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University of Colorado Denver

Animal Care and Use Program
 

Institutional Animal Care and Use Committee

Tips for Protocol Amendments


 

IACUC Amendment meetings are held twice each month.  Please see our meeting deadlines and schedule.

  • Rule of thumb for amendments:  If the goals of the study are the same, you can probably do an amendment.  If the goals of the amendment diverge from the goals of the protocol, you will need to write a new protocol.  Amendments should contain little or no modifications to section B-1 (Project Goals).
  • If you submitted your protocol using the electronic, on line system, you must use the on line system to submit an amendment in Topaz.
  • You can easily do an on line amendment in Topaz by clicking on “My Dashboard” and then “Protocols For Animals”. Next click on the icon “Amend and Renew Protocols” (looks like the recycle symbol) then click on “Amend a Protocol”. Choose the protocol from the list that appears.
  • In the amendment:  Describe in detail what you are proposing to do and how many animals are going to be used. 
  • Do not use the “Copy from another protocol” import feature as this will import all data from another protocol, not just the amendment section.
  •  Make sure all additions are also added to the appropriate sections of the main protocol including Narrative (section B2) and may also include sections such as Animal Identification (section B9), Experimental Groups and Numbers (section B10), Experimental Agents (section B14), Hazardous Material Use – In Animal (section B16), Anesthetics and Analgesics (Section C), and Strains (Appendix B). This is important so that the changes are incorporated into the main protocol and are not lost if you amend the protocol again
  • Provide a short scientific rationale for the additions described.
  •  Define all abbreviations.
  • List all experimental reagents (used in live animals) and make sure the use of these reagents is added to the list in section B.
  • Provide scientific or statistical justification for additional animals.
  • Check all the numbers in Experimental Groups and Numbers (section B10) that they add up to the number in Section B11 and also reflect all of the additional animal numbers.
  • Include a detailed description of drug use (why a particular drug is used, name and property of drug, route of administration, dosage, frequency of use). Make sure all drugs used are of pharmaceutical grade or provide justification as to why you can not use pharmaceutical grade.
  •  Please attach the MSDS and the Hazardous Material Information Questionnaires for the additional chemicals, if not available from the hazardous agents drop down menu in TOPAZ.
  • Re-check the appropriate boxes in Section G as the answers in this section de-populate when a protocol is amended.
  • If survival surgery is being added, please consult a staff veterinarian before you submit the amendment. The IACUC Office can arrange for a veterinarian to consult with you.
  • Make sure the dates of required database searches for alternatives to painful distressful procedures are current.
  • Please remember that only the PI can complete section J - the regulatory assurances - and make the final submission.
  • Provide Personnel Qualification Forms for all personnel being added with the amendment.
  • Only one amendment to a protocol may be processed at a time.  Once an amendment is submitted you must wait until it is approved before beginning another.

Please remember: Do not start experiments proposed in the amendment until it has been approved by the IACUC.  You will receive a purple disposition sheet once the amendment has been approved.  If you do start without IACUC approval, then you are in violation of your protocol.


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