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IACUC Application Writing Tips & Guidance

Tips for Writing your IACUC Protocol

Additional Details about Specific Procedures

Required Signatures

Other Regulatory Reviews


Tips for Writing Your IACUC Protocol

  1. Provide a summary in lay language of the project (General Information Tab) – imagine you were describing your research to a classroom of students or your relatives at a family reunion.

  2. Consider the “Three Rs” and unnecessary duplication (Rationales/Alternatives Tab):
    • Replacement:  Are there any alternatives to the use of live animals?  If yes, you must provide a scientific justification for not using them.
    • Reduction:  Is the number of animals requested in the protocol adequate to achieve scientifically-valid results?  How did you determine that the number is adequate but not unnecessarily large?
    • Refinement:  If procedures are likely to cause pain or distress, what will be done to minimize it?

    • If similar projects or experiments are found in the scientific literature, describe what it is that makes this project unique.
    • See the Alternative Searches Guidelines for additional guidance.
       
  3. Be sure all study team members are listed in the personnel categories according to RMS permissions in which they need (Personnel Tab
    • View Protocol Only (Other Research Personnel) = default permissions
    • Animal Ordering Allowed (Research Personnel)
    • Protocol Editing (Co-Investigator/Senior Researcher, includes animal ordering)
       
  4. Provide justification for why a particular species was chosen and describe any strain or breed characteristics. If multiple strains or breeds of a species is needed, explain why (Species Tab)
     
  5. State your hypothesis and design experiments to test it (Study Segment Tab).  Be sure to provide:
    • Scientific rationale for all experiments
    • Timeline of procedures that will be performed on the animals
    • Post-procedural monitoring performed by the study team (not ULAR)
    • Experimental Endpoints (point at which the live-animal portion of the experiment is complete and animal is euthanized)
    • Humane Endpoints (criteria that are used to euthanize an animal earlier than the expected experimental endpoint)
       
  6. List the animal numbers, specifying the different groups and # per group and provide justification for how the number of animals was determined (Animal Numbers Tab)
    See additional guidance regarding animal numbers
     
  7. Provide details of all procedures (both non-surgical and surgical) that will be performed on the animals (Procedures Tab).
     
  8. Discuss in detail any clinical signs and symptoms, possible side effects and adverse effects associated with either the disease model being studied or the procedures to be performed (Animal Monitoring & Other Info Tab). Describe how animals will be monitored and treated for pain, distress and discomfort, and list the criteria that will be used for determining that animals must be removed from the study and euthanized.

  9. List all agents and drugs that will be administered to live animals (Drugs & Other Agents Tab). 
    NOTE:  All items listed in this tab should also be referenced in other relevant sections of the protocol (Experimental Design, surgical/non-surgical procedures, pain management, etc.).

  10. Describe how animals will be euthanized at the end of the study (Study Segment Tab, Animal Monitoring & Other Info Tab).   Death must be confirmed in all animals prior to carcass disposal; in addition, UCI IACUC Policy requires that all rodents euthanized via CO2 overdose undergo a secondary physical method of euthanasia (e.g., decapitation, cervical dislocation or exsanguination) prior to disposal to prevent unintended recovery.  See the IACUC Policy on Euthanasia for more information.
     

Additional Details about Specific Procedures 

As you enter information into the protocol tabs in RMS, you may be prompted for additional details, depending on your specific experiments and proposed procedures. The following list includes items that the IACUC will require specific details about:

  • Project Continuation: Essentially a progress report; Required ONLY if you are writing a three-year de-novo review of an ongoing, project previously approved by the IACUC
  • Breeding: Required if a breeding colony of animals will be maintained to supply offspring for research purposes (usually genetically-modified rodents).
  • Prolonged Restraint: Required if animals will be restrained for more than very short periods of time while awake. See the IACUC Policy on Animal Restraint.
  • Use of Paralytic Agents: Required for the use of neuromuscular blocking agents in anesthetized animals.
  • Multiple Survival Surgery: Required when individual animals will recover from more than one surgical procedure. Review the IACUC Surgery Policy and Guidelines.
  • Antibody Production: Required for the production of monoclonal or polyclonal antibodies in live animals. Further information on the applicable policies is available.
  • Non-UCI Locations: Required if research procedures with live animals will be conducted at facilities other than the UCI Campus or UCI Medical Center.
  • Researcher-Maintained Animals: Required if laboratory staff will provide care and husbandry of the animals either within ULAR-operated housing facilities or outside of vivarium housing.
  • Housing Exception: Required if animals will be kept outside of ULAR-maintained vivarium housing space for more than 12 hours.
  • Variations in Husbandry/Housing: Required for all variations to standard ULAR-provided husbandry and care. Examples include use of wire-bottom caging, food or water restriction or additions, variations in standard light cycles, temperature or humidity, etc.

Notes:
  • If your research involves Hazardous Agents, you may be required to submit various documents pertaining to their safe use, such as Animal Room Hazard Communication Forms (door signs), Material Safety Data Sheets (MSDS) and Standard Operating Procedures (SOPs) for the handling of hazardous substances. 
     
    Contact EH&S for assistance - See the Vivarium Safety website for more information.
     
  • The IACUC performs a comprehensive pre-review process  – if changes or additional information are necessary, you will have an opportunity to provide it prior to the convened meeting at which the protocol will be discussed.

Required Signatures

The following are required for an IACUC protocol:

  • Signature from the Principal Investigator must be provided, ideally via electronically signing the protocol in RMS (or by completing an Alternative Signature Form)
    • Required after protocol submission and must be obtained prior to committee pre-review.
       
  • Acknowledgement by the Department Chair, Center Director or Dean
    • IACUC administrative staff will reach out to the department after protocol approval

Other Regulatory Reviews

Additional regulatory committee reviews and institutional approvals may be required before the IACUC can release approval to work with live animals:

  • Institutional Biosafety Committee (IBC) review is required for the use of
    • Recombinant DNA
    • Risk Group Agents/Select Agents
    • Biological hazards
    • Use of any materials of human or non-human primate origin
  • Human Stem Cell Research Oversight Committee (hSCRO) is required for the use of human stem cells, including induced pluripotent stem cells (iPS).
  • Institutional Review Board (IRB) approval may be required if human cells will be used in animals.
  • Environmental Health and Safety (EH&S) has oversight responsibility for all safety-related issues in research. Please refer to EH&S laboratory and research guidance for more information.
  • Epidemiology and Infection Protection Committee approval is required for the use of laboratory animals in any human clinical facility.

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