IACUC Training
Protocol Review

The following topics should be considered in the preparation and review of animal care and use protocols:

• Rationale and purpose of the proposed use of animals.
  
• Justification of the species and number of animals requested. Whenever possible, the number of animals requested should be justified statistically.
  
• Availability or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation.
  
• Adequacy of training and experience of personnel in the procedures used.
  
• Unusual housing and husbandry requirements.
  
• Appropriate sedation, analgesia, and anesthesia. (Scales of pain or invasiveness might aid in the preparation and review of protocols.)
  
• Unnecessary duplication of experiments.
  
• Conduct of multiple major operative procedures.
  
• Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated.
  
• Postprocedure care.
  
• Method of euthanasia or disposition of animal.
  
• Safety of working environment for personnel.

Protocols for animal use must be submitted for approval to the IACUC on a current Animal Use Protocol Form. These forms are available on the Sponsored Programs Administration web site at http://www.jmu.edu/sponsprog/iacucforms.html. The information needed on the Animal Use Protocol Form includes the following:

• Pain or Distress - if the procedure has the potential to inflict pain or distress describe the measures taken to alleviate or minimize it.
  
• Restraint - if prolonged restraint is used describe the type and duration of restraints.
• Anesthesia, Analgesia, Tranquilizers - describe use of anesthetic, analgesic or tranquilizing agents in protocol, including species, agents, dose, route of administration and personnel performing procedures.
• Euthanasia - if euthanasia will be carried out describe the disposition of the animal(s) at the conclusion of the study, or method of euthanasia including agent/procedure, dose, route of administration and personnel.
• Surgery - if surgery will be conducted fully describe surgical procedures including surgeon names, job titles and locations.
• Goals and benefits - a clear statement of the benefits of the study to humans, animals, society or to scientific knowledge is needed.
• Description of study design and experimental procedures - must be given in enough detail to allow the IACUC to evaluate the appropriateness of the animal use, and the potential for pain or distress to the animals.
• Disposition of Animals at the Conclusion of the Project - describe what will happen to your animal(s) at the conclusion of the project.
• Justification of species and numbers - Attributes of the species or model should be indicated. The numbers of animals requested for a study should have a rational basis, such as those needed to achieve statistical significance. Experimental groups and the numbers per group should be listed, even if all studies will actually be performed in vitro.
• Location - the location of animal housing and procedural areas is requested to facilitate semiannual reviews.
• Infectious or Toxic Agents - describe any infectious or toxic agents used

PROCEDURES FOR SUBMITTING PROPOSED ANIMAL USE PROTOCOLS

1. Submit the original and one (1) copy of the completed protocol package - Attachment A (including the description of the methodology involving animals and typed abstract) to the chairperson of the IACUC.
   
2. Protocols will not be accepted for review unless the protocol cover page contains signatures of the principal investigator or instructor, each co-investigator named, and the department chairperson.
   
3. Protocols to be reviewed should be received by the IACUC Chairperson not less than 30 days prior to the date approval is required.
   
4. Receive notification of approval from the IACUC prior to starting the project.
   
5. On approval, commencement and expiration dates will be assigned for the project, and a copy of the application form will be returned to the principal investigator or instructor.
   
   • Application approval will be for a maximum of three years.
     
   • The principal investigator or instructor will contact the IACUC chairperson annually, to verify the status of the project:
     
   • If no significant change in the protocol has occurred, approval may be extended for a year.
   • Any significant change in the protocol requires a new application and approval.
   • Approval will be canceled for discontinued projects.
   • Significant departure from the original protocol requires prior approval from the IACUC.

Animal Use Protocol Form - MS Word

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