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Top 10 Reasons that IACUC Submissions are Not Approved

The IACUC protocol is the written document that confirms UCI's adherence to federal animal welfare regulations and ethical guidelines in the use of live animals for research, testing or teaching. The committee reviews each protocol to assure that all procedures are adequately described and appropriately documented.


Even if something is obvious to the researcher, IT HAS TO BE WRITTEN IN THE PROTOCOL. Listed below are some of the most common areas where protocol documentation tends to fall short of IACUC expectations and requirements:
  1. Not enough information:  The protocol does not clearly express either the rationale behind the experiments or the justification for the use of live animals.  Be sure to review all sections of the protocol narrative application and provide ALL requested information.
     
  2. Too much information (in the wrong place):  The Experimental Design section must provide an overview of the project as a whole, including the rationale for the experiments, a summary of the experimental groups and what procedures will be performed on them, and the timeline for those procedures (when they are performed in relation to other procedures and to the endpoint of the experiment).  Details about the procedures themselves do not belong in the Experimental Design section, but it should be clear exactly what will happen to each of the animals and why.
     
  3. The Project Overview is too technical:  The Project Overview is meant to be a lay summary of the project as a whole.  It should be clearly understandable to people with little or no background or experience in your area of expertise.  Leave out the jargon and technical terms, and provide an explanation of what you plan to do that is suitable for a newspaper article or non-scientific cocktail party chatter.
     
  4. The consideration of alternatives to the use of live animals has not been documented:  The IACUC understands that review of the scientific literature is an ongoing part of the research process; however, it must be documented in the protocol in order to meet the requirements of USDA Animal Care Policy #12.  The IACUC Protocol Application form has been specifically designed to guide researchers in appropriately documenting the consideration of alternatives.
     
  5. Animal numbers are not adequately justified:  The number of animals requested for the experiments must be adequate to achieve the research goals of the study – researchers must provide an explanation for how the number of animals was determined.  Wherever possible, statistical power analysis should be employed.
     
  6. Inconsistencies in the narrative:  All sections of the protocol narrative must be consistent – procedures and agents mentioned in the Experimental Design must be described in detail in the appropriate sections of the protocol narrative; animal numbers and pain categories must be consistent throughout the protocol, etc. 
     
  7. Animal Welfare Issues: If an equivalent procedure is reasonably expected to cause pain, distress or discomfort in a human being, you MUST assume that it would also cause pain, distress or discomfort in an animal and address these issues accordingly in the protocol narrative.  Monitoring and assessment parameters must be described in detail, and relief from potential pain and distress must be provided unless there is a strong scientific justification for withholding it.
     
  8. Appendices are not optional:  All required appendices must accompany the protocol narrative submission, as determined in the Application section of the protocol forms. 
    • ALL three-year de-novo renewal submissions must include Appendix A – Progress Report
    • The use of hazardous agents may also require Standard Operating Procedures and door signage, which must be submitted as “Appendix C”.
       
  9. Modification Mishap #1 - Wrong version of the protocol:  IACUC policy requires that the protocol narrative be updated with each approved modification; it is the responsibility of the research team to ensure that the most recent version of the approved protocol narrative is used each time a modification is submitted.  If you recently submitted a modification request that has not yet been approved, it is best to wait until that approval is processed before submitting another one.  If it is not possible to wait until the previous mod is approved, contact us at IACUC@uci.edu for advice on how to proceed.
     
  10. Modification Mishap #2 - Mod doesn’t fit in with the existing approved narrative:  Proposed changes that significantly alter the originally approved protocol may be more appropriately submitted as a new stand-alone protocol.
     

 

 

See Getting IACUC Approval for guidance and tips on how to avoid these issues

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