Managing an FIU IACUC Approved Project

The following guidelines are provided to assist investigators with managing FIU IACUC approved protocols. All investigators are required to adhere to the Investigator Responsibilities outlined below.

Investigator Responsibilities

Principal Investigators are required to:

  1. Ensure that no animal be used without IACUC approval.
  2. Submit IACUC annual renewals for active studies involving animal subjects.
  3. Submit IACUC amendments to make changes to an approved protocol.
  4. Promptly report any injuries or other unanticipated problems.
  5. Assure the adequate training & protection of their personnel.
  6. Adhere to high ethical standards.
  7. Comply with the Affirmation of Compliance on the applicable IACUC Application Forms.

Submitting Annual Renewals

Renewal submissions are submitted via the ‘IACUC Lab Renewal Form’ or the ‘IACUC Field Study Renewal Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Renewal Protocol’ to access the IACUC Renewal Form in the TOPAZ system.

Investigators are responsible for ensuring that their protocols are renewed prior to their expiration dates. Investigators are not permitted to conduct research with animals once the IACUC approval has expired.

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Submitting Amendments

Any additions or changes in the protocols must be submitted to the IACUC for review and approval. Amendments are submitted via the ‘IACUC Amendment Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Amendment Protocol’ to access the IACUC Amendment Form in the TOPAZ system.

Alternatively, investigators can request amendments as part of their annual renewal (via the ‘IACUC Renewal Form’) if the proposed changes are not needed until that renewal time frame. The renewal form will ask if there are any changes being requested and the investigator can then incorporate the proposed changes directly into the renewal form.

The IACUC must approve the additions or changes PRIOR to them being implemented in the study.

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Reporting Adverse Events or Problems

Serious adverse events (by definition) MUST be reported within 24 hours upon learning of the occurrence. Non-serious events must be reported within 5 days of learning of the occurrence.

Adverse Events are submitted via the ‘IACUC Event Report Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Interim Review Protocol’ to access the IACUC Event Report Form in the TOPAZ system.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Adverse Event or Problem, it is advised to first contact the IACUC Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IACUC Coordinator via email. The IACUC Office will later import the contents of the form into the TOPAZ system on your behalf.

Information about Event Reporting
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Reporting Protocol Deviations

The PI is responsible for reporting all instances that involve a deviation from the IACUC approved protocol. A protocol deviation occurs when there is a variance in a research study between what is described in the protocol (reviewed and approved by the IACUC) and the actual activities performed by the research team.

Protocol Deviations are submitted via the ‘IACUC Event Report Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Interim Review Protocol’ to access the IACUC Event Report Form in the TOPAZ system.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Adverse Event or Problem, it is advised to first contact the IACUC Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IACUC Coordinator via email. The IACUC Office will later import the contents of the form into the TOPAZ system on your behalf.

Information about Event Reporting
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Submitting Project Completions

The PI is required to submit a completion report when the study is completed and all activity related to this project has ceased.

Studies completed prior to the end of the approval term need to submit their completion reports via the ‘IACUC Project Completion Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Interim Review Protocol’ to access the IACUC Project Completion Form in the TOPAZ system.

Log into the TOPAZ System
Learn about the TOPAZ System