Protocol Assessment

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Summary

All new protocols and amendments to protocols that meet any one of the requirements listed below will be routed to a DLAR veterinarian for a Protocol Assessment. During this process, a veterinarian will work with you on protocol content relating to the description of the use of research animals and their health and well being. You may be contacted if there are questions, concerns or suggestions needing your attention. Once assessment is completed the veterinarian will submit the protocol to the IACUC on your behalf.

The purpose of the protocol assessment is to help investigators achieve rapid review by the Institution Animal Care and Use Committee (IACUC) and to enhance protocol content quality. 

If a protocol does not meet any of the below requirements it may optionally be submitted to the Protocol Assessment process or be sent directly to the Office of the IACUC without this pre-review service.

Protocol Assessment is NOT REGULATORY REVIEW and APPROVAL by the IACUC!!!

What triggers a Protocol Assessment?

Protocols (New and Amendments) that will require a Protocol Assessment include:

  • All USDA regulated species
  • Specified non-regulated species: fish
  • Protocols involving surgery
  • All USDA category D studies
  • When an approved species is being used that is not on any currently active protocols

IACUC Application page responses

Within the IACUC application the page location(s) that will trigger a Protocol Assessment are listed below:

  • Species Selection page - if a non-regulated species designated by veterinary staff (currently fish) is chosen or if any regulated species are chosen
  • Species Classification page - if USDA category D is chosen
  • Procedures Checklist - if Yes to surgery is chosen

An update was made to the Species Selection page. No longer will the form filler be required to complete Vet Consult information. The details will be based on the Protocol Assessment and will be presented within the protocol's Application Summary page.

Where is the Protocol Assessment page presented?

For both New Applications and Amendments, the Protocol Assessment page will come after the Assurance page. This means the protocol must be submission ready and pass the content Audit. If you need assistance prior to this point in your protocol development, please contact DLAR directly.

When Protocol Assessment is required

  • New Application: when a new application is completed and the PI arrives at the Assurance page the submit button will read Submit for DLAR Protocol Assessment
  • Amendment: when an amendment is completed and the PI completes the Amendment Justification page, the submit button will read, Submit Amendment for DLAR Protocol Assessment. 

    Once the Submit buttons are clicked, the Protocol Assessment window will display. It contains information about what will happen next, so it is important that the information be reviewed. The PI will then click Submit.

When Protocol Assessment is not required

  • New Application: if the protocol does not require a Protocol Assessment, at the Assurance page and once Submit to IACUC for Review is clicked, the Protocol Submission window will now offer two options:
    • Submit to DLAR for Protocol Assessment
    • Finalize Application (send to IACUC)


If Protocol Assessment is chosen, the "Things to know about Protocol Assessment" window displays to confirm that DLAR is indeed the intended destination.


  • Amendment: if the amendment does not require a Protocol Assessment, at the Amendment Justification page and once Submit Amendment to IACUC for Review is clicked a window will display with two options 1) Request Protocol Assessment or 2) Continue to Submission (send to IACUC)
  • If Request Protocol Assessment is clicked, the Protocol Assessment window will display and provide you some details before confirming your need for a Protocol Assessment.
  • If Continue to Submission is clicked, your new application or amendment will be routed to the Office of the IACUC for review.


Protocol Routing

Once a New Application or Amendment is  submitted, and requires a Protocol Assessment or if a Protocol Assessment was requested,  the application will be presented to the DLAR for review by a Veterinarian.

At this time, a Veterinarian will be assigned to review the protocol and if necessary, work with the PI to ensure the most complete application before submission to the OIACUC.

Events after a Protocol Assessment is completed

Once the Protocol Assessment is completed and requires no additional collaboration between the Veterinarian and PI, the DLAR will submit the application to the OIACUC.

At this time, the PI, Co-PI and Delegate to the protocol will receive an email notification communicating the protocol is now submitted to the OIACUC for their review.

The Application Summary to the protocol will now show the name of the Veterinarian who completed the Protocol Assessment in addition to the date the Protocol Assessment was completed.


Protocol Assessment is not OIACUC submission/review

  • Submitting a protocol for Protocol Assessment is not a protocol approval process and is not a submission to the Office of the IACUC.
  • Once a Protocol Assessment is completed by the DLAR Veterinarian it will then be submitted to the Office of the IACUC for review.

Protocol History

The Protocol History will provide you with information as to which office your protocol is at along with the veterinarian or analyst assigned to your protocol.


O.R.C.A Dashboard

In the O.R.C.A Dashboard, New applications and Amendments that are submitted to DLAR for Protocol Assessment will display a Status of Accepted. Once a Veterinarian is assigned to the Protocol Assessment, the Status will display Under DLAR Review.

Once the Protocol Assessment is complete, the Status will show Accepted. Once an OIACUC Analyst is assigned to the protocol, the Status will show Under Review.


Routing diagram

IACUC Application Office Routing_sl.pdf


Videos

Where will the Protocol Assessment be presented in a new application? Video 

Where will the Protocol Assessment be presented in an Amendment? Video

Where will the Protocol Assessment be offered for protocols (New and Amendment) that do not require a Protocol Assessment? Video


Come again!

Continue to access this page as it will provide additional information related to Protocol Assessment.