Frequently Asked Questions

How do I get a CICERO account with animal user role?

  • First, create an account in CICERO. CICERO Instructional videos can be found at: https://www.umaryland.edu/oawa/Education-and-Training/cicero-instructional-videos/
  • When creating your profile, include IACUC module. All users that create an account in CICERO and indicate they will use the IACUC module will receive Research Team Member role. Note that only a user with PI role can submit a protocol / amendment.
  • If you already have a CICERO account, login and click on your name in the upper right-hand corner. Click My Profile and select IACUC module in the “Indicate which modules you expect to use” section under Properties tab.
  • IACUC (Animal) Researcher will appear on the left panel under My Roles & Submissions once the role has been added to the profile. Email iacuc@umaryland.edu if this role does not appear after following the steps outlined above.

I am a new PI at UMB and do not have a UMID yet. How do I create an account in CICERO?

Please email iacuc@umaryland.edu for additional instructions on how to create an account.

How do I get an animal researcher PI role in CICERO?

My protocol was reviewed by the IACUC prior to December 2022. When will I start submitting in CICERO?

  • If a protocol was reviewed by the IACUC prior to December 2022, the protocol will remain in paper and all amendments and progress, adverse event, and final reports will be processed using the paper forms on our website, which need to be emailed to iacuc@umaryland.edu for IACUC review. These protocols will expire in paper.
  • New protocols reviewed by the IACUC starting in December 2022 will live completely in CICERO. Amendments, progress reports, adverse events and final reports will be processed within CICERO.

If my protocol was reviewed and approved in paper, can I submit amendments in CICERO?

No. If a protocol was reviewed by the IACUC prior to December 2022, the protocol will remain in paper and all amendments and progress, adverse event, and final reports will be processed using the paper forms on our website, which need to be emailed to iacuc@umaryland.edu for IACUC review. These protocols will expire in paper.

Can I transfer my existing protocol that was reviewed and approved using the paper system into CICERO before that protocol expires?

  • A new protocol can be submitted in CICERO prior to the expiration date of existing IACUC approved paper protocols. The new protocol will have to be re-reviewed by the IACUC in CICERO and a new approval and expiration date will be generated for the protocol in CICERO. Once the electronic protocol has been approved, PI’s can close their paper protocols by submitting a Final Report form to iacuc@umaryland.edu.
  • Paper protocols will not be ‘grandfathered in’ to the new electronic system.
  • All protocol renewals reviewed by the IACUC starting in December 2022 must be submitted using the electronic system (CICERO).

Will the IACUC office put my paper protocol in CICERO?

  • All protocols must be created by the research team and submitted by the PI.
  • Paper protocols will not be ‘grandfathered in’ to the new electronic system.
  • A new protocol can be submitted in CICERO by the PI prior to the expiration date of existing IACUC approved paper protocols. The new protocol will have to be re-reviewed by the IACUC in CICERO and a new approval and expiration date will be generated for the protocol in CICERO. Once the electronic protocol has been approved, PI’s can close their paper protocols by submitting a Final Report form to iacuc@umaryland.edu.

How do I create an IACUC protocol in CICERO?

 

Login to CICERO, click on IACUC (Animal) Researcher to go to that specific dashboard. Click Create IACUC Protocol.

 

How should I move through the protocol submission to complete the form?

When completing the new protocol it is strongly advised that you use the Continue button to move through the submission. This will ensure that the appropriate questions are answered to populate the subsequent required pages / questions. Jumping around the protocol by sections, when all sections / questions have not been fully completed (all questions answered on a given page), may result in data not being saved when you exit the submission.

I can’t find my research staff to add them to my protocol in the Research Personnel section. What do I do?

  • If the staff member does not have a CICERO account, they need to create one and indicate that they will use the IACUC module.
    • First, create an account in CICERO. CICERO Instructional videos can be found at: https://www.umaryland.edu/oawa/Education-and-Training/cicero-instructional-videos/
    • When creating your profile, include IACUC module. All users that create an account in CICERO and indicate they will use the IACUC module will receive Research Team Member role. Note that only a user with PI role can submit a protocol / amendment.
  • If the staff member already has a CICERO account, IACUC Research team member role needs to be added to their CICERO profile. The staff member must login to CICERO and click on their name in the upper right-hand corner. Click My Profile and select IACUC module in the “Indicate which modules you expect to use” section under Properties tab. Click OK. This will add IACUC Research team member role to the profile, and they will be searchable in the Research Personnel section. Email iacuc@umaryland.edu if staff member does not appear after following the steps outlined above.

Where do I describe my experiments in the protocol?

Experiments are described (using the same template in our paper protocol) on the Experimental Summary/Animal Usage section of the protocol. This page will not appear in the protocol until the investigator has answered the questions on the Justification for the Use of Animals and Species section.

When completing the new protocol it is strongly advised that you use the Continue button to move through the submission. This will ensure that the appropriate questions are answered to populate the subsequent required pages / questions. Jumping around the protocol by sections when all sections / questions have not been fully completed (all questions answered on a given page) may result in data not being saved when you exit the submission.

While responding to questions in the protocol new questions or pages appeared in the submission. Why did this happen?

  • The submission is designed to add / remove questions based on answers provided.
  • The submission is designed to add pages (Research Categories) based on answers provided. For example, if anesthesia is indicated for Animal Identification, the Anesthetics page will populate in the submission.

While responding to questions in the protocol some questions disappeared in the submission. Why did this happen?

 

  • The submission is designed to add / remove questions based on answers provided.

 

How do I get a surgery review in CICERO?

  • If a protocol includes Survival Surgery (any species) or Non-survival Surgery with a USDA-regulated species, Vet Resources is notified that a review is required once the protocol has been submitted. The protocol transitions to Surgery Review state.
  • In an amendment, the appropriate selection(s) must be indicated on the Amendment Request form to notify Vet Resources that a review is required. Select Change in animal procedure (add / modify / remove), select Survival Surgery or Non-Survival Surgery. Yes needs to be selected for the corresponding hide/show question to initiate Surgery Review.

How do I get a VR consult for hazardous agent use in CICERO?

  • If a protocol indicating the use of hazardous agents is submitted, Vet Resources is notified that a review is required when the protocol is submitted.
  • In an amendment, the appropriate hazard being added must be selected on the Amendment Request form to notify Vet Resources that a review is required. Select Change in animal procedure (add / modify / remove), select Exogenous Substances (excluding anesthetics and analgesics). Click each hazard that is being added.

How do I get a VR Rodent Breeding consult in CICERO?

  • If a protocol indicates the use of trio or polygamous breeding, Vet Resources is notified that a review is required when the protocol is submitted.
  • In an amendment, trio or polygamous breeding must be indicated on the Amendment Request form to notify Vet Resources that a review is required. Select Change in animal procedure (add / modify / remove), select Breeding. Answer Yes to the corresponding hide/show question.

How do I get a VR consult for specialized diet/water in CICERO?

  • If a protocol indicates the use of specialized diet/water, Vet Resources is notified that a review is required. No additional action is required by the research team.
  • In an amendment, specialized diet/water must be selected on the Amendment Request form to notify Vet Resources that a review is required. Select Change in animal procedure (add / modify / remove), select Specialized Diet (food or fluid).

How do I submit a protocol in CICERO?

 

  • Click “Submit Protocol” when the submission is ready for IACUC review. If Surgery or a VA review is required, the submission will be routed accordingly.

 

I clicked “Submit Protocol”, but the system won’t submit the protocol.

  • Only the PI listed on the protocol can submit the protocol and amendments.
  • Specific sections of the submission may be incomplete. The system will run validation and indicate where information is missing. All required fields must be completed in order to submit the submission.

I am a new faculty member at UMB. What are the requirements to be a PI on an animal use protocol?

  • A faculty member holding an Assistant, Associate or Full Professor position can be a PI on an animal use protocol.
  • All protocols submitted by new UMB faculty or existing faculty (if this is their first animal use protocol at UMB) MUST receive an OAWA pre-review prior to IACUC review.

This is my first animal use protocol at UMB, is a pre-review required?

 

  • All protocols submitted by PI’s new to UMB or if this is their first animal use protocol at UMB MUST receive an OAWA pre-review prior to IACUC review.

 

Can I request a pre-review of a protocol in CICERO?

  • After you have completed the protocol submission click “Request Pre-Review”. This will route the protocol for a pre-review. Please note that OAWA pre-review and Surgical / VA reviews are ASYNCHRONOUS, with the OAWA pre-review occurring first (if requested). All protocols will receive an administrative review for completeness prior to triaging for IACUC review.
  • All protocols submitted by new UMB faculty or existing faculty (if this is their first animal use protocol at UMB) MUST receive an OAWA pre-review prior to IACUC review.

Can I request a pre-review of an amendment in CICERO?

 

  • This functionality is not currently built out for amendments. However, an IACUC Analyst will review the amendment for completeness prior to sending for IACUC review. If any information is missing the IACUC Analyst will request administrative modifications prior to IACUC review.

 

Can a protocol receive a pre-review and Surgery / VA review at the same time in CICERO?

 

  • OAWA pre-review and Surgical / VA reviews are ASYNCHRONOUS, with the OAWA pre-review occurring first (if requested). All protocols will receive an administrative review for completeness prior to triaging for IACUC review. The administrative review will occur following the Surgical / VA review period.

 

The protocol / amendment is in Surgery Review state, what do I do next?

 

  • The Vet Resources Veterinary staff have been notified and will provide a surgical consult. If modifications are required, the protocol / amendment will transition back to the research team following that review. The submission will not be sent back to the Veterinarian for additional review after the research team makes revisions. If no modifications are needed, the protocol / amendment will transition to the OAWA for review and triage by an IACUC Analyst.

 

The protocol / amendment is in VA Review state, what do I do next?

 

  • The Vet Resources VA Veterinary has been notified and will provide a VA consult. If modifications are required, the protocol / amendment will transition back to the research team following that review. The submission will not be sent back to the VA Veterinarian for additional review after the research team makes revisions. If no modifications are needed, the protocol / amendment will transition to the OAWA for review and triage by an IACUC Analyst.

 

How do I start an amendment in CICERO?

  • Go to the Approved tab within the IACUC (Animal) Research dashboard. Click on the approved protocol you wish to amend. Click “Create Amendment”. Complete the Amendment Request page, click Continue or Save. The system will generate a copy of the approved protocol for you to make changes indicated on the Amendment Request page. Creating a copy of the protocol may take some time depending on the size of the protocol.
  • Click “Submit Amendment” when the submission is ready for IACUC review. If Surgery or a VA review is required, the submission will be routed accordingly.

I clicked “Submit Amendment”, but the system won’t submit the amendment.

  • Only the PI listed on the protocol can submit the protocol and amendments.
  • Specific sections of the submission may be incomplete. The system will run validation and indicate where information is missing. All required fields must be completed in order to submit the submission.

How do I know when I need to take action on a protocol or amendment in CICERO?

 

  • An email will be sent to the PI and point-of-contact if action is required. Additionally, the IACUC Inbox tab of the IACUC (Animal) – Researcher role Dashboard lists submissions that require the research team’s attention / action.

 

How do I address IACUC Contingencies in the submission?

 

  • Click on the yellow comment box next to the question / section to view the comment. Click Reply to provide a response to the IACUC contingency in the text box and click OK. Close the comment box. Make the required modification in the text box / section associated with the IACUC Contingency.

 

How will the IACUC know that I made a change to the submission in CICERO?

 

  • The IACUC has the ability to track changes made to a submission by comparing current and previous versions of the submission.

 

I have an amendment currently under IACUC review and now I need to submit another amendment. Can I submit more than one amendment at a time?

  • The protocol is a living document. When an amendment is created the research team is modifying the currently approved version of the protocol. For this reason, only one amendment can be processed at a time. Once an amendment has been approved, the approved version of the protocol will reflect all changes requested in the amendment.
  • Please note that if substantial changes are made to a pending amendment during a revision / modification period following IACUC review (outside of the requested modifications to secure approval), the amendment will have to be sent back out for IACUC review. This will delay approval of changes requested and reviewed during the initial IACUC review period.

Can I submit a personnel amendment separate from a protocol amendment?

 

  • This functionality is not available in CICERO. Only one amendment (regardless of what is being changed) can be submitted at a time.

 

Will the amendment approval date change the expiration date of the protocol?

 

  • All animal use protocols reviewed and approved in CICERO will have expiration dates calculated from the IACUC approval date. Animal use protocols will expire three years after IACUC approval.

 

How do I make a copy of my protocol?

 

  • Open the protocol and click “Make Copy of Protocol” on the left panel. Note that this activity only appears in the following protocol states: Draft, Draft: Pre-Review Completed, Withhold Approval, Approved, Closed, and Withdrawn. Creating a copy of the protocol may take some time depending on the size of the protocol.

 

When do I submit a progress report?

  • For protocols reviewed and approved in CICERO, progress reports must be submitted 18-months after IACUC approval. Reminder emails will be sent leading up to the due date to submit the report in CICERO.
  • For protocols reviewed and approved in paper, progress reports must be submitted 18-months after the protocol was reviewed by the IACUC. Reminder emails will be sent leading up to the due date to submit the report via email (iacuc@umaryland.edu).

When will my protocol expire in CICERO?

 

  • All animal use protocols reviewed and approved in CICERO will have expiration dates calculated from the IACUC approval date. Animal use protocols will expire three years after IACUC approval. Please note that protocols reviewed and approved using the paper system have an expiration date based on the IACUC meeting date of the month they were reviewed.