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Protocol Submission and Review Process

Protocol Submission Process

All animal projects receive approval from the Institutional Animal Care and Use Committee (IACUC). Faculty members planning to use live vertebrate animals for any University-related activity must submit an animal care and use/protocol form to the IACUC for review, prior to the start of the project. All coursework and/or activities required for degree completion must be covered by an IACUC approved protocol.

Protocol Submission Process:

  1. New or Initial Protocol – When submitting a new or initial protocol application, use the Animal Care and Use Protocol Form found here Complete and email it to iacuc@montclair.edu
  2. Annual Renewal – Approved protocols will require an annual renewal. When submitting an annual renewal of an approved protocol, use the IACUC Annual Renewal Form found here.  Complete and email it to iacuc@montclair.edu.
  3. Protocol Closure – If a study has been completed a protocol closure will be required. When submitting a protocol closure, use an annual renewal form, found here, making sure to check off that study will not continue and fill out final progress report. Complete and email it to iacuc@montclair.edu.
  4. Modification – When submitting a modification to an approved protocol:
    • 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.
  5. When submitting a personnel modification:
    • If making a personnel modification at the time of annual renewal, update the personnel chart on the annual renewal form. If  making a personnel modification outside of the time of annual renewal, 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 Vivarium access requirements).

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:

  1. When submitting a modification to an approved protocol:
    • 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.
  2. When submitting a personnel modification:
    • If making a personnel modification at the time of annual renewal, update the personnel chart on the annual renewal form. If  making a personnel modification outside of the time of annual renewal, 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 Vivarium access requirements).

Protocol Review Process

Approval Period

Regulations suggest a maximum of one year for animal study approvals. The IACUC will send courtesy reminders to PIs approximately 45-60 days before the expiration date of an approved study to allow sufficient time for renewal processing.

New Protocol Initial Review

  1. Obtain an IACUC FORM and submit via email attachment to iacuc@montclair.edu. Studies submitted to the Montclair State University IACUC must include a completed application including all required signatures.
  2. Submit Animal Protocol Review to the IACUC. The IACUC administrator will acknowledge receipt and send the PI a protocol number to be used in all future correspondence. The IACUC administrator will conduct an administrative review of the application. Any missing components or findings will be returned to the PI within three business days.
  3. Preliminary Review by committee. The IACUC will conduct a preliminary review of the application to determine whether the application requires approval through a designated reviewer procedure (DRP) or through a full committee meeting (FCMP). All committee members are provided ample time (5-7 days) to decide if the protocol requires a full committee meeting.
  4. Review
    • Designated Member Review. The IACUC administrator will forward the protocol to an appropriate reviewer as determined by the IACUC chair. The reviewer has 14 business days to review the protocol. All changes and concerns requested by the designated reviewer will be returned back to the IACUC administrator with copies to the IACUC veterinarian and IACUC chair. The IACUC administrator will notify the PI of the requested changes and the PI will be asked to respond within 15 days. The designated review and veterinarian will then review the responses and changes within 5-10 business days.
    • Full Committee Meeting procedure. The IACUC administrator will forward the protocol and documents to the entire committee at least 14 business days prior to the meeting day. During the full committee members may recommend changes to the protocol. The IACUC administrator will notify the PI of the committee findings within two business days of the meeting. The PI will be asked to respond to the committee findings within 15 days.
  5. Protocol Outcomes
    • Approval. A final approval letter will be issued to the PI by the IACUC administrator and signed by the IACUC chair. All protocols must abide by their expiration dates noted on the approval letters. All research activity must cease if a protocol is expired and noted approved under annual renewal.
    • Disapproval. A PI will be notified of disapproval through a signed letter from the IACUC chair.