Modification Submission Process

Why would I need to submit a modification?

A modification would need to be submitted if there are any proposed changes to an already approved IACUC protocol. These changes include, but are not limited to:

  • Adding or changing anesthesia, analgesia or other pharmaceuticals/substances
  • Changing the method of euthanasia (Must follow current AVMA Guidelines)
  • Changes to the duration, frequency, type and/or the number of procedures performed on animals
  • Increasing animal numbers
  • Changes to husbandry procedures including diets, feeding frequency, housing or bedding
  • Change to PI or co-PI
  • Changes that may result in increased pain, distress, or degree of invasiveness
  • Change to species
  • Changes to study objectives
  • Changes that impact personnel safety

**The proposed changes must not be implemented into your research until the modification protocol has been approved by the IACUC.

Modification Submission Process

Please note that there are different processes for submitting a Modification to your protocol methods versus a Modification to your research personnel list:

When submitting a General Modification...
  • Request a copy of the most recently-approved protocol form (will either be the initial submission or most recent modification).
  • If this is the first modification made to this protocol, type “M1” at the start of all modification changes (i.e. newly added text, text strikeouts). If this is the second modification made to this protocol, type “M2” at the start of all modification changes, and so on. This should be added to all sections where modifications are made and inserted at the beginning of the new text and/or text strikeouts. (Note: if the protocol version that you are using won’t allow for bolding, please use asterisks (i.e. **M1** **TEXT**)).
  • Go to the section(s) to which you wish to make modifications.
    •  
      • Do not remove any information currently in the form (please use strikeout) and include a bolded modification tag “M1“, “M2“, etc. at the start of the strikeout (Note: if the protocol version that you are using won’t allow for strikeouts, please use asterisks (i.e. ***M1*** **Delete** **TEXT**)).
      • Add the new information in bold type. Ensure that justification and other protocol sections are updated as appropriate for your modification.
  • If this is not the first modification, unbold the former modifications text without changing or removing it in order to make the new modification text stand out. (Note: if using **asterisks** due to your protocol template version, in lieu of unbolding, remove the earlier modification version asterisks only (i.e. change**M1** **TEXT** to M1 TEXT)).
  • If the modification will only consist of a separate attached Word document, please include in Section I (Experimental Design) in bold type with an “M1,” “M2,” etc. a brief mention of the modification being made in the attachment.
  • Please rename the file to include the modification number and submission date (i.e., 2019-001 Smith_3rd Modification_3_15_21) and email this modified protocol document to IACUC@montclair.edu. In the body of the email, include a note about the modification being made and to which section(s) changes were made.
When submitting a Personnel Modification...
  • If making a personnel modification at the time of annual check-in, update the personnel chart on the annual check-in survey. If making a personnel modification outside of the time of annual check-in, contact the IACUC office to let them know the names of the individuals to be added to the protocol.
  • The IACUC office will confirm that the new personnel have completed the required Occupational Health and CITI training. Once this has been confirmed, the personnel will be administratively added to the protocol and the PI will get a confirmation email.
  • (Note: Personnel who will be working in the Vivarium may have additional training requirements. Please visit the LAR website for the Vivarium Access Requirements).