

   

Study Objectives    
     

Briefly explain in language understandable to a layperson 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.


Rationale for Animal Use    
     
Explain the rationale for animal use in this research.
Include reasons why non-animal models cannot be used
     

Justify the appropriateness of the species selected.

     

Justify the number of animals to be used.
The number of animals should be the minimum number required to obtain statistically valid results


Description of Experimental Design and Animal Procedures

   
     

Briefly explain the experimental design and specify all animal procedures. Explain the experimental course of an animal from its entry into the experiment to the endpoint of the study. Specifically address the following, as applicable:

  • Experimental injections or inoculations
    (substances, doses, sites, volume, route and schedule)  
  • Blood withdrawals
    (volume, frequency, sites, methodology)
  • Surgical procedures
  • Radiation
    (dosage and schedule)
  • Methods of restraint
    (Prolonged restraint must be justified with appropriate oversight to ensure it is minimally distressing. Describe any sedation, acclimation or training to be utilized)
  • Animal identification methods
    (e.g., ear tags, tattoos, collars, cage cards)
  • Other procedures
    (e.g., survival studies, tail biopsies)
  • Resultant effects
  • (e.g., pain or distress, ascites production)
  • Procedures utilized to minimize pain and distress
  • Potential stressors
    (e.g., food or water deprivation, noxious stimuli) and procedures to monitor and minimize distress 
  • Experimental endpoint criteria
    (e.g., tumor size, percentage body weight gain or loss, clinical symptomatology) if administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals are expected to cause significant symptomatology or are potentially lethal. List the criteria to be used to determine when euthanasia is to be performed. Death as an endpoint must always be scientifically justified.
  • Veterinary care
    (indicate desired plan of action in case of animal illness)
   

Surgical Procedures    
     
Will animals be subjected to surgical procedures?
Yes
No
   

If yes, please provide the following information:

   
Type of surgery:
Survival (animal survives the procedure and recovers from anesthesia)
Terminal (animal does not survive the procedure)
   

Describe the surgical procedure(s) to be performed. Include preoperative procedures and monitoring and supportive care during surgery. Include any aseptic methods.

   
     
Who will perform the surgery?
   
What is their training and/or qualifications?
   
Where will surgery be performed?
Building and room(s)
   

If survival surgery, where will post-operative care be provided?
Building and room(s)

   

Describe post-operative care required, frequency of observation, use of medication, and length of recovery. Include names of those responsible for post-operative care.

     

If terminal surgery, describe how humane euthanasia is enacted and how death is determined. 

     

Has major survival surgery (penetration and exposure of a body cavity or producing substantial impairment of physical or physiologic function (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb amputation)) been performed on any animal prior to being placed on this study?
Yes
No

     

Will more than one major survival surgery be performed on an animal while on this study?
Yes
No

If yes, please justify:

Pain or Distress Classification and Consideration of Alternatives

     
Species (common name)
USDA
Classification*
Number of animals
used each year
Three-year total number
of animals
   
Year 1
Year 2
Year 3
 
           
           
           
  Total number of animals used
 

USDA Classifications:

Classification B
: Animals being bred, conditioned, or held for use in teaching, research, experiments, tests, or surgery, but not yet used for such purposes.

Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs.

Classification D: Animals upon which teaching, research, experiments, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used.

Classification E: Animals upon which teaching, research, experiments, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests.

NOTE REGARDING CLASSIFICATION E: An explanation of the procedures producing pain or distress in these animals and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided.

If using Classification E, please provide justification here:

If any procedures fall into Classifications 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. 

For animals in Classification D, specify the anesthetics, analgesics, sedatives or tranquilizers to be used. Include the name of the agent(s), the dosage, route and schedule of administration.

If controlled substances are used, please describe their tracking and security measures.


Method of Euthanasia or Disposition of Animals at End of Study

     

Indicate the proposed method(s) of euthanasia. If a chemical agent is used, specify the dosage and route of administration.

     

If the method(s) of euthanasia include those not recommended by the AVMA Panel Report on Euthanasia (http://www.avma.org/issues/animal_welfare/euthanasia.pdf), provide scientific justification why such methods must be used.

     

Indicate the method of carcass disposal.


Hazardous Agents    
     

Use of hazardous agents requires the approval of the Thiel College Safety Officer. Please forward documentation of approval for the use of recombinant DNA or potential human pathogens to the Institutional Animal Care and Use Committee.

   
     
Hazardous Agent
Yes
No
Agent
Date of Biosafety Approval
Radionuclide
Biological Agent
Hazardous Chemicals or Drugs
Recombinant DNA

 

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

Field Studies    
     
Does the proposed project involve field studies in which animals will be captured?
Yes    

No

   
     

If yes, provide the following information:

   
     
Describe the method(s) for capture, release, and handling of the animals. Indicate if capture and release will take place in the same location.
     
Describe any invasive procedures that will be used (e.g. collection of samples of tissue or blood, drug administration, tagging).
     
If animals are to be held, describe the location where they will be held, the length of time they will be held, and provisions for their care.
     

If Federal permits are required for Field Studies, please forward a copy of the obtained permit(s) to the Institutional Animal Care and Use Committee.


Special Concerns or Requirements of the Study

   
     
List any special housing, equipment, animal care (e.g., special caging, water or feed, or waste disposal, environmental enhancement).
     
Alteration of Routine Care Procedures
Yes
No
Increased number of animals per cage or other type of housing
Decreased frequency of bedding change
Exposure to nonstandard temperatures
Bedding other than standard laboratory bedding
Food restriction of animals usually fed ad libitum
Prolonged (over 18 hours) food deprivation
Prolonged (over 18 hours) water deprivation
Feeding synthetic or deficient diets, or diet supplements
Adding supplements to animals' water
Isolation of animals usually housed in groups

Other
     
Verification Information
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